COVID-19 Vaccination and Testing; Emergency Temporary Standard, 61402-61555 [2021-23643]
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Parts 1910, 1915, 1917, 1918,
1926, and 1928
[Docket No. OSHA–2021–0007]
RIN 1218–AD42
COVID–19 Vaccination and Testing;
Emergency Temporary Standard
Occupational Safety and Health
Administration (OSHA), Department of
Labor.
ACTION: Interim final rule; request for
comments.
AGENCY:
The Occupational Safety and
Health Administration (OSHA) is
issuing an emergency temporary
standard (ETS) to protect unvaccinated
employees of large employers (100 or
more employees) from the risk of
contracting COVID–19 by strongly
encouraging vaccination. Covered
employers must develop, implement,
and enforce a mandatory COVID–19
vaccination policy, with an exception
for employers that instead adopt a
policy requiring employees to either get
vaccinated or elect to undergo regular
COVID–19 testing and wear a face
covering at work in lieu of vaccination.
DATES: The rule is effective November 5,
2021. The incorporation by reference of
certain publications listed in the rule is
approved by the Director of the Federal
Register as of November 5, 2021.
Compliance dates: Compliance dates
for specific provisions are in 29 CFR
1910.501(m).
Comments: Written comments,
including comments on any aspect of
this ETS and whether this ETS should
become a final rule, must be submitted
by December 6, 2021 in Docket No.
OSHA–2021–0007. Comments on the
information collection determination
described in Additional Requirements
(Section V.K. of this preamble) (OMB
review under the Paperwork Reduction
Act of 1995) may be submitted by
January 4, 2022 in Docket No. OSHA–
2021–0008.
ADDRESSES: In accordance with 28
U.S.C. 2112(a), the Agency designates
Edmund C. Baird, the Associate
Solicitor for Occupational Safety and
Health, Office of the Solicitor, U.S.
Department of Labor, to receive
petitions for review of the ETS. Service
can be accomplished by email to zzSOLCovid19-ETS@dol.gov.
Written comments. You may submit
comments and attachments, identified
by Docket No. OSHA–2021–0007,
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SUMMARY:
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electronically at www.regulations.gov,
which is the Federal e-Rulemaking
Portal. Follow the online instructions
for making electronic submissions.
Instructions: All submissions must
include the agency’s name and the
docket number for this rulemaking
(Docket No. OSHA–2021–0007). All
comments, including any personal
information you provide, are placed in
the public docket without change and
may be made available online at
www.regulations.gov. Therefore, OSHA
cautions commenters about submitting
information they do not want made
available to the public, or submitting
materials that contain personal
information (either about themselves or
others), such as Social Security
Numbers and birthdates.
Docket: To read or download
comments or other material in the
docket, go to Docket No. OSHA–2021–
0007 at www.regulations.gov. All
comments and submissions are listed in
the www.regulations.gov index;
however, some information (e.g.,
copyrighted material) is not publicly
available to read or download through
that website. All comments and
submissions, including copyrighted
material, are available for inspection
through the OSHA Docket Office.
Documents submitted to the docket by
OSHA or stakeholders are assigned
document identification numbers
(Document ID) for easy identification
and retrieval. The full Document ID is
the docket number plus a unique fourdigit code. OSHA is identifying
supporting information in this ETS by
author name and publication year, when
appropriate. This information can be
used to search for a supporting
document in the docket at https://
www.regulations.gov. Contact the OSHA
Docket Office at 202–693–2350 (TTY
number: 877–889–5627) for assistance
in locating docket submissions.
FOR FURTHER INFORMATION CONTACT:
General information and press
inquiries: Contact Frank Meilinger,
OSHA Office of Communications, U.S.
Department of Labor; telephone (202)
693–1999; email OSHAComms@dol.gov.
For technical inquiries: Contact
Andrew Levinson, OSHA Directorate of
Standards and Guidance, U.S.
Department of Labor; telephone (202)
693–1950; email ETS@dol.gov.
SUPPLEMENTARY INFORMATION: The
preamble to the ETS on COVID–19
vaccination and testing follows this
outline:
Table of Contents
I. Executive Summary and Request for
Comment
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A. Executive Summary
B. Request for Comment
II. Pertinent Legal Authority
III. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
IV. Feasibility
A. Technological Feasibility
B. Economic Analysis
V. Additional Requirements
VI. Summary and Explanation
A. Purpose
B. Scope and Application
C. Definitions
D. Employer Policy on Vaccination
E. Determination of Employee Vaccination
Status
F. Employer Support for Employee
Vaccination
G. COVID–19 Testing for Employees Who
Are Not Fully Vaccinated
H. Employee Notification to Employer of a
Positive COVID–19 Test and Removal
I. Face Coverings
J. Information Provided to Employees
K. Reporting COVID–19 Fatalities and
Hospitalizations to OSHA
L. Availability of Records
M. Dates
N. Severability
O. Incorporation by Reference
VII. Authority and Signature
I. Executive Summary and Request for
Comment
A. Executive Summary
This ETS is based on the requirements
of the Occupational Safety and Health
Act (OSH Act or Act) and legal
precedent arising under the Act. Under
section 6(c)(1) of the OSH Act, 29 U.S.C.
655(c)(1), OSHA shall issue an ETS if
the agency determines that employees
are subject to grave danger from
exposure to substances or agents
determined to be toxic or physically
harmful or from new hazards, and an
ETS is necessary to protect employees
from such danger. These legal
requirements are more fully discussed
in Pertinent Legal Authority (Section II.
of this preamble). This ETS does not
apply to workplaces subject to E.O.
14042 on Requiring Coronavirus Disease
2019 Vaccination for Federal
Contractors. In addition, OSHA will
treat federal agencies’ compliance with
E.O. 14043, and the Safer Federal
Workforce Task Force guidance issued
under section 4(e) of Executive Order
13991 and section 2 of Executive Order
14043, as sufficient to meet their
obligations under the OSH Act and E.O.
12196.
COVID–19 has killed over 725,000
people in the United States in less than
two years, and infected millions more
(CDC, October 18, 2021—Cumulative
US Deaths). The pandemic continues to
affect workers and workplaces. While
COVID–19 vaccines authorized or
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approved by the U.S. Food and Drug
Administration (FDA) effectively protect
vaccinated individuals against severe
illness and death from COVID–19,
unvaccinated individuals remain at
much higher risk of severe health
outcomes from COVID–19. Further,
unvaccinated workers are much more
likely to contract and transmit COVID–
19 in the workplace than vaccinated
workers. OSHA has determined that
many employees in the U.S. who are not
fully vaccinated against COVID–19 face
grave danger from exposure to SARS–
CoV–2 in the workplace. This finding of
grave danger is based on the severe
health consequences associated with
exposure to the virus along with
evidence demonstrating the
transmissibility of the virus in the
workplace and the prevalence of
infections in employee populations, as
discussed in Grave Danger (Section
III.A. of this preamble).
OSHA has also determined that an
ETS is necessary to protect
unvaccinated workers from the risk of
contracting COVID–19 at work, as
discussed in Need for the ETS (Section
III.B. of this preamble). At the present
time, workers are becoming seriously ill
and dying as a result of occupational
exposures to COVID–19, when a simple
measure, vaccination, can largely
prevent those deaths and illnesses. The
ETS protects these workers through the
most effective and efficient control
available—vaccination—and further
protects workers who remain
unvaccinated through required regular
testing, use of face coverings, and
removal of all infected employees from
the workplace. OSHA also concludes,
based on its enforcement experience
during the pandemic to date, that
continued reliance on existing standards
and regulations, the General Duty
Clause of the OSH Act, 29 U.S.C.
654(a)(1), and workplace guidance, in
lieu of an ETS, is not adequate to protect
unvaccinated employees from the grave
danger of being infected by, and
suffering death or serious health
consequences from, COVID–19.
OSHA will continue to monitor trends
in COVID–19 infections and death as
more of the workforce and the general
population become fully vaccinated
against COVID–19 and the pandemic
continues to evolve. Where OSHA finds
a grave danger from the virus no longer
exists for the covered workforce (or
some portion thereof), or new
information indicates a change in
measures necessary to address the grave
danger, OSHA will update this ETS, as
appropriate.
This ETS applies to employers with a
total of 100 or more employees at any
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time the standard is in effect. In light of
the unique occupational safety and
health dangers presented by COVID–19,
and against the backdrop of the
uncertain economic environment of a
pandemic, OSHA is proceeding in a
stepwise fashion in addressing the
emergency this rule covers. OSHA is
confident that employers with 100 or
more employees have the administrative
capacity to implement the standard’s
requirements promptly, but is less
confident that smaller employers can do
so without undue disruption. OSHA
needs additional time to assess the
capacity of smaller employers, and is
seeking comment to help the agency
make that determination. Nonetheless,
the agency is acting to protect workers
now in adopting a standard that will
reach two-thirds of all private-sector
workers in the nation, including those
working in the largest facilities, where
the most deadly outbreaks of COVID–19
can occur.
The agency has also evaluated the
feasibility of this ETS and has
determined that the requirements of the
ETS are both economically and
technologically feasible, as outlined in
Feasibility (Section IV. of this
preamble). The specific requirements of
the ETS are outlined and described in
Summary and Explanation (Section VI.
of this preamble).
B. Request for Comment
Although this ETS takes effect
immediately, it also serves as a proposal
under Section 6(b) of the OSH Act (29
U.S.C. 655(b)) for a final standard.
Accordingly, OSHA seeks comment on
all aspects of this ETS and whether it
should be adopted as a final standard.
OSHA encourages commenters to
explain why they prefer or disfavor
particular policy choices, and include
any relevant studies, experiences,
anecdotes or other information that may
help support the comment. In
particular, OSHA seeks comments on
the following topics:
1. Employers with fewer than 100
employees. As noted above and fully
discussed in the Summary and
Explanation for Scope and Application
(Section VI.B. of this preamble), OSHA
has implemented a 100-employee
threshold for the requirements of this
standard to focus the ETS on companies
that OSHA is confident will have
sufficient administrative systems in
place to comply quickly with the ETS.
The agency is moving in a stepwise
fashion on the short timeline
necessitated by the danger presented by
COVID–19 while soliciting stakeholder
comment and additional information to
determine whether to adjust the scope
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of the ETS to address smaller employers
in the future. OSHA seeks information
about the ability of employers with
fewer than 100 employees to implement
COVID–19 vaccination and/or testing
programs. Have you instituted
vaccination mandates (with or without
alternatives), or requirements for regular
COVID–19 testing or face covering use?
What have been the benefits of your
approach? What challenges have you
had or could you foresee in
implementing such programs? Is there
anything specific to your industry, or
the size of your business, that poses
particular obstacles in implementing the
requirements in this standard? How
much time would it take, what types of
costs would you incur, and how much
would it cost for you to implement such
requirements?
2. Significant Risk. If OSHA were to
finalize a rule based on this ETS, it
would be a standard adopted under 6(b)
of the OSH Act, which requires a
finding of significant risk from exposure
to COVID–19. As discussed more fully
in Pertinent Legal Authority (Section II.
of this preamble), this is a lower
showing of risk than grave danger, the
finding required to issue a 6(c)
emergency temporary standard. How
should the scope of the rule change to
address the significant risk posed by
COVID–19 in the workplace? Should
portions of the rule, such as face
coverings, apply to fully vaccinated
persons?
3. Prior COVID–19 infections. OSHA
determined that workers who have been
infected with COVID–19 but have not
been fully vaccinated still face a grave
danger from workplace exposure to
SARS–CoV–2. This is an area of ongoing
scientific inquiry. Given scientific
uncertainty and limitations in testing for
infection and immunity, OSHA is
concerned that it would be infeasible for
employers to operationalize a standard
that would permit or require an
exception from vaccination or testing
and face covering based on prior
infection with COVID–19. Is there
additional scientific information on this
topic that OSHA should consider as it
determines whether to proceed with a
permanent rule?
In particular, what scientific criteria
can be used to determine whether a
given employee is sufficiently protected
against reinfection? Are there any
temporal limits associated with this
criteria to account for potential
reductions in immunity over time? Do
you require employees to provide
verification of infection with COVID–
19? If so, what kinds of verification do
you accept (i.e., PCR testing, antigen
testing, etc.)? What challenges have you
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experienced, if any, in operationalizing
such an exception?
4. Experience with COVID–19
vaccination policies. Should OSHA
impose a strict vaccination mandate
(i.e., all employers required to
implement mandatory vaccination
policies as defined in this ETS) with no
alternative compliance option? OSHA
seeks information on COVID–19
vaccination policies that employers
have implemented to protect workers. If
you have implemented a COVID–19
vaccination policy:
(a) When did you implement it, and
what does your policy require? Was
vaccination mandatory or voluntary
under the policy? Do you offer
vaccinations on site? What costs
associated with vaccination did you
cover under the policy? What
percentage of your workforce was
vaccinated as a result? Do you offer paid
leave for receiving a vaccination? If
vaccination is mandatory, have
employees been resistant and if so what
steps were required to enforce the
policy?
(b) How did you verify that employees
were vaccinated? Are there other
reliable means of vaccination
verification not addressed by the ETS
that should be included? Did you allow
attestation where the employee could
not find other proof, and if so, have you
experienced any difficulties with this
approach? Have you experienced any
issues with falsified records of
vaccination, and if so, how did you deal
with them?
(c) Have you experienced a decrease
in infection rates or outbreaks after
implementing this policy?
(d) If you have received any requests
for reasonable accommodation from
vaccination, what strategies did you
implement to address the
accommodation and ensure worker
safety (e.g., telework, working in
isolation, regular testing and the use of
face coverings)?
5. COVID–19 testing and removal.
OSHA seeks information on COVID–19
testing and removal practices
implemented to protect workers.
(a) Do you have a testing and removal
policy in your workplace and, if so,
what does it require? How often do you
require testing and what types of testing
do you use (e.g., at-home tests, tests
performed at laboratories, tests
performed at your worksites)? What
costs have you incurred as part of your
testing and removal policies? Do you
have difficulty in finding adequate
availability of tests? How often? Have
you experienced any issues with
falsified test results, and if so, how did
you deal with them? Have you
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experienced other difficulties in
implementing a testing and removal
scheme, including the length of time to
obtain COVID–19 test results? Do you
offer paid leave for testing?
(b) How often have you detected and
removed COVID–19 positive employees
from the workplace under this policy?
Do you provide paid leave and job
protection to employees you remove for
this reason?
(c) Should OSHA require testing more
often than on a weekly basis?
6. Face coverings. As discussed in the
Summary and Explanation for Face
Coverings (Section VI.I. of this
preamble), ASTM released a
specification standard on February 15,
2021, to establish a national standard
baseline for barrier face coverings
(ASTM F3502–21). Should OSHA
require the use of face coverings
meeting the ASTM F3502–21 standard
instead of the face coverings specified
by the ETS? If so, should OSHA also
require that such face coverings meet
the NIOSH Workplace Performance or
Workplace Performance Plus criteria
(see CDC, September 23, 2021)? Are
there particular workplace settings in
which face coverings meeting one
standard should be favored over
another? Are there alternative criteria
OSHA should consider for face
coverings instead of the F3502–21
standard or NIOSH Workplace
Performance or Workplace Performance
Plus criteria? Is there sufficient capacity
to supply face coverings meeting
F3502–01 and/or NIOSH Workplace
Performance or Workplace Performance
Plus criteria to all employees covered by
the ETS? What costs have you incurred
as part of supplying employees with
face coverings meeting the appropriate
criteria?
7. Other controls. This ETS requires
employees to either be fully vaccinated
against COVID–19 or be tested weekly
and wear face coverings, based on the
type of policy their employer adopts. It
stops short of requiring the full suite of
workplace controls against SARS–CoV–
2 transmission recommended by OSHA
and the CDC, including distancing,
barriers, ventilation, and sanitation. As
OSHA explained in Need for the ETS
(Section III.B. of this preamble), OSHA
has determined that it needs more
information before imposing these
requirements on the entire scope of
industries and employers covered by the
standard. OSHA is interested in hearing
from employers about their experience
in implementing a full suite of
workplace controls against COVID–19.
What measures have you taken to
protect employees against COVID–19 in
your workplace? Are there controls that
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you attempted to employ but found
ineffective or infeasible? What are they?
Why did you conclude that they were
they ineffective or infeasible; for
example, are there particular aspects of
your workplace or industry that make
certain controls infeasible? Do you
require both fully vaccinated and
unvaccinated employees to comply with
these controls? Have you experienced a
reduction in infection rates or outbreaks
since implementing these controls?
8. Educational materials. Have you
implemented any policies or provided
any information that has been helpful in
encouraging an employee to be
vaccinated?
9. Feasibility and health impacts. Do
you have any experience or data that
would inform OSHA’s estimates in its
economic feasibility analysis or any of
the assumptions or estimates used in
OSHA’s identification of the number of
hospitalizations prevented and lives
saved from its health impacts analysis
(see OSHA, October 2021c)?
References
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/coviddata-tracker/. (CDC, October 18, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 23). Types of
Masks and Respirators. https://
www.cdc.gov/coronavirus/2019-ncov/
prevent-getting-sick/types-of-masks.html.
(CDC, September 23, 2021)
Occupational Safety and Health
Administration (OSHA). (2021c,
October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
II. Pertinent Legal Authority
The purpose of the Occupational
Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. 651 et seq., is ‘‘to assure
so far as possible every working man
and woman in the Nation safe and
healthful working conditions and to
preserve our human resources.’’ 29
U.S.C. 651(b). To this end, Congress
authorized the Secretary of Labor
(Secretary) to promulgate and enforce
occupational safety and health
standards under sections 6(b) and (c) of
the OSH Act.1 29 U.S.C. 655(b). These
provisions provide bases for issuing
occupational safety and health
standards under the Act. Once OSHA
has established as a threshold matter
that a health standard is necessary
under section 6(b) or (c)—i.e., to reduce
1 The Secretary has delegated most of his duties
under the OSH Act to the Assistant Secretary of
Labor for Occupational Safety and Health.
Secretary’s Order 08–2020, 85 FR 58393 (Sept. 18,
2020). This section uses the terms Secretary and
OSHA interchangeably.
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a significant risk of material health
impairment, or a grave danger to
employee health—the Act gives the
Secretary ‘‘almost unlimited discretion
to devise means to achieve the
congressionally mandated goal’’ of
protecting employee health, subject to
the constraints of feasibility. See United
Steelworkers of Am. v. Marshall, 647
F.2d 1189, 1230 (D.C. Cir. 1981). A
standard’s individual requirements need
only be ‘‘reasonably related’’ to the
purpose of ensuring a safe and healthful
working environment. Id. at 1237, 1241;
see also Forging Indus. Ass’n v. Sec’y of
Labor, 773 F.2d 1436, 1447 (4th Cir.
1985). OSHA’s authority to regulate
employers is hedged by constitutional
considerations and, pursuant to section
4(b)(1) of the OSH Act, the regulations
and enforcement policies of other
federal agencies. See, e.g., Chao v.
Mallard Bay Drilling, Inc., 534 U.S. 235,
241 (2002).
The OSH Act in section 6(c)(1) states
that the Secretary ‘‘shall’’ issue an
emergency temporary standard (ETS)
upon a finding that the ETS is necessary
to address a grave danger to workers.
See 29 U.S.C. 655(c). In particular, the
Secretary shall provide, without regard
to the requirements of chapter 5, title 5,
United States Code, for an emergency
temporary standard to take immediate
effect upon publication in the Federal
Register if the Secretary makes two
determinations: That employees are
exposed to grave danger from exposure
to substances or agents determined to be
toxic or physically harmful or from new
hazards, and that such emergency
standard is necessary to protect
employees from such danger. 29 U.S.C.
655(c)(1). A separate section of the OSH
Act, section 8(c), authorizes the
Secretary to prescribe regulations
requiring employers to make, keep, and
preserve records that are necessary or
appropriate for the enforcement of the
Act. 29 U.S.C. 657(c)(1). Section 8(c)
also provides that the Secretary shall
require employers to keep records of,
and report, work-related deaths and
illnesses. 29 U.S.C. 657(c)(2).
The ETS provision, section 6(c)(1),
exempts the Secretary from procedural
requirements contained in the OSH Act
and the Administrative Procedure Act,
including those for public notice,
comments, and a rulemaking hearing.
See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C.
552, 553.
The Secretary must issue an ETS in
situations where employees are exposed
to a ‘‘grave danger’’ and immediate
action is necessary to protect those
employees from such danger. 29 U.S.C.
655(c)(1); Pub. Citizen Health Research
Grp. v. Auchter, 702 F.2d 1150, 1156
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(D.C. Cir. 1983). The determination of
what exact level of risk constitutes a
‘‘grave danger’’ is a ‘‘policy
consideration that belongs, in the first
instance, to the Agency.’’ Asbestos Info.
Ass’n, 727 F.2d at 425 (accepting
OSHA’s determination that eighty lives
at risk over six months was a grave
danger); Indus. Union Dep’t, AFL–CIO v.
Am. Petroleum Inst., 448 U.S. 607, 655
n.62 (1980). However, a ‘‘grave danger’’
represents a risk greater than the
‘‘significant risk’’ that OSHA must show
in order to promulgate a permanent
standard under section 6(b) of the OSH
Act, 29 U.S.C. 655(b). Int’l Union,
United Auto., Aerospace, & Agr.
Implement Workers of Am., UAW v.
Donovan, 590 F. Supp. 747, 755–56
(D.D.C. 1984), adopted, 756 F.2d 162
(D.C. Cir. 1985); see also Indus. Union
Dep’t, AFL–CIO, 448 U.S. at 640 n.45
(noting the distinction between the
standard for risk findings in permanent
standards and ETSs).
In determining the type of health
effects that may constitute a ‘‘grave
danger’’ under the OSH Act, the Fifth
Circuit emphasized ‘‘the danger of
incurable, permanent, or fatal
consequences to workers, as opposed to
easily curable and fleeting effects on
their health.’’ Fla. Peach Growers Ass’n,
Inc. v. U. S. Dep’t of Labor, 489 F.2d
120, 132 (5th Cir. 1974). Although the
findings of grave danger and necessity
must be based on evidence of ‘‘actual,
prevailing industrial conditions,’’ see
Int’l Union, 590 F. Supp. at 751, when
OSHA determines that exposure to a
particular hazard would pose a grave
danger to workers, OSHA can assume an
exposure to a grave danger wherever
that hazard is present in a workplace.
Dry Color Mfrs. Ass’n, Inc. v. Dep’t of
Labor, 486 F.2d 98, 102 n.3 (3d Cir.
1973).
In demonstrating whether OSHA had
shown that an ETS is necessary, the
Fifth Circuit considered whether OSHA
had another available means of
addressing the risk that would not
require an ETS. Asbestos Info. Ass’n,
727 F.2d at 426 (holding that necessity
had not been proven where OSHA could
have increased enforcement of alreadyexisting standards to address the grave
risk to workers from asbestos exposure).
Additionally, a standard must be both
economically and technologically
feasible in order to be ‘‘reasonably
necessary and appropriate’’ under
section 3(8) and, by inference,
‘‘necessary’’ under section 6(c)(1)(B) of
the Act. Cf. Am. Textile Mfrs. Inst., Inc.
v. Donovan, 452 U.S. 490, 513 n.31
(1981) (noting ‘‘any standard that was
not economically or technologically
feasible would a fortiori not be
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‘reasonably necessary or appropriate’ ’’
as required by the OSH Act’s definition
of ‘‘occupational safety and health
standard’’ in section 3(8)); see also
Florida Peach Growers, 489 F.2d at 130
(recognizing that the promulgation of
any standard, including an ETS, must
account for its economic effect).
However, given that section 6(c) is
aimed at enabling OSHA to protect
workers in emergency situations, the
agency is not required to make a
feasibility showing with the same rigor
as in ordinary section 6(b) rulemaking.
Asbestos Info. Ass’n, 727 F.2d at 424
n.18.
On judicial review of an ETS, OSHA
is entitled to great deference on the
determinations of grave danger and
necessity required under section 6(c)(1).
See, e.g., Pub. Citizen Health Research
Grp., 702 F.2d at 1156; Asbestos Info.
Ass’n, 727 F.2d at 422 (judicial review
of these legislative determinations
requires deference to the agency); cf.
Am. Dental Ass’n v. Martin, 984 F.2d
823, 831 (7th Cir. 1993) (‘‘the duty of a
reviewing court of generalist judges is
merely to patrol the boundary of
reasonableness’’). These determinations
are ‘‘essentially legislative and rooted in
inferences from complex scientific and
factual data.’’ Pub. Citizen Health
Research Grp., 702 F.2d at 1156. The
agency is not required to support its
conclusions ‘‘with anything
approaching scientific certainty,’’ Indus.
Union Dep’t, AFL–CIO, 448 U.S. at 656,
and has the ‘‘prerogative to choose
between conflicting evidence.’’ Asbestos
Info. Ass’n, 727 F.2d at 425.
The determinations of the Secretary in
issuing standards under section 6 of the
OSH Act, including ETSs, must be
affirmed if supported by ‘‘substantial
evidence in the record considered as a
whole.’’ 29 U.S.C. 655(f). The Supreme
Court described substantial evidence as
‘‘such relevant evidence as a reasonable
mind might accept as adequate to
support a conclusion.’’ Am. Textile
Mfrs. Inst., 452 U.S. at 522–23 (quoting
Universal Camera Corp. v. NLRB, 340
U.S. 474, 477 (1951)). The Court also
noted that ‘‘the possibility of drawing
two inconsistent conclusions from the
evidence does not prevent an
administrative agency’s finding from
being supported by substantial
evidence.’’ Id. at 523 (quoting Consolo
v. FMC, 383 U.S. 607, 620 (1966)). The
Fifth Circuit, recognizing the size and
complexity of the rulemaking record
before it in the case of OSHA’s ETS for
organophosphorus pesticides, stated
that a court’s function in reviewing an
ETS to determine whether it meets the
substantial evidence standard is
‘‘basically [to] determine whether the
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Secretary carried out his essentially
legislative task in a manner reasonable
under the state of the record before
him.’’ Fla Peach Growers Ass’n, 489
F.2d at 129.
Although Congress waived the
ordinary rulemaking procedures in the
interest of ‘‘permitting rapid action to
meet emergencies,’’ section 6(e) of the
OSH Act, 29 U.S.C. 655(e), requires
OSHA to include a statement of reasons
for its action when it issues any
standard. Dry Color Mfrs., 486 F.2d at
105–06 (finding OSHA’s statement of
reasons inadequate). By requiring the
agency to articulate its reasons for
issuing an ETS, the requirement acts as
‘‘an essential safeguard to emergency
temporary standard-setting.’’ Id. at 106.
However, the Third Circuit noted that it
did not require justification of ‘‘every
substance, type of use or production
technique,’’ but rather a ‘‘general
explanation’’ of why the standard is
necessary. Id. at 107.
ETSs are, by design, temporary in
nature. Under section 6(c)(3), an ETS
serves as a proposal for a permanent
standard in accordance with section 6(b)
of the OSH Act (permanent standards),
and the Act calls for the permanent
standard to be finalized within six
months after publication of the ETS. 29
U.S.C. 655(c)(3); see Fla. Peach Growers
Ass’n, 489 F.2d at 124. The ETS is
effective ‘‘until superseded by a
standard promulgated in accordance
with’’ section 6(c)(3). 29 U.S.C.
655(c)(2).
Section 6(c)(1) states that the
Secretary ‘‘shall’’ provide for an ETS
when OSHA makes the prerequisite
findings of grave danger and necessity.
See Pub. Citizen Health Research Grp.,
702 F.2d at 1156 (noting the mandatory
language of section 6(c)). OSHA is
entitled to great deference in its
determinations, and it must also
account for ‘‘the fact that ‘the interests
at stake are not merely economic
interests in a license or a rate structure,
but personal interests in life and
health.’ ’’ Id. (quoting Wellford v.
Ruckelshaus, 439 F.2d 598, 601 (D.C.
Cir. 1971)).
When OSHA issues a standard
pursuant to section 6—whether
permanent or an ETS—section 18 of the
OSH Act provides that OSHA’s standard
preempts any state occupational safety
or health standard ‘‘relating to [the
same] occupational safety or health
issue’’ as the Federal standard. 29 U.S.C.
667(b); see also Gade v. Nat’l Solid
Wastes Mgmt. Ass’n, 505 U.S. 88, 97
(1992). A state can avoid preemption
only if it submits, and receives Federal
approval for, a state plan for the
development and enforcement of
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standards pursuant to section 18 of the
Act, which must be ‘‘at least as
effective’’ as the Federal standards. 29
U.S.C. 667; Indus. Truck Ass’n v. Henry,
125 F.3d 1305, 1311 (9th Cir. 1997).
However, the OSH Act does not
preempt state laws of ‘‘general
applicability’’ that regulate workers and
non-workers alike, so long as they do
not conflict with an OSHA standard.
Gade, 505 U.S. at 107.
As discussed in detail elsewhere in
this preamble, OSHA has determined
that a grave danger exists necessitating
a new ETS (see Grave Danger and Need
for the ETS, Sections III.A. and III.B. of
this preamble), and that compliance
with this ETS is feasible for covered
employers (see Feasibility, Section IV. of
this preamble). OSHA has also provided
a more detailed explanation of each
provision of this ETS in Summary and
Explanation (Section VI. of this
preamble). In addition, OSHA wishes to
provide here some general guidance on
its legal authority to regulate COVID–19
hazards, and for particular provisions of
this ETS.
As a threshold matter, OSHA’s
authority to regulate workplace
exposure to biological hazards like
SARS–CoV–2 is well-established.
Section 6(b)(5) of the OSH Act uses
similar language to section 6(c)(1)(A):
The former sets forth requirements for
promulgating permanent standards
addressing ‘‘toxic materials or harmful
physical agents,’’ and the latter
authorizes OSHA to promulgate an ETS
addressing ‘‘substances or agents
determined to be toxic or physically
harmful’’ (as well as ‘‘new hazards’’).
OSHA has consistently identified
biological hazards similar to SARS–
CoV–2, as well as SARS–CoV–2 itself, to
be ‘‘toxic materials or harmful physical
agents’’ under the Act. Indeed, in its
exposure and medical records access
regulation, OSHA has defined ‘‘toxic
materials or harmful physical agents’’ to
include ‘‘any . . . biological agent
(bacteria, virus, fungus, etc.)’’ for which
there is evidence that it poses a chronic
or acute health hazard. 29 CFR
1910.1020(c)(13). And in addition to
previously regulating exposure to
SARS–CoV–2 as a new and physically
harmful agent in the Healthcare ETS
(see, e.g., 86 FR at 32381), OSHA has
also previously regulated biological
hazards like SARS–CoV–2 as health
hazards under section 6(b)(5), for
example in the Bloodborne Pathogens
(BBP) standard, 29 CFR 1910.1030,
which addresses workplace exposure to
HIV and Hepatitis B. The BBP standard
was upheld (except as to application in
certain limited industries) in American
Dental Association, which observed that
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‘‘the infectious character’’ of the
regulated bloodborne diseases might
warrant ‘‘more regulation than would be
necessary in the case of a
noncommunicable disease.’’ 984 F.2d at
826. In addition, in the preamble to the
respiratory protection standard, 29 CFR
1910.134, which was also promulgated
under section 6(b)(5), ‘‘OSHA
emphasize[d] that [the] respiratory
protection standard does apply to
biological hazards.’’ Respiratory
Protection, 63 FR 1152–01, 1180 (Jan. 8,
1998) (citing Mahone Grain Corp., 10
BNA OSHC 1275 (No. 77–3041, 1981)).
In addition to being a physically
harmful agent covered by section
6(c)(1)(A), SARS–CoV–2 is also, without
question, a ‘‘new hazard’’ covered by
this provision, as discussed in more
detail in Grave Danger (Section III.A. of
this preamble). SARS–CoV–2 was not
known to exist until January 2020, and
since then more than 725,000 people
have died from COVID–19 in the U.S.
alone (CDC, October 18, 2021—
Cumulative US Deaths).
Turning to specific provisions of this
standard, the vaccination requirements
in this ETS are also well within the
bounds of OSHA’s authority.
Vaccination can be a critical tool in the
pursuit of health and safety goals,
particularly in response to an infectious
and highly communicable disease. See,
e.g., Jacobson v. Commonwealth of
Mass., 197 U.S. 11, 27–28 (1905)
(recognizing use of smallpox vaccine as
a reasonable measure to protect public
health and safety); Klaassen v. Trustees
of Ind. Univ., 7 F.4th 592, 593 (7th Cir.
2021) (citing Jacobson and noting that
vaccination may be an appropriate
safety measure against SARS–CoV–2 as
‘‘[v]accination protects not only the
vaccinated persons but also those who
come in contact with them’’). And the
OSH Act itself explicitly acknowledges
that such treatments might be necessary,
in some circumstances. 29 U.S.C.
669(a)(5) (providing in the Act’s
provisions on research and related
activities conducted by the Secretary of
Health and Human Services to aid
OSHA in its formulation of health and
safety standards that ‘‘[n]othing in this
or any other provision of this Act shall
be deemed to authorize or require
medical examination, immunization, or
treatment for those who object thereto
on religious grounds, except where such
is necessary for the protection of the
health or safety of others.’’ (emphasis
added)). In recognition of the health and
safety benefits provided by vaccination,
OSHA has previously exercised its
authority to promulgate vaccine-related
requirements in the COVID–19
Healthcare ETS (29 CFR 1910.502(m))
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and the BBP standard (29 CFR
1910.1030(f)). The BBP standard
illustrates congressional understanding
that the statutory delegation of authority
to OSHA to issue standards includes
authority for vaccine provisions, where
appropriate. See Public Law 102–170,
Title I, Section 100, 105 Stat. 1107
(1991) (directing OSHA to complete the
BBP rulemaking by a date certain, and
providing that if OSHA did not do so,
the proposed rule, which included a
vaccine provision, would become the
final standard).
Additionally, OSHA’s authority to
require employers to bear the costs of
particular provisions of a standard is
solidly grounded in the OSH Act. The
Act reflects Congress’s determination
that the costs of compliance with the
Act and OSHA standards are part of the
cost of doing business and OSHA may
foreclose employers from shifting those
costs to employees. See Am. Textile
Mfrs. Inst., 452 U.S. at 514; Phelps
Dodge Corp. v. OSHRC, 725 F.2d 1237,
1239–40 (9th Cir. 1984); see also Sec’y
of Labor v. Beverly Healthcare-Hillview,
541 F.3d 193 (3d Cir. 2008). Consistent
with this authority, OSHA has largely
required employers to bear the costs of
the provisions of this ETS, including the
typical costs associated with
vaccination. The allocation of
vaccination costs to employers in this
ETS is similar to OSHA’s treatment of
vaccine-related costs in the COVID–19
Healthcare ETS and the BBP standards.
See 29 CFR 1910.502(m), (p); 29 CFR
1910.1030(f)(1)(ii)(A).
The OSH Act provides OSHA with
discretion, however, to decide whether
to impose certain costs—such as those
related to medical examinations or other
tests—on employers ‘‘[w]here [it
determines that such costs are]
appropriate.’’ 29 U.S.C. 655(b)(7). OSHA
has determined that for purposes of this
ETS, it would not be ‘‘appropriate’’ to
impose on employers any costs
associated with COVID–19 testing for
employees who choose not to be
vaccinated. For most of the agency’s
existing standards containing medical
testing and removal provisions, OSHA
has found it necessary to impose the
costs of such provisions on employers
in order to remove barriers to employee
participation in medical examinations
that are critical to effectuating the
standards’ safety and health protections.
See United Steelworkers of Am., 647
F.2d at 1229–31, 1237–38. However, as
explained in greater detail elsewhere in
this preamble (see Need for the ETS,
Section III.B. of this preamble), the
ETS’s safety and health protections are
best effectuated by employee
vaccination, not testing. Accordingly,
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OSHA only requires employers to bear
the costs of employee compliance with
the preferred, and more protective,
vaccination provision, but not costs
associated with testing. The agency does
not believe it appropriate to impose the
costs of testing on an employer where
an employee has made an individual
choice to pursue a less protective
option. For the same reasons, OSHA has
also determined that it is not
appropriate to require employers to pay
for face coverings for employees who
choose not to be vaccinated.2
Finally, the Act and its legislative
history ‘‘both demonstrate
unmistakably’’ OSHA’s authority to
require employers to temporarily
remove workers from the workplace to
prevent exposure to a health hazard.
United Steelworkers of Am., 647 F.2d at
1230. And again, this is an authority
OSHA has repeatedly exercised in prior
standards, including in: COVID–19
Healthcare ETS (29 CFR 1910.502); Lead
(29 CFR 1910.1025); Cadmium (29 CFR
1910.1027); Benzene (29 CFR
1910.1028); Formaldehyde (29 CFR
1910.1048); Methylenedianiline (29 CFR
1910.1050); Methylene Chloride (29
CFR 1910.1052); and Beryllium (29 CFR
1910.1024). It is equally appropriate to
impose that obligation here.
For all of these reasons, as well as
those explained more fully in other
areas of this preamble, OSHA has the
authority—and obligation—to
promulgate this ETS.
References
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/coviddata-tracker/. (CDC, October 18, 2021)
III. Rationale for the ETS
A. Grave Danger
I. Introduction
Section 6(c)(1) of the OSH Act
requires the Secretary to issue an ETS in
situations where employees are exposed
to a ‘‘grave danger’’ and immediate
action is necessary to protect those
employees from such danger (29 U.S.C.
655(c)(1)). Consistent with its legal
duties, OSHA is issuing this ETS to
address the grave danger posed by
occupational exposure to SARS–CoV–2,
2 OSHA notes that while the ETS does not impose
these testing or face covering costs on employers,
in some circumstances employers may be required
to pay for the costs related to testing and/or face
coverings by other laws, regulations, or collectively
negotiated agreements. OSHA has no authority
under the OSH Act to determine whether such
obligations under other laws, regulations, or
agreements might exist.
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the virus that causes COVID–19.3 OSHA
has determined that occupational
exposure to SARS–CoV–2, including the
Delta variant (B.1.617.2 and AY
lineages), presents a grave danger to
unvaccinated workers in the U.S., with
several exceptions explained below.4
This finding of grave danger is based on
the science of how the virus spreads, the
transmissibility of the disease in
workplaces, and the serious adverse
health effects, including death, that can
be suffered by those who are diagnosed
with COVID–19. The protections of this
ETS—which will apply, with some
limitations, to a broad range of
workplace settings where exposure to
SARS–CoV–2 may occur—are designed
to protect employees from infection
with SARS–CoV–2 and from the dire,
sometimes fatal, consequences of such
infection.
The fact that COVID–19 is not a
uniquely work-related hazard does not
change the determination that it is a
grave danger to which employees are
exposed, nor does it excuse employers
from their duty to protect employees
from the occupational transmission of
SARS–CoV–2. The OSH Act is intended
to ‘‘assure so far as possible every
working man and woman in the Nation
safe and healthful working conditions’’
(29 U.S.C. 651(b)), and there is nothing
in the Act to suggest that its protections
do not extend to hazards which might
occur outside of the workplace as well
as within. Indeed, COVID–19 is not the
first hazard that OSHA has regulated
that occurs both inside and outside the
workplace. For example, the hazard of
noise is not unique to the workplace,
but the Fourth Circuit has upheld
OSHA’s Occupational Noise Exposure
standard (29 CFR 1910.95) (Forging
Industry Ass’n v. Sec’ of Labor, 773 F.2d
1437, 1444 (4th Cir. 1985)). Diseases
caused by bloodborne pathogens,
including HIV/AIDS and hepatitis B, are
also not unique to the workplace, but
the Seventh Circuit upheld the majority
of OSHA’s Bloodborne Pathogens
standard (29 CFR 1910.1030) (Am.
Dental Ass’n v. Martin, 984 F.2d 823
(7th Cir. 1993)). OSHA’s Sanitation
3 OSHA is defining the grave danger as workplace
exposure to SARS–CoV–2, the virus that causes the
development of COVID–19. COVID–19 is the
disease that can occur in people exposed to SARSCoV–2, and that leads to the health effects
described in this section. This distinction applies
despite OSHA’s use of the terms SARS–CoV–2 and
COVID–19 interchangeably in some parts of this
preamble.
4 OSHA refers to the grave danger from
occupational exposure to SARS–CoV–2 throughout
this document. Those references are intended to
encompass exposure to SARS–CoV–2 and all
variants of SARS–CoV–2, including the Delta
variant.
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standard, 29 CFR 1910.141, which
requires measures such as cleaning,
waste disposal, potable water, toilets,
and washing facilities, addresses
hazards that exist everywhere—both
within and outside of workplaces.
Moreover, employees have more
freedom to control their environment
outside of work, and to make decisions
about their behavior and their contact
with others to better minimize their risk
of exposure. However, during the
workday, while under the control of
their employer, workers may have little
ability to limit contact with coworkers,
clients, members of the public, patients,
and others, any one of whom could
represent a source of exposure to SARS–
CoV–2. OSHA has a mandate to protect
employees from hazards they are
exposed to at work, even if they may be
exposed to similar hazards outside of
work.
As described above in Pertinent Legal
Authority (Section II. of this preamble),
‘‘grave danger’’ indicates a risk that is
more than ‘‘significant’’ (Int’l Union,
United Auto., Aerospace, & Agr.
Implement Workers of Am., UAW v.
Donovan, 590 F. Supp. 747, 755–56
(D.D.C. 1984); Indus. Union Dep’t, AFL–
CIO v. Am. Petroleum Inst., 448 U.S.
607, 640 n.45, 655 (1980) (stating that a
rate of 1 worker in 1,000 workers
suffering a given health effect
constitutes a ‘‘significant’’ risk)). ‘‘Grave
danger,’’ according to one court, refers
to ‘‘the danger of incurable, permanent,
or fatal consequences to workers, as
opposed to easily curable and fleeting
effects on their health’’ (Fla. Peach
Growers Ass’n, Inc. v. U.S. Dep’t of
Labor, 489 F.2d 120, 132 (5th Cir.
1974)). Fleeting effects were described
as nausea, excessive salivation,
perspiration, or blurred vision and were
considered so minor that they often
went unreported; these effects are in
stark contrast with the adverse health
effects of COVID–19 infections, which
are formally referenced as ranging from
‘‘mild’’ to ‘‘critical,’’ 5 but which can
involve significant illness, hospital
stays, ICU care, death, and long-term
health complications for survivors.
Beyond this, however, ‘‘the
determination of what constitutes a risk
worthy of Agency action is a policy
consideration that belongs, in the first
instance, to the Agency’’ (Asbestos Info.
Ass’n/N. Am. v. OSHA, 727 F.2d 415,
425 (5th Cir. 1984)).
In the context of ordinary 6(b)
rulemaking, the Supreme Court has said
5 See the definitions for the different levels of
severity of COVID–19 illness in the National
Institutes of Health’s COVID–19 treatment
guidelines (NIH, October 12, 2021).
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that the OSH Act is not a ‘‘mathematical
straitjacket,’’ nor does it require the
agency to support its findings ‘‘with
anything approaching scientific
certainty,’’ particularly when operating
on the ‘‘frontiers of scientific
knowledge’’ (Indus. Union Dep’t, AFL–
CIO v. Am. Petroleum Inst., 448 U.S.
607, 655–56 (1980)). Courts reviewing
OSHA’s determination of grave danger
do so with ‘‘great deference’’ (Pub.
Citizen Health Research Grp. v.
Auchter, 702 F.2d 1150, 1156 (D.C. Cir.
1983)). In one case, the Fifth Circuit, in
reviewing an OSHA ETS for asbestos,
declined to question the agency’s
finding that 80 worker lives at risk
nationwide over six months constituted
a grave danger (Asbestos Info. Ass’n/N.
Am., 727 F.2d at 424). OSHA estimates
that this ETS would save over 6,500
worker lives and prevent over 250,000
hospitalizations over the course of the
next six months (OSHA, October 2021c).
Here, the mortality and morbidity risk to
employees from COVID–19 is so dire
that the grave danger from exposures to
SARS–CoV–2 is clear.
SARS–CoV–2 is both a physically
harmful agent and a new hazard (see 29
U.S.C. 655(c)(1)(A)). The majority of
OSHA’s previous ETSs addressed toxic
substances that had been familiar to the
agency for many years prior to issuance
of the ETS. OSHA’s Healthcare ETS,
issued in response to COVID–19 earlier
this year, is one notable exception. In
most cases, OSHA’s ETSs were issued in
response to new information about
substances that had been used in
workplaces for decades (e.g., Vinyl
Chloride (39 FR 12342 (April 5, 1974));
Benzene (42 FR 22516 (May 3, 1977));
1,2-Dibromo-3-chloropropane (42 FR
45536 (Sept. 9, 1977))). In some cases,
the hazards of the toxic substance were
already so well established that OSHA
promulgated an ETS simply to update
an existing standard (e.g., Vinyl cyanide
(43 FR 2586 (Jan. 17, 1978))). The
COVID–19 Healthcare ETS, which was
issued in June 2021, was the sole
instance in which OSHA issued an ETS
to address a grave danger from a
substance that had only recently come
into existence. Although that action by
the agency was challenged, the case has
not gone to briefing (see United Food &
Commercial Workers Int’l Union, AFL–
CIO, CLC and AFL–CIO v. OSHA, Dep’t
of Labor, D.C. Circuit No. 21–1143).
Thus, no court has had occasion to
examine OSHA’s authority under
section (6)(c) of the OSH Act (29 U.S.C.
655(c)) to address a grave danger from
a ‘‘new hazard.’’ Yet by any measure,
SARS–CoV–2 is a new hazard. Unlike
any of the hazards addressed in
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previous ETSs, there were no
documented cases of SARS–CoV–2
infections in the United States until
January 2020. Since then, more than
725,000 people have died in the U.S.
alone (CDC, October 18, 2021—
Cumulative US Deaths). The pandemic
continues to affect workers and
workplaces, with workplace exposures
leading to further exposures among
workers’ families and communities.
Clearly, SARS–CoV–2 is both a
physically harmful agent and a new
hazard that presents a grave danger to
workers in the U.S.
Published on June 21, 2021, OSHA’s
Healthcare ETS (86 FR 32376) was
written in response to the grave danger
posed to healthcare workers in the
United States who faced a heightened
risk of infection from COVID–19. In the
healthcare ETS, OSHA described its
finding of grave danger for healthcare
and healthcare support service workers
(see 86 FR 32381–32412). OSHA now
finds that all unvaccinated workers,
with some exceptions, face a grave
danger from the SARS–CoV–2 virus.6
II. Nature of the Disease
The health effects of symptomatic
COVID–19 illness can range from mild
disease consisting of fever or chills,
cough, and shortness of breath to severe
disease. Severe cases can involve
respiratory failure, blood clots, longterm cardiovascular and neurological
effects, and organ damage, which can
lead to hospitalization, ICU admission,
and death (see 86 FR 32383–32388;
NINDS, September 2, 2021). Even in the
short time since the Healthcare ETS’s
publication in June 2021, the risk posed
by COVID–19 has changed
meaningfully. Since OSHA considered
the impact of COVID–19 when
promulgating the Healthcare ETS, over
135,000 additional Americans have died
from COVID–19, and over 933,000 have
been hospitalized, (CDC, October 18,
2021—Cumulative US Deaths; CDC,
May 28, 2021; CDC, October 18, 2021—
Weekly Review). In August 2021,
COVID–19 was the third leading cause
of death in the United States, trailing
only heart disease and cancer (Ortaliza
et al., August 27, 2021). By September
20, 2021, COVID–19 had killed as many
Americans as the 1918–1919 flu
pandemic (Johnson, September 20,
2021).
While the Healthcare ETS addresses
the risk of illness and death from
6 When OSHA refers to ‘‘unvaccinated’’
individuals in its grave danger finding, it means all
individuals who are not fully vaccinated against
COVID–19, i.e., those who are completely
unvaccinated and those who are partially
vaccinated.
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COVID–19 as the SARS–CoV–2 virus
continues to change over time, it does
not specifically address the increases in
infectiousness and transmission, and
the potentially more severe health
effects, related to the Delta variant. The
rapid rise to predominance of the Delta
variant in the U.S. occurred shortly after
the ETS was published. At this time, the
widespread prevalence of the Delta
variant and its increased
transmissibility have resulted in
increased risk of exposure and disease
relative to the previously-dominant
strains of the SARS–CoV–2 virus.
Adding to the information covered in
the Healthcare ETS, the following
sections provide a brief review of
SARS–CoV–2 and describe the
characteristics of the Delta variant that
are different from previous versions of
SARS–CoV–2 and have changed the
risks posed by COVID–19. The agency
specifically references the material
presented in the Healthcare ETS, which
is still relevant to this analysis, to
support OSHA’s finding of grave danger.
Taken together, the information
available to OSHA demonstrates that
SARS–CoV–2 poses a grave danger to
unvaccinated workers across all
industry sectors.
a. Variants of SARS–CoV–2
Viral mutations have been a serious
concern of scientists, public health
experts, and policymakers from the
beginning of the COVID–19 pandemic.
Viral mutations can affect how a virus
interacts with a cell—altering the virus’s
transmissibility, infection severity, and
sensitivity to vaccines. The U.S.
government’s SARS–CoV–2 Interagency
Group has a variant classification
scheme that defines four classes of
SARS–CoV–2 variants: Variants Being
Monitored (VBM), Variants of Interest
(VOI), Variants of Concern (VOC), and
Variants of High Consequence (VOHC).
These variant designations are based on
their ‘‘proportions at the national and
regional levels and the potential or
known impact of the constellation of
mutations on the effectiveness of
medical countermeasures, severity of
disease, and ability to spread from
person to person’’ (CDC, October 4,
2021), with VOIs considered less serious
than VOCs and VOCs considered less
serious than VOHCs. As of early October
2021, the CDC was monitoring 10
VBMs—Alpha (B.1.1.7, Q.1–Q.8), Beta
(B.1.351, B.1.351.2, B.1.351.3), Gamma
(P.1, P.1.1, P.1.2), Epsilon (B.1.427 and
B.1.429), Eta (B.1.525), Iota (B.1.526),
Kappa (B.1.617.1), B.1.617.3, Mu
(B.1.621, B.1.621.1), and Zeta (P.2)—and
one VOC—Delta (B.1.617.2 and AY.1
sublineages)—in the U.S. (CDC, October
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4, 2021). CDC defines a VOC as ‘‘[a]
variant for which there is evidence of an
increase in transmissibility, more severe
disease (e.g., increased hospitalizations
or deaths), significant reduction in
neutralization by antibodies generated
during previous infection or
vaccination, reduced effectiveness of
treatments or vaccines, or diagnostic
detection failures’’ (CDC, October 4,
2021).
While the proportions of SARS–CoV–
2 variants in the United States have
shifted over time (CDC, May 24, 2021c;
CDC, October 18, 2021—Variant
Proportions, July through October 2021),
the primary variant that drove COVID–
19 transmission in the late Winter and
Spring of 2021 was the Alpha variant.
The CDC noted that Alpha is associated
with an increase in transmission, as
well as potentially increased incidences
of hospitalization and death, compared
to the predominant variants before its
emergence (CDC, October 4, 2021;
Pascall et al., August 24, 2021; Julin et
al., September 22, 2021). As Alpha
transmission subsided in the United
States during the late Spring and early
Summer of 2021, Delta emerged and
quickly became the predominant variant
in the U.S. by July 3, 2021 (CDC,
October 18, 2021—Variant Proportions,
July through October 2021). Delta now
accounts for more than 99% of
circulating virus nationwide (CDC,
October 18, 2021—Variant Proportions,
July through October 2021).
FDA authorized and approved
COVID–19 vaccines currently work well
against all of these variants; however,
there are differences in various variants’
ability to spread and the likelihood of
infection to cause severe illness. Data on
the Beta and Gamma variants do not
indicate that infections from these
variants caused more severe illness or
death than other VOCs. Data on the
Alpha variant does indicate its ability to
cause more severe illness and death in
infected individuals. And some data on
the Delta variant suggests that the Delta
variant may cause more severe illness
than previous variants, including Alpha,
in unvaccinated individuals (CDC,
October 4, 2021).
The emergence of the Delta variant,
along with other VOCs, has resulted in
a more deadly pandemic (Fisman and
Tuite, July 12, 2021). While the Delta
variant is the most transmissible SARS–
CoV–2 variant to date, the possibility
remains for the rise of future VOCs, and
even more dangerous VOHCs, as the
virus continues to spread and mutate.
Inadequate vaccination rates and the
abundance of transmission create an
environment that can foster the
development of new variants that could
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be similarly, or even more, disruptive
(Liu and Rocklov, August, 4, 2021). In
this context, it is critical that OSHA
address the grave danger from COVID–
19 that unvaccinated workers are
currently facing by requiring
vaccination and the other measures
included in this rule, in order to
significantly slow the transmission of
COVID–19 in workers and workplaces
and mitigate the rise of future variants.
b. Transmission
SARS–CoV–2 is a highly
transmissible virus, regardless of
variant. Since the first case was detected
in the U.S., there have been close to 45
million reported cases of COVID–19,
affecting every state and territory, with
thousands more infected each day (CDC,
October 18, 2021—Cumulative US
Cases), and some indication that these
numbers continue to underestimate the
full burden of disease (CDC, July 27,
2021). According to the CDC, the
primary way the SARS–CoV–2 virus
spreads from an infected person to
others is through the respiratory
droplets that are produced when an
infected person coughs, sneezes, sings,
talks, or breathes (CDC, May 7, 2021).
Infection could then occur when
another person breathes in the virus.
Most commonly this occurs when
people are in close contact with one
another in indoor spaces (within
approximately six feet for at least fifteen
minutes) (CDC, August 13, 2021).
Additionally, airborne transmission may
occur in indoor spaces without adequate
ventilation where small respiratory
particles are able to remain suspended
in the air and accumulate (CDC, May 7,
2021; Fennelly, July 24, 2020). While
scientists’ understanding of the Delta
variant’s virology is evolving and
remains at the frontier of science,
current data shows that the routes of
transmission remain the same for all
currently-identified SARS–CoV–2
variants. In addition, all variants can be
transmitted by people who are presymptomatic (i.e., people who are
infected but do not yet feel sick) or
asymptomatic (i.e., people who are
infected but never feel any symptoms of
COVID–19), as well as those who are
symptomatic. Pre-symptomatic and
asymptomatic transmission continue to
pose serious challenges to containing
the spread of COVID–19. For more
extensive information on transmission
routes, as well as pre-symptomatic and
asymptomatic transmission, see the
preamble to the Healthcare ETS (86 FR
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32392–32396), which is hereby
included in the record of this ETS.7
The Delta variant is transmitted from
infectious individuals via the same
routes as previous variants, but is much
more transmissible. Specifically, Delta
differs from previous dominant variants
of SARS–CoV–2 in terms of the
amplification of viral particles expelled
from infected individuals. Testing of
Delta-infected individuals indicates that
their viral loads are—on average—
approximately 1,000x greater than those
of the SARS–CoV–2 variants from the
first COVID–19 wave in early 2020. This
finding suggests much faster replication
of viral particles during early infection
with the Delta variant, resulting in
greater infectiousness (contagiousness)
when compared to earlier versions of
SARS–CoV–2 (Li et al., July 12, 2021).
The transmissibility of viruses is
measured in part by the average number
of subsequently-infected people (or
secondary cases) that are expected to
occur from each existing case (often
referred to as R0). Several comparisons
of the transmissibility of the initial
SARS–CoV–2 variants to the Delta
variant have shown that Delta is
approximately twice as transmissible
(contagious) as previous versions of
SARS–CoV–2 (CDC, August 26, 2021;
Riou and Althaus, January 30, 2020; Li
et al., July 12, 2021; Liu and Rocklov,
August, 4, 2021), likely the result of
higher initial viral loads during the presymptomatic phase (Li et al., July 12,
2021). In addition, as described further
below, data on Delta shows that both
unvaccinated and vaccinated
individuals are more likely to transmit
Delta than previous variants (Liu and
Rocklov, August, 4, 2021; Eyre et al.,
September 29, 2021), making it
especially dangerous to those who
remain unvaccinated.
c. Health Effects
COVID–19 infections can lead to
death. As reported in the Healthcare
ETS, by May 24, 2021, there had been
587,432 deaths and 32,947,548 million
infections in the U.S. alone (CDC, May
24, 2021a; CDC, May 24, 2021b). At that
point in the pandemic, 1.8 out of every
1,000 people in the U.S. had died from
COVID–19 (CDC, May 24, 2021a). Since
then, reported cases have increased to
44,857,861 and the number of deaths
has increased to 723,205 (CDC, October
18, 2021– Cumulative US Cases;
Cumulative US Deaths). By September
2021, an astounding 1 in 500 Americans
had died from COVID–19 (Keating,
7 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
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September 15, 2021). Updated mortality
data 8 currently indicate that people of
working age (18–64 years old) now have
a 1 in 202 chance of dying when they
contract the disease, with the risk much
higher (1 in 72) for those aged 50–64
(CDC, October 18, 2021—Demographic
Trends, Cases by Age Group; CDC,
October 18, 2021—Demographic Trends,
Deaths by Age Group). For a more indepth description of the health effects
resulting from SARS–CoV–2 infection,
see the preamble to the Healthcare ETS
(86 FR 32383–32392), which is hereby
included in the record of this ETS.9
Apart from fatal cases, COVID–19 can
cause serious illness, including longlasting effects on health. Many patients
who become ill with COVID–19 require
hospitalization. Indeed, updated CDC
hospitalization and mortality data
indicate that working age Americans
(18–64 years old) now have a 1 in 14
chance of hospitalization when infected
with COVID–19 (CDC, October 18,
2021—Demographic Trends, Cases by
Age; Total Hospitalizations, by Age).
Those who are hospitalized frequently
need supplemental oxygen and
treatment for the disease’s most
common complications, which include
pneumonia, respiratory failure, acute
respiratory distress syndrome (ARDS),
acute kidney injury, sepsis, myocardial
injury, arrhythmias, and blood clots.
One study, which included 35,502
inpatients nationwide, determined that
the median length of hospital stay was
6 days, unless the cases required ICU
treatment. For those cases, ICU stays
were on median 5 days in addition to
the time spent hospitalized outside of
the ICU (Rosenthal et al., December 10,
2020). Another study that assessed
hospital length of stay for COVID–19
patients in England estimated that a
non-ICU hospital stay averaged between
8 and 9 days, but those estimates ranged
from approximately 12 to 18 days when
patients were admitted to the ICU
(Vekaria et al., July 22, 2021). Moreover,
given that SARS–CoV–2 is still a novel
virus, the severity of long-term health
effects—such as ‘‘post-COVID
conditions’’—are not yet fully
understood.
Many members of the workforce are at
increased risk of death and severe
disease from COVID–19 because of their
age or pre-existing health conditions.
8 Risk of death is based on averages from reported
CDC data. Risks of hospitalization and death are
much higher in unvaccinated individuals, as
discussed further in Grave Danger, Section III.A.IV.
Vaccines Effectively Reduce Severe Health
Outcomes from and Transmission of SARS–CoV–2.
9 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
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The comorbidities that further
exacerbate COVID–19 infections are
common among adults of working age in
the U.S. For instance, 46.1% of
individuals with cancer are in the 20–
64 year old age range (NCI, April 29,
2015), and over 40% of working age
adults are obese (Hales et al., February
2020). Disease severity is also likely
exacerbated by long-standing healthcare
inequities experienced by members of
many racial and economic
demographics (CDC, April 19, 2021).
Recent data suggests that Delta variant
infections may result in even more
severe illness and a higher frequency of
death than previous COVID–19 variants
due to Delta’s increased transmissibility,
virulence, and immune escape (Fisman
and Tuite, July 12, 2021). Symptomatic
Delta variant infections do occur in fully
vaccinated people (Mlcochova et al.,
June 22, 2021; Musser et al., July 22,
2021); however, as reported by the CDC
(CDC, August 26, 2021), the vast
majority of the continuing instances of
severe and fatal COVID–19 infections
are occurring in unvaccinated persons
(discussed further in Grave Danger,
Section III.A.IV. Vaccines Effectively
Reduce Severe Outcomes from and
Transmission of SARS–CoV–2). An
assessment of Delta-related hospital
admissions in Scotland found that
hospitalizations were approximately
doubled in patients with the Delta
variant when compared to the Alpha
variant (Sheikh et al., June 4, 2021). A
similar study conducted using a
retrospective cohort in Ontario, Canada
compared the virulence of novel SARS–
CoV–2 variants and found that the
incidences of hospitalization, ICU
admission, and death were more
pronounced with the Delta variant than
any other SARS–CoV–2 variant (Fisman
and Tuite, July 12, 2021). A large
national cohort study that included all
Alpha and Delta SARS–CoV–2 patients
in England between March 29 and May
23, 2021 found a ‘‘higher hospital
admission or emergency care attendance
risk for patients with COVID–19
infected with the Delta variant
compared with the Alpha variant,’’
suggesting that Delta outbreaks—
especially amongst unvaccinated
populations—may lead to more severe
health consequences and an equivalent
or greater burden on healthcare services
than the Alpha variant (Twohig et al.,
August 27, 2021). However, one more
recent study examining data from
several U.S. states demonstrated a
significant increase in hospitalization
from the pre-Delta to the Delta period,
which may be related to increased
transmissibility of Delta rather than
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more severe health outcomes (Taylor et
al., October 22, 2021).
III. Impact on the Workplace
SARS–CoV–2 is readily transmissible
in workplaces because they are areas
where multiple people come into
contact with one another, often for
extended periods of time. When
employees report to their workplace,
they may regularly come into contact
with co-workers, the public, delivery
people, patients, and any other people
who enter the workplace. Workplace
factors that exacerbate the risk of
transmission of SARS–CoV–2 include
working in indoor settings, working in
poorly-ventilated areas, and spending
hours in close proximity with others.
Full-time employees typically spend 8
hours or more at work each shift, more
time than they spend anywhere else but
where they live. Employees work in
proximity to others in workplaces that
were not originally designed to keep
people six feet away from other people
and that may make it difficult for
employees to perform work tasks while
maintaining a six-foot distance from
others. Even in the cases where workers
can do most of their work from, for
example, a private office within a
workplace, they share common areas
like hallways, restrooms, lunch rooms
and meeting rooms. Furthermore, many
work areas are poorly ventilated (Allen
and Ibrahim, May 25, 2021; Lewis,
March 30, 2021). An additional factor
that exacerbates the risk of transmission
of SARS–CoV–2 is interacting with or
caring for people with suspected or
confirmed COVID–19; this was a
primary driver of OSHA’s determination
of grave danger for healthcare workers
in the Healthcare ETS (see 86 FR 32381–
32383). In recent weeks, the majority of
states in the U.S. have experienced what
CDC defines as ‘‘high or substantial
community transmission,’’ indicating
that there is a clear risk of the virus
being introduced into and circulating in
workplaces (CDC, October 18, 2021—
Community Transmission Rates).
Although COVID–19 is not
exclusively an occupational disease, it
is evident from research accrued since
the beginning of the pandemic that
SARS–CoV–2 transmission can and
does occur in workplaces, affecting
employees and their lives, health, and
livelihoods. This continues to be true
for the Delta variant, with its increased
transmissibility and potentially more
severe health effects. This section
describes some of the clusters,
outbreaks, and other occurrences of
workplace COVID–19 cases that
government agencies, researchers, and
journalists have described, and the
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widespread effects of SARS–CoV–2 in
industry sectors across the national
economy. While the focus is on more
recent data reflecting the impact of the
Delta variant, evidence of workplace
transmission that occurred prior to the
emergence of the Delta variant is also
presented.
The workplace-based clusters
described below provide evidence that
workplaces in a wide range of industries
have been affected by COVID–19, that
many employees face exposure to
infected people in their workspaces, and
that SARS–CoV–2 transmission is
occurring in the workplace, including
during the recent period where the Delta
variant has predominated. Although the
presence of a cluster on its own does not
necessarily establish that the cluster is
work-related (i.e., a result of
transmission at the worksite), many
state investigation reports and
published studies provide evidence that
transmission is work related by
documenting that infections at a
workplace occurred within 14-days (the
incubation period for the virus) of each
other and ruling out the possibility that
transmission occurred outside the
workplace. In addition, the information
below demonstrates that exposures to
SARS–CoV–2 happen regularly in a
wide variety of different types of
workplaces.
The basis for OSHA’s grave danger
finding is that employees can be
exposed to the virus in almost any work
setting; that exposure to SARS–CoV–2
can lead to infection (CDC, September
21, 2021); and that infection in turn can
cause death or serious impairment of
health, especially in those who are
unvaccinated (see Section III.A.IV.
Vaccines Effectively Reduce Severe
Health Outcomes from and
Transmission of SARS–CoV–2). The
information described in this section
supports OSHA’s finding that
employees who work in spaces shared
by others are at risk of exposure to
SARS–CoV–2. The degree of risk from
droplet-based transmission may vary
based on the duration of close proximity
to a person infected with SARS–CoV–2,
including the Delta variant, but the
simple and brief act of sneezing,
coughing, talking, or even breathing can
significantly increase the risk of
transmission if controls are not in place.
SARS–CoV–2, including the Delta
variant, might also be spread through
airborne particles under certain
conditions, particularly in enclosed
settings with inadequate ventilation,
which are common characteristics of
some workplaces.
The peer-reviewed scientific journal
articles, government reports, and news
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articles described below establish the
widespread prevalence of COVID–19
among employees, beginning with a
description of the recent impact from
the Delta variant. OSHA’s findings are
based primarily on the evidence from
peer-reviewed scientific journal articles
and government reports. However, peer
review for scientific journal articles and
the assembly of information for
government reports and other official
sources of information take time, and
therefore those sources do not always
reflect the most up-to-date information
(Chan et al., December 14, 2010). In
addition, while state and local health
departments can report workplace
outbreaks to CDC, the agency does not
provide summary statistics by
workplace so that those outbreaks can
be tracked on a national level. In the
context of the COVID–19 pandemic,
given the recent impacts due to the
Delta variant and the emergence of new
information on a daily basis, it is critical
for OSHA to rely on the most up-to-date
information available. Therefore, OSHA
has occasionally supplemented peerreviewed data and government reports
with additional information on
occupational outbreaks contained in
other sources of media (e.g.,
newspapers, digital media, and
information submitted to or obtained by
private organizations).10 The reported
information from other sources can
provide further evidence of the impact
of an emerging and changing disease,
especially for industries that are not
well represented in the peer-reviewed
scientific literature. Together, these
sources of information represent the
best available evidence of the impact on
employees of the pandemic thus far.
The information described herein
illustrates a significant number of
infections among employees in a variety
of industries, with virtually every state
continuing to experience what CDC
defines as high or substantial
community transmission related to the
recent surge of the Delta variant. The
industries and types of workplaces
described are not the only ones in
which a grave danger exists. The science
of transmission does not vary by
industry or by type of workplace. OSHA
therefore expects transmission to occur
in diverse workplaces all across the
country (see Dry Color Mfrs. Ass’n, Inc.
v. Dep’t of Labor, 486 F.2d 98, 102 n.3
(3d Cir. 1973) (holding that when OSHA
determines a substance poses a grave
10 OSHA did not make findings based solely on
non-peer-reviewed sources such as news articles,
but the agency found that those sources can
sometimes provide useful information when
considered with more robust sources.
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danger to workers, OSHA can assume an
exposure to a grave danger exists
wherever that substance is present in a
workplace)). In addition, the severity of
COVID–19 does not depend on where
an employee is infected; an employee
exposed to SARS–CoV–2 might die
whether exposed while working at a
meat packing facility, a retail
establishment, or an office (see Grave
Danger, Section III.A.V.b. Employees
Who Work Exclusively Outside, below,
for a discussion of the risk of exposure
in outdoor workplaces).
a. General Impact on Workers
Data on SARS–CoV–2 infections,
illnesses, and deaths among employees
in general industry, agriculture,
construction, and maritime support
OSHA’s finding that COVID–19 poses a
grave danger to employees in these
sectors across the U.S. economy. This
section summarizes studies and reports
of COVID–19 illness and fatalities in a
wide range of workplaces across those
industry sectors. Not all workplace
settings are discussed; nor is the data
available to do so. However, the
characteristics of the various affected
workplaces—such as indoor work
settings; contact with coworkers, clients,
or members of the public; and sharing
space with others for prolonged periods
of time—indicate that exposures to
SARS–CoV–2 are occurring in a wide
variety of work settings across all
industries. Therefore, most employees
who work in the presence of other
people (e.g., co-workers, customers,
visitors) need to be protected.
While there is no comprehensive
source of nationwide workplace
infection data, reports from states and
communities on outbreaks related to
workplaces provide key, up-to-date data
that illustrate the likelihood of
employee exposure to SARS–CoV–2 at
workplaces throughout the U.S. OSHA
identified a number of recent reports
from various regions of the country that
together demonstrate the impact that
SARS–CoV–2 can have on a variety of
workplaces, including in service
industries (e.g., restaurants, grocery and
other retail stores, fitness centers,
hospitality, casinos, salons), corrections,
warehousing, childcare, schools, offices,
homeless shelters, transportation, mail/
shipping/delivery services, cleaning
services, emergency services/response,
waste management, construction,
agriculture, food packaging/processing,
and healthcare. Deaths are reported in
many studies performed prior to the
emergence of the Delta variant but,
because the Delta outbreak is so recent
and deaths can occur weeks after
infection, the number of deaths from
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recent infections might be
underestimated. Some of the reports
include cumulative data representing
various phases of the pandemic,
beginning prior to the availability of
vaccines and continuing through the
recent surge of the Delta variant. In
addition, some studies report
investigations of recent outbreaks,
which provide insight on the impact of
the Delta variant as well as impacts
associated with the current vaccination
status of workers.
The Washington State Department of
Health (WSDH) reports outbreaks
occurring in non-healthcare workplaces
(WSDH, September 8, 2021). In nonhealthcare workplaces, outbreaks are
defined as two or more laboratory
confirmed cases of COVID–19, with at
least two cases reporting symptom onset
within 14 days of each other, and
plausible epidemiological evidence of
transmission in a shared location other
than a household. As of September 4,
2021, WSDH reported 5,247 outbreaks
in approximately 40 different types of
non-healthcare work settings. During
the week of August 29 through
September 4, 2021, WSDH identified
137 separate workplace outbreaks. The
types of non-medical workplace settings
that represented more than 5% of the
total outbreaks during that week
included food service/restaurants,
childcare, schools, retail, grocery, and
shelter/homeless services. Other types
of non-healthcare settings where
outbreaks occurred recently included
non-food and food manufacturing,
construction, professional services/
office based, agriculture/produce
packing, transportation/shipping
delivery, government agencies/facilities,
leisure hospitality/recreation,
corrections, utilities, warehousing,
facility/domestic cleaning services,
youth sports/activities, camps, and
public safety. Over the course of the
pandemic, outbreaks have also been
observed at bars/nightclubs, hotels, and
fishing/commercial seafood vessels.
The Oregon Health Authority (OHA)
publishes a weekly report detailing
outbreaks directly related to work
settings. OHA epidemiologists consider
cases to be part of a workplace outbreak
when clusters form with respect to
space and time, within a plausible
incubation period for the virus, and
their investigation does not uncover an
alternative source for the outbreak. For
privacy reasons, OHA only reports
outbreaks with 5 or more cases in
workplaces with 30 or more people.
OHA reported a total of 26,013 cases
and 135 deaths related to workplace
outbreaks as of September 1, 2021. As
of September 1, 2021, OHA was
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investigating more than 124 active
workplace outbreaks (OHA, September
1, 2021). Those outbreaks occurred in a
wide variety of industries including
correctional facilities, emergency
services, waste management, schools
and child care, retail and grocery stores,
restaurants, warehousing, agriculture,
food processing/packaging,
construction, healthcare, mail and
delivery services, office locations,
utilities, transportation, and others.
Tennessee Department of Health was
investigating 557 active COVID–19
clusters as of September 8, 2021 (TDH,
September 8, 2021). Clusters are defined
as two or more laboratory confirmed
COVID–19 cases linked to the same
location or event that is not a household
exposure. The clusters occurred in 13
types of settings, 10 of which were
workplace settings. Outbreaks at
workplaces represented more than half
of the total active outbreaks in the state
at that time. Settings comprising more
than 5% of total clusters included
assisted care living facilities, nursing
homes, and correctional facilities. Other
types of workplaces where outbreaks
occurred included bars, construction,
farms, homeless shelters, and industrial
settings.
The North Carolina Department of
Health and Human Services reports
cumulative numbers of clusters, cases,
and deaths for workers in poultry
processing facilities (beginning in April
of 2020) and other types of workplaces
(beginning in May of 2020) (NCDHHS,
August 30, 2021). Clusters are defined
as a minimum of 5 cases with illness
onset or initial positive results within a
14-day period and plausible
epidemiological linkage between the
cases. Plausible epidemiological linkage
means that multiple cases were in the
same general setting during the same
time period (e.g., same shift, same
physical area) and that a more likely
source of exposure is not identified (e.g.,
household contact or close contact to a
confirmed case in another setting).
During that time period of April/May
2020 through August 30, 2021,
workplaces 11 were associated with
nearly 80% of the 1,969 clusters and
27,097 cases observed and nearly 40%
of the 167 deaths related to the clusters.
Cumulative numbers of clusterassociated deaths were highest in meat
and poultry processing (25 of 5,351
cases), followed by healthcare (10 of
1,036 cases), government services and
manufacturing (5 of 1,048 cases and 5 of
11 NCDHHS identifies a ‘‘workplace’’ category in
their report (e.g., agriculture, construction), but
OSHA includes other settings where employees
would be present (e.g., retail, restaurants, childcare,
healthcare).
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1,856 cases, respectively), and
restaurants and childcare (3 of 421 cases
and 3 of 1,943 cases, respectively).
Recently, in July of 2021, the number of
cases associated with workplace clusters
began increasing in several different
types of work settings, including meat
processing, manufacturing, retail,
restaurants, childcare, schools, and
higher education.
Colorado Department of Public Health
& Environment/Colorado State
Emergency Operations Center (CDPHE/
CSEOC, September 8, 2021) reported
5,584 resolved workplace-related
outbreaks involving 40,156 employee
cases and 79 employee deaths since
May of 2020. The agency’s current
investigations, as of September 8, 2021
included 291 active outbreaks (not
defined), with 2,865 staff cases
(assumed to be cases in employees). The
majority of active outbreaks were
reported in childcare, schools,
healthcare, and corrections. Active
outbreaks were also reported in
construction, retail, homeless shelters,
casinos, restaurants, hotels, offices, law
enforcement, manufacturing, delivery
services, and warehouses. Other types of
work settings that were affected in
resolved outbreaks included
warehouses, bars, government locations,
waste management, utilities, salons,
emergency services, meat processing/
packaging, and postal services. From
June 21, 2021 (the date the healthcare
ETS was published) through September
8, 2021, 1,469 staff cases associated with
outbreaks were reported, for an average
of approximately 19 cases per day.
Similar reporting is available from
Louisiana’s Department of Health (LDH,
August 24, 2021), with 1,347 outbreaks
and 9,130 cases reported as of August
24, 2021. LDH defines an outbreak as 2
or more cases among unrelated
individuals who visited a site within a
14-day period. More than three quarters
of outbreaks through that date were
associated with workplaces. Workplace
settings in Louisiana that experienced
more than 5% of outbreaks included
day care facilities, bars, restaurants,
retail settings, industrial settings, and
office spaces. Other types of workplace
settings or industries where outbreaks
occurred included casinos, gyms/fitness
centers, banks, automotive services,
construction, and ships/boats.
In addition to the state data above,
some published studies and government
reports provide information on recent
workplaces outbreaks. For example, 47
people, including 3 of 11 staff members,
23 gymnasts, and 21 household
contacts, contracted COVID–19 from an
outbreak linked to an Oklahoma
gymnastics facility during April 15
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through May 3, 2021 (Dougherty et al.,
July 16, 2021). All 21 of the virus
samples sequenced were determined to
be the Delta variant. The majority of the
infected individuals (85%) were
unvaccinated. Infections were reported
in 16 adults aged 20 years or older; two
adults were hospitalized and one
required intensive care.
The state of Hawaii defines clusters as
three or more confirmed or probable
cases linked to a site or event within 14
days, with no outside exposure of cases
to each other (Hawaii State, August 19,
2021). The state reported a COVID–19
cluster in July associated with a concert
at a bar that affected 16 people,
including employees, band members,
and concert attendees; infections also
spread to 7 household members. Band
members had performed while sick.
Four of the initial 16 people and none
of the household members who tested
positive for COVID–19 were fully
vaccinated. The concert cluster was
linked to clusters at another workplace
and another concert. The report lists
additional clusters investigated in the
two weeks prior to the report; those
clusters were observed in workplace
locations such as correctional facilities,
bars and nightclubs, restaurants,
construction/industrial sites, travel/
lodging/tourism, schools, food
suppliers, and gyms.
Additional evidence that employees
are at risk of exposure to SARS–CoV–2
in the workplace is available from
published, peer-reviewed studies that
were conducted before the Delta variant
emerged. Those studies demonstrate
that employees have been at risk of
infection, illness, and death throughout
the COVID–19 pandemic. Because the
Delta variant is more transmissible and
likely causes more severe disease than
previous variants, there is even greater
potential for unvaccinated employees to
become seriously ill or die as a result of
exposure to the Delta variant.
Contreras et al. (July, 2021) examined
workplace outbreaks (excluding
healthcare settings, homelessness
services, and emergency medical
services) in Los Angeles county from
March 19 through September 30, 2020.
Workplace outbreaks were defined as 5
or more suspected or laboratory
confirmed COVID–19 cases (prior to
May 29) or 3 or more laboratory
confirmed cases (after May 29)
occurring within 14 days. Nearly 60% of
the 698 identified outbreaks occurred in
three sectors—manufacturing (184,
26.4%), retail trade (137, 19.6%), and
transportation and warehousing (73,
10.5%). Also notable were the 71
outbreaks in the accommodation and
food services industry, which
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represented 10.2% of the outbreaks. The
study authors concluded that outbreaks
were larger and lasted longer at facilities
with more onsite staff.
Outbreaks in Wisconsin from March 4
through November 16, 2020 were also
examined (Pray et al., January 29, 2021).
Non-household outbreaks were defined
as two or more confirmed COVID–19
cases that occurred within 14 days in
persons who attended the same facility
or event and did not share a household.
During the period from March 4 through
November 16, 2020, the largest
percentages of cases were associated
with outbreaks in long-term care
facilities (26.8% of cases), correctional
facilities (14.9% of cases), and colleges
or universities (15% of cases). Also
notable were the substantial number of
cases associated with outbreaks in food
production or manufacturing facilities
(including meat processing and
warehousing; 14.5% of cases) and
schools and childcare facilities (10.6%
of cases).
Bui et al. (August 17, 2020) analyzed
data from the Utah Department of
Health’s COVID–19 case surveillance
system, which included data on
workplace outbreaks. Outbreaks were
defined as two or more laboratory
confirmed cases occurring within a 14
day period among coworkers in a
common workplace (e.g., same facility).
During the time period between March
6 and June 5, 2020, 277 COVID–19
outbreaks were reported, of which 210
(76%) occurred in workplaces. The 210
workplace outbreaks occurred in 15 of
20 industry sectors, and the industry
sectors of manufacturing (43 outbreaks,
20%), construction (32 outbreaks, 15%),
and wholesale trade (29 outbreaks, 14%)
together represented nearly half of
workplace outbreaks. Other sectors that
represented more than 10% of total
outbreaks were retail trade (28
outbreaks, 13%) and accommodation
and food services (25 outbreaks, 12%).
Incidence rates of COVID–19 over the
period of March 6 through June 5, 2020
were 339/100,000 workers in
manufacturing, 122/100,000 workers in
construction, 377/100,000 workers in
wholesale trade, 68/100,000 workers for
retail trade, and 78/100,000 workers for
accommodation and food services. For
COVID–19 cases associated with
workplace outbreaks in which
hospitalization and severity status were
known (1,382 and 1,155, respectively),
the number in all sectors who were
admitted to the hospital was 85 (6%)
and the number with severe outcomes
(intensive care unit admission,
mechanical ventilation, or death) was 40
(3%).
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The impact of SARS–CoV–2
exposures on employee infection,
illness, and death has also been
demonstrated in studies focusing on
specific types of industries, such as
those where employees have frequent
contact with each other and the public
(e.g., grocery stores, bars, fitness
facilities, schools, and law enforcement/
corrections). For example, a study by
Lan et al. (September 26, 2020)
demonstrates the risk of infection in
service industries. The cross-sectional
study examined the risks of SARS–CoV–
2 exposure and infection for employees
in a Boston, Massachusetts-area retail
grocery store market. The study tested
104 grocery store employees, of whom
20% (21 employees) were positive for
COVID–19; 76% of confirmed cases did
not have symptoms. After adjusting for
gender, smoking, age, and the
prevalence of COVID–19 in the
employees’ residential communities,
employees who had direct customer
exposure (e.g., cashiers, sales associates,
cart attendants) were 5.1 times more
likely to have a positive test for COVID–
19 than employees without direct faceto-face customer exposure (e.g.,
stockers, backroom, receiving and
maintenance). The infection rate of 20%
among all employees was significantly
higher than the rate in the surrounding
community.
In February of 2021, an event at an
Illinois bar that accommodates
approximately 100 people resulted in a
COVID–19 outbreak that affected 46
people, including 3 (10%) staff
members, 26 (90%) patrons, and 17
secondary cases (Sami et al., April 9,
2021). People at the event included an
asymptomatic person diagnosed with
COVID–19 on the previous day and 4
symptomatic people who were later
diagnosed with COVID–19. The
outbreak resulted in a school closure
and the hospitalization of a resident at
a long-term care facility.
In Minnesota, 47 COVID–19 outbreaks
were detected at fitness facilities from
August through November of 2020
(Suhs et al., July 23, 2021). One
outbreak at a fitness facility during
October through November of 2020
resulted in 23 COVID–19 cases
including 5 (22%) employees and 18
(78%) members. A genetic analysis of
specimens from 3 employees and 10
members identified 2 distinct genetic
subclusters, indicating two distinct
chains of transmission among members
and employees.
School-related outbreaks were
examined from December 1, 2020
through January 22, 2021 in eight public
elementary schools of a Georgia school
district (Gold et al., February 26, 2021).
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A COVID–19 case was determined to be
school-related if (1) symptom onset or a
positive test was consistent with the
incubation period of the virus following
contact with an index case or a schoolassociated case, (2) close contact
occurred with the index case or schoolassociated case while that person was
infected, and (3) no known contact
occurred with an infected community or
household contact in the two weeks
prior to a positive test for COVID–19.
The investigators identified nine
clusters of three or more
epidemiologically linked COVID–19
cases that involved 13 educators and 32
students in six of the eight elementary
schools. Approximately half of the
school-associated cases involved two
clusters that began with probable
transmission between educators,
followed by educator to student
transmission. Eighteen of 69 household
members tested received positive
results.
A number of studies demonstrate the
impact of COVID–19 in law enforcement
and related fields such as corrections.
For example, a study examining
COVID–19 antibodies in employees
from public service agencies in the New
York City area from May through July of
2020, found that 22.5% of participants
had COVID–19 antibodies (Sami et al.,
March, 2021). The percentage of
correctional officers found to have
COVID–19 antibodies (39.2%) was the
highest observed among all the
occupations. The percentages of police
dispatchers, traffic officers, security
guards, and dispatchers found to have
COVID–19 antibodies (29.8 to 37.3%)
were among the highest levels observed
in all the occupations. The study
authors noted that those jobs involve
frequent or close contact with the public
or are done in places where employees
work in close proximity to their
coworkers.
Wallace et al. (May 15, 2020)
evaluated data on COVID–19 cases and
deaths among correctional facility
employees and inmates from January 21
to April 21, 2020. Data were reported to
CDC by 37 (69%) of 54 state and
territorial health department
jurisdictions. Of these 37 jurisdictions,
32 (86%) reported at least one COVID–
19 case from a correctional facility. Of
the 420 facilities with a case, 221 (53%)
reported cases only among staff
members. In total, 4,893 COVID–19
cases among incarcerated or detained
persons and 2,778 cases among staff
members were reported (total tested not
provided). Among staff member cases,
79 hospitalizations (3%) and 15 deaths
(1%) were reported. The study authors
noted that ‘‘correctional and detention
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facilities face challenges in controlling
the spread of infectious diseases
because of crowded, shared
environments and potential
introductions by staff members and new
intakes.’’
Ward et al. (June 2021) analyzed
COVID–19 prevalence among prisoners
and staff in 45 states from March 31,
2020 through November 4, 2020. During
that time period, COVID–19 cases in
staff were 3 to 5 times higher compared
to the U.S. population. Average daily
increases in cases were 42 per 100,000
prison employees, 61 per 100,000
prisoners, and 13 per 100,000 U.S.
residents. On November 4, 2020,
COVID–19 prevalence for prison staff
was 9,316 cases per 100,000 employees,
which was 3.2 times greater than
prevalence in the U.S. population (2,900
cases per 100,000).
Kirbiyik et al. (November 6, 2020)
analyzed movement through a networkinformed approach to identify likely
high points of transmission within the
Cook County Jail in Chicago, IL. At that
facility, over 900 COVID–19 cases were
reported across 10 housing divisions in
13 buildings from March 1–April 30,
2020. Staff members were required to
report symptoms of COVID–19
(probable cases) or receipt of a positive
test result (confirmed cases). A total of
2,041 staff members (77% of staff) were
included in the network analysis
because information was available about
their shift and division assignments,
and 198 (9.7%) of those staff members
had COVID–19 during the two-month
study period. Connections between staff
members who had COVID–19 were
higher than expected, suggesting likely
transmission among staff members.
Fewer connections than expected were
observed among detained persons with
SARS–CoV–2 infections, suggesting the
effectiveness of medical isolation at
reducing transmission.
The Officer Down Memorial Page,
which tracks police officer fatalities
determined to be occupationally related,
reported that the majority of officer
deaths for 2021 (157 of 269) were
related to COVID–19 (ODMP, September
14, 2021). For the 269 officers who died,
causes of death were not reported for
each month, but the highest numbers of
monthly deaths, 52 in January and 65 in
August (compared to 16 to 34 deaths on
other reported months), were consistent
with the winter surge of COVID–19 and,
more recently, the surge caused by the
Delta variant.
The risk of COVID–19 has also been
examined in industries where
employees have little contact with the
public, such as construction, and food
processing, and where most exposure to
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SARS–CoV–2 likely comes from other
workers. Pasco et al. (October 29, 2020)
examined the association between
construction work during the COVID–19
pandemic and community transmission
and construction worker hospitalization
rates in Austin, Texas from March 13 to
August 20, 2020. A ‘‘Stay Home-Work
Safe’’ order enacted on March 24, 2020,
limited construction to only critical
infrastructure and excluded commercial
and residential work. One week later,
the Texas governor lifted the restriction
for essential workers and allowed all
types of construction work to resume,
while keeping the order in place for
other workers. The authors found that
resuming construction during the
shelter-in-place order led to an increase
in community transmission, an increase
in hospitalizations among community
members, and an increase in
hospitalizations of construction
workers. By mid-July, Austin Public
Health identified at least 42 clusters (not
defined) of COVID–19 cases in the
construction industry; 515 individuals
were hospitalized for COVID–19
illnesses acquired as part of these
clusters, and 77 of those reported
working in construction. The study
found that construction workers had a
nearly 5-fold increased risk of
hospitalization in central Texas
compared with workers in other
occupations. The authors’ model
predicted that allowing unrestricted
construction work would be associated
with an increase in COVID–19
hospitalization rates from 0.38 per 1,000
residents to 1.5 per 1,000 residents
overall, and from 0.22 per 1,000
construction workers to 9.3 per 1,000
construction workers for the
construction industry specifically. The
authors concluded that stringent
workplace safety measures could
significantly mitigate risks related to
COVID–19 in the industry.
The meat packing and processing
industries and related agricultural and
food processing sectors have also been
impacted by COVID–19. Waltenburg et
al. (January, 2021) reported COVID–19
cases in employees from meat and
poultry processing facilities in 31 states
from March 1 through May 31, 2020. As
reported in Table 2 of that report, 28,364
employees in those facilities were
confirmed to have COVID–19 by
laboratory testing and 132 died. Among
the 20 states that reported total numbers
of employees, 11.4% of the workers
were diagnosed with COVID–19 (with a
range of 3.1 to 27.7% of workers in
individual states). For states that
reported at least one COVID–19-related
death, the percentages of employees
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who died in each state ranged from 0.1
to 2.4% of those with COVID–19. The
authors found a high burden of disease
in persons employed at these facilities
who were racial or ethnic minorities.
Higher incidence in these populations
might be due to the likelihood of these
employees working in areas in the plant
where transmission risk is higher.
Steinberg et al. (August 7, 2020)
reported that attack rates (i.e., the
number of individuals who are infected
in comparison to the total number at
risk) among production employees in
the Cut (30.2%), Conversion (30.1%),
and Harvest (29.4%) departments of a
meat processing plant (where spacing
between employees is less than 6 feet)
were double that of salaried employees
(14.8%) whose workstations had been
modified to increase physical distancing
from others.
Waltenburg et al. (January, 2021) also
evaluated COVID–19 incidence in food
manufacturing and agricultural settings
(e.g., manufacturing or farming
involving fruits, vegetables, dairy, baked
goods, eggs, prepared foods), as reported
in 30 states from March through May
2020. In food manufacturing and
farming of fruits, vegetables, dairy, and
other items, 742 workplaces were
affected, including 8,978 infections and
55 fatalities. For states that reported
total numbers of employees, the
proportion of employees who developed
COVID–19 in each state ranged from 2.0
to 43.5%. For states that reported at
least one death, the percentages of
deaths among cases ranged from 0.1 to
3.8%.
Porter et al. (April 30, 2021) reported
that 13 COVID–19 outbreaks occurred at
Alaska seafood processing facilities and
vessels (both of which were described as
high density workplaces) during the
Summer and early Fall of 2020. The 13
outbreaks involved 539 COVID–19
cases, with 2–168 cases per outbreak.
Attack rates in facilities and offshore
vessels ranged from less than 5% to
75%. Outbreaks were also reported in
entry quarantine groups. Because of
these outbreaks, it was determined that
vaccination of these essential workers is
important and requirements for COVID–
19 prevention were updated to include
smaller quarantine groups, serial testing,
and testing before transfers from one
facility or vessel to another.
Finally, two published studies
analyzed death records to determine
how mortality rates among individuals
in various types of workplaces had
changed during the pandemic. Chen et
al. (June 4, 2021) analyzed records of
deaths occurring on or after January 1,
2016 in California and found that
mortality rates in working aged adults
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(18–65 years) increased 22% during the
COVID–19 pandemic period of March
through November 2020 compared to
pre-pandemic periods. Relative to prepandemic periods, the groups of
employees experiencing the highest,
statistically significant increases in
relative excess mortality were those in
food/agriculture (39% increase),
transportation/logistics (31% increase),
facilities (23% increase), and
manufacturing (24% increase). Other
groups that also experienced excess,
statistically significant mortality
compared to pre-pandemic periods were
health or emergency workers (17%
increase), retail workers (21% increase),
and government and community
workers (17% increase). The study
authors concluded that certain
occupational sectors were impacted
disproportionally by mortality during
the pandemic and that essential work
conducted in-person is a likely avenue
of infection transmission.
Hawkins et al. (January 10, 2021)
examined death certificates of
individuals who died in Massachusetts
between March 1 and July 31, 2020. An
age-adjusted mortality rate of 16.4 per
100,000 employees was determined
from 555 death certificates that had
useable occupation information.
Employees in 11 occupational groups
had particularly high mortality rates:
healthcare support; transportation and
material moving; food preparation and
serving; building and grounds cleaning
and maintenance; production,
construction and extraction;
installation/maintenance/repair;
protective services; personal care
services; arts/design/entertainment;
sports/media; and community and
social services. The study authors noted
that occupational groups expected to
have frequent contact with sick people,
close contact with the public, and jobs
that are not practical to do from home
had particularly elevated mortality
rates.
b. Healthcare Workers
As explained in the Healthcare ETS,
COVID–19 presents a grave danger to
workers in all U.S. healthcare settings
where people with COVID–19 are
reasonably expected to be present (86
FR 32381). Healthcare settings covered
by the Healthcare ETS primarily include
settings where people with suspected or
confirmed COVID–19 are treated,
exacerbating the risk present in most
workplaces. To control the higher level
of risk in those settings, OSHA
determined that a suite of workplace
controls was necessary to protect all
employees, whether they are vaccinated
or unvaccinated. As explained further
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below, OSHA now finds that
unvaccinated healthcare workers in
healthcare settings not covered by the
Healthcare ETS are also at grave danger
from exposure to SARS–CoV–2, just like
unvaccinated workers in other
industries. Data continue to be collected
and reported for healthcare workers,
and a small number of peer-reviewed
studies demonstrate the potential
impact of the Delta variant on
healthcare workers.
CDC continues to provide updates for
COVID–19 cases and deaths among
healthcare personnel. However,
information on healthcare personnel
status continues to be reported for only
a fraction (18.91%) of total reported
cases, and death status was reported for
only 82.16% of healthcare personnel
cases as of October 18, 2021 (CDC,
October 18, 2021—Healthcare
Personnel). Given incomplete reporting,
the data from this source represent only
a fraction of actual healthcare cases and
deaths. Nevertheless, CDC reported
666,707 healthcare personnel cases
among the 6,754,306 reported cases that
included information on healthcare
personnel status (9.9%) and 2,229
fatalities among the 547,769 cases that
included death status (0.4%) for
healthcare employees as of October 18,
2021. This is a 26% increase in the
number of cases and a 27% increase in
the number of deaths since the May 24,
2021 data reported in the ETS (CDC,
October 18, 2021—Healthcare
Personnel). The Delta variant is likely
responsible for the majority of those
deaths. No healthcare worker deaths
were reported by CDC during the weeks
of May 30 through June 13, 2021;
however, as the Delta variant’s
prevalence rose after June 20, healthcare
worker deaths began increasing; they
peaked during the period of August 15
through September 12, 2021, when 34 to
36 healthcare worker deaths were
reported per week (CDC October 18,
2021—Healthcare Personnel, Deaths by
Week). Independent reporting by Kaiser
Health News and The Guardian reported
more than 3,600 fatalities in health care
workers as of April 2021 (Spencer and
Jewett, April 8, 2021). That number is
expected to be higher at this time since
the earlier figure did not include the
most recent 5 months of the pandemic,
which includes the period of Delta
variant predominance.
Published studies also demonstrate
that healthcare workers, especially those
who are unvaccinated, remain at risk of
being infected with SARS–CoV–2 (see
Section III.A.IV. Vaccines Effectively
Reduce Severe Health Outcomes from
and Transmission of SARS–CoV–2).
Routine testing of health care personnel,
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first responders, and other frontline
workers in eight U.S. locations in six
states from December 14, 2020 through
August 14, 2021 revealed 194 infections
in 4,136 unvaccinated participants
(89.7% symptomatic) and 34 infections
in 2,976 fully vaccinated participants
(80.6% symptomatic) (Fowlkes et al.,
August 27, 2021). During time periods
when the Delta variant represented
more than 50% of viruses sequenced, 19
infections were detected in 488
unvaccinated participants (94.7%
symptomatic) and 24 infections were
detected in 2,352 vaccinated
participants (75% symptomatic).
Monthly COVID–19 cases in
healthcare workers were reported
during the period from March 1 to July
31, 2021 at the University of California
San Diego (UCSD) health system, which
is a healthcare provider that includes
primary care services such as family
medicine and pediatrics (Keehner et al.,
September 1, 2021; UCSD, 2021). During
that time period, a total of 227 health
care workers tested positive for COVID–
19. One hundred and nine of 130 fully
vaccinated workers who tested positive
(83.8%) were symptomatic and 80 of 90
unvaccinated workers (88.9%) were
symptomatic; one unvaccinated person
was hospitalized for COVID–19
symptoms. By July of 2021, after the end
of California’s mask mandate on June 15
and after the Delta variant became
dominant, the number of cases detected
dramatically increased; the Delta variant
accounted for more than 95% of SARS–
CoV–2 viruses sequenced by the end of
that month. During July of 2021,
symptomatic infections were detected in
94 of 16,492 fully vaccinated workers
and 31 of 1,895 unvaccinated workers.
Attack rates in July of 2021 were 5.7 per
1,000 fully vaccinated workers and 16.4
per 1,000 unvaccinated workers.
In Finland, a Delta variant infection
from a hospitalized patient spread
throughout the hospital and to three
primary care facilities, infecting 103
individuals, including 45 healthcare
workers (Hetema¨ki et al., July 29, 2021).
Twenty-six of the healthcare workers
were infected at the hospital and 19
were infected at primary care facilities.
The affected health care workers
included 28 with direct patient contact
(11 who were not fully vaccinated), 8
unvaccinated healthcare worker
students, and 9 other staff, including
hospital cleaners and secretaries (of
whom 6 were not fully vaccinated).
According to study authors, ‘‘There was
high vaccine coverage among permanent
staff in the central hospital, but lower
for HCW in primary healthcare
facilities. . .’’ Study authors estimated
that vaccine effectiveness against the
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Delta variant in healthcare workers was
approximately 88–91%, suggesting how
much more extensive the outbreak
could have been if a high percentage of
healthcare workers were not fully
vaccinated.
In the UK, a Delta variant infection in
a healthcare worker resulted in an
outbreak in a care home that affected 16
of 21 residents and 8 of 21 staff
(Williams et al., July 8, 2021). One staff
member was hospitalized. Attack rates
were 35.7% in staff who were partially
vaccinated (i.e., received their second
dose of vaccine on the day that the
index case was diagnosed with COVID–
19 or had only received one vaccine
dose) and 40% in staff who were not
vaccinated.
Recent news stories demonstrate that
outbreaks affecting staff members are
still occurring in U.S. healthcare
facilities. An outbreak that began in
August, 2021 at a Washington State
nursing center resulted in infections in
22 staff members and 52 residents. In an
unrelated outbreak, a nursing facility in
Hawaii reported infections in 24
employees and 54 patients (Wingate,
September 24, 2021). Vaccination rates
were reported at 64.5% of residents and
37.1% of staff in the Washington State
facility and 91% of staff and more than
80% of patients at the Hawaii facility.
COVID–19 cases were also observed
in staff at ambulatory care settings prior
to emergence of the Delta variant. Over
an 11-week period beginning on March
20, 2020, 254 tests for SARS–CoV–2
were performed on employees who had
potential exposures at an outpatient
urology center in New York State
(Kapoor et al., 2020). Positive test rates
in employees correlated with rates in
New York State, declining over time,
from 26.1% in the early stage to 7.3%
in the late stage of the study. According
to study authors, the positive test results
coincided with the implementation of
infection control procedures (e.g.,
symptom screening, masking,
distancing, and hygiene). Positivity rates
were similar in administrative and
clinical staff and the study authors
concluded that ‘‘administrative staff in
an outpatient setting were equally—if
not more—vulnerable to SARS–CoV–2
transmission when compared with
clinical staff who were more directly
exposed to patients.’’ The study authors
speculated that possible reasons for the
findings were that clinical staff were
more familiar with PPE and that
administrative staff, especially in checkin and check-out points, tend to work
close to each other.
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c. Conclusion for Employee Impact
The evidence described above
provides examples of the impact that
exposures from SARS–CoV–2, including
those involving the Delta variant, have
had on employees in general industry,
agriculture, construction, maritime, and
healthcare settings. It demonstrates that
SARS–CoV–2 has spread to employees
in these industries and, in many cases,
infection was linked to exposure to
infected persons at the worksite (WSDH,
September 8, 2021; OHA, September 1,
2021; TDH, September 8, 2021;
NCDHHS, August 30, 2021; Hawaii
State, August 19, 2021; Pray et al.,
January 29, 2021; Sami et al., April 9,
2021; Suhs et al., July 23, 2021; Gold et
al., February 26, 2021; Porter et al.,
April 30, 2021; Hetema¨ki et al., July 29,
2021; Williams et al., July 8, 2021). The
documentation of so many workplace
clusters suggests that exposures to
SARS–CoV–2 occur regularly in
workplaces where employees come into
contact with others. This prevalence of
clusters, combined with some evidence
that many infections occurred within
the 14-day incubation period for SARS–
CoV–2 and that exposures to infected
persons outside the workplace were
frequently ruled out, supports the
proposition that exposures to and
transmission of SARS–CoV–2 occur
frequently at work. Multiple studies
demonstrate high rates of COVID
infections, illnesses, and fatalities in the
wide range of occupations that require
frequent or prolonged close contact with
other people, indoor work, and work in
crowded and/or poorly ventilated areas
The large numbers of infected
employees suggest that SARS–CoV–2 is
likely to be present in a wide variety of
workplaces, placing unvaccinated
workers at risk of serious and
potentially fatal health effects.
IV. Vaccines Effectively Reduce Severe
Health Outcomes From and
Transmission of SARS–CoV–2
During the course of the SARS–CoV–
2 pandemic, different variants have
emerged with different characteristics
that better enable transmission and
potentially cause more severe outcomes.
However, vaccines remain very effective
at reducing the occurrence of COVID–
19-related severe illness, disability and
death.12 The Delta variant is more
transmissible than previous variants,
might cause more severe illness than
previous variants in unvaccinated
12 A discussion of vaccination rates, as well as
OSHA’s rationale for why vaccination is a critical
means of protecting workers from the grave danger
described in this section, can be found in Need for
the ETS (Section III.B. of this preamble).
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people, and has led to hospitalization of
individuals in numbers similar to those
of the November 2020 to February 2021
surge. These changes in characteristics
have provided a clearer realization of
the continuing capacity for SARS–CoV–
2 to present a grave danger to workers.
However, it is well evident that even
given these changed characteristics of
Delta, serious disease and death
continue to occur overwhelmingly in
unvaccinated individuals while the
vaccinated are afforded great
protection.13
a. Impact of Vaccination on Severe
Health Outcomes
There are currently three vaccines
that are approved or authorized for the
prevention of COVID–19 in the U.S.:
The Pfizer-BioNTech COVID–19 vaccine
(FDA approved for ages 16 and above;
authorized for ages 12 and above), the
FDA-authorized Moderna COVID–19
vaccine (authorized for ages 18 and
above), and the FDA-authorized Janssen
COVID–19 vaccine (also known as the
Johnson & Johnson vaccine; authorized
for ages 18 and above.) Pfizer-BioNTech
and Moderna are mRNA vaccines that
require two primary series doses
administered three weeks and one
month apart, respectively. Janssen is a
viral vector vaccine administered as a
single primary vaccination dose (CDC,
September 15, 2021). The vaccines were
shown to greatly exceed minimum
efficacy thresholds in preventing
COVID–19 in clinical trial participants
(FDA, December 11, 2020; FDA,
December 18, 2020; FDA, February 26,
2021). Data from clinical trials for all
three vaccines and observational studies
for the two mRNA vaccines clearly
establish that fully vaccinated persons
have a greatly reduced risk of SARS–
CoV–2 infection compared to
unvaccinated individuals. This includes
severe infections requiring
hospitalization and those resulting in
death. For more information about the
effectiveness of vaccines as of late
Spring 2021, see 86 FR 32397, which
OSHA hereby includes in the record for
this ETS.14
Vaccines remain highly effective
against hospitalization and death. A
study evaluating vaccine effectiveness at
preventing hospitalization among those
with SARS–CoV–2 infections in New
13 While mild cases of COVID–19 are included in
the grave danger presented by COVID–19, as stated
in the Healthcare ETS (see 86 FR 32382), OSHA is
focusing on the most severe health effects, i.e., cases
requiring hospitalization and cases resulting in
death, in this new rulemaking effort in order to
prevent the gravest of consequences to workers.
14 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
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York found that effectiveness did not
change from May 3 to July 25, 2021 as
the Alpha variant gave way to the Delta
variant (91.9–96.2% range; Rosenberg et
al., August 27, 2021). Grannis et al. used
data from 187 hospitals in nine states
from June to August 2021 to evaluate
the efficacy of vaccines against
hospitalization when Delta had emerged
as the predominant variant causing
SARS–CoV–2 infections (September 17,
2021). This study found that vaccines
were 89% effective at preventing
hospitalization in individuals aged 18 to
74. Similarly, vaccines were also found
to be 89% effective in preventing
hospitalization in a study collecting
data from five Veteran Affairs Medical
Centers from July 1 to August 6, 2021,
a time when most transmission was
attributed to the Delta variant (Bajema et
al., September 10, 2021).
Two other studies found that,
although the level of protection
provided by vaccination has decreased
somewhat with the emergence of the
Delta variant, vaccines continue to
provide high levels of protection against
hospitalization. In a U.S. study,
researchers found that while the
Moderna and Janssen vaccines mostly
maintained their effectiveness at
preventing hospitalization (going from
93% to 92% after more than 120 days
post-vaccination and 71% to 68% after
more than 28 days post-vaccination,
respectively) from March to August
2021, the effectiveness of the PfizerBioNTech vaccine at preventing those
severe outcomes decreased from 91% to
77% after more than 120 days postvaccination (Self et al., September 17,
2021). An Israeli study on infections
documented between July 11 and July
31, 2021 found a significant decrease in
vaccine efficacy for the Pfizer-BioNTech
vaccine against severe outcomes in
relation to when an individual was
vaccinated, but the absolute difference
was much less than what was observed
in the U.S. study (e.g., 98% effective for
40–59 year olds vaccinated in March
versus 94% effective for those in the
same age group who were vaccinated in
January) (Goldberg et al., August 30,
2021).
Vaccines also remain extremely
effective at preventing death. A UK
study evaluated the effectiveness of the
Pfizer-BioNTech vaccine against death
and found it to be 96.3% effective
against the Alpha strain and 95.2%
protective against the Delta strain
(Andrews et al., September 21, 2021).
Two Israeli studies, Haas et al. and
Saciuk et al., performed during time
periods where Alpha was predominant,
found the Pfizer-BioNTech vaccine to be
96.7% and 91.1% effective,
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respectively, against death (Haas et al.,
May 15, 2021; Saciuk et al., June 25,
2021). A California study found that the
Moderna vaccine was 97.9% effective
against death (Bruxvoort et al.,
September 2, 2021). A study on patients
served by the Veterans Health
Administration found that PfizerBioNTech and Moderna vaccines
provided 99% effectiveness against
death (Young-Xu et al., July 14, 2021).
The risks of hospitalization and death
appear to have increased for
unvaccinated individuals since the
Delta variant became a common source
of infections. A study of Los Angeles
County SARS–CoV–2 infections found
that vaccinations reduced
hospitalization risk by a factor of 10 on
May 1, 2021, when the Alpha variant
was dominant, but that the risk of
hospitalization was even more greatly
reduced (by a factor of 29.2) on July 25,
2021, when the Delta variant was
dominant (Griffin et al., August 27,
2021). This difference suggests both that
vaccines continue to provide a high
level of protection against disease that
results in hospitalization and that risk
has increased for those who are
unvaccinated. Similar increased risk for
unvaccinated individuals was reported
in a study that evaluated hospitalization
and death data from 13 U.S.
jurisdictions between June 20 and July
17, 2021, a period when the Delta
variant gained prominence (Scobie et
al., September 17, 2021). For
unvaccinated 18 to 49 year olds, the risk
of hospitalization was 15.2 times
greater, and the risk of death was 17.2
times greater, than the risks for
vaccinated people in the same age
range. For unvaccinated 50 to 64 year
olds, the risk of hospitalization was 10.9
times greater, and the risk of death was
17.9 times greater, than for those who
are vaccinated. These studies illustrate
that vaccination is an extremely
effective control measure to minimize
severe outcomes resulting from Delta
variant infections.
b. Impact of Vaccination on Infection
and Transmission
Vaccines continue to provide robust
protection for vaccinated individuals
against SARS–CoV–2 infections, even
though several studies indicate that
vaccine efficacy against infection may
have decreased somewhat with the
emergence of the Delta variant (Fowlkes
et al., August 27, 2021; Rosenberg et al.,
August 27, 2021; Nanduri et al., August
27, 2021; Seppala et al., September 2,
2021; Bernal et al., August 12, 2021).
For example, vaccination was observed
to reduce the risk of infection by a factor
of 8.4 on May 1, 2021, when the Alpha
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variant was predominant in Los Angeles
county (Griffin et al., August 27, 2021).
However, the level of protection had
fallen to a factor of 4.9 by July 25, 2021,
when Delta made up 88% of infections
in the county. The findings from this
study indicate that while vaccines
maintain robust protection against
severe outcomes, protection against
infection has fallen with the increased
circulation of the Delta variant. A
broader study using data from 13 U.S.
jurisdictions had similar findings,
observing that the protection vaccines
afforded against infection decreased
from a factor of 11.1 (i.e., vaccinated
people were 11.1 times less likely than
unvaccinated people to become
infected) between April 4 and June 19,
2021, to a factor of 4.6 between June 20
and July 17, 2021 (Scobie et al.,
September 17, 2021). An additional
study noted, however, that the decrease
in vaccine protectiveness against
symptomatic infection from the Delta
variant could be due to the waning of
immunity specifically in older
populations. Andrews et al. (September
21, 2021) found that while the PfizerBioNTech vaccine effectiveness
decreased from 94.1% to 67.4% in those
65 years old and older, vaccine
effectiveness for those 40 to 64 years old
only decreased from 92.9% to 80.6%.
While infections themselves do not
normally result in serious illness for
those who are vaccinated, evidence
shows that vaccinated individuals who
become infected with the Delta variant
can transmit the disease more easily to
others than with previous variants. This
development poses a great concern for
the unvaccinated, who generally do not
have the protections against severe
outcomes that vaccination affords.
Before Delta, vaccinated individuals
were shown to have lower estimated
viral loads when infected than those
who were unvaccinated, which
suggested that infected vaccinated
individuals were likely not a major
concern for transmission (LevineTiefenbrun et al., March 29, 2021).
Transmission studies prior to the
emergence of Delta appear to bear this
out. A Scottish study performed during
a time period when the Alpha variant
was predominant in the region, showed
that a fully vaccinated individual was
3.2 times less likely than an
unvaccinated individual to transmit the
virus to unvaccinated family members
(Shah et al., September 10, 2021;
supplementary appendix). A
population-based study from the
Netherlands found that vaccination
decreased secondary transmission to
household members from 31% to 11%
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(de Gier et al., August 5, 2021).
Additionally, a study from the UK
found that household transmission
decreased by as much as 50% when the
infected individual was vaccinated
(Harris et al., June 23, 2021).
More recent research suggests that the
Delta variant may have reduced the
level of protection vaccination affords
against transmission of the virus to
others, but still significantly reduces
transmission risk in comparison to
infected unvaccinated individuals. A
UK study found that fully vaccinated
individuals infected by the Delta variant
are able to transmit the virus to both
vaccinated and, to a greater degree,
unvaccinated persons (Singanayagam et
al., September 6, 2021). Still, the rate at
which transmission to unvaccinated
individuals occurred was nearly double
the rate of transmission to vaccinated
individuals (35.7% compared to 19.7%).
Similarly, Eyre et al., (September 29,
2021) found that during the
predominance of Alpha, full vaccination
with the Pfizer-BioNTech vaccines
resulted in a significant reduction in
transmission to others (an adjusted
Odds Ratio (aOR) of 0.18, meaning that
being unvaccinated increased the odds
of transmission by over five times). With
the rise of the Delta variant, that
reduction in transmission to others was
less than with the Alpha variant, but
still significantly more than for
unvaccinated individuals (aOR of 0.35,
meaning that being unvaccinated
increased the odds of transmission by
almost three times).
The greater ability for vaccinated
individuals to transmit the Delta variant
of SARS–CoV–2 to others (compared to
previous variants) appears to be linked
to the generation of similar viral loads
(as estimated by Ct threshold) in the
vaccinated compared to the
unvaccinated (Ct threshold is the
number of RT–PCR cycles that need to
be run in order to amplify the RNA
enough to be detected—fewer cycles
means a greater initial amount of virus
was collected) (Singanayagam et al.,
September 6, 2021). This observation
has been made in several studies. A
study from Israel observed that viral
loads among those infected with the
Delta variant were only decreased in
people who had been vaccinated
recently (within the past two months) or
in those who had recently received a
booster dose (Levine-Tiefenbrun et al.,
September 1, 2021). In a study of SARS–
CoV–2 infections in Los Angeles
County, performed when the Delta
variant was predominant, vaccination
status did not appear to affect the
estimated viral loads, suggesting that
infected individuals who are vaccinated
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may be just as likely to transmit the
virus (Griffin et al., August 27, 2021).
Additionally, estimated viral loads did
not appear to be significantly different
with respect to vaccination status in a
Wisconsin study (Riemersma et al., July
31, 2021). Regardless of viral loads in
vaccinated and unvaccinated
individuals, the fact remains clear that
unvaccinated people pose a higher risk
of transmission to others than
vaccinated people, simply because they
are much more likely to get COVID–19
in the first place.
These studies, however, appear to
overstate increases in transmission risk
from vaccinated individuals related to
the Delta variant. From May to July
2021, UK researchers tested individuals
at random to better characterize viral
load estimates in people with
asymptomatic as well as symptomatic
infections; they found that vaccination
was associated with a significantly
lower estimated viral load (Elliott et al.,
September 10, 2021). This more
comprehensive study (i.e., Elliott et al.,
September 10, 2021) may have been able
to better characterize the course of
infection and to incorporate vaccinated
individuals whose viral loads were
decreasing quickly. The findings in
Elliott et al. are consistent with studies
observing that viral load may fall more
quickly in vaccinated individuals,
resulting in a shorter infectious period
and possibly fewer transmission events
(Chia et al., July 31, 2021; Eyre et al.,
September 29, 2021).
c. Conclusion for the Impact of Vaccines
The studies discussed above indicate
that vaccines continue to effectively
protect vaccinated individuals against
SARS–CoV–2 infections, while the risk
of infection, hospitalization, and death
increased among unvaccinated people
as the Delta variant became
predominant in the U.S. The Delta
variant is even more dangerous to
unvaccinated individuals than previous
variants because of the higher
transmission potential from both
unvaccinated and vaccinated people.
Because unvaccinated individuals are at
much higher risk of severe health
outcomes from infection with SARS–
CoV–2, and also pose a greater
transmission risk to those around them,
it is critical to assure that as many
people as possible are fully vaccinated
in order to prevent transmission at
work.
V. Coverage of OSHA’s Grave Danger
Finding
Based on the information discussed
above, OSHA finds that many
unvaccinated workers across the U.S.
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economy are facing a grave danger of
severe health effects or death from
exposure to SARS–CoV–2. Fully
vaccinated workers are not included in
this grave danger finding because, as
described throughout this section, those
who are fully vaccinated are much
better protected from the effects of
SARS–CoV–2 and, in particular, the
most severe effects, than are those who
are unvaccinated.15 Beyond that,
OSHA’s grave danger determination
exempts several categories of workers
based on characteristics of their work or
workplace: (1) Workers who do not
report to a workplace where other
individuals are present or who telework
from home; and (2) workers who
perform their work exclusively
outdoors. The basis for these
exemptions is explained below. In this
section, OSHA also addresses the basis
for OSHA’s grave danger finding for
workers who are unvaccinated yet had
a prior COVID–19 infection, and
explains the Agency’s more nuanced
grave danger finding in the healthcare
industry.
a. Employees Who Telework and
Employees Who Do Not Report to a
Workplace Where Other People Are
Present.
Employees who report to workplaces
where no other people are present face
no grave danger from occupational
exposure to COVID–19 because such
exposure requires the presence of other
people. For those who work from their
homes, or from workplaces where no
other people are present (such as a
remote worksite), the chances of being
exposed to SARS–CoV–2 through a
work activity are negligible. Therefore,
OSHA is exempting those workers who
do not come into contact with others for
work purposes from its grave danger
finding as well as the scope of the ETS
(for more information, see the Summary
and Explanation for Scope and
Application, Section VI.B. of this
preamble).
b. Employees Who Work Exclusively
Outside
Employees who work exclusively
outside face a much lower risk of
15 The exclusion of vaccinated workers from this
grave danger finding does not mean that vaccinated
workers face no risk from exposure to SARS–CoV–
2. The best available evidence clearly shows that
vaccination provides great protection from infection
and severe outcomes, but breakthrough infections
do occur and vaccinated individuals can still
transmit the virus to others. In some cases, the level
of risk to vaccinated workers may even rise to the
level of a significant risk, the standard OSHA must
meet for promulgation of a permanent standard
under section 6(b)(5) of the OSH Act (29 U.S.C.
655(b)(5)).
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exposure to SARS–CoV–2 at work,
because their workplaces typically do
not include any of the characteristics
that normally enable transmission to
occur (e.g., indoors, lack of ventilation,
crowding). Bulfone et al. attributed the
lower risk of transmission in outdoor
settings (i.e., open air or structures with
one wall) to increased ventilation with
fresh air and a greater ability to
maintain physical distancing (November
29, 2020). While the best available
evidence firmly establishes a grave
danger in indoor settings, the CDC has
stated that the risk of outdoor
transmission is ‘‘low’’ (CDC, September
1, 2021) and OSHA is unable to
establish a grave danger in outdoor
settings from exposure during normal
work activities.
OSHA recognizes that outdoor
transmission has been identified in a
few specific incidents (e.g., 2 of 7,324
cases, Qian et al., October 27, 2020).
However, general reviews of
transmission studies that include largescale and high-density outdoor
gatherings indicate that indoor
transmission overwhelmingly is
responsible for SARS–CoV–2
transmission. Additionally, the lack of
evidence tied to specific case studies
illustrating outdoor transmission in
comparison to the bevy of case studies
on indoor transmission makes it
difficult to support a conclusion that
outdoor transmission rises to the level
of a grave danger.
Bulfone et al. reviewed a collection of
SARS–CoV–2 studies that evaluated
infections in outdoor and indoor
settings (November 29, 2020), and found
that transmission is significantly less
likely to occur in outdoor settings than
in indoor settings. The studies overall
found that the risk of outdoor
transmission was less than 10% of the
risk of transmission in indoor settings,
with three of the studies concluding risk
was 5% or less of the risk of
transmission in indoor settings. While
acknowledging significant gaps in
knowledge, the authors of a different
study suggested that increases in
transmission related to large events such
as the Sturgis motorcycle rally may be
related to lack of local efforts to prevent
transmission indoors (e.g., requiring the
wearing of masks, closing indoor
dining), rather than the outdoor setting
for the rally (Dave et al., December 2,
2020). In contrast, transmission rates
did not increase as expected following
the Summer 2020 protests on racial
injustice. This outcome was attributed,
in part, to participants having been less
likely to enter indoor commercial
establishments.
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Weed and Foad (September 10, 2020)
found that transmission of SARS–CoV–
2 related to large scale outdoor
gatherings could be largely attributed to
individual behaviors related to that
event, such as communal travel and
indoor congregation at other facilities
(e.g., restaurants, shared
accommodations), rather than to the
time spent outdoors at those gatherings.
Similarly, a Public Health England
evaluation of the literature on SARS–
CoV–2 and surrogate respiratory viruses
(December 18, 2020) also concluded that
when transmission does occur at
outdoor events, outdoor activities were
mixed with indoor setting use. Public
Health England concluded that the vast
majority of transmission happens in
indoor settings, with very little evidence
for outdoor transmission.
A systemic review of SARS–CoV–2
clusters identified 201 events through
May 26, 2020 (Leclerc et al., April 28,
2021), only 4 of which occurred at
predominantly outdoor settings. For
those 4 clusters, the authors noted that
they were not able to evaluate specific
transmission events and attributed it to
local health agencies being
overwhelmed by the pandemic. OSHA
notes that the designations of settings in
this study are somewhat generic, as
outdoor construction sites will often
have indoor locations, such as mobile
offices, or locations with reduced
airflow, such as areas with a roof or
ceiling and two or more walls.
Regardless, this study illustrates the
comparable abundance of evidence
available to evaluate SARS–CoV–2
transmission in indoor settings versus
outdoor settings.
Cevik et al. (August 1, 2021) reviewed
studies on the transmission dynamics of
SARS–CoV–2 infections from large
scale, contact-tracing studies. The
authors recommended that, based on the
evidence that outdoor transmission
dynamics resulted in significantly fewer
infections than in indoor settings,
public health entities should greatly
encourage use of outdoor settings. The
researchers highlighted a study by
Nishiura et al. (April 16, 2020), who
evaluated 110 cases in Japan at the
beginning of the pandemic and found
that outdoor settings reduced
transmission risk by 18.7 times and
reduced the risk of super-spreader
events by 32.5 times.
Agricultural workplace settings have
experienced significant SARS–CoV–2
infections. However, transmission in
these settings is difficult to characterize
because many jobs in this sector include
both outdoor and indoor activities.
Miller et al. (April 30, 2021) evaluated
an outbreak among farmworkers in
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Washington State. The researchers
found that 28% of workers with
predominantly indoor tasks where they
were unable to maintain physical
distance were infected, compared to 6%
of workers who performed
predominantly outdoors tasks in the
orchards. Conversely, a study on
farmworkers in Monterey County,
California found a significant
correlation between evidence of
infection and individuals who worked
in the fields as opposed to indoor work
(Mora et al., September 15, 2021). The
paper noted that infections were
predominant in individuals who lived
in crowded conditions, commuted
together to the fields, and spoke at home
in indigenous languages, which is
important as written health messages
are often not available in all worker
languages. These papers cannot identify
where or when infections occurred in
order to discern causation. The
associations observed may indicate that
SARS–CoV–2 infections may be more
related to aspects related to indoor
exposures outside of the work activities
(e.g., crowded living conditions) or
potentially overlooked indoor aspects
connected to outdoor work (e.g., shared
commuting).
Several studies discussed below in
more detail have evaluated outdoors onfield transmission from infected
participants during football, soccer, and
rugby matches. These events include
repeated close physical contact between
players, without PPE or physical
distancing, over the course of fairly long
events, with increased exertion leading
to greater respiratory effort and
production of respiratory droplets.
These events also include opposing
cohorts who only interact during onfield activities. Therefore, these studies
provide some evidence for the low
likelihood of outdoor transmission in
other workplace activities greatly
impacted by the pandemic, such as in
construction.
Mack et al. (January 29, 2021) detailed
the National Football League’s complex
program to assess and prevent
transmission, which included devices
that recorded distance and duration of
interactions with others, for the purpose
of improving identification of
individuals with high-risk exposures.
Although 329 positive cases were
identified among roughly 11,400 players
and staff, there were no reported cases
of on-field transmission by infected
players. The results led the NFL to focus
more on reducing transmission in
indoor settings, including
transportation.
Egger et al. (March 18, 2021) reviewed
three soccer matches involving 18
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players who had SARS–CoV–2; one
match involved a team where 44% of
the players were infected. Video
analysis was used to determine the type
of contact between players, such as
contact to face or hand slaps. None of
the existing cases were associated with
on-field play and no secondary
transmission from on-the-field contacts
was observed. Jones et al. (February 11,
2021), evaluated four rugby Super
League matches involving eight players
who were found to be infected with
SARS–CoV–2. Using video footage and
global positioning data, the researchers
were able to identify 28 players as highrisk contacts with the infected players.
These high-risk players together had as
many as 32 tackles and were within two
meters of infected players as often as
121 times during the four matches. Of
the 28 players noted as high-risk
contacts, one became infected with
SARS–CoV–2. However, researchers
determined that the transmission
resulted from internal team outbreaks
and not from exposure on the field.
OSHA acknowledges that the risk of
transmission of SARS–CoV–2 in
outdoor settings is not zero, and that
there may be some low risk to workers
performing general tasks exclusively in
outdoor settings. However, where
studies have been able to differentiate
between indoor and outdoor exposures,
they indicate that indoor exposures are
the much more significant drivers of
SARS–CoV–2 infections. Therefore, the
best available evidence at this time does
not provide OSHA with the information
needed to establish SARS–CoV–2 as a
grave danger for general work activities
in outdoor settings (see Int’l Union,
United Auto., Aerospace, & Agr.
Implement Workers of Am., UAW, 590
F. Supp. at 755–56, describing a ‘‘grave
danger’’ as a risk that is more than
‘‘significant’’). Therefore, OSHA has
excluded employees who work
exclusively outdoors from the scope of
this ETS (see the Summary and
Explanation for Scope and Application,
Section VI.B. of this preamble).
c. Employees in Healthcare
Because OSHA issued a separate
grave danger determination several
months ago for some healthcare
workers, some explanation of how its
current finding applies to healthcare
workers is necessary. In June 2021,
OSHA issued its Healthcare ETS (86 FR
32376) after determining that some
healthcare workers faced a grave danger
of infection from SARS–CoV–2. This
grave danger determination, along with
the protections of the Healthcare ETS,
applied to healthcare and healthcare
support workers in settings where
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people with suspected or confirmed
cases of COVID–19 are treated, and was
based on the increased potential for
transmission of the virus in such
settings (see 86 FR 32411–32412). These
workers are currently covered by the
protections of the Healthcare ETS (29
CFR 1910.502). OSHA does not have
data to demonstrate that unvaccinated
workers in settings covered by the
Healthcare ETS face a grave danger from
SARS–CoV–2 when the requirements of
that standard are followed. However, if
the Healthcare ETS were no longer in
effect, OSHA would consider the
workers who were covered by it, and
who remain unvaccinated, to be at grave
danger for the reasons described in this
ETS.
OSHA’s new finding of grave danger
applies to healthcare and healthcare
support workers who are not covered by
the Healthcare ETS, to the extent they
remain unvaccinated. In this ETS, as
discussed in this section, OSHA has
made a broader determination of grave
danger that applies to most
unvaccinated workers, regardless of
industry. OSHA’s current finding of
grave danger supporting this ETS does
not depend on whether a workplace is
one where people with suspected or
confirmed COVID–19 are expected to be
present. Therefore, the finding of grave
danger applies to unvaccinated workers
in healthcare settings that are not
covered by 29 CFR 1910.502 to the same
extent it applies to unvaccinated
workers in all other industry sectors.
d. Employees Who Were Previously
Infected With SARS–CoV–2
OSHA has carefully evaluated the
effectiveness of previous SARS–CoV–2
infections in providing protection
against reinfection. This section
provides a detailed description of the
current scientific information in order to
ascertain what the best available
scientific evidence on this topic
indicates regarding the risk to
individuals with previous COVID–19
infections from exposure to SARS–CoV–
2. While the agency acknowledges that
the science is evolving, OSHA finds that
there is insufficient evidence to allow
the agency to consider infectionacquired immunity to allay the grave
danger of exposure to, and reinfection
from, SARS–CoV–2.
To determine whether employees
with infection-induced immunity from
SARS–CoV–2 (i.e., those who were
infected with SARS–CoV–2 but have not
been vaccinated) face a grave danger,
OSHA reviewed the scientific evidence
on the protective effects of vaccineinduced SARS–CoV–2 immunity versus
infection-induced immunity. Individual
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immunity to any infectious disease,
including SARS–CoV–2, is achieved
through a complex response to exposure
by the immune system. This response
consists of disease-specific antibody
production guided and augmented by
certain types of immune cells, such as
T and B cells, which work together to
neutralize or destroy the disease-causing
agent. Immune responses to viruses like
SARS–CoV–2 can be measured in
several ways. For instance, blood serum
can be taken and exposed to specific
proteins found on the SARS–CoV–2
virus, in order to measure the presence
of antibodies in the blood. Another
antibody test, the neutralization test,
measures the ability of the antibodies
present in a serum to neutralize
infectivity and prevent cells from being
infected. T cell immunity can be
measured using techniques that target a
specific biomolecule that is specific to
SARS–CoV–2.
A considerable number of individuals
who were previously infected with
SARS–CoV–2 do not appear to have
acquired effective immunity to the virus
(Psichogiou et al., September 13, 2021;
Wei et al., July 5, 2021; Cavanaugh et
al., August 13, 2021). The level of
protection afforded by infectioninduced immunity appears to depend
on the severity of individuals’
infections. In a study from Greece,
immunogenicity was compared between
healthcare workers who were
vaccinated with Pfizer-BioNTech and
unvaccinated patients who acquired a
natural infection (Psichogiou et al.,
September 13, 2021). The researchers
found that the immune response in
unvaccinated individuals correlated to
the severity of their disease. Fully
vaccinated healthcare workers had
immune responses (measured as
antibody levels specific to SARS–CoV–
2) that were 1.3 times greater than
patients who had critical cases of
COVID–19 cases, 2.5 times greater than
patients who had moderate to severe
cases, and 10.5 times greater than
patients who had asymptomatic/mild
illnesses. Similarly, another study found
that 24.0% (1,742 of 7,256) of
individuals who had a previous SARS–
CoV–2 infection were seronegative (i.e.,
did not produce antibodies in response
to the virus), suggesting that the
previous infection provided insufficient
protection against future infection (Wei
et al., July 5, 2021). Individuals who
were seronegative were typically older,
had lower viral burdens when infected,
and were more likely to be
asymptomatic. The authors posited that
the immunity of those who were
seropositive (i.e., did produce
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antibodies in response to the virus)
would provide some measure of
protection, but that these individuals
would benefit from a vaccination
booster. This position appears to be
validated by a study that compared the
reinfection rates of individuals in
Kentucky based on their post-recovery
vaccination status (Cavanaugh et al.,
August 13, 2021). Unvaccinated
individuals with previous infection
were found to be 2.3 times more likely
to be reinfected than those who were
vaccinated after their prior infection.
These studies demonstrate not only that
those with milder infections may not be
protected against future infection, but
that it is difficult to tell, on an
individual level, which individuals
might have had prior infections that
conveyed protection equivalent to that
provided by vaccination.
A number of other studies indicate
that fully vaccinated individuals may be
better protected against future infection
than those with previous infections. A
study in Massachusetts concluded that
the immunity conveyed from a previous
SARS–CoV–2 infection was effectively
equivalent to the immunity of an
uninfected individual who has had only
one dose of an mRNA vaccine
(Naranbhai et al., October 13, 2021). The
authors found that fully vaccinated
individuals have an immune response
(i.e., antibodies and neutralization) well
above the levels observed in
unvaccinated, previously-infected
individuals. German researchers found
that individuals who were fully
vaccinated with Pfizer-BioNTech had a
significantly greater immune response
(as measured by antibody levels) than
unvaccinated individuals who had
infections, concluding that vaccination
would be needed for those unvaccinated
individuals to have similar protection
against infection (Herzberg et al., June
13, 2021). Similarly, a Dutch study
observed that vaccination greatly
improved the immune response (as
measured by antibodies and virusspecific T cells) of individuals who had
recovered from COVID–19 (Geers et al.,
May 25, 2021). Planas et al. (August 12,
2021) also noted that immune response
(as measured by neutralization) to the
Alpha, Beta, and Delta (B.1.617.2)
variants in unvaccinated, previouslyinfected individuals was considerably
less than the immune response in
individuals five weeks after their second
Pfizer-BioNTech dose. When
unvaccinated, previously-infected
individuals were vaccinated, their
immune response (as measured by
neutralization) increased by more than
an order of magnitude. Likewise, Wang
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et al. (July 15, 2021) found that the
immune response (as measured by
neutralization) of those with previous
SARS–CoV–2 infection increased by
more than an order of magnitude against
Alpha (B.1.1.7), Beta (B.1.351), Iota
(B.1.526), and Gamma (P.1) variants
when they were vaccinated. These
studies show that infection-induced
immunity may not equal the protection
afforded by vaccination and that
vaccination greatly improves the
immune response of those who were
previously infected.
The aforementioned studies indicate
that immunity acquired through
infection appears to be less protective
than vaccination. There are also a
number of epidemiological studies that
provide some evidence that infectionacquired immunity has the potential to
provide a significant level of protection
against reinfection. As OSHA discusses
in greater detail below, these studies
suffer from methodological limitations
that render them inconclusive about the
level of immunity conferred by
infection, and therefore OSHA is unable
to establish that such immunity
eliminates grave danger. This
determination is based in three parts.
First, the epidemiological literature
OSHA reviewed generally suffers from
selection bias to a degree that it serves
as an unreliable basis on which to reach
a robust conclusion on whether
previous infection removes workers
from grave danger. In general, the
studies described below do not account
for people who had mild COVID–19
infections, leading to study findings
regarding the level of protection
afforded by prior infection that are not
generally applicable. Second, the tests
employed in the studies are being used
in ways that they were not originally
designed to be employed. These tests
are powerful tools, but there are
limitations to their use in determining if
a specific individual is, in fact,
protected from the grave danger of
SARS–CoV–2. Particularly problematic
is the lack of established thresholds to
determine full protection from
reinfection or even a standardized
methodology to determine infection
severity or immune response. Thus,
while these studies broadly establish
some increase in protectiveness against
SARS–CoV–2 among the studied
populations, they as yet are unable to
provide a reasonable degree of certainty
on whether the degree of protection
afforded any particular individual from
their prior infection is sufficient to
eliminate the grave danger from
reinfection (see Milne, et al., October 21,
2021.) Third, while the research
methodology itself creates difficulties in
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the context of OSHA’s grave danger
inquiry, the implications of trying to
apply investigative research
methodology to clinical practice are
even more challenging. The need for the
development of standardized methods
and criteria for establishing sufficient
immunity preclude the application of
the studies’ findings to robust and
reliable clinical practice. These three
rationales for OSHA’s finding are
described in more detail below.
Several epidemiological studies used
previous RT–PCR positive cases to
define previous infections (Hansen et
al., March 27, 2021; Pilz et al., February
11, 2021; Vitale et al., May 28, 2021;
Pouwels et al., October 14, 2021; Braeye
et al., September 15, 2021; Hall et al.,
April 17, 2021). RT–PCR tests,
particularly in the beginning of the
pandemic, were given high priority to
discern who seeking medical care was,
in fact, infected. For instance, the
progression of testing from medical
needs to more of a community
perspective is illustrated in Denmark
(Vrangbaek et al., April 29, 2021).
Denmark, considered one of the gold
standard countries for its
comprehensive testing program, missed
five infections for every one it identified
in the spring of 2020 (Espenhaim et al.,
August 22, 2021). Hansen et al. (March
27, 2021) depended greatly on these first
surge infection definitions to determine
that survivors had protection of 80.5%
effectiveness during the second surge in
Denmark from September through
December, 2020. By only noting RT–
PCR positives from the spring when
testing was limited and highly focused
on health care needs, it seems apparent
that the study excluded many less
severe cases (which are less likely to
result in an effective immune response
against reinfection), leading to results
that may suggest greater protection is
afforded by infection than in actuality.
Even by December of 2020, it appears
Denmark’s gold standard
comprehensive testing approach was
only able to capture roughly half of all
infections. Similar systemic
undercounts have also been determined
to be true in the United States where
approximately three out of four
infections have never been reported
(CDC, July 27, 2021b).
It is important to recognize that RT–
PCR testing was not implemented to
find every infection, but was used
instead to assist in determining when
medical and community interventions
were necessary. Infections without
symptoms or with mild symptoms likely
would not require medical intervention
and, therefore, would likely not be
identified via testing. The absence of
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this population that is more vulnerable
to reinfection, in these studies,
undercuts their usefulness in OSHA’s
grave danger analysis, because they may
overestimate the protectiveness of
immunity acquired through infection.
Several other studies in regions less
known for their sampling approach than
Denmark also were heavily dependent
on early, limited pandemic RT–PCR
testing. An Austrian study found a
roughly ten-fold decrease in reinfection
in survivors of reported infections from
February to April 30, 2020 in
comparison with the general public
(Pilz et al., February 11, 2021). The
authors noted that ‘‘infections in the
first wave are likely to have been far
more common than the documented
ones’’ and referred to their results as a
‘‘rough estimate.’’ Researchers at the
Cleveland Clinic also found a reduced
rate of reinfection in those who had a
reported previous infection compared
with those with no prior infection
(13.8% infection rate for those
previously uninfected and 4.9%
infection rate for those previously
infected), but noted that testing was
limited in that the ‘‘Cleveland Clinic did
not test asymptomatic patients unless
they were admitted to hospital or
undergoing a procedure/surgery’’
(Sheehan et al., March 15, 2021). These
criteria for testing create uncertainty in
determining the level of effectiveness
previous infection provides against
SARS–CoV–2 because many individuals
with asymptomatic infections would not
have been tested. Similar issues are also
found in studies on populations in Italy,
Belgium, and the UK (Vitale et al., May
28, 2021; Braeye et al., September 15,
2021; Pouwels et al., October 14, 2021).
To avoid the well-known problems
with RT–PCRs defining previous
infection, other studies have defined
previous infection as testing positive for
antibodies specific for SARS–CoV–2
(Lumley et al., February 11, 2021; AbuRaddad et al., April 28, 2021; Hall et al.,
April 17, 2021). As noted above,
previous infection does not necessarily
result in a seropositive outcome; one
study indicated that nearly a quarter
(24%) of those infected with SARS–
CoV–2 subsequently showed no sign of
an immune response in SARS–CoV–2specific antibody testing (Wei et al., July
5, 2021). Therefore, studies only
considering seropositive individuals are
in essence studying only the individuals
most likely to have protection from
reinfection. Lumley et al. (February 11,
2021) found that those having a
seropositive response had almost an
order of magnitude fewer infections
(e.g., 0.11 adjusted incidence rate ratio).
Likewise, Abu-Raddad et al. (April 28,
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2021) found that seropositive
individuals were reinfected less (0.7%)
during their study period in comparison
to seronegative individuals (3.09%). In
addition to the bias associated with
using antibodies to determine previous
infection, the authors also noted that
there may have been issues with being
able to document cases with mild or no
symptoms.
Hall et al. (April 17, 2021) cast a
wider net by defining previous infection
to include both positive RT–PCR tests
and seropositivity. The researchers
found that those who were considered
previously infected had an 84% lower
risk of infection compared to those who
were unvaccinated with no record of
infection. While the study does attempt
to capture as many previously-infected
individuals as possible, this does not
actually address the weaknesses of each
method. Those with less severe
infections were less likely to have
sought out or been able to get an RT–
PCR test during the first surge, which is
when an overwhelming number of the
previous infections were recorded in
this study (March through May, 2020).
Additionally, the less severe infections
that are most likely underrepresented in
the study appear to be the ones that are
less likely to produce seropositivity.
Shenai et al. (September 21, 2021)
pooled several studies with the above
issues and concluded that immunity
acquired through a previous infection
from SARS–CoV–2 may be as protective
as, or more protective than, the
immunity afforded by vaccination to an
individual without previous infection.
However, authors of several of those
underlying studies used in the analysis
noted that their studies were limited by
not having the capability to fully
account for asymptomatic infections
(the aforementioned Lumley et al., July
3, 2021; Gazit et al., August 25, 2021;
Shrestha et al., June 19, 2021). As noted
earlier, infection severity appears to be
correlated with the robustness of
immunity acquired through that
infection, so the failure to account for
asymptomatic infections may mean that
this finding is related to the protection
afforded by more severe disease. While
pooled analyses can be utilized to make
powerful observations, those
observations are highly dependent upon
the underlying studies not sharing the
same methodological weakness which,
in this case, was the studies’ exclusion
of asymptomatic infections.
Moreover, while the evidence
suggests that severe infection may
provide significant protection against
reinfection in some cases (Milne et al.,
October 21, 2021), the level of
protection cannot be determined on an
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individual basis. The studies discussed
above are based on tests that show only
whether a person was or was not
infected and provide no information
about the severity of the infection.
Because the studies are likely biased
towards those who had a relatively
serious infection, their findings cannot
be generalized to all individuals with
prior infections.
RT–PCR and antibody testing are
powerful tools with many clinical and
research applications. However, the
application of these tools cannot
determine what degree of protection a
particular individual has against SARS–
CoV–2 without a great deal of additional
study concerning thresholds
establishing individual immunity.
Therefore, these tools are not yet able to
assist OSHA in making more nuanced
findings about which workers who had
COVID–19 previously are at grave
danger. There is no established
threshold to determine full protection
from reinfection or a standardized
methodology to determine infection
severity or immune response. Studies
use Ct threshold to approximate viral
loads and infer disease severity, but that
metric depends on many variables (e.g.
time of collection during infection,
quality of collection, handling of
sample, specifics of the test protocol
and materials, precision in performing
the protocol) that are often of far less
importance when it is used as a crude
diagnostic to determine the presence of
an infection. In other words, it is
reasonable to say that the lower the Ct
count, the greater the likelihood that an
individual is at a lower reinfection risk;
however, the Ct count is greatly
dependent on the RT–PCR test used,
and how different laboratories may run
that test, which cannot be discerned.
Similarly, research needs to be done to
better identify the minimum protective
threshold of anti-SARS–CoV–2 serum
neutralizing antibodies (Milne et al.,
October 21, 2021). Thus, these studies
currently do not allow OSHA to
determine, with a reasonable degree of
certainty, how much protection
employees with prior infections have
against reinfection.
Furthermore, while the research
methodology itself raises challenges in
making the grave danger determination,
the implications of trying to apply
investigative research methodology to
clinical practice are even more difficult.
The lack of standardized methods and
standardized measures for immunity
preclude their application to robust and
reliable clinical practice. One major
drawback discussed above is that, in
contrast to vaccine studies where
researchers know who was vaccinated
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with a standardized dosing regime,
scientific inquiries likely will not be
able to identify most individuals who
were infected, the degree of disease
experienced for those with a confirmed
infection, and the immunity against
reinfection. As of October 18, 2021,
several RT–PCR assays have been
authorized without standardization or
assessment with respect to measuring
disease severity (FDA, October 18,
2021). As noted above, the use of the Ct
threshold to approximate viral loads
and infer disease severity is unreliable.
As the FDA notes, the same is true about
antibody tests, which are considered to
be poor indicators for individuals to use
to determine whether they are protected
from reinfection (FDA, May 19, 2021).
There are many different SARS–CoV–2specific antibody tests that focus on
different specificity. Not only are the
outcomes of these tests not directly
comparable to each other, but the
specificity of these tests is not related to
any notion of protection against
reinfection. It can be reasonably said
that a greater antibody response means
a greater likelihood of protection against
infection, but, again, the science is not
clear what those thresholds are and
whether a threshold would be
comparable between laboratories. At
this point in time, even if OSHA
determined that some individuals with
prior infections are not at grave danger
from exposure to SARS–CoV–2, there is
no agreement on what indicators of
infection might be sufficient to confer
this level of immunity or how a
healthcare provider or employer could
document that a certain level of
immunity had been achieved.
Based on the best available evidence
described above, OSHA concludes that
while some individuals who were
infected with SARS–CoV–2 may have
significant protection from subsequent
infections, the level of protection
afforded by infection may be
significantly impacted by the severity of
the infection and some previously
infected individuals may have no future
protection at all. In addition, given the
limitations of the studies described
above, there is considerable uncertainty
as to whether any given individual is
adequately protected against reinfection.
Furthermore, the level of protection, if
any, provided by a given person’s
SARS–CoV–2 infection cannot be
ascertained based on currently-available
testing methods. Therefore, OSHA finds
that the requirements of this ETS are
necessary to protect unvaccinated
individuals who had prior SARS–CoV–
2 infections from the grave danger from
exposure to SARS–CoV–2.
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OSHA recognizes that its finding
regarding infection-induced immunity
is being made in an area of inquiry that
is currently on the ‘‘frontiers of
scientific knowledge’’ (Indus. Union
Dep’t, AFL–CIO v. Am. Petroleum Inst.,
448 U.S. 607, 656 (1980)). For these
reasons, OSHA finds that those who
have previously been infected with
SARS–CoV–2 and are not yet fully
vaccinated are at grave danger from
SARS–CoV–2 exposure and that it is
necessary to protect these workers via
vaccination, or testing and the use of
face coverings, under this standard.
OSHA will continue to follow
developments on this issue, however,
and make appropriate adjustments to
this ETS if the evidence warrants.
VI. Conclusion.
OSHA finds that many employees in
the U.S. who are not fully vaccinated
against COVID–19 face a grave danger
from exposure to SARS–CoV–2 in the
workplace. OSHA’s determination is
based on the severe health
consequences of exposure to the virus,
including death; powerful lines of
evidence demonstrating the
transmissibility of the virus in the
workplace; and the prevalence of
infections in employee populations.
With respect to the grave health
consequences of exposure to SARS–
CoV–2, OSHA has found that regardless
of where and how exposure occurs,
COVID–19 can result in death. Even for
those who survive a SARS–CoV–2
infection, the virus can cause serious,
long-lasting, and potentially permanent
health effects. Serious cases of COVID–
19 require hospitalization and dramatic
medical interventions, and might leave
employees with permanent and
disabling health effects. Both death and
serious cases of COVID–19 requiring
hospitalization provide independent
bases for OSHA’s finding of grave
danger. The evidence is clear that the
safe and effective vaccines authorized
and/or approved for use in the United
States greatly reduce the likelihood of
these severe outcomes.
The best available evidence on the
science of transmission of the virus
makes clear that SARS–CoV–2 is
transmissible from person to person in
shared workplace settings. The
likelihood of transmission can be
exacerbated by common characteristics
of many workplaces, including working
indoors, working with others for
extended periods of time, poor
ventilation, and close contact with
potentially infectious individuals. The
likelihood of transmission in the
workplace is also exacerbated by the
presence of unvaccinated workers, who
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are more likely than those who are
vaccinated to be infected and transmit
the virus to others. Every workplace
SARS–CoV–2 exposure or transmission
has the potential to cause severe illness
or even death, particularly in
unvaccinated workers. Taken together,
the severe health consequences of
COVID–19 and the evidence of its
transmission in environments
characteristic of the workplaces covered
by this ETS demonstrate that exposure
to SARS–CoV–2 represents a grave
danger to unvaccinated employees in
many workplaces throughout the
country.
The existence of a grave danger to
employees from SARS–CoV–2 is further
supported by the toll the pandemic has
already taken on the nation as a whole
and the number of workers who remain
unvaccinated. Although OSHA cannot
state with precision the total number of
workers in our nation who have
contracted COVID–19 at work and
became sick or died, COVID–19 has
killed 723,205 people in the United
States as of October 18, 2021 (CDC,
October 18, 2021—Cumulative US
Deaths). That death toll includes
131,478 people who were 18 to 64 years
old, prime working age (CDC, October
18, 2021—Demographic Trends, Deaths
by Age Group). OSHA estimates that
there are over 26 million workers
subject to the rule who remain
unvaccinated at present and therefore
are in grave danger. As a result of this
ETS, the agency estimates that 72% of
them will be vaccinated (see OSHA,
October 2021c).
Current mortality data shows that
unvaccinated people of working age
have a 1 in 202 chance of dying when
they contract COVID–19 (CDC, October
18, 2021—Demographic Trends, Cases
by Age Group; Demographic Trends,
Deaths by Age Group). As of October 18,
2021, close to 45 million people in the
United States have been reported to
have infections, and thousands of new
cases were being identified daily (CDC,
October 18, 2021—Daily Cases).One in
14 reported cases of COVID–19 in
people ages 18 to 64 becomes severe and
requires hospitalization (CDC, October
18, 2021—Demographic Trends, Cases
by Age; Total Hospitalizations, by Age).
Moreover, public health officials agree
that these numbers fail to show the full
extent of the deaths and illnesses from
this disease, and racial and ethnic
minority groups are disproportionately
represented among COVID–19 cases,
hospitalizations, and deaths (CDC,
December 10, 2020; CDC, May 26, 2021;
Escobar et al., February 9, 2021; Gross
et al., October 2020; McLaren, June
2020; CDC, October 6, 2021). Given this
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context, OSHA is confident in its
finding that exposure to SARS–CoV–2
poses a grave danger to the employees
covered by this ETS.
The above analysis fully satisfies the
OSH Act’s requirements for finding a
grave danger. Although OSHA usually
performs a quantitative risk assessment
based on extrapolations among exposure
levels before promulgating a health
standard under section 6(b)(5) of the
OSH Act (29 U.S.C. 655(b)(5)), that type
of analysis is not necessary in this
situation. OSHA has most often invoked
section 6(b)(5) authority to regulate
exposures to chemical hazards
involving much smaller populations,
many fewer cases, extrapolations from
animal evidence, long-term exposure,
and delayed effects. In those situations,
mathematical modelling is necessary to
evaluate the extent of the risk at
different exposure levels. The gravity of
the danger presented by a disease with
acute effects like COVID–19, on the
other hand, is made obvious by a
straightforward count of deaths and
illnesses caused by the disease, which
reach sums not seen in at least a
century. The evidence compiled above
amply supports OSHA’s finding that
SARS–CoV–2 presents a grave danger in
American workplaces. In the context of
ordinary 6(b) rulemaking, the Supreme
Court has said that the OSH Act is not
a ‘‘mathematical straitjacket,’’ nor does
it require the agency to support its
findings ‘‘with anything approaching
scientific certainty,’’ particularly when
operating on the ‘‘frontiers of scientific
knowledge’’ (Indus. Union Dep’t, AFL–
CIO v. Am. Petroleum Inst., 448 U.S.
607, 655–56 (1980)). This is true a
fortiori in the current national crisis,
where OSHA must act to ensure
employees are adequately protected
from the hazard presented by the
COVID–19 pandemic (see 29 U.S.C
655(c)(1)).The grave danger from SARS–
CoV–2 represents the biggest threat to
employees in OSHA’s more than 50-year
history. The threat applies to employees
in all sectors covered by OSHA,
including general industry,
construction, maritime, agriculture, and
healthcare. Having made the
determination of grave danger, as well
as the determination that an ETS is
necessary to protect employees from
exposure to SARS–CoV–2 (see Need for
the ETS, Section III.B. of this preamble),
OSHA is required to issue this standard
to protect employees from getting sick
or dying from COVID–19 acquired at
work (see 29 U.S.C. 655(c)(1)).
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B. Need for the ETS
This ETS is necessary to protect
unvaccinated workers from the risk of
contracting COVID–19, including its
more contagious variants, such as the
B.1.617.2 (Delta), at work. The rule
protects workers through the most
effective and efficient workplace control
available: Vaccination. Additionally,
this ETS is necessary to protect workers
who remain unvaccinated through
required regular testing, use of face
coverings, and removal of infected
employees from the workplace.
I. Events Leading to the ETS
This section describes the evolution
of OSHA’s actions to protect employees
from the grave danger posed by COVID–
19 and the agency’s reasons for issuing
this ETS at this time.
a. OSHA’s 2020 Actions Regarding
COVID–19
Beginning in early 2020, OSHA began
to monitor the growing cases of the
SARS–CoV–2 virus that were occurring
around the country. Because scientific
information about the disease, its
potential duration, and ways to mitigate
it were undeveloped, OSHA decided to
monitor the situation. As noted below,
OSHA subsequently issued numerous
guidance documents advising interested
employers of steps they could take to
mitigate the hazard arising from the
virus.
Also beginning in early 2020, OSHA
received numerous petitions and
supporting letters from members of
Congress, unions, advocacy groups, and
one group of large employers urging the
agency to take immediate action by
issuing an ETS to protect employees
from exposure to the virus that causes
COVID–19 (Scott and Adams, January
30, 2020; NNU, March 4, 2020; AFL–
CIO, March 6, 2020; Menendez et al.,
March 9, 2020; Wellington, March 12,
2020; DeVito, March 12, 2020; Carome,
March 13, 2020; SMART, March 30,
2020; Blumenthal et al., April 8, 2020;
Murray et al., April 29, 2020; Luong,
April 30, 2020; Novoa, June 24, 2020;
Solt, April 28, 2020; Castro et al., April
29, 2020; Talbott and Adely, May 4,
2020; Public Citizen, March 13, 2020;
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LULAC, March 31, 2020; Meuser, May
1, 2020; Raskin, April 29, 2020;
Cartwright et al., May 7, 2020; Frosh et
al., May 12, 2020; Pellerin, March 19,
2020; Yborra, March 19, 2020; Owen,
March 19, 2020; Brown et al., April 30,
2020; Price et al., May 1, 2020;
ORCHSE, October 9, 2020). These
petitions and supporting letters argued
that many employees had been infected
because of workplace exposures to the
virus that causes COVID–19, and that
immediate, legally enforceable action is
necessary for protection. OSHA quickly
began issuing detailed guidance
documents and alerts beginning in
March 2020 that helped employers to
determine employee risk levels of
COVID–19 exposure and made
recommendations for appropriate
controls. As explained in detail in
Section IV. of the Healthcare ETS, 86 FR
32376, 32412–13 (June 21, 2021) and
hereby included in the record for this
ETS,16 at the time, OSHA leadership
believed that implementing a
combination of enforcement tools,
including guidance, existing OSHA
standards, and the General Duty Clause,
would provide the necessary protection
for workers. OSHA also expressed
concern that an ETS might
unintentionally enshrine requirements
that are subsequently proven ineffective
in reducing transmission.
When it decided not to issue an ETS
in the spring of 2020, OSHA determined
that the agency could provide sufficient
employee protection against COVID–19
through enforcing existing workplace
standards and the General Duty Clause
of the OSH Act, coupled with issuing
industry-specific, non-mandatory
guidance. However, in doing so OSHA
indicated that its conclusion that an
ETS was not necessary was specific to
that time, and that the agency would
continue to monitor the situation and
take additional steps as appropriate (see,
e.g., OSHA, March 18, 2020 Letter to
Congressman Scott (stating ‘‘[W]e
currently see no additional benefit from
an ETS in the current circumstances
relating to COVID–19. OSHA is
continuing to monitor this quickly
evolving situation and will take the
appropriate steps to protect workers
from COVID–19 in coordination with
the overall U.S. government response
effort.’’ (emphasis supplied); DOL May
29, 2020 at 20 (stating ‘‘OSHA has
determined this steep threshold [of
necessity] is not met here, at least not
at this time.’’ (emphasis supplied))).
16 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
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In addition to the various petitions for
rulemaking that were submitted to
OSHA, the AFL–CIO filed a petition for
a writ of mandamus with the U.S. Court
of Appeals for the D.C. Circuit,
requesting that the court compel OSHA
to issue an ETS. (AFL–CIO, May 18,
2020). In its administrative decision and
filing in that case, OSHA explained that
the determination not to issue an ETS
was based on the conditions and
information available to the agency at
that time and was subject to change as
additional information indicated the
need for an ETS. On June 11, 2020, the
U.S. Court of Appeals for the D.C.
Circuit issued a one paragraph per
curiam order denying the AFL–CIO’s
petition to require OSHA to issue an
ETS. To be clear, nothing in OSHA’s
prior position or the D.C. Circuit’s
decision in In re Am. Fed’n of Labor &
Cong. of Indus. Orgs., No. 20–1158,
2020 WL 3125324 (D.C. Cir. June 11,
2020); rehearing en banc denied (July
28, 2020) precludes OSHA’s decision to
promulgate an ETS now. To the
contrary, at an early phase of the
pandemic, when vaccines were not yet
available and when it was not yet
known how extensive the impact would
be on illness and death, the court
decided not to second-guess OSHA’s
decision to hold off on regulation in
order to see if its nonregulatory
enforcement tools could be used to
provide adequate protection against the
virus. ‘‘OSHA’s decision not to issue an
ETS is entitled to considerable
deference,’’ the court explained, noting
‘‘the unprecedented nature of the
COVID–19 pandemic’’ and concluding
merely that ‘‘OSHA reasonably
determined that an ETS is not necessary
at this time.’’ (Id., with emphasis
added).
Employers do not have a reliance
interest in OSHA’s prior decision not to
issue an ETS on May 29, 2020, which
did not alter the status quo or require
employers to change their behavior. See
Dep’t of Homeland Security v. Regents
of the Univ. of California, 140 S. Ct.
1891, 1913–14 (2020). As OSHA
indicated when it made the decision,
the determination was based on the
conditions and information available to
the agency at that time and was subject
to change as additional information
indicated the need for an ETS. In light
of the agency’s express qualifications
and the surrounding context, any
employer reliance would have been
unjustified and cannot outweigh the
countervailing urgent need to protect
workers covered by this ETS from the
grave danger posed by COVID–19.
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b. OSHA’s Decision To Promulgate a
Healthcare ETS
OSHA subsequently issued the
Healthcare ETS to protect healthcare
workers. 86 FR 32376. (June 21, 2021),
codified at 29 CFR 1910.502. Looking
back on a year of experience, OSHA
found that its enforcement efforts had
encountered significant obstacles,
demonstrating that existing standards,
regulations, and the General Duty
Clause were inadequate to address the
grave danger faced by healthcare
employees. 86 FR 32415. In
promulgating that ETS, OSHA
recognized that ‘‘the impact of [COVID–
19] has been borne disproportionately
by the healthcare and healthcare
support workers tasked with caring for
those infected by this disease.’’ 86 FR
32377. Furthermore, states and localities
had taken increasingly divergent
approaches to workplace protections
against COVID–19, making it clear that
a federal standard was needed to ensure
sufficient protection in all states. 86 FR
32377. Therefore, OSHA focused on the
unique situation experienced by
healthcare industry workers as the
frontline caregivers and support workers
for those suffering from COVID–19. See
86 FR 32376, 32411–12.
The Healthcare ETS requires
employers to institute a suite of
engineering controls, administrative
controls, work practices, and personal
protective equipment to combat the
COVID–19 hazard. In the Preamble to
the Healthcare ETS, OSHA observed
that the development of safe and highly
effective vaccines is a critical milestone
in the nation’s response to COVID–19,
and that fully vaccinated persons have
a greatly reduced risk of death,
hospitalization and other health
consequences. 86 FR 32396. The
Healthcare ETS therefore includes
provisions intended to encourage
employees to become vaccinated,
including a requirement for employers
to provide reasonable paid leave for
vaccination and recovery from any side
effects. 86 FR 32415, 29 CFR
1910.502(m).
In the Healthcare ETS OSHA found
that employees who work in covered
healthcare workplaces are exposed to
grave danger. 86 FR 32411. The agency
also stated that in light of the
effectiveness of vaccines, there was
‘‘insufficient evidence in the record to
support a grave danger finding for nonhealthcare workplaces where all
employees are vaccinated.’’ 86 FR 32396
(emphasis supplied). OSHA made no
finding at that time regarding
unvaccinated workers in non-healthcare
workplaces.
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No employer challenged the
Healthcare ETS in court. The United
Food and Commercial Workers Union
(UFCW) together with the AFL–CIO
filed a petition for review asserting that
the rule should have gone further and
included more industries in its scope
(UFCW and AFL–CIO, June 24, 2021).
That case is being held in abeyance
pending the issuance of this ETS.
c. Subsequent Developments
The preamble to the Healthcare ETS
notes that new COVID–19 variants
might emerge that are more
transmissible and cause more severe
illness, but does not specifically
mention the Delta Variant. See 86 FR
32384. Since publication of the
Healthcare ETS, the Delta Variant has
become the dominant form of the virus
in the United States, causing large
spikes in transmission, and surges of
hospitalizations, and deaths,
overwhelmingly among the
unvaccinated (CDC, August 26, 2021;
CDC, October 18, 2021—Variant
Proportions, July Through October,
2021). As discussed in more detail in
Grave Danger (Section III.A. of this
preamble), the Delta Variant is at least
twice as contagious as previous COVID–
19 variants, and research suggests that it
also causes more severe illness in the
unvaccinated population (CDC, August
26, 2021). More infections mean more
potential for exposures, including in
workplaces (see Grave Danger, Section
III.A. of this preamble, for further
discussion on workplace outbreaks,
clusters, and the general impact of
transmission in the workplace.). More
infections also mean more opportunities
for the virus to undergo mutations to its
genetic code, resulting in genetic
variants with the potential to infect or
re-infect people.
Some variability in infection rates in
a pandemic is to be expected. While the
curves of new infections and deaths can
bend down after peaks, they often
reverse course only to reach additional
peaks in the future (Moore et al., April
30, 2020). Last year experts expressed
concern that one or more subsequent
waves of COVID–19 were possible in
2021 (Moore et al., April 30, 2020),
especially with new variants of COVID–
19 in circulation (Doughton, February 9,
2021). That potential tragically became
a reality with the spread of the Delta
Variant.
In June 2021, when the Healthcare
ETS was published, COVID–19
transmission rates in the United States
were at a low point, with the 7-day
moving average of reported cases to be
about 12,000. (CDC, August 26, 2021)
However, by the end of July, the 7-day
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moving average reached over 60,000 as
the Delta Variant spread across the
country. (CDC, August 26, 2021). The 7day moving average of reported cases at
the beginning of September, 2021
exceeded 161,000 (CDC, October 18,
2021—Daily Cases). The most recent 7day moving average of reported cases,
while lower than the peak in late
August and early September, is still over
85,000. (CDC, October 18, 2021—Daily
Cases). These rates are also far higher
than the rate when OSHA first declined
to issue an ETS. (CDC, August 27, 2020
(20,401 confirmed cases per day on May
29, 2020)). The jump in infections has
resulted in increased hospitalizations
and deaths for unvaccinated workers, as
discussed in detail in Grave Danger
(Section III.A. of this preamble). While
the most current data reflect a decline
in new cases from the peak, the level of
new cases remains high. CDC data
shows that, as of October 18, 2021,
approximately 85% of U.S. counties
were experiencing ‘‘high’’ rates of
community transmission, and another
10% were experiencing ‘‘substantial’’
community transmission (CDC, October
18, 2021—Daily Cases). Although the
number of new detected cases is
currently declining nationwide (see
CDC, October 18, 2021—Community
Transmission Rates), the agency cannot
assume based on past experience that
nationwide case levels will not increase
again. Indeed, many northern states are
currently experiencing increases in their
rate of new cases (see CDC, October 18,
2021—Cases, Deaths, and Laboratory
Testing (NAATS) by State; Slotnik,
October 18, 2021), including Vermont,
which set a new record for new COVID–
19 cases in mid-October 2021 (Murray,
October 18, 2021). Unless vaccination
rates increase, the experience of
northern states during this fall could
presage a greater resurgence in cases
this winter as colder weather drives
more individuals indoors (see Firozi
and Dupree, October 18, 2021).
While it is important to recognize that
the Delta Variant has caused a spike in
hospitalization and death in the United
States, the SARS–CoV–2 virus, and not
just a particular variant of that virus, is
the hazard that workers face (see Grave
Danger, Section III.A. of this preamble).
Like any virus, SARS–CoV–2 has the
ability to mutate over time and produce
variants that may be more or less severe.
Indeed, the World Health Organization
and the CDC both track new variants
that have continued to arise, such as the
Lamda and Mu Variants (WHO, October
12, 2021; CDC, October 4, 2021). At this
time, the CDC is tracking 11 different
variants of COVID–19 (CDC, October 4,
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61431
2021). The World Health Organization
has classified the Lambda and Mu
variants as ‘‘variants of interest,’’
meaning that they have genetic changes
that affect transmissibility, disease
severity, immune escape, diagnostic or
therapeutic escape; and have been
identified to cause significant
community transmission or multiple
COVID–19 clusters, in multiple
countries with increasing relative
prevalence alongside increasing number
of cases over time, or other apparent
epidemiological impacts to suggest an
emerging risk to global public health
(WHO, October 12, 2021). Medical
experts have also explained that
vaccination reduces the opportunities
for the virus to continue to mutate by
reducing transmission and length of
infection. And, there is no indication
that future variants of COVID–19 will
not be equally or even more dangerous
than Delta without a higher rate of
vaccination (Bollinger and Ray, July 23,
2021).
Meanwhile, evidence on the power of
vaccines to safely protect individuals
from infection and especially from
serious disease has continued to
accumulate. (CDC, May 21, 2021). For
example, as explained in more detail in
Grave Danger (Section III.A. of this
preamble), multiple studies have
demonstrated that vaccines are highly
effective at reducing instances of
hospitalization and death. In September
the CDC compiled data from various
studies that demonstrated overall
authorized vaccines reduced death and
severe case rates by 91 and 92%
respectively in the population studied
between April and July (Scobie et al.,
September 17, 2021, Table 1.).
Additionally, the FDA granted approval
to the Pfizer-BioNTech COVID–19
Vaccine for individuals 16 years of age
and older on August 23, 2021 (FDA,
August 23, 2021). In announcing the
decision, the FDA Commissioner
explained that ‘‘[w]hile this and other
vaccines have met the FDA’s rigorous,
scientific standards for emergency use
authorization, as the first FDA-approved
COVID–19 vaccine, the public can be
very confident that this vaccine meets
the high standards for safety,
effectiveness, and manufacturing quality
the FDA requires of an approved
product.’’ (FDA, August 23, 2021.)
Despite this important milestone, and
the demonstrated effectiveness of the
approved and authorized vaccines
available to the public, millions of
employees remain unvaccinated,
approximately 39% of workers who are
covered by this ETS (See Economic
Analysis, Section IV.B. of this ETS). The
rate of vaccination in the United States
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has slowed significantly from its peak in
April, when the daily number of
vaccination doses administered
exceeded three million at one point. In
recent months, daily vaccination rates
have hovered around one million doses
administered, or lower (CDC, October
18, 2021—Daily Vaccination Rate). The
shortfall in vaccination leaves the
nation’s working population vulnerable
to sickness, hospitalization and death,
whether today under the Delta Variant,
or under future variants that may arise
(CDC, October 18, 2021—Daily
Vaccination Rate); see also Grave Danger
(Section III.A. of this preamble).
Moreover, in recent months, an
increasing number of states have
promulgated Executive Orders or
statutes that prohibit workplace
vaccination policies that require
vaccination or proof of vaccination
status, thus attempting to prevent
employers from implementing the most
efficient and effective method for
protecting workers from the hazard of
COVID–19 (see, e.g., Texas Executive
Order GA–40, October 11, 2021;
Montana H.B. 702, July 1, 2021;
Arkansas S.B. 739, October 4, 2021 and
Arkansas H.B. 1977, October 1, 2021;
AZ Executive Order 2021–18, August
16, 2021). While some States’ bans have
focused on preventing local
governments from requiring their public
employees to be vaccinated or show
proof of vaccination, the Texas,
Montana, and Arkansas requirements
apply to private employers as well.
Other states have banned local
ordinances that require employers to
ensure that customers who enter their
premises wear masks, thus endangering
the employees who work there,
particularly those who are unvaccinated
(see, e.g., Florida Executive Order 21–
102, May 3, 2021; Texas Executive
Order GA–34, March 2, 2021).
In short, at the present time, workers
are becoming sick and dying
unnecessarily as a result of occupational
exposures, when there is a simple and
effective measure, vaccination, that can
largely prevent those deaths and
illnesses (see Grave Danger, Section
III.A. of this preamble). Congress
charged OSHA with responsibility for
issuing emergency standards when they
are necessary to protect employees from
grave danger. 29 U.S.C. 655(c). In light
of the current situation, OSHA is issuing
this emergency rule.
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American Federation of Labor and
Congress of Industrial Organizations
(AFL–CIO). (2021, June 24). ‘‘Petition for
Review, filed with the D.C. Circuit on
June 24, 2021.’’ (UFCW and AFL–CIO,
June 24, 2021)
Wellington M. (2020, March 12). ‘‘Grant
OSHA emergency standard for COVID–
19 to protect front-line workers’’
(Wellington, March 12, 2020)
World Health Organization (WHO). (2021,
October 12). Tracking SARS–CoV–2
variants. https://www.who.int/en/
activities/tracking-SARS-CoV-2-variants/
. (WHO, October 12, 2021)
Yborra G. (2020, March 19). ‘‘Grant OSHA
emergency standard to protect frontline
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workers from COVID–19.’’ (Yborra,
March 19, 2020)
II. This ETS Is Necessary To Protect
Unvaccinated Employees From Grave
Danger
As explained at length in the
preceding section (Grave Danger,
Section III.A. of this preamble), OSHA
has determined that most unvaccinated
workers across the U.S. economy are
facing a grave danger posed by the
COVID–19 hazard.17 This new hazard
has taken the lives of more than 725,000
people—many of them workers—in the
United States since it was first detected
in this country in early 2020. As the
federal agency tasked with protecting
the safety and health of workers in the
United States, OSHA is required to act
when it finds that workers are exposed
to a grave danger. 29 U.S.C. 655(c)(1).
OSHA now finds that this emergency
temporary standard is necessary to
protect employees who are
unvaccinated. Asbestos Info. Ass’n, 727
F.2d at 423 (‘‘failure to act does not
conclusively establish that a situation is
not an emergency . . . [when there is a
grave danger to workers,] to hold that
because OSHA did not act previously it
cannot do so now only compounds the
consequences of the Agency’s failure to
act.’’). As explained in detail below,
OSHA has determined that vaccination
is the most effective control for abating
the grave danger that unvaccinated
employees face from the COVID–19
hazard. And, for workers who are not
vaccinated, the use of testing, face
coverings, and removal from the
workplace, while not as effective as
vaccination, is still effective and
necessary.
OSHA has determined that the best
method for addressing the grave danger
that COVID–19 poses to unvaccinated
workers is to strongly encourage the use
of the single most effective and efficient
protection available: Vaccination. OSHA
17 As explained in the Grave Danger section, this
ETS focuses on protecting unvaccinated workers
from the grave danger that COVID–19 poses in the
workplace. OSHA did not include fully vaccinated
workers in its finding of grave danger because such
workers are generally much better protected from
the effects of COVID–19, and, in particular, the
most severe effects, than workers who are
unvaccinated. OSHA’s action in adopting this ETS
for unvaccinated workers does not mean that
vaccinated workers do not face a significant risk
from COVID–19, or that the OSH Act’s general duty
clause poses no obligation on employers to protect
their vaccinated workers from COVID–19. Indeed,
symptomatic infections can occur in fully
vaccinated people, and COVID–19 therefore poses
at least some risk to vaccinated workers. OSHA has
requested comment on the risks faced by vaccinated
workers from COVID–19, and what additional
measures, if any, should be taken to protect both
vaccinated and unvaccinated workers (see Request
for Comments, Section I.B. of this preamble).
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has long recognized the importance of
vaccinating workers against preventable
illnesses to which they may be exposed
on the job. See 56 FR 64004, 64152 (Dec.
6, 1991) (discussing requirement in
Bloodborne Pathogens standard for
employer to make hepatitis B vaccine
available to any employees with
occupational exposure to blood and
other potentially infectious materials).
As explained in Grave Danger (Section
III.A. of this preamble), COVID–19
vaccines do not completely eliminate
the potential for infection, but
significantly reduce the likelihood of
infection, and in turn, transmission of
the virus to others. Data from clinical
trials for all three vaccines and
observational studies for the two mRNA
vaccines clearly establish that fully
vaccinated persons have a greatly
reduced risk of SARS–CoV–2 infection
compared to unvaccinated individuals
(see FDA, December 11, 2020; FDA,
December 18, 2020; FDA, February 26,
2021).
More importantly, vaccination is the
single most effective method for
protecting workers from the most
serious consequences of a COVID–19
infection: Hospitalization and death.
Although symptomatic infections can
occur in fully vaccinated people, they
are less likely to occur, and are far less
likely to result in severe health
outcomes or death. As discussed in
Grave Danger (Section III.A. of this
preamble), studies have established that
the available COVID–19 vaccines are
highly effective at preventing
hospitalization, and even more effective
at preventing death. For example, one
study found that unvaccinated adults
age 18 to 49 were 15.2 times more likely
to be hospitalized and 17.2 times more
likely to die of COVID–19 than fully
vaccinated people in the same age
range, and unvaccinated adults age 50 to
64 were 10.9 times more likely to be
hospitalized and 17.9 times more likely
to die than their fully vaccinated peers
(Scobie et al., September 17, 2021). The
New York Times reported on October 1,
2021, that of the approximately 100,000
individuals who died of COVID–19
since mid-June 2021, less than 3% had
been identified by the CDC as
vaccinated individuals (Boseman and
Leatherby, October 1, 2021).
Vaccines are also uniquely effective
when compared to non-pharmaceutical
methods for controlling exposure to
COVID–19 at the workplace. To be sure,
non-pharmaceutical controls play an
important role in employers’ efforts to
prevent exposure to the virus; as
discussed in detail earlier, OSHA has,
throughout the pandemic, advised
employers to implement various
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administrative, engineering, and other
controls to reduce workplace exposure
to the virus. And, for certain work
settings in the healthcare industry
where people with COVID–19 are
reasonably expected to be present,
OSHA both encouraged vaccination and
mandated a suite of protections, many
of which involve physical controls (see
29 CFR 1910.502). Indeed, workers who
work indoors and near others are best
protected from COVID–19 when they
are fully vaccinated and their exposure
to COVID–19 is reduced (to the extent
possible) by non-pharmaceutical
controls.
Non-pharmaceutical controls,
however, focus on preventing employee
exposure to the virus, and do not
directly affect an employee’s immune
response if exposure to the virus does
occur. Additionally, nonpharmaceutical controls often rely on
the actions of individuals and/or the
integrity of equipment to be effective;
for example, to use PPE to control
exposure, a worker must correctly don
appropriate PPE each time there is
potential exposure, must properly clean,
store, and maintain the PPE between
uses, and must replace the PPE when it
is no longer effective (see, e.g., 29 CFR
1910.132 (general PPE requirements in
general industry workplaces)).
Accordingly, OSHA standards have
always followed the principle of the
hierarchy of controls, under which
employers must control hazards by
means other than PPE whenever
feasible, and PPE is a supplementary
control. See e.g., 29 CFR 1910.134(a); 29
CFR 1910.1030(d)(2).
Physical distancing requires workers
to maintain constant awareness of their
environment in order to avoid coming
into close proximity with colleagues,
customers, or other individuals, even
though the realities of their jobs and/or
the design of the workplace may be
unaccommodating to that effort.
Requiring employees to examine
themselves for signs and symptoms
consistent with SARS–CoV–2 infection
before reporting to work is prone to
human error and entirely ineffective
when the employee is infected but
asymptomatic or pre-symptomatic.
In contrast, a worker is considered
fully vaccinated after completing
primary vaccination with a COVID–19
vaccine, or the second dose of any
combination of two doses of a COVID–
19 vaccine that is approved, authorized,
or listed as a two-dose primary
vaccination by the FDA or WHO (see the
Summary and Explanation for
paragraph (c), Section VI.C. of this
preamble). Once fully vaccinated, a
worker enjoys automatic and long-
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lasting benefits; namely, a drastic
reduction in the risk of severe health
effects or death. The vaccine works by
bolstering the worker’s immune system
and does not depend on the worker’s
acumen or actions to afford its
protection. Moreover, where an
employer implements one or more nonpharmaceutical controls at the
workplace, vaccination provides
workers with a backstop of protection
that greatly reduces their risk of serious
health effects if they are exposed to the
virus despite the presence of other
controls. Vaccination thus ensures that
workers need not rely on other factors,
be it the workplace environment, the
effectiveness of equipment, or the
actions of other individuals, to be
substantially protected from the worst
potential outcomes of a COVID–19
infection.
This ETS focuses on encouraging
vaccination because it is the most
efficient and effective method for
addressing the grave danger.
Vaccination is patently appropriate and
feasible for almost every worker in all
industries, and will drastically reduce
the risk that unvaccinated workers will
suffer the serious health outcomes
associated with SARS–CoV–2 infection.
As described in Section III.A. of this
preamble (Grave Danger), employees
who are unvaccinated are in grave
danger from the SARS–CoV–2 virus, but
employees who are fully vaccinated are
not. Since it is the lack of vaccination
that results in grave danger, vaccination
will best allay the grave danger. This
ETS, which is designed to strongly
encourage vaccination, is thus
‘‘necessary to protect employees’’ from
a grave danger. 29 U.S.C. 655(c).
OSHA continues to encourage
employers to implement additional
controls that may be appropriate to
eliminate exposure to the SARS–CoV–2
virus at their workplace, but, as
discussed further below, OSHA has not
required employers to implement a
comprehensive and multilayered set of
COVID–19 exposure controls in this
ETS. This decision reflects the
extraordinary and exigent circumstances
have required OSHA to immediately
promulgate this emergency temporary
standard. Although OSHA was able to
design a comprehensive infection
prevention program for the specific
healthcare settings to which the June
2021 Healthcare ETS applied, this rule
encompasses all industries covered by
the OSH Act, and targets unvaccinated
workers in any indoor work setting not
covered by the Healthcare ETS where
more than one person is present.
Crafting a multi-layered standard that is
comprehensive and feasible for all
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covered work settings, including mixed
settings of vaccinated and unvaccinated
workers, is an extraordinarily
challenging and complicated
undertaking, yet the grave danger that
COVID–19 poses to unvaccinated
workers obliges the agency to act as
quickly possible. As discussed above,
OSHA has identified vaccination as the
single most efficient and effective means
for removing an unvaccinated worker
from the grave danger.
Given the urgency of the rulemaking,
and the singular effectiveness of
vaccination in removing unvaccinated
workers from the grave danger, OSHA is
promulgating this ETS to immediately
address the grave danger that COVID–19
poses to unvaccinated workers by
strongly encouraging vaccination. As
discussed in Pertinent Legal Authority
(Section II. of this preamble), a ‘‘grave
danger’’ represents a risk greater than
the ‘‘significant risk’’ that OSHA must
show in order to promulgate a
permanent standard under section 6(b)
of the OSH Act, 29 U.S.C. 655(b). OSHA
will consider whether it is necessary to
require additional controls to avert a
significant risk of harm in the
rulemaking proceedings that follow this
ETS. OSHA directs employers to its
website, www.osha.gov/coronavirus,
and the CDC’s website, www.cdc.gov/
coronavirus, for guidance on the
engineering, administrative, and other
exposure controls that may be effective
and appropriate for their workplace.
OSHA expects that, by strongly
encouraging vaccination, this ETS will
have a positive impact on worker
health. As discussed above, millions of
workers remain unvaccinated and are
presently exposed to risks of
hospitalization and death many times
higher than their vaccinated coworkers.
Although predicting the health impact
of this ETS is particularly challenging,
given the ever-changing nature of the
pandemic and the many factors that
may motivate workers to become fully
vaccinated, OSHA has attempted to
quantify the potential number of
hospitalizations and fatalities that this
ETS could avert by increasing workforce
vaccination rates (see OSHA, October
2021c). OSHA has estimated that, as a
result of the ETS, over 6,500 fewer
currently unvaccinated workers will die
from COVID–19 over the next six
months. OSHA also estimates that this
ETS will prevent over 250,000 currently
unvaccinated workers from being
hospitalized during that same time
period. Even if OSHA’s estimate does
not prove to be precisely accurate,
OSHA is confident that this ETS will
save hundreds of lives and prevent
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thousands of workers from becoming
severely ill.
a. OSHA Finds It Necessary To Strongly
Encourage Vaccination
Despite the proven safety and efficacy
of the available COVID–19 vaccines,
many workers remain unvaccinated and
are currently exposed to a grave danger.
As discussed in Grave Danger (Section
III.A. of this preamble), countless
COVID–19 outbreaks have occurred in
myriad work settings where employees
come into contact with others, and in
recent weeks, the majority of states in
the U.S. have experienced what CDC
defines as high or substantial
community transmission, indicating
that there is a clear risk of the virus
being introduced into and circulating in
workplaces (CDC, October 18, 2021—
Community Transmission Rates). As of
October 18, 2021, more than 184 million
people in the United States have been
fully vaccinated, but only 68.5% of
people ages 18 years or older are fully
vaccinated (CDC, October 18, 2021—
Fully Vaccinated). OSHA has estimated
that approximately 62.4% percent of
adults aged 18–74 within the scope of
this ETS are either fully vaccinated or
received their first vaccine dose during
the previous two weeks, leaving
approximately 31.7 million
unvaccinated (i.e., not fully vaccinated
and did not receive a first dose with in
the past two weeks) (see Economic
Analysis, Section IV.B. of this preamble,
Table IV.B.7). Meanwhile, the rate of
new vaccinations has slowed
considerably; on October 15, 2021, the
7-day moving average number of
administered vaccine doses reported to
the CDC per day was 841,731 doses, a
steep reduction from the peak 3,448,156
dose average that the CDC reported on
April 11, 2021 (CDC, October 18, 2021—
Weekly Review).
Given the pervasiveness of the virus
in workplaces across the country and
the unparalleled efficacy of vaccines at
preventing serious health effects, OSHA
finds it necessary to strongly encourage
vaccination. Encouraging vaccination is
principally necessary to reduce the
likelihood that workers who are infected
by the SARS–CoV–2 virus will suffer
the worst outcomes of an infection
(hospitalization and death). Put simply,
the single best method for protecting an
unvaccinated worker from the serious
health consequences of a COVID–19
infection is for that worker to become
fully vaccinated.
Additionally, encouraging vaccination
is necessary to reduce the overall
prevalence of the SARS–CoV–2 virus at
workplaces. Because vaccinated workers
are less likely than unvaccinated
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workers to be infected by the virus, they
are less likely to spread the virus to
others at their workplace, including to
unvaccinated coworkers. Increasing
workforce vaccination rates will
therefore reduce the risk that
unvaccinated workers will be infected
by a coworker.
Evidence shows that mandating
vaccination has proven to be an
effective method for increasing
vaccination rates, and that vaccination
mandates have generally been more
effective than merely encouraging
vaccination. Significant numbers of
workers would get vaccinated if their
employers required it, and many
workers who were vaccinated over the
last four months were motivated by
their employer requiring vaccination.
The Kaiser Family Foundation (KFF)
vaccine monitor, an ongoing research
project tracking the public’s attitudes
and experiences with COVID–19
vaccinations, conducted a survey from
September 13 to September 22, 2021,
among a nationally representative
random digit dial telephone sample of
1,519 adults ages 18 and older, and
found that those who received their first
dose of a COVID–19 vaccine after June
1, 2021 were motivated by mandates of
various sorts, including one in five
(19%) who say a major reason was that
their employer required it (KFF,
September 2021). A survey conducted
by Change Research from August 30 to
September 2, 2021 regarding Americans’
views on COVID–19 vaccines found that
among the 1,775 respondents, ‘‘one of
the things that was most likely to lead
someone to get vaccinated was if their
employer required it’’ (Towey,
September 27, 2021).
Vaccine mandates imposed by state
governments and large employers have
also demonstrated the effectiveness of
mandates in increasing vaccination
rates. For example, when Tyson Foods
announced its vaccination requirement
in early August 2021, only 45% of its
workforce had received a vaccination
dose, but as of September 30, 2021, the
New York Times reported that has
increased to 91% (White House, October
7, 2021; Hirsch, September 30, 2021).
Similarly, United Airlines reported that
97% of its U.S.-based employees were
fully vaccinated against COVID–19
within a week of the deadline of the
company’s vaccination mandate, and
the 3% who were not fully vaccinated
included several employees who sought
a medical or religious exemption from
vaccination (The Associated Press,
September 22, 2021). In Washington
State, the weekly vaccination rate
increased 34% after the Governor
announced vaccine requirements for
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state workers (White House, October 7,
2021). The success of these COVID–19
vaccination mandates comports with the
National Safety Council’s recent finding
that employers that instituted a COVID–
19 vaccination mandate produced a
35% increase in employee vaccination
(NSC, September 2021). Similarly, the
White House recently reported that its
analysis of vaccination requirements
imposed by healthcare systems,
educational institutions, public-sector
agencies, and private businesses
demonstrated that such requirements
increased their vaccination rates by
more than 20 percentage points and
have routinely seen their share of fully
vaccinated workers rise above 90
percent (White House, October 7, 2021).
Given the effectiveness of vaccination
mandates in increasing vaccination
rates, OSHA expects that, in most
instances, an employer implementing a
policy that requires all employees to be
vaccinated will be the most effective
approach for increasing the vaccination
rate of its employees and ensuring that
they have the best protection available
against the worst consequences of a
COVID–19 infection. Although OSHA
may well have the authority to impose
a vaccination mandate, OSHA has
decided against pursuing strict
vaccination requirement and has instead
crafted the ETS to strongly encourage
vaccination. Employers are in the best
position to understand their workforces
and the approach that will work most
effectively with them to secure
employee cooperation and protection.
OSHA’s traditional practice when
including medical procedures, such as
medical surveillance testing and
vaccinations, in its health standards has
been to require the employer to make
the medical procedure available to
employees, and has viewed mandating
those procedures as a measure to avoid
if possible. For example, when the
agency promulgated its standard
regulating occupational exposure to
lead, OSHA considered mandating that
employees participate in physical
examinations and biological monitoring,
but ultimately required employers to
make them available to employees (see
43 FR 54354, 54450 (Nov. 21, 1978)).
OSHA decided against mandating those
procedures in part because it believed a
voluntary approach would elicit more
effective employee participation in the
medical program and in part because of
the agency’s concerns about the
Government intruding into a private and
sensitive area of workers’ lives (43 FR at
54450–51). OSHA has followed that
same approach of requiring employers
to ‘‘provide’’ or ‘‘make available’’
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medical procedures to employees in
numerous subsequent standards, such
as the standards for asbestos (29 CFR
1910.1001), benzene (1910.1028), cotton
dust (1910.1043), and formaldehyde
(1910.1048).
OSHA adhered to this approach when
it promulgated the Bloodborne
Pathogens standard. The agency
considered mandating a Hepatitis B
vaccination, but instead required
employers to make the Hepatitis B
vaccination available to employees. 56
FR 64004, 64155 (Dec. 6, 1991); 29 CFR
1910.1030(f)(1)(i), (f)(2)(i). OSHA
explained that the agency may have the
legal authority to mandate vaccination,
but believed that, under the
circumstances, a voluntary vaccination
program would ‘‘foster greater employee
cooperation and trust in the system’’
and ‘‘enhance [ ] compliance while
respecting individuals’ beliefs and
rights to privacy.’’ 56 FR at 64155.
In keeping with this traditional
practice, the agency has stopped short of
including a strict vaccination mandate
with no alternative compliance option
in this ETS. OSHA has never done so,
and if it were to take that step, OSHA
believes it more prudent to do so where
the agency has ample time to fully
assess the potential ramifications of
imposing a vaccination mandate on
covered employers and employees.
Here, exigent circumstances demand
that OSHA take immediate action to
protect workers from the grave danger
posed by COVID–19, but OSHA has not
had a full opportunity to study the
potential spectrum of impacts on
employers and employees, including the
economic and health impacts, that
would occur if OSHA imposed a strict
vaccination mandate with no alternative
compliance option. Moreover,
employers in their unique workplace
settings may be best situated to
understand their workforce and the
strategies that will maximize worker
protection while minimizing workplace
disruptions. These considerations
persuade the agency that this ETS
should afford employers some flexibility
in the form of an alternative option to
strictly mandating vaccination. In light
of the unique and grave danger posed by
COVID–19, OSHA has requested
comment on whether a strict
vaccination mandate is warranted and
the agency will consider all the
information it receives as it determines
how to proceed with this rulemaking
(see Request for Comment, Section I.B.
of this preamble).
Although this ETS does not impose a
strict vaccination mandate, OSHA has
determined that, to adequately address
the grave danger that COVID–19 poses
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to unvaccinated workers, a more
proactive approach is necessary than
simply requiring employers to make
vaccination available to employees.
None of the standards that OSHA
promulgated prior to this year
concerned an infectious agent as readily
transmissible as COVID–19. Standards
like the Lead standard do not concern
infectious agents that can be transmitted
between individuals at a workplace;
accordingly, the medical procedures
that employers are required to make
available under those standards are
solely aimed at protecting the health of
the worker who is undergoing the
procedure. The Bloodborne Pathogens
standard concerned exposure to
infectious biological agents (Hepatitis B
and HIV) that can be transmitted
between individuals, but the potential
for those agents to be transmitted
between workers is minimal in
comparison to the SARS–CoV–2 virus;
Hepatitis B and HIV are transmitted
through blood and certain body fluids,
whereas the SARS–CoV–2 virus spreads
through respiratory droplets that can
travel through the air from worker-toworker (see Grave Danger, Section III.A.
of this preamble). Vaccination against
COVID–19 is thus particularly
important in reducing the potential for
workers to become infected and spread
the virus to others at the workplace, in
addition to protecting the worker from
severe health outcomes if they are
infected. Moreover, the ease with which
the SARS–CoV–2 virus spreads between
workers makes it more urgent for
workers to be vaccinated, and this
urgency contributes to the agency’s
decision to strongly encourage
vaccination.
Accordingly, to further the goal of
increasing workforce vaccination rates,
this ETS requires employers to
implement a mandatory vaccination
policy unless they adopt a policy in
which employees may either be fully
vaccinated or regularly tested for
COVID–19 and wear a face covering in
most situations when they work near
other individuals. Employers have the
duty under the OSH Act to provide safe
workplaces to their employees,
including protecting employees from
known hazards by complying with
occupational safety and health
standards (see 29 U.S.C. 654), and this
ETS therefore provides employers with
two compliance options for protecting
unvaccinated workers from the grave
danger posed by COVID–19. But while
this ETS offers employers a choice in
how to comply, OSHA has presented
implementation of a vaccination
mandate as the preferred compliance
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option; as discussed above, vaccine
mandates have proven to be effective in
increasing vaccination rates, and OSHA
expects that, in most instances,
implementing a vaccination mandate
will be the most effective method for
increasing a workforce’s vaccination
rate. As discussed below, OSHA also
recognizes that requiring that all
employees be vaccinated provides more
protection to vaccinated workers than
regularly testing unvaccinated workers
for COVID–19 and requiring them to
wear face coverings when they work
near others. This ETS will preempt
inconsistent state and local
requirements, including requirements
that ban or limit employers’ authority to
require vaccination (see the Summary
and Explanation for paragraph (a),
Section VI.A. of this preamble), and will
therefore provide the necessary legal
authorization to covered employers to
implement mandatory vaccination
policies, if they choose to comply in this
preferred manner.
Although the ETS does not require all
covered employers to implement a
mandatory vaccination policy, OSHA
expects that employers that choose that
compliance option will enjoy
advantages that employers that opt out
of the vaccination mandate option will
not. Most obviously, employers with a
mandatory vaccination policy will enjoy
a dramatically reduced risk that their
employees will become severely ill or
die of a COVID–19 infection. In
addition, employers who implement a
vaccination mandate will likely have
fewer workers temporarily removed
from the workplace due to a COVID–19
positive test; this rule requires all
covered employers to remove from the
workplace any employee who tests
positive for COVID–19 or receives a
diagnosis of COVID–19 (see the
Summary and Explanation for
paragraph (h), Section VI.H. of this
preamble), and because vaccinated
workers are less likely than
unvaccinated workers to be infected by
the virus, OSHA expects employers
with a mandatory vaccination policy
will be statistically less likely to be
obliged to remove a COVID-positive
employee from the workplace in
accordance with paragraph (h)(2).
Additionally, only employers who
decline to implement a mandatory
vaccination program are required by the
rule to assume the administrative
burden necessary to ensure that
unvaccinated workers are regularly
tested for COVID–19 and wear face
coverings when they work near others.
Where employers opt out of
implementing a mandatory vaccination
program, the ETS encourages employees
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to elect to be fully vaccinated. As
discussed in the Summary and
Explanation for paragraph (f) (Section
VI.F. of this preamble), the ETS requires
all covered employers to support
vaccination by providing employees
with reasonable time, including up to
four hours of paid time, to receive each
vaccination dose, and reasonable time
and paid sick leave to recover from
vaccination side effects. Many workers
have been deterred from receiving
vaccination by fears of missing work
and/or losing pay to obtain vaccination
and/or recover from side effects (see
Section VI.F. of this preamble; see, e.g.,
KFF, May 6, 2021; KFF, May 17, 2021),
and OSHA finds that this employer
support is necessary to ensure that
employees can become fully vaccinated
without concern that they will be
sacrificing pay or their jobs to do so.
All covered employers are required by
the ETS to bear the cost of providing up
to four hours of paid time and
reasonable paid sick leave needed to
support vaccination, but where an
employee chooses to remain
unvaccinated, the ETS does not require
employers to pay for the costs
associated with regular COVID–19
testing or the use of face coverings (see
the Summary and Explanation for
paragraphs (g) and (i), Sections VI.G.
and VI.I. of this preamble). In some
cases, employers may be required to pay
testing and/or face covering costs under
other federal or state laws or collective
bargaining obligations, and some may
choose to do so even without such a
mandate, but otherwise employees will
be required to bear the costs if they
choose to be regularly tested and wear
a face covering in lieu of vaccination.
This ETS more strongly encourages
vaccination than the June 2021
Healthcare ETS. OSHA designed the
Healthcare ETS, which addresses the
grave danger that COVID–19 poses
workers in specific health care settings
where COVID–19-positive individuals
are reasonably likely to be present, to
encourage vaccination (see 86 FR at
32415, 32423, 32565, 32597).
Specifically, the Healthcare ETS
encourages vaccination by requiring
employers to provide employees
reasonable and paid time to receive
vaccination doses and recover from side
effects (29 CFR 1910.502(m)), and by
exempting from its scope ‘‘well-defined
hospital ambulatory care settings where
all employees are fully vaccinated’’ and
all non-employees are screened and
denied entry if they are suspected or
confirmed to have COVID–19
(1910.502(a)(2)(iv)) and ‘‘home
healthcare settings where all employees
are fully vaccinated’’ and all
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nonemployees at that location are
screened prior to employee entry so that
people with suspected or confirmed
COVID–19 are not present (1910.502
(a)(2)(v)).
Similar to the Healthcare ETS, this
ETS requires employers to support
vaccination by providing employees
with reasonable time, including up to
four hours of paid time, to receive
vaccination, and reasonable time and
paid sick leave to recover from
vaccination side effects (see discussion
above and the Summary and
Explanation for paragraph (f), Section
VI.F. of this preamble). However, as
discussed above, this ETS goes further
and expressly requires the
implementation of a mandatory
vaccination policy, unless the employer
implements an alternative policy that
requires unvaccinated workers to be
regularly tested for COVID–19 and to
wear face coverings in most situations
when they work near others. While
nothing in the Healthcare ETS prohibits
covered employers from implementing a
mandatory vaccination policy, this ETS
presents the implementation of a
mandatory vaccination policy as a
preferred compliance option, and will
preempt inconsistent state and local
requirements that ban or limit
employers’ authority to require
vaccination. Additionally, where the
employer opts out of implementing a
mandatory vaccination policy, and the
employee opts out of vaccination, this
ETS places no obligation on the
employer to pay for costs associated
with the regular testing of unvaccinated
workers for COVID–19 or their use of
face coverings, which will provide a
financial incentive for some employees
to be fully vaccinated.
OSHA finds it necessary to more
strongly encourage vaccination in this
ETS than in the Healthcare ETS in the
manner described above. The
Healthcare ETS’s provisions that
encouraged vaccination were packaged
with a comprehensive infection
prevention program that was tailored to
the specific healthcare work settings to
which the ETS applied, including a
suite of layered and overlapping
controls. In contrast, OSHA is
promulgating this ETS to address the
grave danger that COVID–19 now poses
to all unvaccinated workers who work
indoors and in the presence of others.
As mentioned above, crafting a
comprehensive and multi-layered
standard that is comprehensive and
feasible for the myriad work settings to
which this ETS will apply, including
workplaces as diverse as schools,
restaurants, retail settings, offices,
prisons, and factories, is an
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extraordinarily challenging and
complicated undertaking.
Exigent circumstances require OSHA
to immediately promulgate this ETS to
protect unvaccinated workers, and
vaccination is the single most efficient
and effective method for removing
unvaccinated workers from the grave
danger. Given the urgency of the
rulemaking and the singular efficacy of
vaccination, OSHA has decided against
including comprehensive and
multilayered exposure controls in this
ETS, and is instead focusing the ETS on
strongly encouraging vaccination.
Strongly encouraging vaccination is
thus critical to the effectiveness of this
ETS at protecting unvaccinated workers
from the grave danger. In Request for
Comment (Section I.B. of this preamble),
OSHA seeks information on what
additional measures, if any, should be
required to protect employees against
COVID–19.
Moreover, stronger encouragement of
vaccination is needed in this ETS than
in the Healthcare ETS because workers
who are protected by the Healthcare
ETS are more likely to be vaccinated
and/or subject to a vaccination mandate.
The Healthcare ETS, 29 CFR 1910.502,
focused on healthcare work settings
where COVID–19 is reasonably expected
to be present, and, this ETS does not
apply in settings where any employee
provides healthcare services or
healthcare support services while they
are covered by the requirements of 29
CFR 1910.502 (see the Summary and
Explanation for paragraph (b), Section
VI.B. of this preamble). Evidence shows
that workers in settings covered by
§ 1910.502 already have a high rate of
vaccination. As of July 2021, healthcare
workers had a higher rate of vaccination
than non-healthcare workers (Lazer et
al., August, 2021), and many healthcare
workers are currently subject to
vaccination mandates. Twenty-two
states and the District of Columbia have
instituted vaccination mandates that are
applicable to healthcare workers
(NASHP, October 1, 2021), and nearly
300 hospitals and broader health
systems have implemented vaccine
mandates for their employees (Renton et
al., October 14, 2021). The White House
reported that almost 2,500 hospitals,
40% of all U.S. hospitals, across all 50
states, the District of Columbia, and
Puerto Rico, have announced
vaccination requirements for their
workforce, and noted numerous
examples of highly successful mandates
in those workplaces (White House,
October 7, 2021). News reports attest
that many of these vaccination
mandates have had great success in
increasing the vaccination rate of the
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targeted healthcare workers (Goldberg,
July 9, 2021; Otterman and Goldstein,
September 28, 2021; Hubler, September
30, 2021; Beer, October 4, 2021). Even
more healthcare workers covered by 29
CFR 1910.502 will be subject to a
vaccination mandate under the Centers
for Medicare & Medicaid Services (CMS)
rule published elsewhere in this issue of
the Federal Register that requires
COVID–19 vaccinations for workers in
most healthcare settings that receive
Medicare or Medicaid reimbursement,
including but not limited to hospitals,
dialysis facilities, ambulatory surgical
settings, and home health agencies. This
CMS rule applies to at least 76,000
providers (i.e., employers) and covers a
majority of healthcare workers across
the country. OSHA expects that the
combination of incentives to
vaccination in the Healthcare ETS and
vaccination mandates applicable to
healthcare workers will leave few
healthcare workers within the scope of
the Healthcare ETS unvaccinated.
b. Unvaccinated Workers Must Be
Regularly Tested for COVID–19 and Use
Face Coverings
As discussed above, this ETS
presumptively requires employers to
implement a mandatory vaccination
policy, but permits employers to opt out
of that requirement. Nonetheless, the
grave danger that COVID–19 poses to
unvaccinated workers demands that
alternative protective measures be taken
at workplaces where the employer does
not implement a mandatory vaccination
policy. Given that the SARS–CoV–2
virus is highly contagious, transmitted
easily through the air, and can lead to
severe and/or fatal outcomes in
unvaccinated workers, it is critical that
employers who do not require their
employees to be vaccinated implement
controls to mitigate the potential for
COVID–19 outbreaks to occur. As
discussed above, and in Grave Danger
(Section III.A. of this preamble),
unvaccinated workers are more likely
than vaccinated workers to be infected
with COVID–19 and transmit the virus
to others, and thus pose a heightened
risk of spreading the virus at the
workplace, including to other
unvaccinated workers.
To reduce the risk that unvaccinated
workers will spread COVID–19 at the
workplace, this rule requires employers
that do not implement a mandatory
vaccination policy to ensure that
unvaccinated workers who report to a
workplace where others are present are
tested at least once a week for COVID–
19. As discussed in the Summary and
Explanation for paragraph (g) (Section
VI.G. of this preamble), it is well-
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established that, by identifying and
isolating infected individuals, regularly
testing individuals for COVID–19
infection can be an effective method for
reducing virus transmission. Regularly
testing unvaccinated workers is
essential because SARS–CoV–2
infection is often attributable to
asymptomatic or presymptomatic
transmission (Bender et al., February 18,
2021; Byambasuren et al., December 11,
2020; Johansson et al., January 7, 2021;
Klompas et al., September 2021). In
accordance with the CDC’s
recommendations, OSHA has set the
minimum frequency of testing at 7 days
because the agency expects that it will
be effective in slowing the spread of
COVID–19, while taking into account
associated cost considerations (see the
Summary and Explanation for
paragraph (g), Section VI.G. of this
preamble). As noted in the Request for
Comment (Section I.B. of this preamble),
OSHA is gathering additional
information about whether OSHA
should require testing more often than
on a weekly basis.
The requirement for unvaccinated
workers to be regularly tested for
COVID–19 operates in tandem with
paragraph (h)(2), which requires that all
employers remove from the workplace
any employee who receives a positive
COVID–19 test, or a COVID–19
diagnosis (see the Summary and
Explanation for paragraph (h), Section
VI.H. of this preamble). Paragraph (h)(2)
ensures that the COVID–19-positive
employee will be isolated from the
workplace until it is safe for the
employee to return, and also allows the
employee to seek medical care sooner
and reduce the likelihood that they will
suffer the most severe consequences of
an infection (e.g., by seeking
monoclonal antibody treatment). The
combination of the testing and medical
removal provisions will reduce the
likelihood that an unvaccinated worker
who has been infected with COVID–19,
including those who are not
experiencing symptoms of infection,
will be permitted to spread the virus to
others at the workplace, including
unvaccinated coworkers.
Additionally, OSHA finds it necessary
to require employers that do not
implement a mandatory vaccination
policy to ensure that unvaccinated
workers wear face coverings in most
situations when they are working near
others. This reflects OSHA’s recognition
that regularly testing unvaccinated
workers for COVID–19 will not be 100%
effective in identifying infected workers
before they enter the workplace. Most
obviously, testing employees once a
week will not prevent an unvaccinated
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worker from exposing others at the
workplace if the worker becomes
infected and reports to the workplace in
between their weekly tests. And, even if
the rule required unvaccinated workers
to be tested more frequently than once
a week, infected persons may still be
missed, particularly in areas with high
community spread (Chin et al.,
September 9, 2020).
Accordingly, requiring unvaccinated
workers to wear face coverings in most
situations when they are working near
others will further mitigate the potential
for unvaccinated workers to spread the
virus at the workplace. As discussed in
the Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble), it is well-established that
face coverings provide effective source
control; that is, they largely prevent
respiratory droplets emitted by the
wearer of the face covering from
spreading to others, and thus make it
significantly less likely that the person
wearing the mask will transmit the
virus, if they are infected. Face
coverings are also believed to provide
the wearer some limited protection from
exposure to the respiratory droplets of
co-workers and others (e.g., customers)
(CDC, May 7, 2021), but the principal
benefit of face coverings is to
significantly reduce the wearer’s ability
to spread the virus. By requiring
unvaccinated workers to wear face
coverings, this rule significantly reduces
the likelihood that an infected
unvaccinated worker who enters the
workplace despite the testing
requirements will spread the virus to
others, including unvaccinated
coworkers.
OSHA acknowledges that regularly
testing unvaccinated workers for
COVID–19 and requiring them to wear
face coverings when they work near
others is less protective of unvaccinated
workers than simply requiring all
workers to be vaccinated. To be sure,
OSHA strongly prefers that employers
adopt a mandatory vaccination policy,
as vaccination is singularly effective at
protecting workers from the severe
consequences that can result from a
COVID–19 infection. And, where
employers do not adopt a mandatory
vaccination policy, employers may also
consider alternative feasible measures
that would remove employees who
remain unvaccinated from the scope of
this ETS, such as increasing telework
(see the Summary and Explanation for
paragraph (b), Section VI.B. of this
preamble). Nonetheless, as discussed
above, OSHA has not imposed a strict
vaccination mandate on all covered
employees who work in the presence of
others and not exclusively outdoors,
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given that the agency has never
previously used its authority to strictly
mandate vaccination, and the exigent
and extraordinary circumstances driving
this emergency rulemaking have not
afforded OSHA a full opportunity to
assess the potential ramifications of
including a strict vaccination mandate
in this rule. Given these circumstances,
and employers’ unique understanding of
the compliance approaches that will
best increase vaccination rates among
their workforce, OSHA has designed a
rule that preserves a limited degree of
employer flexibility, and strongly
encourages, but does not strictly require,
vaccination. OSHA has requested
comment in this ETS on whether a strict
vaccination mandate would be
appropriate and the agency will
consider those comments as it
determines how to proceed with this
rulemaking.
References
Beer T. (2021, October 4). COVID–19 Vaccine
Mandates Are Working—Here’s The
Proof. Forbes. https://www.forbes.com/
sites/tommybeer/2021/10/04/covid-19vaccine-mandates-are-working-heresthe-proof/?sh=1a08d2e72305. (Beer,
October 4, 2021)
Bender JK et al. (2021, February 18). Analysis
of asymptomatic and presymptomatic
transmission in SARS–CoV–2 outbreak,
Germany, 2020. Emerging Infectious
Diseases. 27(4). https://doi.org/10.3201/
eid2704.204576. (Bender et al., February
18, 2021)
Boseman J and Leatherby L. (2021, October
1). U.S. Coronavirus Death Toll
Surpasses 700,000 Despite Wide
Availability of Vaccines. The New York
Times. https://www.nytimes.com/2021/
10/01/us/us-covid-deaths-700k.html.
(Boseman and Leatherby, October 1,
2021)
Byambasuren O et al., (2020, December 11).
Estimating the extent of asymptomatic
COVID–19 and its potential for
community transmission: Systematic
review and meta-analysis. Official
Journal of the Association of Medical
Microbiology and Infectious Disease
Canada. 5(4): 223–234 doi:10.3138/
jammi-2020-0030. (Byambasuren et al.,
December 11, 2020)
Centers for Disease Control and Prevention
(CDC). (2021, May 7). Science brief:
Community use of cloth masks to control
the spread of SARS–CoV–2. https://
www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/masking-scienceSARS-cov2.html. (CDC, May 7, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/coviddata-tracker/. (CDC, October 18, 2021)
Chin E et al. (2020, September 9). Frequency
of routine testing for COVID–19 in highrisk healthcare environments to reduce
outbreaks. https://doi.org/10.1101/
2020.04.30.20087015. (Chin et al.,
September 9, 2020)
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Food and Drug Administration (FDA). (2020,
December 11). Emergency use
authorization for an unapproved product
review memorandum (Pfizer-BioNTech
COVID–19 vaccine/BNT 162b2 mRNA–
1273). https://www.fda.gov/emergencypreparedness-and-response/coronavirusdisease-2019-covid-19/pfizer-biontechcovid-19-vaccine. (FDA, December 11,
2020)
Food and Drug Administration (FDA). (2020,
December 18). Emergency use
authorization for an unapproved product
review memorandum (Moderna COVID–
19 vaccine/mRNA–1273). https://
www.fda.gov/emergency-preparednessand-response/coronavirus-disease-2019covid-19/moderna-covid-19-vaccine.
(FDA, December 18, 2020)
Food and Drug Administration (FDA). (2021,
February 26). Janssen COVID–19
vaccine. Vaccines and Related Biological
Products Advisory Committee February
26, 2021 Meeting Briefing Document.
https://www.fda.gov/media/146219/
download. (FDA, February 26, 2021)
Goldberg C. (2021, July 9). Hospital Vaccine
Mandates Suggest Success in Boosting
U.S. Shots. Bloomberg News. https://
www.bloomberg.com/news/articles/202107-09/early-mandates-boost-workervaccine-rates-prompt-few-to-quit.
(Goldberg, July 9, 2021)
Hirsch L. (2021, September 30). After
Mandate, 91% of Tyson Workers Are
Vaccinated. https://www.nytimes.com/
2021/09/30/business/tyson-foodsvaccination-mandate-rate.html. (Hirsch,
September 30, 2021)
Hubler S. (2021, September 30). ‘Mandates
Are Working’: Employer Ultimatums Life
Vaccination Rates, So Far. The New York
Times. https://www.nytimes.com/2021/
09/30/us/california-vaccine-mandatehealth-care.html. (Hubler, September 30,
2021)
Johansson MA et al., (2021, January 7).
SARS–CoV–2 transmission from people
without COVID–19 symptoms. JAMA
Network Open. 4(1): e2035057.
doi:10.1001/jamanetworkopen.
2020.35057. (Johansson et al., January 7,
2021)
Kaiser Family Foundation (KFF). (2021, May
6). KFF COVID–19 Vaccine Monitor:
April 2021. https://www.kff.org/
coronavirus-covid-19/poll-finding/kffcovid-19-vaccine-monitor-april-2021/.
(KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May
17). How employer actions could
facilitate equity in COVID–19
vaccinations. https://www.kff.org/policywatch/how-employer-actions-couldfacilitate-equity-in-covid-19vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021,
September). Does The Public Want To
Get A COVID–19 Vaccine? When?
https://www.kff.org/coronavirus-covid19/dashboard/kff-covid-19-vaccinemonitor-dashboard/?utm_
source=web&utm_
medium=trending&utm_
campaign=COVID-19-vaccinemonitor#messagesandinformation. (KFF,
September 2021)
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Klompas M et al. (2021, September). The case
for mandating COVID–19 vaccines for
health care workers. Annals of Internal
Medicine. https://doi.org/10.7326/M212366. (Klompas et al., September 2021)
Lazer D et al. (2021, August). The COVID
States Project: A 50-State COVID–19
Survey Report #62: COVID–19 Vaccine
Attitudes Among Healthcare Workers.
https://news.northeastern.edu/uploads/
COVID19%20CONSORTIUM%20
REPORT%2062%20HCW%20
August%202021.pdf. (Lazer et al.,
August, 2021)
National Academy for State Health Policy
(NASHP). (2021, October 1). State Efforts
to Ban or Enforce COVID–19 Vaccine
Mandates and Passports. https://
www.nashp.org/state-lawmakers-submitbills-to-ban-employer-vaccine-mandates/
. (NASHP, October 1, 2021)
National Safety Council (NSC). (2021,
September). A Year in Review, and
What’s Next: COVID–19 Employer
Approaches and Worker Experiences.
https://www.nsc.org/faforms/safer-yearone-final-report. (NSC, September 2021)
Occupational Safety and Health
Administration (OSHA). (2021c,
October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
Otterman S and Goldstein J. (2021,
September 28). Thousands of N.Y.
Health Care Workers Get Vaccinated
Ahead of Deadline. The New York
Times. https://www.nytimes.com/2021/
09/28/nyregion/vaccine-health-careworkers-mandate.html. (Otterman and
Goldstein, September 28, 2021)
Renton B et al. (2021, October 14). New:
Hospital Vaccine Mandate Tracker.
Global Epidemics, Brown School of
Public Health. https://
globalepidemics.org/2021/07/24/newhospital-vaccine-mandate-tracker/.
(Renton et al., October 14, 2021)
Scobie HM et al. (2021, September 17).
Monitoring Incidence of COVID–19
Cases, Hospitalizations, and Deaths, by
Vaccination Status—13 U.S.
Jurisdictions, April 4–July 17, 2021.
MMWR Morb Mortal Wkly Rep 2021; 70:
early release. https://www.cdc.gov/
mmwr/volumes/70/wr/mm7037e1.htm.
(Scobie et al., September 17, 2021)
The Associated Press. (2021, September 22).
United Airlines says 97% of US
employees have been vaccinated. https://
www.wifr.com/2021/09/22/unitedairlines-say-97-us-employees-have-beenvaccinated/. (The Associated Press,
September 22, 2021)
Towey R. (2021, September 27). CNBC poll
shows very little will persuade
unvaccinated Americans to get Covid
shots. https://www.cnbc.com/2021/09/
10/cnbc-poll-shows-very-little-willpersuade-unvaccinated-americans-toget-covid-shots.html. (Towey, September
27, 2021)
White House. (2021, October 7). White House
Report: Vaccination Requirements Are
Helping Vaccinate More People, Protect
Americans from COVID–19, and
Strengthen the Economy. https://
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www.whitehouse.gov/wp-content/
uploads/2021/10/VaccinationRequirements-Report.pdf. (White House,
October 7, 2021)
III. No Other Agency Action is Adequate
To Protect Employees Against Grave
Danger
OSHA’s experience to date shows that
the agency’s existing tools are
inadequate to meet the grave danger
posed by COVID–19 to unvaccinated
workers not covered by the Healthcare
ETS. OSHA has determined that its
existing standards, regulations, the OSH
Act’s General Duty Clause, and nonmandatory guidance will not adequately
promote the most effective means to
protect these workers: Vaccination. The
agency has determined that this ETS is
necessary to address these inadequacies.
Multiple developments support this
change in approach. First, large
numbers of employees are continuing to
contract COVID–19 and die. (See Grave
Danger, Section III.A. of this preamble).
Further, based on a thorough review of
its existing approach to protecting
employees from COVID–19 and the
current state of the pandemic, OSHA
finds that existing OSHA standards,
regulations, the General Duty Clause,
and non-mandatory guidance are not
adequate to protect employees outside
healthcare from COVID–19. The
Preamble to the Healthcare ETS
includes a detailed analysis
demonstrating the inadequacy of
existing tools in the healthcare industry.
See 86 FR 32414–32423. In general, the
same analysis applies here. The reasons
existing tools were inadequate to protect
healthcare workers apply in other
industry sectors as well. The Healthcare
ETS itself, while necessary to protect
healthcare workers, of course applies
only to that industry. Finally, the
numerous guidance products published
by other entities, such as CDC, are not
adequate to protect employees because
they are not enforceable; there is no
penalty for noncompliance. 86 FR at
32415. Even as the CDC has increasingly
recommended vaccination to protect
from the dangers of transmission and
severe illness related to the SARS–CoV–
2 virus, vaccination rates remain uneven
around the country. (CDC, September 9,
2021; Leonhardt, September 7, 2021;
KFF, October 6, 2021; McPhillips and
Cohen, May 19, 2021).
The need for this ETS is also reflected
in the number of states and localities
that have issued their own mandatory
standards in recognition that OSHA’s
existing measures (including nonmandatory guidance, compliance
assistance, and enforcement of existing
standards) have failed to prevent the
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spread of the virus in workplaces.
Additionally, as mentioned previously,
other states have banned certain
employers from implementing
workplace vaccination mandates or
from verifying an employee’s
vaccination status or from requiring face
coverings. A national standard is
necessary to establish clear
requirements regarding vaccination,
testing and face coverings that will
protect employees in all states and
preempt state or local ordinances that
prevent employers from implementing
necessary protections.
a. The Current Standards and
Regulations Are Inadequate
In the Healthcare ETS, OSHA
considered its enforcement efforts with
regard to existing standards and
regulations that OSHA had identified as
potentially applicable to occupational
exposure to SARS–CoV–2. OSHA’s
analysis in Section IV of the Healthcare
ETS, 86 FR 32376, 32416–17 and hereby
included in the record of this ETS,18 is
applicable here in considering the need
for this ETS, which covers a much
broader set of employers in all
industries. There OSHA found that none
of the existing OSHA standards could
sufficiently abate the hazard posed by
COVID–19 in healthcare settings. Here
again OSHA concludes that the
potentially applicable existing standards
are insufficient to address the grave
danger faced by workers covered by this
ETS. None of the current standards,
even if more rigorously enforced, can
sufficiently address this cross-industry
hazard of national proportions to abate
the grave danger posed by COVID–19 or
lead to the same benefits that this ETS
will achieve. See Asbestos Info. Ass’n/
N. Am. v. Occupational Safety & Health
Admin., 727 F.2d 415, 427 (5th Cir.
1984) (‘‘[M]uch of the claimed benefit
could be obtained simply by enforcing
the current standard.’’).
Through its enforcement guidance,
OSHA identified a number of current
standards and regulations that might
apply when workers have occupational
exposure to SARS–CoV–2, most of
which are the same standards OSHA
considered in the Healthcare ETS.
(Updated Interim Enforcement Response
Plan for Coronavirus Disease 2019
(COVID–19)) (OSHA, July 7, 2021).
OSHA has also cited the Hazard
communication standard (29 CFR
1910.1200) during COVID–19
investigations. Accordingly, a list of
18 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
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potentially applicable standards and
regulations follows:
• 29 CFR part 1904, Recording and
Reporting Occupational Injuries and
Illnesses. This regulation requires
certain employers to keep records of
work-related fatalities, injuries, and
illnesses and report them to the
government in specific circumstances.
• 29 CFR 1910.132, General
requirements—Personal Protective
Equipment (PPE). This standard
requires that appropriate PPE, including
PPE for eyes, face, head, and
extremities, protective clothing,
respiratory devices, and protective
shields and barriers, be provided, used,
and maintained in a sanitary and
reliable condition.
• 29 CFR 1910.134, Respiratory
protection. This standard requires that
employers provide, and ensure the use
of, appropriate respiratory protection
when necessary to protect employee
health.
• 29 CFR 1910.141, Sanitation. This
standard applies to permanent places of
employment and contains, among other
requirements, general housekeeping and
waste disposal requirements.
• 29 CFR 1910.145, Specification for
accident prevention signs and tags. This
standard requires the use of biological
hazard signs and tags, in addition to
other types of accident prevention signs
and tags.
• 29 CFR Subpart U—COVID–19
Emergency Temporary Standard. The
Healthcare ETS, promulgated on June
21, 2021 includes various controls
(patient screening and management,
respirators and other PPE, limiting
exposure to aerosol-generating
procedures, physical distancing,
physical barriers, cleaning, disinfection,
ventilation, health screening and
medical management, access to
vaccination, anti-retaliation provisions,
and medical removal protection) to
address the grave danger posed by
COVID–19 to healthcare workers.
• 29 CFR 1910.1020, Access to
employee exposure and medical
records. This standard requires that
employers provide employees and their
designated representatives access to
relevant exposure and medical records.
• 29 CFR 1910.1200, Hazard
communication. This standard requires
employers to keep Safety Data Sheets
(SDS) for chemical hazards, provide
SDSs to employees and their
representatives when requested, and
train employees about those hazards.
The standard does not apply to
biological hazards, but hazard
communication becomes an issue for
the SARS–CoV–2 virus when chemicals
are used to disinfect surfaces.
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OSHA again finds that none of these
existing standards provide for the types
of workplace controls that are necessary
to combat the grave danger addressed by
this ETS. First, none of the listed
potentially applicable standards require
vaccination against SARS–CoV–2, the
most efficient and effective control to
combat the grave danger posed by the
virus. (The Bloodborne Pathogen
Standard requires that the hepatitis B
vaccine be made available to certain
employees, but that is not that is not
relevant here, since the hepatitis
vaccine provides no protection against
COVID–19). Nor are the additional
safety measures included in this ETS—
vaccination verification, screening
testing, face coverings, and medical
removal of COVID–19 positive
workers— required by existing
standards other than OSHA’s Healthcare
ETS (covering employees exempted
from this new ETS while the Healthcare
ETS is in effect).
Second, because existing standards do
not contain provisions specifically
targeted at the COVID–19 hazard, it may
be difficult for employers and
employees to determine what particular
COVID–19 safety measures are required
by existing standards, or how the
separate standards are expected to work
together as applied to COVID–19. An
ETS that contains provisions
specifically addressing COVID–19
hazards in covered workplaces will
provide clear instructions. More
certainty will lead to more compliance,
and more compliance will lead to
improved protection of employees
covered by this standard.
Third, requirements in some
standards may be appropriate for other
situations but simply do not
contemplate COVID–19 and fail to
address important aspects of the hazard.
For example, the general sanitation
standard requires employers to provide
warm water, soap, and towels that can
be used in hand washing, but does not
require disinfection or provision of
hand sanitizer where handwashing
facilities cannot be made readily
available. See 86 FR 32417. Although
the sanitation standard might appear at
first glance to be relevant here, it simply
does not require the types of controls
that would, even if more rigorously
enforced, sufficiently reduce the threat
of COVID–19 in the workplace. As such,
OSHA affirms its previous
determination that some of the abovelisted standards—including the
sanitation standard—are in practice too
difficult to apply to the COVID–19
hazard and have never been cited in
COVID enforcement. 86 FR 32416.
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Fourth, existing recordkeeping and
reporting regulations do not adequately
allow the employer or the agency to
assess the full scope of COVID–19
workplace exposures and protection.
OSHA’s general recordkeeping
regulations were not written with the
nature of COVID–19 transmission or
illness in mind. In order to adequately
understand and thereby control the
spread of COVID–19 in the workforce, it
is critical that the employer has records
of employees’ vaccination status, and of
the testing undergone by employees
who do not receive vaccination, and
that it knows of all cases of COVID–19
occurring among employees. However,
such information is outside of the scope
of OSHA’s existing recordkeeping
requirements, which are limited to
injuries or illnesses that the employer
knows to be work-related.
Moreover, existing reporting
regulations do not adequately ensure
that OSHA has the full picture of the
impact of COVID–19 because those
regulations only require employers to
report in-patient hospitalizations that
occur within 24 hours of the workrelated incident and to report fatalities
that occur within thirty days of the
work-related incident. 86 FR at 32417.
Many COVID–19 infections will not
result in hospitalization or death until
well after these limited reporting
periods. Under existing regulations,
such cases are not required to be
reported to OSHA, which limits the
agency’s ability to fully understand the
impact of COVID–19 on the workforce.
86 FR 32417. This ETS includes a
provision, paragraph (k), that removes
the time limitation on reporting for
COVID–19 cases.
In conclusion, OSHA’s experience has
demonstrated that existing standards
and regulations are inadequate to
address the current COVID–19 hazard.
b. The General Duty Clause Is
Inadequate To Meet the Current Crisis
Section 5(a)(1) of the OSH Act, or the
General Duty Clause, provides the
general mandate that each employer
‘‘furnish to each of [its] employees
employment and a place of employment
which are free from recognized hazards
that are causing or are likely to cause
death or serious physical harm to [its]
employees.’’ 29 U.S.C. 654(a)(1). For
General Duty Clause citations to be
upheld, OSHA must demonstrate
elements of proof that are
supplementary to, and can be more
difficult to show than, the elements of
proof required for violations of specific
standards, where a hazard is presumed.
Specifically, to prove a violation of the
General Duty Clause, OSHA needs to
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establish—in each individual case—
that: (1) An activity or condition in the
employer’s workplace presented a
hazard to an employee; (2) the hazard
was recognized; (3) the hazard was
causing or was likely to cause death or
serious physical harm; and (4) feasible
means to eliminate or materially reduce
the hazard existed. BHC Nw. Psychiatric
Hosp., LLC v. Sec’y of Labor, 951 F.3d
558, 563 (D.C. Cir. 2020). OSHA often
relies on the General Duty Clause to fill
gaps where specific standards do not
address a hazard and OSHA enforces it
through case-by-case adjudicative
proceedings. See United States v.
Strum, 84 F.3d 1, 5 (1st Cir. 1996).
OSHA has previously found the
General Duty Clause to be inadequate to
protect employees from dangers posed
by infectious agents. In promulgating
the bloodborne pathogens standard,
OSHA explained that enforcement
under the General Duty Clause was
insufficient to protect employees from
the serious hazards those pathogens
present. 56 FR 64007 (December 6,
1991). In the recently promulgated
Healthcare ETS, OSHA found that the
General Duty Clause was insufficient to
protect healthcare workers from the
grave danger they faced as well. 86 FR
32418. While OSHA initially attempted
to use the General Duty Clause to
protect employees across all industries
from COVID–19-related hazards,
OSHA’s experience has demonstrated
that the Clause is grossly inadequate to
protect employees covered by this ETS
from the grave danger posed by COVID–
19 in the workplace. As explained more
fully below, OSHA finds this ETS is
necessary to protect employees from the
hazards of COVID–19.
As an initial matter, the General Duty
Clause does not provide employers with
specific requirements to follow or a
roadmap for implementing appropriate
abatement measures. The ETS, however,
provides a clear statement of what
OSHA expects employers to do to
protect workers, thus facilitating better
compliance. The General Duty Clause is
so named because it imposes a general
duty to keep the workplace free of
recognized serious hazards; the ETS, in
contrast, lays out clear requirements for
employers to implement vaccination
policies including vaccination
verification, support for employee
vaccination, screening testing and face
coverings for unvaccinated workers, and
medical removal of COVID–19 positive
employees. Conveying obligations as
clearly and specifically as possible
makes it much more likely that
employers will comply with those
obligations and thereby protect workers
from COVID–19 hazards. See, e.g.,
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Integra Health Mgmt., Inc., 2019 WL
1142920, at *7 n.10 (No. 13–1124, 2019)
(noting that standards ‘‘give clear notice
of what is required of the regulated
community’’); 56 FR 64007 (‘‘because
the standard is much more specific than
the current requirements [general
standards and the general duty clause],
employers and employees are given
more guidance in carrying out the goal
of reducing the risks of occupational
exposure to bloodborne pathogens’’).
Moreover, several characteristics of
General Duty Clause enforcement
actions make them an inadequate means
to address hazards associated with
COVID–19. First, it would be virtually
impossible for OSHA to require and
enforce the most important workerprotective elements of the ETS (such as
vaccination and testing) under the
General Duty Clause. Second, OSHA’s
burden of proof for establishing a
General Duty Clause violation is heavier
than for standards violations. Third,
promulgating an ETS will enable OSHA
to issue more meaningful penalties for
willful and egregious violations, thus
creating effective deterrence against
employers who intentionally disregard
their obligations under the Act or
demonstrate plain indifference to
employee safety. As discussed in more
detail below, all of these considerations
demonstrate OSHA’s need to
promulgate this ETS in order to protect
unvaccinated workers covered by this
standard from hazards posed by
COVID–19.
The General Duty Clause is ill-suited to
requiring employers to adopt
vaccination and testing policies,
like those required by the ETS
Because the General Duty Clause
requires OSHA to establish the
existence and feasibility of abatement
measures that can materially reduce a
hazard, it is difficult for OSHA to use
the clause to require specific control
measures where an employer is doing
something, but not what the Secretary
has determined is needed to fully
address the serious hazard. See, e.g.,
Waldon Health Care Center, 16 BNA
OSHC 1052, 1993 WL 119662 at * (No.
89–2804, 1993) (vacating OSHA citation
requiring pre-exposure hepatitis B
vaccination under General Duty Clause
by finding that although vaccination
would more fully reduce the hazard, the
employer’s chosen means of abatement
were sufficient); Brown & Root, Inc.,
Power Plant Div., 8 BNA OSHC 2140,
1980 WL 10668 at *5 (No. 76–1296,
1980) (‘‘[T]he employer may defend
against a section 5(a)(1) citation by
asserting that it was using a method of
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abatement other than the one suggested
by the Secretary.’’).
Further, even where OSHA
establishes a violation of the General
Duty Clause, the employer is under no
obligation to implement the feasible
means of abatement proven by OSHA as
part of its prima facie case. Cyrus Mines
Corp., 11 OSH Cas. (BNA) 1063, 1982
WL 22717, at *4 (No. 76–616, 1983)
(‘‘[The employer] is not required to
adopt the abatement method suggested
by the Secretary, even one found
feasible by the Commission; it may
satisfy its duty to comply with the
standard by using any feasible method
that is appropriate to abate the
violation.’’); Brown & Root, Inc., Power
Plant Div., 1980 WL 10668 at *5. Thus,
even in cases where OSHA prevails, the
employer need not necessarily
implement the specific abatement
measure(s) OSHA established would
materially reduce the hazard. The
employer could select alternative
controls and then it would be up to
OSHA, if it wished to cite the employer
again, to establish that the recognized
hazard continued to exist and that its
preferred controls could materially
reduce the hazard even further.
Given the severity and pervasiveness
of the COVID–19 hazard, OSHA has
determined that the specific abatement
measures provided in this ETS are
necessary to protect workers from grave
danger. Under the General Duty Clause
alone, it would be nearly impossible to
require employers to provide these
specific measures, and even then, it
could only be on a case-by-case
enforcement basis. Considering the
magnitude and ubiquity of the danger
that SARS–CoV–2 poses to workers
across the country, the case-by-case
adjudicatory regime set up through the
General Duty Clause is simply not
adequate to combat the risk of severe
illness and death caused by the virus.
General Duty Clause Citations Impose a
Heavy Litigation Burden on OSHA
Under the General Duty Clause OSHA
must prove that there is a recognized
hazard, i.e., a workplace condition or
practice to which employees are
exposed, creating the potential for death
or serious physical harm to employees.
See SeaWorld of Florida LLC v. Perez,
748 F.3d 1202, 1207 (D.C. Cir. 2014);
Integra Health Management, 2019 WL
1142920, at *5. Whether a particular
workplace condition or practice is a
‘‘recognized hazard’’ under the General
Duty Clause is a question of fact that
must be decided in each individual
case. See SeaWorld of Florida LLC, 748
F.3d at 1208. In the case of a COVID–
19-related citation, this means showing
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not just that the virus is a hazard as a
general matter—a fairly indisputable
point—but also that the specific
conditions in the cited workplace, such
as unvaccinated, unmasked employees
working in close proximity to other
employees for extended periods, create
a COVID–19-related hazard.
In contrast, an OSHA standard that
requires or prohibits specific conditions
or practices establishes the existence of
a hazard. See Harry C. Crooker & Sons,
Inc. v. Occupational Safety & Health
Rev. Comm’n, 537 F.3d 79, 85 (1st Cir.
2008); Bunge Corp. v. Sec’y of Labor,
638 F.2d 831, 834 (5th Cir. 1981). Thus,
in enforcement proceedings under
OSHA standards, as opposed to the
General Duty Clause, ‘‘the Secretary
need not prove that the violative
conditions are actually hazardous.’’
Modern Drop Forge Co. v. Sec’y of
Labor, 683 F.2d 1105, 1114 (7th Cir.
1982). With OSHA’s finding that the
hazard of exposure to COVID–19 can
exist for unvaccinated workers in all
covered workplaces (see Grave Danger,
Section III.A. of this preamble), the ETS
will eliminate the burden to repeatedly
prove, workplace by workplace, the
existence of a COVID–19 hazard under
the General Duty Clause.
One of the most significant
advantages to standards like the ETS
that establish the existence of the hazard
at the rulemaking stage is that the
Secretary can require specific abatement
measures without having to prove that
a specific cited workplace is already
hazardous.19 In contrast, as discussed
above, under the General Duty Clause
the Secretary cannot require abatement
before proving in the enforcement
proceeding that an existing condition at
the workplace is hazardous. For
example, in a challenge to OSHA’s
Grain Handling Standard, which was
promulgated in part to protect
employees from the risk of fire and
explosion from accumulations of grain
dust, the Fifth Circuit acknowledged
OSHA’s inability to effectively protect
employees from these hazards under the
General Duty Clause in upholding, in
large part, the standard. See Nat’l Grain
& Feed Ass’n v. Occupational Safety &
Health Admin., 866 F.2d 717, 721 (5th
Cir. 1988) (noting Secretary’s difficulty
in proving explosion hazards of grain
handling under General Duty Clause).
19 ‘‘The Act does not wait for an employee to die
or become injured. It authorizes the promulgation
of health and safety standards and the issuance of
citations in the hope that these will act to prevent
deaths and injuries from ever occurring.’’ Whirlpool
Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also
Arkansas-Best Freight Sys., Inc. v. Occupational
Safety & Health Rev. Comm’n, 529 F.2d 649, 653
(8th Cir. 1976) (noting that the ‘‘[OSH] Act is
intended to prevent the first injury’’).
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Although OSHA had attempted to
address fire and explosion hazards in
the grain handling industry under the
General Duty Clause, ‘‘employers
generally were successful in arguing
that OSHA had not proved that the
specific condition cited could cause a
fire or explosion.’’ Id. at 721 & n.6
(citing cases holding that OSHA failed
to establish a fire or explosion hazard
under the General Duty Clause). The
Grain Handling Standard, in contrast,
established specific limits on
accumulations of grain dust based on its
combustible and explosive nature, and
the standard allowed OSHA to cite
employers for exceeding those limits
without the need to prove at the
enforcement stage that each cited
accumulation was likely to cause a fire
or explosion. See id. at 725–26.
The same logic applies to COVID–19
hazards. Given OSHA’s burden under
the General Duty Clause to prove that
conditions at the cited workplace are
hazardous, it is difficult for OSHA to
ensure necessary abatement before
individual employee lives and health
are unnecessarily endangered by
exposure to COVID–19, despite
widespread evidence of the grave
danger posed by worker exposure to
COVID–19. Indeed, despite publishing a
voluminous collection of COVID–19
guidance online and receiving and
investigating thousands of complaints,
OSHA did not believe it could justify
the issuance of more than 20 COVID–19
related General Duty Clause citations
over the entire span of the pandemic so
far, because of the quantum of proof the
Secretary must amass under the General
Duty Clause. Unlike enforcement under
the General Duty Clause, this ETS
allows OSHA to cite employers for each
protective requirement they fail to
implement without the need to wait for
employee infection or death to prove in
an enforcement proceeding that the
particular cited workplace was
hazardous without that particular
measure in place. Thus, this ETS, which
covers millions of workers nation-wide,
is significantly preferable to the General
Duty Clause with respect to such a
highly transmissible virus because the
inability to prevent a single exposure
can quickly result in an exponential
increase in exposures and illnesses or
fatalities even at a single worksite.
An additional limitation of the
General Duty Clause is that proving that
there are feasible means to materially
reduce a recognized hazard typically
requires testimony from an expert
witness in each separate case, which
limits OSHA’s ability to prosecute these
cases as broadly as needed to protect
workers, in light of the expense
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involved. See, e.g., Integra Health
Management, 2019 WL 1142920, at *13
(requiring expert witness to prove
proposed abatement measures would
materially reduce hazard). In contrast,
where an OSHA standard specifies the
means of compliance, the agency has
already made the necessary technical
determinations in the rulemaking and
therefore does not need to establish
feasibility of compliance as part of its
prima facie case in an enforcement
proceeding. See, e.g., A.J. McNulty & Co.
v. Sec’y of Labor, 283 F.3d 328, 334
(D.C. Cir. 2002); S. Colorado Prestress
Co. v. Occupational Safety & Health
Rev. Comm’n, 586 F.2d 1342, 1351 (10th
Cir. 1978). Preventing the initial
exposure and protecting as many
workers as quickly as possible is
especially critical in the context of
COVID–19 because, as explained in
Grave Danger, Section III.A. of this
preamble, it can spread so easily in
workplaces.
The ETS will also permit OSHA to
achieve meaningful deterrence
when necessary to address willful
or egregious failures to protect
employees against the COVID–19
hazard
As described above, in contrast to the
broad language of the General Duty
Clause, this ETS will prescribe specific
measures employers covered by this
standard must implement. This
specificity will make it easier for OSHA
to determine whether an employer has
intentionally disregarded its obligations
or exhibited a plain indifference to
employee safety or health. In such
instances, OSHA can classify the
citations as ‘‘willful,’’ allowing it to
propose higher penalties, with increased
deterrent effects. In promulgating the
Healthcare ETS, OSHA noted that early
in the pandemic, shifting guidance on
the safety measures employers should
take to protect their employees from
COVID–19 created ambiguity regarding
employers’ specific obligations. Thus,
OSHA could not readily determine
whether a particular employer had
‘‘intentionally’’ disregarded obligations
that were not yet clear. And, even as the
guidance began to stabilize, OSHA’s
ability to determine ‘‘intentional
disregard’’ or ‘‘plain indifference’’ was
difficult, for example, when an
employer took some steps address the
COVID–19 hazard. 86 FR 32420. The
Healthcare ETS largely resolved this
issue for employers covered by that
standard, by laying out clearly what
parameters to put in place to protect
healthcare workers. However, this
general challenge persists in OSHA’s
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attempts at enforcement in other
industries.
Further, OSHA has adopted its
‘‘egregious violation’’ policy to impose
sufficiently large penalties that achieve
appropriate deterrence against bad actor
employers who willfully disregard their
obligation to protect their employees
when certain aggravating circumstances
are present, such as a large number of
injuries or illnesses, bad faith, or an
extensive history of noncompliance
(OSHA Directive CPL 02–00–080
(October 21, 1990)). Its purpose is to
increase the deterrent impact of OSHA’s
enforcement activity. This policy
utilizes OSHA’s authority to issue a
separate penalty for each instance of
noncompliance with an OSHA standard,
such as each employee lacking the same
required protections, or each
workstation lacking the same required
controls. It can be more difficult to use
this policy under the General Duty
Clause because the Fifth Circuit and the
Occupational Safety and Health Review
Commission have held that, under the
General Duty Clause, OSHA may only
cite a hazardous condition once,
regardless of its scope or the number of
workers affected. Reich v. Arcadian
Corp., 110 F.3d 1192, 1199 (5th Cir.
1997). Thus, even where OSHA finds
that an employer willfully failed to
protect a large number of employees
from a COVID–19 hazard, OSHA might
not be able to cite the employer on a
per-instance basis for failing to protect
each of its employees. The provisions of
this ETS have been intentionally drafted
to make clear OSHA’s authority to
separately cite employers for each
instance of the employer’s failure to
protect employees and for each affected
employee, where appropriate.
By providing needed clarity, the ETS
will facilitate ‘‘willful’’ and ‘‘egregious’’
determinations that are critical
enforcement tools OSHA can use to
adequately address violations by
employers who have shown a conscious
disregard for the health and safety of
their workers in response to the
pandemic. Without the necessary
clarity, OSHA has been limited in its
ability to impose penalties high enough
to motivate the very large employers
who are unlikely to be deterred by
penalty assessments of tens of
thousands of dollars, but whose
noncompliance can endanger thousands
of workers. Indeed, OSHA has only been
able to issue two COVID–19-related
‘‘willful’’ citations and no ‘‘egregious’’
citations since the start of the pandemic
because of the challenges described
above.
For all of the reasons described above,
and after over a year of attempting to
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use the General Duty Clause to address
this widespread hazard, OSHA finds
that the General Duty Clause is not an
adequate enforcement tool to protect
employees covered by this standard
from the grave danger posed by COVID–
19.
c. OSHA and Other Entity Guidance Is
Insufficient
OSHA has issued numerous nonmandatory guidance products to advise
employers on how to protect workers
from SARS–CoV–2 infection (see
https://www.osha.gov/coronavirus).
Even the most comprehensive guidance
makes clear, as it must, that the
guidance itself imposes no new legal
obligations, and that its
recommendations are ‘‘advisory in
nature.’’ (See OSHA’s online guidance,
Protecting Workers: Guidance on
Mitigating and Preventing the Spread of
COVID–19 in the Workplace (OSHA,
Updated August 13, 2021); and OSHA’s
earlier 35-page booklet, Guidance on
Preparing Workplaces for COVID–19,
(OSHA, March 9, 2020)). This guidance,
as well as guidance products issued by
other government agencies and
organizations, including the CDC, the
Centers for Medicare & Medicaid
Services (CMS), the Institute of
Medicine (IOM), and the World Health
Organization (WHO), help protect
employees to the extent that employers
voluntarily choose to implement the
practices they recommend.
Unfortunately, OSHA’s experience and
the continued spread of COVID–19
throughout the country shows that does
not happen consistently or rigorously
enough, resulting in inadequate
protection for employees. For example,
the CDC has strongly recommended
vaccination since vaccines became
widely available earlier in the year, but
many employees have yet to take this
simple step, which would protect
themselves and their co-workers from
the danger of COVID–19.
As documented in numerous peerreviewed scientific publications, CDC,
IOM, and WHO have recognized a lack
of compliance with non-mandatory
recommended infection-control
practices (Siegel et al., 2007; IOM, 2009;
WHO, 2009). As noted in the preamble
to the Healthcare ETS, OSHA was aware
of these findings when it previously
concluded that an ETS was not
necessary, but at the time of that
conclusion, the agency erroneously
believed that it would be able to
effectively use the non-mandatory
guidance as a basis for establishing the
mandatory requirements of the General
Duty Clause, and informing employers
of their compliance obligations under
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existing standards. 86 FR 32421. As
explained above, that has not proven to
be an effective strategy. Moreover, when
OSHA made its initial necessity
determination at the beginning of the
pandemic, it made an assumption that
given the unprecedented nature of the
COVID–19 pandemic, there would be an
unusual level of widespread voluntary
compliance by the regulated community
with COVID–19-related safety
guidelines. (See, e.g., DOL, May 29,
2020 at 20 (observing that ‘‘[n]ever in
the last century have the American
people been as mindful, wary, and
cautious about a health risk as they are
now with respect to COVID–19,’’ and
that many ‘‘protective measures are
being implemented voluntarily, as
reflected in a plethora of industry
guidelines, company-specific plans, and
other sources’’)).
Since that time, however,
developments have led OSHA to
conclude that the same uneven
compliance documented by CDC, IOM,
and WHO is also occurring for the
COVID–19 guidance issued by OSHA
and other agencies. For example, rising
‘‘COVID fatigue’’ or ‘‘pandemic fatigue’’
has been reported for nearly a year
already—i.e., a decrease in voluntary
use of COVID–19 mitigation measures
over time (Meichtry et al., October 26,
2020; Silva and Martin, November 14,
2020; Belanger and Leander, December
9, 2020; Millard, February 18, 2021).
Other reasons that people have not
followed COVID–19 guidance include
fear of financial loss; skepticism about
the danger posed by COVID–19; and
even a simple human tendency, called
‘‘psychological reactance,’’ to resist
curbs on personal freedoms, i.e., an urge
to do the opposite of what somebody
tells you to do (Belanger and Leander,
December 9, 2020; Markman, April 20,
2020). OSHA is seeing evidence of these
trends in its COVID–19 enforcement.
For example, although OSHA has issued
guidance since the spring of 2020
encouraging the use of physical
distancing and barriers as a means of
protecting employees at fixed work
locations, there have been a number of
news reports indicating that employers
ignore that guidance (Romo, November
19, 2020; Richards, May 5, 2020; Lynch,
July 9, 2020). This was evidenced by a
cross-sectional study performed from
late summer to early fall of 2020 in New
York and New Jersey that found noncompliance and widespread
inconsistencies in COVID–19 response
programs (Koshy et al., February 4,
2021). Indeed, OSHA continues to
receive complaints and referrals
attesting to such workplace practices.
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(OSHA, October 17, 2021). Worse, some
employers must now deal with
employees who not only have yet to be
vaccinated but compound the danger by
hiding their unvaccinated status and
declining to wear source protection that
would identify them as unvaccinated,
even though it could provide some
protection to their coworkers, in
workplaces where there is a stigma
attached to being unvaccinated. (Ember
and Murphy Marcos, August 7, 2021).
This ETS contains notification and
vaccine verification requirements that
address these avoidant behaviors and
mitigate the hazard of undisclosed
exposure and transmission (see the
Summary and Explanation for
paragraphs (e), (g), and (h), Sections
VI.E., VI.G., and VI.H. of this preamble).
OSHA’s more recent guidance update
encourages employers to facilitate
employee vaccination by providing paid
time off and encourages testing and
masks for unvaccinated workers.
However, as discussed previously,
vaccination rates remain inconsistent
across the country and have slowed
significantly since the spring of 2021.
And infection rates remain high,
especially among the unvaccinated. It is
clear, as discussed previously, that
voluntary self-regulation by employers
will not sufficiently reduce the danger
that COVID–19 poses in workplaces
covered by this standard. As noted in
the White House Report on vaccination
requirements released on October 7, at
this time only 25% of businesses have
vaccine mandates in place (White
House, October 7, 2021). Since this ETS
and other federal efforts to require
vaccination were announced more
private and public sector institutions
have begun to prepare to implement
vaccination requirements, further
demonstrating the need for this rule as
an impetus for employer action (White
House, October 7, 2021).
The high number of COVID–19related complaints and reports that
OSHA continues to receive on a regular
basis suggests a lack of widespread
compliance with existing voluntary
guidance: From March 2020 to October
2021, OSHA has continued to receive
hundreds of COVID–19-related
complaints every month, including over
400 complaints during the month of
August 2021, and over 450 complaints
to date in the month of September
(OSHA, October 11, 2021). And, as of
October 17, OSHA has received 223
additional COVID–19-related
complaints. (OSHA, October 17, 2021).
If guidance were followed more strictly,
or if there were enough voluntary
compliance with steps to prevent
illness, OSHA would expect to see a
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significant reduction in COVID–19related complaints from employees.
The dramatic increases in the
percentage of the population that
contracted the virus during the summer
of 2021 indicates a continued risk of
COVID–19 transmission in workplace
settings (for more information on the
prevalence of COVID–19 see Grave
Danger, Section III.A. of this preamble)
despite OSHA’s publication of
numerous specific and comprehensive
guidance documents. OSHA has found
that neither reliance on voluntary action
by employers nor OSHA non-mandatory
guidance is an adequate substitute for
specific, mandatory workplace
standards at the federal level. Public
Citizen v. Auchter, 702 F.2d 1150 at
1153 (voluntary action by employers
‘‘alerted and responsive’’ to new health
data is not an adequate substitute for
government action).
d. A Uniform Nationwide Response to
the Pandemic Is Necessary To Protect
Workers
As the pandemic has continued in the
United States, there has been increasing
recognition of the need for a more
consistent national approach (GAO,
September, 2020; Budryk, November 17,
2020; Horsley, May 1, 2020; DOL OIG,
February 25, 2021). Many employers
have advised OSHA that they would
welcome a nationwide ETS. For
example, in its October 9, 2020 petition
for a COVID–19 ETS, ORCHSE
Strategies, LLC explained that it is
‘‘imperative’’ that OSHA issue an ETS to
provide employers one standardized set
of requirements to address safety and
health for their workers (ORCHSE,
October 9, 2020). This group of
prominent business representatives
explained that an ETS would eliminate
confusion and unnecessary burden on
workplaces that are struggling to
understand how best to protect their
employees in the face of confusing and
differing requirements across states and
localities.
The lack of a national standard on this
hazard has led to increasing imbalance
in state and local regulation, a problem
that OSHA already identified as
concerning in its Healthcare ETS. See 86
FR 32413 (‘‘The resulting patchwork of
state and local regulations led to
inadequate and varying levels of
protection for workers across the
country, and has caused problems for
many employees and businesses.’’)
Since the Healthcare ETS was
published, states and localities have
taken increasingly more divergent
approaches to COVID–19 vaccination,
vaccination verification, screening
testing, and the use of face coverings in
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the workplace. Currently, the spectrum
ranges from states and localities
requiring vaccine mandates and face
coverings to states prohibiting or
restricting them, with many states
falling somewhere in between. Due to
uneven approaches to vaccination
across the country, states with the
lowest rates of vaccination have
COVID–19 infection rates four times as
high as in states with the highest
vaccine rates. (Leonhardt, September 7,
2021). Given that thousands of working
age people continue to be infected with
COVID–19 each week, many of whom
will become hospitalized or die, OSHA
recognizes that a patchwork approach to
worker safety has not been successful in
mitigating this infectious disease
outbreak (CDC, October 18, 2021—
Cases, By Age). It has become clear that
a Federal standard, by way of this ETS,
is necessary to provide clear and
consistent protection to employees
across the country. As explained in
Pertinent Legal Authority (Section II. of
this preamble) and the Summary and
Explanation for paragraph (a) (Section
VI.A. of this preamble), OSHA has the
authority to comprehensively address
the issue(s) described in this ETS, and
the standard is intended to preempt
conflicting state and local laws.
In sum, based on its enforcement
experience during the pandemic to date,
OSHA concludes that continued
reliance on existing standards and
regulations, the General Duty Clause,
and guidance, in lieu of an ETS, is not
adequate to protect unvaccinated
employees from the grave danger of
being infected by, and suffering death or
serious health consequences from,
COVID–19.
References
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9). What Motivates COVID Rule
Breakers? Scientific American. https://
www.scientificamerican.com/article/
what-motivates-covid-rule-breakers/.
(Belanger and Leander, December 9,
2020)
Budryk Z. (2020, November 17). Fauci calls
for ‘a uniform approach’ to coronavirus
pandemic. The Hill. https://thehill.com/
policy/healthcare/526378-fauci-calls-fora-uniform-approach-to-the-coronaviruspandemic?rl=1. (Budryk, November 17,
2020)
Centers for Disease Control and Prevention
(CDC). (2021, September 9). Your
COVID–19 Vaccination. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/your-vaccination.html. (CDC,
September 9, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/coviddata-tracker/. (CDC, October 18, 2021)
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Ember S and Murphy Marcos C. (2021,
August 7). They Don’t Want the Shot.
They Don’t Want Colleagues to Know.
The New York Times. https://
www.nytimes.com/2021/08/07/business/
workplace-vaccinations-coronavirusreopenings.html. (Ember and Murphy
Marcos, August 7, 2021)
Government Accountability Office (GAO).
(2020, September). COVID–19: Federal
Efforts Could Be Strengthened by Timely
and Concerted Actions. https://
www.gao.gov/assets/710/709934.pdf.
(GAO, September 2020)
Horsley S. (2020, May 1). U.S. Workplace
Safety Rules Missing in the Pandemic.
National Public Radio. https://
www.npr.org/2020/05/01/849212026/its-the-wild-west-u-s-workplace-safetyrules-missing-in-the-pandemic. (Horsley,
May 1, 2020)
Institute of Medicine (IOM). (2009).
Respiratory Protection for Healthcare
Workers in a Workplace Against Novel
H1N1 Influenza A: A letter report. The
National Academies Press. https://
www.nap.edu/catalog/12748.html. (IOM,
2009)
Kaiser Family Foundation (KFF). (2021,
October 6). Latest Data on COVID–19
Vaccinations by Race/Ethnicity. https://
www.kff.org/coronavirus-covid-19/issuebrief/latest-data-on-covid-19vaccinations-by-race-ethnicity/. (KFF,
October 6, 2021)
Koshy K et al., (February 4, 2021).
Perspectives of region II OSHA
authorized safety and health trainers
about initial COVID–19 response
programs. Safety Science 138. https://
doi.org/10.1016/j.ssci.2021.105193.
(Koshy et al., February 4, 2021)
Leonhardt D. (2021, September 7). One in
5,000. The New York Times. https://
www.nytimes.com/2021/09/07/briefing/
risk-breakthrough-infections-delta.html.
(Leonhardt, September 7, 2021)
Lynch R. (2020, July 9). Orange County to
crack down on gyms that ignore Covid19 safety guidelines. Orlando Business
Journal. https://www.bizjournals.com/
orlando/news/2020/07/09/orangecounty-gyms-could-face-scrutiny-fornot.html. (Lynch, July 9, 2020)
Markman A. (2020, April 20). Why are there
still so many coronavirus skeptics? Fast
Company. https://
www.fastcompany.com/90492518/whyare-there-still-so-many-coronavirusskeptics. (Markman, April 20, 2020)
McPhillips D and Cohen E. (2021, May 19).
Uneven vaccination rates across the US
linked to COVID–19 case trends, worry
experts. CNN Health. https://
www.cnn.com/2021/05/19/health/
uneven-vaccination-rates-covid-19trends/. (McPhillips and
Cohen, May 19, 2021)
Meichtry S et al. (2020, October 26).
Pandemic Fatigue is Real—And It’s
Spreading; Collective exhaustion with
coronavirus restrictions has emerged as a
formidable adversary for governments.
The Wall Street Journal. https://
www.wsj.com/articles/pandemic-fatigueis-realand-its-spreading-11603704601.
(Meichtry et al., October 26, 2020)
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Millard E. (2021, February 18). How to not
let pandemic fatigue turn into pandemic
burnout. Everyday Health. https://
www.everydayhealth.com/coronavirus/
how-to-not-let-pandemic-fatigue-turninto-pandemic-burnout/. (Millard,
February 18, 2021)
Occupational Safety and Health
Administration (OSHA). (2020, March 9).
Guidance on Preparing Workplaces for
Covid-19. https://www.osha.gov/sites/
default/files/publications/
OSHA3990.pdf. (OSHA, March 9, 2020
Occupational Safety and Health
Administration (OSHA). (2021, July 7).
Updated Interim Enforcement Response
Plan for Coronavirus Disease 2019
(COVID–19). https://www.osha.gov/lawsregs/standardinterpretations/2021–07–
07. (OSHA, July 7, 2021)
Occupational Safety and Health
Administration (OSHA). (2021, August
13). Guidance on Preparing Workplaces
for Covid-19. https://www.osha.gov/
sites/default/files/publications/
OSHA3990.pdf. (OSHA, August 13,
2021)
Occupational Safety and Health
Administration (OSHA). (2021, August
13). Protecting Workers: Guidance on
Mitigating and Preventing the Spread of
COVID–19 in the Workplace. https://
www.osha.gov/coronavirus/safework.
(OSHA, Updated August 13, 2021)
Occupational Safety and Health
Administration (OSHA). (2021, October
17). Summary Data for Federal and State
Programs—Enforcement. https://
www.osha.gov/enforcement/covid-19data#complaints_referrals. (OSHA,
October 17, 2021)
ORCHSE Strategies. (2020, October 9).
‘‘Petition to the U.S. Department of
Labor—Occupational Safety and Health
Administration (OSHA) for an
Emergency Temporary Standard (ETS)
for Infectious Disease.’’ (ORCHSE,
October 9, 2020)
Richards C. (2020, May 5). 2 Utah County
businesses told staff to ignore COVID–19
guidelines, resulting in 68 positive cases.
Daily Herald. https://
www.heraldextra.com/news/local/2utah-county-businesses-told-staff-toignore-covid-19-guidelines-resulting-in68-positive/article_d8426991-a693-58799d88-f9e094aef5b5.html. (Richards, May
5, 2020)
Romo V. (2020, November 19). Tyson
managers suspended after allegedly
betting if workers would contract
COVID. National Public Radio. https://
www.npr.org/2020/11/19/936905707/
tyson-managers-suspended-afterallegedly-betting-if-workers-wouldcontract-covid. (Romo, November 19,
2020)
Siegel J, Rhinehart E, Jackson M, Chiarello L,
and the Healthcare Infection Control
Practices Advisory Committee. (2007).
2007 Guideline for isolation precautions:
Preventing transmission of infectious
agents in healthcare settings. https://
www.cdc.gov/infectioncontrol/pdf/
guidelines/isolation-guidelines-H.pdf.
(Siegel et al., 2007)
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Silva C and Martin M. (2020, November 14).
U.S. Surgeon General Blames ‘‘Pandemic
Fatigue’’ for Recent COVID–19 Surge.
NPR. https://www.npr.org/sections/
coronavirus-live-updates/2020/11/14/
934986232/u-s-surgeon-general-blamespandemic-fatigue-for-recent-covid-19surge. (Silva and Martin, November 14,
2020)
United States Department of Labor (DOL) and
Office of the Inspector General (OIG).
(2021, February 25). COVID–19:
Increased Worksite Complaints and
Reduced OSHA Inspections Leave U.S.
Workers’ Safety at Increased Risk. https://
www.oig.dol.gov/public/reports/oa/2021/
19-21-003-10-105.pdf. (DOL OIG,
February 25, 2021)
United States Department of Labor (DOL).
(2020, May 29). In Re: American
Federation Of Labor And Congress Of
Industrial Organizations. Department Of
Labor’s Response to the Emergency
Petition for a Writ of Mandamus, No. 20–
1158 (D.C. Cir., May 29, 2020). (DOL,
May 29, 2020)
White House. (2021, October 7). White House
Report: Vaccination requirements are
helping vaccinate more people, protect
Americans from COVID–19, and
strengthen the economy. https://
www.whitehouse.gov/wp-content/
uploads/2021/10/VaccinationRequirements-Report.pdf. (White House,
October 7, 2021)
World Health Organization (WHO). (2009).
WHO Guidelines on Hand Hygiene in
Health Care: A Summary—First Global
Patient Safety Challenge Clean Care is
Safer Care. https://
www.ncbi.nlm.nih.gov/books/
NBK144013/pdf/Bookshelf_
NBK144013.pdf. (WHO, 2009)
IV. Conclusion
This pandemic continues to take a
massive toll on American society, and
addressing it requires a comprehensive
national response. This ETS is part of
that response. OSHA shares the nation’s
hope for the promise of recovery created
by the vaccines. But in the meantime, it
recognizes that we have not yet
succeeded in defeating the virus, and
that many workers across the country
are in grave danger. Therefore, this ETS,
with mitigation measures emphasizing
worker vaccination, is necessary.
Although OSHA finds it necessary to
institute specific mitigation measures
for the immediate future, the agency can
adjust as conditions change. Even after
issuing an ETS, OSHA retains the
flexibility to update the ETS to adjust to
the subsequent evolution of CDC
workplace guidance. This ETS
addresses (and incorporates as a main
component) the major development in
infection control over the last year—the
development and growing
implementation of COVID–19 vaccines.
Going forward, further developments
can be addressed through OSHA’s
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authority to modify the ETS if needed,
or to terminate it entirely if vaccination
and other efforts end the current
emergency. However, at this point in
time, the available evidence indicates
that the ETS is necessary to protect
unvaccinated employees across the
country from the grave danger of
COVID–19.
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IV. Feasibility
A. Technological Feasibility
This section presents an overview of
the technological feasibility assessment
for OSHA’s Emergency Temporary
Standard (ETS) for COVID–19 that
requires all employers with 100 or more
employees to ensure that all employees
are fully vaccinated unless they
implement a policy requiring employees
to undergo testing for COVID–19 at least
once every seven days and wear face
coverings.
Technological feasibility has been
interpreted broadly to mean ‘‘capable of
being done’’ (Am. Textile Mfrs. Inst. v.
Donovan, 452 U.S. 490, 509–510
(1981)). A standard is technologically
feasible if the protective measures it
requires already exist, can be brought
into existence with available
technology, or can be created with
technology that can reasonably be
expected to be developed, i.e.,
technology that ‘‘looms on today’s
horizon’’ (United Steelworkers of Am.,
AFL–CIO–CLC v. Marshall, 647 F.2d
1189, 1272 (D.C. Cir. 1980) (Lead I));
Amer. Iron & Steel Inst. v. OSHA, 939
F.2d 975, 980 (D.C. Cir. 1991) (Lead II);
American Iron and Steel Inst. v. OSHA,
577 F.2d 825 (3d Cir. 1978)). Courts
have also interpreted technological
feasibility to mean that a typical firm in
each affected industry or application
group will reasonably be able to
implement the requirements of the
standard in most operations most of the
time (see Public Citizen v. OSHA, 557
F.3d 165 (3d Cir. 2009); Lead I, 647 F.2d
at 1272; Lead II, 939 F.2d at 990).
OSHA issued an ETS in June 2021 to
protect healthcare and healthcare
support employees in covered
healthcare settings from exposure to
SARS–CoV–2. See 86 FR 32376 (June
21, 2021) (Healthcare ETS). OSHA
found the requirements in that ETS to
be technologically feasible, including a
requirement for employers to pay for
vaccination of employees that is very
similar to the requirement in this new
ETS. OSHA’s finding that the
Healthcare ETS was technologically
feasible was primarily based on
available evidence showing that most
healthcare employers, and employers
across all industry sectors, had already
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implemented, or were in process of
implementing, procedures similar to
those required by the Healthcare ETS.
Similarly, OSHA’s feasibility findings
for this ETS are based on evidence that
vaccination and testing policies, along
with the use of face coverings consistent
with recommendations from the CDC,
have been implemented in multiple
industry sectors as testing and
vaccinations were made more widely
available during the course of the
pandemic.
As discussed in Summary and
Explanation (Section VI. of this
preamble), this ETS for vaccination and
testing applies to all employers with 100
or more employees, except as noted
here. It does not apply to workplaces
covered under the Safer Federal
Workforce Task Force COVID–19
Workplace Safety: Guidance for Federal
Contractors and Subcontractors or
settings where any employee provides
healthcare services or healthcare
support services when subject to the
requirements of the Healthcare ETS (29
CFR 1910.502). It also does not apply to
employees who do not report to a
workplace where other individuals such
as coworkers or customers are present,
employees while they are working from
home, or employees who work
exclusively outdoors.
As noted above, OSHA has the legal
duty to demonstrate that the average
employer covered by this ETS can
comply with that standard in most
operations most of the time. This legal
analysis is therefore focused solely on
whether employers with 100 or more
employees can comply with the
standard. OSHA’s rationale for that
scope threshold of 100 or more
employees is explained in the Summary
and Explanation for paragraph (b),
Section VI.B. of this preamble.
As discussed below, OSHA finds no
technological feasibility barriers related
to compliance with the requirements in
the ETS. These requirements include
establishing and implementing a written
mandatory COVID–19 vaccination
policy or alternative policy requiring
testing and face coverings; determining
employee vaccination status; supporting
employee vaccination by providing paid
time for vaccination and time off for
recovery; ensuring that employees who
are not fully vaccinated are tested for
COVID–19 at least once every seven
days and wear face coverings; and
recordkeeping for employee vaccination
status and testing.
OSHA reviewed numerous large-scale
employer surveys and vaccination and
testing policies developed by
employers, public health organizations,
trade association, and local, state, and
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federal governmental bodies. While
OSHA discusses several examples of
these plans and policies below,20
OSHA’s feasibility determination is
based on all evidence in the rulemaking
record. The majority of the survey data
and other publicly available material
that OSHA reviewed pertains to large
employers with 100 or more employees.
Additionally, OSHA thoroughly
reviewed current and future projections
of the availability of COVID–19 tests,
testing supplies, and laboratory
capacity. Based on a review of
vaccination and testing policies among
large employers, OSHA has determined
that most employers covered by this
standard across a wide range of
industries have either already
implemented vaccination and testing
programs and require unvaccinated
employees to wear face coverings, or are
capable of implementing programs that
comply with the requirements in the
ETS most of the time. OSHA therefore
finds that the standard is
technologically feasible.
I. Employer Policy on Vaccination
Paragraph (d)(1) of the ETS requires
each covered employer to establish and
implement a written mandatory
vaccination policy unless the employer
adopts an alternative policy requiring
COVID–19 testing and face coverings for
unvaccinated employees, which is
discussed later. To meet the definition
of ‘‘mandatory vaccination policy’’
under paragraph (c), the policy must
require: Vaccination of all employees,
including all new employees as soon as
practicable, other than those employees
(1) for whom a vaccine is medically
contraindicated, (2) for whom medical
necessity requires a delay in
vaccination, or (3) those legally entitled
to a reasonable accommodation under
federal civil rights laws because they
have a disability or sincerely-held
religious beliefs, practices, or
observances that conflict with the
vaccination requirement.
OSHA requires employers to
implement a mandatory vaccination
requirement, but provides an exemption
for an alternative policy that allows
employees to choose either to be fully
vaccinated or to be regularly tested and
wear a face covering. This compliance
options mean that the ETS is
20 While OSHA references several employers’
policies, this is not intended to serve as an
endorsement of those plans or an indication that
those plans comply with the ETS. Rather, the plans
and best practice documents show that developing
and implementing policies to address employee
COVID–19 vaccination in various workplaces is
capable of being done in a variety of industries, and
therefore, compliance with the ETS is
technologically feasible.
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technologically feasible if employers
across various industries are capable of
implementing either policy, but
nevertheless OSHA analyzes both
employer policy options to demonstrate
that there are no significant
technological barriers to either
approach.
OSHA reviewed several large-scale
employer surveys related to vaccination
policies across the country covering a
wide range of industry sectors. Surveys
conducted by Arizona State University
(ASU) and the World Economic Forum
(WEF), called COVID–19 Workplace
Commons—Keeping Workers Well,
show that most employers already have
some type of vaccination policy, with
more than 60 percent of surveyed
employers requiring vaccinations for
some or all employees. These survey
results further support OSHA’s
determination that the vaccination
policy requirement is feasible.
The ASU WEF workplace COVID–19
surveys collected information from
employers across industry sectors about
their response to the COVID–19
pandemic. The results and responses
from more than 1,400 companies are
publicly available through the ASU
College of Health Solutions web page
COVID–19 Diagnostics Commons (ASU,
October 5, 2021). Case studies from
employers are also available within the
interactive dashboard on that web page.
The surveys consisted of numerous
questions about workplace pandemic
response, including questions related to
vaccination policies and testing
unvaccinated employees.
The most recent COVID–19 survey
data was collected between August 2,
2021 and August 20, 2021 and reported
in September 2021 (accessible through
the COVID–19 Workplace Commons).
More than 1,400 companies operating
1143 facilities in 23 industry sectors
were part of the survey, the majority of
which are companies of the size covered
by the ETS. Ninety percent of facilities
surveyed had 100 or more employees at
their facilities, and 56% had more than
100 but less than 1,000 employees at
their facilities. The industry sectors
surveyed include: Technology and
software; business and professional
services; manufacturing; construction;
healthcare, hospitals, and clinics; retail
stores; retail food stores; consumer retail
service; energy and utilities; nonprofit
organizations; education (colleges and
universities); education (pre-K to 12);
real estate and property management;
agriculture and food production;
healthcare services; media and
entertainment; government and quasipublic; biotech, pharmaceuticals, and
diagnostics; restaurants and food
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service; hotels and casinos;
transportation, distribution, and
logistics; consumer transportation; and
recreation (ASU WEF, September 2021).
The survey responses related to
vaccination policies support OSHA’s
determination that it is feasible for
covered employers to implement
mandatory COVID–19 vaccination
policies. The survey results showed that
45% of employers surveyed require all
employees to be vaccinated against
COVID–19, and an additional 16%
require some of its employees to be
vaccinated against COVID–19. (ASU
WEF, September 2021). Only three
percent of employers surveyed did not
have a vaccination policy at the time
(ASU WEF, September 2021). While this
survey covers a wide range of industries
it may not represent the percentage of
companies implementing mandatory
vaccination policies in general
populations but for the feasibility
purposes it demonstrates that it has and
can be done.
OSHA also reviewed slightly older
survey data, which, even though it
shows somewhat lower rates of
employer vaccination mandates, still
supports OSHA’s finding that such
vaccination polices are feasible. In late
June 2021, the National Safety Council
(NSC) conducted three national surveys,
one organizational and two workforce,
of private companies, nonprofits, legal
experts, public health professionals,
medical professionals and government
agencies that have addressed workforce
COVID–19 vaccinations based on best
practices and proven workplace safety
strategies. The survey results show that
many employers and organizations are
currently requiring employees to be
vaccinated.
The three surveys were distributed to
300 employers and organizations across
the country and from a wide range of
industries to collect data on pandemic
response, including implementation of
COVID–19 vaccine policies and testing
among their workforce. Of the
employers and organizations surveyed
in June 2021, the NSC found that 20%
were implementing some form of a
worker vaccination requirement. While
OSHA believes that the ASU WEF
surveys (which included more
employers and are more recent) are
better indicators of current employer
vaccination policies, the NSC surveys
also support the feasibility of employer
vaccination mandates (NSC, September
2021)
The NSC, in partnership with the
Health Action Alliance (HAA) and the
Centers for Disease Control and
Prevention (CDC), have developed a
multifaceted, comprehensive effort
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called SAFER, aimed at helping
employers prioritize health and safety as
they develop plans and polices for their
employees to return to the workplace
(NSC, May 17, 2021). Through SAFER,
the NSC and HAA developed a webbased decision tool to guide employers
on health, legal, and other
considerations to prioritize the health
and safety of workers. Due to the Delta
Variant surge of new COVID–19 cases
across the United States, the NSC and
HAA revised the SAFER resources,
including the online tool, to include
information about employer
requirements for COVID–19
vaccinations. These include guides for
developing plans and policies to
support employee vaccination through
mandates and incentives; the collection
and maintenance of COVID–19
vaccination records; and various
considerations for testing unvaccinated
workers. (HAA and NSC, September 17,
2021). The availability of these publiclyaccessible tools to help employers
develop vaccination policies further
reduces any potential barriers for
covered employers to establish and
implement a written policy requiring
each employee to be fully vaccinated
against COVID–19, or alternatively to
establish a policy allowing employees to
choose whether to be fully vaccinated or
tested for COVID–19 at least every seven
days and wear face coverings.
The HAA maintains an online list of
large companies requiring vaccinations
for all or part of their workforce or
customers. OSHA reviewed the list of
companies, drawn from news reports
and employer websites, with
requirements for COVID–19 vaccination.
Most of the companies listed require
some or all employees to be vaccinated
against COVID–19 while allowing
medical exemptions or reasonable
accommodations for disability or
religious reasons. There are currently
188 listed companies across numerous
industry sectors, including Amtrak,
Deloitte, Google, The Walt Disney
Company, Walmart, and the U.S.
Chamber of Commerce.21
While healthcare employers subject to
29 CFR 1910.502 are not covered by this
ETS, a number of large healthcare
employers have implemented
mandatory vaccine policies. This also
shows the feasibility of the employers
implementing mandatory vaccination
requirements, often on large scales.
According to the American Hospital
Association (AHA), over 1,800 hospitals
21 https://www.healthaction.org/resources/
vaccines/covid-19-vaccines-employer-requirementshealth-action-alliance?0405d6f4_page=1 (last
visited October 2, 2021).
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have one or more vaccination
requirements in place (Becker’s Hospital
Review, October 11, 2021). Large
healthcare employers mandating that
their employees be vaccinated include
Kaiser Permanente, the nation’s largest
integrated, nonprofit health care
organization with more than 216,000
employees and more than 23,000
physicians (Kaiser Permanente, August
2, 2021); Trinity Health, one of the
largest multi-institutional Catholic
health care delivery systems in the
nation, with more than 123,000
employees and 90 hospitals in 22 states
(Trinity Health, July 8, 2021); Sanford
Health, which operates in 26 states and
employs nearly 50,000 people (Sanford
Health, July 22, 2021); and Genesis
Health Care, a large U.S. nursing home
chain with over 40,000 employees
working in more than 250 centers across
23 states (Genesis Health Care,
September 29, 2021).
Under paragraph (d)(2), if employers
do not establish and implement a
written mandatory vaccination policy,
the employer must establish and
implement a written policy allowing
any employees not subject to a
mandatory vaccination policy to either
choose to be fully vaccinated or
regularly tested for COVID–19 and wear
a face covering. A substantial number of
employers already have such policies in
place. For example, the ASU WEF
survey shows that 30% of employers
surveyed require unvaccinated
employees to participate in mandatory
COVID–19 testing and 30% of
employers require face coverings for
unvaccinated employees (ASU WEF,
September 2021).
OSHA also notes a number of state
COVID–19 vaccination requirements. In
response to the Delta Variant surge, 19
states have implemented written
COVID–19 vaccination and testing
policies for state employees and 23
states have done so for healthcare
employees (NASHP, October 1, 2021).
For example, on September 20, 2021,
the Colorado Department of Public
Health and Environment (CDPHE)
implemented policies requiring state
employees and personnel at health care
facilities and hospitals to be fully
vaccinated against COVID–19. All state
employees must either be fully
vaccinated against COVID–19 or
participate in twice-weekly testing.
Employees are allowed work time to get
tested and administrative or Public
Health Emergency Leave to get
vaccinated. Employees who are not fully
vaccinated must wear masks inside state
facilities when they are around others.
On August 30, 2021, the State Board of
Health approved a vaccine requirement
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for personnel in health care settings
with high-risk patients. All personnel
affected by this rule needed to receive
their first dose of COVID–19 vaccine by
September 30, 2021, and must be fully
vaccinated by October 31, 2021 (CDPHE,
September 17, 2021).
A number of local governments have
also implemented policies requiring
COVID–19 vaccination or testing for
employees. For example, the Fulton
County Board of Commissioners in
Georgia recently approved a ‘‘Vax or
Test’’ policy requiring employees to get
vaccinated or tested for COVID–19 each
week. Since September 6, 2021, Fulton
County has required all County
employees, as a condition of
employment, to either be vaccinated
against COVID–19 or be tested weekly
for COVID–19 unless an employee is
granted a reasonable accommodation
(Fulton County Government, September
03, 2021). The multitude of local, state,
and employer vaccination or testing
mandates across the country support
OSHA’s finding that such policies are
feasible.
II. Determining Employee Vaccination
Status
Paragraph (e) of the ETS requires
employers to determine the vaccination
status of each employee. Employers
must require employees to provide an
acceptable proof of vaccination status,
including whether they are fully or
partially vaccinated. As discussed in
Summary and Explanation (Section VI.
of this preamble), acceptable proof of
vaccination status is: (i) The record of
immunization from a health care
provider or pharmacy; (ii) a copy of the
COVID–19 Vaccination Record Card;
(iii) a copy of medical records
documenting the vaccination; (iv) a
copy of immunization records from a
public health, state, or tribal
immunization information system; or a
copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s). A
signed and dated employee attestation is
acceptable in instances when an
employee is unable to produce proof of
vaccination. Given the attestation
option, there are no technological
barriers to the provision for proof of
vaccination status. As discussed below,
many employers requiring proof of
vaccination have successfully
implemented such policies even
without allowing the flexibility of the
attestation option.
The employer must maintain a record
and a roster of each employee’s
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vaccination status. This information is
subject to applicable legal requirements
for confidentiality of medical
information. These records must be
preserved while the ETS is in effect.
OSHA is not aware of any technological
challenges that the large employers
covered by this ETS would face with
respect to collecting and maintaining
records. This is a performance-based
requirement, meaning that employers
have the flexibility to structure their
systems to fit within current systems,
such as those relating to personnel
records, tax records, and other sensitive
or confidential records gathered and
maintained by large employers.
A number of the surveys discussed
above also show that most employers
with vaccine mandates require proof of
vaccination. For example, ASU WEF
workplace COVID–19 survey from fall
2021 found that 60% of employers that
required vaccinations also required
proof of vaccination from employees.
The NSC study from June 2021 found
that 45% of employers with COVID–19
vaccination requirements required proof
of vaccination, such as submitting a
copy of the COVID–19 vaccination card.
An additional 30% of employers
surveyed verify employee vaccination
status through self-reporting based on
the honor system.
Additionally, a large-scale survey
conducted by the Willis Towers Watson
consulting firm between August 18 and
25, 2021, showed that a majority of
employers currently track their
employees’ vaccination status. Nearly
one thousand employers responded to
this survey, and they collectively
employ 9.7 million workers from
industries across the public and private
sectors including manufacturing,
general services, wholesale and retail, IT
and telecom, healthcare, financial
services, energy and utilities, and public
sector and education (Willis Towers
Watson, June 23, 2021). Nearly six in 10
(59%) currently track their workers’
vaccination status and another 19% are
planning or considering doing so later
this year. A majority (62%) of those
employers who currently track their
workers’ vaccination status require
proof of vaccination, such as CDC
vaccination cards, while 36% rely on
employees to self-report (Willis Towers
Watson, September 1, 2021).
Other evidence in the record also
supports the feasibility both of gathering
proof of vaccination and determining
employees’ vaccination status. Many
large employers with vaccination
policies require employees to submit
proof of vaccination. For example,
Tyson Foods requires employees to
submit proof of vaccination to Tyson
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Foods Vaccination Verification Program
in order to qualify for the company’s
vaccination incentive (Tyson Foods,
August 3, 2021). Similarly, Capital One
bank requires all employees,
contractors, vendors, and visitors to
Capital One facilities to show proof of
vaccination. (Capital One, August 11,
2021). The International Union of
Painters and Allied Trades (IUPAT),
which represents 140,000 craftspeople
in the U.S. and Canada and has
implemented vaccine requirements for
its members, also requires all of its own
non–bargaining unit office and field
employees to show proof of vaccination.
(IUPAT, May 10, 2021).
CVS Health, a health conglomerate
with more than 300,000 employees,
including more than 40,000 physicians,
pharmacists, nurses and nurse
practitioners, has mandated COVID–19
vaccination for its nurses, pharmacists
and other employees who interact with
patients and requires proof of
vaccination for those employees (CVS
Health, August 23, 2021).
The surveys and employer policies
reviewed by OSHA all support the
agency’s finding that it is feasible for
employers to determine their
employees’ vaccination status and
collect proof of vaccination.
III. Providing Support for Vaccination
Paragraph (f) of the ETS requires
employers to support COVID–19
vaccination for each employee by
providing a reasonable amount of time
to each employee for vaccination and
reasonable time and paid sick leave to
each employee for side effects
experienced following vaccination. The
feasibility of paying for the time is
addressed in OSHA’s economic
analysis.
This technological feasibility
determination focuses on whether
employers would encounter obstacles in
implementing payment policies that
would make this requirement infeasible
for the large employers covered by this
ETS. OSHA has determined that there
are no such obstacles. Most
significantly, OSHA has already
required this type of system for
employers covered by the Healthcare
ETS and nearly four months after that
ETS took effect, OSHA is not aware that
employers covered by that ETS
experienced any technological
compliance difficulties with respect to
that requirement. In addition, many
employers have already implemented
policies such as those required to
comply with this new ETS as a way of
incentivizing employee vaccination. For
example, the ASU WEF workplace
COVID–19 survey from fall 2021 found
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that 60% of employers surveyed offered
incentives for employees to be
vaccinated. These incentives ranged
from additional paid time off, cash, the
ability to bypass regular testing and/or
daily health screening requirements,
and gifts. Eighteen percent of surveyed
employers already provide additional
time off for COVID–19 vaccination.
Moreover, the NSC survey found that
86% of surveyed organizations had
implemented policies such as paid time
off, assistance with scheduling and
transportation, and/or onsite
vaccination.
OSHA’s review of plans and best
practice documents from the HAA
registry and from other publiclyavailable sources also inform OSHA’s
finding that it is feasible for large
employers to support employee
vaccination (HAA, October 10, 2021).
As part of this review, OSHA analyzed
the ways that employers are currently
supporting employee vaccination. One
employer in the restaurant industry, the
Fifty/50 Group, a Chicago-based
restaurant group comprised of 14
establishments that requires employees
to be fully vaccinated, offers paid time
off for anyone getting a vaccine or
feeling the mild after-effects. (Fifty/50
Group, May 18, 2021). Another
employer in the animal slaughtering and
processing industry, Tyson Foods,
requires COVID–19 vaccinations for its
U.S. workforce and also offers $200 and
up to four hours of regular pay if
employees are vaccinated outside of
their normal shift or through an external
source (Tyson Foods, August 3, 2021).
In addition, Tyson Foods supports
onsite vaccination events in
collaboration with local health
departments and healthcare providers to
improve accessibility to vaccination.
Tyson Foods has hosted more than 100
vaccination events at its locations across
the country.
The evidence in the record
demonstrates that many employers are
already offering the types of vaccination
support required by paragraph (f).
Combined with OSHA’s previous
finding for a similar provision in the
Healthcare ETS and the lack of
compliance difficulties reported while
that ETS has been in effect, OSHA
therefore finds this requirement is
technologically feasible.
IV. COVID–19 Testing for Employees
Who Are Not Fully Vaccinated
Paragraph (g) of the ETS requires
employers to ensure that employees
who are not fully vaccinated and who
report at least once every seven days to
a workplace where other individuals
such as coworkers or customers are
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present are: (1) Tested for COVID–19 at
least once every seven days; and (2)
provide documentation of the most
recent COVID–19 test result to the
employer no later than the seventh day
following the date the employee last
provided a test result. Employers must
also ensure that employees who are not
fully vaccinated and do not report
during a period of seven or more days
to a workplace where other individuals
are present are: (1) Tested for COVID–
19 within seven days prior to returning
to the workplace; and (2) provide
documentation of that test result upon
return to the workplace.
Employees who are not fully
vaccinated must be tested with a
COVID–19 test, which is a test for
SARS–CoV–2 that is: (i) Cleared,
approved, or authorized, including in an
Emergency Use Authorization (EUA) by
the U.S. Food and Drug Administration
(FDA) to detect current infection with
the SARS–CoV–2 virus (e.g., a viral
test); (ii) administered in accordance
with the authorized instructions; and
(iii) not both self-administered and selfread unless observed by the employer or
an authorized telehealth proctor.
Examples of tests that satisfy this
requirement include tests with
specimens that are processed by a
laboratory (including home or on-site
collected specimens which are
processed either individually or as
pooled specimens), proctored over-thecounter tests, point of care tests, and
tests where specimen collection is either
done or observed by an employer.
COVID–19 testing has become more
widely available throughout the
pandemic and as of September 2021, the
FDA has authorized approximately 250
tests and collection kits that diagnose
current infection with the SARS–
CoV–2 virus and may be acceptable
under the ETS (FDA, September 10,
2021), and by October 1, 2021, the
number of EUAs issued had grown to
324 (FDA, October 1, 2021). The ETS
permits compliance through use of a
wide range of FDA-authorized tests that
are readily available, so there is little
doubt that testing itself is
technologically feasible.
This technological feasibility analysis
therefore focuses on whether testing
will continue to be readily available in
quantities sufficient to meet the
potential increase in testing demand
while this ETS is in place. Given the
wide variety of tests that can be used to
comply with this ETS and OSHA’s
review of information about the existing
manufacturing and distribution
capabilities of test manufacturers, the
agency does not anticipate feasibility
issues related to ensuring that
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employees can get access to one of the
acceptable tests within the time frames
required by the ETS.
a. Brief Overview of Testing and
Administration
COVID–19 tests that are cleared,
approved, or authorized, including in an
Emergency Use Authorization (EUA), by
the FDA to detect current infection with
the SARS–CoV–2 virus (e.g., a viral test)
satisfy the ETS. FDA-cleared, approved,
or authorized molecular diagnostic tests
and antigen tests are permitted under
the ETS when used as authorized by the
FDA and with a Clinical Laboratory
Improvement Amendments of 1988
(CLIA) certification when appropriate.
As described in the Summary and
Explanation for paragraph (g) (Section
VI.G. of this preamble), NAATs are a
type of molecular test that detect genetic
material. As of October 14, 2021, the
FDA had issued EUAs for 264 molecular
COVID–19 tests including tests
specified to be used ‘‘with certain
conditions of authorization required of
the manufacturer and authorized
laboratories’’, 81 of which are
authorized for home collection.
Additionally, the FDA has issued EUAs
for 2 OTC molecular COVID–19 test kits
available without a prescription (FDA,
October 14, 2021b).
NAATs, such as real-time reverse
transcription-polymerase chain reaction
(RT–PCR), have greater accuracy than
antigen tests. However, most FDAauthorized NAATs need to be processed
in a laboratory certified under the
Clinical Laboratory Improvement
Amendments of 1988 (referred to as a
‘‘CLIA-certified laboratory’’) with
variable time to results (∼1–2 days).
While the NAAT test is a more reliable
test, the antigen test is faster and less
expensive.
An antigen test is an in vitro
diagnostic test used to detect active
SARS–CoV–2 infection. As of October
14, 2021, the FDA had issued 37 EUAs
for COVID–19 antigen tests, including
eight EUAs for over-the-counter (OTC)
antigen tests that can be used without a
prescription (FDA, October 14, 2021a).
Administration of an antigen test that
meets the definition of COVID–19 test
under this ETS falls into one of several
categories: OTC employee self-tests that
are observed by employers or authorized
telehealth proctors; point-of-care (POC)
or OTC tests performed by employers
with a CLIA certificate of waiver; and
other FDA cleared, approved, or
authorized antigen tests that are
analyzed in a CLIA certified laboratory
setting (FDA, October 14, 2021a). The
FDA has authorized POC tests that can
be used at a place of employment when
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the facility is operating under a CLIA
certificate of waiver. A CLIA certificate
of waiver can be issued by CMS and
may, when consistent with FDA’s
authorization, allow a laboratory to run
a SARS–CoV–2 test outside a high or
moderate complexity traditional clinical
laboratory setting (CDC, September 9,
2021). In accordance with the CLIA
certificate of waiver, the laboratory or
POC testing site must use a test
authorized for that location, like an FDA
EUA POC test, and must adhere to the
authorized test instructions to avoid
human error. Certain COVID–19 antigen
diagnostic tests can be analyzed on-site
(where the person took the nasal swab)
when that facility is operating under a
CLIA certificate of waiver, while others
must be analyzed in a CLIA certified
high or moderate complexity laboratory
setting. Some COVID–19 antigen
diagnostic tests are authorized for use at
home, without the need to send a
sample to a laboratory. Antigen tests
generally return results in
approximately 15–30 minutes. The CDC
provides training materials created by
test manufacturers for POC antigen
testing and reading of results for SARS–
CoV–2 (CDC, July 8, 2021).
COVID–19 antigen diagnostic tests are
found at physician offices; urgent care
facilities; pharmacies, such as CVS or
Walgreens; school health clinics; longterm care facilities and nursing homes;
temporary locations, such as drivethrough sites managed by local
organizations; and other locations across
the country (CDC, July 8, 2021; CVS
Health, October 2021; Walgreens,
October 8, 2021). The availability of
government-offered antigen tests varies
by state, and may be free or subsidized
and accessible without a prescription or
physician note (RiteAid, October 2021;
Walgreens, October 2021; HHS, June 11,
2021). The Department of Health and
Human Services (HHS) provides a
publicly-available list of communitybased testing locations in each state that
offer free COVID–19 testing for insured
and uninsured residents (HHS, August
17, 2021). Pharmacies and other
locations often provide antigen tests by
appointment, although some will allow
testing for walk-ins (CVS Health,
September 2021; Walgreens, October 8,
2021). COVID test kits are currently
available from several on-line retailers
(Amazon, October 12, 2021).
b. Testing Frequency
The ASU WEF survey data also
supports OSHA’s finding that the
requirement for employees who are not
fully vaccinated to be tested at least
every seven days is feasible. The ASU
WEF found that 73% of survey surveyed
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employers (797 employers) had testing
policies for their workforce, and 76% of
those employers had implemented
mandatory testing requirements.
Additionally, 25% of employers with
testing polices had implemented
requirements for routine testing of a
portion of or the entire workforce, and
41% no longer require testing for fully
vaccinated employees. Of the employers
that test employees, 27% of those
perform viral testing daily and 46%
perform viral test once a week. Finally,
38% of companies exclusively
administer polymerase chain reaction
(PCR) tests (PCR tests are a type of
NAAT), 17% exclusively administer
antigen tests, and 45% administer both.
Companies administer a range of
COVID–19 tests and conduct testing at
a variety of locations (some companies
use more than one location). Forty-two
percent of companies test workers at
health testing laboratories, 35% test
onsite at work, 28% test at hospitals,
23% test at retail pharmacies, 13% test
at universities, 9% test at home to be
sent a lab for evaluation, and 5% test at
home for immediate results (ASU WEF,
September 2021).
OSHA also evaluated evidence of
employers’ current testing efforts by
reviewing existing COVID–19 practices
developed by employers, trade
associations, and other organizations.
Based on its review, OSHA concludes
that it is feasible for most covered
employees (and therefore their
employers) to be tested in compliance
with the ETS requirements for
frequency of testing.
OSHA notes that there are several
options for large employers to consider
if they want to help facilitate testing for
employees who are not vaccinated.
Delta Airlines, for example, currently
requires weekly COVID–19 testing for
all of its employees who are not
vaccinated, and the company has
engaged the Mayo Clinic Laboratories to
help design the employee testing
program, assist in administering
diagnostic and serology tests, and
analyze the results to determine broader
trends and provide recommendations to
Delta’s existing policies and procedures
(Mayo Clinic Laboratories, June 30,
2020). Delta Airlines also operates
onsite testing in cities with large
employee populations including
Atlanta, Minneapolis, and New York. It
recently extended an at-home specimen
collection option to all U.S. employees,
through which Quest Diagnostics will
send self-collection kits directly to an
employee’s doorstep upon request and
support complete laboratory
confirmation for results (Delta, August
25, 2021).
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c. Availability of COVID–19 Tests
In the spring and early summer
months of 2021, demand for tests
decreased as vaccinations began to
increase and the number of COVID–19
cases declined before the Delta surge
and some manufacturers slowed
production of COVID–19 tests.
However, the number of tests performed
daily has grown considerably over the
summer due to the Delta Variant surge
and re-openings of workplaces and
schools. In parallel with the Delta surge,
COVID–19 testing has increased from a
daily average of about 450,000 in early
July 2021 to about 1.8 million by midSeptember 2021, or roughly 12.6 million
per week (JHU, October 8, 2021). This
data does not include any selfadministered OTC tests, which will be
discussed below.
OSHA’s review of the evidence shows
that the increasing rate of production of
COVID–19 tests is more than adequate
to meet rising demand related to
compliance with the ETS testing option
before the 60-day delayed testing
compliance date (see paragraph
(m)(2)(ii)). This determination is largely
based on the number of tests with FDA
EUAs actively being produced through
the National Institutes of Health (NIH)
Rapid Acceleration of Diagnostics
(RADx) initiative described below.
According to the Johns Hopkins
University of Medicine Coronavirus
Resource Center, the total tests
administered in August 2021 was
approximately 44.4 million (or
approximately 11.1 million per week).
Id. During that same month, the total
tests produced by the NIH RADx
contracts was approximately 121
million (which would average to 30.25
million per week), resulting in a
substantial surplus of available tests
(NIBIB, September 28, 2021). As
discussed in Economic Analysis,
Section IV.B. of this preamble, Table
IV.B.8, OSHA estimates that as many as
7.2 million tests may be administered
weekly under this standard; however,
7.2 million is almost certainly an
overestimate because it does not
exclude employees who are already
required to be tested by their employers
and would continue to be tested at the
same frequency after the ETS. Even if
testing is increased by 7.2 million tests
per week because of the ETS, that would
still mean a surplus of nearly 12 million
tests per week beyond what would be
need to continue at current testing
levels with the addition of ETS-related
tests (30.25 ¥ 11.1 ¥ 7.2 = 11.95
million surplus per week).
The total number of tests
administered during June, July, and
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August 2021, the period of the summer
including the Delta Variant surge and
other reasons for substantial testing
increases such as re-opening of schools,
was approximately 87 million tests, an
average of approximately 6.7 million per
week (JHU, October 8, 2021). During
that period, more than 400 million
COVID–19 tests were produced through
the NIH RADx initiative, or roughly 33
million per week. OSHA anticipates that
this surplus of tests will continue to
increase the availability of tests that can
be used to comply with the ETS.
The data from the Johns Hopkins
Coronavirus Resource Center is
collected from state and county
government sources, so it does not
include any self-administered OTC
tests. Additionally, while all states
report PCR testing, not all states report
antigen testing. Nevertheless, the data
from Johns Hopkins Coronavirus
Resource Center is the best available
evidence from which to estimate the
total number of tests administered
during a given period of time. Even
though the number of administered tests
reported through the Johns Hopkins
Coronavirus Resource Center does not
include unreported OTC tests, the NIH
RADx program data shows a large
surplus and sufficient additional
COVID–19 test capacity relative to the
number of administered tests reported.
Additionally, the NIH RADx program
will further allow for increased test
distribution through retail markets and
will address any increase in demand
due to companies that may stockpile
tests. This increased availability will
strengthen test capacity, further
enabling compliance with the ETS
testing provision (NIBIB, September 28,
2021). OSHA has determined that even
with an estimated additional 7.2 million
tests administered weekly due to the
ETS (see Economic Analysis (Section
IV.B. of this preamble)), there are
sufficient COVID–19 tests available to
allow for both employers and employees
to obtain COVID–19 tests through a
variety of retail sources (e.g., local
pharmacies, on-line purchasing as
discussed above).
Determinations of testing capacity are
aggregate measures of domestic and
global market and supply chains.
Throughout the pandemic, diagnostic
testing capacity has been stressed by the
increased demand, as some products
that are part of a global market cannot
adapt by simply increasing
manufacturing in one country (e.g.,
laboratory instruments), and other
products manufactured domestically
require capital investments to address
rising demands (e.g., extraction kits)
(CRS, February 25, 2021). As discussed
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below, because of the substantial
investments made, OSHA projects that
the diagnostic testing capacity can meet
the increased demand due to this ETS.
OSHA evaluated multiple projections
of current and future testing capacity
and determined that projections related
to the NIH initiatives discussed below
are the most reliable estimates of current
and future testing capacity for its
technological feasibility assessment.
Test manufacturers receiving NIH, FDA,
and Biomedical Advanced Research and
Development Authority (BARDA) (a
component of HHS) funding as part of
these programs undergo a submission
and authorization process where their
production capacity and pipeline are
assessed and production quantities are
validated. As explained below, as of
August 2021, the NIH data indicates
testing capacity stands at about 30
million tests per week, and capacity
continues to grow (NIBIB, September
28, 2021). OSHA notes that this number
underestimates the total number of tests
available each week, as it only includes
companies that have received funding
for tests and testing supplies through
the NIH initiatives described below.
The NIH has identified constraints on
testing capacity as an area of focus and
investment since the beginning of the
COVID–19 pandemic, and OSHA
examined potential constraints on
testing capacity as part of its feasibility
analysis. As described below, massive
investments in testing capabilities,
particularly in underserved areas, have
largely mitigated issues with the
availability of COVID–19 tests. Further,
testing capacity continues to grow as
new tests are developed and brought to
market and manufacturers can ramp up
supply to meet any future testing
demands if need be.
The FDA has authorized more than
320 tests and collection kits that
diagnose current infection with the
SARS–CoV–2 virus and may be
acceptable under the ETS (FDA, October
1, 2021). Among other criteria, the
standard allows for the use of tests with
specimens that are processed by a CLIA
certified laboratory (including home or
on-site collected specimens which are
processed either individually or as
pooled specimens), proctored over-thecounter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer. As explained above, many
employers across various industry
sectors have already implemented
policies for onsite testing. The use of
FDA-authorized POC tests by these
employers would be compliant with the
testing provision of the ETS if the entity
administering the test holds a CLIA
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certificate as required by the EUA.
COVID–19 OTC tests that are both selfadministered and self-read by
employees do not satisfy the testing
requirement unless observed by the
employer or an authorized telehealth
proctor. In the event that the employer
is merely observing the employee
conduct a test, a CLIA certificate would
not be needed.
There have been extensive
investments, including by the federal
government, to help ensure that COVID–
19 tests are widely available. Section
2401 of the American Rescue Plan
appropriated $47,800,000 to the
Secretary of the HHS, to remain
available until expended, to carry out
activities to detect, diagnose, trace, and
monitor SARS–CoV–2 and COVID–19
infections and related strategies to
mitigate the spread of COVID–19. Funds
were made available to implement a
national testing strategy; provide
technical assistance, guidance, support,
and awards grants or cooperative
agreements to State, local, and territorial
public health departments; and support
the development, manufacturing,
procurement, distribution, and
administration of tests to detect or
diagnose SARS–CoV–2 and COVID–19;
and establish federal, state, local and
territorial testing capabilities.
On April 29, 2020, the NIH
established the RADx initiative with a
$1.5 billion investment. The RADx
initiative has used this funding to speed
development of rapid and widelyaccessible COVID–19 testing (NIH, April
29, 2020). On October 6, 2020, the NIH
and BARDA established the RADx
Technology (RADx-Tech) and RADx
Advanced Technology Platforms (RADxATP) programs to speed innovation in
the development, commercialization,
and implementation of technologies for
COVID–19 testing specifically for latestage scale-up projects. Through the
RADx Tech and RADx-ATP programs,
the NIH and BARDA have awarded a
total of $476.4 million in manufacturing
expansion contracts supporting a
combined portfolio of 22 companies in
the U.S. (NIH, October 6, 2020).
These programs have significantly
increased testing capacity throughout
the country. Since being established,
RADx has worked closely with the FDA,
the CDC, and BARDA to move more
advanced diagnostic technologies
swiftly through the development
pipeline toward commercialization and
broad availability. On April 28, 2021,
the Institute of Electrical and Electronic
Engineers (IEEE) dedicated a special
issue in the Journal of Engineering in
Medicine and Biology exploring the
innovative structure and operation of
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the RADx Tech program and determined
that the initiatives had succeeded in
dramatically increasing COVID–19
testing capacity in the United States.
The IEEE report found that the RADx
Tech/ATP programs, in conjunction
with BARDA and the FDA, had
streamlined and bolstered the national
COVID–19 testing capacity. At the time
of the report, the RADx Tech/ATP
programs had increased the number of
testing makers to 150 companies that, as
a result of the NIH/BARDA investments,
had the capacity to produce up to 1.9
million tests per day (IEEE, April 28,
2021).
The NIH RADx-TECH/ATP initiative
entered its second phase on September
28, 2021, and at that time the supported
companies had collectively produced
over 500 million tests, received 27 FDA
authorizations, and developed the first
OTC COVID–19 test for use at home.
These September 2021 investments are
supporting late stage development of
innovative point-of-care and homebased tests, as well as improved clinical
laboratory tests that will increase the
capacity of testing in the U.S. A full list
of active contracts and supported U.S.
COVID–19 testing manufacturers can be
found on the NIH RADx-TECH/ATP
programs: Phase 2 awards (NIBIB,
October 14, 2021).
The following example shows the NIH
RADx EUA pipeline process. On May 9,
2020, the FDA authorized the first EUA
for a COVID–19 antigen test, a new
category of tests for use in the ongoing
pandemic. Quidel was awarded a
contract under the NIH RADx TECH/
ATP phase 1 initiative for the Sofia 2
SARS Antigen FIA for use in high and
moderate complexity laboratories
certified by CLIA, as well as for pointof-care testing by facilities operating
under a CLIA certificate of waiver (FDA,
May 9, 2020). On July 31, 2020, Quidel
announced that it had received a
contract for $71 million under the NIH
RADx TECH/ATP program, phase 1, to
accelerate the expansion of its
manufacturing capacity for production
of the SARS–CoV–2 rapid antigen test
and quickly exceeded that capacity
(Quidel Corp., July 31, 2020). On March
31, 2021, the FDA then authorized a
second EUA from Quidel under contract
with the NIH RADx initiative for the
QuickVue At-Home OTC COVID–19
Test, another antigen test where certain
individuals can rapidly collect and test
their sample at home, without needing
to send a sample to a CLIA certifed
laboratory for analysis (FDA, March 31,
2021). Furthermore, based on the
success of the Quidel for the Sofia 2
SARS Antigen FIA increasing
production capacity, the NIH granted
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another $70 million contract for
manufacturing Capacity Scale-Up for
Sofia SARS Antigen and Sofia Influenza
A+B/SARS FIAs on June 11, 2021 (FDA,
June 11, 2021).
The RADx-TECH/ATP initiative
maintains a dashboard of manufacturer
testing data from supported U.S. firms.
OSHA reviewed the data available on
the dashboard as part of its
determination of feasibility. In August
2021, the data showed that U.S.
manufacturers supported by the NIH
RADx-TECH/ATP were producing
approximately 30 million tests per week
(NIBIB, September 28, 2021).
While consumers in some parts of the
country have encountered difficulty
obtaining rapid at-home tests, on
October 4, 2021, the FDA granted EUA
for the ACON Laboratories Flowflex
COVID–19 Home Test, which is
anticipated to double rapid at-home
testing capacity in the United States
within weeks (and well before
compliance dates for testing required by
this ETS) (FDA, October 4, 2021). By the
end of the 2021 (ahead of the paragraph
(g) compliance date), the manufacturer
plans to produce more than 100 million
tests per month and plans to produce
more than 200 million tests per month
by February 2022 (FDA, October 4,
2021). On October 6, 2021, the
Administration announced a plan to
buy $1 billion worth of rapid at-home
COVID–19 tests; this purchase, coupled
with the October 4 authorization of the
Flowflex COVID–19 test, is expected to
increase the number of available athome COVID–19 tests to 200 million per
month by December 2021 (Washington
Post, October 6, 2021).
These investments have had a
pronounced impact on the availability
of testing and employers’ use of testing
in the workplace. ASU’s recent report,
How Work has Changed: The Lasting
Impact of COVID–19 on the Workplace,
ascribed the jump in the percentage of
employers that test their employees
from 17% in the fall of 2020 to 70% in
the fall of 2021 in large part to the
increased availability of testing. In
particular, the report noted that by the
spring of 2021, ‘‘it became relatively
easy to acquire tests and hire testing
service providers. There are more labs
and companies with EUA’s and most
have enough capacity that there are few
shortages.’’ (ASU WEF, September
2021).
Moreover, to ensure a broad,
sustained capacity for COVID–19 test
production, multiple COVID–19 test
manufacturers have been mobilized by
authority of the Defense Production Act.
Under the Administration’s plan to
increase COVID–19 testing, the federal
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government will directly purchase and
distribute 280 million- rapid point-ofcare and over-the-counter at-home
COVID–19 tests, sending 25 million free
at-home rapid tests to community health
centers and food banks. These actions
will provide tests for use by
communities to build adequate
stockpiles, as well as the sustained
production to be able to scale up
production as needed in the future.
Additionally, to ensure convenient
access to free testing, 10,000 pharmacies
will be added to the Department of
Health and Human Services free testing
program.
In response to rising demands for
testing, U.S. manufacturers have
increased production of COVID–19 test
kit, reagents, and supplies. Advanced
Medical Technology Association
(AdvaMed), a trade group for testing
manufacturers, reported that its
members are ramping up production of
rapid point-of-care test supplies to meet
demand and that laboratory-based
testing capacity for test confirmation is
strong. AdvaMed has created a national
COVID–19 Diagnostic Supply Registry
of COVID–19 test manufacturers that
support state and federal governments
in their pandemic responses. Registry
participants are thirteen leading
diagnostic manufacturers whose tests
together comprise approximately 75–
80% of the COVID–19 in vitro
diagnostic devices (IVD) on the market
in the U.S. While these manufacturers
produce a majority of molecular
COVID–19 tests, they do not produce a
majority of the total COVID–19 tests
manufactured. These COVID–19 test
manufacturers collectively shipped
approximately 3.8 million tests in July
2021, 8.2 million tests in August 2021,
and 9.4 million molecular tests for the
week ending September 4th, 2021
(AdvaMed, September 10, 2021). While
these figures are not representative of
the total weekly testing capacity in the
U.S., this data demonstrates that testing
capacity has grown significantly over
the past few months and reflects the
success manufacturers have had in
ramping up production of tests.
While current test availability is
sufficient to meet the increased testing
demands due to the ETS, OSHA is also
confident that the RADx-TECH/ATP
initiatives will continue to spur testing
capacity and growth. The RADx-TECH/
ATP initiatives have focused on moving
test makers’ products through the late
stage pipeline and securing FDA
authorization for entry into the market.
So far, there have been 27 such
authorizations. As of September 2021,
there were 824 eligible late-stage scale
up proposals from various test makers
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up for review for NIH/BARDA funding.
Furthermore, 517 of these submissions
are for the authorization and production
of multiple types of COVID–19 tests
including one or more of the following:
Blood, sputum, nasal swab, oral swab,
fecal, saliva, or other types. OSHA
considers this to be further support for
its determination that testing capacity
will continue to grow and that increased
COVID–19 testing supplies are on the
horizon (NIBIB, September 28, 2021).
Based on data from the Johns Hopkins
Coronavirus Resource Center, which
examined publicly-available data from
multiple sources, approximately 12.4
million tests were conducted during the
week of August 26–September 2, 2021.
As noted earlier, in the economic
analysis of this ETS, OSHA projects
testing rates to increase by
approximately 7.2 million tests per
week starting 60 days after publication
of the ETS. As described above, many
employers are currently testing their
workforce. This 7.2 million is almost
certainly an overestimate because it
does not exclude employees who are
already required to be tested by their
employers and would continue to be
tested at the same frequency after the
ETS. The data reviewed by OSHA on
the RADx-TECH/ATP Dashboard shows
that the manufacturers supported by the
initiative are producing approximately
30 million tests per week, and capacity
continues to grow. As explained above,
it is expected that roughly 50 million athome COVID–19 tests will be available
each week by December 2021. OSHA
therefore finds that there are (and will
continue to be) sufficient COVID–19
tests available to meet the anticipated
demand related to compliance with
paragraph (g) by the 60-day delayed
compliance date.
d. Availability of COVID–19 Test
Supplies
OSHA has also analyzed the
availability of COVID–19 test supplies
for use by COVID–19 test kit
manufacturers, diagnostic laboratories,
and determined that there are sufficient
supplies to allow compliance with the
ETS testing option. The COVID–19
pandemic and recent Delta Variant
surge have caused some disruptions in
the availability of testing supplies such
as swabs, viral transport medium, RNA
extraction kits, serology consumables,
diagnostic reagents, plastic
consumables, and diagnostic
instruments. The COVID–19 testing
supply market is driven by the need to
rapidly screen large segments of the
population and deliver test results. The
data presented throughout this
assessment has shown demand for
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laboratory COVID–19 tests is rising
across the country.
Testing for COVID–19 involves many
different components that are
manufactured, transported, and used
independently (e.g., bulk solvents,
extracting reagents, packaging) or semiindependently (e.g., test kits). Most of
the supplies used in COVID–19 testing
are disposable, requiring a constant
sustained capacity for new supplies.
Some distribution channels move
supplies directly to medical and
laboratory end-users and others move
supplies through distributors. In either
case, the combination of increased
testing demand and the established
supply chains indicate that testing kits
will be available in sufficient quantities
throughout the country, including in
rural areas where large employers may
be located.
There have been substantial
investments from federal and state
programs and private industry to
stimulate the production and
distribution of testing supplies to bolster
testing capacity across the country.
Many products, such as swabs and
reagents for RNA extraction kits,
exhibited rising demand and, at some
point during the pandemic, were subject
to shortages that threatened continued
testing capacity. For example, there was
only one domestic manufacturer of
medical grade flocked swabs, Puritan
Medical Products Company of Guilford,
Maine, and the company’s prepandemic capacity was insufficient to
meet demand of increased testing in the
early period of the COVID–19 pandemic
(Puritan Products, April 20, 2020). On
July 29, 2020, the Department of
Defense (DOD), in coordination with the
Department of Health and Human
Services, awarded $51.15 million to
Puritan to expand industrial production
capacity of flock tip testing swabs (DOD,
July 31, 2020). On March 26, 2021,
Puritan was awarded another $146.77
million to increase the company’s total
production capacity to 250 million foam
tip swabs per month at its Tennessee
facility by February 2022 (DOD, March
29, 2021).
Other private sector companies were
mobilized to change the products they
manufactured to accelerate production
of COVID–19 test components, such as
swabs, reagents, and solvents for RNA
extraction kits. For example,
Microbrush, a U.S.-based manufacturer
of sterile applicators for the dental
industry, began production of a
nasopharyngeal test swab to meet the
growing demand for COVID–19 testing
requirements in July 2020. The
Microbrush test swabs are sterilized and
individually packaged in a medical-
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grade pouch intended for
nasopharyngeal sample collection such
as in dental procedures and also
COVID–19 testing (Microbrush, July 1,
2020).
RNA extraction kits are used by the
majority of NAAT protocols. These kits
are sets of consumable plastic laboratory
materials (small centrifuge tubes, filters,
and collection vials) and chemical
reagents (solutions for breaking the
virus apart and purification) assembled
by a manufacturer. Each kit has enough
materials to process several dozen
samples. The use of RNA extraction kits
is not exclusive to COVID–19 testing,
meaning that a market existed preCOVID–19, and manufacturers were
able to adapt to fluctuations in demand
spurred by the pandemic.
There are multiple companies with
facilities in the United States that
produce RNA extraction kits for the
domestic market that have been
awarded federal grants to increase the
supply of COVID–19 test kits and
reagent supplies. For example, in
December 2020, the DOD and HHS
identified several key reagents with the
potential for supply chain bottlenecks
and awarded a $4.8 million Indefinite
Delivery/Indefinite Quantity contract to
Anatrace Products, LLC to support
increased production of key reagents for
sample processing; Polyadenylic Acid
(Poly A), Guanidinium Thiocyanate
(GTC), and Proteinase K (Pro K) to
process samples (DOD, December 21,
2020). Additionally, QIAGEN (based in
Germany with U.S. manufacturing in
Germantown, Maryland) produces
extraction kits for authorized COVID–19
tests and has responded to the
pandemic by scaling their production to
around the clock production to
strengthen testing kit capacity (Qiagen,
October 2, 2021). On August 23, 2021,
DOD, on behalf of and in coordination
with HHS, awarded a $600,000 contract
to QIAGEN to expand manufacturing
capacity of enzymatic reagents and
reagent kits used in COVID–19
molecular diagnostic tests, thereby
allowing QIAGEN to increase its
monthly production of reagent kits by
7,000 and enzymes by 5,100 milligrams
by the end of February 2022 to support
domestic laboratory testing for COVID–
19 (DOD, August 23, 2021).
Additionally, manufacturers of raw
materials and solvents for COVID–19
test kits have implemented strategies to
strengthen their portions of the COVID–
19 test supply chain. Millipore Sigma, a
large producer of solvents and raw
materials for tests, has created a global
task force to actively evaluate the
overall supply chain of products and
key raw material suppliers to mitigate
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any potential disruption of COVID–19
testing capacity (Millipore Sigma,
October 2021). In light of the foregoing,
OSHA believes that there is sufficient—
and increasing—availability of COVID–
19 testing supplies to enable compliance
with the ETS testing option.
e. Sufficiency of Laboratory Capacity
As noted above, a wide range of tests
are acceptable under the ETS, including
those that can be observed by employers
without laboratory processing.
Moreover, there has been rapid growth
in the availability of OTC tests that do
not require laboratory processing.
Authorized OTC tests self-administered
by employees and proctored by the
employer do not require a CLIA
certificate of waiver.
The Association of Public Health
Laboratories (APHL) has conducted
weekly surveys of its membership to
monitor their current and projected
capability and capacity to test for
COVID–19. Data from this survey is
used to inform HHS, FEMA, CDC, and
other federal partners to support public
health laboratory supply and reagent
needs. OSHA reviewed the weekly
COVID–19 survey results through the
APHL COVID–19 Lab Testing Capacity
and Capability Data Dashboard. The
data comes from voluntary participation
in the weekly surveys collected from
approximately 100 state, local and
territorial public health laboratories
(PHLs) and reported to the CDC. The
APHL weekly survey data supports
OSHA’s feasibility determination and
demonstrates that COVID–19 testing
demand will be met. For example, from
August 15, 2021 to September 12, 2021,
the APHL weekly survey data found that
96–100% of PHLs are meeting their
current testing demand since the Delta
Variant surge began (APHL, September
27, 2021).
Laboratory capacity for processing
and confirmation of at-home COVID–19
rapid tests provided by manufacturer
retailers such as Walmart has also
increased. Laboratory and diagnostic
service providers have implemented
parallel strategies to strengthen
laboratory capacity for confirmation of
at-home COVID–19 rapid tests available
on the market for employers and
employees to utilize. For example,
Quest Diagnostics, which is the
laboratory processing the samples and
delivering results to those tested at
Walmart’s drive-through and curbside
testing sites, has scaled up laboratory
testing capacity and rapid antigen test
inventory should demand increase
(Walmart, July 9, 2021). Quest
Diagnostics has added COVID–19
testing platforms in laboratories in
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regions where demand is comparatively
high and has implemented an online
consumer-initiated test service for
individuals and small businesses to
request COVID–19 testing. In August
2021, Quest Diagnostics began to offer
clinician-guided rapid COVID–19
antigen testing to employers through a
guided telehealth visit using a selfadministered, nasal swab antigen test
that provides results in 15 minutes that
is then shipped to a Quest Diagnostics
lab for confirmation (Quest Diagnostics,
September 28, 2021).
Based on the evidence reviewed,
OSHA has determined that there is
adequate laboratory capacity to enable
compliance with the ETS testing option.
f. Access to Testing in Underserved
Communities
Individuals in underserved
communities (including Black, Latino,
and Indigenous and Native American
persons, Asian Americans and Pacific
Islanders and other persons of color;
members of religious minorities;
lesbian, gay, bisexual, transgender, and
queer persons; persons with disabilities;
persons who live in rural areas; and
persons otherwise adversely affected by
persistent poverty or inequality) are
disproportionately burdened by the
COVID–19 pandemic as many
individuals in these communities are
essential workers who cannot work from
home, increasing their risk of being
exposed to the virus. Access to COVID–
19 testing in these communities has
been identified as contributing factor to
COVID–19 related health disparities in
these communities. For example, the
NSC June 2021 survey found that the
most common barrier to testing for rural
employers and workers is access to
vaccination and testing sites (NSC,
September 2021).
Several federal efforts have recently
been implemented to strengthen testing
capabilities in underserved
communities. The NIH has invested
heavily to improve COVID–19 testing in
underserved communities throughout
the COVID–19 pandemic. On September
30, 2020, the NIH received nearly $234
million to improve COVID–19 testing
for underserved and vulnerable
populations that have been
disproportionately affected by this
pandemic and launched the RADx
Underserved Populations (RADx-UP)
program (NIH, September 30, 2020).
The RADx-UP program has primary
components supported by these NIH
grants to increase availability,
accessibility, and acceptance of testing
among underserved and vulnerable
populations. The RADx-UP program
also provides overarching support and
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guidance on administrative operations
and logistics, facilitating effective use of
COVID–19 testing technologies,
supporting community and health
system engagement, and providing
overall infrastructure for data collection,
integration, and sharing from a
coordination and data collection center
(NIH, September 30, 2021). Through the
RADx-UP program, the NIH has
continued to support the needs of
underserved populations and is
currently funding 70 community-based
projects across the country (NIH,
September 30, 2021).
The CDC has also focused its efforts
to improve COVID–19 testing in
underserved communities throughout
the COVID–19 pandemic. For example,
on September 20, 2021, Maine Health,
the largest health care organization in
Maine and also serving northern New
Hampshire, was awarded nearly $1
million for COVID–19 testing in higher
risk communities (Maine Health,
September 20, 2021). In March 2021, the
CDC implemented a plan to invest $2.25
billion over two years to address
COVID–19 related health disparities and
advance health equity among
populations that are at high-risk and
underserved, including racial and
ethnic minority groups and people
living in rural areas. Since that time, the
CDC has awarded grants to public
health departments to improve testing
capabilities; improve data collection
and reporting; and build, leverage, and
expand infrastructure support for testing
(CDC, March 17, 2021). On September
30, 2021, the CDC awarded an $8.1
million grant to the Arizona Center for
Rural Health (ACRH) to address COVID–
19 disparities across Arizona by
improving the delivery of COVID–19
testing to rural and underserved
communities (ASU CRH, September 30,
2021). A number of other federal and
state government agencies have been
expanding support for COVID–19
testing in underserved communities as
well. On June 11, 2021, HHS through
the Health Resources and Services
Administration (HRSA) provided $424.7
million in American Rescue Plan
funding to over 4,200 Rural Health
Clinics (RHCs) for COVID–19 testing
(HHS, June 11, 2021).
Private industry has also mobilized
considerably to increase access and
testing capacity in rural and other
underserved communities. The NSC
June 2021 survey found that a common
barrier to employers and employees in
rural and other underserved
communities is transportation and
access to vaccination and testing sites
(NSC, September 2021). In its final
report, the NSC recommended
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employers in these communities host
on-site vaccinations to increase worker
access. Applications for mobile
vaccination are available on most local
and state health department websites
(NSC, September 2021; ASU WEF,
September 2021).
CVS has collaborated with several
organizations, including the National
Medical Association, to increase access
to testing in underserved communities
and has developed mobile solutions that
allow health care professionals to bring
testing capabilities to businesses in
these communities as they re-open (CVS
Health, September 2021). Walgreens has
implemented efforts to increase access
in underserved communities such as
rural and/or lower socioeconomic
communities as well, with now more
than half of Walgreens testing sites
currently located in areas the CDC has
identified as socially vulnerable and
underserved (Walgreens, October 2021).
Because of these investments, OSHA
concludes that employers and their
employees in underserved communities,
including those in rural areas, will have
sufficient access to COVID–19 tests and
will be able to comply with the ETS’s
testing requirements for employees who
are not fully vaccinated.
V. Management of Confidential Medical
Records, Including Employee COVID–19
Vaccination and Testing Records
The ETS requires employers to
maintain a record of each employee’s
vaccination status. Employers must also
maintain a record of each test result
provided by each employee. These
records must be maintained as
confidential medical records and must
not be disclosed except as required or
authorized by this ETS or other federal
law. The records are not subject to the
retention requirements of 29 CFR
1910.1020(d)(1)(i) but must be
maintained and preserved while the
ETS is in effect.
Other OSHA rules have a similar
requirement to maintain employee
medical records, which could include
vaccination records. See, e.g.,
Bloodborne Pathogens (29 CFR
1910.1030), Respiratory Protection (29
CFR 1910.134), Respirable Crystalline
Silica (29 CFR 1910.1053), Beryllium
(29 CFR 1910.1024), Lead (29 CFR
1910.1025), and OSHA’s requirements
for employee access to medical and
exposure records (29 CFR 1910.1020).
OSHA is not aware of any potential
technological feasibility issues related to
recordkeeping.
The requirement under this ETS to
maintain records of employees’ COVID–
19 vaccination status and COVID–19
test results is similar to requirements in
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Fmt 4701
Sfmt 4700
the aforementioned OSHA standards,
and OSHA therefore concludes that
compliance is feasible. Employers
subject to the ETS will be able to
comply with the provisions in the ETS
using straightforward recordkeeping
systems that are already widely used by
large employers as part of their usual
and customary business practices.
OSHA concludes that it is feasible for
such employers to comply with the
requirements in the ETS for maintaining
records related to COVID–19
vaccination status and COVID–19 test
results.
VI. Other Provisions
There are no technological feasibility
barriers related to compliance with
other requirements in the ETS (e.g., face
coverings, employee notification). As
explained above, many of the employer
plans and best practice documents
reviewed by OSHA indicate that
employers have implemented the
measures in these provisions across
industry sectors. OSHA highlights two
of the ETS’s other requirements below,
which are explored in more depth in
other sections of this preamble.
• Face Coverings. Paragraph (i) of the
ETS requires the employer to ensure
that all employees who are not fully
vaccinated wear a face covering when
indoors and when occupying a vehicle
with another person for work purposes,
except: (i) When an employee is alone
in a room with floor to ceiling walls and
a closed door; (ii) for a limited time
while the employee is eating or drinking
at the workplace or for identification
purposes in compliance with safety and
security requirements; (iii) when
employees are wearing respirators or
face masks; or (iv) where the employer
can show that the use of face coverings
is infeasible or creates a greater hazard.
The definition of face covering allows
various different types of masks,
including clear face coverings or cloth
face coverings with a clear plastic panel
which may be used to facilitate
communication with people who are
deaf or hard-of-hearing or others who
need to see a speaker’s mouth or facial
expressions to understand speech or
sign language respectively. The types of
face coverings permitted under this ETS
are widely used and readily available.
The results of the ASU WEF June 2021
survey found that 30% of employers
required face coverings for unvaccinated
employees, which demonstrates that
this provision of the ETS is currently
being implemented by a substantial
number of employers and is ‘‘capable of
being done.’’ (ASU WEF, September
2021). OSHA identifies no technological
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feasibility issues with this provision of
the ETS.
• Notification. Paragraph (h) of the
ETS contains COVID–19 notification
requirements for both the employer and
the employee. Under this provision, the
employer must require each employee
to promptly notify the employer if they
receive a positive COVID–19 test or are
diagnosed with COVID–19 by a licensed
healthcare provider and must
immediately remove any employee from
the workplace who receives a positive
COVID–19 test or is diagnosed with
COVID–19 by a licensed healthcare
provider. OSHA identifies no
technological feasibility issues in
connection with the ETS’s notification
requirements. It is the employer’s
responsibility to ensure that appropriate
instructions and procedures are in place
so that designated representatives of the
employer (e.g., managers, supervisors)
and employees conform to the rule’s
requirements.
VII. Conclusion
OSHA has determined that complying
with this ETS is technologically feasible
for typical firms covered by this
standard, at least most of the time (see
Public Citizen v. OSHA, 557 F.3d 165
(3d Cir. 2009); Lead I, 647 F.2d at 1272;
Lead II, 939 F.2d at 990). OSHA
reviewed extensive evidence across
industries and did not identify any
industry-specific compliance barriers.
Evidence in the record that shows that
the written workplace COVID–19
vaccination policy requiring each
employee to be fully vaccinated against
COVID–19 unless they establish and
implement a written policy that permits
an employee to choose to be tested for
COVID–19 at least every seven days and
wear a face covering is feasible. In fact,
such policies have already been
implemented by hundreds of large
companies across industry sectors.
OSHA has also determined that there
are sufficient COVID–19 tests available
and adequate laboratory capacity to
meet the anticipated increased testing
demand related to compliance with the
ETS testing option.
Additionally, the ETS’s requirements
to determine employee vaccination
status, support employee vaccination by
providing time off for vaccination and
time off for recovery, and maintain
records of employee COVID–19
vaccination status and COVID–19 test
results are also technologically feasible.
As discussed above, that many
employers and organizations have
already implemented such requirements
demonstrates that they are ‘‘capable of
being done.’’ Moreover, the
recordkeeping requirements in this ETS
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largely mirror the requirements for the
collection and maintenance of similar
employee medical records in OSHA’s
Bloodborne Pathogens standard (29 CFR
1910.1030) and the Respiratory
Protection standard (29 CFR 1910.134).
The ETS provides a flexible compliance
option for employers to tailor their
procedures and practices to the needs of
their workplace. OSHA finds that
employers in typical firms in all
industry sectors can comply with the
requirements of the ETS, and
compliance with the ETS is therefore
technologically feasible.
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B. Economic Analysis
I. Introduction
This section presents OSHA’s
estimates of the costs and impacts,
anticipated to result from the COVID–19
Vaccination and Testing ETS, 29 CFR
1910.501. The purpose of this ETS is to
address the grave danger of COVID–19
in the workplace by promoting
vaccination, while allowing an
alternative for face covering and testing
requirements, and also to remove
COVID–19 positive workers from the
workplace regardless of vaccination
status. The estimated costs are based on
employers achieving full compliance
with the requirements of the ETS. They
do not include prior costs associated
with firms whose current practices are
already in compliance with the ETS
requirements. The purpose of this
analysis is to:
• Identify the entities/establishments
and industries affected by the ETS;
• Estimate and evaluate the costs and
economic impacts that regulated
entities/establishments will incur to
achieve compliance with the ETS; and
• Evaluate the economic feasibility of
the rule for affected industries.
In this analysis, OSHA is fulfilling the
requirement under the OSH Act to show
the economic feasibility of this ETS.
This analysis is different from the cost
portion of a regulatory impact analysis
prepared in accordance with Executive
Order 12866 in that the agency is
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focused only on costs to employers
when evaluating economic feasibility. In
a regulatory impact analysis, the costs to
all parties (e.g., employers, employees,
and governments) are included. While
this is not the case for an economic
feasibility analysis, it does not
necessarily mean that the ETS imposes
no costs or burdens on parties other
than employers. For example, the rule
imposes certain costs on employees who
choose not to become vaccinated (e.g.,
for face coverings and testing. While
these costs are not relevant for the
purpose of establishing economic
feasibility, these costs would be
attributable to the ETS in a regulatory
impact analysis. In addition, these costs
are not mandatory because any
employee who does not wish to pay
them may choose to become vaccinated
or leave employment (see discussion
below on turnover), after which the
costs would not be incurred. Some
employees may also be entitled to a
reasonable accommodation that may
avoid additional cost (e.g., telework).
‘‘[T]he Supreme Court has
conclusively ruled that economic
feasibility [under the OSH Act] does not
involve a cost-benefit analysis.’’ Pub.
Citizen Health Research Grp. v. U.S.
Dept. of Labor, 557 F.3d 165, 177 (3d
Cir. 2009); see also Asbestos Info. Ass’n,
727 F.2d at 424 n.18 (noting that formal
cost benefit is not required for an ETS,
and indeed may be impossible in an
emergency). The OSH Act ‘‘place[s] the
‘benefit’ of worker health above all other
considerations save those making
attainment of this ‘benefit’
unachievable.’’ Cotton Dust, 452 U.S. at
509. Therefore, ‘‘[a]ny standard based
on a balancing of costs and benefits by
the Secretary that strikes a different
balance than that struck by Congress
would be inconsistent with the
command set forth in’’ the statute. Id.
While this case law arose with respect
to health standards issued under section
6(b)(5) of the Act, which specifically
require feasibility, OSHA finds the same
concerns applicable to emergency
temporary standards issued under
section 6(c) of the Act. An ETS ‘‘serve[s]
as a proposed rule’’ for a section 6(b)(5)
standard, and therefore the same limits
on any requirement for cost-benefit
analysis should apply. Indeed, OSHA
has also rejected the use of formal cost
benefit analysis for safety standards,
which are not governed by section
6(b)(5). See 58 FR 16,612, 16,622–23
(Mar. 30, 1993) (‘‘in OSHA’s judgment,
its statutory mandate to achieve safe and
healthful workplaces for the nation’s
employees limits the role monetization
of benefits and analysis of extra-
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workplace effects can play in setting
safety standards.’’).22 A standard must
be economically feasible in order to be
‘‘reasonably necessary and appropriate’’
under section 3(8) and, by inference,
‘‘necessary’’ under section 6(c)(1)(B) of
the OSH Act. Cf. Am. Textile Mfrs. Inst.,
Inc. v. Donovan, 452 U.S. 490, 513 n.31
(1981) (noting ‘‘any standard that was
not economically . . . feasible would a
fortiori not be ‘reasonably necessary or
appropriate’ ’’ as required by the OSH
Act’s definition of ‘‘occupational safety
and health standard’’ in section 3(8));
see also Florida Peach Growers, 489
F.2d at 130 (recognizing that the
promulgation of any standard, including
an ETS, must account for its economic
effect). A standard is economically
feasible when industries can absorb or
pass on the costs of compliance without
threatening industry’s long-term
profitability or competitive structure,
Cotton Dust, 452 U.S. at 530 n.55, or
‘‘threaten[ing] massive dislocation to, or
imperil[ing] the existence of, the
industry.’’ United Steelworkers of Am.
v. Marshall, 647 F.2d 1189, 1272 (D.C.
Cir. 1981) (Lead I). Given that section
6(c) is aimed at enabling OSHA to
protect workers in emergency situations,
the agency is not required to make the
showing with the same rigor as in
ordinary section 6(b) rulemaking.
Asbestos Info. Ass’n/N. Am. v. OSHA,
727 F.2d 415, 424 n.18 (5th Cir. 1984).
In Asbestos Information Association, the
Fifth Circuit concluded that the costs of
compliance were not unreasonable to
address a grave danger where the costs
of the ETS did not exceed 7.2% of
revenues in any affected industry. Id. at
424.
The scope of judicial review of
OSHA’s determinations regarding
feasibility (both technological and
economic) ‘‘is narrowly circumscribed.’’
N. Am.’s Bldg. Trades Unions v. OSHA,
878 F.3d 271, 296 (D.C. Cir. 2017)
(Silica). ‘‘OSHA is not required to prove
economic feasibility with certainty, but
is required to use the best available
evidence and to support its conclusions
with substantial evidence.’’ Amer. Iron
& Steel Inst. v. OSHA, 939 F.2d 975,
980–81 (D.C. Cir. 1991) (Lead II); 29
U.S.C. 655(b)(5), (f). ‘‘Courts,
[moreover], ‘cannot expect hard and
precise estimates of costs.’ ’’ Silica, 878
22 To support its Asbestos ETS, OSHA conducted
an economic feasibility analysis on these terms. 48
FR 51086, 51136–38 (Nov. 4, 1983). In upholding
that analysis, the Fifth Circuit said that OSHA was
required to show that the balance of costs to
benefits was not unreasonable. Asbestos Info. Ass’n,
727 F.2d at 423. As explained above, OSHA does
not believe that is a correct statement of the
economic feasibility test. However, even under that
approach this ETS easily passes muster.
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F.3d at 296 (quoting Lead II, 939 F.2d
at 1006). Rather, OSHA’s estimates must
represent ‘‘a reasonable assessment of
the likely range of costs of its standard,
and the likely effects of those costs on
the industry.’’ Lead I, 647 F.2d at 1266.
The ‘‘mere ‘possibility of drawing two
inconsistent conclusions from the
evidence,’ or deriving two divergent
cost models from the data ‘does not
prevent [the] agency’s finding from
being supported by substantial
evidence.’ ’’ Silica, 878 F.3d at 296
(quoting Cotton Dust, 452 U.S. at 523).
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of the intended regulation and,
if regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, and public
health and safety effects; distributive
impacts; and equity). Executive Order
13563 emphasized the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. Because of
the continued impact of the pandemic
on occupational safety and health,
OSHA has prepared this ETS and the
accompanying economic analysis on an
extremely condensed timeline. Thus, in
light of the Secretary’s conclusion that
the COVID–19 pandemic constitutes an
emergency situation, the Secretary has
notified OIRA that it is necessary for
OSHA to promulgate this regulation
more quickly than normal review
procedures allow, pursuant to E.O.
12866 Sec. 6 (a)(3)(D). OIRA has waived
compliance with Sec. 6(a)(3)(B) and (C)
for this economically significant rule.
II. COVID–19 ETS Industry Profile
a. Introduction
In this section, OSHA provides
estimates of the number of affected
entities, establishments, and employees
for the industries that have settings
covered by this ETS. The term ‘‘entity’’
describes a legal for-profit business, a
non-profit organization, or a local
governmental unit, whereas the term
‘‘establishment’’ describes a particular
physical site of economic activity. Some
entities own and operate more than one
establishment.
Throughout this analysis, where
estimates were derived from available
data those sources have been noted in
the text. Estimates without sources
noted in the text are based on agency
expertise.
b. Scope of the COVID–19 ETS
This ETS applies to all employers
with a total of 100 or more employees
at any time this ETS is in effect.
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However, the requirements of this ETS
do not apply to: (1) Workplaces covered
under the Safer Federal Workforce Task
Force COVID–19 Workplace Safety:
Guidance for Federal Contractors and
Subcontractors (Contractor Guidance);
or (2) settings where any employee
provides healthcare services or
healthcare support services when
subject to the requirements of 29 CFR
1910.502 (i.e., the Healthcare ETS).
Furthermore, the requirements of this
ETS do not apply to the employees of
covered employers: (1) Who do not
report to a workplace where other
individuals, such as coworkers or
customers, are present; or (2) while
working from home; or (3) who work
exclusively outdoors. Based on this
scope, employers in nearly every sector
are expected to be covered by this ETS.
OSHA’s assumptions may result in an
overestimate of the number of
employees affected by the ETS. First,
OSHA is not estimating the number and
type of workplaces covered by the Safer
Federal Workforce Task Force COVID–
19 Workplace Safety: Guidance for
Federal Contractors and Subcontractors
or removing them from the profile of
employers affected by this ETS. OSHA
assumes for the purpose of this analysis
that employers covered under the
Contractor Guidance will also have
contracts to perform work in workplaces
where they are not covered under that
Guidance (i.e., where the employer
contracts with an entity other than the
federal government), and so those
employers are included in the scope
here.
Second, OSHA estimates that all
employers in all private sector
industries are affected by this ETS to
some extent. Although this ETS imposes
no compliance burden on employers
whose employees work remotely 100
percent of the time, in OSHA’s analysis,
no employers with 100 or more
employees have all of their employees
working remotely 100 percent of the
time (i.e., at least some employees in
each affected firm do not work
remotely). Moreover, OSHA’s analysis
does not take into account that some
employees may engage in part-time
telework (i.e., it assumes that employees
either work remotely full-time or do not
work remotely at all). Finally, OSHA’s
analysis does not fully take into account
the exemption for employees who do
not report to a workplace where other
individuals are present, meaning that
this analysis may overestimate the
number of employees affected by the
rule.
As stated, the requirements of this
ETS do not apply to the employees of
covered employers who work
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exclusively outdoors. To determine the
percentage of employees in occupations
for which the exception is relevant, the
agency uses data from the BLS’s 2020
Occupational Requirements Survey
(ORS) (BLS, 2020). This survey looks at
various aspects of job requirements. In
particular, the survey lists occupations
where workers are outdoors
‘‘constantly,’’ which OSHA interprets as
being nearly continuously outdoors.
Because the majority of workers who
work outdoors ‘‘constantly’’ likely work
indoors at least some of the time, the
agency judges that no more than 10
percent of the workers who are
primarily outdoors are actually there
exclusively. See Table IV.B.1 for the
occupations, the ORS percentages, and
final percentages for workers OSHA
estimates are exempt from the scope of
this ETS based on the outdoor work
exemption.
OSHA’s estimate of employees who
work exclusively outdoors does not
account for employers who only need to
make slight adjustments to their current
work practices to ensure that their
employees qualify for the outdoor
exemption, such as by holding tool box
talks outdoors instead of in a traditional
indoor location. This may result in more
employees falling within the exemption
than estimated by OSHA; therefore,
OSHA’s cost analysis likely
overestimates costs.
The requirements of the ETS also do
not apply to settings where any
employee provides healthcare services
or healthcare support services when
subject to the requirements of 29 CFR
1910.502 (the Healthcare ETS). The
Healthcare ETS is a temporary standard
that may not remain in effect for the
entire period that 29 CFR 1910.501
remains in effect. This means that some
employers or employees covered by the
Healthcare ETS, those in firms that have
100 or more employees, may ultimately
be covered by 29 CFR 1910.501 (because
the exception in 29 CFR 1910.501 is
limited to when employers are subject
to the requirements of the Healthcare
ETS). This potentially impacts two
types of costs: Employer-based costs
(e.g., employer policy on vaccination)
and employee-based (periodic) costs
(e.g., recordkeeping).
Employer-Based Costs: For the
purpose of the economic analysis only,
OSHA treats the Healthcare ETS as
though it will no longer be in effect after
December, 2021, because at that point
the Healthcare ETS will have been in
effect for the six months that OSHA had
calculated costs for that ETS. Therefore,
OSHA estimates that some employers
including those with 100 or more
employees subject to the 29 CFR
1910.502 exemption, will need to take
employer-based costs because all these
employers will ultimately be subject to
29 CFR 1910.501 under this assumption.
Employee-Based Costs: OSHA’s
estimates incorporate two assumptions
for the purposes of this analysis only.
First, for the purposes of assumptions
for this analysis only, § 1910.501 will
remain in effect for 6 months. Second,
many employers and employees
currently covered only by the
Healthcare ETS will be subject to the
requirements of 29 CFR 1910.501 for
approximately 4 months (4 months of
the 6 month estimated lifespan of 29
CFR 1910.501). OSHA’s estimate of
those employees exempted by the
Healthcare ETS was based on the
Industry Profile of employees in firms
with 100 employees or more covered by
the Healthcare ETS, as estimated in
Table VI.B.3 in the economic analysis
for that rulemaking (see 86 FR 32488).
OSHA notes that some employees
currently covered by the Healthcare ETS
might also be currently covered by 29
CFR 1910.501 (albeit at different times
or in different locations) because the
Healthcare ETS is settings-based. For
example, a pharmacist would normally
not need to comply with the
requirements of § 1910.502 when just
filling prescriptions in a retail pharmacy
store (see 29 CFR 1910.502(a)(2)(ii)), but
would need to comply when
administering vaccinations within an
embedded clinic inside that retail
pharmacy. Thus, there are a number of
variables that could impact the extent to
which the pharmacist’s employer might
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incur any costs. However, even to the
extent that such costs might occur (e.g.,
recordkeeping for testing if the
pharmacist works for an employer
covered by 29 CFR 1910.501 and is
unvaccinated), OSHA judges that they
would be de minimis for several
reasons. First, this pool of workers is
likely to be very small, especially when
compared to the population of workers
covered by the Healthcare ETS. Second,
most employees subject to both
standards will have been fully
vaccinated before OSHA takes costs for
these employees under 29 CFR 1910.501
by operation of the CMS rule mandating
vaccination or as a result of the
voluntary vaccination incentives
promoted by OSHA’s Healthcare ETS
(therefore negating most of the costs
associated with vaccination and testing
under 29 CFR 1910.501). Third, any
underestimate of periodic costs will
only apply during the first two months
after 29 CFR 1910.501 goes into effect
and the standard has a delayed
compliance date of 30 days after the
effective date for most provisions,
except for testing, which has a delayed
compliance date of 60 days. This will
further lessen the periodic costs
associated with any potential
underestimate.
In all respects (other than the 4⁄6 share
of employee-based costs), OSHA is
taking the same approach in the
Industry Profile and Cost Estimates for
employers and employees currently
covered by the Healthcare ETS as it does
for all other industries. These employers
and employees are fully integrated into
Table IV.B.5, below, which contains a
summary of covered entities and
employees. Moreover, the same
assumptions on outdoor work and other
scope exemptions that OSHA explains
earlier holds for these employers and
employees. In addition, OSHA makes
the same downward adjustment in
telework for these employers and
employees in accordance with the
methodology it sets out below. Thus, the
Healthcare ETS profile used in this ETS
to account for employees exempted by
the Healthcare ETS into the Profile in
the event the Healthcare ETS expires
(i.e., in Table IV.B.5, below) is an
updated version of Table VI.B.3 in the
Healthcare ETS (see 86 FR 32488).23
OSHA notes that some firms may decide
to proactively comply with certain 29
CFR 1910.501 requirements (such as
mandating vaccination for all employees
that were removed from the Industry
Profile) before the end date of the
Healthcare ETS based on the conclusion
that 29 CFR 1910.501 will ultimately
apply in full to them. Since these costs
still occur due to 29 CFR 1910.501,
OSHA is appropriately including them
in this cost analysis.
There are 9.9 million employees who
will newly be covered by 29 CFR
1910.501 starting in December whose
employers will incur an additional $318
million in costs. These costs are
integrated into the agency’s main cost
analysis, which is described later in this
economic analysis.
Only some state- and localgovernment entities are included in this
analysis. State- and local-government
entities are specifically excluded from
coverage under the OSH Act (29 U.S.C.
652(5)). Workers employed by these
entities only have OSH Act protections
if they work in states that have an
OSHA-approved State Plan. (29 U.S.C.
667). Consequently, this analysis
excludes public entities in states that do
not have OSHA-approved State Plans.
Table IV.B.2 presents the states that
have OSHA-approved State Plans and
their public entities are included in the
analysis.
OSHA notes, finally, that the
percentage of employers mandating
vaccination, and hence the employee
vaccination rate, would likely rise to
some degree absent this ETS due to
other federal actions, such as the
vaccination mandate for federal
contractors, the CMS rule published
elsewhere in this issue of the Federal
Register, and as a result of vaccination
mandates that have been adopted at
state and local levels. This analysis does
not account for increases in vaccination
that would occur absent the standard,
resulting in a likely overestimate of the
costs.
OSHA uses the estimates in a paper
by J.I. Dingel and B. Neiman, ‘‘How
Many Jobs Can be Done at Home?,’’
published in July 2020, as a starting
point to determine the percentage of
employees, by occupation, who are not
expected to work remotely (i.e., the
percentage of workers for whom
employers have employee-based costs
under this ETS) (Dingel and Neiman,
July 2020).
In Dingel and Neiman’s paper, the
authors estimate the number of jobs in
the U.S. economy that workers can
feasibly perform remotely. The authors
use two different surveys from the
23 The CMS rule published elsewhere in this issue
of the Federal Register mandates vaccination for
employees in facilities that receive Medicare or
Medicaid. OSHA is ignoring this for the purpose of
its cost analysis and taking costs into account as if
the CMS rule were not promulgated. This creates
a substantial overestimate.
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c. Teleworking
Dingel-Neiman Approach for Estimating
Who Can Work Remotely
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Occupational Information Network
(O*Net) 24 to evaluate which
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24 24 The O*Net Program is a major source of
occupational information for the U.S. The O*NET
database surveys ask both specific occupational
experts and workers in those occupations questions
covering multiple aspects of almost 1,000
occupations covering the entire U.S. economy. See
https://www.onetonline.org/ for more information.
The occupation definitions in the O*NET data are
Standard Occupation Codes—the same definitions
that are used in the BLS OEWS data. Dingel and
Neiman use the responses to two surveys included
in release 24.2 of the database administered by
O*NET, the Worker Context Questionnaire and the
Generalized Work Activities Questionnaire. The
occupation with the median number of respondents
had 26 respondents for each work context question
and 25 respondents for each generalized work
activities question per detailed-level SOC
occupation code.
In the O*Net Questionnaires, survey respondents
responded to statements about the nature and
requirements of the daily tasks associated with their
job on a 1–5 ordinal scale, where 5 represents the
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occupations can be performed remotely
and combine the O*Net estimates with
the Bureau of Labor Statistics’ (BLS)
Occupational Employment and Wage
Statistics (OEWS) data on employment
by occupation to estimate the total
number of workers nationally who can
work remotely.
To evaluate the survey responses,
Dingel and Neiman first determined the
strongest agreement and 1 represents the strongest
disagreement (see Table IV.B.3). The O*Net data
contain the average response to each question for
each occupation code. For instance, for occupation
‘‘Chief Executives’’ (SOC 11–1011), the average
response to the prompt ‘‘Performing General
Physical Activities is very important’’ was 1.39,
indicating that performing general physical activity
is not, on average, critical to the work of chief
executives. The average responses by occupation for
other prompts in the relevant surveys utilized by
Dingel and Neiman are contained in those surveys.
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occupations for which the average
response to a given prompt met a preset
threshold. Table IV.B.3 presents the
Dingel and Neiman response threshold
for each survey question as well as the
percent of occupations that meet each
respective predetermined threshold. For
example, in 10.8 percent of occupations,
the average response to the ‘‘Performing
general physical activities’’ (4.A.3.a.1)
question met the threshold, falling in
the range of 4 to 5.
Dingel and Neiman determined that
employees in a given occupation can
telework full time if they did not meet
the predetermined threshold for any of
the questions highlighted in grey and
denoted with a ‘‘Yes’’ in the column
that reports whether that activity is used
in determining whether a job can be
done remotely in Table IV.B.3.
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Source: (Dingel and Neiman, July 2020).
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Adjusting Dingel and Neiman To Reflect
Current Conditions
While many employees can and are
working remotely, many have returned
to their places of employment. This
conclusion is borne out by BLS’s
Current Population Survey (CPS) (BLS,
2021c). To address the tendency toward
employees returning to work on site and
more accurately reflect current remote
work conditions, OSHA made two
adjustments to Dingel and Neiman’s
estimates. In the COVID–19 Healthcare
ETS, OSHA also used Dingel and
Neiman’s paper to estimate the number
of workers who teleworked in response
to the pandemic and the ETS under the
assumption that anyone who could
work remotely would do so in response
to the pandemic and the Healthcare
ETS. Dingel and Neiman’s estimates are
therefore framed as the upper-bound of
potential teleworking.
The adjustments OSHA made reflect
changing circumstances. First, based on
agency expertise, OSHA changed the
status of certain occupations in its
occupational list from working remotely
to not working remotely. For example,
when Dingel and Neiman published
their study, many schools were
operating virtually so the Dingel and
Neiman finding that teachers were able
to work remotely lined up with the
situation where teachers were working
remotely. At this point in the pandemic,
on the other hand, in-person learning
has mostly recommenced. To this end,
OSHA changed the status of teachers
and other employees in the education
sector from working remotely to not
working remotely in this analysis. As
another example, many activities that
ceased or were reduced significantly
have now resumed and many locations
that were closed to the public have
reopened (e.g., athletic events, shows,
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gyms, casinos and places of worship),
and, since more people have returned to
the office, there is more need for
childcare. Therefore, OSHA also
changed the status of these employees
and others from telework to nontelework. This has the ultimate effect of
increasing costs estimates for the rule.
Appendix A (Table A–1), in the
accompanying document in the docket,
‘‘Vaccination, and Testing ETS:
Economic Profile and Cost Chapter
Appendices’’ (OSHA, October 2021b),
presents Dingel and Neiman’s (July
2020) unmodified percentages of
workers that can work remotely in each
detailed occupation (based on BLS’s
Standard Occupation Code (SOC)).25
Appendix A also presents, in separate
columns, percentages reflecting the
modifications OSHA made in those
occupations where OSHA changed the
results from telework to non-telework
for the reasons stated, as well as
percentages reflecting the modifications
made in occupations where employees
work exclusively outdoors.
According to the OSHA-adjusted
Dingel and Neiman estimates, 14
25 Except for the adjustments to Dingel and
Neiman discussed above, OSHA used the Dingel
and Neiman estimates for telework by occupation
without change. The agency recognizes that the
authors’ methodology (i.e., the use of 0–1
thresholds) led to a small number of results that
may appear not to reflect real-world experiences
within an occupation. However, Dingel and Neiman
represents the best available evidence for
determining the percentage of employees, by
occupation, who are expected to work remotely.
OSHA is aware of no other source for this
information that contains the level of detail
necessary to conduct this analysis. Moreover, as
explained above, OSHA modified the results for
individual occupations when it had a reasoned
basis for doing so. In any event, every NAICS
industry is comprised of many occupations, so for
every occupation where OSHA suspects remote
work is overestimated in Dingel and Neiman’s
results, there may be another where remote work is
underestimated.
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percent of the jobs in the United States
are performed entirely at home, with
significant variation across cities and
industries. It should be noted that the
Dingel and Neiman analysis does not
specify a proportion of jobs that can be
performed at home part of the time;
under the analysis, employees are either
working remotely full-time or are
working on site full time.
The second adjustment OSHA made
used monthly COVID-specific
teleworking data from telework
questions added during the pandemic to
the CPS to estimate the reduction in
teleworking since its peak and applied
those estimates to further adjust
downward the number of workers
currently teleworking (BLS, 2021c).
Specifically, the CPS questions asked
respondents whether they were
teleworking due to COVID–19 (as
opposed to teleworking for other
reasons) and OSHA estimated the
difference in teleworking from the peak
of COVID-related teleworking in all
industries, which occurred in May 2020,
through August 2021 (see Table
IV.B.4).26 The reduction in teleworking
was then applied as the change in
percentage points to the estimated
overall level of employees covered by
the ETS in each NAICS code estimated
based on data from Dingel and Neiman
(July 2020). OSHA’s final teleworking
estimates are provided in Appendix B in
the accompanying document in the
docket, ‘‘Vaccination, and Testing ETS:
Economic Profile and Cost Chapter
Appendices’’ (OSHA, October 2021b).
Reductions due to employees working
exclusively outdoors were applied to
reduce the percentage of covered
employees in Appendix B as well.
26 The CPS data were available only at the 2-digit
NAICS level as shown in Table IV.B.4.
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Other Teleworking Literature
A number of companies have
announced plans to allow employees to
work from home at least through the
end of 2021—suggesting that the levels
of remote work will not be returning to
pre pandemic levels in the near future.
Many technology and internet based
companies, such as Dropbox, Coinbase,
VMWare, and Slack, have announced a
complete, permanent move to fully
remote work (Courtney, September 27,
2021). Large employers such as
Facebook, Amazon, and Siemens plan to
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maintain some physical workspace but
now offer their employees who are
telework eligible the option to work
from home at least part of the time on
a permanent basis (Id.). Google, Ford,
Amazon, Apple and other large
employers are expecting their telework
eligible workers to return to on-site
work (in some capacity) no earlier than
January 2022 with Lyft anticipating a
February 2022 return (Cerullo, August
31, 2021). As a final example, a survey
of businesses in Massachusetts found
that about 40 percent of teleworkers
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anticipate they will not be returning to
the office in January 2022 or earlier
(Chesto, June 22, 2021).
Additional studies provide qualitative
support for the conclusion that a range
of employees will ‘‘predictably’’ work
from home both during the pandemic
and beyond. In Bick, Blandin, and
Martens’s paper, ‘‘Work from Home
Before and After the COVID–19
Outbreak’’ the authors use the following
information to establish the physical
location of employment (home or
workplace) of workers: Data from the
Real-Time Population Survey (RPS), a
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national labor market survey of adults
between ages 18–64 that mirrors the
Current Population Survey (CPS) and
collects information used in pandemic
analysis, such as commuting behavior
before and after the World Health
Organization declared a global
pandemic; mobility data on commuting;
and information from the CPS since
May 2020 on ‘pandemic-related’
telework (Bick et al., February 2021).
Based on these data, Bick et al., found
that there was a sudden decline in
commuting trips in the U.S. after the
initial COVID–19 outbreak, and that
even when these trips subsequently
began increasing back toward the
original number of commuting trips, the
overall number of trips did not return to
normal at the end of 2020 because many
teleworking employees continued
working from home. The authors found
that the surge in work from home came
almost entirely from employees working
from home every workday in the
reference week. The authors also suggest
that, for some occupations, especially
those occupations with more educated
workers, the change to increased work
from home appears to be a long-term
change; the data showed that, as of
December 2020, 12.5 percent of these
workers reported they expect to be
working from home full-time in the
future, and 24.5 percent reported they
expect to be working from home parttime.
In ‘‘COVID–19 and Remote Work: An
Early Look At U.S. Data,’’ Brynjolfsson
et al., noted that some of the shift to
working from home seems to be a longterm phenomenon (Brynjolfsson et al.,
June 2020). The authors found, using an
online survey, that 35.2 percent of
workers had switched to working from
home. Additionally, 15 percent of
workers reported they were already
working from home before COVID–19.
Therefore, this study finds that about
half of workers are now working from
home—an even greater percentage than
estimated by Dingel and Neiman.
Finally, in ‘‘Why Working from Home
Will Stick,’’ Barrero et al. predict that 22
percent of all full workdays will be
performed from home after the
pandemic ends, compared to 5 percent
before (Barrero et al., April 2021). The
authors highlight five factors
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contributing towards the more
permanent shift to telework: Diminished
stigma, better-than-expected
experiences working from home,
investments in physical and human
capital enabling work from home,
reluctance to return to pre-pandemic
activities, and innovation supporting
work from home.
d. Affected Entities and Employees
OSHA used data from the U.S.
Census’ 2017 Statistics of U.S.
Businesses (SUSB) to identify private
sector entities and employees affected
by this section of the ETS (U.S. Census
Bureau, 2019), and used the BLS 2017
Quarterly Census of Employment and
Wages (QCEW) to characterize state and
local government entities (BLS, 2017).
SUSB provides estimates of entities and
employees by employer size range,
which OSHA used to exclude employers
with fewer than 100 employees.27
For rail transportation (NAICS 482),
which is not included in SUSB or
QCEW data, OSHA relied on Federal
Railroad Administration and
Association of American Railroads
statistics reported in OSHA’s 2020 final
rule, Cranes and Derricks in
Construction: Railroad Roadway Work.
See 85 FR 57109 (September 15, 2020).
OSHA used these data sources to
identify public and private railroad
employers with more than 100
employees. For agricultural NAICS (111
and 112), OSHA relies on the National
Agricultural Statistics Service, 2017
Census of Agriculture (NASS, 2017) to
obtain estimates of total entities,
employees, and revenues. Since these
data do not indicate the number of
entities with more than 100 employees,
OSHA assumes it is the same as the
average proportion as the support
activity sectors for crop and animal
production (NAICS 114 and 115). OSHA
similarly specifies teleworking
27 SUSB with revenue data is only collected every
5 years. While OSHA could attempt to extrapolate
these data to more recent years, the results would
be imprecise because they would change the
revenue-employee size distributions. Those
distributions are crucial for measuring impacts so
the agency has opted to use the data as is. The total
number of employees in OSHA’s estimate is fairly
close to that of SUSB. The 2017 SUSB data includes
a total of 128.6 million employees, while the more
recent 2018 SUSB data includes a total of 130.9
million.
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conditions for NAICS 111 and 112 using
the average result for support activities
for agriculture (NAICS 114 and 115). For
the postal service industry, NAICS
491110, which is not included in SUSB,
OSHA obtains total entity and
employment data for private postal
services from the QCEW. Since these
data do not indicate the number of
entities with more than 100 employees,
OSHA assumes it is the same as the
average proportion as the related
industries, couriers and express delivery
(NAICS 492110), and local delivery
(NAICS 492120).
OSHA used the BLS 2020
Occupational Employment and Wage
Statistics (OEWS), which provides
NAICS-specific estimates of
employment and wages by occupation,
along with the data in Appendix B
(discussed earlier), to determine the
subset of non-teleworking employees
affected by the ETS.
Table IV.B.5 summarizes the set of
entities covered by the ETS. OSHA
estimates a total of approximately
263,879 entities and approximately 1.9
million establishments incur costs
under the ETS.28 OSHA estimates these
entities employ approximately 102.7
million employees, and of these, OSHA
estimates approximately 84.2 million
employees are covered by the ETS and
are not excluded from coverage by
working remotely 100 percent of the
time or exclusively outside.29 For the
purpose of this analysis, OSHA
estimates that all employees that OSHA
estimated will work remotely will
continue to do so for the duration of this
ETS.30
28 This includes public entities only in states with
an approved OSHA State Plan. See Table IV.B.2
above for further discussion of state plans.
29 OSHA’s estimate of covered employees is based
on the discussion in the text. For example, as OSHA
writes above: OSHA assumes for the purpose of its
analysis that employers covered under the
Contractor Guidance will conduct work at least
some of the time in workplaces not covered under
that Guidance and so are fully integrated into the
scope of the ETS; and the employers and employees
covered by the Healthcare ETS are also fully
integrated into the scope of the ETS.
30 Conditions are changing rapidly, and though
many firms are planning to keep expanded telework
to some extent, as the rate of vaccinated workers
increases, there may be increased movement back
to the workplace beyond what OSHA has estimated
here.
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the number who will test under the
ETS. OSHA’s methodology for this
analysis is detailed below.
III. Baseline Vaccine Status for Covered
Employees
To estimate the cost of the ETS,
OSHA must first estimate the baseline
vaccination status for the 84.2m covered
employees (those who work for
employers with 100 or more employees
and are not otherwise excluded from
coverage). OSHA recognizes that
employees’ current vaccination status
continues to change on a daily basis.
When specifying baseline vaccination
rates, OSHA used the most recently
available vaccination data from CDC,
reflecting current conditions. For the
remaining set of unvaccinated
employees covered by the ETS, after
accounting for baseline vaccinations,
OSHA estimates the number of these
employees who will be vaccinated and
To estimate the current vaccinate rate
for covered employees, OSHA obtained
recent vaccination data by age group
from the CDC COVID Data Tracker
(CDC, October 4, 2021a).31 For age
groups covering 18–74 years old, these
data include the number of people who
are fully-vaccinated as well as the
number of people of who have initiated
their first shot in the past two weeks
(relative to the October 4, 2021 data).32
OSHA estimates the vaccination rate for
each group (percent of total population
in the age group who are vaccinated)
based on the total number of people
who are fully-vaccinated and had their
first shot in the past two weeks, as a
fraction of the population in each age
group, obtained from the BLS Current
Population Survey (CPS) (BLS, 2021d).
Then, to estimate the overall average
vaccination rate across age groups 18–74
years old, OSHA weighted each group
based on the distribution of the labor
force by age, also obtained from the BLS
CPS (BLS, 2021d). As shown in Table
IV.B.6, OSHA estimates an overall
vaccination rate of 61.3 percent for
covered employees (and 38.7 percent
unvaccinated). The healthcare sector
had an earlier push to get healthcare
workers vaccinated and has a higher
current rate, estimated to be 70
percent.33
31 The data from the CDC website was retrieved
on October 4, 2021.
32 Age groups included: 18–24, 25–39, 40–49, 50–
64, and 65–74. OSHA had not included the group
65–74 in the economic analysis of the Healthcare
ETS this past spring because for the healthcare
sector, using the population wide average of
workers in this age bracket was felt would
overcount the number of such workers in this
sector. OSHA is including this group now that more
of the other age populations have been vaccinated
and those concerns are no longer as relevant. This
ETS will therefore indicate that a slightly higher
percentage of universe of covered employees is
vaccinated than if that age group of 65–74 was
excluded altogether, but it also increases the
number of employees for which additional
compliance costs are factored in. OSHA interprets
the ultimate result as a more accurate reflection of
the workplace and notes that more costs are
included than if the age group had been excluded
from the analysis.
33 The agency takes a recent survey (Lazer et al.,
August 16, 2021) which breaks out rates for
healthcare vaccination and non-healthcare, and
rather than replacing the CDC base vaccination rate
uses the CDC rate to make an adjustment upwards
to the healthcare rate of 70 percent.
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a. Estimate the Current Vaccination Rate
for Covered Employees
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b. Adjust Baseline Vaccination for
Continuing Trends
OSHA adjusts the current vaccination
rate to account for continuing trends in
vaccinations among covered employees
due to employers’ continued
implementation of vaccine mandates
and other policies (described below),
under the ETS. To make this
adjustment, OSHA requires 1) further
characterization of the set of
unvaccinated employees in terms of
their likelihood to receive the vaccine,
and 2) specification of the extent of
employer-mandated and other employer
vaccination policies.
Based on vaccine confidence data
from CDC (CDC, October 2021a), 13.8
percent of the population ‘‘probably or
definitely will not’’ get the vaccine;
hereafter referred to as ‘‘vaccinehesitant’’. Since this group is by
definition part of the currently
unvaccinated, OSHA characterizes the
currently unvaccinated (37.6 percent) as
being comprised of those who are
vaccine—hesitant (13.8 percent) and the
remainder, who while unvaccinated, are
not hesitant because they are not in the
‘‘probably or definitely will not’’ group
(23.8 percent).
Among those who are vaccinehesitant, OSHA estimates that 5 percent
of covered employees (or about 36
percent of the vaccine-hesitant), are
hesitant due to a religious (4 percent) or
medical (1 percent) exemption. The
remaining 8.8 percent include those
who are vaccine-hesitant for other
reasons. For the 4 percent estimate for
religious exemptions, OSHA relies on
data from Vermont, which removed its
vaccine exemption for nonreligious
personal beliefs in 2016 and saw the
proportion of kindergarten students
with a religious exemption rise to about
4 percent (Graham, September 15,
2021). In analyzing this issue, the
agency also reviewed other religious
exemption data concerning state
workers in Oregon and Washington; the
agency decided not to rely on these data
because the Vermont data is a more
accurate measure of the correct religious
exemption rate, although the data does
represent parents deciding on whether
to claim an exemption for their child,
not for themselves. This is because,
unlike the Vermont data, the Oregon
and Washington data contain workers
that have applied, but not yet been
accepted, for a religious exemption
(O’Sullivan, September 18, 2021; KEZI
News, September 25, 2021). In Oregon,
5 percent and in Washington 8 percent
of the employees have requested
accommodations though only a fraction
so far have been accepted. However, the
data are not inconsistent with the
Vermont data even though the process
in both Oregon and Washington are not
yet complete. For the 1 percent estimate
for medical exemptions, OSHA relied
on the Household Pulse Survey (HPS)
conducted by the U.S. Census (U.S.
Census Bureau, 2021). In Table 6a of the
Health Tables for Week 31, September 1,
2021 through September 13, 2021, about
1% of the US population said they
would not get the vaccine because
‘‘Doctor has not recommended it,’’ and
OSHA uses this response as a proxy for
all medical conditions.34
Table IV.B.7 presents the number of
employees in each vaccination category,
which informs OSHA’s subsequent
estimates of which currently
unvaccinated employees may be
vaccinated by employer-mandates,
vaccinated under the ETS, or tested
under the ETS.
34 Table 6a presents that 3,884,902 of the
population will not take the vaccine because the
‘‘doctor has not recommended it’’ out of a total of
38,936,606 who will not get the vaccine for any
reason. Medical reasons are then about 10% of the
general population that will not get the vaccine, and
the ones who won’t get the vaccine are about 10%
of the whole population, giving 1% (.10 * .10).
Based on the above, OSHA estimates
that the 84.2m covered employees
includes 52.5 million (62 percent)
vaccinated employees and 31.7 million
unvaccinated employees (38 percent).
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Next, OSHA estimates the number of
currently unvaccinated employees that
are likely to become vaccinated while
the ETS is in effect, based on their
employers’ policies. Based on limited
data on current vaccine mandate
implementation and forecasts for future
implementation (Mishra and Hartstein,
August 23, 2021; ASU COVID–19
Diagnostic Commons, October 6, 2021),
OSHA estimates that 25 percent of firms
in scope currently have a mandate, and
assumes that this will rise to 60 percent
of employers after the ETS is in place.
The baseline of 25 percent is based on
recent surveys showing a range of
approximately 13–45 percent of
employers currently requiring or
planning to require vaccination among
employees (see Willis Towers Watson,
June 23, 2021; Mishra and Hartstein,
August 23, 2021; ASU COVID–19
Diagnostic Commons, October 6, 2021).
Absent the ETS, OSHA assumes that the
percentage of firms would remain 25
percent (with some measure of upward
adjustment due to other federal vaccine
mandates affecting select populations,
as discussed above). To the extent more
firms than OSHA estimates would
mandate vaccination independent of the
ETS and thereby increase the
vaccination rate (again because of
factors such as other federal vaccine
mandates), then the agency’s costs are
overestimated because the agency’s
baseline vaccination rate is too low. The
assumption of an increase from 25 to 60
percent is based on the same set of
surveys that indicate that the share of
employers who will mandate
vaccinations after the ETS (including
those that already mandate
vaccinations) range from 25–75 percent,
see above references. The agency also
assumes that employees are distributed
in the same proportion across employers
with and without a vaccine mandate
(e.g., if 60 percent of firms mandate
vaccination, 60 percent of employees
will be vaccinated due to the mandate
(less those who remain unvaccinated
due to religious or medical exemptions).
OSHA assumes that all unvaccinated
employees subject to an employer
mandate will be vaccinated under that
employer mandate, except for those
seeking a medical or religious
exemption. For unvaccinated employees
not subject to an employer mandate,
OSHA assumes that they will also be
vaccinated at their employer’s request,
except for employees who are vaccinehesitant, which includes not only those
who remain unvaccinated for medical
and religious reasons, but also those
who are hesitant for any other reason.
OSHA carries through its assumptions
and estimates into its total cost
estimates. For example, OSHA estimates
that the 25 percent of firms in scope that
currently have a vaccination mandate
will not need to implement a new
written policy on vaccination in
response to the ETS since they will
already have implemented a policy that
meets the requirements of the ETS.
In total, OSHA estimates that 27
percent of covered employees (22.7
million) will be vaccinated based on
employer policies under the ETS; or 72
percent of covered employees who are
currently unvaccinated. The resulting
vaccination rate, adjusted for the ETS, is
estimated based on the total of those
who are currently vaccinated and those
who will be vaccinated under employer
policies, 89.4 percent as shown in Table
IV.B.8. Calculations of this nature, while
not discussed in more detail in this
analysis, are contained fully in the
spreadsheets supporting this analysis
(OSHA, October 2021a).35
35 OSHA notes that these estimates differ for
employees covered by the Healthcare ETS. OSHA
calculated these estimates separately because, as
stated above, OSHA is only taking costs for these
employees in the last four months of the assumed
6-month period while the ETS remains in effect.
While OSHA does not describe in detail how it
derived estimates for employees covered by the
Healthcare ETS in this analysis, the derivation of
those estimates run parallel to those described
above. For more information, please see the
spreadsheets supporting this analysis. (OSHA,
October 2021a).
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From Table IV.B.8, OSHA estimates
that approximately 75.3 million (89.4
percent) of covered employees will be
vaccinated when the ETS is in full
effect, and that approximately 8.9
million employees (10.6 percent, made
up of approximately 6.3 million covered
employees who will be tested for COVID
under the ETS and approximately 2.6
million employees who return to
telework (see next paragraph)) will
remain unvaccinated. This final set of
unvaccinated employees includes all
employees not vaccinated because of
religious or medical accommodations or
medical contraindication, plus the
portion of those who are vaccinehesitant for any other reason, who were
not vaccinated because their employer
has opted for a voluntary vaccination
policy.
From the above, OSHA estimates that
about 5 percent of all covered
employees will seek and receive
religious or medical accommodations or
exemption for medical contraindication.
While the agency encourages employers
to consider the most protective
accommodations such as telework,
which would prevent the employee
from being exposed at work or from
transmitting the virus at work, for cost
analysis purposes the agency assumes
these workers will largely be tested in
order for their employers to comply
with the ETS. Consistent with the
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overall average 22 percent of those who
returned to work after teleworking
earlier in the pandemic (see teleworking
discussion above), OSHA assumes for
this cost analysis that only 22 percent of
workers needing a reasonable
accommodation will return to full time
telework as a reasonable
accommodation. OSHA also assumes
that the 78 percent remainder will
follow the testing/masking protocols in
the ETS as a reasonable accommodation.
For hesitant employees who will not
seek a religious or medical
accommodation, and who work in a
firm with a testing option, the agency
assumes as above that those who were
teleworking before (again on average 22
percent) will return to telework rather
than being tested.
c. Cost of Absenteeism to Employers
Even mild cases of Covid-19 can be
costly to employers as they can induce
productivity losses due to work
absences, both among those infected
and their close contacts who may be
subject to quarantine requirements.
While many workers were able to
engage in telework in March-April 2020,
several occupational groups deemed
essential, including childcare workers,
personal care aids, healthcare support
occupations, and food processing
workers, exhibited significantly higher
rates of absenteeism during that period,
which the authors attributed to some
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workers contracting COVID–19
(Groenewold et al., July 10, 2020).
Absenteeism can also affect the
productivity of workers who are
present, similar to how turnover can
impose costs on incumbent workers
(Kuhn and Yu, April 2021).
In aggregate, productivity losses from
absences can be costly, as evidenced by
the economic losses from seasonal
influenza. One estimate found that the
United States loses 20.1 million days of
economic productivity every year due to
influenza, an ongoing loss equivalent to
80,400 full-time worker-years (Putri et
al., June 22, 2018). Another recent study
found that higher influenza vaccination
rates result in both fewer deaths and
significantly reduced illness-related
work absences (White, 2021).
OSHA recognizes that absenteeism
has been a problem. However, as
explained in other sections of the
preamble, the ETS vaccination and
testing and face covering requirements
are necessary to reduce the spread of
COVID–19 in the workplace, which may
in part reduce absenteeism. The ETS
might in a limited sense also increase
absenteeism because the rule requires
employers to temporarily remove from
the workplace any employee who
receives a positive COVID–19 test or is
diagnosed with COVID–19 by a licensed
healthcare provider. However, this
provision will also help to further
reduce absenteeism because, when an
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infected employee is promptly removed
from the workplace, that can prevent
one employee from infecting other
employees in the workplace and
potentially causing an outbreak or a
super-spreader event. Thus, OSHA
concludes that the ETS may, on net,
help ameliorate absenteeism by
reducing illnesses, but in any event will
not increase absenteeism (see OSHA,
October 2021c).
d. The Effect of Employee Turnover
One of the primary concerns among
employers in imposing vaccination
mandates is loss of staff, with 60 percent
of employers selecting it as a concern
with regard to mandating COVID–19
vaccination, according to one survey
(Mishra and Hartstein, August 23,
2021).36 To this end, employer
vaccination mandates could lead to
employee turnover; employees could
either leave on their own volition or
employers who have instituted strict
vaccination policies may fire workers
who are not vaccinated, or place them
on unpaid leave.
On the other hand, there is
countervailing evidence to suggest that
employers who implement a vaccine
mandate will be met with an influx of
potential workers. Many employees
would prefer a mandate in place, and
would be more likely to stay with, or
apply to, a firm that had a vaccine
mandate in place. For example,
although Inova health system in
Northern Virginia, lost 89 workers for
noncompliance with the system’s
vaccination mandate, that loss
amounted to less than 0.5 percent of its
workforce, (Portnoy, October 3, 2021),
and, in any event, Inova’s CEO stated
that the vaccine mandate has helped
with recruitment, and that its workers
are concerned for their own safety and
want to know they are working with
vaccinated colleagues. This same article
listed some other Virginia healthcare
systems with higher rates of loss in
connection with vaccine mandates.
Valley Health terminated 1 percent of its
employees, while Luminis Health had
about 2 percent of its workers still
unvaccinated at the time of its mandate
deadline. As another example, although
United Airlines had 593 employees (out
of the company’s 67,000 U.S.
employees) who had not complied with
the company’s vaccination mandate at
the end of September (a number that
dropped below 240 employees by
October 1), the company reported it has
36 This survey done in August, 2021, has 1,630
responses, reported by HR staff, attorneys, and
executives. Described as being ‘‘from a variety of
industries,’’ 83 percent of respondents were from
companies with more than 100 employees.
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received 20,000 applications for 2,000
flight attendant positions, a much
higher ratio than before the pandemic
(Chokshi and Scheiber, October 2,
2021). In addition, one survey reports
that among employee resignations due
to COVID–19 workplace policies, 42
percent reported lack of workplace
safety policies, 17 percent reported that
existing workplace policies were not
stringent enough, and only 39 percent
reported overly restrictive workplace
policies, suggesting that many
employees will welcome vaccine
mandates (ASU COVID–19 Diagnostic
Commons, October 6, 2021).37
While employee turnover is a natural
part of business in any industry, higher
employee turnover rate than normal can
have a direct impact on profit and
revenue. The normal range of employee
turnover differs widely by industry,
with an average turnover rate of about
50 percent per year overall for the
private sector.38 For example, between
2016 and 2020, employee turnover
ranged from 55 percent to 70 percent in
the retail industry and from 40 percent
to 60 percent in the transportation
industry (the industry sectors with the
highest employment).39
OSHA acknowledges that a vaccine
mandate may result in increased
employee turnover, but one recent
survey 40 suggests it is very unlikely that
this potential increase in employee
turnover will exceed the ranges that
industries have experienced over time.
The survey, though limited because
many respondents did not have
mandates in place at that time, shows
that there was no impact on turnover for
71 percent of those with mandates in
place. Only 25 percent saw a slight
increase in turnover (1 percent to 5
percent above normal) and only 4
percent saw a significant increase (more
than 5 percent above normal). As such,
OSHA does not anticipate that the
potentially increased employee turnover
attributable to vaccine mandates will be
substantial enough to negate normal
profit and revenue.
To this end, an important factor to
consider in examining turnover in
connection with vaccine mandates is
the unquantified cost savings and other
37 This August 2021 global survey (all results
presented here are for the US only) has 1,143
responses. It covers 28 industries, including:
Technology and Software, Business and
Professional Services, Manufacturing, Construction,
and Healthcare. Ninety percent of respondents were
from companies with more than 100 employees.
38 BLS (March 11, 2021).
39 Id.
40 Umland, October 13, 2021. This October 2021
survey has 1,059 total respondents, though only 365
have implemented a vaccination mandate and
answered this turnover question.
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positive economic impacts accruing to
employers that institute vaccine
mandates. These include reduced
absenteeism due to fewer COVID–19
illnesses and quarantines, as discussed
above. Other positive economic impacts
of a vaccine mandate are increased retail
trade from customers that feel less at
risk and better relations with suppliers
and other business partners. These all
would contribute to improved business
and increased profits.
The existence of these cost savings
and other positive economic impacts
accruing to employers that comply with
the ETS suggests that the actual net
costs of the ETS could be much lower
than the costs reported in this section of
the economic analysis. As OSHA
discusses above, OSHA has provided
evidence to support its estimate that 25
percent of covered employers already
voluntarily require that their employees
be vaccinated and a much larger
percentage are considering a vaccine
mandate. This supports the conclusion
that these businesses agree that doing so
will ultimately save costs.
In addition, under the ETS, employers
may implement a policy that allows for
testing and face covering instead. Firms
will have a tendency to self-select: If a
large proportion of its work force has
indicated concern about a vaccine
mandate, the firm is more likely to
choose the testing option to retain their
workers. This is one factor that led the
agency to estimate that approximately
40 percent of employers will allow
employees to choose testing and face
coverings in lieu of vaccination. To the
extent employers are concerned about
employee testing costs, employers can
generally absorb testing costs or help
employees reduce those costs through
low-cost assistance such as employer
proctoring of tests (even though that is
not required by this ETS). Departure of
personnel because of vaccine mandates
is also likely to be less common when
vaccine mandates are more prevalent
across employers in a region or
industry. One survey reports that 65
percent of employers state that actions
of other companies in their industry are
very, or at least moderately, important
in deciding to mandate vaccination
(Mishra and Hartstein, August 23, 2021).
Mandatory vaccinations for COVID–
19 are still relatively new because
vaccines only became available in
quantities sufficient to support such
mandates only about 6 months ago, and
the FDA has only recently moved past
emergency clearance to final clearance.
While there is not an abundance of
evidence about whether employees have
actually left or joined an employer
based on a vaccine mandate,
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particularly one with an alternative
allowing for testing in lieu of
vaccination, OSHA has examined the
best available evidence it could locate in
the timeline necessary to respond with
urgency to the grave danger addressed
in this ETS. Based on that, OSHA is
persuaded that the net effect of the
OSHA ETS on employee turnover will
be relatively small, given the option for
employers to implement a testing and
face covering policy and the
countervailing forces surrounding
turnover that will limit those effects, as
discussed above.
Finally, OSHA finds one line of
evidence particularly persuasive
because it involves data instead of polls:
While different surveys may suggest
different levels of worker intentions
(joining or remaining with a safer
employer versus leaving an employer to
avoid vaccination),41 the data suggests
that the number of employees who
actually leave an employer is much
lower than the number who claimed
they might: 1% to 3% or less actually
leave, compared to the 48–50% who
claimed they would.42 As discussed
earlier, this turnover number is well
below the average turnover rate in most
industries. Thus, OSHA concludes that
whether or not the ETS proves helpful
to recruitment efforts for some
41 Two polls from June 2021, when the number
of COVID–19 cases had dropped dramatically just
before the Delta Variant led to a surge in cases,
indicated that 50% of unvaccinated employees
surveyed said that they would leave their job rather
than accept a vaccination mandate from their
employer. (KFF et al., June 30, 2021) (the same
percentage also responded that ‘‘The number of
cases is so low that there is no need for more people
to get the vaccine.’’). A separate poll from the same
time also stated that 48% of ‘‘vaccine hesitant’’
employees claimed they would quit their jobs rather
than be vaccinated. (Barry et al., September 24,
2021—citing yet unpublished June 2021 poll). In a
more recent poll, about 44% of workers said that
they would consider leaving their jobs if they were
forced to get vaccinated, while around 38% of
workers would consider leaving their current
employer if the organization did not enact a vaccine
mandate. (Kelly August 12, 2021). Interestingly, in
that survey there was a direct correlation between
the age of the worker and the desire to have a
vaccinated workplace: Younger workers, usually
the most mobile portion of the workforce, had a
much higher desire for a vaccinated workforce
(50% of Generation Z employees, as compared to
33% of Baby Boomers).
42 An article titled ‘‘Unvaccinated Workers Say
They’d Rather Quit Than Get a Shot, but Data
Suggest Otherwise’’ noted the 48%–50% threat to
leave, but included hard data showing nothing
close to those levels actually occurred: Houston
Methodist Hospital required its 25,000 workers
(including its 3,580 unvaccinated employees) to get
a vaccine by June 7, and only 153 resigned or were
fired (4% of the 3,580 unvaccinated employees;
0.6% of the total number of employees); other
examples of the numbers of employees who left in
response to their employers’ mandatory vaccine
policy involved 5 out of 527 (0.9%), 2 out of 250
(0.8%), 6 out of 260 (3%), and 125 out of 35,800
(0.3%). (Barry et al., September 24, 2021).
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employers, it will not, on balance, add
significant new costs to covered
employers or threaten the economic
feasibility of any industry during a six
month period.
OSHA seeks comments on these
estimates and conclusions, as well as
further data that it could use to refine
its estimates.
IV. Cost Analysis for COVID–19
Vaccination and Testing ETS,
§ 1910.501
In this section, OSHA provides
estimates of the per-entity and total
costs for the requirements of this ETS.
Section 6(c)(3) of the OSH Act states
that the Secretary will publish a final
standard ‘‘no later than six months after
publication of the emergency standard.’’
Costs are therefore estimated over a sixmonth time period. Note that the
estimates are presented in this section at
the 3-digit NAICS level, but the analysis
was conducted at the 6-digit NAICS
level and aggregated to the 3-digit level
for presentation purposes. The 6-digit
NAICS level data is accessible in the
supporting spreadsheet. It should be
noted that this analysis deals strictly
with averages. For any given entity,
actual costs may be higher or lower than
the point estimate shown here, but
using an average allows OSHA to
evaluate feasibility by industry as
required by the OSH Act. In addition,
OSHA has limited data on many of the
parameters needed in this analysis and
has estimated them based on the
available data, estimates for similar
requirements for other OSHA standards,
consultation with experts in other
government agencies, and internal
agency judgment where necessary.
OSHA’s estimates are therefore based on
the best evidence available to the agency
at the time this analysis of costs and
feasibility was performed.
As mentioned above, OSHA estimates
that approximately 264,000 entities
have employees who will be subject to
the requirements of the ETS, including
approximately 84.2 million employees.
Many ETS requirements result in labor
burdens that are monetized using the
labor rates described next.
a. Wage Rates
OSHA used occupation-specific wage
rates from BLS 2020 OEWS data (BLS,
2021a). Within each affected 6-digit
NAICS industry, OSHA calculated the
employee-weighted average wage to be
used in the analysis. OSHA estimated
loaded wages using the BLS’ Employer
Cost for Employee Compensation data
(BLS, 2021b), as well as OSHA’s
standard estimate for overhead of 17
percent times the base wage.
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Costs are estimated using three labor
rates for each NAICS industry: The
average labor rate for all employees, the
labor rate for General and Operations
Managers (SOC code 11–1021), and the
labor rate for Office Clerks, General
(SOC 43–9060). Industry-specific wage
rates are presented in Appendix C in the
accompanying document in the docket,
‘‘Vaccination and Testing ETS:
Economic Profile and Cost Chapter
Appendices (OSHA, October, 2021b).’’
b. Rule Familiarization, Employer
Policy on Vaccination, and Information
Provided to Employees
ETS Requirements
Section 1910.501(d)(1) of the ETS
specifies that the employer must
establish and implement a written
mandatory vaccination policy. The
employer is exempted from the
requirement in paragraph (d)(1) only if
the employer establishes and
implements a written policy allowing
any employee not subject to a
mandatory vaccination policy to either
choose to be fully vaccinated against
COVID–19 or to provide proof of regular
testing for COVID–19 in accordance
with paragraph (g) of the ETS and to
wear a face covering in accordance with
paragraph (i) of the ETS.43
In addition, under § 1910.501(j),
information provided to employees, the
ETS requires the employer to inform
each employee, in a language and at a
literacy level the employee understand
about: (1) The requirements of the ETS
as well as any employer policies and
procedures established to implement
the ETS; (2) COVID–19 vaccine efficacy,
safety, and the benefits of being
vaccinated; (3) the requirements of 29
CFR 1904.35(b)(1)(iv) and Section 11(c)
of the OSH Act; and (4) the prohibitions
of 18 U.S.C. 1001 and Section 17(g) of
the OSH Act.
As stated, the ETS face covering
requirements are contained in paragraph
43 Note to paragraph (d): Under federal law,
including the Americans with Disabilities Act
(ADA) and Title VII of the Civil Rights Act of 1964,
some workers may be entitled to a reasonable
accommodation from their employer, absent undue
hardship. If the worker requesting a reasonable
accommodation cannot be vaccinated against
COVID–19 and/or wear a face covering because of
a disability, as defined by the ADA, or if the
vaccination, testing, and/or wearing a face covering
conflicts with the worker’s sincerely held religious
belief, practice or observance, the worker may be
entitled to a reasonable accommodation. For more
information about evaluating requests for these
types of reasonable accommodations for disability
or sincerely held religious belief, employers should
consult the Equal Employment Opportunity
Commission’s regulations, guidance, and technical
assistance including at: https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19-and-adarehabilitation-act-and-other-eeo-laws.
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(i) of the ETS. Under that paragraph, the
employer, with certain exceptions
specified in the ETS, must ensure that
each employee who is not fully
vaccinated wears a face covering when
indoors and when occupying a vehicle
with another person for work purposes.
The ETS does not require, nor does it
prohibit, the employer to pay for any
costs associated with face coverings
(although employer payment for face
coverings may be required by other
laws, regulations, or collective
bargaining agreements or other
collectively negotiated agreements).
However, the employer must permit the
employee to wear a respirator instead of
a face covering whether required or not.
In addition, the employer may provide
respirators or face coverings to the
employee, even if not required. In such
circumstances, where the employer
provides respirators, the employer must
also comply with § 1910.504, Mini
respiratory protection program.
OSHA estimates no costs associated
with an employee voluntarily bringing
in their own respirator to use instead of
a face covering other than those costs
that OSHA is estimating below in
connection with 29 CFR 1910.501(j),
information provided to employees.
That section provides, again, that the
employer must inform each employee,
in a language and at a literacy level the
employee understands about the
requirements of the ETS as well as any
employer policies and procedures
established to implement the ETS. One
policy the employer would need to
establish to implement the ETS is a
policy to comply with the requirements
of 29 CFR 1910.504 when an employee
voluntarily brings in their own
respirator. Those requirements require
only that the employer provide certain
information to the employee (see 29
CFR 1910.504(c)).
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OSHA is also estimating no costs in
connection with the employer providing
respirators to the employee. The ETS
does not require the employer to
provide respirators to employees.
Therefore, any such provision is
voluntary and not relevant to economic
feasibility of this rule.
The face covering provisions in
paragraph (i) contain several other
requirements, none of which have costs
associated with them.
Cost Analysis Assumptions
In this section, OSHA estimates the
cost for establishing the employer policy
on vaccination, providing required
information to employees, and rule
familiarization. OSHA assumes each
entity will require an average one-time
labor burden of 1 hour of management
labor for rule familiarization. OSHA
based this unit cost on that taken for
rule familiarization in the Healthcare
ETS (86 FR at 32496), but adjusted the
time downward by a half-hour because
this ETS is a simpler standard than the
Healthcare ETS.
To establish a written policy in
accordance with paragraph (d) of the
ETS, OSHA assumes a one-time average
labor burden of 5 hours of manager time
per firm. OSHA bases this estimate on
its cost estimates in the Healthcare ETS,
where OSHA estimated that
development of the COVID–19 Plan
required by that standard would take
between 5 and 40 hours (see 86 FR at
32496–32497). OSHA concludes that 5
hours is a reasonable estimate because
the development of a written policy on
vaccination will be much simpler than
the development of the written COVID–
19 Plan required by the Healthcare ETS
(see 29 CFR 1910.502(c)).44 OSHA
44 The estimates for the time to create the written
vaccine policy plan under this ETS may differ from
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notes, that like the Healthcare ETS (id.),
the cost of implementing the plan for
this ETS are included in the costs of
implementing the corresponding
requirements in the ETS, which are
discussed below.
To provide information to employees
in accordance with paragraph (j) of the
ETS, OSHA assumes a one-time average
labor burden per firm of 10 minutes of
manager time. The agency expects
activities like posting the information
on a community board, mass emailing,
etc., will satisfy this requirement.
The total cost for rule familiarization,
establishing an employer policy on
vaccination and providing required
information to employees is calculated
as the product of:
• One-time labor burden for rule
familiarization and establishing a policy
(a total of 6 hours of manager time per
entity) plus a one-time labor burden for
providing information to employees (10
minutes of manager time per entity);
• The labor rate for General and
Operations Managers (SOC code 11–
1021, NAICS-specific wages); and,
• The total number of covered
entities.
Cost for Employer Policy on Vaccination
and Information Provided to Employees
Costs per entity and total costs for
employer policy on vaccination and
information provided to employees are
shown below in Table IV.B.9.
BILLING CODE 4120–01–P
the time to create the various processes under the
CMS rule published elsewhere in this issue of the
Federal Register since the requirements of what is
needed to be included in the plans differ. For
example, the CMS plan requires a process for
ensuring the implementation of additional
precautions to mitigate the transmission and spread
of COVID–19 while OSHA’s vaccination policy
requirements do not include this requirement.
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c. Determining Employee Vaccination
Status
ETS Requirements
Under § 1910.501(e):
Paragraph (e)(1). The employer must
determine the vaccination status of each
employee. This determination must
include whether the employee is fully
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vaccinated, which is 2 weeks after the
full required vaccine course is
completed.
Paragraph (e)(2). The employer must
require each vaccinated employee to
provide acceptable proof of vaccination
status, including whether they are fully
or partially vaccinated. Acceptable
proof of vaccination status is:
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• The record of immunization from a
health care provider or pharmacy;
• A copy of the COVID–19
Vaccination Record Card;
• A copy of medical records
documenting the vaccination;
• A copy of immunization records
from a public health, state, or tribal
immunization information system; or
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• A copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s).
In instances where an employee is
unable to produce acceptable proof of
vaccination, per above, a signed and
dated statement by the employee,
subject to criminal penalties for
knowingly providing false information:
• Attesting to their vaccination status
(fully vaccinated or partially
vaccinated); and
• Attesting that they have lost and are
otherwise unable to produce proof
required by the ETS.
Paragraph (e)(3). Any employee who
does not provide one of the acceptable
forms of proof of vaccination status in
paragraph (e)(2) of the ETS to the
employer must be treated as not fully
vaccinated for the purpose of the ETS.
Paragraph (e)(4). The employer must
maintain a record of each employee’s
vaccination status and must preserve
acceptable proof of vaccination for each
employee who is fully or partially
vaccinated. The employer must
maintain a roster of each employee’s
vaccination status. These records and
roster are considered to be employee
medical records and must be
maintained as such records in
accordance with 29 CFR 1910.1020 and
must not be disclosed except as required
or authorized by the ETS or other
federal law. These records and roster are
not subject to the retention requirements
of 29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while the
ETS remains in effect.
Paragraph (e)(5). Finally, when an
employer has ascertained employee
vaccination status prior to the effective
date of this section through another
form of attestation or proof, and retained
records of that ascertainment, the
employer is exempt from the
requirements in paragraphs (e)(1)–(e)(3)
only for each employee whose fully
vaccinated status has been documented
prior to the effective date of this section.
For purposes of paragraph (e)(4), the
employer’s records of ascertainment of
vaccination status for each such person
constitute acceptable proof of
vaccination.
The full costs for these provisions are
taken under the costs for recordkeeping,
discussed below, because determining
vaccination status, providing acceptable
proof of vaccination status, and creating
and maintaining a roster of each
employee’s vaccination status will be
part and parcel of the recordkeeping
process.
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d. Employer Support for Employee
Vaccination
ETS Requirements
Under 29 CFR 1910.501(f):
The employer must support COVID–
19 vaccination by providing:
• Time for vaccination. The employer
must: (i) Provide a reasonable amount of
time to each employee for each of their
primary vaccination series dose(s); and
(ii) provide up to 4 hours paid time,
including travel time, at the employee’s
regular rate of pay for this purpose.
• Time for recovery. The employer
must provide reasonable time and paid
sick leave to recover from side effects
experienced following any primary
vaccination series dose to each
employee for each dose.
Under the ETS, fully vaccinated
means (i) a person’s status 2 weeks after
completing primary vaccination with a
COVID–19 vaccine with, if applicable,
at least the minimum recommended
interval between doses in accordance
with the approval, authorization, or
listing that is: (A) Approved or
authorized for emergency use by the
FDA; (B) listed for emergency use by the
World Health Organization (WHO); or
(C) administered as part of a clinical
trial at a U.S. site, if the recipient is
documented to have primary
vaccination with the ‘‘active’’ (not
placebo) COVID–19 vaccine candidate,
for which vaccine efficacy has been
independently confirmed (e.g., by a data
and safety monitoring board), or if the
clinical trial participant from the U.S.
site had received a COVID–19 vaccine
that is neither approved nor authorized
for use by FDA but is listed for
emergency use by WHO; or (ii) a
person’s status 2 weeks after receiving
the second dose of any combination of
two doses of a COVID–19 vaccine that
is approved or authorized by the FDA,
or listed as a two-dose series by the
WHO (i.e., heterologous primary series
of such vaccines, receiving doses of
different COVID–19 vaccines as part of
one primary series). The second dose of
the series must not be received earlier
than 17 days (21 days with a 4-day grace
period) after the first dose.
Cost Analysis Assumptions
OSHA assumes there will be no costs
to employers or employees associated
with the vaccine itself.45 However, to
provide support for vaccination of
employees, OSHA estimates that it will
take an average of 15 minutes of travel
time, each way, per employee to travel
45 While
there may be some administrative costs
borne by the government, such costs are not
germane to this analysis of whether the ETS is
economically feasible for covered employers.
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to a vaccination site (for a total of 30
minutes). OSHA then estimates 5
minutes to wait, fill out any necessary
paperwork, and receive the shot, and a
post-shot wait time of 20 minutes, per
employee. Some firms, particularly
larger ones, will find it cheaper to have
vaccines administered on site. They
may have an on-site health clinic or may
hire a 3rd party purveyor to come to the
facility.46 This will minimize travel and
also allow the companies to mitigate
some of the logistical issues that may be
preventing employees from receiving a
vaccine (finding a convenient
appointment time, etc.). OSHA
estimates that 10 percent of firms with
employees between 100 to 500
employees will select this option, while,
given decreased average costs associated
with economies of scale, 25 percent of
firms with over 500 employees will
select this option. OSHA was unable to
obtain an estimate of the cost savings
associated with on-site vaccination in
the time allotted to issue this emergency
standard, so it is assuming that the costs
for off-site vaccination are the same as
the costs for on-site vaccination. This
results in a likely over-estimate of costs
given that the entities that choose the
on-site option will do so as a cost-saving
measure.
In OSHA’s cost analysis, OSHA
assumes that all employees will be
vaccinated during working hours and
employers would adjust the employee
work schedule to ensure that the
employee would not become eligible for
overtime pay as a result of the
vaccination time. However, it should be
noted that, if an employee chooses to
receive the vaccine outside of work
hours, OSHA does not require
employers to grant paid time to the
employee for the time spent receiving
the vaccine during non-work hours
(although other laws may include
additional requirements for employers,
such as those addressing reasonable
accommodations or exemptions).
OSHA’s analysis may be an
overestimate as it reflects an assumption
that all vaccinations are received during
work hours.
CDC data indicated that 5 percent of
employees vaccinated have received the
Johnson & Johnson vaccine, and 95
percent have received either Pfizer or
Moderna (CDC, October 2021b). OSHA
applies the same allocation to
employees being vaccinated under the
ETS. For those receiving Pfizer or
Moderna, the labor burden outlined
46 Prior to the effective date of this rule, some
companies offered on-site vaccination according to
a limited survey. (Willis Towers Watson, June 23,
2021). See also CDC on creating an on-site program
(CDC, March 25, 2021; CDC, October 4, 2021b).
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above occurs twice, since vaccination
requires two shots.
The employer must provide
reasonable time and paid sick leave to
recover from side effects experienced
following any vaccination dose to each
employee for each vaccination dose.
Employers may require employees to
use paid sick leave benefits otherwise
provided by the employer to offset these
costs, if available. The average amount
of time off an employee may need for
side effects while receiving the vaccine
doses necessary to achieve full
vaccination (one or two doses,
depending on the vaccine) depends on
several factors. First, the percentage of
people who will have side effects that
are severe enough to require time.
Second, the average time duration for
those who have such a severe reaction.
For estimates of these parameters OSHA
is using a recent study (Levi et al.,
September 29, 2021) which surveyed
workers at a state-wide health care
system who had been vaccinated. The
study found that, for the first dose, 4.9%
needed administrative leave, with an
average length of absence of 1.66 days.
For the second dose, 19.79% needed
leave and their average length of
absence was 1.39 days. Together, the
average time on leave is .36 days (.049
* 1.66 + .1979 * 1.39) for a person
receiving two doses, which reflects the
fact that many people who receive the
vaccine do not have any side effects for
either dose while others have more
severe side effects.
In order to determine the amount of
paid sick leave that would be available
to employees, OSHA relied on data from
BLS (BLS, 2021e). BLS estimates that for
civilian workers in establishments with
100+ employees, 88% have access to
paid sick leave (Table 33). BLS states
that the average number of paid sick
leave available is 9 days (Table 36).
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Because there is the same number of
days across all levels of employee
tenure (1 year, 5 years, 10 years, and 20
years), OSHA used 9 days for all
covered employees. The agency assumes
that 75% of the available paid sick leave
has been used by the current 4th quarter
of the calendar year. So the average
number of days available is 1.98 days:
9 (days) * 88% (employees with
available paid sick leave) * 25%
(amount of leave remaining in the year)
= 1.98 days available. Given that the
average overall time out due to side
effects is 0.36 days (see above), OSHA
concludes that, on average, employees
should have sufficient existing paid sick
leave available to cover the time needed
as a result of vaccine-related side
effects. As a result, OSHA is taking no
costs to employers in connection with
the ETS’s requirement to provide time
for recovery from vaccination (except as
provided below), as these costs will
have been incurred by the employer
independent of the ETS.
While this analysis is entirely
consistent with OSHA’s standard
procedure of strictly using averages in
cost analysis, it nonetheless masks some
significant effects resulting from the
time for recovery requirements. From
the BLS data, OSHA knows there are
12% of establishments that have 100+
employees and do not provide paid sick
leave. Correspondingly, there is a group
of entities with no paid sick leave that
will obviously incur costs that result
directly from these requirements. In
addition, some employees may not
have, or some other entities may not
offer, sufficient paid sick leave to cover
these costs.
To account for the 12 percent of firms
that do not offer paid sick leave, the
agency uses the above estimate of
average days for two doses, 0.36 days,
and multiplies the average employee
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wage by NAICS to calculate the cost per
employee. Since OSHA does not know
which firms make up the 12 percent, the
agency spreads this total cost across all
firms by employee. Since firms without
any sick leave are likely to be lowerwage firms, this will likely lead to a cost
overestimate.
Therefore, the total cost for paid time
off for vaccination is based on the costs
for providing paid sick leave for the 12
percent of firms that do not offer paid
sick leave and:
• Travel time per employee of
covered firms of 15 minutes each way
per vaccination dose (total of 30
minutes).
• Pre-shot wait time per employee of
covered firms of 5 minutes per
vaccination dose.
• Post-shot wait time per employee of
covered firms of 20 minutes per
vaccination dose.47
• The average labor rate for
employees (NAICS-specific wages).
• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Johnson & Johnson
vaccine.
• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Pfizer and Moderna
vaccines, multiplied by two to account
for two shots.
Cost for Support for Employee
Vaccination
Costs per firm and total costs for
vaccination are shown below in Table
IV.B.10.
BILLING CODE 4120–01–P
47 According to the CDC, people with allergies
require a wait time of 30 minutes, but they are a
small group, and, in any event, the CDC
recommends that routine wait time is 15 minutes,
so the agency considers that its average of 20
minutes is probably an overestimate. (See CDC,
October 4, 2021a; CDC, March 3,2021.)
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e. COVID–19 Testing for Employees
Who Are Not Fully Vaccinated
ETS Requirements
Section 1910.501(g)(1) of the ETS
requires the employer to ensure that
each employee who is not fully
vaccinated do the following:
An employee who reports at least
once every 7 days to a workplace where
other individuals, such as coworkers or
customers, are present:
• Must be tested for COVID–19 at
least once every 7 days; and
• Must provide documentation of the
most recent COVID–19 test result to the
employer no later than the 7th day
following the date on which the
employee last provided a test result.
An employee who does not report
during a period of 7 or more days to a
workplace where other individuals,
such as coworkers or customers, are
present (e.g., teleworking for two weeks
prior to reporting to a workplace with
others):
• Must be tested for COVID–19
within 7 days prior to returning to the
workplace; and
• Must provide documentation of that
test result to the employer upon return
to the workplace.
Furthermore, if an employee does not
provide documentation of a COVID–19
test result as required by paragraph
(g)(1) of the ETS, the employer must
keep that employee removed from the
workplace until they provide a test
result. In addition, when an employee
has received a positive COVID–19 test,
or has been diagnosed with COVID–19
by a licensed healthcare provider, the
employer must not require that
employee to undergo COVID–19 testing
as required under paragraph (g) of this
section for 90 days following the date of
their positive test or diagnosis. Finally,
the employer must maintain a record of
each test result provided by each
employee under paragraph (g)(1) of this
section or obtained during tests
conducted by the employer. These
records are considered to be employee
medical records and must be
maintained as such records in
accordance with 29 CFR 1910.1020 and
must not be disclosed except as required
or authorized by this section or other
federal law. These records are not
subject to the retention requirements of
29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
OSHA addresses the costs associated
with testing in the next section. The
remaining costs required by paragraph
(g) are taken under the costs for
recordkeeping, discussed below,
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because providing documentation of test
results to the employer will be part and
parcel of the recordkeeping process.
Employees who are partially
vaccinated are also required to be tested
weekly until they are fully vaccinated.
Those receiving the J&J vaccine will
require two weeks of testing after the
single shot, employees who received the
Pfizer-BioNTech Vaccine will require 5
weeks of testing (3 weeks between shots
and 2 weeks following the second shot),
and Moderna recipients require 6 weeks
of testing (4 weeks between shots and 2
weeks following the second shot) (CDC,
October 4, 2021b). Notwithstanding this,
in the agency’s total cost estimate OSHA
accounts for the fact that employers
need not comply with the requirements
of this section in paragraph (g) by 60
days after the rule’s effective date, and
that employees who have completed the
entire primary vaccination series by that
date do not have to be tested, even if
they have not yet completed the 2 week
waiting period.
There is no requirement in the rule
that the employer pay for this testing so
these testing-related costs are not
included in the main analysis (although,
as discussed below OSHA takes into
account costs for testing in connection
with the ETS’s recordkeeping
requirements). The agency estimates
that 6.3 million weekly tests will need
to be given due to this ETS (see Table
IV.B.8). This 6.3 million is likely an
overestimate of new costs because it
encompasses tests for employees who
were already required to conduct testing
by their employers prior to this ETS.
OSHA also notes that its cost
estimates for testing do not take into
account the 90-day break in testing that
occurs following the date of a positive
test or diagnosis. OSHA’s cost estimates
are also potentially overcounting costs
in that OSHA does not take into account
that not all employees for whom testing
is required will report at least once
every 7 days to a workplace where other
individuals, such as coworkers or
customers, are present. Thus, OSHA’s
estimate assumes that employees for
whom testing is required will need to be
tested at least once every 7 days and not
less frequently as will often be the case.
OSHA notes, in addition, that there
are no costs associated with paragraph
(g)’s removal provision. The ETS does
not require the employer to provide
paid time off to any employee for
removal as a result of the employee’s
refusal/failure to provide
documentation of a COVID–19 test
result as required by paragraph (g)(1) of
the ETS.
Finally, OSHA notes that a COVID–19
test under the ETS is a test for SARS–
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CoV–2 that is: (i) Cleared, approved, or
authorized, including in an Emergency
Use Authorization (EUA), by the FDA to
detect current infection with the SARS–
CoV–2 virus (e.g., a viral test); (ii)
Administered in accordance with the
authorized instructions; and (iii) Not
both self-administered and self-read
unless observed by the employer or an
authorized telehealth proctor. Examples
of tests that satisfy this requirement
include tests with specimens that are
processed by a laboratory (including
home or on-site collected specimens
which are processed either individually
or as pooled specimens), proctored overthe-counter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer. Employers may have costs
associated with doing, observing or
proctoring employee testing, if
employers choose to do so. However, for
economic feasibility purposes, OSHA
does not account for these costs in its
estimates because they are not required
for compliance with the ETS.
Costs Associated with Reasonable
Accommodation: Testing, Face
Coverings, and Determinations
The ETS does not require the
employer to pay for any costs associated
with testing; however employer
payment for testing may be required by
other laws, regulations, or collective
bargaining agreements. Thus, while
OSHA does not include any costs for
reasonable accommodation requests in
its main cost analysis in recognition that
such costs would result from the
application of other laws, OSHA notes
that even if employers were to agree to
pay for COVID–19 testing as part of a
reasonable accommodation or some
other reason required by law, such costs
would not alter OSHA’s findings
regarding the economic feasibility of the
rule.48 OSHA reached this conclusion
after conducting a separate analysis of
reasonable accommodation costs that an
employer might assume if they do not
represent an undue hardship for the
employer. This analysis is available in
the docket at OSHA, October 2021d.
OSHA notes that this separate
analysis is limited to employees who
request accommodation, and accounts
for costs of reviewing medical and/or
religious accommodation requests, as
48 OSHA notes that while the testing required
under this standard might be an option for
employees who request a reasonable
accommodation to avoid vaccination, other
alternatives such as telework would be more
protective to the employee by preventing COVID–
19 exposure. These alternatives may also be
available at no additional cost to the employer or
employee.
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well as costs for COVID–19 testing and
face coverings that would satisfy the
requirements of this ETS. OSHA expects
a reasonable accommodation request
could lead to a review of the employee’s
request by a manager and then a
conference between the manager and
the employee. OSHA concludes that the
combination of these costs would not
alter OSHA’s findings regarding the
economic feasibility of the ETS.
f. Employee Notification to Employer of
a Positive COVID–19 Test and Removal
ETS Requirements
Under § 1910.501(h):
Regardless of COVID–19 vaccination
status or any COVID–19 testing required
under paragraph (g) of the ETS, the
employer must:
• Require each employee to promptly
notify the employer when they receive
a positive COVID–19 test or are
diagnosed with COVID–19 by a licensed
healthcare provider; and
• Immediately remove from the
workplace any employee who receives a
positive COVID–19 test or is diagnosed
with COVID–19 by a licensed healthcare
provider and keep the employee
removed until the employee: (i)
Receives a negative result on a COVID–
19 nucleic acid amplification test
(NAAT) following a positive result on a
COVID–19 antigen test if the employee
chooses to seek a NAAT test for
confirmatory testing; (ii) meets the
return to work criteria in CDC’s
‘‘Isolation Guidance’’ (incorporated by
reference, § 1910.509); or (iii) receives a
recommendation to return to work from
a licensed healthcare provider.
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Costs Analysis Assumptions
The ETS does not require employers
to provide paid time off to any
employee for removal from the
workplace as a result of a positive
COVID–19 test or diagnosis of COVID–
19; however paid time off may be
required by other laws, regulations, or
collective bargaining agreements or
other collectively negotiated
agreements. Therefore, there are no
costs associated with paragraph (h)’s
removal provision.
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With respect to notification, to the
extent employee notification is
connected to the ETS’s testing and
documentation requirements in
paragraph (g), those costs to the
employer are taken under the costs for
recordkeeping, discussed below,
because, as explained above, receiving
documentation of test results under
paragraph (g) will be part and parcel of
the recordkeeping process.
OSHA notes also that the costs
associated with employee notification
by vaccinated employees (not required
by this ETS to undergo testing) should
also be negligible because it will not
occur with any real frequency. The very
low breakthrough rates of infection
among vaccinated persons suggests that
the overwhelming majority of COVID–
19 cases reported to a covered employer
will be in the pool of unvaccinated
employees.
g. Reporting COVID–19 Fatalities and
Hospitalizations to OSHA
ETS Requirements
Under § 1910.501(j):
The employer must report to OSHA:
• Each work-related COVID–19
fatality within 8 hours of the employer
learning about the fatality.
• Each work-related COVID–19 inpatient hospitalization within 24 hours
of the employer learning about the inpatient hospitalization.
When reporting COVID–19 fatalities
and in-patient hospitalizations to OSHA
in accordance with paragraph (j)(1) of
the ETS, the employer must follow the
requirements in 29 CFR part 1904.39,
except for 29 CFR part 1904.39(a)(1) and
(2) and (b)(6).
Cost Analysis Assumptions
OSHA estimates a total of 1,464
fatalities and 59,570 hospitalizations for
employees of covered firms.49 This
49 These counts represent hospitalizations and
fatalities that would occur to the in-scope labor
force despite the ETS. The numbers are derived
using methodology similar to that used in Health
Impacts to generate hospitalizations and fatalities
prevented. An infection rate and case fatality rate
are multiplied by the number of unvaccinated
workers to derive a total number of fatalities. That
number is used to derive hospitalizations. The
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analysis is broadly consistent, using
updated data, with OSHA’s analysis of
a nearly identical provision in 29 CFR
1910.502, the Healthcare ETS. OSHA
also estimates, based on the Healthcare
ETS, that reporting of each fatality and
hospitalization will require 45 minutes
of an employer’s time (86 FR at 32516).
This includes hospitalizations and
fatalities for employees that remain
unvaccinated, as well as a small
percentage of hospitalizations and
fatalities of vaccinated employees due to
breakthrough cases. Because of the
timing requirements in the rule, the
agency assumes that a hospitalization
followed by a death will need two
reports from the employer (i.e., the
agency assumes that reporting for
hospitalizations will occur within 8
hours, before reporting for fatalities
occurs, within 24 hours). This will
result in a slight over-estimate.
The total cost for reporting COVID–19
fatalities and hospitalizations to OSHA
is calculated as the product of:
• One-time labor burden of 45
minutes per report of hospitalization or
fatality.
• Wage range for General and
Operations Managers (SOC code 11–
1021, NAICS-specific wages).
• Total number of fatalities for
employees at covered firms.
• Total number of hospitalizations for
employees at covered firms.
Cost for Reporting COVID–19 Fatalities
and Hospitalizations to OSHA
Costs per entity and total costs for
vaccination are shown below in Table
IV.B.11.
number of hospitalizations and fatalities to
vaccinated employees is calculated in a similar
fashion, but with a lower infection rate because
vaccination makes it considerably less likely that an
individual will be tested and found to be infected.
See (OSHA, October 2021a and OSHA, October
2021c). One difference in methodology between
these counts and the Health Impacts analysis is that
these counts use a baseline of the last 19 months
of CDC data to estimate the case fatality rate (similar
to Alternative C in the Health Impacts analysis),
rather than a baseline of the last 6 months (which
OSHA used for the main Health Impacts analysis).
This results in an estimate toward the upper bound
for these counts (i.e., an overestimate of costs).
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ETS Requirements
As discussed above, the full costs for
the requirements in paragraph (e) of the
ETS are taken under the costs for
recordkeeping because determining
vaccination status, providing acceptable
proof of vaccination status, and creating
and maintaining a roster of each
employee’s vaccination status will be
part and parcel of the recordkeeping
process. Under paragraph (e)(4) of the
ETS, the employer must maintain a
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record of each employee’s vaccination
status and must preserve acceptable
proof of vaccination for each employee
who is fully or partially vaccinated. The
employer must also maintain a roster of
each employee’s vaccination status.
These records and roster are considered
to be employee medical records and
must be maintained in accordance with
29 CFR 1910.1020 as such records and
must not be disclosed except as required
or authorized by the ETS or other
federal law. These records and roster are
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not subject to the retention requirements
of 29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while the
ETS remains in effect.
With respect to vaccination, it should
be noted that, under paragraph (e)(5) of
the ETS, when an employer has
ascertained employee vaccination status
prior to the effective date of this section
through another form of attestation or
proof, and retained records of that
ascertainment, the employer is exempt
from the determination of vaccination
requirements in paragraphs (e)(1)–(e)(3)
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only for each employee whose fully
vaccinated status has been documented
prior to the effective date of this section.
For purposes of the recordkeeping
requirements in paragraph (e)(4), the
employer’s records of ascertainment of
vaccination status for each such person
constitute acceptable proof of
vaccination. OSHA estimates, based on
this provision, that 60% of employees
who were vaccinated prior to the
promulgation of the ETS will not need
to document vaccination status in
connection with paragraph (e) (ASU
COVID–19 Diagnostic Commons,
October 6, 2021).
As also discussed above, the costs for
the requirements for documenting test
results in paragraph (g), including the
timing for when recordkeeping costs for
testing accrue under the ETS, are taken
under the costs for recordkeeping
because providing documentation of test
results to the employer will be part and
parcel of the recordkeeping process.
Under paragraph (g)(4) of the ETS, the
employer must maintain a record of
each test result provided by each
employee under paragraph (g)(1) of the
ETS or obtained during tests conducted
by the employer. These records must be
maintained in accordance with 29 CFR
1910.1020 and must not be disclosed
except as required or authorized by this
section or other federal law. These
records are not subject to the retention
requirements of 29 CFR
1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
With respect to testing, it should be
noted that, under paragraph (m) of the
ETS, employers are not required to
comply with the requirements in
paragraph (g) of the ETS until 60 days
after the effective date of the ETS,
meaning that for cost analysis purposes
OSHA assumes that employers would
not receive any testing records until the
end of that 60-day period.
Finally, under paragraph
1910.501(l)(1) of the ETS, availability of
records, by the end of the next business
day after a request, the employer must
make available, for examination and
copying, the individual COVID–19
vaccine documentation and any
COVID–19 test results for a particular
employee to that employee and to
anyone having written authorized
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consent of that employee. In addition,
under paragraph 1910.501(l)(2) of the
ETS, by the end of the next business day
after a request by an employee or an
employee representative, the employer
must make available to the requester the
aggregate number of fully vaccinated
employees at a workplace along with
the total number of employees at that
workplace. Under paragraph
1910.501(l)(3) of the ETS, the employer
must also provide to the Assistant
Secretary for examination and copying:
(i) Within 4 business hours of a request,
the employer’s written policy required
by paragraph (d) of the ETS, and the
aggregate numbers described in
paragraph (l)(2) of the ETS; and (ii) By
the end of the next business day after a
request, all other records and other
documents required to be maintained by
the ETS.
Cost Analysis Assumptions
To fulfill the recordkeeping
requirements in the ETS, OSHA
estimates that it will take an average of
5 minutes of clerical time per employee
record. OSHA bases this cost estimate
on the estimate for recordkeeping in the
Healthcare ETS (86 FR at 32515). While
OSHA estimated an average of 10
minutes of clerical time per employee
record in the Healthcare ETS, that
standard includes more extensive
recordkeeping requirements than what
is being required under this ETS. See 29
CFR 1910.502(q)(2)(ii) (Healthcare ETS
record must contain, for each instance,
the employee’s name, one form of
contact information, occupation,
location where the employee worked,
the date of the employee’s last day at the
workplace, the date of the positive test
for, or diagnosis of, COVID–19, and the
date the employee first had one or more
COVID–19 symptoms, if any were
experienced).
In addition, OSHA includes in this
estimate 5 minutes of employee time to
provide documentation of vaccination
status or testing, as applicable, to the
employer. OSHA notes that, for an
employee who is vaccinated, the
employer will determine the
vaccination status of that employees and
obtain acceptable proof of vaccination
status at the same time, thus negating
the need to create two separate records
for these requirements.
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OSHA notes that there will be a cost
associated with setting up the
recordkeeping system (e.g., a
spreadsheet) used to comply with the
ETS. OSHA takes these costs in
connection with the costs for the
employer policy on vaccination, which
are described above.
Given the relative complexity of
recordkeeping in the Healthcare ETS,
OSHA has simplified its assumptions to
reflect a variety of small costs in a
combined estimate. As in the Healthcare
ETS, the cost estimate of 5 minutes per
event is likely much higher than
necessary to account for just the actions
of receiving and maintaining copies of
records, so retaining this time will yield
a tendency toward overestimation.
However, this cost also reflects a margin
to encompass additional outlier costs
such as a second documentation of
vaccination status for all employees
who need to submit documentation
twice (first for partial vaccination and
then for full vaccination) under the ETS.
This 5 minutes for recordkeeping also
encompasses the marginal time for
creating and maintaining a roster of
each employee’s vaccination status
(paragraph (e)) and making aggregate
employee data available (paragraph (l)).
Since normally the system used for
recordkeeping will be electronic in
businesses with more than 100
employees, the time to create an
aggregate report and a roster should be
de minimis. Finally, this inflated
recordkeeping cost encompasses time
for employee notification to the
employer of a positive COVID–19 test
connected to the ETS’s testing and
documentation requirements in
paragraph (g),which is a notification
under paragraph (h). Finally, the burden
of making available, for examination
and copying, the individual COVID–19
vaccine documentation and any
COVID–19 test results for a particular
employee are included in this estimate
because this documentation will
normally be pulled from the electronic
recordkeeping system described
above.50
50 The cost of providing to the Assistant Secretary
for examination and copying the employer’s written
policy required by paragraph (d) of the ETS will be
de minimis.
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The total cost for these requirements
is calculated based on:
• One-time labor burden of 5 minutes
of employee labor to provide
documentation and 5 minutes of clerk
labor per employee record (one record
per test administered and one record per
documentation of vaccination status).
• The average labor rate for Office
Clerks, General (SOC 43–9060, NAICSspecific wages) and employees
providing documentation (average wage
over all employees, NAICS-specific
wages)
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• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Johnson & Johnson
vaccine, who receive one shot.
• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Pfizer-BioNTech and
Moderna vaccines, multiplied by two to
account for two shots.
• Total number of tests for employees
at covered firms who are unvaccinated
and will get vaccinated by receiving the
Johnson and Johnson vaccine.
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• Total number of tests for employees
at covered firms who are unvaccinated
and will get vaccinated by receiving the
Pfizer and Moderna vaccines.
• Total number of employees at
covered firms who are unvaccinated and
will be tested weekly.
Cost for Recordkeeping
Costs per entity and total costs for
recordkeeping are shown below in Table
IV.B.12.
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i. Summary of Total Cost
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Total Cost and Total Cost per Entity
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
j. Sensitivity Analysis
As stated above, based on limited data
on current vaccine mandate
implementation and forecasts for future
implementation (Mishra and Hartstein,
August 23, 2021; ASU COVID–19
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Diagnostic Commons, October 6, 2021),
OSHA estimates that 25 percent of firms
in scope currently have a vaccination
mandate, and assumes that this will rise
to 60 percent of covered employers after
the ETS is in place. Because the agency
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has no historic reference on which to
base its assumptions regarding vaccine
mandates, the agency adjusted the
percentage of firms that will institute a
vaccine mandate because of the ETS as
part of a sensitivity analysis. Along with
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the baseline estimate of 60 percent of
firms having a mandate, the agency
looked at a vaccine mandate rate of 40
percent and 80 percent for covered
firms, which OSHA judged to be a
reasonable range based on the data
available. The total costs associated
with a 40 percent vaccine mandate are
$2.998 billion, and the total costs
associated with an 80 percent vaccine
mandate are $2.964 billion. This
compares to the baseline costs
associated with a 60 percent vaccine
mandate of $2.981 billion. A higher
vaccine mandate increases the share of
employees who get vaccinated while
reducing the share that must get weekly
testing. It is this shift in shares that
causes the costs to change because the
total costs associated with weekly
testing (recordkeeping) are more
expensive than the total costs associated
with vaccination under the ETS
(employer support for vaccination,
recordkeeping).
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Barry J et al. (2021, September 24).
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Centers for Disease Control and Prevention
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Centers for Disease Control and Prevention
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(CDC, October 4, 2021a)
Center for Disease Control and Prevention
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October 4, 2021b)
Cerullo M. (2021, August 31). The New
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Chesto J. (2021, June 22). Almost 40 percent
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Boston Globe. https://
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business/back-office-not-so-fast/.
(Chesto, June 22, 2021)
Chokshi N and Scheiber N. (2021, October 2).
Inside United Airlines’ Decision to
Mandate Coronavirus Vaccines. The New
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2021/10/02/business/united-airlinescoronavirus-vaccine-mandate.html.
(Chokshi and Scheiber, October 2, 2021)
Courtney E. (2021, September 27). 30
Companies Switching to Long-Term
Remote Work. flexjobs. https://
www.flexjobs.com/blog/post/companiesswitching-remote-work-long-term/.
Accessed September 27, 2021. (Courtney,
September 27, 2021).
Dingel J and Neiman B. (2020, July). How
many jobs can be done at home? Journal
of Public Economics. Volume 189, July
2020, 104235. https://
www.sciencedirect.com/science/article/
pii/S0047272720300992. (Dingel and
Neiman, July 2020)
Graham R. (2021, September 15). Vaccine
Resistors Seek Exemptions. But What
Counts as Religious? The New York
Times. https://www.nytimes.com/2021/
09/11/us/covid-vaccine-religionexemption.html. (Graham, September 15,
2021)
Groenewold M et al., (2020, July 10).
Increases in Health-Related Workplace
Absenteeism Among Workers in
Essential Critical Infrastructure
Occupations During the COVID–19
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2020. Centers for Disease Control and
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Kaiser Family Foundation (KFF). (2021, June
30). KFF COVID–19 Vaccine Monitor:
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coronavirus-covid-19/poll-finding/kffcovid-19-vaccine-monitor-june-2021/.
(KFF, June 30, 2021)
Kelly J. (2021, August 12) Study Shows That
44% Of Employees Would Quit If
Ordered To Get Vaccinated. https://
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12/study-shows-that-44-of-employeeswould-quit-if-ordered-to-get-vaccinated/.
(Kelly, August 12, 2021)
KEZI News. (2021, September 25). Here’s
How Many Oregon State Employees
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content/news/Heres-how-many-Oregonstate-employees-have-requested-aCOVID-vaccine-exemption575395141.html. (KEZI News, September
25, 2021)
Kuhn P and Yu L. (2021, April). How Costly
is Turnover? Evidence from Retail.
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(Kuhn and Yu, April, 2021)
Lazer D et al. (2021, August 16). The COVID
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#62: COVID–19 Vaccine Attitudes
Among Healthcare Workers. The COVID
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August 16, 2021)
Levi M et al. (2021, September 29). COVID–
19 mRNA vaccination, reactogenicity,
work-related absences and the impact on
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2021).
Mishra D and Hartstein B. (2021, August 23).
Littler COVID–19 Vaccine Employer
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(NASS). (2017). Census of Agriculture.
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O’Sullivan J. (2021, September 18).
Washington state workers are getting
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(O’Sullivan, September 18, 2021).
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Occupational Safety and Health
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and Testing ETS. (OSHA, October 2021a)
Occupational Safety and Health
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Chapter Appendices. (OSHA, October
2021b)
Occupational Safety and Health
Administration (OSHA). (2021c,
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Occupational Safety and Health
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(OSHA, October 2021d)
Portnoy J. (2021, October, 3). Several
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have been suspended or fired over
coronavirus vaccine mandates. The
Washington Post. https://
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October 3, 2021)
Putri W et al. (2018, June, 22). Economic
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Umland B. (2021, October 13). Survey Looks
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October 13, 2021)
U.S. Census Bureau. (2019). Statistics of U.S.
Businesses (SUSB). https://
www.census.gov/programs-survey/
susb.html. (U.S. Census Bureau, 2019)
U.S. Census Bureau. (2021). Household Pulse
Survey (HPS), Week 37 Table 6A.
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data.html. (U.S. Census Bureau, 2021)
White C. (2021). Measuring Social and
Externality Benefits of Influenza
Vaccination. Journal of Human
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798143. (White, 2021)
Willis Towers Watson. (2021, June 23).
COVID–19 Vaccination and Reopening
the Workplace Survey. https://
www.willistowerswatson.com/en-US/
Insights/2021/06/covid-19-vaccinationand-reopening-the-workplace-survey.
(Willis Towers Watson, June 23, 2021)
V. ETS Economic Feasibility
Determination
a. OSHA’s Screening Tests for Economic
Feasibility
As noted in the introduction to the
economic analysis, an OSHA standard is
economically feasible when industries
can absorb or pass on the costs of
compliance without threatening
industry’s long-term profitability or
competitive structure, Cotton Dust, 452
U.S. at 530 n.55, or ‘‘threaten[ing]
massive dislocation to, or imperil[ing]
the existence of, the industry.’’ United
Steelworkers of Am. v. Marshall (Lead
I), 647 F.2d 1189, 1272 (D.C. Cir. 1981).
To determine whether a rule is
economically feasible, OSHA typically
begins by using two screening tests to
determine whether the costs of the rule
are beneath the threshold level at which
the economic feasibility of an affected
industry might be threatened. The first
screening test is a revenue test. While
there is no hard and fast rule on which
to base the threshold, OSHA generally
considers a standard to be economically
feasible for an affected industry when
the annualized costs of compliance are
less than one percent of annual
revenues. The one-percent revenue
threshold is intentionally set at a low
level so that OSHA can confidently
assert that the rule is economically
feasible for industries that are below the
threshold (i.e., industries for which the
costs of compliance are less than one
percent of annual revenues). To put the
one-percent threshold into perspective,
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OSHA calculated the average
compounded annual rate of growth or
decay in average revenues over the 15year period from 2002 to 2017 (inflated
to 2005 to 2020 dollars) for firms with
100 or more employees in the 479
NAICS (out of 546) industries covered
by this ETS for which Census data were
available and found that the average
annual real rate of change in revenues
in absolute terms for the average firm
was 2.2 percentage points a year.51 In
other words, revenues are generally
observed to change by well more than
one percent per year, on average, for
firms with 100 or more employees in
covered industries, indicating that
changes of this magnitude are normal in
these industries and that covered firms
are typically able to withstand such
changes over the course of a year, much
less six months. As discussed below, the
average percentage change due to this
ETS for all covered NAICS is a fraction
of this fluctuation in revenues.
The second screening test that OSHA
traditionally uses to consider whether a
standard is economically feasible for an
affected industry is if the costs of
compliance are less than ten percent of
annual profits (see, e.g., OSHA’s
economic analysis of its Silica standard,
81 FR 16286, 16533 (March 25, 2016);
upheld in N. Am.’s Bldg. Trades Unions
v. OSHA, 878 F.3d 271, 300 (D.C. Cir.
2017)). The ten-percent profit test is also
intended to be at a sufficiently low level
so as to allow OSHA to identify
industries that might require further
examination. Specifically, the profit
screen is primarily used to alert OSHA
to potential impacts on industries where
the price elasticity of demand does not
allow for ready absorption of new costs
in higher prices (e.g., industries with
foreign competition where the American
firms would incur costs that their
foreign competitors would not because
they are not subject to OSHA
requirements). In addition, setting the
threshold for the profit test low permits
OSHA to reasonably conclude that the
rule would be economically feasible for
industries below the threshold. To put
the ten-percent profit threshold test into
perspective, evidence used by OSHA in
its 2016 OSHA silica rule indicates that,
for the combined affected
manufacturing industries in general
industry and maritime from 2000
through 2012, the average year-to-year
fluctuation in profit rates (both up and
51 These results are presented in the Excel ETS
Revenue Threshold Test Tables available in the
Docket for this ETS. The data used for six-digit
NAICS were from the Bureau of the Census,
available every five years (2002, 2007, 2012, 2107).
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down) was 138.5 percent (81 FR
16545).52
When an industry ‘‘passes’’ both the
‘‘cost-to-revenue’’ and ‘‘cost-to-profit’’
screening tests, OSHA is assured that
the costs of compliance with the rule are
economically feasible for that industry.
The vast majority of the industries
covered by the ETS fall into this
category.
A rule is not necessarily economically
infeasible, however, for the industries
that do not pass the initial revenue
screening test (i.e., those for which the
costs of compliance with the rule are
one percent or more of annual
revenues), the initial profit screening
test (i.e, those for which the costs of
compliance are ten percent or more of
annual profits), or both. Instead, OSHA
normally views those industries as
requiring additional examination as to
whether the rule would be economically
feasible (see N. Am.’s Bldg. Trades
Unions v. OSHA, 878 F.3d at 291).
OSHA therefore conducts further
analysis of the industries that ‘‘fail’’ one
or both of the screening tests in order to
evaluate whether the rule would
threaten the existence or competitive
structure of those industries (see United
Steelworkers of Am., AFL–CIO–CLC v.
Marshall, 647 F.2d 1189, 1272 (D.C. Cir.
1980)).
Time Parameters for Analysis
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OSHA’s economic analyses almost
always measure the costs of a standard
on an annual basis, conducting the
screening tests by measuring the cost of
the standard against the annual profits
and annual revenues for a given
industry. One year is typically the
minimum period for evaluating the
status of a business; for example, most
business filings for tax or financial
purposes are annual in nature.
Some compliance costs are up-front
costs and others are spread over the
duration of the ETS; regardless, the
costs of the rule overall will not
typically be incurred or absorbed by
businesses all at once. However, OSHA
does not expect that the ETS will
require employers to incur initial capital
costs for equipment to be used over
many years (which would typically be
addressed through installments over a
year or a longer period to leverage loans
or payment options to allow more time
52 Profits are subject to the dynamics of the
overall economy. Many factors, including a national
or global recession, a downturn in a particular
industry, foreign competition, or the increased
competitiveness of producers of close domestic
substitutes are all easily capable of causing a
decline in profit rates in an industry of well in
excess of ten percent in one year or for several years
in succession (See OSHA, March 24, 2016).
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to marshal revenue and minimize
impacts on reserves).
The compliance costs for this ETS are
for a temporary rule for a period of six
months (which, again, is the time period
that OSHA assumes this ETS will last,
solely for economic purposes). While
OSHA believes the most appropriate
screens would be based on annual
profits and revenue, it has followed the
more cautious route of basing the
screens on 6 months of profits and
revenues to avoid any potential
uncertainty about whether the ETS is
economically feasible for the industries
covered by this ETS. Using one year of
revenues and profits as the
denominators in the cost-to-revenue and
cost-to-profit ratios would have resulted
in ratios that are half of the estimated
ratios presented in this analysis. It is
therefore unsurprising that businesses
in some number of NAICs have edged
above the profit-thresholds using a 6
month screen (as will be discussed
later), and OSHA believes that edging
above the screening thresholds is less of
an indicator of economic peril in this
context than in the context of a
permanent rulemaking analysis.
Nevertheless, OSHA has examined each
of the NAICS that did not clear either of
these conservative screening tests and
has concluded that the ETS is
economically feasible for each one.
Data Used for the Screening Tests
The estimated costs of complying
with the ETS, which OSHA relied upon
to examine feasibility is based on the
two tests described above (see OSHA,
October 2021a). The revenue numbers
used to determine cost-to-revenue ratios
were obtained from the 2017 Economic
Census for firms with 100 or more
employees in covered industries. This is
the most current information available
from this source, which OSHA
considers to be the best available source
of revenue data for U.S. businesses.53
OSHA adjusted these figures to 2020
dollars using the Bureau of Economic
Analysis’s GDP deflator, which is
OSHA’s standard source for inflation
and deflation analysis.
The profit screening test for feasibility
(i.e., the cost-to-profit ratio) was
calculated as ETS costs divided by
profits. Profits were calculated as profit
rates multiplied by revenues. The
before-tax profit rates that OSHA used
were estimated using corporate balance
sheet data from the Internal Revenue
Service (IRS), 2013 Corporation Source
53 For information regarding the standards and
practices used by the Census Bureau to ensure the
quality and integrity of its data, see (US Census
Bureau, October 8, 2021a; US Census Bureau,
October 8, 2021b).
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Book (IRS, 2013). The IRS discontinued
the publication of these data after 2013,
and therefore the most current years
available are 2000–2013.54 The most
recent version of the Source Book
represents the best available evidence
for these data on profit rates.55
For each of the years 2000 through
2013, OSHA calculated profit rates by
dividing the ‘‘net income’’ from all firms
(both profitable and unprofitable) by
total receipts from all firms (both
profitable and unprofitable) for each
NAICS.56 OSHA then averaged these
rates across the 14-year (2000 through
2013) period. Since some data provided
by the IRS were not available at
disaggregated levels for all industries
and profit rates, data at more highly
aggregated levels were used for some
industries; that is, where data were not
available for each six-digit NAICS code,
data for the corresponding four- or fivedigit NAICS codes were used. Data were
used for all firms in the NAICS (as
opposed to just firms with 100 or more
employees) since data disaggregated by
employment size-class were not
available. Profit rates are expressed as a
percentage (see OSHA, October 2021a).
Profits themselves were used to
calculate the cost-to-profit estimates for
all firms contained in a particular
NAICS code (see OSHA, October 2021a).
OSHA has estimated costs over a 6month timeframe for this ETS. As
discussed above, OSHA has therefore
used six months of revenue to conduct
the cost-to-revenue tests and six months
of profit to conduct the cost-to-profit
tests.
General Use of Revenues and Profits To
Measure Economic Feasibility
As with other OSHA rulemaking
efforts, the agency relies on the two
screening tests (costs less than one
percent of revenue and costs less than
ten percent of profit) as an initial
indicator of economic feasibility. OSHA
has generally found that the cost-torevenue test is a more reliable indicator
of feasibility simply because the
revenue data are more accurate than the
profit data. There are several reasons for
this.
First, OSHA has been using corporate
balance sheet data from the IRS as the
best available evidence for estimating
54 See
IRS, 2013.
also investigated Bizminer and RMA as
potential sources of profit information and
determined that they do not represent adequate and
random samples of the affected industries.
56 There is one code reported per tax entity and
it may not be representative to the six-digit level.
See Corporation Sourcebook on limitations of the
industry classification for details. (IRS, 2013).
55 OSHA
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corporate profits for years.57
Nevertheless, because firms typically
have an incentive to minimize their tax
burden, it is reasonable to expect that
some of the reported accounting data
may have been strategically adjusted to
reduce reported profits and their
associated tax implications. Business
profits are much more likely to reflect
such strategic accounting than business
revenues; accordingly, revenues are a
more accurate measure than profits for
evaluating economic feasibility for a
multitude of reasons.58
Second, because OSHA is using data
from both profitable and unprofitable
firms, the average profit rate for a small
number of industries is negative (as
described above, using 14 years of data
that predate the pandemic). This result
could have occurred because of the way
profits are calculated, which
unnaturally skews average profit rates
downward by including firms that have
large losses (negative profits) or
subnormal profits and have already
closed or are in the process of closing,
irrespective of any action by OSHA. The
negative rates could also be the result of
macroeconomic fluctuations during the
14-year period used to determine the
average, a period in which some of these
industries may have experienced
unusually adverse financial impacts
(see, e.g., the explanation in Chapter VI,
pp. VI–20 of the Final Economic and
Regulatory Flexibility Analysis for
OSHA’s Rule on Occupational Exposure
to Respirable Crystalline Silica, Docket
No. OSHA–2010–0034–4247, which
notes the skew from negative impacts
during recession years (OSHA, March
24, 2016)). Or they could result from
57 OSHA funded and accepted a final report by
Contractor Henry Beale (Beale Report, 2003) that
reviewed alternative financial data sources and
concluded that the IRS data were the best. Since
then OSHA has been relying on IRS data to provide
the financial data to support its rulemaking
analyses. See, for example, Occupational Safety and
Health Administration (OSHA) (2016), Final
Economic and Regulatory Flexibility Analysis for
OSHA’s Rule on Occupational Exposure to
Respirable Crystalline Silica, Chapter VI, pp. VI–2
to VI–3, Docket No. OSHA–2010–0034–4247
(OSHA, March 24, 2016), which includes a more
recent review of data sources for corporate financial
profit data and further support for OSHA’s choice
of IRS data.
58 In fact, all other Department of Labor agencies
rely solely on revenues to assess economic impacts,
such as Regulatory Flexibility Act certifications, in
their rulemakings (see, e.g., Employment and
Training Administration, Final Rule on
Strengthening Wage Protections for the Temporary
and Permanent Employment of Certain Aliens in
the United States, https://www.govinfo.gov/content/
pkg/FR-2021-01-14/pdf/2021-00218.pdf; Wage and
Hour Division, Tip Regulations Under the Fair
Labor Standards Act (FLSA), https://
www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/
2020-28555.pdf).
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tax-related incentives, as previously
noted.
Whatever the reason, the cost-to-profit
calculations for NAICS with negative
profit rates fail to provide reliable
information about the long-term
profitability of these industries,
independent of the ETS. Companies and
industries that consistently lose money
do not typically stay in business, and
would almost certainly not still be in
business in 2021 if that loss continued
at the same level for each of the 8 years
since the profit data was published in
2012. Revenue streams are a more
dependable measure for those firms
because those streams tend to be more
stable and more indicative of the actual
capabilities of sustainable firms than
reported negative profit margins. As a
result, for the purposes of this analysis,
OSHA has relied more heavily on its
cost-to-revenue estimates, in lieu of
cost-to-profit estimates, as the more
reliable indicator for economic
feasibility for the industries with
negative profit rates.
Third, and similarly, profit rates that
are only slightly positive (i.e., less than
one percent) are inconclusive and not
useful for the purpose of OSHA’s costto-profit test. In economics terms, profit
entails a reasonable rate of return on
investment, and long-term profits of less
than one percent a year are not generally
reasonable for firms that expect to
remain in business. Thus data showing
industry-wide profits in this range do
not measure the true ability of
companies to pay for the ETS costs. As
previously stated, revenue streams tend
to be more stable and more indicative of
the actual capabilities of sustainable
firms. Therefore, where possible, OSHA
prefers to rely on the cost-to-revenue
test to evaluate economic feasibility for
industries that have a less than one
percent profit rate.
The qualification, and by far the most
important reason for the general
primacy of revenues versus profits as
the appropriate metric for determining
economic feasibility, for most OSHA
rules, is that the regulated firms are able
to pass on the costs of the rule in the
form of higher prices. When they
cannot, the profit test functions
primarily as a screen for a limited
purpose: Alerting OSHA to potential
impacts where unregulated competitors
can prevent firms from passing costs
along to customers.
To understand this point, some
economic background is needed. The
price elasticity of demand refers to the
relationship between the price charged
for a product or service and the quantity
demanded for that product or service:
The more elastic the relationship, the
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larger the decrease in the quantity
demanded for a product when the price
goes up. When demand is elastic,
establishments have less ability to pass
compliance costs on to customers in the
form of a price increase and must absorb
such costs in the form of reduced
profits. In contrast, when demand is
relatively inelastic, the quantity
demanded for the product or service
will be less affected by a change in
price. In such cases, establishments can
recover most of the variable costs of
compliance (i.e., costs that are highly
correlated with the amount of output)
by raising the prices they charge; under
this scenario, if costs are variable rather
than fixed, business activity and profit
rates are largely unchanged for small
changes in costs. Ultimately, where
demand is relatively inelastic, any
impacts are primarily borne by those
customers who purchase the relevant
product or service for a slightly higher
price. Most of the costs of this ETS are
variable costs because they depend
primarily on the level of production or
the number of employees at an
establishment. For example, under the
ETS, a firm with 500 employees must
determine and record the vaccination
status of 500 employees, while a firm
with 250 employees need determine and
record the vaccination status of only 250
employees.59
In general, ‘‘[w]hen an industry is
subjected to a higher cost, it does not
simply swallow it; it raises its price and
reduces its output, and in this way
shifts a part of the cost to its consumers
and a part to its suppliers’’ (Am. Dental
Ass’n v. Sec’y of Labor, 984 F.2d 823,
829 (7th Cir. 1993)). A reduction in
output could happen in a variety of
ways: Individual establishments could
reduce their levels of service (e.g., retail
firms) or production (e.g.,
manufacturing), both of which could
take the form of a reduction of worker
hours; some marginal establishments
could close; or, in the case of an
industry with high turnover of
establishments, new entry could be
delayed until demand equals supply. In
many cases, a decrease in overall output
for an industry will be a combination of
all three kinds of reductions. The
primary means of achieving the
reduction in output most likely depends
on the rate of turnover in the industry
and on the form that the costs of the
regulation take. Further, the temporary
nature of the ETS and its associated
59 While fixed cost can be more limiting in terms
of options for businesses, most of the costs of this
rule are not fixed. Instead, most of the compliance
costs vary with the level of output or employment
at a facility.
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costs suggests that firms may have more
flexibility to respond than when facing
a permanent increase in costs. For
example, firms may be able to
temporarily increase prices or
temporarily defer planned capital
expenditures or other maintenance to
cover compliance costs.
There are two situations typically
mentioned when an industry subject to
regulatory costs might be unable to pass
those costs on: (1) Foreign competition
not subject to the regulation, or (2)
domestic competitors in other
industries, not subject to the regulation,
that produce goods or services that are
close substitutes. Otherwise, when all
affected domestic industries are covered
by a rule and foreign businesses must
also comply with the rule or are unable
to compete effectively, the ability of a
competing industry to offer a substitute
product or service at a lower price is
greatly diminished.
There is a third situation that is
relevant to this ETS—when only some
firms in a domestic industry (in this
case, only employers with 100 or more
employees) are subject to the ETS and
its regulatory costs. In principle,
competition from smaller employers in
a NAICS could prevent the larger
employers from passing on their costs in
the form of higher prices and instead
require them to absorb the costs in the
form of lost profits. There are, however,
several important caveats:
1. As a practical matter, it is
implausible to expect that covered
employers (with 100 or more
employees) would feel constrained by
smaller competitors in their industry so
as not to pass on costs for a rule lasting
6 months that imposes costs equal to
0.02 percent of revenues, on average
across all NAICS, over that time period
(see OSHA, October 2021a). This time
period would likely be too short for
small firms to expand to take business
away from the larger firms or for new
firms to form to take advantage of such
minor and transitory business
opportunities. Furthermore, smaller
firms (particularly very small firms—
those with fewer than 20 employees)
typically can’t compete on price with
large firms that have cost advantages
due to various economies of scale; as a
result, smaller firms often serve a
specialized niche market rather than
compete directly with larger firms. To
the extent that this ETS creates new
business opportunities for these smaller
uncovered firms, they would also be
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covered by the ETS as soon as they
reached 100 employees.60
2. An important factor to consider in
calculating the costs and impacts and
economic feasibility of this ETS is the
unquantified and unmonetized cost
savings and other positive economic
impacts accruing to employers that
comply with the ETS. These include
reduced absenteeism due to COVID–19
illnesses 61 and quarantine.62 Other
positive economic impacts that
compliant employers would enjoy from
a safer business environment are
increased retail trade from customers
that feel less at risk and better relations
with suppliers and other business
partners. These all would contribute to
improved business and increased
profits.
3. The existence of these cost savings
and other positive economic impacts
accruing to employers that comply with
the ETS suggests that the actual net
costs of the ETS will be much lower
than the costs reported in the
supporting economic analysis for this
ETS used to estimate cost impacts and
demonstrate economic feasibility. In
fact, for some share of covered
employers, the net costs of the ETS may
well be negative. Indeed, this is being
confirmed by revealed preference in the
market. Elsewhere in the economic
analysis for this ETS (Cost Analysis
section 4.2), OSHA has provided
evidence to support its estimate that 25
percent of covered employers already
voluntarily require that their employees
be vaccinated and a much larger
percentage are considering a vaccine
mandate. This strongly supports the
conclusion that these businesses agree
that doing so will ultimately save costs.
b. Economic Feasibility Analysis and
Determination
This section summarizes OSHA’s
feasibility findings for industries
covered by the ETS. As stated
previously, the agency uses two
screening tests (costs less than one
percent of revenue and costs less than
60 This cost advantage may be exaggerated or nonexistent in many cases (see the discussion directly
below in the text in Caveat 2).
61 Several occupational groups less able to avoid
exposure to SARS–CoV–2 infection exhibited
significantly higher rates of absenteeism in March–
April 2020 compared to earlier periods
(Groenewold et al., July 10, 2020).
62 For a discussion of turnover (i.e. whether the
ETS could affect the likelihood that an employee
will remain with an employer, either because the
imposition of a vaccine requirement will lead some
employees to leave and find employment at an
establishment not subject to the ETS, or,
alternatively, to stay due to a preference for
enhanced COVID–19 safety procedures), please see
the cost section (Section III.d.) of this economic
analysis.
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61499
ten percent of profit) as an initial
indicator of economic feasibility. In this
section, OSHA discusses the industries
that fall above the threshold level for
either screening test.
The overall effect of compliance with
the general section of the ETS on
covered industries is very small (see
OSHA, October 2021a). The vast
majority of the covered NAICS have
very low cost-to-revenue and cost-toprofit ratios, with the overall averages
being 0.02 percent of revenues and 0.49
percent of profits. To put this into
perspective, if the average firm decided
to raise prices to cover the costs of the
ETS, the price of a $100 product or
service, for example, would have to be
increased by 2 cents (during the sixmonth period).
Based on the information presented
here, the costs of the ETS are below both
the threshold revenue test (1 percent of
revenues) and the threshold profit test
(10 percent of profits) for the vast
majority of NAICS industries.63 This
indicates that the average firm in these
industries will be able either to raise
prices to cover ETS costs or to absorb
the costs of the ETS out of available
profits. In either case, OSHA concludes
that the ETS is economically feasible for
all of these industries.
Critically, there are no industries
covered by the general section of the
ETS that are above OSHA’s cost-torevenue threshold level of one percent
and most are a small fraction of this
level. Because OSHA is using data from
both profitable and unprofitable firms,
the average profit rate for a small
number of industries is negative. There
are 14 NAICS with negative cost-toprofit ratios, resulting from negative
average profit rates. These industries
with negative profit rates are domestic
service industries that are not subject to
international competition.
There are eight six-digit NAICS
industries, covering all establishments
in those industries covered by the
general section of the ETS, with cost-toprofit ratios above 10 percent:
1. NAICS 221118—Other Electric
Power Generation, 23.97 percent;
2. NAICS 488119—Other Airport
Operations, 18.41 percent;
3. NAICS 488410—Motor Vehicle
Towing, 15.75 percent;
4. NAICS 488490—Other Support
Activities for Road Transportation,
14.32 percent;
5. NAICS 713920—Skiing Facilities,
13.16 percent; and
63 By OSHA’s calculation, 524 out of the 546 sixdigit NAICS covered by the ETS.
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6. NAICS 713940—Fitness and
Recreational Sports Centers, 12.33
percent;
7. NAICS 713120—Amusement
Arcades, 11.18 percent; and
8. NAICS 488320—Marine Cargo
Handling, 10.03 percent.
The average profit rate reported over
the 14 years for which OSHA has profit
data for all the NAICS affected by the
ETS is 4.2 percent. All of the eight
NAICS industries with a cost-to-profit
ratio above the 10 percent threshold
report an annual profit rate below one
percent—75 percent or more below the
overall average for all NAICS covered by
the ETS. These eight industries all
provide domestic services and are not
subject to international competition.
The fact that the covered firms in
these 22 NAICS industries (the 14 with
negative cost-to-profit ratios and the 8
with more sustainable cost-to-profit
ratios) exceeded the profit screen
suggests that they might in theory have
difficulty paying for the costs of the ETS
out of profits gained over the six-month
duration of the ETS if they had no
savings or access to capital, but even if
that were true it would be highly
unlikely to place the firms in financial
jeopardy. OSHA examines these
industries more closely below, but
before even considering the reasons in
NAICs-specific analysis it is important
to consider the larger context. For the
ETS to threaten the economic solvency
of these firms, the following 3
conditions must apply:
1. These firms must not enjoy certain
cost savings and positive economic
impacts from the ETS that would
partially or totally offset their costs.
This condition is questionable because
of the estimated 25 percent of employers
sampled that reported voluntarily
imposing a vaccine mandate and the
substantial number more contemplating
the voluntary adoption of such a
mandate. They can be expected to base
their decisions, partly or entirely, on
anticipated cost savings or positive
economic impacts (which would reduce
or eliminate their risk of insolvency due
to the ETS).
2. These firms (all with 100 or more
employees) must not be able to raise
prices to cover ETS costs because of the
threat that smaller firms in their NAICS
industry, not covered by the ETS, could
underprice them and take away their
business. This condition is unlikely or
limited because of the economies of
scale the larger firms enjoy and the fact
that the smaller firms out of necessity
tend to serve a market niche not in
direct competition with the larger firms.
Also, there is a severe limit to the extent
that firms with fewer than 100
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employees can take away significant
portions of business from the larger
firms without becoming subject to the
requirements of the rule themselves. If
the larger firms do not feel threatened
by being underpriced by smaller firms
in these NAICS industries, then they
could raise prices an average of less
than 0.05 percent 64 to cover the cost of
the ETS—a small fraction of the 1.0
percent of revenues threshold (beneath
which OSHA has determined that
economic feasibility is not a concern).
3. These firms must not generate
sufficient profits or have adequate
borrowing capacity during the six
months the ETS is in force to cover the
costs of the ETS. There are several
reasons to doubt that this condition
broadly applies. First, the estimates of
business profits come from corporate
balance sheet data that firms report to
the IRS. But, as previously noted, it is
generally the case that firms have an
incentive to minimize their tax burden,
and it is reasonable to expect that some
of the reported accounting data may
have been strategically adjusted to
reduce reported profits and their
associated tax implications. Another
point concerning the IRS data is that
they include the negative profits of
firms that are going out of business or
have since gone out of business. To the
extent that these points are true, many
or most of the covered firms in these
NAICS industries (still in business)
actually would generate sufficient profit
to cover the cost of the ETS. A related
point is that for this condition to apply,
the firms must not be able to borrow the
money to pay for the costs of the ETS.
Recall, however, that these are all large
firms with 100+ employees. It is
reasonable to expect that many or most
firms of this size in the 22 NAICS
industries at issue either have available
funds or could obtain a short-term loan
to cover costs equal to the 0.01 to 0.11
percent of revenues that these firms
would incur over the six-month period
that OSHA assumes the ETS will remain
in effect. Firms of this size normally
have banking relationships and some
unencumbered assets. They also have
access to national and international
capital markets. If these firms can
borrow funds to pay for the ETS, then
the profit restriction doesn’t matter.
Finally, OSHA anticipates concern
that limiting the scope of the ETS to
64 If not underpriced by smaller firms, covered
firms in the 8 NAICS industries reporting ETS costs
above 10 percent of profits could cover these costs
by raising prices an average of 0.08 percent (highest,
0.11 percent); covered firms in the 14 NAICS
industries reporting negative profits could cover
ETS costs with a price increase of 0.01 percent
(highest, 0.02 percent).
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employers with 100 or more employees
will somehow put these larger firms in
economic jeopardy from the smaller
firms to which the ETS does not
currently apply. This is highly
improbable for several reasons
discussed earlier, including the fact that
these are large employers with
advantages of economies of scale and
access to capital and the fact that this is
a temporary standard that would result,
at most, in marginal impacts over 6
months (on average, equal to costs of
0.02 percent of revenues, which, again,
translates to a cost increase of a penny
on a fifty dollar item).
But even that misses the main point:
Economic feasibility refers to the
industry, not to the firm. OSHA must
construct a reasonable estimate of
compliance costs and demonstrate a
reasonable likelihood that these costs
will not threaten the existence or
competitive structure of an industry,
even if it does portend disaster for some
marginal firms (Lead I, 647 F.2d at
1272). In the (again) highly unlikely
event that individual firms exit an
industry and are replaced by other firms
in the industry, then the ETS would
preserve the economic feasibility of the
covered industries. If an employer
covered by this standard actually had to
increase its prices slightly to account for
the cost of this standard, there are two
potential groups of smaller businesses
that could seek to supplant the covered
firms. The first group of businesses are
much smaller than the covered firms.
Those businesses, however, will
typically have higher costs and prices to
begin with due to their scale
disadvantages to the larger firms. The
larger firm’s small price increases
attributable to this ETS would not be
likely to create an actionable
competitive advantage for this group of
smaller businesses. The second group of
businesses are those closer in size to the
100-employee cutoff. If the marginal
price increases did actually cause some
of the larger firms to fail and the slightly
smaller firms to take their place, the
industry itself would not suffer a
massive dislocation or be imperiled.
And, of course, if all of the firms in an
industry are large employers with 100 or
more employees, no competitive
disadvantage from within the industry
would exist (even hypothetically), and
there would be no question that they
could cover the cost of ETS by raising
prices to customers accordingly.
Although the preceding discussion
demonstrates that the ETS is
economically feasible, OSHA has
provided an additional examination of
each of the NAICS that have crossed the
profit screen (again noting that none of
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these failed the revenue screen): The
eight NAICS industries with positive
profit ratios but profit rates below 1
percent.
1. NAICS 221118—Other Electric Power
Generation, 23.97 Percent
This U.S. industry comprises
establishments primarily engaged in
operating electric power generation
facilities (except hydroelectric, fossil
fuel, nuclear, solar, wind, geothermal,
biomass). These facilities convert other
forms of energy, such as tidal power,
into electric energy. The electric energy
produced in these establishments is
provided to electric power transmission
systems or to electric power distribution
systems.
Using tides to generate power is not
yet economically viable, according to
one source, because ‘‘[t]otal availability
of tidal power is restricted by its
relatively high cost and limited number
of sites having high flow velocities and
tidal ranges,’’ although ‘‘with [ ] recent
advancements in tidal technologies, the
total availability of tidal power in terms
of turbine technology as well as design
may be higher than before, and the
economic costs may be reduced
significantly to competitive levels.’’ In
support, in the same article, ‘‘recent
reports state that the UK, which has the
largest tidal and wave resource in
Europe, is capable of harnessing up to
153GW of tidal power capacity with the
help of three types of technologies and
thus meeting 20% of current UK
electricity demand and reducing carbon
emissions. Hence it is evident that wave
and tidal energy could contribute more
to the increasing electricity demands
across the globe.’’ 65
At the time OSHA obtained the most
recent NAICS data, there were 7 affected
entities in this NAICS industry. The
entities in this NAICS industry include
firms like Berkshire Hathaway Energy
Company, (with annual sales of $19.8
billion, whose ‘‘portfolio consists of
locally managed business that share a
vision for a secure and sustainable
energy future’’); Dominion Energy (with
annual sales of $13.4 billion); and other
leading firms in this industry including
some of the largest power generation
companies in the US (See NAICS
Association, 2018a; NAICS Association
2018d; and NAICS Association 2018e).
As this NAICS industry is not yet
viable, (in the United States, at least), it
is to be expected that revenues and
profits would be low. In fact, OSHA
believes the best way to view this
industry is as a series of incredibly wellfunded start-up companies during the
65 See
Walker, January 22, 2013.
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investment phase of the business, where
short-term losses are expected and offset
with the anticipation of enormous
revenue growth potential (in an
acknowledged very limited energy
market.) Given these factors, OSHA’s
typical revenue and profit screen are a
poor predictor of future viability with
respect to this NAICS industry
(although, as pointed out, this NAICS
industry, like all other NAICS
industries, falls well below the revenue
screen threshold). The estimated cost of
this ETS per firm is $866 in this NAICS
industry, which equals about 11 cents
per hundred dollars of revenue over a
limited six-month duration. OSHA
concludes that this industry will be able
to withstand this small cost in order to
keep its workers protected during the
pandemic.
2. NAICS 488119—Other Airport
Operations, 18.41 Percent 66
The services this industry offers are
integrated into a particular geographic
location and entail specific tasks, such
as parking and baggage handling
services, that must be done to ensure the
proper functioning of airports, thus
negating the potential for substitution
during the 6 month period that OSHA
is assuming the ETS will be in effect for
economic purposes. In addition,
because these are services that need to
be done in particular domestic locations
(i.e., airports), there is no risk of
international competition.
3. NAICS 488410—Motor Vehicle
Towing, 15.75 Percent 67
The actual cost impacts on this
industry are likely significantly
overstated to the extent that most
employees performing towing services
ride alone in their trucks and their
services do not typically require
exposure to others. In the event that
individual large towing firms are
concerned about economic impacts, it
would not be difficult to structure their
employee interactions with the
company and customers to take
advantage of the scope restrictions.
Moreover, the primary services this
industry offers involve the use of
specialized vehicles designed uniquely
for towing, thus lowering the risk of
substitution. In addition, because these
66 This U.S. industry comprises establishments
primarily engaged in (1) operating international,
national, or regional airports, or public flying fields
or (2) supporting airport operations, such as rental
of hangar space, and providing baggage handling
and/or cargo handling services.
67 This industry comprises establishments
primarily engaged in towing light or heavy motor
vehicles, both local and long-distance. These
establishments may provide incidental services,
such as storage and emergency road repair services.
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services are geographically based, there
is no risk of international competition.
4. NAICS 488490—Other Support
Activities for Road Transportation,
14.32 Percent 68
This industry offers services that must
be done to ensure proper operation of
roadways (for example, bridge, tunnel,
and highway operations, pilot car
services (i.e., wide load warning
services), driving services (e.g.,
automobile, truck delivery), and truck or
weighing station operations), thus
negating the potential for substitution.
In addition, because these services need
to be done in particular domestic
locations (i.e., roadways), there is no
risk of international competition.
5. NAICS 713920—Skiing Facilities,
13.16 Percent 69
This industry caters to a wealthy
clientele who ensure an inelastic
demand easily capable of absorbing any
fractional increases attributable to this
ETS.70 In addition, skiing is done
outdoors, which will incentivize
clientele to continue engaging in this
particular activity in lieu of indoor
substitutions, during the pandemic.
Finally, there is little to no risk of
international competition from foreign
ski resorts because the added and
substantial costs of international travel
outweigh the costs associated with
marginally higher prices resulting from
the ETS.
6. NAICS 713940—Fitness and
Recreational Sports Centers, 12.33
Percent 71
As these settings are generally located
close to where clients live or work, there
is no risk of international competition.
Some of the largest employers in this
industry have already responded to
customer feedback by not only requiring
employees to be vaccinated, but also
68 This industry comprises establishments
primarily engaged in providing services (except
motor vehicle towing) to road network users.
69 This industry comprises establishments
engaged in (1) operating downhill, cross country, or
related skiing areas and/or (2) operating equipment,
such as ski lifts and tows. These establishments
often provide food and beverage services,
equipment rental services, and ski instruction
services. Four season resorts without
accommodations are included in this industry.
70 See Brown, January 19, 2017, ‘‘[o]f the 9.4
million skiers in the U.S., more than half earn a
salary higher than $100,000. For some context, only
20 percent of American households have a
combined income of $100K. . . .’’)
71 This industry comprises establishments
primarily engaged in operating fitness and
recreational sports facilities featuring exercise and
other active physical fitness conditioning or
recreational sports activities, such as swimming,
skating, or racquet sports.
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members.72 This suggests both that the
costs estimates attributed to the ETS are
overstated for these employers because
higher levels of compliance may have
already occurred than projected in
OSHA’s analysis, and that the ETS
requirements reflect more of an industry
trend than a threat to the existence of
the industry.
7. NAICS 713120—Amusement
Arcades, 11.18 Percent 73
This industry caters to a select
clientele who have chosen to engage in
leisure activities in the unique settings
offered by the industry, thus negating
the likelihood for substitution. In
addition, because these settings are
localized, there is no risk of
international competition.
8. NAICS 488320—Marine Cargo
Handling, 10.03 Percent 74
The services this industry offers are
integrated into a particular location and
entail specific tasks, such as loading and
unloading services at ports and harbors,
longshoremen services, marine cargo
handling services, ship hold cleaning
services, and stevedoring services, that
must be done to ensure the proper
movement of cargo off of and onto
ships, thus negating the potential for
substitution. In addition, because these
are services that need to be done in
particular domestic locations (e.g.,
docks), there is no risk of international
competition.
As with towing, the actual cost
impacts on this industry are likely
significantly overstated to the extent
that some of the employees may be able
to perform their work exclusively
outdoors.
The Fourteen NAICS Industries With
Negative Profit Ratios
1. Air Transportation 75
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NAICS 481111 (Scheduled Passenger
Air Transportation), NAICS 481112
72 See Jackson, August 2, 2021 ‘‘Equinox also
noted in the press release that ‘an overwhelming
majority of members’ have expressed support for a
vaccination requirement for entry to Equinox
clubs.’’
73 This industry comprises establishments
primarily engaged in operating amusement (except
gambling, billiard, or pool) arcades and parlors.
74 This industry comprises establishments
primarily engaged in providing stevedoring and
other marine cargo handling services (except
warehousing).
75 NAICS 481111 (Scheduled Passenger Air
Transportation) provides air transportation of
passengers or passengers and freight over regular
routes and on regular schedules, including
commuter and helicopter carriers (except scenic
and sightseeing). NAICS 481112 (Scheduled Freight
Air Transportation) provides air transportation of
cargo without transporting passengers over regular
routes and on regular schedules, including
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(Scheduled Freight Air Transportation),
NAICS 481211 (Nonscheduled
Chartered Passenger Air
Transportation), NAICS 481212
(Nonscheduled Chartered Freight Air
Transportation), NAICS 481219 (Other
Nonscheduled Air Transportation).
This group of NAICS industries is
comprised of U.S. industries that
primarily engage in providing air
transportation. There is little to no risk
of substitution for this group of NAICS
industries. Air transportation provides
unique and important benefits that
cannot be substituted via other forms of
transportation (e.g., rail, freight, bus).
(See ATAG, September 2005). To this
end, air transportation is often the
speediest means of transporting
passengers and cargo, giving it a unique
purpose that cannot be met by other
forms of transport. It should be noted
that the five NAICS in this group of
industries are the only NAICS in NAICS
4811 (Scheduled Air Transportation)
and 4812 (Nonscheduled Air
Transportation). The other industries in
NAICS 48 (Transportation) do not
provide air transportation (See NAICS
Association, 2018b). This further
reduces the risk of substitution, as all
five NAICS at issue have a negative
profit ratio and therefore face similar
challenges that appear to be endemic to
air transportation. Firms in this industry
that have been able to weather the
pandemic this long are typically highly
capitalized or have access to loans, so it
is highly likely that they could also
weather the temporary marginal costs of
OSHA’s ETS.
There is also no risk of international
competition with respect to this group
of NAICS industries because any
workers, whether they work for an
international company or not, who are
in the US, are subject to US laws,
including the ETS, and foreign air
carriers will need to follow the ETS for
those workers. In addition, OSHA
suspects that any smaller foreign air
carriers will not have an incentive to
expand their routes significantly or
change their routes to domestic US
scheduled air transportation of mail on a contract
basis. NAICS 481211 (Nonscheduled Chartered
Passenger Air Transportation) provides air
transportation of passengers or passengers and
cargo with no regular routes and regular schedules.
NAICS 481212 (Nonscheduled Chartered Freight
Air Transportation) provides air transportation of
cargo without transporting passengers with no
regular routes and regular schedules. NAICS 481219
(Other Nonscheduled Air Transportation) provides
air transportation with no regular routes and regular
schedules (except nonscheduled chartered
passenger and/or cargo air transportation). These
establishments provide a variety of specialty air
transportation or flying services based on
individual customer needs using general purpose
aircraft.
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routes to take advantage of the 100employee cutoff in the ETS in the 6months the ETS is assumed to be in
effect.
2. Telecommunications 76
NAICS 517311 (Wired
Telecommunications Carriers), NAICS
517312 (Wireless Telecommunications
Carriers (except Satellite), NAICS
517410 (Satellite Telecommunications),
NAICS 517911 (Telecommunications
Resellers), NAICS 517919 (All Other
Telecommunications).
This group of NAICS industries is
entirely comprised of U.S. industries,
except for NAICS 517410 (Satellite
Telecommunications). All of these
industries provide specialized unique
services in the telecommunications
industry that require specialized unique
knowledge and are thus resistant to
substitution. While it is perhaps
76 NAICS 517311 (Wired Telecommunications
Carriers) comprises establishments primarily
engaged in operating and/or providing access to
transmission facilities and infrastructure that they
own and/or lease for the transmission of voice, data,
text, sound, and video using wired
telecommunications networks. Establishments in
this industry use the wired telecommunications
network facilities that they operate to provide a
variety of services, such as wired telephony
services, including VoIP services; wired (cable)
audio and video programming distribution; wired
broadband internet services; and, by exception,
establishments providing satellite television
distribution services using facilities and
infrastructure that they operate are included in this
industry. NAICS 517312 (Wireless
Telecommunications Carriers (except Satellite))
comprises establishments primarily engaged in
operating and maintaining switching and
transmission facilities to provide communications
via the airwaves. Establishments in this industry
have spectrum licenses and provide services using
that spectrum, such as cellular phone services,
paging services, wireless internet access, and
wireless video services. NAICS 517410 (Satellite
Telecommunications) comprises establishments
primarily engaged in providing telecommunications
services to other establishments in the
telecommunications and broadcasting industries by
forwarding and receiving communications signals
via a system of satellites or reselling satellite
telecommunications. NAICS 517911
(Telecommunications Resellers) comprises
establishments engaged in purchasing access and
network capacity from owners and operators of
telecommunications networks and reselling wired
and wireless telecommunications services (except
satellite) to businesses and households.
Establishments in this industry resell
telecommunications; they do not operate
transmission facilities and infrastructure. NAICS
517919 (All Other Telecommunications) comprises
establishments primarily engaged in providing
specialized telecommunications services, such as
satellite tracking, communications telemetry, and
radar station operation, and also includes
establishments primarily engaged in providing
satellite terminal stations and associated facilities
connected with one or more terrestrial systems and
capable of transmitting telecommunications to, and
receiving telecommunications from, satellite
systems, as well as establishments providing
internet services or Voice over internet protocol
(VoIP) services via client-supplied
telecommunications connections.
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possible that different forms of
telecommunications might be
substituted for one another (e.g., the
substitution of wired
telecommunications carriers for wireless
telecommunications carriers), the reality
is that these different forms exist
separately and feed different markets
and customer needs that are
independent of the ETS. Moreover, the
five NAICS in this group of industries
are the only NAICS in NAICS 5173
(Wired and Wireless
Telecommunications Carriers), NAICS
5174 (Satellite Telecommunications),
and NAICS 5179 (Other
Telecommunications). The other
industries in NAICS 51 (Information)
are not engaged in telecommunications
(NAICS Association, 2018c). This
further reduces the risk of one industry
substituting for the others, as all five
NAICS at issue have a negative profit
ratio and therefore face similar
challenges that appear to be endemic to
telecommunications.
Moreover, three of the five NAICS
industries in this group (NAICS 517311,
517312, 517410) operate or control the
infrastructure needed for engaging in
the particular type of
telecommunications in which those
industries engage. This not only fully
negates the risk of substitution, but also
negates the risk of international
competition for these industries.
The other two industries in the group
apparently do not operate or control the
infrastructure needed for
telecommunications. However, the
telecommunications industry faces strict
state and federal licensing requirements,
which severely limit the risk of
competition both internationally and
from smaller firms seeking to take
advantage of the ETS’s 100-employee
cutoff. (See FCC, 2014; FCC, October 12,
2021a; FCC, October 12, 2021b;
Caltrans, October 12, 2021; and UTC,
October 12, 2021).
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3. Car and Equipment Rental 77
NAICS 532111 (Passenger Car Rental),
NAICS 532112 (Passenger Car Leasing),
77 NAICS 532111 (Passenger Car Rental)
comprises establishments primarily engaged in
renting passenger cars without drivers, generally for
short periods of time. NAICS 532112 (Passenger Car
Leasing) comprises establishments primarily
engaged in leasing passenger cars without drivers,
generally for long periods of time. NAICS 532120
(Truck, Utility Trailer, and RV (Recreational
Vehicle) Rental and Leasing comprises
establishments primarily engaged in renting or
leasing, without drivers, one or more of the
following: Trucks, truck tractors, buses, semitrailers, utility trailers, or RVs (recreational
vehicles). NAICS 532310 (General Rental Centers)
comprises establishments primarily engaged in
renting a range of consumer, commercial, and
industrial equipment. Establishments in this
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NAICS 532120 (Truck, Utility Trailer),
and RV (Recreational Vehicle) Rental
and Leasing) NAICS 532310 (General
Rental Centers).
This group of industries rent motor
vehicles (NAICS 532111, 532112,
532120) or equipment (NAICS 532310),
for example, audio visual equipment,
contractors’ and builders’ tools and
equipment, home repair tools, lawn and
garden equipment, moving equipment
and supplies, and party and banquet
equipment and supplies, to individuals
and businesses, for personal and
professional use. There is no risk of
substitution with respect to these
industries, as these industries rent
specific items to those who want to use
them. There is also no risk of foreign
competition with respect to these
industries, as consumers and businesses
rent and pick up vehicles, as well as the
type of equipment offered for rent by
NAICS 532310, from specific locations,
including car rental and other rental
centers.
These industries have not been hard
hit by the pandemic, as many
consumers have turned from group
travel to individual transportation. For
example, RV rentals and leasing has
soared during the pandemic, which is
not reflected in the pre-pandemic profit
and revenue data available for this
analysis.78
References
Air Transport Action Group (ATAG). (2005,
September). The economic & social
benefits of air transport. https://
www.icao.int/meetings/wrdss2011/
documents/jointworkshop2005/atag_
socialbenefitsairtransport.pdf. (ATAG,
September 2005)
Beale HBR. (2003). Financial Data Sources.
Microeconomic Applications Inc. (Beale
Report, 2003)
Brown J. (2017, January 19). Bring More
Diversity to Skiing. https://
www.powder.com/stories/opinion/
extend-the-family/. (Brown, January 19,
2017)
Caltrans. (2021, October 12). Wireless
Licensing Program, California
Department of Transportation. https://
dot.ca.gov/programs/right-of-way/
wireless-licensing-program. (Caltrans,
October 12, 2021)
Federal Communications Commission (FCC).
(2021, October 12a) Licensing. https://
industry typically operate from conveniently
located facilities where they maintain inventories of
goods and equipment that they rent for short
periods of time. The type of equipment that
establishments in this industry provide often
includes, but is not limited to: Audio visual
equipment, contractors’ and builders’ tools and
equipment, home repair tools, lawn and garden
equipment, moving equipment and supplies, and
party and banquet equipment and supplies.
78 See Park, January 23, 2021.
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www.fcc.gov/licensing-databases/
licensing. (FCC, October 12, 2021a)
Federal Communications Commission (FCC).
(2021, October 12b) Satellite. https://
www.fcc.gov/general/satellite. (FCC,
October 12, 2021b)
Groenewold M et al., (2020, July 10).
Increases in Health-Related Workplace
Absenteeism Among Workers in
Essential Critical Infrastructure
Occupations During the COVID–19
Pandemic—United States, March–April
2020. Centers for Disease Control and
Prevention MMWR Vol. 69, No. 27.
(Groenewold et al., July 10, 2020)
Internal Revenue Service (IRS). (2013). 2013
Corporation Source Book. https://
www.irs.gov/statistics/soi-tax-statscorporation-source-book-us-total-andsectors-listing. (IRS, 2013)
Jackson S. (2021, August 2). Gyms like
Equinox and SoulCycle will soon require
members to show proof of vaccination to
use their clubs and studios. https://
www.businessinsider.com/equinoxsoulcycle-will-require-covid-19-vaccinesfor-members-staff-2021–8. (Jackson,
August 2, 2021)
NAICS Association. (2018a). NAICS Codes
Description, 2018: 221118—Other
Electric Power Generation. https://
www.naics.com/naics-code-description/
?code=221118. Last accessed October 12,
2021. (NAICS Association, 2018a)
NAICS Association. (2018b). Six Digit NAICS
Codes and Titles, 2018: Codes 48–49.
https://www.naics.com/six-digit-naics/
?code=48-49. Last accessed October 12,
2021. (NAICS Association, 2018b)
NAICS Association. (2018c). Six Digit NAICS
Codes and Titles, 2018: Code 51. https://
www.naics.com/six-digit-naics/
?code=51. Last accessed October 12,
2021. (NAICS Association, 2018c)
NAICS Association. (2018d). NAICS Profile
Page, 2018: Berkshire Hathaway Energy
Co. https://www.naics.com/companyprofile-page/?co=4973. Last accessed
October 12, 2021. (NAICS Association,
2018d)
NAICS Association. (2018e). NAICS Profile
Page, 2018: Dominion Energy Inc.
https://www.naics.com/company-profilepage/?co=11715. Last accessed October
12, 2021. (NAICS Association, 2018e)
Occupational Safety and Health
Administration (OSHA). (2016, March
24). Final Economic and Regulatory
Flexibility Analysis for OSHA’s Rule on
Occupational Exposure to Respirable
Crystalline Silica, Chapter VI, pp. VI–20.
Docket No. OSHA–2010–0034–4247.
(OSHA, March 24, 2016)
Occupational Safety and Health
Administration (OSHA). (2021a,
October). Analytical Spreadsheets in
Support of the COVID–19 Vaccination
and Testing ETS. (OSHA, October 2021a)
Park S. (2021, January 23). RV sales soar
during coronavirus pandemic. https://
www.foxbusiness.com/lifestyle/rv-salessoar-during-pandemic-travel-road-trip.
(Park, January 23, 2021)
U.S. Census Bureau. (2021, October 8a).
Scientific Integrity. https://
www.census.gov/about/policies/quality/
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scientific_integrity.html. (US Census
Bureau, October 8, 2021a)
U.S. Census Bureau. (2021, October 8b).
Statement of Commitment to Scientific
Integrity by Principal Statistical
Agencies. https://www.census.gov/
content/dam/Census/about/about-thebureau/policies_and_notices/
scientificintegrity/Scientific_Integrity_
Statement_of_the_Principal_Statistical_
Agencies.pdf. (US Census Bureau,
October 8, 2021b)
Walker C. (2013, January 22). Is Tidal Power
a Viable Source of Energy? https://
www.azocleantech.com/article.aspx?
ArticleID=350. (Walker, January 22,
2013)
Washington Utilities and Transportation
Commission (UTC). (2021, October 12).
Eligible Telecommunications Carriers.
https://www.utc.wa.gov/regulatedindustries/utilities/telecommunications/
federal-universal-service-funds/eligibletelecommunications-carriers. (UTC,
October 12, 2021)
V. Additional Requirements
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A. Regulatory Flexibility Act
Whenever an agency is required by
the Administrative Procedure Act, 5
U.S.C. 553, or another law, to publish a
general notice of proposed rulemaking,
the Regulatory Flexibility Act (RFA), 5
U.S.C. 601 et seq., requires the agency
to prepare an initial regulatory
flexibility analysis (IRFA). 5 U.S.C.
601(2), 603(a). Since this ETS ‘‘shall
serve as a proposed rule’’ for a final
standard under section 6(c)(3) of the
OSH Act, it is treated as a general notice
of proposed rulemaking under the RFA.
An agency may waive or defer the IRFA
in the event a rule is promulgated in
response to an emergency that makes
compliance with the requirements of
section 603 impracticable. 5 U.S.C.
608(a). The agency hereby certifies that
compliance with the IRFA requirement
is impracticable under the
circumstances. OSHA prepared this ETS
on an expedited basis in response to a
national emergency affecting the lives
and health of the nation’s workers; the
IRFA is inherently a relatively lengthy
process that would be impracticable to
undertake for a standard of such broad
applicability in the limited time
available. Because OSHA is not
preparing an IRFA for the ETS, the
agency is also not required to convene
a small entity panel under section
609(b).
B. Unfunded Mandates Reform Act
(UMRA), 2 U.S.C. 1501 et seq.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1532, requires agencies to
assess the anticipated costs and benefits
of a rule before issuing ‘‘any general
notice of proposed rulemaking’’ that
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includes a Federal mandate that may
result in expenditures in any one year
by state, local, or Tribal governments, or
by the private sector, of at least $100
million, adjusted annually for inflation.
The assessment requirement also
applies to ‘‘any final rule for which a
general notice of proposed rulemaking
was published.’’ Although no general
notice of proposed rulemaking was
published, the agency has analyzed the
ETS’s economic feasibility and health
impacts in Section IV.B. of this
preamble (Economic Analysis) and
Health Impacts Appendix (OSHA,
October 2021c).
C. Executive Order 13175
Section 5 of E.O. 13175, on
Consultation and Coordination with
Indian Tribal Governments, requires
agencies to consult with tribal officials
early in the process of developing
regulations that: (1) Have tribal
implications, that impose substantial
direct compliance costs on Indian
governments, and that are not required
by statute; or (2) have tribal implications
and preempt tribal law. 65 FR 67249,
67250 (Nov. 6, 2000). E.O. 13175
requires that such consultation occur to
the extent practicable. Given the
expedited nature of issuing the ETS, it
was not practicable for OSHA to consult
and incorporate non-federal input prior
to promulgation of the standard. OSHA
commits to meaningful consultation
with tribal representatives after
publication of the ETS and during the
comment period before finalizing any
permanent standard. Such consultation
will be consistent with the
Administrative Procedure Act.
D. National Environmental Policy Act
OSHA has reviewed this ETS
according to the National
Environmental Policy Act (NEPA) of
1969, 42 U.S.C. 4321 et seq., the
regulations of the Council on
Environmental Quality, 40 CFR chapter
V, subchapter A, and the Department of
Labor’s NEPA procedures, 29 CFR part
11. As a result of this review, the agency
has determined that the rule will have
no significant impact on air, water, or
soil quality; plant or animal life; the use
of land; or other aspects of the external
environment. Although the ETS
contains testing requirements, and test
kits and supplies can generate some
additional materials that will enter the
waste stream, the impact of this ETS
will be minimal. As discussed in more
detail in Technological Feasibility
(Section IV.A. of this preamble), there is
already a surplus of available tests, and
projected production of COVID–19 tests
will be more than sufficient to meet
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demands for testing created as a result
of the rule. Therefore, tests used for
purposes of or for compliance with this
ETS are not being produced as a result
of this standard, and the standard will
not generate significant new streams of
waste beyond what would be generated
in the absence of the standard.
E. Congressional Review Act
This ETS is considered a major rule
under the Congressional Review Act
(CRA), 5 U.S.C. 801 et seq. Section
801(a)(3) of the CRA normally requires
a 60-day delay in the effective date of
a major rule. 5 U.S.C. 801(a)(3), 804(2).
However, section 808(2) of the CRA
allows the issuing agency to make a rule
effective sooner than otherwise
provided by the CRA if the agency
makes a good cause finding that notice
and public procedure are impracticable,
unnecessary, or contrary to the public
interest. 5 U.S.C. 808(2). OSHA finds
that there is good cause to make this
rule effective upon publication because
notice and public procedure with
respect to this ETS are both
impracticable and contrary to the public
interest, given the expedited timeline on
which this standard was developed and
the grave danger threatening workers’
lives and health (see Grave Danger and
Need for the ETS, both in Section III. of
this preamble). Congress authorized
OSHA to take swift action in
promulgating an ETS to address this
type of grave danger, and provided
explicitly that an ETS is effective upon
publication, 29 U.S.C. 655(c)(1);
delaying the effective date of such an
expedited process would thwart that
purpose. It is specifically because of the
emergency nature of this rulemaking
that the OSH Act allows for OSHA to
proceed without the extensive public
input the agency normally solicits in
issuing occupational safety and health
standards. 29 U.S.C. 655(c)(1). For rules
to which section 808(2) applies, the
agency may set the effective date. In this
case, consistent with the OSH Act
requirement cited above, the ETS takes
immediate effect upon publication in
the Federal Register.
F. Administrative Procedure Act
The Administrative Procedure Act
(APA) normally requires notice and
comment, and a 30-day delay of the
effective date of a final rule, for
recordkeeping and reporting regulations
promulgated under section 8(c) of the
OSH Act. 29 U.S.C. 657(c); 5 U.S.C.
553(b), (d). This ETS contains
recordkeeping and reporting
requirements tailored to address
COVID–19 illness. To the extent that
these requirements are not already
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exempt from the APA’s requirements for
notice and comment under section 6(c)
of the Act (29 U.S.C. 655(c)), OSHA
invokes the ‘‘good cause’’ exemption to
the APA’s notice requirement because
the agency finds that notice and public
procedure are impracticable and
contrary to the public interest under 5
U.S.C. 553(b)(B). As explained in more
detail in Grave Danger and Need for the
ETS (both in Section III. of this
preamble), this finding is based on the
critical importance of implementing the
requirements in this ETS, including the
recordkeeping and reporting provisions,
as soon as possible to address the grave
danger that COVID–19 presents to
workers.
As noted above, the ETS is required
by the OSH Act to take immediate effect
upon publication. 29 U.S.C. 655(c)(1).
For that reason, and the underlying
public health emergency that prompted
this ETS as discussed above, OSHA
finds good cause to waive the normal
30-day delay in the effective date of a
final rule from the date of its
publication in the Federal Register. See
5 U.S.C. 553(d)(3). OSHA notes,
however, that OSHA does not require
compliance with any provision of the
ETS within the first 30 days after it
becomes effective.
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G. Consensus Standards
OSHA must consider adopting an
existing national consensus standard
that differs substantially from OSHA’s
standard if the consensus standard
would better effectuate the purposes of
the Act. See section 12(d)(1) of the
National Technology Transfer and
Advancement Act of 1995 (15 U.S.C.A.
272 Note); see also 29 U.S.C. 655(b)(8).
OSHA considered incorporation of
ASTM F3502–21 in this ETS, as
required. However, the agency has
insufficient evidence to make a general
finding of feasibility at this time. The
agency notes that face coverings that
meet ASTM F3502–21 criteria also meet
the definition of ‘‘face coverings’’ in this
ETS (see the discussion of this issue in
Summary and Explanation, Section VI.
of this preamble). The agency has asked
questions about this topic to gather
additional information.
H. Executive Order 13045
Executive Order 13045, on Protection
of Children from Environmental Health
Risks and Safety Risks, requires that
Federal agencies submitting covered
regulatory actions to OIRA for review
pursuant to Executive Order 12866 must
provide OIRA with (1) an evaluation of
the environmental health or safety
effects that the planned regulation may
have on children, and (2) an explanation
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of why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the agency (62 FR 19885
(April 23, 1997)). Executive Order 13045
defines ‘‘covered regulatory actions’’ as
rules that may (1) be economically
significant under Executive Order
12866, and (2) concern an
environmental health risk or safety risk
that an agency has reason to believe may
disproportionately affect children.
Because OSHA has no reason to believe
that the risk from COVID–19
disproportionately affects children, the
ETS is not a covered regulatory action
and OSHA is not required to provide
OIRA with further analysis under
section 5 of the executive order.
However, to the extent children are
exposed to COVID–19 either as
employees or at home as a result of
family members’ workplace exposures
to COVID–19, the ETS should provide
some protection for children.
I. Federalism
The agency reviewed this ETS
according to Executive Order 13132, on
Federalism, which requires that Federal
agencies, to the extent possible, refrain
from limiting State policy options,
consult with States before taking actions
that would restrict States’ policy
options, and take such actions only
when clear constitutional authority
exists and the problem is of national
scope. 64 FR 43255 (August 10, 1999).
The Executive Order generally allows
Federal agencies to preempt State law
only as provided by Congress or where
State law conflicts with Federal law. In
such cases, Federal agencies must limit
preemption of State law to the extent
possible.
The Occupational Safety and Health
Act is an exercise of Congress’s
Commerce Clause authority, and under
Section 18 of the Act, 29 U.S.C. 667,
Congress expressly provided that States
may adopt, with Federal approval, a
plan for the development and
enforcement of occupational safety and
health standards. OSHA refers to States
that obtain Federal approval for such
plans as ‘‘State Plans.’’ Occupational
safety and health standards developed
by State Plans must be at least as
effective in providing safe and healthful
employment and places of employment
as the Federal standards. As discussed
below, State Plans must submit to
Federal OSHA for approval, standards
that differ from Federal standards
addressing the same issues, in order for
such standards to become part of the
OSHA-approved State Plan. Subject to
these requirements, State Plans are free
to develop and enforce their own
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occupational safety and health
standards.
This ETS complies with E.O. 13132.
The problems addressed by this ETS for
COVID–19 are national in scope. As
explained in Grave Danger (Section
III.A. of this preamble), employees face
a grave danger from exposure to
COVID–19 in the workplace. Employees
across the country face the danger of
exposure to COVID–19 at work, and as
explained in Need for the ETS (Section
III.B. of this preamble), a national
standard is needed to protect workers
from the grave danger of COVID–19 by
strongly encouraging vaccination and
limiting the presence of COVID–19
positive workers in the workplace
through testing and to ensure that a
clear and consistent baseline approach
is taken across the country to protect
them. The SARS–CoV–2 virus is highly
communicable and infects workers
without regard to state borders, making
a national approach necessary.
Accordingly, the ETS establishes
minimum requirements for employers
in every State to protect employees from
the risks of exposure to COVID–19.
In States without OSHA-approved
State Plans, Congress provides for
OSHA standards to preempt State
occupational safety and health
standards for issues addressed by the
Federal standards. In these States, this
ETS limits State policy options in the
same manner as every standard
promulgated by the agency.
Furthermore, as discussed in the
Summary and Explanation for Purpose,
nothing in the ETS is intended to limit
generally applicable public health
measures instituted by state or local
governments that go beyond, and are not
inconsistent with, the requirements of
the ETS. (See Summary and
Explanation for Purpose, Section VI.A.
of this preamble); Gade v. National
Solid Wastes Management Ass’n, 505
U.S. 88, 107 (1992). In States with
OSHA-approved State Plans, this ETS
does not significantly limit State policy
options. Any special workplace
problems or conditions in a State with
an OSHA-approved State Plan may be
dealt with by that State’s standard,
provided the standard is at least as
effective as this ETS.
As discussed in the Summary and
Explanation for Purpose in this
preamble, OSHA has included a
provision that states the purpose of this
ETS, as well as OSHA’s intent to
preempt all inconsistent State and local
requirements that relate to the issues
addressed by this ETS. (See section
1910.501(a); Summary and Explanation
for Purpose, Section VI.A. of this
preamble). This includes State and local
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requirements banning or limiting the
authority of employers to require
vaccination, face covering, or testing. As
discussed in that section, such State and
local bans would be preempted by this
ETS, even in States with OSHAapproved State Plans, because such bans
are not approved by federal OSHA as
part of the State Plan and could not be
approved, because such bans are clearly
not as effective—and, indeed, are
contrary to—the federal ETS. See
Indust. Truck Ass’n v. Henry, 125 F.3d
1305, 1311 (9th Cir. 1997).
J. State Plans
When Federal OSHA promulgates an
emergency temporary standard, States
and U.S. Territories with their own
OSHA-approved occupational safety
and health plans (‘‘State Plans’’) must
either amend their standards to be
identical or ‘‘at least as effective as’’ the
new standard, or show that an existing
State Plan standard covering this area is
‘‘at least as effective’’ as the new Federal
standard. 29 CFR 1953.5(b). This ETS
imposes new requirements to protect
workers across the nation from COVID–
19. Adoption of this ETS, or an ETS that
is at least as effective as this ETS, by
State Plans must be completed within
30 days of the promulgation date of the
final Federal rule, and State Plans must
notify Federal OSHA of the action they
will take within 15 days. The State Plan
standard must remain in effect for the
duration of the Federal ETS. As noted
above in Federalism (Section V.I. of this
preamble), this ETS preempts all State
and local requirements, including in
States with State Plans, that ban or limit
the authority of employers to require
vaccination, face covering, or testing.
(See also the Summary and Explanation
for Purpose, Section VI.A. of this
preamble). As with all non-identical
State Plan standards, OSHA will review
any comparable State standards to
determine whether they are at least as
effective as this ETS. A State Plan
standard that prohibits employers from
requiring vaccination would not be at
least as effective as this ETS because
OSHA has recognized in this ETS that
vaccination is the most protective policy
choice for employers to adopt to protect
their workplaces.
Of the 28 States and Territories with
OSHA-approved State Plans, 22 cover
both public and private-sector
employees: Alaska, Arizona, California,
Hawaii, Indiana, Iowa, Kentucky,
Maryland, Michigan, Minnesota,
Nevada, New Mexico, North Carolina,
Oregon, Puerto Rico, South Carolina,
Tennessee, Utah, Vermont, Virginia,
Washington, and Wyoming. The
remaining six States and Territories
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cover only state and local government
employees: Connecticut, Illinois, Maine,
New Jersey, New York, and the Virgin
Islands.
K. Paperwork Reduction Act
I. Overview
The Emergency Temporary Standard
(ETS) for COVID–19 Vaccination and
Testing contains collection of
information requirements that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501, et seq., and
OMB’s regulations at 5 CFR part 1320.
The PRA defines a collection of
information to mean the obtaining,
causing to be obtained, soliciting, or
requiring the disclosure to third parties
or the public, of facts or opinions by or
for an agency, regardless of form or
format (44 U.S.C. 3502(3)(A)). OSHA
has determined an ETS is necessary to
protect workers from the grave danger
posed by COVID–19 and is issuing an
ETS that amends 29 CFR 1910 subpart
U to provide COVID–19 protections to
workers of employers with 100 or more
employees. Section 1910.501 contains
collections of information necessary to
effectuate the purpose of the ETS. The
collections of information appear in
paragraphs 1910.501(d), (e)(2), (e)(4),
(f)(1), (g)(1), (g)(4), (h)(1), (j), (k)(1),
(k)(2), (l)(1), and (l)(2). For a more
comprehensive discussion of these
provisions, see the sectional analysis
earlier in this preamble. These
information collections are applied by
cross reference to other industries in
regulations 29 CFR 1915.1501 (Shipyard
Employment), 1917.31 (Marine
Terminals), 1918.110 (Longshoring),
1926.58 (Construction), 1928.21
(Agriculture).79
Under the PRA, a Federal agency
cannot conduct or sponsor a collection
of information unless OMB approves it
and the agency displays a currently
valid OMB control number (44 U.S.C.
3507). Notwithstanding any other
provision of law, if a collection of
information does not display a currently
valid control number, an employer shall
not be subject to penalty for failing to
comply with the collection of
information (44 U.S.C. 3512). The PRA
has special provisions for emergency
situations that are applicable to this
ETS. OMB may authorize a collection of
information without regard to the
79 The ETS applies to agricultural establishments
with 11 or more employees engaged on any day in
hand-labor occupations in the field and agricultural
establishments that maintain a temporary labor
camp, regardless of how many employees are
engaged on any day in hand-labor occupations in
the field).
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normal clearance procedures if either (a)
the relevant agency determines that the
collection of information is essential to
the mission of the agency and public
harm is reasonably likely to result if
normal clearance procedures are
followed, or (b) the use of normal
clearance procedures is reasonably
likely to cause a statutory or court
ordered deadline to be missed (44
U.S.C. 3507(j) and 5 CFR 1320.13).
Because COVID–19 presents an ongoing
public health threat to workers and
American businesses, OSHA has
requested the use of these emergency
procedures for this ETS. In accordance
with 44 U.S.C. 3507(j)(1), OMB
approved the request and assigned this
ETS an OMB control number that is
valid for 180 days. Therefore, the
information collection provisions
contained within this ETS will take
effect at the same time as all other
provisions.
II. Summary of Information Collection
Requirements
This information collection is
summarized as follows.
1. Title: COVID–19 Vaccination and
Testing Emergency Temporary Standard
(29 CFR 1910, subpart U; 1915, subpart
Z; 1917, subpart B; 1918, subpart K;
1926, subpart D; 1928, subpart B).
2. Type of Review: Emergency.
3. OMB Control Number: 1218–0278.
4. Affected Public: This rule applies to
employers with a total of 100 or more
employees except where the workplace
is covered under the Safer Federal
Workforce Task Force COVID–19
Workplace Safety: Guidance for Federal
Contractors and Subcontractors; or in
setting where the employee provides
healthcare services or healthcare
support services that falls under the
requirements of 29 CFR 1910.502. This
rule does not apply to employees of
covered employers who work from
home, exclusively outdoors, or who do
not report to a workplace where other
individuals such as coworkers or
customers are present.
5. Description of the ICR. This ICR
contains collections of information
requirements for employers with 100 or
more employees. The employer must
establish, implement, and enforce a
written mandatory vaccination policy
that requires each employee to be fully
vaccinated against COVID–19 unless the
employer implements a policy that
allows employees to choose between
being fully vaccinated or both tested
and wearing a face covering. Employers
must determine employee vaccination
status, and must require than any
employees who are not vaccinated be
tested for COVID–19 at least once every
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7 days. Employers must provide
specified information to employees
regarding COVID–19 vaccine efficacy,
safety, and the benefits of being
vaccinated, and must maintain a record
of the COVID–19 vaccination status,
proof of vaccination, and copies of
employee COVID–19 test results, and
the aggregate number of fully vaccinated
employees at a workplace along with
the total number of employees at that
workplace.
6. Number of respondents: 1,858,935.
7. Frequency: Varies.
8. Number of Responses: 205,262,803.
9. Estimated Burden Hours:
79,720,444.
10. Estimated Cost (Capital-operation
and maintenance): $1,383,751,520.
These totals are explained and
supported in the agency’s Supporting
Statement as required by the PRA.
III. Request for Comment
Although the ETS takes effect
immediately, with implementation
dates specified in the Dates provision of
this publication, it also serves as a
temporary standard that can only be
made permanent following an
opportunity for public notice and
comment. OSHA therefore invites the
public to submit comments to OSHA on
the proposed collections of information
with regard to the following.
• Whether the proposed collections of
information are necessary for the proper
performance of the Agency’s functions,
including whether the information is
useful.
• The accuracy of OSHA’s estimate of
the burden (time and cost) of the
collections of information, including the
validity of the methodology and
assumptions used.
• The quality, utility, and clarity of
the information collected.
• Ways to minimize the compliance
burden on employers, for example, by
using automated or other technological
techniques for collecting and
transmitting information.
Please submit comments related to the
Paperwork Act analysis to OSHA in the
PRA docket (Docket Number OSHA–
2021–0008). Comments related to other
parts of the ETS should be submitted to
the rulemaking docket (Docket Number
OSHA–2021–0007). OSHA will accept
comments for 60 days on the
information collection aspects of the
rule. For instructions on submitting
these comments to the rulemaking and/
or PRA docket, see the sections of this
Federal Register notice titled DATES and
ADDRESSES.
References
Occupational Safety and Health
Administration (OSHA). (2021c,
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October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
VI. Summary and Explanation
A. Purpose
The ETS includes a sentence that
states the purpose of the rule. The first
part of the sentence in the paragraph
indicates that the standard addresses the
grave danger of COVID–19 in the
workplace by establishing workplace
vaccination, vaccination verification,
face covering and testing requirements.
The second part of the sentence
addresses the preemption of State and
local laws, regulations, executive orders,
and other requirements, by this Federal
standard. It indicates OSHA’s intention
that the ETS address comprehensively
the occupational safety and health
issues of vaccination, wearing face
coverings, and testing for COVID–19,
and thus that the standard is intended
to preempt States, and political
subdivisions of States, from adopting
and enforcing workplace requirements
relating to these issues, except under the
authority of a Federally-approved State
Plan. In particular, OSHA intends to
preempt any State or local requirements
that ban or limit an employer’s authority
to require vaccination, face covering, or
testing.
Preemption of such State and local
requirements derives from section 18 of
OSH Act and general principles of
conflict preemption. See Gade v.
National Solid Wastes Management
Ass’n, 505 U.S. 88 (1992).80 Gade
clarified two important principles. First,
section 18 expresses Congress’ intent to
preempt State workplace safety or
health laws relating to issues on which
Federal OSHA has promulgated
occupational safety and health
standards. Under section 18, a State can
avoid preemption of such laws only if
it submits and receives Federal approval
for a State Plan for the development and
enforcement of standards. OSHAapproved State Plans operate under
authority of State law and must adopt
occupational safety and health
standards which, among other things,
must be at least as effective in providing
safe and healthful employment and
places of employment as Federal
standards. 29 U.S.C. 667.
80 The Court held that the dual impact licensing
statutes were preempted; however, no rationale
commanded a majority. A four-justice plurality
found that supplementary State regulation is
impliedly preempted. Id. at 98–99. Justice
Kennedy’s concurrence would have found express
preemption rather than implied preemption, Id. at
110–111, but otherwise agreed that ‘‘in the OSH
statute Congress intended to pre-empt
supplementary state regulation.’’ Id. at 113.
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Second, State and local laws that do
not constitute occupational safety or
health laws because they are ‘‘laws of
general applicability’’ that regulate
workers and nonworkers alike are
preempted only if they conflict with the
federal standard. Laws of general
applicability that are consistent with the
federal standard are not preempted.
Gade, 505 U.S. at 107.
While section 18 applies to every
occupational safety and health standard
that OSHA promulgates, this ETS raises
particular concerns because of the
current landscape of existing State and
local requirements that may overlap
with, or directly conflict with, the
requirements of this ETS. As discussed
in Need for the ETS (Section III.B. of
this preamble), OSHA is adopting this
ETS in response to an unprecedented
health crisis that has resulted in a global
pandemic severely impacting the health
and wellbeing of people in the United
States, and globally. This ETS is issued
based on OSHA’s determination that
employees in the United States face a
grave danger from workplace exposures
to SARS–CoV–2, that the ETS is
necessary to protect those workers, and
that the measures for vaccination,
vaccine verification, face coverings, and
testing that this ETS requires will help
ensure that workers covered by the ETS
are protected from severe illness and
death resulting from contracting
COVID–19 in the workplace.
As explained in Need for the ETS
(Section III.B. of this preamble), the lack
of a national standard on this hazard has
led to disparate State and local
requirements, and this underscores the
need for OSHA’s ETS to provide clear
and consistent protection to employees
across the country. Over the past
months, an increasing number of States
have passed laws or enacted other
requirements banning workplace
vaccination policies that would
mandate vaccination or require proof of
vaccination status, thus prohibiting
employers operating in those
jurisdictions from implementing this
proven method of protecting workers
from the hazard of COVID–19 that is at
the core of this ETS (see, e.g., Texas
Executive Order GA–40, October 11,
2021; Montana H.B. 702, July 1, 2021;
Arkansas S.B. 739, October 4, 2021 and
Arkansas H.B. 1977, October 1, 2021;
AZ Executive Order 2021–18, Aug. 16,
2021). While some States’ bans have
focused on preventing local
governments from requiring their public
employees to be vaccinated or show
proof of vaccination, the Texas,
Montana, and Arkansas requirements
apply to private employers as well.
Likewise, some States and localities
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have enacted requirements that prohibit
businesses, government offices, schools
or other public spaces from requiring
that face coverings be worn (see, e.g.,
Florida Executive Order 21–102, May 3,
2021; Texas Executive Order GA–34,
March 2, 2021; Texas Executive Order
GA–36, May 18, 2021). State and local
requirements that prohibit employers
from implementing employee
vaccination mandates, or from requiring
face coverings in workplaces, serve as a
barrier to OSHA’s implementation of
this ETS, and to the protection of
America’s workforce from this deadly
virus.
As discussed below, state restrictions
of this kind are clearly preempted
whether they take the form of direct
workplace regulation or are part of a law
of general applicability because they
relate to the issues addressed by this
standard and conflict with it. Gade, 505
U.S. at 99, 107. As is also discussed
below, this is true even for State or local
requirements that may not prevent
employers from compliance with the
ETS, but that prescribe or limit the
employer’s ability to mandate
vaccination for its workforce as the
employer’s chosen means of
compliance. See Gade, 505 at 107; see
also Geier v. American Honda, 529 U.S.
861, 869, 875–886 (2000) (finding
Department of Transportation (DOT)
regulations preempted a State tort action
where the state action ‘‘upset the careful
regulatory scheme established by federal
law’’ and placing weight on DOT’s
interpretation that such tort suit would
be ‘‘an obstacle to the accomplishment
and execution’’ of Agency objectives).
An employer’s choice to mandate
vaccination is a critical aspect of this
ETS, and state laws that remove that
choice conflict with it.
Thus, to ensure that the ETS
supplants the existing State and local
vaccination bans and other
requirements that could undercut its
effectiveness, and to foreclose the
possibility of future bans, OSHA has
clearly defined the issues addressed by
this section to encompass vaccination,
face covering, and testing needed to
protect against transmission of COVID–
19 to employees in the workplace. To
avoid ambiguity, OSHA has stated
expressly that it intends this ETS to
preempt all State and local workplace
requirements that ‘‘relate’’ to these
issues, except pursuant to a State Plan.
29 U.S.C. 667(b).
The ‘‘unavoidable implication’’ of
section 18 is that because OSHA has
adopted this ETS, States may no longer
regulate these issues except with
OSHA’s approval and the authority of a
Federally-approved State Plan. Gade,
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505 U.S. at 99. As the Court explained,
section 18 preempts States without
approved plans from adopting or
enforcing any laws that constitute, ‘‘in
a direct, clear and substantial way
regulation of worker health and safety’’
relating to an issue addressed by an
OSHA standard. Id. at 107.
State and local requirements that ban
or otherwise limit workplace
vaccination, face covering, or testing
clearly ‘‘relate’’ to the occupational
safety and health ‘‘issues’’ that OSHA is
regulating in this ETS. 29 U.S.C. 667(b).
Such bans regulate key workplace
COVID–19 protections that are
encompassed by this ETS ‘‘in a direct,
clear and substantial way.’’ Gade, 505
U.S. at 107. The direct effect of such
bans is to prohibit employers from
requiring employees to implement
measures, such as vaccination
requirements, face coverings, or testing.
These workplace protective measures
are covered by, and, in many
circumstances required by, this ETS. For
example, vaccination mandate bans
directed at employers specifically bar
them from requiring employee
vaccination requirements for the
purposes of protecting their workforce.
Prohibitions on face covering mandates
likewise directly prohibit individuals in
positions of authority, including
employers, from requiring face covering
use.
Although the expressly stated
purposes for State and local
requirements banning or limiting
employers from requiring vaccinations,
face coverings, or testing may not be
occupational safety and health,81 this
does not control their preemption under
section 18 of the OSH Act. In assessing
State and local requirements’ impact on
a federal statutory scheme, courts ‘‘have
refused to rely solely on the legislature’s
professed purpose and have looked as
well to the effects of the law.’’ Gade, 505
U.S. at 105; see also, e.g., Perez v.
Campbell, 402 U. S. 637, 651–652 (1971)
(‘‘[A]ny state legislation which frustrates
the full effectiveness of federal law is
rendered invalid by the Supremacy
Clause’’); Napier v. Atlantic Coast Line
R. Co., 272 U.S. 605, 612 (1926) (preemption analysis does not depend on
whether federal and State laws ‘‘are
81 The express purposes of such requirements
banning or limiting employers from requiring
vaccination, face coverings, or testing may often not
relate to occupational safety and health. For
example, Governor Greg Abbott’s Texas face
covering mandate ban in Executive Order GA–16,
is based on alleged decreasing COVID–19 rates and
the need to alleviate ‘‘confusion,’’ (Texas Executive
Order GA–36, May 18, 2021); the stated purpose of
Montana’s vaccination mandate ban is to address
health care privacy interests (Montana H.B. 702,
July 1, 2021).
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aimed at distinct and different evils’’
but whether they ‘‘operate upon the
same object’’).
That a State has articulated a purpose
other than, or in addition to, workplace
health and safety would not divest the
OSH Act of its preemptive force,
because preemption law looks to the
effects as well as the purpose of a State
law, and thus a dual-impact State law
cannot avoid OSH Act preemption
simply because the regulation serves
several objectives. Gade, 505 U.S. at 107
(holding ‘‘a law directed at workplace
safety is not saved from pre-emption
simply because the State can
demonstrate some additional effect
outside of the workplace’’ and ‘‘[t]hat
such law may also have a
nonoccupational impact does not render
it any less of an occupational standard
for purposes of pre-emption analysis’’).
Thus, to the extent that the stated
purpose of a requirement that bans or
limits employers from requiring
vaccinations, face coverings, or testing
is something other than, or in addition
to, occupational health, such laws,
which have a specific and direct impact
on worker health, are nevertheless
preempted.
Further, section 18 preempts even
‘‘nonconflicting’’ State and local
occupational safety and health
requirements relating to the issues
addressed by this standard. Gade, 505
U.S. at 98–99, 103; see id. at 100 (‘‘state
laws regulating the same issue as federal
laws are not saved, even if they merely
supplement the federal standard’’). This
is because OSHA ‘‘’pre-empts the field’
for any nonapproved State law
regulating the same safety and health
issue.’’ See Gade, 505 U.S. at 104, n. 2,
citing English v. General Electric. Co.,
496 U.S. 72, 79–80, n.5 (‘‘[F]ield
preemption may be understood as a
species of conflict pre-emption: A State
law that falls within a pre-empted field
conflicts with Congress’ intent (either
express or plainly implied) to exclude
state regulation’’); see also id. at 105
(discussing effect of field preemption).
See generally Geier, 529 U.S. at 869,
875–886 (finding State law preemption
where it ‘‘upset the careful regulatory
scheme established by federal law’’);
Williamson v. Mazda Motor of Am., Inc.,
562 U.S. 323, 330–36 (2011) (affirming
the conflict pre-emption principle that
‘‘a state law that stands as an obstacle
to the accomplishment and execution of
the full purposes and objectives of a
federal law is pre-empted’’ and finding
preemption where State law interfered
with ‘‘significant objective’’ of the
federal regulation).
For example, the ETS would preempt
State or local governments from
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dictating that employers adopt a scheme
of testing and face coverings that
complies with 1910.501(g) and (i) of the
ETS, but that bars employers from
electing the preferred vaccine mandate
alternative in paragraph (d), because
this interferes with OSHA’s significant
regulatory objectives and its preemption
of the field.82 (See Need for the ETS
(Section III.B. of this preamble)
discussing that vaccination is the
preferred compliance option under this
rule because it is the most effective
method of protecting workers from
COVID–19). Likewise, the ETS would
preempt such State or local
occupational requirements, even to the
extent that they may regulate employers
with fewer than 100 employees,
notwithstanding that the requirements
in this ETS only apply to employers
with more than 100 employees.
Case law is instructive on this point.
In Gade, the Supreme Court found
regulations implementing a State statute
that required training for workers
handling hazardous waste that went
beyond, but did not conflict with,
OSHA’s hazardous waste training
requirements to be preempted by the
OSHA requirements. Id. Likewise, in
Industrial Truck Association
Incorporated v. Henry, the Ninth Circuit
found that OSHA’s hazard
communication standard preempted
California’s Hazard Communication
regulations that were not submitted to
OSHA for approval through its State
Plan, even to the extent that California’s
Hazard Communication rule regulated
manufacturers and distributers who
were excluded from coverage under
federal OSHA’s rule. Indust. Truck
Ass’n v. Henry, 125 F.3d 1305, 1311–14
(9th Cir. 1997). In the same way, the
ETS preempts all State and local
requirements that bar or limit the ability
of an employer to require workplace
vaccination, testing, and face coverings
to protected employees against COVID–
19 in any respect, since OSHA has
occupied the entire field of regulation
on these issues.
OSHA’s definition of the ‘‘issue’’ in
this rule should be afforded weight,
since the OSH Act vests OSHA with
standard-setting responsibility and,
82 OSHA is aware that some States have adopted
or are considering adopting such requirements,
which this ETS would preempt (see, e.g., Arkansas
S.B. 739, October 4, 2021 and Arkansas H.B. 1977,
October 1, 2021, which Arkansas Governor Asa
Hutchinson allowed to became law without his
signature, and which require employers in Arkansas
to allow employees to opt out of vaccination for
purposes of complying with federal vaccination
requirements; see also Governor Hutchinson,
October 13, 2021; Marr, October 7, 2021 (describing
the Arkansas legislation and noting that other states
may contemplate similar legislation)).
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therefore, the authority to determine
which ‘‘issues’’ to address with
occupational safety and health
standards. See Indust. Truck, 125 F.3d
at 1311 (relying on OSHA’s regulation
and statements in the preamble to
identify the relevant ‘‘issue’’ for
preemption purposes in OSHA’s Hazard
Communication standard).
Importantly, although OSHA’s stated
intention is to preempt conflicting State
and local requirements relating to the
issues addressed by this standard,
OSHA recognizes that the OSH Act does
not allow, and OSHA does not intend,
for the ETS to preempt non-conflicting
State or local requirements of general
applicability. In Gade, the Supreme
Court qualified its ruling by saving from
preemption non-conflicting State and
local ‘‘laws of general applicability
(such as laws regarding traffic safety or
fire safety) that do not conflict with
OSHA standards and that regulate the
conduct of workers and nonworkers
alike.’’ Gade, 505 U.S. at 107. The
Majority reasoned that, ‘‘[a]lthough
some laws of general applicability may
have a ‘direct and substantial’ effect on
worker safety, they cannot fairly be
characterized as ‘occupational’
standards, because they regulate
workers simply as members of the
general public.’’ Id.
During the pandemic, many States
and municipal governments have
adopted requirements intended to
protect public health by helping to
prevent the spread of COVID–19 in
public spaces. These have included
requirements mandating face coverings
in indoor public spaces, including
businesses, government buildings, and
schools (see, e.g., Baltimore City Health
Department, August 10, 2021; Illinois
Executive Order 2021–20, August 26,
2021; Hawai’i Emergency Proclamation,
October 1, 2021). In addition, in recent
months, some States and municipal
governments have adopted requirements
mandating that members of the public
provide proof of vaccination or recent
COVID–19 testing in order to enter
restaurants, bars, or other businesses or
public spaces (see, e.g., NYC Emergency
Executive Order 225, August 16, 2021
(mandating COVID–19 vaccination for
most individuals for indoor
entertainment, recreation, dining and
fitness settings)). Requirements such as
these apply to ‘‘workers and nonworkers
alike’’ and ‘‘regulate workers simply as
member of the general public’’ and are
accordingly not preempted. Gade, 505
U.S.at 107.
Based on OSHA’s observations and
experience during the past year and a
half that the pandemic has been
ongoing, OSHA is confident that
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protective State and local regulations of
general applicability that mandate face
coverings or vaccination will
complement, rather than interfere with
OSHA’s enforcement of the ETS, and
also does not intend to preempt such
requirements. Indeed, OSHA believes
that such measures have significantly
reduced the harmful effects of the
pandemic and total fatalities. See Steel
Institute of NY v. The City of NY, 716
F.3d 31, 38 (affording some weight to
OSHA’s view that municipal regulations
governing construction cranes did not
interfere with OSHA’s regulatory
scheme in its crane standards and
ultimately adopted OSHA’s view in
finding these municipal regulations
were not preempted by OSHA crane
standards).83
In Steel Institute, the Second Circuit
held that OSHA’s crane regulations did
not preempt New York City municipal
regulations governing construction
cranes, finding that such regulations
were requirements of general
applicability, notwithstanding their
direct bearing on worker safety, because
their primary purpose and effect was to
preserve the safety of the general public,
and they regulated workers and
nonworkers alike. Id. The Steel Institute
court noted the ‘‘strong presumption
against preemption when states and
localities ‘‘exercise[ ] their police
powers to protect the health and safety
of their citizens.’’ Id. at 36, citing
Medtronic, Inc. v. Lohr, 518 U.S. 470,
475 (1996). The Second Circuit was also
influenced by the clear danger
presented to the public by unsafe crane
operation. This is analogous to the
situation here, because exposure to
COVID–19 is a hazard that directly
impacts everyone. Thus, generally
applicable State and local mandates
requiring face coverings or vaccination
should not be preempted and should
83 OSHA’s Cranes and Derricks in Construction
rule directly discussed its expectations and intent
regarding the preemptive effect of the rule,
including that it was not intended to preempt
generally applicable municipal regulations, such as
building codes, which serve public safety purposes.
Cranes and Derricks in Construction, 75 FR 47,906,
48,128 (August 9, 2010). This rule also includes a
provision that requires employers to comply with
State crane operator licensing requirements that
meet the federal floor for crane operator
certification in the rule. 29 CFR 1926.1427(c)(1).
OSHA has also indicated that its rule would not
preempt State or local requirements in other
rulemakings. See e.g., 72 FR 7136, 7188 (Feb. 14,
2007) (Preamble to OSHA’s most recent electrical
safety standard) (‘‘State and local fire and building
codes, which are designed to protect a larger group
of persons than employees,’’ are not preempted); 29
CFR 1910.134(e) (requiring compliance with State
and local laws by requiring ‘‘a licensed health care
professional’’ to perform a medical evaluation of an
employee’s ability to use a respirator).
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remain in effect, notwithstanding this
ETS.84
On the other hand, as noted above,
this standard will preempt requirements
that conflict with it, regardless of
whether the requirements are part of a
law of general applicability.85
The effect of the ETS on State law
requirements in State Plan States works
somewhat differently. As previously
noted, under section 18 of the OSH Act
States that wish to assume
responsibility for the development and
enforcement of ‘‘occupational safety and
health standards relating to any
occupational safety or health issue with
respect to which a Federal standard has
been promulgated’’ may submit a State
Plan to OSHA for approval. Id. section
667(b); see also id. section 667(c)
(describing requirements for OSHA
approval of State Plans on issues for
which OSHA has adopted standards).
There are 22 States and territories that
have OSHA-approved State Plans for
private employers, and 6 additional
States and territories that have OSHAapproved State Plans for public
employers only.
Under section 18(c)(2) of the OSH
Act, State Plans are required to adopt
and enforce occupational safety and
health standards that are at least as
effective as federal OSHA’s
requirements. Id. section 667(c)(2). In
addition, the OSH Act requires that
State Plans must cover State and local
government employees (including, e.g.,
State and local school systems within
the scope of this rule), even though
federal OSHA does not have coverage
over such employees in States without
OSHA-approved State Plans.
Once OSHA promulgates an ETS,
OSHA’s regulations provide that those
States have ‘‘30 days after the date of
promulgation of the Federal standard to
84 In addition, some State and local governments
have adopted vaccination mandates directed at
State and/or local government employees. The OSH
Act and OSHA’s standards would not preempt such
requirements since State or local government
employers and employees are exempt from OSHA
coverage under the OSH Act. 29 U.S.C. 652 (5)
(defining employer to exclude ‘‘any State or
political subdivision of a State’’). However, many
State and local government employers in States
with OSHA-approved State Plans will be covered
by State occupational safety and health
requirements, and State Plans must adopt
requirements for State and local government
employers, as well as covered private sector
employers, that are at least as effective as federal
OSHA’s requirements; State Plans may also choose
to adopt more protective occupational safety and
health requirements. 29 U.S.C. 667(c).
85 As previously discussed, bans on mandating
vaccinations or face coverings have not typically
been generally applicable, but even the least
workplace-specific, most generally applied bans
will not survive preemption because they directly
interfere with the ETS’s regulatory scheme.
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adopt a State emergency temporary
standard,’’ or to demonstrate ‘‘that
promulgation of an emergency
temporary standard is not necessary
because the State standard is already the
same or at least as effective as the
Federal standard change.’’ 29 CFR
1953.5(b)(1). The new ETS becomes part
of the OSHA-approved State Plan
through the State Plan’s submission to
OSHA documentation showing it
adopted an identical ETS or a ‘‘Plan
Change Supplement’’ showing that it
has adopted requirements that are ‘‘at
least as effective’’ as federal OSHA’s
ETS. 29 CFR 1953.5(b)(3); 1953.4.
Even in States with OSHA-approved
State Plans, any State law relating to an
occupational safety and health issue
that OSHA regulates is preempted
unless it is submitted for OSHA’s
approval as a supplement to the State
Plan. Indust. Truck Ass’n, 125 F.3d at
1311 (‘‘If a State wishes to regulate an
issue of worker safety for which a
federal standard is in effect, its only
option is to obtain the prior approval of
the Secretary of Labor . . . [and] [i]t
would make the state plan approval
requirement superfluous if a state could
pick and choose which occupational
health and safety regulations to submit
to OSHA’’). Thus, a State or local
requirement banning or limiting
employer vaccine mandates would
similarly be preempted because it has
not been approved by federal OSHA as
part of the State Plan. And, indeed, it
could not be approved by federal OSHA,
because such bans or limitations
undercut the ETS’s requirements and
are clearly not as effective as the federal
ETS. See 29 U.S.C. 667(c)(2).86
Finally, this provision includes a note
that this section establishes minimum
requirements for employers, that
nothing in this section prevents
employers from agreeing with their
employees to implement additional
measures, and that this section does not
supplant collective bargaining
agreements or other collectively
negotiated agreements in effect that may
have negotiated terms that exceed the
requirements herein. It also references
the National Labor Relations Act of
1935, which protects most private-sector
employees’ right to take collective
action. The purpose of this note is to
remind employers and employees that
OSHA’s ETS establishes a floor for
protections, and that it does not
preclude bargaining for additional
protective measures. For example,
86 For example, Arizona has an OSHA-approved
State Plan, but its vaccination ban, which is not part
of its State Plan, is preempted by this ETS (see AZ
Executive Order 2021–18, Aug. 16, 2021).
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employers might agree to cover the costs
of face coverings or medical removal, or
to a requirement that all employees,
regardless of vaccination status, wear
face coverings while working indoors.
References
An Act Prohibiting Discrimination Based on
a Person’s Vaccination Status or
Possession of an Immunity Passport;
Montana H.B. 702. (2021, July 1). https://
leg.mt.gov/bills/2021/billpdf/
HB0702.pdf. (Montana H.B. 702, July 1,
2021)
Arizona Executive Order 2021–18. (2021,
August 16). https://azgovernor.gov/sites/
default/files/eo_2021–18.pdf. (AZ
Executive Order 2021–18, August 16,
2021)
Arkansas H.B. 1977. (2021, October 1). To
Provide Employee Exemptions From
Federal Mandates and Employer
Mandates Related to Coronavirus 2019
(COVID–19); and to Declare an
Emergency. https://
www.arkleg.state.ar.us/Bills/
FTPDocument?path=%
2FAMEND%2F2021R%2FPublic%
2FHB1977–H1.pdf. (Arkansas H.B. 1977,
October 1, 2021)
Arkansas S.B. 739. (2021, October 4). An Act
Concerning Employment Issues Related
to Coronavirus 2019 (COVID–19); To
Provide Employee Exemptions From
Federal Mandates and Employer
Mandates Related to Coronavirus 2019
(COVID–19); To Declare and Emergency;
and For Other Purposes. https://
www.arkleg.state.ar.us/Bills/
FTPDocument?path=%
2FBills%2F2021R%
2FPublic%2FSB739.pdf. (Arkansas S.B.
739, October 4, 2021)
Arkansas Governor Asa Hutchinson. (2021,
October 13). Press Release: Governor
Hutchinson Allows Vaccine Mandate,
Redistricting Bills to Become Law
Without His Signature. https://governor.
arkansas.gov/news-media/pressreleases/governor-hutchinson-allowsvaccine-mandate-redistricting-bills-tobecome-la. (Governor Hutchinson,
October 13, 2021)
Baltimore City Health Department. (2021,
August 10). Health Commissioner
Updated Directive and Order for Face
Coverings. https://www.baltimore
city.gov/sites/default/files/HEALTH%20
COMMISSIONER%
20AUGUST%2010,%202021%
20DIRECTIVE%20AND%
20ORDER%20FOR%
20FACE%20COVERINGS_FINAL.pdf.
(Baltimore City Health Department,
August 10, 2021)
Emergency Executive Order 225. (2021,
August 16). Key to NYC: Requiring
COVID–19 Vaccination for Indoor
Entertainment, Recreation, Dining and
Fitness Settings. https://www1.nyc.gov/
office-of-the-mayor/news/225–001/
emergency-executive-order-225. (NYC
Emergency Executive Order 225, August
16, 2021)
Florida Executive Order 21–102. (2021, May
3). https://www.flgov.com/wp-content/
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uploads/orders/2021/EO_21–102.pdf.
(Florida Executive Order 21–102, May 3,
2021)
Hawai’i Emergency Proclamation Related to
the State’s COVID–19 Delta Response.
(2021, October 1). https://governor.
hawaii.gov/wp-content/uploads/2021/
10/2109152–ATG_EmergencyProclamation-Related-to-the-StatesCOVID–19-Delta-Response-distributionsigned.pdf. (Hawai’i Emergency
Proclamation, October 1, 2021)
Illinois Executive Order 2021–20. (2021,
August 26). https://www.illinois.gov/
government/executive-orders/executiveorder.executive-order-number20.2021.html. (Illinois Executive Order
2021–20, August 26, 2021)
Marr C. (2021, October 7). Workplace
Vaccine Exemption Bills Sent to
Arkansas Governor. Bloomberg Law.
https://news.bloomberglaw.com/dailylabor-report/workplace-vaccineexemption-bills-sent-to-arkansasgovernor. (Marr, October 7, 2021)
Texas Executive Order GA–34. (2021, March
2). Executive Order No. GA–34 relating
to the opening of Texas in response to
the COVID–19 disaster. https://
open.texas.gov/uploads/files/
organization/opentexas/E.O.-GA–34opening-Texas-response-to-COVIDdisaster-IMAGE–03–02–2021.pdf. (Texas
Executive Order GA–34, March 2, 2021)
Texas Executive Order GA–36. (2021, May
18). Executive Order No. GA–36 relating
to the prohibition of governmental
entities and officials from mandating
face coverings or restricting activities in
response to the COVID–19 disaster.
https://gov.texas.gov/uploads/files/
press/E.O.-GA–36_prohibition_on_
mandating_face_coverings_response_to_
COVID–19_disaster_IMAGE_05–18–
2021.pdf. (Texas Executive Order GA–
36, May 18, 2021)
Texas Executive Order GA–40. (2021,
October 11). Executive Order No. GA–40
relating to prohibiting vaccine mandates,
subject to legislative action. https://
gov.texas.gov/uploads/files/press/E.O.GA–40_prohibiting_vaccine_mandates_
legislative_action_IMAGE_10–11–
2021.pdf. (Texas Executive Order GA–
40, October 11, 2021)
B. Scope and Application
Paragraph (b)(1) of this ETS provides
that the ETS applies to all employers
that have a total of at least 100
employees at any time the ETS is in
effect. OSHA has determined that the
unvaccinated employees of these
employers face a grave danger of
exposure to SARS–CoV–2, including the
Delta variant, while they are at work
(see Grave Danger, Section III.A. of this
preamble). Because this grave danger
finding applies to all unvaccinated
employees who come into contact with
other people in indoor work settings as
part of their employment, this ETS is
not limited by industrial sector or
NAICS code. Therefore, this standard
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generally covers employers in all
workplaces that are under OSHA’s
authority and jurisdiction, including
industries as diverse as manufacturing,
retail, delivery services, warehouses,
meatpacking, agriculture, construction,
logging, maritime, and healthcare.
I. Decision To Limit Coverage of This
ETS to Employers With 100 or More
Employees
This ETS applies to employers with a
total of 100 or more employees at any
time the standard is in effect. In light of
the unique occupational safety and
health dangers presented by COVID–19,
and against the backdrop of the
uncertain economic environment of a
pandemic, OSHA established this
coverage threshold for four reasons.
First, OSHA is confident that employers
with 100 or more employees will be able
to meet the standard’s requirements
promptly, as the emergency addressed
by the standard necessitates. OSHA is
less confident that smaller employers
can do so without undue disruption.
Second, this coverage threshold will
enable the standard to reach two-thirds
of all private-sector workers in the
nation, providing them with prompt
protection. Third, the standard will
reach the largest facilities, where the
most deadly outbreaks of COVID–19 can
occur. Fourth, the 100-employee
threshold in this standard is comparable
with the size thresholds established by
congressional and agency decisions in
analogous contexts.
a. Challenges to Feasibility Analysis for
Small Businesses
An OSHA standard, including an
ETS, must be both economically and
technologically feasible. A standard is
economically feasible under the OSH
Act if it neither threatens ‘‘massive
dislocation to’’ nor upsets the
‘‘competitive stability of’’ the regulated
industries. United Steelworkers of Am.,
AFL–CIO–CLC v. Marshall, 647 F.2d
1189, 1265 (D.C. Cir. 1980).
Technological feasibility has been
interpreted broadly to mean ‘‘capable of
being done’’ Am. Textile Mfrs. Inst. v.
Donovan, 452 U.S. 490, 509–510 (1981).
As shown in Economic Analysis,
Section IV.B. of this preamble, OSHA is
confident that this standard is feasible
for employers with 100 or more
employees. OSHA is not at this time
making any determination about
whether it would be appropriate to
extend the ETS to cover smaller
employers. Put simply, the agency is
requiring that employers it is confident
can implement the provisions of the
standard without delay do so. At the
same time, the agency is soliciting
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61511
public comment and seeking additional
information to assess the ability of
smaller employers to do so in the
rulemaking commenced by this ETS.
OSHA will determine the issue on the
basis of the record, after receiving
public comment.87 The SARS–CoV–2
virus continues to spread rapidly, and
each day that passes, tens of thousands
more people are infected. The
employees of larger firms should not
have to wait for the protections of this
standard while OSHA takes the
additional time necessary to assess the
feasibility of the standard for smaller
employers.
The pandemic has presented special
challenges for small businesses.
According to a survey conducted during
its early stages, 66% of businesses with
fewer than 100 employees had suffered
revenues losses exceeding 30%. (SHRM,
May 6, 2020a). By contrast, only 27% of
larger businesses with more than 100
employees had seen revenue drops of
more than 30% (SHRM, May 6, 2020b).
More recently, 61% of the members of
the National Federation of Independent
Businesses, mostly very small
businesses, responded to a survey
reported that they were experiencing
staff shortages, with half of that group
reporting a moderate to significant loss
of sales because of unfilled positions
(NFIB, July 12, 2021).
The requirements of the ETS could
have a differential impact on small
businesses compared with larger firms.
Many small businesses lack separate
human resources departments and
struggle to carry out HR functions. A
study found that some 70% of small
businesses (with 5 to 49 employees)
handle HR tasks in an ad hoc way.
(ADP, December 2016). Only 23% of ad
hoc managers believed they had the
tools and resources necessary to perform
HR tasks well, and only 19% were fully
confident in their ability to handle HR
tasks without making mistakes (ADP,
December 2016). Another survey found
that HR functions are proportionally far
more expensive for smaller firms than
for larger (small firms defined as up to
250 workers) (SHRM, 2015). The ETS
requires employers to establish new
systems to track vaccination status
among workers, to keep related records,
and for firms that allow the testing
option, to keep records of each test.
87 If OSHA receives information suggesting that a
broader scope would be appropriate, the agency
could expand the scope of the ETS quickly through
a supplemental action. Fla. Peach Growers Ass’n,
Inc. v. U. S. Dep’t of Labor, 489 F.2d 120, 127 (5th
Cir. 1974) (‘‘It is inconceivable that Congress,
having granted the Secretary the authority to react
quickly in fast-breaking emergency situations,
intended to limit his ability to react to
developments subsequent to his initial response.’’)
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These records must be treated as
confidential medical records subject to
detailed regulations, which is not
something most smaller employers
typically need to do or have existing
systems in place to address. 29 CFR
1910.1020. While OSHA has imposed
similar requirements on smaller
employers before, it has typically done
so in highly regulated industries, such
as healthcare, or in industries involving
complicated industrial processes, which
already require a certain degree of
administrative capacity even when not
responding to a grave danger, through a
rulemaking process that provides
additional time for notice and
implementation, and when there is
more time to assess the impact that the
standard would have on small business.
This emergency standard by contrast
applies across the board to all
industries, including less regulated
retail and service sectors.
Moreover, OSHA estimates that some
5% of employees may have a medical
contraindication or request an
accommodation from the rule’s
requirements for disability or sincerely
held religious belief reasons. (Please see
Economic Analysis, Section IV.B. of this
preamble). Assessing these requests may
require more resources for smaller firms
with less experience in this area,
particularly if they lack HR staff. By the
same token, a delay in applying the ETS
to businesses with fewer than 100
employees would allow those
businesses the benefit of learning from
the models established by larger
businesses with respect to
accommodations. Similarly,
implementing the ETS’s testing
provisions in a stepwise fashion will
allow OSHA the time necessary to
assess any impact the new requirements
may have on the testing infrastructure
and related supply chains before
considering extending those
requirements to additional employers.
b. The ETS Provides Prompt Protection
for Most of America’s Workforce
The 100 employee threshold means
the ETS will reach two-thirds of the
nation’s private sector workforce,
providing protection to millions of
workers while issues regarding smaller
firms are reviewed. OSHA considered
that a 100 employee threshold was
superior to a 150 employee threshold in
this respect, because it would protect
more employees: 67% rather than 63%,
which is a difference of 4.856 million
workers. (U.S. Census Bureau, May
2021). And while a 50 employee
threshold would have covered more
employees (78%), it would have
required additional feasibility analysis,
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while still leaving many employees
outside the standard. (U.S. Census
Bureau, May 2021).
c. The ETS Will Help Prevent Large
Outbreaks of COVID–19
The ETS’s focus on employers with
more than 100 employees will also help
prevent large-scale outbreaks. As
addressed in more detail in the
discussion of Grave Danger (Section
III.A. of this preamble), all unvaccinated
employees who work in indoor settings
face a grave danger from COVID–19,
which is why the scope of the ETS is
not limited to worksites of a specific
size. The standard is based on employer
size primarily because administrative
capacity is more closely related to
employer size. In addition, employer
size provides a clear measure that is
easy for employers (and OSHA) to track,
as opposed to an alternative such as a
workplace-based approach, which could
fluctuate from day to day and mean
more places and information for the
employer to track. But OSHA also chose
the 100 employee size threshold in
recognition of the fact that larger
employers are more likely to have many
employees gathered in the same
location. For employers with 100 or
more employees, the median number of
employees at any one location is
approximately 50 (the average is also
50). (U.S. Census Bureau, May 2021).
For employers with fewer than 100
employees, the median number of any
one location is approximately 2 (with an
average number of 7) (U.S. Census
Bureau, May 2021).
Employees at larger locations are
statistically more likely to be exposed to
someone with COVID–19 during the
course of their shifts, and thus face a
heightened risk of virus transmission.
Studies indicate that introduction of
infection and the risk of infection
transmission is increased with the size
of a gathering (Champredon et al., April,
2021), and with larger populations
(Shacham et al., July 5, 2021). See also
(Contreras et al., July, 2021) (concluding
that outbreaks were larger and lasted
longer at facilities with more onsite
staff). It is therefore not surprising that
significant COVID–19 outbreaks have
occurred at large facilities of employers
with 100 or more employees 88 (Oregon
88 See, e.g., Oregon Health Authority, October 6,
2021, (publishing data on outbreaks in large
workplaces including two Amazon facilities,
several hospitals, and a Walmart distribution
center); CDPHE, Oct. 6, 2021, (identifying an active
Covid outbreak in Cargill’s Fort Morgan, CO meat
processing plant, which employs more than 2,000
workers). While some have speculated that clusters
of infections among employees at the same facility
might result initially from shared exposures outside
of work, the original source of the infection would
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Health Authority, October 6, 2021;
CDPHE, October 6, 2021). A study of
outbreaks in Los Angeles County found
that the median number of employees in
an establishment in which an outbreak
occurred was 95, well above the 50
employee median for locations of
employers covered by this rule,
indicating that the rule will protect
employees in the places where
outbreaks are most likely to occur.
(Contreras et al., July, 2021). And those
outbreaks occurred even before the
emergence of the SARS–CoV–2 Delta
variant, which the CDC says ‘‘causes
more infections and spreads faster than
early forms of SARS–CoV–2.’’ (CDC,
August 26, 2021) In fact, the studies
noted earlier in this paragraph were
published just as the Delta variant was
emerging, meaning that the risk of
transmission cited in those studies has
likely increased.
While virus transmission is certainly
not limited to large facilities, the
potential scope of an outbreak is
inherently more limited when fewer
employees are present. In limiting the
scope of the ETS to employers with 100
or more employees, OSHA is
prioritizing coverage of those businesses
in which the spread of the virus could
potentially affect the largest number of
employees and for which the agency is
most confident that it is feasible to
apply the standard.
d. Analogous Regulatory Regimes Use
Comparable Employee Size Thresholds
Congress and federal agencies have
frequently recognized that an employee
size threshold may be appropriate in
different regulatory contexts. They have
not settled on any one number as the
most appropriate, presumably because
that depends on balancing different
considerations that are relevant to the
particular context, as OSHA has done
here. But several analogous regulatory
regimes use employee size thresholds
comparable to the one selected here, in
light of similar concerns about
administrative feasibility.
For example, the EEOC has issued
regulations requiring employers with
100 or more employees to submit
annual reports related to equal
employment opportunity in their
workforce, in recognition that larger
employers are better equipped to absorb
the types of administrative burdens
have little bearing on the statistical probability of
exposure and transmission once the infected people
are together in the workplace with unvaccinated coworkers. The most effective way to prevent further
transmission is to protect the other workers through
vaccination or, when that is not possible, identify
and remove the infected workers from the
workplace as quickly as possible.
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imposed by surveying, tracking and
recordkeeping requirements. See 42
U.S.C. 2000e–8(c), 29 CFR 1602.7–.14
and 41 CFR 60–1.7(a). In earlier
measures adopted in response to the
COVID–19 pandemic, Congress adopted
special protections and exemptions
based on employee counts. The Families
First Coronavirus Response Act, Public
Law 116–127 (2020), sections 7001 and
7003 provided tax credits to businesses
with fewer than 500 employees to assist
compliance with the Act’s expansion of
paid sick and family leave, in
recognition of the challenges facing
smaller employers. Congress again
relied on the same 500 employee
threshold when it later extended tax
credits only to employers who granted
employees paid time off to be
vaccinated, implicitly acknowledging
the financial obstacles that can exist for
smaller employers for the same activity
that this ETS promotes (and without the
vaccine policy and verification
requirement in this ETS). American
Rescue Plan Act, Public Law 117–2, Sec.
9641 (2021).
In the Affordable Care Act, Congress
set the maximum size of a ‘‘small
employer’’ at 100 employees for
purposes of allowing greater flexibility
to these employers. 42 U.S.C.A.
18024(b)(3). Likewise, private
employers with fewer than 50
employees are exempt from complying
with the Family and Medical Leave Act,
in recognition of smaller employers’
decreased administrative capacity, as
well as their inability to easily
accommodate employee absences. 29
U.S.C.A. 2611(2)(b)(2).
e. The 100 Employee Coverage
Provision Is a Reasonable Exercise of the
Secretary’s Authority
OSHA’s choice of a 100 employee
threshold is based on balancing the
fundamentally incommensurable
considerations described above. Under
the statute OSHA ‘‘shall’’ issue an ETS
when employees are exposed to grave
danger, and is not to follow normal
notice and comment procedures to build
a record. 29 U.S.C. 655(e). But OSHA
may not issue an ETS unless it shows
that the rule is feasible for the
employers covered, and it has not yet
made a feasibility determination for
smaller employers. In the circumstances
of this case, OSHA considered that an
ETS was urgently needed to protect
employees, that a 100 employee
threshold would protect the great
majority of them and prevent the largest
outbreaks, that it would avoid the
delays that would be needed if the
agency were required to gather
information and analyze feasibility for
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smaller employers, and that a
comparable size threshold has been
found appropriate in similar contexts.
Where employees are dying every day,
it is not unreasonable for the agency to
prioritize doing what it can to address
the problem quickly, regardless of
whether there are further actions it
might be able to take later.
Doing so implements the statutory
delegation of authority to the agency to
establish priorities for issuing standards
by giving ‘‘due regard to the urgency of
the need’’ for standards for particular
workplaces. 29 U.S.C. 655(g). The courts
have recognized that this provision
authorizes the Secretary to make
reasonable decisions limiting the scope
of a standard, particularly where as here
the agency has said it will address the
reserved issue in subsequent
rulemaking. Forging Indus. Assoc. v.
Donovan, 773 F.2d 1436, 1454 (4th Cir.
1985) (hearing conservation standard);
United Steelworkers of Am. v. Marshall,
647 F.2d 1189, 1309–1310 (D.C. Cir.
1980) (lead standard).
Where competing considerations are
in play and there is no clear perfect
choice, OSHA has a degree of discretion
to draw a reasonable line. Courts have
consistently recognized that agencies
have discretion to draw reasonable
lines. As the D.C. Circuit has explained:
An agency has ‘‘wide discretion’’ in
making line-drawing decisions and
‘‘[t]he relevant question is whether the
agency’s numbers are within a zone of
reasonableness, not whether its numbers
are precisely right.’’ WorldCom, Inc. v.
FCC, 238 F.3d 449, 462 (D.C. Cir. 2001)
(quotation marks omitted). An agency
‘‘is not required to identify the optimal
threshold with pinpoint precision. It is
only required to identify the standard
and explain its relationship to the
underlying regulatory concerns.’’ Id. at
461–62. Nat’l Shooting Sports Found. v.
Jones, 716 F.3d. 200, 214–215 (D.C. Cir
2013). See also Providence Yakima Med.
Ctr. v. Sebelius, 611 F.3d 1181, 1190–
1191 (9th Cir. 2010).
For the reasons discussed above, the
balance the agency struck here falls well
within this zone of reasonableness.
II. Explanation of Who Is Included in
the 100-Employee Threshold
The applicability of this ETS is based
on the size of an employer, in terms of
number of employees, rather than on the
type or number of workplaces. In
determining the number of employees,
employers must include all employees
across all of their U.S. locations,
regardless of employees’ vaccination
status or where they perform their work.
Part-time employees do count towards
the company total, but independent
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contractors do not. As discussed above,
OSHA has not found that the standard
is feasible for firms with fewer than 100
employees, because it needs additional
time to assess the impact of the standard
on these employers, particularly as
many smaller firms lack separate human
resources departments and may face
additional challenges when carrying out
human resources functions. In contrast,
OSHA has determined that the standard
is feasible for firms with 100 or more
employees, regardless of where those
employees report to work. These firms
generally have greater administrative
capacities, and including all such
employers in the scope of this ETS
ensures that OSHA can cover two-thirds
of all workers in the private sector as
quickly as possible.
For a single corporate entity with
multiple locations, all employees at all
locations are counted for purposes of
the 100-employee threshold for coverage
under this ETS. In a traditional
franchisor-franchisee relationship in
which each franchise location is
independently owned and operated, the
franchisor and franchisees would be
separate entities for coverage purposes,
such that the franchisor would only
count ‘‘corporate’’ employees, and each
franchisee would only count employees
of that individual franchise. In other
situations, two or more related entities
may be regarded as a single employer
for OSH Act purposes if they handle
safety matters as one company, in which
case the employees of all entities
making up the integrated single
employer must be counted.
In scenarios in which employees of a
staffing agency are placed at a host
employer location, only the staffing
agency would count these jointly
employed workers for purposes of the
100-employee threshold for coverage
under this ETS. Although the staffing
agency and the host employer would
normally share responsibility for these
workers under the OSH Act, this ETS
raises unique concerns in that OSHA
has set the threshold for coverage based
primarily on administrative capacity for
purposes of protecting workers as
quickly as possible, as discussed above,
and the staffing agency would typically
handle administrative matters for these
workers. Thus, for purposes of the 100employee threshold, only the staffing
agency would count the jointly
employed employees. The host
employer, however, would still be
covered by this ETS if it has 100 or more
employees in addition to the employees
of the staffing agency. For enforcement
purposes, traditional joint employer
principles would apply where both
employers are covered by the ETS, as
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illustrated further by the examples
below. See also https://www.osha.gov/
temporaryworkers/.
On a typical multi-employer worksite
such as a construction site, each
company represented—the host
employer, the general contractor, and
each subcontractor—would only need to
count its own employees, and the host
employer and general contractor would
not need to count the total number of
workers at each site. That said, each
employer must count the total number
of workers it employs regardless of
where they report for work on a
particular day. Thus, for example, if a
general contractor has more than 100
employees spread out over multiple
construction sites, that employer is
covered under this ETS even if it does
not have 100 or more employees present
at any one worksite. Covering the
employees of larger employers at multiemployer worksites would mitigate the
spread of COVID–19 at the workplace
even where not all employees are
covered by this ETS because fully
vaccinated employees (or unvaccinated
employees wearing face coverings and
submitting to weekly testing) would be
less likely to spread the virus to
unvaccinated workers at the site who
are not covered by this ETS.
The determination as to whether a
particular employer is covered by the
standard should be made separately
from whether individual employees are
covered by the standard’s requirements,
as described by paragraph (b)(3) (e.g.,
some employers may be covered but
have no duties with respect to some of
their employees under this standard).
Some additional examples include:
• If an employer has 75 part-time
employees and 25 full-time employees,
the employer would be within the scope
of this ETS because it has 100
employees.
• If an employer has 150 employees,
100 of whom work from their homes
full-time and 50 of whom work in the
office at least part of the time, the
employer would be within the scope of
this ETS because it has more than 100
employees.
• If an employer has 102 employees
and only 3 ever report to an office
location, that employer would be
covered.
• If an employer has 150 employees,
and 100 of them perform maintenance
work in customers’ homes, primarily
working from their company vehicles
(i.e., mobile workplaces), and rarely or
never report to the main office, that
employer would also fall within the
scope.
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• If an employer has 200 employees,
all of whom are vaccinated, that
employer would be covered.
• If an employer has 125 employees,
and 115 of them work exclusively
outdoors, that employer would be
covered.
• If a single corporation has 50 small
locations (e.g., kiosks, concession
stands) with at least 100 total employees
in its combined locations, that employer
would be covered even if some of the
locations have no more than one or two
employees assigned to work there.
• If a host employer has 80
permanent employees and 30 temporary
employees supplied by a staffing
agency, the host employer would not
count the staffing agency employees for
coverage purposes and therefore would
not be covered. (So long as the staffing
agency has at least 100 employees,
however, the staffing agency would be
responsible for ensuring compliance
with the ETS for the jointly employed
workers.)
• If a host employer has 110
permanent employees and 10 temporary
employees from a small staffing agency
(with fewer than 100 employees of its
own), the host employer is covered
under this ETS and the staffing agency
is not.
• If a host employer has 110
permanent employees and 10 employees
from a large staffing agency (with more
than 100 employees of its own), both the
host employer and the staffing agency
are covered under this standard, and
traditional joint employer principles
apply.
• Generally, in a traditional
franchisor-franchisee relationship, if the
franchisor has more than 100 employees
but each individual franchisee has fewer
than 100 employees, the franchisor
would be covered by this ETS but the
individual franchises would not be
covered.
As explained earlier, part of OSHA’s
rationale in adopting the 100-employee
threshold is to focus the ETS on
companies that OSHA is confident will
have sufficient administrative systems
in place to comply quickly with the
ETS. Thus, the ETS applies to all
employers who have the requisite
number of employees at any time this
ETS is in effect. Along with employers
that always have more than 100
employees, OSHA intends to cover
employers that fluctuate above and
below the 100-employee threshold
during the term of the ETS because
those employers will typically have
already developed systems and
capabilities for compliance; a decrease
in the number of employees is therefore
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unlikely to make them less capable of
compliance.
The determination of whether an
employer falls within the scope of this
ETS based on number of employees
should initially be made as of the
effective date of the standard, as set out
in paragraph (m)(1). If the employer has
100 or more employees on the effective
date, this ETS applies for the duration
of the standard. If the employer has
fewer than 100 employees on the
effective date of the standard, the
standard would not apply to that
employer as of the effective date.
However, if that same employer
subsequently hires more workers and
hits the 100-employee threshold for
coverage, the employer would then be
expected to come into compliance with
the standard’s requirements. Once an
employer has come within the scope of
the ETS, the standard continues to
apply for the remainder of the time the
standard is in effect, regardless of
fluctuations in the size of the
employer’s workforce. For example, an
employer that has 103 employees on the
effective date of the standard, but then
loses four within the next month, would
continue to be covered by the ETS.
OSHA is confident that employers with
100 or more employees at any point
while this ETS is in effect have the
administrative capacity to comply with
the ETS, even if the number of
employees fluctuates somewhat above
and below 100.
Paragraph (b)(2) of this ETS sets forth
two exemptions to the standard.89
Under paragraph (b)(2)(i), this ETS does
not apply to workplaces covered by the
Safer Federal Workforce Task Force
COVID–19 Workplace Safety: Guidance
for Federal Contractors and
Subcontractors (see Safer Federal
Workforce Task Force, September 24,
2021). With limited exceptions, such as
where a medical contraindication,
disability, or sincerely held religious
belief would prevent an employee from
complying with certain provisions,
those guidelines require covered
89 Note that, in addition to the scope exceptions
contained in the ETS itself, which are discussed in
this section, there may be situations where the ETS
does not apply by operation of the OSH Act. For
example, the OSH Act does not apply to working
conditions of employees with respect to which
other Federal agencies have exercised their
statutory authority to prescribe or enforce standards
or regulations affecting occupational safety or
health (see 29 U.S.C. 653(b)(1)). Moreover, the ETS
does not apply where states with OSHA-approved
occupational safety and health programs (‘‘State
Plans’’) have coverage (see 29 U.S.C. 667). State
Plans must adopt and enforce COVID–19
requirements that are at least as effective as this
ETS. Finally, the ETS does not apply to state and
local government employers in states without State
Plans (see 29 U.S.C. 652(5)).
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contractors to ensure that all covered
contractor employees (1) are fully
vaccinated by December 8, 2021; (2)
follow CDC guidelines for masks and
physical distancing, including masking
and distancing requirements based on
the employee’s vaccination status and
the level of community transmission of
COVID–19 where the workplace is
located; and (3) designate a person to
coordinate COVID–19 workplace safety
efforts at covered workplaces. Because
covered contractor employees are
already covered by the protections in
those guidelines, OSHA has determined
that complying with this standard in
addition to the federal contractor
guidelines is not necessary to protect
covered contractor employees from a
grave danger posed by COVID–19.
Although there may be some respects in
which the OSHA standard is somewhat
more protective, such as providing paid
leave for vaccination, the federal
contractor guidelines are somewhat
more protective in other respects, such
as requiring vaccination for everyone
who does not have a right to an
accommodation rather than allowing
employees to submit to testing in lieu of
vaccination. In essence, they are similar
but slightly different schemes that
provide roughly equivalent protection,
and OSHA has determined that
imposing a second set of similar
protections on covered federal
contractors by subjecting them to this
ETS in addition to the federal contractor
guidance is not necessary at this time to
reduce a grave danger to covered
contractor employees from COVID–19.
Under Executive Order 14043, every
federal agency must implement a
program requiring each of its federal
employees to be vaccinated against
COVID–19, except as required by law.
86 FR 50989. OSHA will regard a
federal agency’s compliance with this
requirement, and the related Safer
Federal Workforce Task Force guidance
issued under section 4(e) of Executive
Order 13991 and section 2 of Executive
Order 14043 (including guidance on
employer support in the form of paid
time for vaccination and paid leave for
post-vaccination recovery), as sufficient
to meet its obligation to comply with
this ETS under Section 19 of the OSH
Act and Executive Order 12196. In
essence, the federal government has
chosen the mandatory vaccination
option of this rule, and all federal
employees are required to be fully
vaccinated by the compliance date of
this standard, except where entitled to
a reasonable accommodation. The Safer
Federal Workforce Task Force’s
guidelines for vaccination verification
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are consistent with the ETS’s (see Safer
Federal Workforce Task Force, October
11, 2021). Note, however, that under the
OSH Act, the U.S. Postal Service is
treated as a private employer, see 29
U.S.C. 652(5), and it is therefore
required to comply with this ETS in the
same manner as any other employer
covered by the Act.
For similar reasons, paragraph
(b)(2)(ii) provides that this ETS does not
apply in settings where any employee
provides healthcare services or
healthcare support services while they
are covered by the requirements of 29
CFR 1910.502. Section 1910.502
requires a multi-layered suite of
protections for employees covered by its
requirements, including patient
screening and management, facemasks
or respirators, other personal protective
equipment (PPE), limiting exposure to
aerosol-generating procedures, physical
distancing, physical barriers, cleaning,
disinfection, ventilation, health
screening and medical management,
access to vaccination, and medical
removal protection. Section 1910.502
was carefully tailored to the healthcare
workplaces it covers and, given the full
suite of protections it requires,
including (like this ETS) the provision
of paid time for vaccination, OSHA has
determined that it adequately protects
the employees covered by its
requirements from the grave danger
posed by COVID–19. Therefore,
complying with the additional
requirements of this ETS is not
necessary to protect those employees
while they are covered by that
standard’s protections.
OSHA’s intent was to leave no
coverage gaps between section 1910.502
and this ETS. In other words, the
purpose of paragraph (b)(2)(ii) is to
ensure that all workers in healthcare
and healthcare support jobs who are at
grave danger from exposure to SARSCoV–2 are protected by either section
1910.502 or this ETS while performing
their jobs. Therefore, it will be necessary
for employers with employees covered
by section 1910.502 to determine if they
also have employees covered by this
ETS. For example, a healthcare
employer with more than 100
employees that has non-hospital
ambulatory care facilities that are
exempt under section 1910.502(a)(2)(iii)
(for non-hospital ambulatory care
settings where all non-employees are
screened prior to entry and those with
suspected or confirmed COVID–19 are
prohibited from entry) would be
required to protect the employees in
those ambulatory care facilities under
this ETS. Similarly, a retail pharmacy
chain that operates a series of
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ambulatory care clinics embedded in its
stores, where those embedded clinics
are the only areas in the store that are
covered under 1910.502 (see section
1910.502(a)(3)(i)), would have to ensure
that the remainder of its employees in
other parts of its stores are protected
under this ETS if the company has 100
or more employees company-wide,
including those covered under
1910.502.
Paragraph (b)(3) provides that, even
where the standard applies to a
particular employer, its requirements do
not apply to employees: (i) Who do not
report to a workplace where other
individuals such as coworkers or
customers are present; (ii) while
working from home; or (iii) who work
exclusively outdoors. OSHA intends
these provisions to exempt workplace
settings where workers do not interact
indoors with other individuals, and to
exempt work performed in the
employee’s home regardless of whether
other individuals may be present in the
home.
OSHA has determined that the
provisions of this ETS are not necessary
to protect employees from COVID–19
when they are working alone, or when
they are working from home (see Grave
Danger, Section III.A. of this preamble).
These two provisions may overlap in
some cases, but also can apply to
slightly different situations. Paragraph
(b)(3)(i) would apply to work in a
solitary location, such as a research
station where only one person (the
employee) is present at a time. In that
situation, the employee is not exposed
to any potentially infectious individuals
at work. Paragraph (b)(3)(ii) would
apply to employees working in their
homes, regardless of whether other
individuals who are not employees of
the same employer are present. In a
home telework environment, many
factors—such as the presence of family
members and other individuals
unrelated to the employee’s work, who
may not be fully vaccinated or wearing
face coverings—may be beyond the
employer’s control. Employees are
typically in the best position to manage
COVID–19 risks in their homes. Note
that the exemption in paragraph
(b)(3)(ii) only applies to employees
while they are working from home. An
employee who switches back and forth
from teleworking to working in a setting
where other people are present (e.g., an
office) is covered by this ETS and must
be vaccinated if required by the
employer. If the employer does not
require vaccination, the teleworking
employee must either be vaccinated or
complete testing and wear a face
covering in accordance with their
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employer’s policy under paragraph (d).
How often such an employee must be
tested for COVID–19 and wear a face
covering, however, depends on how
often they report to the office (see, e.g.,
paragraph (g)(1)(ii)).
Paragraph (b)(3)(iii) provides that,
even if a particular employer is covered
by the standard, the requirements of the
standard do not apply to employees
who work exclusively outdoors. OSHA
has determined that COVID–19 does not
pose a grave danger to employees who
work exclusively outdoors because of
the significantly reduced likelihood of
transmission in outdoor settings. As
discussed in more detail in Grave
Danger (Section III.A. of this preamble),
the record contains very little evidence
of COVID–19 transmission in outdoor
settings. And, in studies where clusters
were identified in worksites
characterized as being outdoors, the
study authors were not able to identify
specific incidents that led to
transmission. In addition, workplaces
characterized as ‘‘outdoors’’ may in fact
involve significant time spent indoors.
For example, on a construction site,
workers inside a partially complete
structure are not truly outdoors, and
some individuals on a construction site
may spend significant amounts of time
in a construction trailer where other
individuals are present. Workers at
outdoor locations may also routinely
share work vehicles. These indoor
exposures could account for COVID–19
clusters among employees at worksites
otherwise characterized as being
outdoors. And employees whose
outdoor time is interrupted by the
indoor periods will still be subject to the
requirements in this ETS.
Studies of athletic teams further
indicate that evidence of COVID–19
clusters among workers characterized as
working outdoors could actually be
caused by indoor exposures. Even
where athletes were in very close
contact during outdoor exposures on the
playing field, the study authors could
not identify a single case of COVID–19
transmission between teams that
occurred outdoors (see Mack et al.,
January 29, 2021; Egger et al., March 18,
2021; Jones et al., February 11, 2021).
For all of these reasons, and as
discussed more fully in Grave Danger
(Section III.A. of this preamble), OSHA
has determined that COVID–19 does not
pose a grave danger to employees who
work exclusively outdoors.
As a practical matter, determining the
applicability of paragraph (b)(3)(iii)
depends on the working conditions of
individual employees. For example, if a
landscaping contractor has at least 100
employees and is not covered by the
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exemptions in paragraph (b)(2), the
standard applies to that employer even
if a majority of the company’s
employees work exclusively outdoors.
The standard’s protections would only
apply to employees working in indoor
settings around other individuals (other
than telework in their own homes), not
to those employees working exclusively
outdoors. In some cases, it may be true
that the standard applies to an employer
but the employer would not have to
implement its provisions at all because
all of its employees fall within
exemptions in paragraph (b)(3). Going
back to the example of the large
landscaping contractor, if all indoor
workers either work from home or in
locations where no other individuals are
present, and all outdoors workers work
exclusively outdoors and do not drive to
worksites together in a company
vehicle, the employer would be covered
by the ETS but not required to comply
with its provisions.
An employee will only be covered by
the exemption in paragraph (b)(3)(iii) if
the employee works exclusively
outdoors. Thus, an employee who works
indoors on some days and outdoors on
other days would not be exempt from
the requirements of this ETS. Likewise,
if an employee works primarily
outdoors but routinely occupies
vehicles with other employees as part of
work duties, that employee is not
covered by the exemption in paragraph
(b)(3)(iii). However, if an employee
works outdoors for the duration of every
workday except for de minimis use of
indoor spaces where other individuals
may be present—such as a multi-stall
bathroom or an administrative office—
that employee would be considered to
work exclusively outdoors and covered
by the exemption under paragraph
(b)(3)(iii) as long as time spent indoors
is brief, or occurs exclusively in the
employee’s home (e.g., a lunch break at
home). Extremely brief periods of
indoor work would not normally expose
employees to a high risk of contracting
COVID–19; however, OSHA will look at
cumulative time spent indoors to
determine whether that time is de
minimis. Thus, if there are several brief
periods in a day when an employee goes
inside, OSHA will total those periods of
time when determining whether the
exception for exclusively outdoors work
applies.
Finally, to qualify for this exception,
the employee’s work must truly occur
‘‘outdoors,’’ which would not include
buildings under construction where
substantial portions of the structure are
in place, such as walls and ceiling
elements that would impede the natural
flow of fresh air at the worksite.
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Workplaces that are truly outdoors
typically do not include any of the
characteristics that normally enable
transmission of SARS–CoV–2 to occur,
such as poor ventilation, enclosed
spaces, and crowding. As discussed in
Bulfone et al. (November 29, 2020), the
lower risk of transmission in outdoor
settings (i.e., open air or structures with
only one wall) is likely due to increased
ventilation with fresh air and a greater
ability to maintain physical distancing
(see Grave Danger, Section III.A. of this
preamble, for more information on risk
of transmission outdoors).
References
Always Designing for People (ADP). (2016,
December). Opportunity is calling.
Answer it. Insights and solutions for
moving beyond risky ad hoc HR
management. (ADP, December 2016)
Bulfone TC et al. (2020, November 29).
Outdoor Transmission of SARS-CoV–2
and Other Respiratory Viruses: A
Systematic Review. (2020). The Journal
of Infectious Diseases 223: 550–561.
https://doi.org/10.1093/infdis/jiaa742.
(Bulfone et al., November 29, 2020)
Centers for Disease Control and Prevention
(CDC). (2021, August 26). Delta Variant:
What We Know About the Science.
https://www.cdc.gov/coronavirus/2019ncov/variants/delta-variant.html?s_
cid=11512:cdc%20delta%20variant:sem.
ga:p:RG:GM:gen:PTN:FY21. (CDC,
August 26, 2021)
Champredon D et al. (2021, May 12).
Modelling approach to assessing risk of
transmission of SARS-CoV–2 at
gatherings. https://www.canada.ca/en/
public-health/services/reportspublications/canada-communicabledisease-report-ccdr/monthly-issue/202147/issue-4-april-2021/assessing-risktransmission-sars-cov-2-gatherings.html.
(Champredon et al., May 12, 2021)
Colorado Department of Public Health and
Environment (CDPHE). (2021, October
6). CDPHE COVID–19 outbreak map
updated October 6, 2021. https://
cdphe.maps.arcgis.com/apps/
webappviewer/?id=
dcc0b993632a4bc68dc7b9a1dd015cfe.
(CDPHE, October 6, 2021)
Contreras Z et al. (2021, July). Industry
Sectors Highly Affected by Worksite
Outbreaks of Coronavirus Disease, Los
Angeles County, California, USA, March
19-September 30, 2020. Emerg Infect Dis.
2021; 27(7): 1769–1775. doi:10.3201/
eid2707.210425. (Contreras et al., July,
2021)
Egger F et al. (2021, March 18). Does playing
football (soccer) lead to SARS–CoV–2
transmission?—a case study of 3 matches
with 19 infected football players. Science
and Medicine in Football. doi:10.1080/
24733938.2021.1895442. (Egger et al.,
March 18, 2021)
Jones B et al. (2021, February 11). SARS–
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positive players? Br J Sports Med
doi:10.1136/bjsports-2020–103714.
(Jones et al., February 11, 2021)
Mack CD et al. (2021, January 29).
Implementation and evolution of
mitigation measures, testing, and contact
tracing in the national football league,
August 9–November 21, 2020. MMWR
70: 130–135. doi:https://dx.doi.org/
10.15585/mmwr.mm7004e2. (Mack et al.,
January 29, 2021)
National Federation of Independent Business
(NFIB) Research Center. (2021, July 12).
Covid-19 small business survey (18):
federal small business programs, the
vaccine, labor shortage, and supply
chain disruptions. https://
assets.nfib.com/nfibcom/Covid-19-18Questionnaire.pdf. (NFIB, July 12, 2021)
Oregon Health Authority. (2021, October 6).
COVID–19 weekly outbreak report—
October 6, 2021. https://
www.oregon.gov/oha/covid19/
Documents/DataReports/WeeklyOutbreak-COVID-19-Report.pdf. (Oregon
Health Authority, October 6, 2021)
Safer Federal Workforce Task Force. (2021,
September 24). COVID–19 Workplace
Safety: Guidance for Federal Contractors
and Subcontractors. https://
www.saferfederal/workforce./gov/
downloads/Draft%/20contractor%/
20guidance%/20doc_20210922.pdf.
(Safer Federal Workforce Task Force,
September 24, 2021)
Safer Federal Workforce Task Force. (2021,
October 11). Vaccinations: Vaccination
Documentation and Information. https://
www.saferfederalworkforce.gov/faq/
vaccinations/. (Safer Federal Workforce
Task Force, October 11, 2021)
Shacham E et al. (2021, July 5). Examining
the relationship between COVID–19
vaccinations and reported incidence.
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2021.06.30.21259794. (Shacham et al.,
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Society for Human Resource Management
(SHRM). (2015). How organizational staff
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Society for Human Resource Management
(SHRM). (2020a, May 6). Navigating
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small businesses. https://shrm.org/hrtoday/trends-and-forecasting/researchandsurveys/Documents/
SHRM%20CV19%20SBO%20Research%
20Presentation%20v1.1.pdf. (SHRM,
May 6, 2020a)
Society for Human Resource Management
(SHRM). (2020b, May 6). Survey:
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survey-covid-19-could-shutter-mostsmall-businesses.aspx. (SHRM, May 6,
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susb/2017-susb-annual.html. (US Census
Bureau, May 2021)
C. Definitions
Paragraph (c) of the ETS provides
definitions of terms used in the section.
‘‘Assistant Secretary’’ means the
Assistant Secretary of Labor for
Occupational Safety and Health, U.S.
Department of Labor, or designee. This
definition provides clarification about
who can request and receive records
specified in paragraph (l)(3) of this
section. A designee includes a
representative conducting an inspection
or an investigation.
‘‘COVID–19 (Coronavirus Disease
2019)’’ means the disease caused by
SARS–CoV–2 (severe acute respiratory
syndrome coronavirus 2). SARS–CoV–2
is a highly transmissible virus that
spreads primarily through the
respiratory droplets that are produced
when an infected person coughs,
sneezes, sings, talks, or breathes. The
nature of the disease, variants of SARS–
CoV–2, disease transmission, and
associated health effects are all
described in great detail in Grave
Danger (Section III.A. of this preamble).
For clarity and ease of reference, the
ETS also uses the term ‘‘COVID–19’’
when describing exposures or potential
exposures to SARS–CoV–2. The
requirements of the ETS are intended to
address the grave danger of exposure to
COVID–19 in the workplace.
A ‘‘COVID–19 test’’ means a test for
SARS–CoV–2 that is: (1) Cleared,
approved, or authorized, including in an
Emergency Use Authorization (EUA), by
the U.S. Food and Drug Administration
(FDA) to detect current infection with
the SARS–CoV–2 virus (e.g., a viral
test); (2) administered in accordance
with the authorized instructions; and (3)
not both self-administered and self-read
unless observed by the employer or an
authorized telehealth proctor. Examples
of tests that satisfy this requirement
include tests with specimens that are
processed by a laboratory (including
home or on-site collected specimens
which are processed either individually
or as pooled specimens), proctored overthe-counter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer.
Under paragraph (g), employees who
are not fully vaccinated must be tested
for COVID–19. When an employee must
be tested, the test is considered
acceptable only if the test and the
administration of the test satisfy the
definition of COVID–19 test in this
standard.
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COVID–19 tests can broadly be
divided into two categories, diagnostic
tests and antibody tests. Diagnostic tests
detect parts of the SARS–CoV–2 virus
and can be used to diagnose current
infection. On the other hand, antibody
tests look for antibodies in the immune
system produced in response to SARS–
CoV–2, and are not used to diagnose an
active COVID–19 infection. Antibody
tests do not meet the definition of
COVID–19 test for the purposes of this
ETS.
Diagnostic tests for current infection
fall into two categories: Nucleic acid
amplification tests (NAATs) and antigen
tests. NAATs are a type of molecular
test that detect genetic material (nucleic
acids); NAATs for COVID–19 identify
the ribonucleic acid (RNA) sequences
that comprise the genetic material of the
virus. NAATs can reliably detect small
amounts of SARS–CoV–2 and are
unlikely to return a false-negative result.
NAATs use many different methods to
detect the virus, including reverse
transcription-polymerase chain reaction
(RT–PCR), which is a high-sensitivity,
high-specificity 90 test for diagnosing
SARS–CoV–2 infection. Other types of
NAATs that use isothermal
amplification methods include nicking
endonuclease amplification reaction
(NEAR), transcription mediated
amplification (TMA), loop-mediated
isothermal amplification (LAMP),
helicase-dependent amplification
(HDA), clustered regularly interspaced
short palindromic repeats (CRISPR), and
strand displacement amplification
(SDA) (CDC, June 14, 2021).
Most NAATs need to be processed in
a laboratory with variable time to
receive results (approximately 1–2
days), but some NAATs are point-ofcare tests with results available in about
15–45 minutes. As of October 14, 2021,
264 molecular tests (NAATs) and
collection devices have EUA from the
FDA for COVID–19 (FDA, October 14,
2021b). These tests may be acceptable
under the ETS.
Antigen tests may also meet the
definition of COVID–19 test under this
standard. Antigen tests indicate current
infection by detecting the presence of a
specific viral antigen. Most can be
processed at the point of care with
results available in about 1530 minutes.
Antigen tests generally have similar
specificity to, but are less sensitive than,
NAATs (CDC, October 7, 2021). As of
October 14, 2021, thirty-seven antigen
90 Test sensitivity indicates the ability of a test to
correctly identify people who have a disease. Test
specificity indicates the ability of a test to correctly
identify people who do not have a disease. A test
with high sensitivity and high specificity minimizes
inaccurate results.
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tests have EUA from the FDA for
COVID–19 (FDA, October 14, 2021a).
These tests may be acceptable under the
ETS.
Most antigen tests and some NAATs
are conducted at the point of care,
which means the test processing and
result reading is performed at or near
the place where a specimen is collected
so that results can be obtained within
minutes rather than hours or days.
Rapid point-of-care tests are
administered in various settings
operating under a Clinical Laboratory
Improvement Amendments of 1988
(CLIA) certificate of waiver, such as
physician offices, urgent care facilities,
pharmacies, school health clinics,
workplace health clinics, long-term care
facilities and nursing homes, and at
temporary locations, such as drivethrough sites managed by local health
organizations (FDA, November 16,
2020).
To be a valid COVID–19 test under
this standard, a test may not be both
self-administered and self-read unless
observed by the employer or an
authorized telehealth proctor. OSHA
included the requirement for some type
of independent confirmation of the test
result in order to ensure the integrity of
the result given the ‘‘many social and
financial pressures for test-takers to
misrepresent their results’’ (Schulte et
al., May 19, 2021). This independent
confirmation can be accomplished in
multiple ways, including through the
involvement of a licensed healthcare
provider or a point-of-care test provider.
If an over-the-counter (OTC) test is
being used, it must be used in
accordance with the authorized
instructions. The employer can validate
the test through the use of a proctored
test that is supervised by an authorized
telehealth provider. Alternatively, the
employer could proctor the OTC test
itself.
Employers have the flexibility to
select the testing scenario that is most
appropriate for their workplace. Some
employees and employers may rely on
testing that is conducted by a healthcare
provider (e.g., doctor or nurse) who
arranges for the specimen to be analyzed
at a laboratory or at a point-of-care
testing location (e.g., a pharmacy). The
involvement of licensed or accredited
healthcare providers allows employers
to have a high degree of confidence in
the suitability of the test and the test
results. Some large employers who set
up their own on-site testing program
may partner with a healthcare
organization (e.g., a local hospital or
clinic) or rely on a licensed healthcare
provider to help obtain a CLIA
certificate of waiver. Other employers
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may simply require that employees
perform and read their own OTC test
while an authorized employee observes
the administration and reading of the
test to ensure that a new test kit was
used and that the test was administered
properly (e.g., nostrils were swabbed),
and to witness the test result.
Due to the potential for employee
misconduct (e.g., falsified results), tests
that are both self-administered and selfread are not acceptable unless they are
observed by the employer or an
authorized telehealth proctor. Some
COVID–19 tests are authorized by the
FDA to be performed only with the
supervision of a telehealth proctor,
which is someone who is trained to
observe sample collection and provide
instructions and result interpretation
assistance to individuals using the test.
The term ‘‘authorized telehealth
proctor’’ refers to proctors who follow
the requirements for proctoring
specified by the FDA authorization. For
a more detailed discussion on COVID–
19 testing requirements under this ETS,
see the Summary and Explanation for
paragraph (g) (Section VI.G. of this
preamble).
A ‘‘face covering’’ means a covering
that: (1) Completely covers the nose and
mouth; (2) is made with two or more
layers of a breathable fabric that is
tightly woven (i.e., fabrics that do not let
light pass through when held up to a
light source); (3) is secured to the head
with ties, ear loops, or elastic bands that
go behind the head. If gaiters are worn,
they should have two layers of fabric or
be folded to make two layers; (4) fits
snugly over the nose, mouth, and chin
with no large gaps on the outside of the
face; and (5) is a solid piece of material
without slits, exhalation valves, visible
holes, punctures, or other openings.
This definition includes clear face
coverings or cloth face coverings with a
clear plastic panel that, despite the noncloth material allowing light to pass
through, otherwise meet this definition
and which may be used to facilitate
communication with people who are
deaf or hard-of-hearing or others who
need to see a speaker’s mouth or facial
expressions to understand speech or
sign language respectively. Face
coverings can be manufactured or
homemade, and they can incorporate a
variety of designs, structures, and
materials. Face coverings provide
variable levels of protection based on
their design and construction.
As explained in paragraph (i), face
covering use is required based on an
employee’s vaccination status. The
criteria in the definition help to ensure
that face coverings that are worn by
workers who are not fully vaccinated
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will provide effective source control and
some degree of personal protection.
Source control means reducing the
spread of large respiratory droplets to
others by covering a person’s mouth and
nose. The personal protection afforded
by face coverings, as well as the benefits
and necessity, are described in the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble).
Face coverings differ from facemasks
and respirators, which are also defined
in paragraph (c) of this section. Face
coverings, unlike facemasks and
respirators, are not considered to be
personal protective equipment (PPE)
under OSHA’s general PPE standard (29
CFR 1910.132), as discussed in the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble).
Lastly, face coverings as required by
this standard do not have to meet a
consensus standard, although face
coverings that adhere to such consensus
standards, with design and construction
specifications, meet the definition and
may offer both greater protection and
the confidence that at least a minimum
level of protection has been provided.
The National Institute for Occupational
Safety and Health (NIOSH) recommends
that employers and workers who want
a face covering that provides a known
level of protection use face coverings
that meet a new standard, called
Workplace Performance and Workplace
Performance Plus masks, for
workplaces. As discussed in the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble), the new NIOSH criteria and
the ASTM Specification for Barrier Face
Coverings, F3502–21 (ASTM Standard)
provide a greater level of source control
performance for workers when wearing
the face covering according to
manufacturer’s instructions. The NIOSH
criteria require that face coverings
conform to the ASTM Standard and
meet additional quantitative leakage
criteria. Although not required by the
standard, OSHA notes that face
coverings that meet ASTM F3502–21
requirements and the new NIOSH
criteria may offer a higher level of
source control and wearer protection
than those face coverings that do not
meet a consensus standard.
A ‘‘facemask’’ means a surgical,
medical procedure, dental, or isolation
mask that is FDA-cleared, authorized by
an FDA EUA, or offered or distributed
as described in an FDA enforcement
policy. Facemasks may also be referred
to as ‘‘medical procedure masks.’’ This
definition provides clarification about
the exception to the face covering
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requirement under paragraph (i)(1)(iii)
that permits facemask use in lieu of face
coverings. OSHA notes that facemasks
are not respirators, which are also
defined in this section.
Facemasks provide protection against
exposure to splashes, sprays, and spatter
of body fluids. Facemasks offer both
source control, as defined in this section
under face coverings, and protection for
the wearer. OSHA has previously
established that facemasks are essential
PPE for employees in healthcare, under
both the general PPE standard (29 CFR
part 1910.132) and the Bloodborne
Pathogens standard (29 CFR part
1910.1030). Although not required, the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble) addresses their inclusion in
this standard. Additional information
on such facemasks can be found in
relevant FDA guidance.
‘‘Fully vaccinated’’ means (i) a
person’s status 2 weeks after completing
primary vaccination with a COVID–19
vaccine with, if applicable, at least the
minimum recommended interval
between doses in accordance with the
approval, authorization, or listing that
is: (A) Approved or authorized for
emergency use by the FDA; (B) listed for
emergency use by the World Health
Organization (WHO); or (C)
administered as part of a clinical trial at
U.S. site, if the recipient is documented
to have of primary vaccination with the
‘‘active’’ (not placebo) COVID–19
vaccine candidate, for which vaccine
efficacy has been independently
confirmed (e.g., by a data and safety
monitoring board) or if the clinical trial
participant from the U.S. sites had
received a COVID–19 vaccine that is
neither approved nor authorized for use
by the FDA but is listed for emergency
use by the WHO. Currently-authorized
FDA vaccines include Janssen (Johnson
& Johnson), which is a single-dose
primary vaccination, and PfizerBioNTech and Moderna, which have a
two-dose primary vaccination series.
This definition is consistent with the
CDC definition of fully vaccinated (CDC,
September 16, 2021).
The definition of ‘‘fully vaccinated’’
also means a person’s status 2 weeks
after receiving the second dose of any
combination of two doses of a COVID–
19 vaccine that is approved or
authorized by the FDA, or listed as a
two-dose series by the WHO (i.e.,
heterologous primary series of such
vaccines, receiving doses of different
COVID–19 vaccines as part of one
primary series). The second dose of the
series must not be received earlier than
17 days (21 days with a 4-day grace
period) after the first dose (CDC,
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October 15, 2021). OSHA has included
this because people who have received
a heterologous primary vaccination
series (including mixing of mRNA,
adenoviral, and mRNA plus adenoviral
products) are considered by the CDC to
also meet this definition. OSHA
considers a vaccination series that meets
the definition in subparagraph (ii) to be
a primary vaccination for purposes of
the requirements to support vaccination
in paragraph (f).
The employer obligations under the
ETS differ based on whether each
employee is fully vaccinated. This
definition is relevant to the definition of
mandatory vaccination policy, in this
paragraph (c), as well as the provisions
under paragraph (d) regarding written
vaccination policy requirements and
relevant procedures for workers who are
fully vaccinated. Paragraph (e)(2) also
addresses fully vaccinated employees,
including the determination of
vaccination status and acceptable forms
of proof. Lastly, the definition provides
clarity with regard to the requirements
of paragraphs (g) and (i) respectively,
which contain requirements for regular
COVID–19 testing and face covering use
among employees who are not fully
vaccinated.
Paragraph (e) requires employers to
determine each employee’s vaccination
status, including whether they are fully
or partially vaccinated. By ‘‘partially
vaccinated,’’ OSHA means someone
who has started a primary vaccination
series but not completed it (e.g., has
received one dose of a two-dose series)
or has completed their primary
vaccination and two weeks have not
elapsed since the last dose of the
primary vaccination.
A ‘‘mandatory vaccination policy’’ is
an employer policy requiring each
employee to be fully vaccinated. To
meet the definition of a mandatory
vaccination policy, the policy must
require: Vaccination of all employees,
including vaccination of all new
employees as soon as practicable, other
than those employees (1) for whom a
vaccine is medically contraindicated, (2)
for whom medical necessity requires a
delay in vaccination,91 or (3) who are
legally entitled to a reasonable
accommodation under federal civil
rights laws because they have a
disability or sincerely held religious
beliefs, practices, or observances that
conflict with the vaccination
requirement. OSHA intends that
‘‘employee,’’ as used in this definition,
91 As defined by CDC’s informational document,
Summary Document for Interim Clinical
Considerations for Use of COVID–19 Vaccines
Currently Authorized in the United States (CDC,
September 29, 2021).
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includes only employees that are
covered by this ETS and does not
include employees who are excluded
from coverage under paragraph (b)(3).
Paragraph (d)(1) of the standard
requires an employer to establish,
implement, and enforce a written
mandatory vaccination policy that
meets this definition. The benefits of
vaccination, including the effectiveness
of vaccination mandates, are discussed
in Grave Danger (Section III.A. of this
preamble) and Need for the ETS
(Section III.B. of this preamble).
OSHA recognizes that vaccination
policies may vary, as indicated in
paragraph (d)(2). Any policy that
permits the employee to choose between
vaccination and COVID–19 testing and
face covering use would not be
considered a mandatory vaccination
policy under paragraph (d)(1), although
such policy is permissible under
paragraph (d)(2). In some cases,
employers may implement vaccination
policies that differ by location or type of
business operation and thus the
application of paragraph (d)(2) might
vary across an employer’s workforce.
This is discussed in greater detail in the
Summary and Explanation for
paragraph (d) (Section VI.D. of this
preamble).
A ‘‘respirator’’ is a type of PPE that is
certified by NIOSH under 42 CFR part
84 or is authorized under an EUA by the
FDA. These specifications are intended
to ensure some consistent level of
testing, approval, and protection and to
prevent the use of counterfeit respirators
that will not offer adequate protection,
which is important because respirators
are intended to protect the wearer when
directly exposed to hazards. Respirators
protect against airborne hazards by
removing specific air contaminants from
the ambient (surrounding) air or by
supplying breathable air from a safe
source. Common types of respirators
include filtering facepiece respirators
(e.g., N95), elastomeric respirators, and
powered air-purifying respirators
(PAPRs). Face coverings, facemasks, and
face shields are not respirators.
As stated above, there are various
types of respirators that would fall
within this definition. A filtering
facepiece respirator (FFR) is a negativepressure particulate respirator with a
non-replaceable filter as an integral part
of the facepiece or with the entire
facepiece composed of the nonreplaceable filtering medium. N95 FFRs
are the most common type of FFR and
are the type of respirator most often
used to control exposures to infections
transmitted via the airborne route.
When properly worn, N95 FFRs filter at
least 95% of airborne particles. An
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elastomeric respirator is a tight-fitting
respirator with a facepiece that is made
of synthetic or rubber material that
permits it to be disinfected, cleaned,
and reused according to the
manufacturer’s instructions. Elastomeric
respirators are equipped with
replaceable cartridges, canisters, or
filters. Lastly, a powered air-purifying
respirator (PAPR) is an air-purifying
respirator that uses a blower to force the
ambient air through air-purifying
elements to the inlet covering.
This standard does not require the use
of respirators. This definition is
included because it relates to paragraph
(i)(1)(iii), which exempts employees
from wearing face coverings when they
are wearing respirators or facemasks. In
addition, paragraph (i)(4) requires
employers to permit employees to wear
a respirator instead of a face covering
and permits employers to provide
respirators to their employees, instead
of face coverings. When respirators are
used pursuant to paragraph (i)(4), the
employer must also comply with
§ 1910.504, the Mini Respiratory
Protection Program.
NIOSH has developed a set of
regulations in 42 CFR part 84 for testing
and certifying non-powered, airpurifying, particulate-filter respirators.
To help address concerns about
availability during the COVID–19
pandemic, the FDA has issued EUAs for
certain PPE products, including
respiratory protective devices such as
respirators. For the purposes of this
standard, respirators certified by
NIOSH, under 42 CFR part 84 or
authorized under an EUA by the FDA
meet the definition. Additional
information on such respirators can be
found in relevant FDA and NIOSH
guidance.
A ‘‘workplace’’ is a physical location
(e.g., fixed, mobile) where the
employer’s work or operations are
performed. It does not include an
employee’s residence, even if the
employee is teleworking from their
residence. Examples of fixed locations
include: Offices, retail establishments,
co-working facilities, and factories or
manufacturing facilities. A workplace
includes the entire site (including
outdoor and indoor areas, a structure or
a group of structures) or an area within
a site where work or any work-related
activity occurs (e.g., taking breaks, going
to the restroom, eating, entering or
exiting work). The workplace includes
the entirety of any space associated with
the site (e.g., workstations, hallways,
stairwells, breakrooms, bathrooms,
elevators) and any other space that an
employee might occupy in arriving,
working, or leaving. Examples of
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employees who have mobile workplaces
include maintenance and repair
technicians who go to homes or
businesses to provide repair services, or
those who provide delivery services.
References
Centers for Disease Control and Prevention
(CDC). (2021, June 14). Nucleic Acid
Amplification Tests. https://
www.cdc.gov/coronavirus/2019-ncov/
lab/naats.html. (CDC, June 14, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 16). When
You’ve Been Fully Vaccinated: How to
Protect Yourself and Others. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated.html. (CDC,
September 16, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 29). Summary
Document for Interim Clinical
Considerations for Use of COVID–19
Vaccines Currently Authorized in the
United States. https://www.cdc.gov/
vaccines/covid-19/downloads/summaryinterim-clinical-considerations.pdf.
(CDC, September 29, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 7). Interim
Guidance for SARS–CoV–2 Testing in
Non-Healthcare Workplaces. https://
www.cdc.gov/coronavirus/2019-ncov/
community/organizations/testing-nonhealthcare-workplaces.html. (CDC,
October 7, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 15). Interim Public
Health Recommendations for Fully
Vaccinated People. https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/fullyvaccinated-guidance.html. (CDC,
October 15, 2021)
Equal Employment Opportunity Commission
(EEOC). (2021, October 25). What You
Should Know About COVID–19 and the
ADA, the Rehabilitation Act, and Other
EEO Laws. https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19and-ada-rehabilitation-act-and-othereeo-laws. (EEOC, October 25, 2021)
Food and Drug Administration (FDA). (2020,
November 16). COVID–19 Test Settings:
FAQs on Testing for SARS–CoV–2.
https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medicaldevices/covid-19-test-settings-faqstesting-sars-cov-2. (FDA, November 16,
2020)
Food and Drug Administration (FDA).
(2021a, October 14). In Vitro Diagnostics
EUAs—Antigen Diagnostic Tests for
SARS–CoV–2. https://www.fda.gov/
medical-devices/coronavirus-disease2019-covid-19-emergency-useauthorizations-medical-devices/in-vitrodiagnostics-euas-antigen-diagnostictests-sars-cov-2. (FDA, October 14,
2021a)
Food and Drug Administration (FDA).
(2021b, October 14)). In Vitro Diagnostics
EUAs—Molecular Diagnostic Tests for
SARS–CoV–2. https://www.fda.gov/
medical-devices/coronavirus-disease2019-covid-19-emergency-use-
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authorizations-medical-devices/in-vitrodiagnostics-euas-molecular-diagnostictests-sars-cov-2. (FDA, October 14,
2021b)
Schulte P et al. (2021, May 19). Proposed
Framework for Considering SARS–CoV–
2 Antigen Testing of Unexposed
Asymptomatic Workers in Selected
Workplaces. J Occup Environ Med. 2021
Aug; 63(8): 646–656. Published online
2021, May 19. https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC8327768/. (Schulte et al., May 19,
2021)
D. Employer Policy on Vaccination
Vaccination is a vital tool to reduce
the presence and severity of COVID–19
cases in the workplace, in communities,
and in the nation as a whole. Despite
the robust protection against COVID–19
that vaccination affords, millions of
eligible individuals have not yet been
vaccinated. Current efforts to increase
the proportion of the U.S. population
that is fully vaccinated against COVID–
19 are critical to ending the COVID–19
pandemic (CDC, September 15, 2021).
As described more fully in Need for the
ETS (Section III.B. of this preamble),
mandatory vaccination policies work.
Therefore, OSHA has determined that
requiring or strongly encouraging
vaccination—the most effective and
efficient control for reducing COVID–
19—is key to ensuring the protection of
workers against the grave danger of
exposure to SARS–CoV–2 in the
workplace (see Grave Danger, Section
III.A. of this preamble). Therefore, this
ETS requires employers to adopt
mandatory vaccination policies for their
workplaces, with an exception for
employers that instead adopt a policy
allowing employees to elect to undergo
regular COVID–19 testing and wear a
face covering at work in lieu of
vaccination. In Need for the ETS
(Section III.B of this preamble), OSHA
explains its rationale for providing the
exception.
Paragraph (d) of this ETS is a critical
element in ensuring employees’
protection, as it requires covered
employers to develop, implement, and
enforce written policies on COVID–19
vaccination for their workforces.
Paragraph (d)(1) requires the employer
to establish, implement, and enforce a
written mandatory vaccination policy.
As defined in paragraph (c), a
mandatory vaccination policy is an
employer policy requiring each
employee to be fully vaccinated. Such a
policy must require vaccination of all
employees, other than those employees
who fall into one of three categories: (1)
Those for whom a vaccine is medically
contraindicated, (2) those for whom
medical necessity requires a delay in
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vaccination, or (3) those who are legally
entitled to a reasonable accommodation
under federal civil rights laws because
they have a disability or sincerely held
religious beliefs, practices, or
observances that conflict with the
vaccination requirement. The policy
must also require all new employees to
be vaccinated as soon as practicable.
Paragraph (d)(2) is a limited
exemption from the mandatory
vaccination policy requirement. As
discussed in Need for the ETS (Section
III.B. of this preamble), vaccination
mandates are effective at increasing
overall vaccination rates and protecting
employees and, therefore, the agency
encourages all employers to implement
a mandatory vaccination policy. Under
paragraph (d)(2), however, employers
can avoid the mandate in paragraph
(d)(1) if the employer establishes,
implements, and enforces a written
policy allowing any employee not
subject to a mandatory vaccination
policy to choose either to: (1) Be fully
vaccinated against COVID–19 or (2)
provide proof of regular testing for
COVID–19 in accordance with
paragraph (g) of this section and wear a
face covering in accordance with
paragraph (i). An employer who chooses
to operate under paragraph (d)(2),
however, must still offer the support for
vaccination required under paragraph (f)
and may not prevent employees from
getting vaccinated. Adopting a policy
under paragraph (d)(2) simply means
that employees themselves may choose
not to get vaccinated, in which case they
must get tested and wear face coverings
per the requirements of the standard.
OSHA recognizes there may be
employers who develop and implement
partial mandatory vaccination policies,
i.e., that apply to only a portion of their
workforce. An example might be a retail
corporation employer who has a
mixture of staff working at the corporate
headquarters, performing intermittent
telework from home, and working in
stores serving customers. In this type of
situation, the employer may choose to
require vaccination of only some subset
of its employees (e.g., those working in
stores), and to treat vaccination as
optional for others (e.g., those who work
from headquarters or who perform
intermittent telework). This approach
would comply with the standard so long
as the employer complies in full with
paragraph (d)(1) and (d)(2) for the
respective groups.
OSHA uses the terms establish,
implement, and enforce in paragraph (d)
to emphasize that it is necessary for an
employer to first determine its policy
and create a written record of that
policy. After determining the policy, an
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employer must then ensure that it is
following the policy, as laid out in its
written plan. Finally, employers must
ensure that they enforce the
requirements of their policies with
respect to their workforce, through
training and the use of such
mechanisms as work rules and the
workplace disciplinary system, if
necessary. These requirements apply to
the written policy required under
paragraph (d), whether employers
choose to implement the mandatory
vaccination policy under paragraph
(d)(1) or utilize the exemption under
paragraph (d)(2) for all or a portion of
their workforce.
To ensure that employers’ vaccination
policies under paragraph (d) are
comprehensive and effective, the
policies should address all of the
applicable requirements in paragraphs
(e)–(j) of this standard, including:
Requirements for COVID–19
vaccination; applicable exclusions from
the written policy (e.g., medical
contraindications, medical necessity
requiring delay in vaccination, or
reasonable accommodations for workers
with disabilities or sincerely held
religious beliefs); information on
determining an employee’s vaccination
status and how this information will be
collected (as described in paragraph (e));
paid time and sick leave for vaccination
purposes (as described in paragraph (f));
notification of positive COVID–19 tests
and removal of COVID–19 positive
employees from the workplace (as
described in paragraph (h)); information
to be provided to employees (pursuant
to paragraph (j)—e.g., how the employer
is making that information available to
employees); and disciplinary action for
employees who do not abide by the
policy. In addition to addressing the
requirements of paragraphs (e)–(j) of this
standard, the employer should include
all relevant information regarding the
policy’s effective date, who the policy
applies to, deadlines (e.g., for
submitting vaccination information, for
getting vaccinated), and procedures for
compliance and enforcement, all of
which are necessary components of an
effective plan. Having a comprehensive
written policy will provide a solid
foundation for an effective COVID–19
vaccination program, while making it
easier for employers to inform
employees about the program-related
policies and procedures, as required
under paragraph (j)(1).
If an employer utilizes the exemption
under paragraph (d)(2), its workplace
may contain employees who are
vaccinated and unvaccinated. This
might be the case even for employers
who establish a mandatory vaccination
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policy under paragraph (d)(1); for
example, an employer with a mandatory
vaccination policy might have
employees who cannot be vaccinated for
medical reasons. Given the additional
safety protocols under this standard for
individuals who are not fully vaccinated
(see paragraphs (g) and (i)), an employer
who has both vaccinated and
unvaccinated employees will have to
develop and include the relevant
procedures for two sets of employees in
the written policy. The procedures for
those who are fully vaccinated should
contain all the information previously
discussed relevant to establishing,
implementing, and enforcing a
comprehensive written policy.
However, the procedures applicable to
employees who are not fully vaccinated
(i.e., those who decline vaccination,
those who are unable to receive
vaccination and are, absent undue
hardship to their employers, entitled to
reasonable accommodation) and those
who are unable to provide proof of
vaccination as required by paragraph (e)
(who must be treated as not fully
vaccinated), must include COVID–19
testing and face covering use as required
by paragraphs (g) and (i), respectively,
unless the reasonable accommodation
from vaccination removes the employee
from the scope of § 1910.501 (e.g., full
time telework consistent with one of the
exceptions in § 1910.501(b)(3)). OSHA
intends that such an employer will
develop one written plan that includes
different policies and procedures for
vaccinated and unvaccinated
employees. The requirements of
paragraphs (e), (f), (h), and (j) should be
addressed in the policy regardless of the
vaccination requirements adopted by
the employer.
As with all elements of the written
plan, an effective written plan will
explain the testing requirements
contained in paragraph (g) for
unvaccinated employees, and how the
employer will implement and enforce
those policies. As described in
paragraph (g)(1), the testing
requirements differ for employees who
report at least once every 7 days to a
workplace compared to those who do
not. Thus, the policy may describe
different testing procedures for those
different groups of employees,
depending on how often they physically
report to a workplace where other
individuals are present. As described in
paragraph (g)(3), the testing
requirements are temporarily suspended
for 90 days following a positive COVID–
19 test or diagnosis. Thus, the
employer’s policy and procedures to
implement this temporary suspension of
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testing should be included in their
written workplace policy. In addition to
the testing requirements in paragraph
(g), an effective policy must address
mandatory face covering use as
described in paragraph (i), including
procedures for employee compliance.
Employers can get more information on
the requirements for paragraphs (e)
through (j), and what they must do to
comply with those provisions of the
standard, in the relevant Summary and
Explanation sections (see Section VI. of
this preamble).
As an employer develops their written
policy, they must address how the
policy will apply to new employees.
Although many new hires will be fully
vaccinated, there should be procedures
within the plan to collect information
about the new employee’s vaccination
status, and determine when an
unvaccinated new hire must be
vaccinated and, for employers using a
plan under paragraph (d)(2), when
COVID–19 testing and face covering use
will commence if an employee remains
unvaccinated. All new hires should be
treated similarly to any employee who
has not entered the workplace in the last
seven days and will need to be fully
vaccinated or provide proof of a
negative COVID–19 test within the last
seven days prior to entering the
workplace for the first time. It is not
OSHA’s intention to discourage
employers from hiring new employees,
but rather to ensure that new employees
are as well-protected from COVID–19
hazards in the workplace as current
employees and are less likely to spread
the virus to other employees.
An employer may have already
developed and implemented a written
policy on vaccination, testing, and/or
face covering use to protect employees
from COVID–19. It is not OSHA’s intent
for employers to duplicate current
effective policies covering the
requirements of this ETS; however, each
employer with a current policy must
evaluate that policy to ensure it satisfies
all of the requirements of this rule.
Employers with existing policies must
modify and/or update their current
policies to incorporate any missing
required elements, and must provide
information on these new updates or
modifications to all employees in
accordance with paragraph (j)(1). Once
the employer has developed its policy
pursuant to paragraph (d), the policy
must be reduced to writing in order to
be compliant with paragraph (d).
The note to paragraph (d) was
included in recognition that, under
federal law, some employees may be
entitled to a reasonable accommodation
from their employer, absent undue
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hardship. If the worker requesting a
reasonable accommodation cannot be
vaccinated and/or wear a face covering
because of a disability, as defined by the
Americans with Disabilities Act (ADA),
that worker may be entitled to a
reasonable accommodation. In addition,
if the vaccination, and/or testing for
COVID–19, and/or wearing a face
covering conflicts with a sincerely held
religious belief, practice or observance,
a worker may be entitled to a reasonable
accommodation. Such accommodations
exist independently of the Occupational
Safety and Health Act and, therefore,
OSHA does not administer or enforce
these laws. Examples of relevant federal
laws under which an accommodation
can be requested include the Americans
with Disabilities Act (ADA) and Title
VII of the Civil Rights Act of 1964.
For more information, the note refers
to a resource produced by the Equal
Employment Opportunity Commission
(EEOC), which is responsible for
enforcing federal laws that prohibit
employment-related discrimination
based on a person’s race, color, religion,
sex (including pregnancy, gender
identity, and sexual orientation),
national origin, age (40 or older),
disability, or genetic information. The
EEOC resource listed in the note, What
You Should Know About COVID–19
and the ADA, the Rehabilitation Act,
and Other EEO Laws, available at
https://www.eeoc.gov/wysk/what-youshould-know-about-covid-19-and-adarehabilitation-act-and-other-eeo-laws,
should be helpful to employers in
navigating employees’ requests for
accommodations, including the process
for determining a reasonable
accommodation and information on
undue hardship (EEOC, October 25,
2021). An additional resource that might
be helpful is the CDC’s informational
document, Summary Document for
Interim Clinical Considerations for Use
of COVID–19 Vaccines Currently
Authorized in the United States (CDC,
September 29, 2021), which lists the
recognized clinical contraindications to
receiving a COVID–19 vaccine.
References
Centers for Disease Control and Prevention
(CDC). (2021, September 15). Science
Brief: Background rationale and evidence
for public health recommendations for
fully vaccinated people. https://
www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinatedpeople.html. (CDC, September 15, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 29). Summary
Document for Interim Clinical
Considerations for Use of COVID–19
Vaccines Currently Authorized in the
United States. https://www.cdc.gov/
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vaccines/covid-19/downloads/summaryinterim-clinical-considerations.pdf.
(CDC, September 29, 2021)
Equal Employment Opportunity Commission
(EEOC). (2021, October 25). What You
Should Know About COVID–19 and the
ADA, the Rehabilitation Act, and Other
EEO Laws. https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19and-ada-rehabilitation-act-and-othereeo-laws. (EEOC, October 25, 2021)
E. Determination of Employee
Vaccination Status
To comply with the requirements of
the standard, it is essential that
employers are aware of each employee’s
vaccination status. As discussed in the
Summary and Explanation for
paragraph (d) (Section VI.D. of this
preamble), effective implementation and
enforcement of a written vaccination
policy requires the employer to know
the vaccination status of all employees.
Furthermore, the employer must know
each employee’s vaccination status in
order to ensure that the vaccination,
testing, and face covering requirements
of the standard are met. As such,
paragraph (e) includes provisions for
determining each employee’s
vaccination status. The standard
requires employers to determine the
vaccination status of each employee
(paragraph (e)(1)), and also to maintain
records of each employee’s vaccination
status, preserve acceptable proof of
vaccination for each employee who is
fully or partially vaccinated, and
maintain a roster of each employee’s
vaccination status (paragraph (e)(4)). As
discussed more fully below,
maintenance of records in accordance
with this paragraph is subject to
applicable legal requirements for
confidentiality of medical information.
Additional provisions in paragraph (e)
define acceptable proof of vaccination
status for vaccinated employees
(paragraph (e)(2)) and provide that any
employee who does not submit an
acceptable form of proof of vaccination
status must be treated as not fully
vaccinated (paragraph (e)(3)).
Paragraph (e)(1) requires the employer
to determine the vaccination status of
each employee, including whether the
employee is fully vaccinated. Under
paragraph (e)(2), the employer must
require each vaccinated employee to
provide acceptable proof of vaccination
status, including whether they are fully
or partially vaccinated. This is an
ongoing requirement for the employer
(i.e., the employer needs to update this
information as employees proceed
through the vaccination process).
Paragraph (e)(2) defines what
‘‘acceptable proof of vaccination status’’
means for purposes of the ETS, and
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employers must accept any of the proofs
listed in accordance with the terms of
the standard and as explained more
fully below. Under paragraph (e)(2), the
following are acceptable for proof of
vaccination: (i) The record of
immunization from a health care
provider or pharmacy; (ii) a copy of the
U.S. CDC COVID–19 Vaccination
Record Card (CDC Form MLS–319813_
r, published on September 3, 2020)
(CDC, October 5, 2021); (iii) a copy of
medical records documenting the
vaccination; (iv) a copy of immunization
records from a public health, state, or
tribal immunization information system;
or (v) a copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s).
To be acceptable as proof of
vaccination, any documentation should
generally include the employee’s name,
type of vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s). In
some cases, state immunization records
may not include one or more of these
data fields, such as clinic site; in those
circumstances, an employer can still
rely upon the State immunization
record as acceptable proof of
vaccination. OSHA notes that clinic
sites can include temporary vaccination
facilities used during large vaccine
distribution campaigns, such as schools,
churches, or sports stadiums. Copies,
including digital copies, of the listed
forms of proof are acceptable means of
documentation so long as they clearly
and legibly display the necessary
information. Digital copies can include,
for example, a digital photograph,
scanned image, or PDF of an acceptable
form of proof. Some state governments
are utilizing digital COVID–19 vaccine
records showing the same information
as the U.S. CDC COVID–19 Vaccination
Record Card (CDC Form MLS–319813_
r, published on September 3, 2020) and
providing quick response (QR) codes
that when scanned will provide the
same information (see, e.g., New York
State Government, n.d., Retrieved
October 4, 2021). In certain states, the
QR code confirms the vaccine record as
an official record of the state (see, e.g.,
State of California, n.d., Retrieved
October 7, 2021) and therefore would
provide acceptable proof of vaccination
under the ETS (see paragraph (e)(2)(iv)).
However, as discussed later, the
employer must retain a copy of the
vaccination information retrieved when
the QR code is scanned, not just the QR
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code itself, to comply with paragraph
(e)(4). In requesting proof of
vaccination, the employer must take
care to comply with any applicable
Federal laws, including requirements
under the Privacy Act, 5 U.S.C. 552a,
and the Americans with Disabilities Act
(ADA), 42 U.S.C. 12101 et seq.
Each employee who has been partially
or fully vaccinated should be able to
provide one of the forms of acceptable
proof listed above (paragraphs (e)(2)(i)–
(e)(2)(v)). An employee who does not
possess their COVID–19 vaccination
record (e.g., because it was lost or
stolen) should contact their vaccination
provider (e.g., local pharmacy,
physician’s office) to obtain a new copy
or utilize their state health department’s
immunization information system. In
instances where an employee is unable
to produce acceptable proof of
vaccination under paragraphs (e)(2)(i)–
(e)(2)(v), paragraph (e)(2)(vi) provides
that a signed and dated statement by the
employee will be acceptable. The
employee’s statement must: (A) Attest to
their vaccination status (fully
vaccinated or partially vaccinated); (B)
attest that they have lost or are
otherwise unable to produce proof
required by the standard; and (C)
include the following language: ‘‘I
declare (or certify, verify, or state) that
this statement about my vaccination
status is true and accurate. I understand
that knowingly providing false
information regarding my vaccination
status on this form may subject me to
criminal penalties.’’ The note to
paragraph (e)(2)(vi) explains that an
employee who attests to their
vaccination status should, to the best of
their recollection, include the following
information in their attestation: The
type of vaccine administered; date(s) of
administration; and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s). For
example, some of the information may
be easier to recall, such as receiving a
vaccine at a mass vaccination site or
local pharmacy, while the dates of
administration might only be
remembered as falling within a
particular month or months. OSHA
understands that employees may not be
able to recall certain information, such
as the type of vaccine received.
Employees providing attestations
should include as much of this
information as they can remember to the
best of their ability.
Any statement provided under
paragraph (e)(2)(vi) must include an
attestation that the employee is unable
to produce another type of proof of
vaccination (paragraph (e)(2)(vi)(B)).
Thus, before an employee statement will
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be acceptable for proof of vaccination
under paragraph (e)(2)(vi), the employee
must have attempted to secure alternate
forms of documentation via other means
(e.g., from the vaccine administrator or
their state health department) and been
unsuccessful in doing so. The agency
recognizes that securing vaccination
documentation may be challenging for
some members of the workforce, such as
migrant workers, employees who do not
have access to a computer, or employees
who may not recall who administered
their vaccines (e.g., if the vaccination
was provided at a temporary location,
such as a church, or during a state or
local mass vaccination campaign). Thus,
for employees who have no other means
of obtaining proof of vaccination, the
standard permits employers to accept
attestations meeting the requirements in
paragraph (e)(2)(vi) as proof of
vaccination. However, employers
should explain to their employees that
they need to produce vaccination proof
through the other means listed in
paragraph (e)(2), such as by contacting
the vaccination administrator, if they
are able to do so. Once the employee has
provided a signed and dated attestation
that meets the requirements of
paragraph (e)(2)(vi), the employer no
longer needs to seek out one of the other
forms of vaccination proof for that
employee and, depending on the
content of the attestation, the employer
may consider that employee either fully
or partially vaccinated for purposes of
the ETS.
Recently, there has been evidence of
fraud associated with people attesting to
their vaccination status (Bergal,
September 16, 2021). While employers
may not invite or facilitate fraud, the
ETS does not require employers to
monitor for or detect fraud. By defining
what constitutes acceptable proof of
vaccination under the ETS, OSHA is
ensuring that employers can accept
proof meeting the requirements of
paragraph (e) for purposes of
compliance with the standard. However,
the standard’s requirements for proof of
vaccination are integral to ensuring that
employees are protected appropriately,
either through vaccination (the
preferred and most effective workplace
control in this ETS), or through regular
testing and use of face coverings. Thus,
it is paramount that employees provide
truthful information regarding their
vaccination status.
As discussed in more detail in the
Summary and Explanation for
paragraph (j) (Section VI.J. of this
section), 18 U.S.C. 1001(a), which
provides for fines or imprisonment of
generally up to 5 years for any person
who ‘‘in any matter within the
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jurisdiction’’ of the executive branch
U.S. Government ‘‘knowingly and
willfully’’ engages in any of the
following:
(1) Falsifies, conceals, or covers up by
any trick, scheme, or device a material
fact;
(2) makes any materially false,
fictitious, or fraudulent statement or
representation; or
(3) makes or uses any false writing or
document knowing the same to contain
any materially false, fictitious, or
fraudulent statement or entry.
Similarly, the OSH Act recognizes
that OSHA’s ability to protect workers’
safety and health hinges on truthful
reporting. For that reason section 17(g)
of the OSH Act subjects anyone who
‘‘knowingly makes any false statement,
representation, or certification in any
application, record, report, plan, or
other document filed or required to be
maintained pursuant to this chapter’’ to
criminal penalties. 29 U.S.C. 666(g).
False statements made in any proof
submitted under paragraph (e)(2) of the
standard could fall under either or both
of 18 U.S.C. 1001 or section 17(g) of the
OSH Act. And by requiring a specific
declaration about the truth and accuracy
of employee statements provided under
paragraph (e)(2)(vi), employees who are
unable to provide any means of proof
other than their own attestation are
being made aware that their words are
being held to the same standard of
truthfulness as any other record
presented for proof of vaccination.
OSHA notes that these same
prohibitions on false statements and
documentation can apply to employers.
If an employer knows that proof
submitted by an employee is fraudulent,
and even with this knowledge, accepts
and maintains the fraudulent proof as a
record of compliance with this ETS, it
may be subject to the penalties in 18
U.S.C. 1001 and 17(g) of the OSH Act.
Paragraph (e)(3) provides the
mechanism for employers to determine
vaccination status for employees who
do not submit any of the acceptable
forms of proof of vaccination status.
Under paragraph (e)(3), any employee
who does not provide their employer
with one of the acceptable forms of
proof of vaccination status in paragraph
(e)(2) must be treated as not fully
vaccinated for the purpose of the
standard. An unvaccinated employee
does not need to provide any
documentation regarding vaccination
status under this ETS; however, failing
to provide acceptable proof of
vaccination status will signal the
employer to consider the employee as
not fully vaccinated and to note that as
their status in the roster. For employers
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that include COVID–19 testing in their
written policies under paragraph (d),
employees without acceptable proof of
vaccination status must submit to
weekly tests (as required by paragraph
(g)) and wear a face covering (as
required by paragraph (i)).
Paragraph (e)(4) requires the employer
to maintain a record of each employee’s
vaccination status and preserve
acceptable proof of vaccination for each
employee who is fully or partially
vaccinated. As discussed previously, the
employer has various options for
acquiring proof of vaccination from each
employee. An employer may allow
employees to provide a digital copy of
acceptable records, including, for
example, a digital photograph, scanned
image, or PDF of such a record that
clearly and legibly displays the
necessary vaccination information.
However, to be in compliance with
paragraph (e)(4), the employer must
ensure they are able to maintain a
record of each employee’s vaccination
status. Therefore, obtaining an
employee’s vaccination information
verbally would not comply with
paragraph (e)(2) or satisfy the record
maintenance requirements of the
standard. Similarly, the record
maintenance requirements of paragraph
(e)(4) cannot be fulfilled by an employee
merely showing the employer their
vaccination status (e.g., by bringing the
CDC COVID–19 vaccination card to the
workplace and showing it to an
employer representative or showing an
employer representative a picture of the
immunization records on a personal
cellphone). To satisfy paragraph (e)(4),
the employer must retain a copy of the
documentation. As mentioned above,
some states and local governments
utilize QR codes to facilitate proof of
vaccination. This can be an acceptable
form of proof for compliance with the
standard so long as the employer retains
a copy of the information retrieved by
scanning the QR code and maintains
that record. Required records of
vaccination status can be maintained
physically or electronically, but the
employer must ensure they have access
to the records at all times.
In addition to obtaining and
maintaining individual records of each
employee’s vaccination status and
preserving acceptable proof of
vaccination for each employee who is
partially or fully vaccinated, under
paragraph (e)(4) the employer must
maintain a roster of each employee’s
vaccination status, subject to applicable
confidentiality requirements. The roster
must list all employees and clearly
indicate for each one whether they are
fully vaccinated, partially (not fully)
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vaccinated, not fully vaccinated because
of a medical or religious
accommodation (see Note to paragraph
(d)), or not fully vaccinated because
they have not provided acceptable proof
of their vaccination status. As noted
previously, any employee that has not
provided acceptable proof of their
vaccination status must be treated as not
fully vaccinated. Although
unvaccinated employees will not have
proof of vaccination status, the standard
requires the employer to include all
employees, regardless of vaccination
status, on the roster.
The roster allows the employer to
easily access the vaccination status for
any employee quickly and easily. This
will be useful should the employer need
to respond to a request from an
employee or employee representative
for the aggregate number of fully
vaccinated employees at a workplace
(along with the total number of
employees at that workplace), as
required under paragraph (l)(2).
Additionally, the roster will help the
employer implement the written policy
developed in accordance with
paragraph (d) and comply with other
requirements of the ETS. And finally,
the roster, which must be provided to
OSHA on request (paragraph (l)(3)), will
aid OSHA’s ability to effectively and
efficiently enforce this ETS.
The records and roster required by
paragraph (e)(4) are considered to be
employee medical records and must be
maintained as such records in
accordance with 29 CFR 1910.1020 and
must not be disclosed except as required
or authorized by this ETS or other
federal law, including the Americans
with Disabilities Act (ADA), 42 U.S.C.
12101 et seq. These records and roster
are not subject to the retention
requirements of 29 CFR
1910.1020(d)(1)(i) but must be
maintained and preserved while this
ETS remains in effect. OSHA considers
vaccination records required by
paragraphs (e)(2) and (e)(4) of the ETS
to be employee medical records
concerning the health status of an
employee and is requiring this
personally identifiable medical
information to be maintained in a
confidential manner. OSHA notes that
under paragraph (e)(4), vaccination
records and rosters are employee
medical records, and must be treated as
employee medical records under 29 CFR
1910.1020, without regard to whether
the records satisfy the definition of
employee medical record at 29 CFR
1910.1020(c)(6)(i).
Paragraph (e) in 29 CFR 1910.1020
includes requirements for access to
employee medical records by
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employees, their designated
representatives, and OSHA. However, as
discussed in more detail below,
paragraph (l) of the ETS includes
specific timeframes within which
employers must make vaccine records
available to employees, OSHA, and
other specified individuals.
Accordingly, the timeframes for
providing access to employee medical
records in 29 CFR 1910.1020(e) do not
apply, and employers must follow the
specific timeframes set forth in
paragraph (l) of the ETS for providing
access to vaccination records.
Additionally, 29 CFR 1910.1020(d)
addresses the preservation of employee
exposure and medical records.
Paragraph (d)(1)(i) in section 1910.1020
generally provides that unless a specific
occupational safety and health standard
provides a different period of time, each
employer must preserve and maintain
employee medical records for at least
the duration of employment plus thirty
(30) years. Paragraph (e)(4) of the ETS
specifically provides that the
vaccination records required by the ETS
are not subject to the retention
requirements of 29 CFR
1910.1020(d)(1)(i). Instead, paragraph
(e)(4) states that vaccination records
must be maintained and preserved only
so long as the ETS remains in effect.
Finally, while the provisions on
timeframes for access to records and the
retention provisions of 29 CFR
1910.1020 do not apply to vaccine
records required by the ETS, other
provisions in that regulation can still
apply. For example, 29 CFR
1910.1020(h) includes requirements for
the transfer of employee medical
records when an employer ceases to do
business.
OSHA recognizes the possibility that
an employer may have already collected
information about the vaccination status
of employees, including proof of
vaccination, prior to the effective date of
this ETS. Under paragraph (e)(5), when
an employer has ascertained employee
vaccination status prior to the effective
date of the ETS through another form of
attestation or proof, and retained
records of that ascertainment, the
employer is exempt from the
requirements in paragraphs (e)(1)–(e)(3).
The exemption applies only for each
employee whose fully vaccinated status
has been documented prior to the
effective date of the standard. For
example, an employer may have asked
each employee to self-report their
vaccination status without requiring the
employee to provide any form of proof.
If that self-reporting was through oral
conversation only, and not documented
in some way, the employer is not
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considered to have retained records of
that ascertainment for the purposes of
this ETS. However, if, for example, the
employer had the employees provide
their vaccine information on a dated
form, or through individual emails
retained by the employer, or on an
employer portal specifically created for
employees to provide documentation
status, or the employer created and
retained some other means of
documentation, the employer is
considered to have retained records of
ascertainment for the purposes of this
ETS. Even if the record does not have
all of the elements of the acceptable
forms of proof listed in paragraph (e)(2),
so long as the employer has ascertained
employee vaccination status prior to the
effective date of the ETS through
another form of attestation or proof, and
retained records of that ascertainment,
the employer does not need to redetermine vaccination status (paragraph
(e)(1)) or obtain proof of vaccination
status (paragraph (e)(2)) for fully
vaccinated employees. For purposes of
paragraph (e)(4), the employer’s records
of vaccination status for each employee
whose fully vaccinated status was
previously documented constitute
acceptable proof of vaccination.
However, the employer must still
develop a roster of each employee’s
vaccination status and include on that
roster the employees for whom it had
previously determined and retained
records of vaccination status. OSHA
notes that if the employer has not
ascertained employee vaccination status
for employees prior to the effective date
of the ETS, then all requirements of
paragraph (e) would apply. And all
requirements of paragraph (e) also apply
with respect to employees for whom the
employer ascertained only partial
vaccination status prior to the effective
date of the ETS.
References
Bergal J. (2021, September 16). Fake Vaccine
Card Sales Have Skyrocketed Since
Biden Mandate. https://
www.pewtrusts.org/en/research-andanalysis/blogs/stateline/2021/09/16/
fake-vaccine-card-sales-haveskyrocketed-since-biden-mandate.
(Bergal, September 16, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, October 5). Getting Your
CDC COVID–19 Vaccination Record
Card. https://www.cdc.gov/coronavirus/
2019-ncov/vaccines/vaccinationcard.html. (CDC, October 5, 2021).
New York State Government. (n.d.) Excelsior
Pass and Excelsior Pass Plus. Retrieved
October 4, 2021 from https://
covid19vaccine.health.ny.gov/excelsiorpass-and-excelsior-pass-plus. (New York
State Government, n.d., Retrieved
October 4, 2021).
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61525
State of California. (n.d.) Frequently Asked
Questions. Retrieved October 7, 2021
from https://
myvaccinerecord.cdph.ca.gov/faq. (State
of California, n.d., Retrieved October 7,
2021).
F. Employer Support for Employee
Vaccination
As discussed in the Summary and
Explanation for paragraph (d) (Section
VI.D. of this preamble), as well as in
Grave Danger and Need for the ETS
(Sections III.A. and III.B. of this
preamble), vaccination is the single
most efficient and effective method for
protecting unvaccinated workers from
the grave danger posed by COVID–19.
This emergency temporary standard is
therefore designed to strongly encourage
vaccination. As discussed in detail
below, paragraph (f) requires employers
to support vaccination by providing
employees reasonable time, including
up to four hours of paid time, to receive
each primary vaccination dose, and
reasonable time and paid sick leave to
recover from side effects experienced
following each primary vaccination
dose. For purposes of the requirements
to support vaccination in paragraph (f),
OSHA considers a vaccination series
that meets the criteria in subparagraph
(ii) of the definition of ‘‘fullyvaccinated’’ (i.e., a heterologous primary
series of such vaccines, receiving doses
of different COVID–19 vaccines as part
of one primary series) to be a primary
vaccination series, along with the
primary vaccination described in
subparagraph (i) of that definition (see
the Summary and Explanation for
paragraph (c), Section VI.C. of this
preamble, for more information on the
definition of fully vaccinated).
Removing logistical barriers to
obtaining vaccination is essential to
increasing workforce vaccination rates,
and one such barrier for many
employees is their lack of time off of
work to receive the vaccine and recover
from any potential side effects (SEIU
Healthcare, February 8, 2021).
Employees’ concerns about missing
work to obtain and recover from a
COVID–19 vaccination dose are well
documented. In a McKinsey survey,
12% of respondents stated that the time
spent away from work to get vaccinated
or due to vaccine side effects was a
barrier to vaccination (Azimi et al.,
April 9, 2021). In a survey conducted of
unvaccinated adults in April 2021, a
fifth of respondents said they were very
or somewhat concerned that they may
need to take time off to go and get the
vaccine, and 48% of respondents said
that they were very or somewhat
concerned that they might miss work if
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the vaccine side effects make them feel
sick (KFF, May 6, 2021). Black and
Hispanic adults were particularly
worried about the potential time
necessary to receive the vaccine and to
recover from vaccine side effects; 64%
of unvaccinated Hispanic adults and
55% of unvaccinated Black adults
expressed concern that they might have
to miss work due to the side effects of
a COVID–19 vaccine, and 30% of
Hispanic adults and 23% of Black
adults were concerned that they might
need to take time off work to get a
COVID–19 vaccine (KFF, May 6, 2021;
KFF, May 17, 2021). News and journal
articles further evince this concern (Roy
et al., December 29, 2020; Cleveland
Documenters, 2021; Rosenberg and
Stein, August 18, 2021).
This concern reflects the fact that
many workers do not have access to
paid time off to receive vaccination or
to recover from side effects. A KFF
survey found that only half of all
workers reported that their employer
provided them with paid time off either
to get a COVID–19 vaccine or to recover
from any side effects (KFF, June 30,
2021). A subsequent KFF survey found
that only about one-third of workers
were sure that their employer offered
them paid time off to get a COVID–19
vaccine and recover from side effects
(KFF, September 28, 2021). Although
employee access to paid sick leave is
less of a concern for employers with 100
or more employees, approximately 12%
of employees in these situations do not
have paid sick leave (BLS, September
2021) and in some cases, employees
may have already exhausted paid sick
leave they have received and would
need additional time from their
employers to recover from vaccine side
effects.
The scarcity of paid time off for
vaccination and side effect recovery is
particularly acute for certain
demographic groups. The June 2021
KFF survey found that only 38% of
Black workers reported getting either
paid time off to get a COVID–19 vaccine
or to recover from side effects, and that
only 41% of workers with household
incomes less than $40,000 annually had
access to such paid time off (KFF, June
30, 2021). Similarly, the September
2021 KFF survey found that lower-wage
workers were particularly unlikely to
report access to paid time off for
vaccination or recovery, with only 23%
of workers whose household incomes
was less than $40,000 reporting that
they could take paid time off to get
vaccinated, and only 28% of that group
reporting that they could take paid time
off to recover from side effects (KFF,
September 28, 2021). Lower-wage
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workers’ lack of access to paid time off
for vaccination comports with a
different report indicating that, before
the pandemic, about 65% of the lowestwage workers had no access to paid sick
leave, meaning that any time off for
vaccination or recovery would result in
lost wages for those who can least afford
those losses (BLS, September 2021). The
need for paid time off to receive
vaccination is also particularly
important for workers with disabilities
and workers in rural areas because
travel to and from vaccination sites may
take more time or be more logistically
difficult for those populations (National
Safety Council, 2021).
Paying workers for the time spent to
receive vaccination and to recover from
side effects has proven to be an effective
method for increasing vaccination rates.
In June 2021, KFF found that
approximately 75% of employed adults
surveyed who received paid time off to
get the vaccine or to recover from side
effects had received at least one dose of
the vaccine compared to only 51% of
those surveyed who did not receive paid
time off from their employer (KFF, June
30, 2021). KFF also found that
employees who are provided paid time
off and are encouraged by their
employers to get vaccinated are more
likely to get vaccinated, even after
controlling for demographic
characteristics that may impact
vaccination uptake (KFF, June 30, 2021).
Another KFF survey found that 28% of
unvaccinated respondents who did not
want to get the vaccine as soon as
possible said that they would be more
likely to obtain vaccination if their
employer gave them paid time off to get
vaccinated and recover from any side
effects (KFF, May 6, 2021). KFF has also
found that increasing access to paid
leave for vaccination or recovery from
side effects can also help further reduce
disparities in vaccination by age and
income (KFF, September 28, 2021).
In a different survey, paid time off for
vaccination and the recovery period
post-vaccination was the single mostinfluential action for encouraging
employee vaccination, with 75% of
respondents indicating that such paid
time off would significantly or
moderately increase the likelihood that
they would get vaccinated (Azimi et al.,
April 9, 2021). Another survey of nearly
9,000 service workers across large
grocery, retail, food service, pharmacy,
and delivery firms, found that
vaccination rates were lower than other
frontline workers who also regularly
work in-person and indoors, and when
employers supported and facilitated
vaccination, such as through providing
paid time off or paid sick leave for
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vaccination or for recovery from side
effects, employee vaccination rates were
higher than if no support was provided,
and in May 2021, workers with paid
sick leave were 15% more likely to have
gotten the vaccine than workers without
such leave (Bellew et al., June 2021).
To address this barrier to vaccination,
paragraph (f) requires employers to
support COVID–19 vaccination by
providing each employee with
reasonable time, including up to four
hours of paid time, to receive each
primary vaccination dose, and
reasonable time and paid sick leave to
recover from side effects experienced
following any primary vaccination dose.
Providing this time is essential for all
unvaccinated employees who are
covered by this rule to ensure that they
can receive primary vaccination dose(s)
and recover from side effects without
sacrificing pay or their jobs. In
workplaces where employers implement
a mandatory vaccination policy in
accordance with paragraph (d)(1) of this
rule, the requirements of paragraph (f)
ensure that employees are able to
comply with the mandatory vaccination
policy without concern about missing
work to do so. In workplaces where the
employer opts out of implementing a
mandatory vaccination policy in
accordance with paragraph (d)(2), the
requirements of paragraph (f) encourage
employees to choose vaccination, and
ensure that employees who choose to
obtain vaccination, rather than be
regularly tested for COVID–19 and wear
a face covering in most situations when
they work near others, are not penalized
for making that choice.
Paragraph (f)(1) requires employers to
support COVID–19 vaccination for each
employee by providing reasonable time
to each employee during work hours for
each of their primary vaccination
dose(s), including up to four hours of
paid time, at the employee’s regular rate
of pay, for the purposes of vaccination.
Reasonable time may include, but is not
limited to, time spent during work
hours related to the vaccination
appointment(s), such as registering,
completing required paperwork, all time
spent at the vaccination site (e.g.,
receiving the vaccination dose, postvaccination monitoring by the vaccine
provider), and time spent traveling to
and from the location for vaccination
(including travel to an off-site location
(e.g., a pharmacy), or situations in
which an employee working remotely
(e.g., telework) or in an alternate
location must travel to the workplace to
receive the vaccine).
Employers are not, however, obligated
by this ETS to reimburse employees for
transportation costs (e.g., gas money,
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train/bus fare, etc.) incurred to receive
the vaccination. This could include the
costs of travel to an off-site vaccination
location (e.g., a pharmacy) or travel from
an alternate work location (e.g.,
telework) to the workplace to receive a
vaccination dose.
Because employers are required to
provide reasonable time for vaccination
during work hours, if an employee
chooses to receive a primary vaccination
dose outside of work hours, employers
are not required to grant paid time to the
employee for the time spent receiving
the vaccine during non-work hours.
However, even if employees receive a
primary vaccination dose outside of
work hours, employers must still afford
them reasonable time and paid sick
leave to recover from side effects that
they experience during scheduled work
time in accordance with paragraph
(f)(2).
An employer may make other efforts
to facilitate vaccination of its employees
by, for example, hosting a vaccine clinic
at the workplace (e.g., mobile trailer) or
partnering with another entity, such as
a pharmacy or healthcare provider, so
that employees can be vaccinated at the
workplace or at an off-site location. If an
employer chooses to make the vaccine
available to its employees, it must
support full vaccination (i.e., provide all
doses in a primary vaccination, as
applicable), and assure the availability
of reasonable time and paid time to each
employee to receive the full primary
vaccination, and reasonable time and
paid sick leave to recover from side
effects that they may experience. Any
additional costs incurred by the
employer to bring vaccination on-site
would be covered by the employer,
though such an approach would likely
reduce the amount of paid time needed
for vaccine administration (but not side
effects) because of reduced employee
travel time.
Paragraph (f)(1) specifies that the
amount of paid time that an employer
is required to provide each employee to
receive each primary vaccination dose is
capped at four hours. OSHA has
determined that four hours would
provide reasonable time for most
employees to get each vaccination dose.
Vaccines are widely available to the
public at clinics, pharmacies, and other
locations across the country (see CDC,
October 8, 2021). Providing four hours
of paid time to receive each primary
vaccination dose is consistent with
OSHA’s presumption of the amount of
time needed to receive a vaccination
dose in the June 2021 Healthcare ETS
(86 FR 32598), and with the U.S. Office
of Personnel Management’s guidance to
federal government agencies on the use
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of the emergency paid leave created for
federal employees in the American
Rescue Plan Act of 2021 (Public Law
117–2), which encouraged agencies to
offer up to four hours of administrative
leave per dose to cover time spent
getting a vaccine dose, plus additional
time if reasonably necessary, instead of
having employees use emergency paid
leave (OPM, April 29, 2021). OSHA
expects that most employees will need
less than four hours to receive a
vaccination dose.
The maximum of four hours of paid
time that employers must provide under
paragraph (f)(1)(ii) for the
administration of each primary
vaccination dose cannot be offset by any
other leave that the employee has
accrued, such as sick leave or vacation
leave. OSHA is concerned that
employees forced to use their sick leave
or vacation leave for vaccination would
have a disincentive to gaining the health
protection of vaccination. Employers
must pay employees for up to four hours
of time at the employee’s regular rate of
pay. This may be achieved by paying for
the time to be vaccinated as work hours
for up to four hours. Requiring
employers to pay for vaccine
administration is consistent with
OSHA’s normal approach of requiring
employers to bear the costs of
compliance with safety and health
standards.
OSHA understands that employees
may need much less than four hours to
receive a primary vaccination dose, for
example, if vaccinations are offered onsite. However, OSHA also understands
that, in some circumstances, an
employee may need more than four
hours to receive a primary vaccination
dose, in which case the additional time,
as long as it is reasonable, would be
considered unpaid but protected leave.
The employer cannot terminate the
employee if they use a reasonable
amount of time to receive their primary
vaccination doses. The employee may
use other leave time that they have
available (e.g., sick leave or vacation
time) to cover the additional time
needed to receive a vaccination dose
that would otherwise be unpaid.
Paragraph (f)(2) also requires
employers to support COVID–19
vaccination for each employee by
providing reasonable time and paid sick
leave to recover from side effects
experienced following any primary
vaccination dose to each employee for
each dose. The paid sick leave can be
in the form of an employee’s accrued
sick leave, if available. If the employee
does not have available sick leave, leave
must be provided for this purpose.
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Although some individuals
experience no side effects from COVID–
19 vaccination doses, the CDC has
identified a range of side effects that
other individuals may experience
following a vaccination dose (CDC,
April 2, 2021; CDC, September 30,
2021). Side effects may affect
individuals’ ability to engage in daily
activities, are typically mild-tomoderate in severity, and usually go
away in a few days. Common side
effects include pain, redness, and
swelling at the site of injection, and
systemic side effects throughout the
body, including tiredness, headache,
muscle pain, chills, fever, and nausea.
Side effects may be sufficiently severe to
require the employee to take sick leave
from work, but will rarely extend
beyond a few days. One study found
that ‘‘unanticipated paid administrative
leave was only required for 4.9% and
19.79% of individuals after the first and
second doses of vaccine, respectively’’
(Levi et al., September 25, 2021).
Employees would not typically be
expected to need leave solely to address
redness or swelling at the site of
injection, but it is not uncommon for
vaccine recipients to require some
recovery time for many of the other side
effects. The CDC notes, however, that
cough, shortness of breath, runny nose,
sore throat, or loss of taste or smell are
not consistent with post-vaccination
symptoms and instead may be
symptoms of COVID–19 or another
infection (CDC, April 2, 2021).
If an employee already has accrued
paid sick leave, an employer may
require the employee to use that paid
sick leave when recovering from side
effects experienced following a primary
vaccination dose. Additionally, if an
employer does not specify between
different types of leave (i.e., employees
are granted only one type of leave), the
employer may require employees to use
that leave when recovering from
vaccination side effects. If an employer
provides employees with multiple types
of leave, such as sick leave and vacation
leave, the employer can only require
employees to use the sick leave when
recovering from vaccination side effects.
Employers cannot require employees to
use advanced sick leave to cover
reasonable time needed to recover from
vaccination side effects under paragraph
(f)(2). An employer may not require an
employee to accrue negative paid sick
leave or borrow against future paid sick
leave to recover from vaccination side
effects. In other words, the employer
cannot require an employee to go into
the negative for paid sick leave if the
employee does not have accrued paid
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sick leave when they need to recover
from side effects experienced following
a primary vaccination dose. Neither the
paid time required to receive any
vaccine dose(s) nor the paid sick leave
required to recover from side effects
experienced following any vaccination
dose are retroactive requirements for
vaccine dose(s) received prior to the
promulgation of this ETS.
Paragraph (f)(2) requires employers to
provide reasonable time and paid sick
leave to employees to recover from side
effects experienced following a primary
vaccination dose, but does not specify
the amount of paid sick leave that the
employer is required to provide for that
purpose. Employers may set a cap on
the amount of paid sick leave available
to employees to recover from any side
effects, but the cap must be reasonable.
CDC notes that although some people
have no side effects, side effects, if
experienced, should go away in a few
days (CDC, September 30, 2021).
Another study found that the average
unanticipated paid administrative leave
required by individuals experiencing
side effects was around two days (1.66
days for the first dose and 1.39 days for
the second dose) (Levi et al., September
25, 2021). Generally, OSHA presumes
that, if an employer makes available up
to two days of paid sick leave per
primary vaccination dose for side
effects, the employer would be in
compliance with this requirement.
When setting the cap, an employer
would not be expected to account for
the unlikely possibility of the
vaccination resulting in a prolonged
illness in the vaccinated employee (e.g.,
a severe allergic reaction).
OSHA is aware that other federal,
state, or local laws, or collective
bargaining agreements, may require
employers to provide employees
additional paid time for vaccination
and/or paid sick leave to recover from
vaccination side effects. Where such an
overlap exists, the requirements of this
standard are satisfied so long as the
employer provides each employee
reasonable time and four hours of paid
time to receive each primary
vaccination dose, and reasonable time
and paid sick leave to recover from side
effects experienced following a primary
vaccination dose.
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References
Azimi T et al. (2021, April 9). Getting to
work: Employers’ role in COVID–19
vaccination.1(Azimi et al., April 9, 2021)
1 Azimi T et al. (2021, April 9). Getting to work:
Employers’ role in COVID–19 vaccination. https://
www.mckinsey.com/industries/pharmaceuticalsand-medical-products/our-insights/getting-to-work-
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Bellew E et al. (2021, June). Half of service
sector workers are not yet vaccinated for
COVID–19: What gets in the way? The
Shift Project: Research Brief. https://
shift.hks.harvard.edu/wp-content/
uploads/2021/06/Vax_Brief_6.28.212.pdf. (Bellew et al., June 2021)
Centers for Disease Control and Prevention
(CDC). (2021, April 2). Post-vaccination
considerations for workplaces. https://
www.cdc.gov/coronavirus/2019-ncov/
community/workplaces-businesses/
vaccination-considerations-forworkplaces.html. (CDC, April 2, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 30). Possible
side effects after getting a COVID–19
vaccine. https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/expect/
after.html. (CDC, September 30, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, accessed October 8). We
can do this: Vaccines.gov website.
https://www.vaccines.gov/. (CDC,
October 8, 2021)
Cleveland Documenters. (2021). Why some
Clevelanders are still on the fence or not
getting vaccinated: Voices on the
vaccine. The Cleveland Observer.
https://www.freshwatercleveland.com/
street-level/VaccineVoice050521.aspx.
(Cleveland Documenters, 2021)
Kaiser Family Foundation (KFF). (2021, May
6). KFF COVID–19 Vaccine Monitor:
April 2021. https://www.kff.org/
coronavirus-covid-19/poll-finding/kffcovid-19-vaccine-monitor-april-2021/.
(KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May
17). How employer actions could
facilitate equity in COVID–19
vaccinations. https://www.kff.org/policywatch/how-employer-actions-couldfacilitate-equity-in-covid-19vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021, June
30). KFF COVID–19 Vaccine Monitor:
June 2021. https://www.kff.org/reportsection/kff-covid-19-vaccine-monitorjune-2021-findings/. (KFF, June 30, 2021)
Kaiser Family Foundation (KFF). (2021,
September 28). KFF COVID–19 Vaccine
Monitor: September 2021. https://
www.kff.org/coronavirus-covid-19/pollfinding/kff-covid-19-vaccine-monitorseptember-2021/. (KFF, September 28,
2021)
Levi ML et al. (2021, September 25). COVID–
19 mRNA vaccination, reactogenicity,
work-related absences and the impact on
operating room staffing: A crosssectional study. Perioperative Care and
Operating Room Management preprint.
https://doi.org/10.1016/
j.pcorm.2021.100220. (Levi et al.,
September 25, 2021)
National Safety Council. (2021). A Year in
Review, and What’s Next: COVID–19
Employer Approaches and Worker
Experiences. https://www.nsc.org/
faforms/safer-year-one-final-report.
(National Safety Council, 2021)
Rosenberg E and Stein J. (2021, August 18).
America’s failure to pay workers time off
employers-role-in-covid-19-vaccination# (Azimi et
al., April 9, 2021)
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undermines vaccine campaign,
according to surveys, policy experts.
Washington Post. https://
www.washingtonpost.com/us-policy/
2021/08/16/paid-leave-covid-vaccine/.
(Rosenberg and Stein, August 18, 2021)
Roy B et al. (2020, December 29). Health Care
Workers’ Reluctance to Take the COVID–
19 Vaccine: A Consumer-Marketing
Approach to Identifying and Overcoming
Hesitancy.NEJM Catalyst. https://
catalyst.nejm.org/doi/pdf/10.1056/
CAT.20.0676. (Roy et al., December 29,
2020)
SEIU Healthcare. (2021, February 8).
Research shows 81% of healthcare
workers willing to take COVID–19
vaccines but personal financial pressures
remain a significant barrier for uptake.
https://www.newswire.ca/news-releases/
research-shows-81-of-healthcareworkers-willing-to-take-covid-19vaccines-but-personal-financialpressures-remain-a-significant-barrierfor-uptake-888810789.html. (SEIU
Healthcare, February 8, 2021)
United States Bureau of Labor Statistics
(BLS). (2021, September). National
Compensation Survey: Employee
Benefits in the United States, March
2021. https://www.bls.gov/ncs/ebs/
benefits/2021/employee-benefits-in-theunited-states-march-2021.pdf. (BLS,
September, 2021)
United States Office of Personnel
Management (OPM). (2021, April 29).
American Rescue Plan: COVID–19
Emergency Paid Leave for Federal
Employees. https://chcoc.gov/sites/
default/files/
Attachment%205%20COVID–
19%20Emergency%20Paid%20
Leave%20Questions%20
and%20Answers_0.pdf. (OPM, April 29,
2021)
G. COVID–19 Testing for Employees
Who Are Not Fully Vaccinated
Paragraph (g) of this ETS addresses
employers’ obligations with respect to
employees who are not fully vaccinated,
including the requirement to ensure
unvaccinated employees are tested for
COVID–19. As explained in Need for the
ETS (Section III.B. of this preamble),
OSHA strongly prefers that employers
implement written mandatory
vaccination policies because that is the
most effective and efficient workplace
control available for preventing the
spread of COVID–19. However, this ETS
is also necessary to protect workers who
remain unvaccinated through required
regular testing, use of face coverings,
and removal of infected employees from
the workplace, and to protect other
workers from the greater likelihood that
unvaccinated workers may spread
COVID–19 in the workplace. People
who are unvaccinated are at increased
risk of becoming infected with COVID–
19 and are more likely to spread the
disease when compared to people who
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are fully vaccinated (CDC, September
15, 2021). Additionally, people who are
unvaccinated are more likely to
experience severe clinical outcomes if
they become infected than people who
are vaccinated (Lopez Bernal et al., July
21, 2021). Therefore, routine COVID–19
testing of unvaccinated employees is
necessary to identify employees with
COVID–19 so they can be removed from
the workplace to prevent transmission
to other employees and to facilitate
early medical intervention for infected
employees when appropriate.
Routine testing of unvaccinated
employees is necessary regardless of
whether the unvaccinated employees
have symptoms because SARS–CoV–2
infection is often attributable to
asymptomatic and/or pre-symptomatic
transmission (i.e., individuals who are
not exhibiting symptoms) (Bender et al.,
February 18, 2021; Klompas, September
2021; Johansson et al., January 7, 2021;
Byambasuren et al., December 11, 2020).
Although less effective and efficient
than vaccination, the CDC has
recognized regularly testing
unvaccinated employees for COVID–19
as a useful tool for identifying
asymptomatic and/or pre-symptomatic
infected individuals so that they can be
isolated (CDC, May 4, 2021; CDC,
October 7, 2021). In contrast, the CDC
recommends that fully vaccinated
employees with no symptoms and no
known exposure should be exempt from
routine testing programs (CDC, May 4,
2021). Additional information about the
risks of COVID–19 transmission in
vaccinated and unvaccinated workers is
discussed in Grave Danger (Section
III.A. of this preamble).
Testing for COVID–19 can broadly be
divided into two categories: diagnostic
testing and screening testing. The
purpose of diagnostic testing is to
identify current infection when a person
has signs or symptoms consistent with
COVID–19, or when a person is
asymptomatic but has recent known or
suspected exposure to SARS–CoV–2.
The information provided by diagnostic
testing can be used by a healthcare
provider to diagnose or treat a patient.
The purpose of screening testing is to
identify infected people who are
asymptomatic and do not have known,
suspected, or reported exposure to
COVID–19. Screening testing helps to
identify unknown cases both so that
measures can be taken to prevent further
transmission to others (e.g., removal
from the workplace and home isolation)
and also to allow infected, but
asymptomatic, people to begin medical
treatment, as appropriate, so they can
better avoid the most severe outcomes of
COVID–19 (e.g., high risk individuals
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seeking monoclonal antibody treatment
or anti-viral medication). Although the
testing required in paragraph (g)(1) of
this ETS is screening testing, both
screening and diagnostic testing can
help prevent the spread of COVID–19.
Paragraph (g) does not preclude
additional diagnostic testing if an
employee shows signs or symptoms
consistent with COVID–19 or has recent
known or suspected exposure to SARS–
CoV–2.
Both screening and diagnostic testing
involve the use of viral COVID–19 tests
to detect current infection, as opposed
to antibody COVID–19 tests, which are
used to detect whether a person has
antibodies for COVID–19. A positive
antibody test indicates someone has
antibodies to SARS–CoV–2, the virus
that causes COVID–19, which could
either be the result of a prior infection
with the virus or vaccination against
COVID–19 (FDA, May 19, 2021; CDC,
September 10, 2021). Viral tests for
current infection fall into two
categories: Nucleic acid amplification
tests (NAATs) and antigen tests. The
Food and Drug Administration (FDA)
(October 6, 2021) has issued a number
of Emergency Use Authorizations
(EUAs) for viral COVID–19 tests. It is
important to note that OSHA’s
definition of ‘‘COVID–19 test’’ requires
that COVID–19 tests be cleared,
approved, or authorized by the FDA and
administered in accordance with
authorized instructions, with the noted
exception of not allowing tests that are
both self-administered and self-read by
the employee unless observed by the
employer or an authorized telehealth
proctor. In this regard, OSHA recognizes
that it is within FDA’s authority and
jurisdiction to help to assure the
appropriate safety, efficacy, and
accuracy of COVID–19 tests. The
definition of ‘‘COVID–19 test’’ has
previously been discussed in the
Summary and Explanation for
paragraph (c) (Section VI.C. of this
preamble). Additional information
about the type of COVID–19 tests that
would satisfy the requirements of
paragraph (g) are available in that
section of this preamble.
As explained above, the most effective
and efficient workplace control for
preventing the spread of COVID–19 is
vaccination and OSHA strongly prefers
that employers implement written
mandatory vaccination policies.
However, where employers have
unvaccinated employees, regular
COVID–19 screening tests are necessary
so infected employees can be identified
and removed from the workplace to
prevent workplace transmission and to
facilitate early medical intervention,
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when appropriate. In addition to being
more likely to become infected with
COVID–19, people who are
unvaccinated are more likely to
experience severe clinical outcomes
from COVID–19 than fully vaccinated
people (see Grave Danger, Section III.A.
of this preamble). In a recent CDC
Morbidity and Mortality Weekly Report
(MMWR) out of Los Angeles County, the
SARS–CoV–2 infection rate among
unvaccinated persons was 4.9 times and
the hospitalization rate was 29.2 times
the rates among fully vaccinated
persons (Griffin et al., August 27, 2021).
As explained below, regular screening
testing of individuals for COVID–19 is
an effective method of identifying
asymptomatic and pre-symptomatic
infections. Screening testing of
unvaccinated employees is necessary
because symptom and temperature
checks will miss both asymptomatic and
pre-symptomatic infections, which is a
serious problem because presymptomatic and asymptomatic
transmission are significant drivers of
the continued spread of COVID–19
(Johansson et al., January 7, 2021). Once
infected employees are identified, they
can be removed from the workplace,
thereby reducing virus transmission to
other employees.
Several studies have indicated that
the time from exposure to becoming
contagious for COVID–19 is shorter than
the time for symptoms to develop
(incubation period), meaning that
individuals can transmit SARS–CoV–2
before they begin to feel ill (i.e., presymptomatic transmission) (Nishiura et
al., March 4, 2020; Tindale et al., June
22, 2020). Pre-symptomatic individuals
can transmit the virus to others before
they know they are sick. These
individuals should isolate but would
not know to do so if they are unaware
of their infection. It is also possible for
individuals to be infected and
subsequently transmit the virus without
ever exhibiting symptoms. This is called
asymptomatic transmission. A metaanalysis of 351 studies from January 1,
2020, to April 2, 2021, estimated that
42.8% of those infected with the SARS–
CoV–2 virus exhibited no symptoms at
the time of testing and so had either
asymptomatic or pre-symptomatic
infections (Sah et al., August 10, 2021).
In another meta-analysis of studies,
which included people of all ages at risk
of contracting COVID–19 who were
tested regardless of presence or absence
of symptoms, seventeen percent of cases
never developed symptoms during
entire COVID–19 infection (i.e.,
asymptomatic infection). In those
studies, a diagnosis was confirmed with
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a positive result on a RT–PCR and all
positive cases had a follow-up period of
at least seven days to distinguish
asymptomatic cases from presymptomatic cases (Byambasuren et al.,
December 11, 2020). In another study,
researchers used a decision analytical
model to assess the proportion of
SARS–CoV–2 transmission from presymptomatic, never symptomatic, and
symptomatic individuals in the
community. Based on their modeling,
they predicted that 59% of transmission
came from asymptomatic transmission,
including 35% from pre-symptomatic
individuals and 24% from individuals
who never develop symptoms
(Johansson et al., January 7, 2021).
The existence of pre-symptomatic and
asymptomatic infections pose serious
challenges to containing the spread of
SARS–CoV–2. Although the risk of
asymptomatic transmission is 42%
lower than from symptomatic COVID–
19 patients (Byambasuren et al.,
December 11, 2020), asymptomatic
transmission may result in more
transmissions than symptomatic cases
because asymptomatic persons are less
likely to be aware of their infection and
can unknowingly continue to spread the
disease to others (Sah et al., August 10,
2021). The challenge of containing presymptomatic and asymptomatic SARS–
CoV–2 transmission is amplified among
unvaccinated individuals because, as
explained above, they are more likely to
become infected with COVID–19 in the
first place.
Because unvaccinated employees are
at higher risk of COVID–19 infection
and COVID–19 transmission among
individuals without symptoms is a
significant driver of the spread of
COVID–19, OSHA has determined it is
necessary to prevent the presymptomatic and asymptomatic
transmission of COVID–19 from
unvaccinated workers, through a
requirement for weekly screening
testing. Screening testing with antigen
tests is a rapidly evolving and important
tool that can be used to reduce the
spread of SARS–CoV–2 in the
workplace, particularly when coupled
with other COVID–19 prevention and
control measures (e.g., workplace
removal of infected persons, proper use
of face coverings) (Schulte et al., May
19, 2021). The CDC recommends
screening testing of unvaccinated
asymptomatic workers as a useful tool
to detect COVID–19 and stop
transmission quickly. Screening testing
is particularly useful in areas with
moderate to high community
transmission of COVID–19, which is
currently the overwhelming majority of
the United States (CDC, October 7,
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2021). In a study with a well-defined
population of SARS–CoV–2 infected
individuals, researchers found that
frequent testing (i.e., at least twice per
week) maximizes the likelihood of
detecting infected individuals.
However, even when used weekly, rapid
antigen tests still had a 76% probability
of detection (i.e., weekly rapid antigen
tests correctly identified 76% of true
positive infected COVID–19
individuals) (Smith et al., September 15,
2021). By identifying pre-symptomatic
and asymptomatic unvaccinated
employees, employers can remove them
from the workplace to prevent those
employees from spreading SARS–CoV–
2 to other employees. More information
about the removal requirements in this
ETS is available in the Summary and
Explanation for paragraph (h) (Section
VI.H. of this preamble).
Since the incubation period for
COVID–19 can be up to 14 days, the
CDC recommends that screening testing
be conducted at least weekly in nonhealthcare workplaces (CDC, October 7,
2021; CDC, May 4, 2021). Other
researchers also recognize the
effectiveness of weekly screening testing
to control surges of COVID–19
infections (Larremore, January 1, 2021).
Consequently, in workplaces with
unvaccinated employees, OSHA has set
the minimum frequency of testing
unvaccinated workers at seven days
because the agency expects that it will
be effective in slowing the spread of
COVID–19 in those workplaces, when
used in tandem with face coverings
(paragraph (i)) and removal of infected
individuals (paragraph (h)). OSHA
emphasizes that each of these infection
controls provides some protection from
COVID–19 by itself, but that they work
best when used together, layering their
protective impact to boost overall
effectiveness. Although some studies
have shown that more regular screening
testing (e.g., twice weekly) would
identify even more cases, OSHA has
decided to require testing only on a
weekly basis. This is in line with the
CDC recommendations, and as noted
above the evidence shows that this
frequency is effective in detecting
asymptomatic and pre-symptomatic
cases. A more frequent testing schedule
would result in significant additional
costs, and OSHA is hesitant to impose
these costs and depart from CDC
recommendations without a fuller
record generated through the benefit of
notice and comment rulemaking. OSHA
seeks comment on this issue.
Nonetheless, it should be noted that
nothing in this rule prevents screening
testing from being conducted more
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frequently based on factors such as the
level of community transmission,
workplace experience with outbreaks,
and type of workplace (e.g., specific
workplace factors such as high volume
retail or critical infrastructure sector).
Early detection of COVID–19-positive
employees through screening testing of
unvaccinated employees also facilitates
early medical intervention, when
appropriate, to avoid the most severe
health outcomes associated with
COVID–19. Early effective treatment of
disease can help avert progression to
more serious illness, especially for
patients at high risk of disease
progression and severe illness, with the
additional benefit of reducing the
burden on healthcare systems (CDC,
December 4, 2021). For example, antiSARS–CoV–2 monoclonal antibodies
have been shown to reduce the risk of
hospitalization and death in the
outpatient setting in those with mild to
moderate COVID–19 symptoms and
certain risk factors for disease
progression. Treatment should be
started as soon as possible after the
patient receives a positive result on a
COVID–19 test and within 10 days of
symptom onset (NIH, September 24,
2021). Any COVID–19 medical
treatment should be used in accordance
with a licensed healthcare provider. The
screening tests required by this rule will
facilitate such treatment.
Pursuant to paragraph (g)(1)(i),
covered employers must ensure that
each employee who is not fully
vaccinated and reports at least once
every seven days to a workplace where
other individuals (e.g., coworkers,
customers) are present: (A) Is tested for
COVID–19 at least once every seven
days; and (B) provides documentation of
the most recent COVID–19 test result to
the employer no later than the 7th day
following the date on which the
employee last provided a test result.
Employers must ensure these
unvaccinated employees are tested at
least once every seven calendar days,
regardless of their work schedule. For
example, an unvaccinated part-time
employee who is scheduled to work
only every Monday and Tuesday must
still be tested at least once every seven
days. Because employees must provide
documentation of their most recent
COVID–19 test results to their
employers no later than the 7th day
following the date on which they last
provided a test result, employees may
want to set a schedule for their testing
(e.g., get a COVID–19 test every
Wednesday). A consistent testing day
may help employees ensure their
documentation is provided every seven
calendar days.
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Paragraph (g)(1)(ii) addresses
situations where an employee does not
report to a workplace where other
individuals, such as coworkers or
customers, are present during a period
of seven or more days (e.g., when an
employee is teleworking for an extended
period of time). In such cases, the
employer must ensure the employee is
tested for COVID–19 within seven days
prior to returning to the workplace and
provides documentation of that test
result to the employer upon return to
the workplace. For example, if an
unvaccinated office employee has been
teleworking for two weeks but must
report to the office, where other
employees will be present (e.g.,
coworkers, security officers, mailroom
workers), on a specific Monday to copy
and fax documents, that employee must
receive a COVID–19 test within the
seven days prior to the Monday and
provide documentation of that test
result to the employer upon return to
the workplace. The employee’s test
must occur within the seven days before
the Monday the employee is scheduled
to report to the office, but it also must
happen early enough to allow time for
the results to be received before
returning to the workplace. Similarly,
unvaccinated new hires would need to
be tested for COVID–19 within seven
days prior to reporting to a workplace
where other employees will be present
and provide documentation of their test
results no later than arrival on their first
day of work. Since point-of-care testing
that uses an antigen test allows for
results within minutes, OSHA does not
expect that scheduling tests or
providing results to employers will be
an impediment.
OSHA chose the seven-day period for
employees returning to work after more
than a week away from the workplace
based on the evidence noted above
about the effectiveness of testing at
seven-day intervals. While it considered
using a shorter time period in this
situation, OSHA concluded that it
would be less confusing for employers
to use a uniform time period for both
situations. OSHA was concerned that
requiring different time periods in the
two situations would cause confusion
among both employees and supervisors
implementing the program that would
undermine the effectiveness of the
testing scheme. OSHA seeks comment
on this issue.
An employer has some discretion
regarding how to satisfy its obligations
under paragraph (g)(1), but those
policies and procedures must be
detailed in the employer’s written
policy pursuant to paragraph (d)(2) of
this ETS. For example, the employer
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must specify how testing will be
conducted (e.g., testing provided by the
employer at the workplace, employees
independently scheduling tests at pointof-care locations, etc.). The employer
must also specify in their policy how
employees should provide their COVID–
19 test results to the employer (e.g., an
online portal, to the human resources
department). The Summary and
Explanation for paragraph (d) (Section
VI.D. of this preamble) provides
additional information regarding the
requirements of paragraph (d)(2) of this
ETS. Test results given to the employer
must contain information that identifies
the worker (i.e., full name plus at least
one other identifier, such as date of
birth), the specimen collection date, the
type of test, the entity issuing the result
(e.g., laboratory, healthcare entity), and
the test result.
If an employer is notified that an
employee has a positive screening test,
the employer must remove that
employee from the workplace pursuant
to paragraph (h)(2) of this ETS. The
employee should quarantine and the
employer must not allow the employee
to return to the workplace until they
meet the requirements in paragraphs
(h)(2)(i) through (iii). More discussion of
employee notification to their employer
of a COVID–19 positive status and
removal requirements is available in the
Summary and Explanation for
paragraph (h) (Section VI.H. of this
preamble).
OSHA expects that most screening
testing will be antigen testing that is
conducted at point-of-care locations due
to the reduced cost and faster processing
time when compared to NAAT testing
in laboratories. Most NAATs need to be
processed in a laboratory with variable
time to results (approximately 1–2
days). In contrast, most antigen tests can
be processed at the point of care with
results available in about 15–30 minutes
(CDC, October 7, 2021). Rapid point-ofcare tests are administered in various
settings, such as: Physician offices,
urgent care facilities, pharmacies,
school health clinics, workplace health
clinics, long-term care facilities and
nursing homes, and at temporary
locations, such as drive-through sites
managed by local organizations. As
explained above, COVID–19 tests that
are both self-administered and self-read
do not meet the definition of ‘‘COVID–
19 test’’ in this ETS (unless observed by
the employer or an authorized
telehealth proctor) and therefore do not
satisfy the testing requirements of
paragraph (g).
Because antigen testing in point-ofcare locations will typically produce
results within minutes, the use of
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antigen testing should not result in an
inability to provide the employer with
test results in a timely fashion.
However, the agency recognizes that
where the employee or employer uses
an off-site laboratory for testing, there
may be delays beyond the employee’s or
employer’s control. In the event that
there is a delay in the laboratory
reporting results and the employer
permits the employee to continue
working, OSHA will look at the pattern
and practice of the individual employee
or the employer’s testing verification
process and consider refraining from
enforcement where the facts show good
faith in attempting to comply with the
standard.
OSHA has determined that employers
may use pooling procedures to satisfy
the requirements of screening testing
under paragraph (g)(1). Pooling (also
referred to as pool testing or pooled
testing) means combining the same type
of specimen from several people and
conducting one laboratory test on the
combined pool of specimens to detect
SARS–CoV–2 (e.g., four samples may be
tested together, using only the resources
needed for a single test). The advantages
of pooling include preserving testing
resources, reducing the amount of time
required to test large numbers of
specimens (increasing throughput), and
lowering the overall cost of testing
(CDC, June 30, 2021).
If pooling procedures are used and a
pooled test result comes back negative,
then all the specimens can be presumed
negative with the single test. In other
words, all of the employees who
provided specimens for that pool test
can be assumed to have a negative test
result for SARS–CoV–2 infection.
Therefore, documentation of the
negative pooled test result would satisfy
the paragraph (g)(1) documentation
requirement for each employee in the
pool and no additional testing is
necessary. However, if the pooled test
result is positive, immediate additional
testing would be necessary to determine
which employees are positive or
negative. Each of the original specimens
collected in the pool must be tested
individually to determine which
specimen(s) is (are) positive. If original
specimens from the workers in a pooled
test with a positive result are
insufficient to be subsequently tested
individually, those workers in the
positive pool would need to be
immediately re-swabbed and tested. The
individual employee test results would
be necessary to satisfy the employee
documentation requirements of
paragraph (g)(1). Where pooled testing is
used (in accordance with paragraph
(g)(1)), CDC and FDA procedures and
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recommendations for implementing
screening pooled tests should be
followed (CDC, June 30, 2021; FDA,
August 24, 2020). OSHA notes that only
some tests are authorized for pooled
testing, and should be performed per the
authorization.
In a note to paragraph (g)(1), OSHA
explains that this section does not
require the employer to pay for any
costs associated with testing. As
explained in Pertinent Legal Authority,
Section II. of this preamble, the OSH
Act authorizes OSHA to require
employers to bear the costs of
compliance with occupational safety
and health standards, but OSHA has
discretion to decide whether to impose
certain costs—such as those related to
medical examinations or other tests—on
employers ‘‘[w]here [it determines that
such costs are] appropriate.’’ 29 U.S.C.
655(b)(7). OSHA has commonly
required employers to bear the costs of
compliance with standards as a cost of
doing business, including requiring
employers to bear the costs of medical
examinations and procedures (see, e.g.,
29 CFR 1910.1018(n)(1)(i) (inorganic
arsenic standard requires employers to
ensure that medical examinations and
procedures are provided ‘‘without cost
to the employee’’); see also United
Steelworkers, 647 F.2d at 1229–31
(discussing Lead standard’s medical
removal provisions and OSHA’s
authority for imposing cost of medical
removal on employers)). Requiring
employers to bear the costs of
compliance makes it more likely that
employees will take advantage of
workplace protections (see 86 FR
32605). For example, employees are
more likely to use personal protective
equipment (PPE) when employers
provide the PPE to their employees at
no cost (see 72 FR 64342, 64344).
In this ETS, OSHA has largely
required employers to bear the costs of
compliance, including the typical costs
associated with vaccination, but has
determined that it would not be
appropriate to impose on employers any
costs associated with COVID–19 testing
for employees who choose not to be
vaccinated. As explained in Need for
the ETS, Section III.B. of this preamble,
this ETS is designed to strongly
encourage vaccination because
vaccination is the most efficient and
effective control for protecting
unvaccinated workers from the grave
danger posed by COVID–19. COVID–19
testing is only required under the ETS
where an employee has made an
individual choice to forgo vaccination
and pursue a less protective option.
Given the superior protectiveness of
vaccination, and OSHA’s intent for this
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ETS to strongly encourage vaccination,
requiring employers to bear the costs of
COVID–19 testing would be counterproductive. As mentioned above,
requiring employers to pay for
workplace protections makes it more
likely that employees will take
advantage of that protection, and in this
ETS, OSHA intends to strongly
encourage employees to choose
vaccination, not regular COVID–19
testing. Because employees who choose
to remain unvaccinated will generally
be required to pay for their own COVID–
19 testing, this standard creates a
financial incentive for those employees
to become fully vaccinated and avoid
that cost.
Although this ETS does not require
employers to pay for testing, employer
payment for testing may be required by
other laws, regulations, or collective
bargaining agreements or other
collectively negotiated agreements. This
section also does not prohibit the
employer from paying for costs
associated with testing required by
paragraph (g)(1) of this section.
Otherwise, the agency leaves the
decision regarding who pays for the
testing to the employer. Because OSHA
does not specify who pays for the
testing, OSHA expects that some
workers and/or their representatives
will negotiate the terms of payment.
OSHA has also considered that some
employers may choose to pay for some
or all of the costs of testing as an
inducement to keep employees in a tight
labor market. Other employers may
choose to put the full cost of testing on
employees in recognition of the
employee’s decision not to become fully
vaccinated. It is also possible that some
employers may be required to cover the
cost of testing for employees pursuant to
other laws or regulations. OSHA notes,
for instance, that in certain
circumstances, the employer may be
required, under the Fair Labor
Standards Act, to pay for the time it
takes an employee to be tested (e.g., if
employee testing is conducted in the
middle of a work shift). The subject of
payment for the costs associated with
testing pursuant to other laws or
regulations not associated with the OSH
Act is beyond OSHA’s authority and
jurisdiction. As explained in a note to
paragraph (d) of this ETS, under various
anti-discrimination laws, workers who
cannot be tested because of a sincerely
held religious belief may ask for a
reasonable accommodation from their
employer. For more information about
evaluating requests for reasonable
accommodation for a sincerely held
religious belief, employers should
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consult the Equal Employment
Opportunity Commission’s website:
https://www.eeoc.gov/wysk/what-youshould-know-about-covid-19-and-adarehabilitation-act-and-other-eeo-laws.
Pursuant to paragraph (g)(2), if an
employee does not provide the result of
a COVID–19 test as required by
paragraph (g)(1), the employer must
keep the employee removed from the
workplace until the employee provides
a test result. This provision is
imperative because workers with
asymptomatic or pre-symptomatic
SARS–CoV–2 infection are significant
contributors to COVID–19 transmission,
and screening testing will help to
identify and remove those individuals
from the workplace. Employees
providing accurate and weekly test
results to their employer is of utmost
importance for preventing and reducing
the transmission of COVID–19 in the
workplace.
Paragraph (g)(3) provides that when
an employee has received a positive
COVID–19 test, or has been diagnosed
with COVID–19 by a licensed healthcare
provider, the employer must not require
that employee to undergo COVID–19
testing for 90 days following the date of
their positive test or diagnosis. This
provision is specifically intended to
prohibit screening testing for 90 days
because of the high likelihood of false
positive results that do not indicate
active infection but are rather a
reflection of past infection. Studies of
patients who were hospitalized and
recovered indicate that SARS–CoV–2
RNA can be detected in upper
respiratory tract specimens for up to
three months (90 days) after symptom
onset (CDC, August 2, 2021; CDC,
September 14, 2021). If employees were
to be subjected to screening tests in such
a situation it would both undermine the
confidence in the COVID–19 screening
tests and could result in a harm to the
worker of being unnecessarily removed
from the workplace and subjected to the
additional burden of unnecessary tests.
Where employers implement a
vaccination policy that allows
employees to choose to provide proof of
regular testing and wear a face covering
rather than getting vaccinated, the
employer’s policy and procedures to
implement this temporary suspension of
testing must be included in their written
workplace policy as required by
paragraph (d)(2) of this ETS.
Paragraph (g)(4) provides that the
employer must maintain a record of
each test result required to be provided
by each employee under paragraph
(g)(1) of this ETS or obtained during
tests conducted by the employer. These
records must be maintained in
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accordance with 29 CFR 1910.1020 as
an employee medical record and must
not be disclosed except as required by
this ETS or other federal law. However,
these records are not subject to the
retention requirements of 29 CFR
1910.1020(d)(1)(i) (Employee medical
records), but must be maintained and
preserved while this ETS remains in
effect.
Additionally, paragraph (l) of this ETS
includes specific timeframes for
providing access to records, including
the COVID–19 test results required by
paragraph (g)(1). As a result, the
timeframes for providing access to
employee medical records in 29 CFR
1910.1020(e) do not apply. Instead,
when providing access to an employee,
anyone with written authorized consent
from that employee, and OSHA,
employers must follow the access
timeframes set forth in paragraph (l) of
this ETS. The Summary and
Explanation for paragraph (l) (Section
VI.L. of this preamble) contains
additional information about accessing
records gathered pursuant to paragraph
(g)(1).
Finally, while the access timeframes
in 29 CFR 1910.1020(e) and retention
requirements of 29 CFR
1910.1020(d)(1)(i) do not apply to test
result records required by this ETS, the
other provisions in 29 CFR 1910.1020
do apply. For example, 29 CFR
1910.1020(h) includes requirements for
the transfer of employee medical
records when an employer ceases to do
business. Like the vaccine records
required by paragraph (e)(4) of this ETS,
and because they concern the health
status of an employee, test result records
required by paragraph (g)(1) are
employee medical records for purposes
of 29 CFR 1910.1020. These test result
records contain personally identifiable
medical information and must be
maintained in a confidential manner.
The Summary and Explanation for
paragraph (e) (Section VI.E. of this
preamble) contains additional
information about the interplay between
this ETS and OSHA’s regulation at 29
CFR 1910.1020.
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References
Bender et al., (2021, February 18). Analysis
of Asymptomatic and Presymptomatic
Transmission in SARS–CoV–2 Outbreak,
Germany, 2020. https://wwwnc.cdc.gov/
eid/article/27/4/20-4576_article. (Bender
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Byambasuren O et al. (2020, December 11).
Estimating the extent of asymptomatic
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Centers for Disease Control and Prevention
(CDC). (2021, June 30). Interim Guidance
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https://www.cdc.gov/coronavirus/2019ncov/lab/pooling-procedures.html. (CDC,
June 30, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, August 2). COVID–19
Testing Overview. https://www.cdc.gov/
coronavirus/2019-ncov/symptomstesting/testing.html. (CDC, August 2,
2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 10). Using
Antibody Tests for COVID–19. https://
www.cdc.gov/coronavirus/2019-ncov/
lab/resources/antibody-tests.html. (CDC,
September 10, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 14). Ending
Isolation and Precautions for People with
COVID–19: Interim Guidance. https://
www.cdc.gov/coronavirus/2019-ncov/
hcp/duration-isolation.html. (CDC,
September 14, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 15). Science
Brief: COVID–19 Vaccines and
Vaccination. https://www.cdc.gov/
coronavirus/2019-ncov/science/sciencebriefs/fully-vaccinated-people.html.
(CDC, September 15, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, October 7) Interim
Guidance for SARS–CoV–2 Testing in
Non-Healthcare Workplaces. https://
www.cdc.gov/coronavirus/2019-ncov/
community/organizations/testing-nonhealthcare-workplaces.html. (CDC,
October 7, 2021).
Food and Drug Administration (FDA). (2020,
August 24). Pooled Sample Testing and
Screening Testing for COVID–19. https://
www.fda.gov/medical-devices/
coronavirus-covid-19-and-medicaldevices/pooled-sample-testing-andscreening-testing-covid-19. (FDA, August
24, 2020).
Food and Drug Administration (FDA). (2021,
May 19). Antibody Testing Is Not
Currently Recommended to Assess
Immunity After COVID–19 Vaccination:
FDA Safety Communication. https://
www.fda.gov/medical-devices/safetycommunications/antibody-testing-notcurrently-recommended-assessimmunity-after-covid-19-vaccinationfda-safety. (FDA, May 19, 2021).
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coronavirus-disease-2019-covid-19emergency-use-authorizations-medicaldevices/in-vitro-diagnostics-euas. (FDA,
October 6, 2021).
Griffin JB et al. (2021, August 27). SARS–
CoV–2 infections and hospitalizations
among persons aged ≥16 years, by
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10.15585/mmwr.mm7034e5. (Griffin et
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Johansson MA et al. (2021, January 7). SARS–
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Klompas M et al., (2021, September). The
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10.7326/M21-2366. (Klompas et al.,
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Larremore DB et al. (2021, January 1). Test
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(Larremore, January 1, 2021).
Lopez Bernal et al. (2021, July 21).
Effectiveness of COVID–19 vaccines
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NEJMoa2108891. (Lopez Bernal, July 21,
2021).
National Institutes of Health (NIH). (2021,
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19. https://www.covid19treatmentguide
lines.nih.gov/management/clinicalmanagement/nonhospitalized-adults-therapeutic-management/. (NIH,
September 24, 2021).
Nishiura H et al. (2020, March 4). Serial
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(Nishiura et al., March 4, 2020).
Sah P et al. (2021, August 10). Asymptomatic
SARS–COV–2 infection: A systematic
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118(34), 1–12. https://doi.org/10.1073/
pnas.2109229118. (Sah et al., August 10,
2021).
Schulte P et al. (2021, May 19). Proposed
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2 Antigen Testing of Unexposed
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Workplaces. J Occup Environ Med. 2021
Aug; 63(8): 646–656. Published online
2021, May 19. https://www.ncbi
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. (Schulte et al., May 19, 2021).
Smith R et al. (2021, September 15).
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(Smith et al., September 15, 2021).
Tindale LC et al. (2020, June 22). Evidence
for transmission of COVID–19 prior to
symptom onset. Elife. 2020; 9: e57149.
Published 2020 Jun 22. doi:10.7554/
eLife.57149. (Tindale et al., June 22,
2020).
H. Employee Notification to Employer of
a Positive COVID–19 Test and Removal
Employers can substantially reduce
disease transmission in the workplace
by removing employees who are
confirmed to have COVID–19 based on
a COVID–19 test or diagnosis by a
healthcare provider. It is necessary that
employees who are confirmed to have
COVID–19 be removed from the
workplace to prevent transmission to
other employees. Several studies have
focused on the impact of isolating
persons with COVID–19 from others
during their likely known infectious
period, and those studies show that
isolation is a strategy that reduces the
transmission of infections. For example,
Kucharski et al. (2020) found that
transmission of SARS–CoV–2 would
decrease by 29% with self-isolation
within the household, which would
extend to 37% if the entire household
quarantined. Similarly, Wells et al.
(2021) found that isolation of
individuals at symptom onset would
decrease the reproductive rate (R0) of
COVID–19 from 2.5 to 1.6. Lastly,
Moghadas et al. (2020) reported results
that highlight the role of silent
transmission, from a combination of the
pre-symptomatic stage and
asymptomatic infections, as the primary
driver of COVID–19 outbreaks and
underscore the need for mitigation
strategies, including those that detect
and isolate infectious individuals prior
to the onset of symptoms. Isolating
contagious employees from their coworkers can prevent further spread at
the workplace and safeguard the health
of other employees.
Paragraph (h) provides that employers
must require each employee to promptly
notify the employer when the employee
receives a positive COVID–19 test or is
diagnosed with COVID–19 by a licensed
healthcare provider. This notification
must occur regardless of employee
vaccination status. As discussed in
Grave Danger (Section III.A. of this
preamble), exposure to SARS–CoV–2 in
the workplace presents a grave danger to
employees; removing those who are
confirmed to have COVID–19 from the
workplace mitigates that grave danger.
This is true even for fully vaccinated
employees since they also have the
potential to transmit COVID–19 to other
individuals, including other employees.
Because the goal of this ETS, and the
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notification requirements in this
paragraph, is to reduce transmission of
COVID–19 in the workplace, employees
are required to notify the employer of
any COVID–19 positive test or diagnosis
that they receive, not just positive
results that are received from testing
required under paragraph (g) of this
ETS.
Paragraph (h)(1) states that the
employer must require each employee
who is COVID–19 positive to notify the
employer of their COVID–19 test result
or diagnosis ‘‘promptly.’’ For employees
who are not at the workplace when they
receive a positive COVID–19 test result
or diagnosis, ‘‘promptly’’ notifying the
employer means notifying the employer
as soon as practicable before the
employee is scheduled to start their
shift or return to work. In the event that
the employee is in the workplace when
they receive a positive COVID–19 test
result or diagnosis of COVID–19,
‘‘promptly’’ notifying the employer
means notifying the employer as soon as
safely possible while avoiding exposing
any other individuals in the workplace.
The employer should establish
notification procedures and inform
employees about these procedures (see
paragraph (j)(1)), so that employees are
aware of the appropriate method for
providing this notification to their
employer. These notification procedures
can be based on the employer’s current
protocols for employees to notify the
employer if they are not able to come to
work or need to leave work because of
illness or injury. However the employer
chooses to implement its notification
procedures, it must ensure that an
employee notification of a positive
COVID–19 test or diagnoses results in
the employee’s immediate removal from
the workplace, as required under
paragraph (h)(2). For example, the
employer may require employees to
report any positive COVID–19 test or
diagnosis to a company supervisor with
the authority to temporarily remove the
employee from the workplace. If an
employer takes all steps required under
this paragraph but an employee fails to
report required information, the ETS
does not dictate that any disciplinary
action be taken against the employee. If
an employer is cited by OSHA under
this provision under such
circumstances, the employer is entitled
to contest the citation if it can establish
an employee misconduct defense in
accordance with applicable case law.
The notification requirement in
paragraph (h)(1) is an important
measure to ensure employers can take
adequate steps to protect their
employees from the hazard of COVID–
19 because it is connected to a parallel
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requirement in paragraph (h)(2) to
remove, from the workplace, any
employee who receives a positive
COVID–19 test or is diagnosed with
COVID–19. It is important to remove
employees who test positive or are
diagnosed with COVID–19 from the
workplace as soon as possible to prevent
the transmission of COVID–19 to other
employees. Therefore, the requirement
that employees promptly inform their
employer of a positive COVID–19 test
result or COVID–19 diagnosis is
necessary because this information
allows the employer to take actions to
protect other employees, including most
critically by removing employees whose
illness poses a direct threat of infection
to other employees in the workplace.
Paragraph (h)(2) requires employers to
immediately remove from the workplace
any employee, regardless of vaccination
status, who receives a positive COVID–
19 test or is diagnosed with COVID–19
by a licensed healthcare provider.
OSHA determined that directing an
employee who tests positive or is
diagnosed with COVID–19 to stay home
until return to work criteria are
achieved is critical to preventing the
transmission of COVID–19 in the
workplace. Similar to the notification
required in paragraph (h)(1), this
removal must occur regardless of
employee vaccination status since
someone who is fully vaccinated can
still transmit COVID–19 to others,
including other employees (see Grave
Danger, Section III.A. of this preamble).
OSHA notes that, in most
circumstances, any positive COVID–19
test would result in removal. However,
this is not necessarily the case where an
employer uses pooled COVID–19
testing, a method where one laboratory
test is conducted using the specimens of
several people to detect the virus that
causes COVID–19 (CDC, June 30, 2021).
If an employer conducts pooled testing
for COVID–19, a positive pooled test
result would trigger a need to
immediately re-test those employees in
the pool using an individual COVID–19
test because the positive pooled result
would not satisfy the requirements of
paragraph (g). Only those employees
who test positive on their individual retest would need to be removed from the
workplace.
OSHA intends ‘‘removal’’ under
paragraph (h)(2) to refer only to the
temporary removal from the workplace
of an employee while that employee is
infectious. The requirement in
paragraph (h)(2) to temporarily remove
a COVID–19 positive employee from the
workplace does not mean permanent
removal of an employee from their
position. Any time an employee is
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required to be removed from the
workplace under paragraph (h)(2) of this
section, the employer can require the
employee to work remotely or in
isolation if suitable work is available
and if the employee is not too ill to
work. In cases where working remotely
or in isolation is not possible, OSHA
encourages employers to consider
flexible and creative solutions, such as
a temporary reassignment to a different
position that can be performed by
telework. However, if an employee is
too ill to work, remote work should not
be required, and sick leave or other
leave should be made available as
consistent with the employer’s general
policies and practices, and as may be
required under applicable laws.
After an employee has been removed
from the workplace as required by
paragraph (h)(2), the employer must
ensure that they do not return to the
workplace until the employee meets one
of three criteria outlined in paragraphs
(h)(2)(i) through (h)(2)(iii). The purpose
of these provisions is to ensure that an
employee who has COVID–19 does not
return to work until the risk that they
will transmit the disease to others in the
workplace has been minimized. Each of
these provisions is based on the best
scientific evidence available on when a
person with COVID–19 is no longer
likely to transmit the virus.
Under paragraph (h)(2)(i), the
employee can return to work if they
receive a negative result on a COVID–19
nucleic acid amplification test (NAAT)
following a positive result on a COVID–
19 antigen test (the most common
screening test). There is a small
possibility for employees to receive false
positive test results when conducting
regular screening with an antigen test.
Positive results are usually highly
accurate at moderate-to-high peak viral
load, but false positives can occur,
depending on the course of infection
(FDA, April 2021). OSHA recognizes
that an employee might choose to seek
a NAAT test for confirmatory testing.
NAATs are considered the ‘‘gold
standard’’ for clinical diagnosis of
SARS–CoV–2 and may have a higher
sensitivity (i.e., ability to correctly
generate a positive result) than antigen
tests (CDC, September 9, 2021). If an
employee tested positive for COVID–19
via an antigen test, but then received
follow-up confirmatory testing via a
NAAT and the NAAT was negative, the
positive antigen test can be considered
a false positive and the employee can
return to work (CDC, September 9,
2021). For a more detailed discussion of
COVID–19 tests, see the Summary and
Explanation for paragraph (c) (Section
VI.C. of this preamble).
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The employee may also return to
work if they meet the return to work
criteria in CDC’s ‘‘Isolation Guidance’’
(incorporated by reference, § 1910.509)
(CDC, February 18, 2021) as described
in paragraph (h)(2)(ii). CDC’s guidance
states that a COVID–19 positive person
can stop isolating when three criteria
are met: (1) At least ten days have
passed since the first appearance of the
person’s symptoms; (2) the person has
gone at least 24 hours without a fever
(without the use of fever-reducing
medication); and (3) the person’s other
symptoms of COVID–19 are improving
(excluding loss of taste and smell). If a
person has tested positive but never
experiences symptoms, then the person
can stop isolating after ten days from the
date of their positive test. These
recommendations are based on
scientific evidence reviewed by CDC,
which indicates that levels of viral RNA
in upper respiratory tract samples begin
decreasing after the onset of symptoms
(CDC, September 14, 2021). The
rationale for including CDC’s ‘‘Isolation
Guidance’’ in the ETS was addressed in
detail in Need for Specific Provisions in
the agency’s prior rulemaking on
1910.502 (see 86 FR 32376, 32455).
Finally, the employee may return to
work, per paragraph (h)(2)(iii), if the
employee receives a return-to-work
recommendation from a licensed
healthcare provider. The appropriate
duration of removal from work for any
given individual may differ depending
on factors such as disease severity or the
health of the employee’s immune
system. For this reason, the ETS permits
employers to make decisions about an
employee’s return to work in
accordance with guidance from a
licensed healthcare provider (who
would be better acquainted with a
particular employee’s condition). If a
licensed healthcare provider
recommends a longer period of isolation
for a particular employee than the CDC’s
‘‘Isolation Guidance’’ would otherwise
recommend, then the employer would
need to abide by that longer period
rather than returning the employee to
work after ten days.
OSHA’s removal requirements as
outlined in paragraph (h)(2) are
intended to set the floor for what is
required; however, OSHA encourages
employers who are able to do so to have
a more robust program of medical
removal, as indeed some employers
have already done. In addition to
removal from the workplace based on a
positive COVID–19 test or diagnosis of
COVID–19, employers may consider
removal based on COVID–19 symptoms
or certain exposure or close contacts
employees have had outside of the
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workplace. Similarly, employers may
consider removing employees from the
workplace if the employer learns that
the employee was notified by a state or
local public health authority to
quarantine or isolate; the employer
might even be contacted by such an
authority directly. Although this ETS
does not require removal from the
workplace in those situations, the
employer might choose to remove
employees from the workplace, above
and beyond what is required by this
ETS.
Finally, the note to paragraph (h)(2)
clarifies that this ETS does not require
employers to provide paid time to any
employee for removal as a result of a
positive COVID–19 test or diagnosis of
COVID–19; however, paid time may be
required by other laws, regulations, or
collective bargaining agreements or
other collectively negotiated
agreements. On the other hand, the ETS
does not preclude employers from
choosing to pay employees for time
required for removal under this
standard. Additionally, employers
should allow their employees to make
use of any accrued leave in accordance
with the employer’s policies and
practices on use of leave. This
provision, while not placing the burden
on the employer to provide paid time,
should not be read as depriving
employees of the benefits they are
normally entitled to as part of their
employment.
Because it does not require employers
to provide paid time to employees who
are removed for a positive COVID–19
test or diagnosis of COVID–19, this ETS
differs from OSHA’s COVID–19
Healthcare ETS, which applies to
employees in the healthcare industry
who are expected to be exposed to
COVID–19, and requires paid medical
removal protection benefits
(§ 1910.502(l)(5)) for most employees.
This difference reflects the structure and
focus of this ETS relative to the
Healthcare ETS. The Healthcare ETS
requires employees to report symptoms
of COVID–19 to their employers, as well
as positive COVID–19 tests or diagnoses
(see § 1910.502(l)(2)), but does not
require employees to be regularly tested
for COVID–19. A primary function of
the payment for medical removal in that
standard is, therefore, to remove the
potential for financial disincentives that
might deter employees from reporting
any signs or symptoms of COVID–19
that they experience. Because this ETS
already requires testing for
unvaccinated workers, which should
result in employers learning of cases of
COVID–19 in unvaccinated workers,
and does not otherwise require
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employees to report signs and
symptoms of COVID–19 to their
employers, OSHA found that requiring
employer payment for removal was not
necessary in this standard.
As the note to paragraph (h) indicates,
the employer may be required to follow
other laws or regulations that would
require paid medical removal. For
example, if an employee covered by this
ETS believes they were exposed to
COVID–19 in the workplace and then
tested positive, that employee may be
entitled to workers’ compensation
benefits. Workers’ compensation is a
system already in place to provide
benefits to employees who get sick or
injured on the job from occupational
disease or a work-related injury. Some
states have expressly clarified or
expanded their workers compensation
rules to allow for COVID–19 claims
during the pandemic (see, e.g.,
Industrial Commission of Arizona, May
15, 2020; Connecticut Executive Order
No. 7JJJ, July 24, 2020; Minn. Stat. Ann.
§ 176.011 Subd. (15)(f), 2020)).
Finally, the ETS does not contain
specific requirements under this
paragraph for the employer to establish
or maintain records of employee
notifications of a positive COVID–19
test or diagnosis of COVID–19 by a
licensed healthcare provider. However,
should an employer determine that a
reported case of COVID–19 is workrelated, the employer must continue to
record that information on the OSHA
Forms 300, 300A, and 301, or on
equivalent forms, if required to do so
under 29 CFR part 1904. This also
includes confirmed cases of COVID–19
identified under paragraph (h) that an
employer determines are work-related.
Under 29 CFR part 1904, COVID–19 is
a recordable illness and employers are
responsible for recording cases of
COVID–19 if: (1) The case is a
confirmed case of COVID–19 as defined
by the Centers for Disease Control and
Prevention (CDC); (2) the case is workrelated as defined by 29 CFR part
1904.5; and (3) the case involves one or
more of the general recording criteria in
set forth in 29 CFR part 1904.7 (e.g.,
medical treatment beyond first aid, days
away from work). Under 29 CFR part
1904, employers must generally provide
access to the 300 log to employees,
former employees, and their
representatives with the names of
injured or ill employees included on the
form. If, however, the employee requests
that their name not be entered on the
300 log, the employer must treat their
illness as a privacy concern case and
may not enter their name on the log (see
29 CFR 1904.29(b)(6), (b)(7)(vi)).
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References
Centers for Disease Control and Prevention
(CDC). (2021, February 18). Isolate if you
are sick. https://www.cdc.gov/
coronavirus/2019-ncov/if-you-are-sick/
isolation.html. (CDC, February 18, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, June 30). Interim Guidance
for Use of Pooling Procedures in SARSCoV–2 Diagnostic and Screening Testing.
https://www.cdc.gov/coronavirus/2019ncov/lab/pooling-procedures.html. (CDC,
June 30, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 9). Interim
Guidance for Antigen Testing for SARSCoV–2. https://www.cdc.gov/
coronavirus/2019-ncov/lab/resources/
antigen-tests-guidelines.html. (CDC,
September 9, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 14). Ending
Isolation and Precautions for People with
COVID–19: Interim Guidance. https://
www.cdc.gov/coronavirus/2019-ncov/
hcp/duration-isolation.html. (CDC,
September 14, 2021).
Connecticut Executive Order No. 7JJJ. (2020,
July 24). Executive Order No. 7JJJ
Protection of public health and safety
during COVID–19 pandemic and
response—rebuttable presumption
regarding workers compensation benefits
related to contraction of COVID–19.
https://portal.ct.gov/-/media/Office-ofthe-Governor/Executive-Orders/LamontExecutive-Orders/Executive-Order-No7JJJ.pdf. (Connecticut Executive Order
No. 7JJJ, July 24, 2020).
Food and Drug Administration (FDA). (2021,
April). Coronavirus Disease 2019 Testing
Basics. https://www.fda.gov/media/
140161/download. (FDA, April 2021).
Industrial Commission of Arizona. (2020,
May 15). COVID–19 Workers’
Compensation Claims. https://
www.azica.gov/sites/default/files/
SPS%20-COVID-19%20FINAL.pdf.
(Industrial Commission of Arizona, May
15, 2020).
Kucharski AJ et al. (2020). Effectiveness of
isolation, testing, contact tracing, and
physical distancing on reducing
transmission of SARS–CoV–2 in
different settings: a mathematical
modelling study. The Lancet Infectious
Disease. 2020 Oct; 20(10): 1151–1160.
doi:10.1016/S1473–3099(20)30457–6.
Epub 2020 Jun 16. PMID: 32559451;
PMCID: PMC7511527. (Kucharski et al.,
2020)
Minnesota Statutes Annotated, Section
176.011 Definitions. Subd. 15(f). (2020).
https://www.revisor.mn.gov/statutes/
cite/176.011/pdf. (Minn. Stat. Ann.
§ 176.011 Subd. (15)(f), 2020)
Moghadas S et al. (2020, July 6). The
implications of silent transmission for
the control of COVID–19 outbreaks.
Proceedings of the National Academy of
Sciences of the United States of America,
117(30), 17513–17515. doi:https://
doi.org/10.1073/pnas.2008373117.
(Moghadas et al., July 6, 2020)
Wells CR et al. (2021). Optimal COVID–19
quarantine and testing strategies. Nature
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Communications 2021 Jan 7; 12(1): 356.
doi:10.1038/s41467–020–20742–8.
PMID: 33414470; PMCID: PMC7788536.
(Wells et al., 2021)
I. Face Coverings
Paragraph (i) of this standard
addresses the use of face coverings. As
previously discussed in Grave Danger
(Section III.A. of this preamble),
COVID–19 spreads when an infected
person breathes out droplets and very
small particles that contain the virus.
These droplets and particles can be
breathed in by other people or land on
their eyes, noses, or mouth. Face
coverings reduce the risk of droplet
transmission of COVID–19. The CDC
recommends that people who are not
fully vaccinated wear a face covering
(e.g., a mask) in indoor public places.
(CDC, July 14, 2021). Additional
discussion on the efficacy of face
coverings is provided below.
Face coverings are simple bidirectional barriers that tend to keep
droplets, and to a lesser extent airborne
particulates, on the side of the filter
from which they originate. An
explanation of the term ‘‘face covering’’,
as used in this ETS, can be found in the
Summary and Explanation for
paragraph (c) (Section VI.C. of this
preamble). The CDC (August 13, 2021)
recommends unvaccinated people wear
face coverings when indoors to prevent
getting and spreading COVID–19 mostly
by blocking large respiratory droplets
from either leaving the face covering of
the wearer (source control) or by
preventing someone else’s droplets from
reaching the wearer (personal
protection). The need for face coverings
in workplaces applies particularly to
unvaccinated workers due to their
increased potential for asymptomatic
and pre-symptomatic transmission of
COVID–19.
The CDC Healthcare Infection Control
Practices Advisory Committee’s
(HICPAC) ‘‘Isolation Guidance’’ for
healthcare settings has long
recommended facemasks, among other
controls, to prevent the transmission of
viruses that cause respiratory illnesses
(Siegel et al., 2007). Face coverings play
an important dual role in protecting
workers from droplet transmission of
COVID–19. One of their key purposes is
to function as source control. In this
role, the face covering helps protect
people around the wearer by reducing
the number of infectious droplets
released into the air by the wearer and
limiting the distance traveled by any
particles that are released. As a result,
anyone near the wearer is exposed to
fewer (if any) droplets and the
transmission risk is lowered (OSHA,
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January 28, 2021; Siegel et al., 2007).
Face coverings also provide a degree of
particulate filtration to reduce the
amount of inhaled particulate matter,
meaning face coverings can help protect
the wearer themselves, by reducing their
inhalation of droplets produced by an
infected person nearby (CDC, May 7,
2021; Brooks et al., February 10, 2021).
The efficacy of any given face
covering in either functioning as source
control or protecting the wearer will
depend on the construction, design, and
material used for the face covering. The
CDC has stated that ‘‘masks are
primarily intended to reduce the
emission of virus-laden droplets
(‘‘source control’’), which is especially
relevant for asymptomatic or
presymptomatic infected wearers who
feel well and may be unaware of their
infectiousness to others, and who are
estimated to account for more than 50%
of transmissions’’ (CDC, May 7, 2021).
The CDC has also stated that: ‘‘Multilayer cloth masks block release of
exhaled respiratory particles into the
environment, along with the
microorganisms these particles carry.
Cloth masks not only effectively block
most large droplets (i.e., 20–30 microns
and larger) but they can also block the
exhalation of fine droplets and particles
(also often referred to as aerosols)
smaller than 10 microns; which increase
in number with the volume of speech
and specific types of phonation. Multilayer cloth masks can both block up to
50–70% of these fine droplets and
particles and limit the forward spread of
those that are not captured. Upwards of
80% blockage has been achieved in
human experiments that have measured
blocking of all respiratory droplets, with
cloth masks in some studies performing
on par with surgical masks as barriers
for source control’’ (CDC, May 7, 2021).
Thus, the construction of the face
covering is a significant factor in
determining its efficacy at reducing
COVID–19 transmission.
While face coverings are generally
effective as source control, because of
the potential variations in protective
properties, OSHA has not considered
face coverings that are not certified to a
consensus standard to be personal
protective equipment (PPE) under
OSHA’s general PPE standard (29 CFR
1910.132), as there is insufficient
assurance that any given face covering
is of safe design and construction for the
work to be performed, which is required
by the PPE standard. Despite these
limitations, many of the available face
coverings have proven to be effective at
providing source control, and where a
face covering is also effective in
providing personal protection, the
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wearer will be at reduced risk of, and
could be protected from, infection.
Accordingly, over the course of the
pandemic, through its guidance, OSHA
has strongly encouraged workers to
wear face coverings when they are in
close contact with others to reduce the
risk of spreading COVID–19 despite the
shortcomings that have prevented the
agency from considering them to be PPE
that complies with the requirement of
the PPE standard. To enhance the
effectiveness of any face covering
required by this standard, this ETS
imposes certain minimum design
criteria, consistent with CDC
recommendations. Thus, the face
covering must consist of at least two
layers of material that is either tightly
woven or non-woven, and the face
covering must not have visible holes or
openings. CDC has found face coverings
that are tightly woven and made with at
least two layers are more effective at
filtering droplets than face coverings
that are loosely woven or consist of a
single layer of fabric (CDC, May 7, 2021;
Ueki et al., June 25, 2020).
OSHA’s determination on the
importance of face coverings is
supported by a substantial body of
evidence. As described in further detail
below, consistent and correct use of face
coverings is widely recognized and
scientifically supported as an important
evidence-based strategy for COVID–19
control. Accordingly, with specific
exceptions relevant to outdoor areas and
vaccinated persons, the CDC
recommends everyone two years of age
and older wear a face covering in public
settings and when around people
outside of their household (CDC, August
13, 2021). And, on January 21, 2021,
President Biden issued Executive Order
13998, which recognizes the use of face
coverings or facemasks as a necessary,
science-based public health measure to
prevent the spread of COVID–19, and
therefore directed regulatory action to
require that they be worn in compliance
with CDC guidance while traveling on
public transportation (e.g., buses, trains,
subway) and while at airports
(Executive Order 13998, 86 FR 7205,
7205 (Jan. 21, 2021); CDC, February 2,
2021). Similarly, the World Health
Organization (WHO) has recognized face
coverings as a key measure in
suppressing COVID–19 transmission,
and thus, saving lives. The WHO
observes that face coverings serve two
purposes, to both protect healthy people
from acquiring COVID–19 and to
prevent sick people from further
spreading it. Since December of 2020,
the WHO has recommended that the
general public wear face coverings in
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indoor settings and in outdoor settings
where physical distancing cannot be
maintained (WHO, December 1, 2020).
In the United States, several states
have imposed statewide face covering
mandates in order to mitigate the spread
of COVID–19. One study examined data
on statewide face covering mandates
during March 1–October 22, 2020, and
found that statewide face covering
mandates were associated with a
decline in weekly COVID–19–associated
hospitalization growth rates by up to 5.6
percentage points for adults aged 18–64
years after mandate implementation,
compared with growth rates during the
4 weeks preceding implementation of
the mandate (Joo et al., February 12,
2021). Similarly, another study
examined the association of state-issued
face covering mandates with COVID–19
cases and deaths during March 1–
December 31, 2020, and found
mandating face coverings was
associated with a decrease in daily
COVID–19 case and death growth rates
within 20 days of implementation (Guy
et al., March 12, 2021).
School face covering policies for
students, staff members, faculty, and
visitors are associated with a reduction
in COVID–19 outbreaks. Between July
15 and August 31, 2021, schools in
Arizona were analyzed for school mask
policies, which provided that all
persons, regardless of vaccination
status, were required to wear a mask
indoors. The odds of a school-associated
COVID–19 outbreak in schools without
a mask requirement were 3.5 times
higher than those in schools with an
early mask requirement (Odds Ratio =
3.5; 95% Confidence Interval = 1.8–6.9)
(Jehn et al., October 1, 2021).
The effectiveness of face coverings in
limiting the emission and spread of
droplets has also been demonstrated in
numerous studies. For example,
multiple studies in which droplets were
visualized while individuals were
talking or a manikin was used to
simulate coughs and sneezes
demonstrated that two-layer face
coverings limited the number of
droplets released into the air, and
limited the forward spread of those not
captured (Fischer et al., September 2,
2020; Verma et al., June 30, 2020; CDC,
May 7, 2021).
The effectiveness of face coverings in
preventing infections was also observed
in a number of epidemiological studies.
For example, in June of 2020 an
outbreak was studied aboard the USS
Theodore Roosevelt, an environment
notable for congregate living quarters,
close working environments, and a
sample of mostly young, healthy adults.
The investigation found that use of face
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coverings on board was associated with
a 70% reduced risk of transmission,
which demonstrates that the use of face
coverings, especially among
asymptomatic cases, can help mitigate
future transmission (Payne et al., June
12, 2020). Another publication, released
in July of 2020, included an
investigation of a high-exposure event
among 139 clients exposed to two
symptomatic hair stylists with
confirmed cases of COVID–19. Both of
the stylists and all of their clients wore
face coverings during their interactions.
Among 67 clients subsequently tested
for COVID–19, all test results were
negative; no symptomatic secondary
cases were reported by any clients,
including those who were not tested.
The study concluded that the strict use
of face coverings likely mitigated the
spread of COVID–19 (Hendrix et al.,
July 17, 2020).
Several other observational
epidemiological studies have reviewed
data regarding the ‘‘real-world’’
effectiveness of face covering usage.
First, in a study of 124 Beijing
households with one or more
laboratory-confirmed case of COVID–19,
face covering use by both the index
patient and all family contacts before
the index patient developed symptoms
reduced secondary transmission (i.e.,
infections occurring within two weeks
of symptom onset in the index case)
within the households by 79% (Wang et
al., May 11, 2020). Second, a
retrospective case-control study from
Thailand documented that, among more
than 1,000 persons interviewed as part
of contact tracing investigations, those
who reported having always worn a face
covering during high-risk exposures
experienced a greater than 70% reduced
risk of infection compared with persons
who did not wear face coverings under
these circumstances. The risk for
infection was not significantly lower in
those who reported only sometimes
wearing face coverings compared to
those who did not wear face coverings
at all. This evidence supports the
conclusion that face coverings must be
worn consistently and correctly to
meaningfully reduce the risk of
infection (Doung-ngern et al., September
14, 2020).
Community-level analyses have also
confirmed the benefit of universal face
covering use in: A unified hospital
system (Wang et al., July 14, 2020); a
German city (Mitze et al., June 1, 2020);
a U.S. state (Gallaway et al., October 6,
2020); a panel of 15 U.S. states and
Washington, DC (Lyu and Wehby, June
16, 2020; Hatzius et al., June 29, 2020);
as well as both Canada (Karaivanov et
al., October 1, 2020) and the U.S.
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(Chernozhukov et al., September 15,
2020) nationally. Each community
analysis demonstrated that, following
universal face covering directives from
both organizational and political
leadership, new infections were shown
to fall significantly. These analyses have
also shown reductions in mortality and
the need for lockdowns, with their
associated monetary/gross domestic
product losses (Leffler et al., December
2, 2020; Hatzius et al., June 29, 2020).
Additionally, multiple investigations
involving infected passengers aboard
flights longer than ten hours strongly
suggest that face covering usage
prevented in-flight transmissions, as
demonstrated by the absence of
infection developing in other passengers
and crew in the 14 days following
exposure (Schwartz et al., April 14,
2020; Freedman and Wilder-Smith,
September 25, 2020).
Researchers from the COVID–19
Systematic Urgent Review Group Effort
investigated the effects of face coverings
and eye protection on virus
transmission in both healthcare and
non-healthcare settings. They identified
172 observational studies for their
systematic review and 44 comparative
studies for their meta-analysis,
including data on 25,697 COVID–19,
SARS, or MERS patients. They
concluded for the general public, based
mainly on evidence from face covering
use within households and among
contacts of cases, that disposable
surgical masks or face coverings
(reusable multi-layer cotton face
coverings) are associated with
protection from viral transmission.
Through the meta-analysis, combining
39 of the studies’ results, they found a
14.3% reduction in the difference of
anticipated absolute effect (e.g., the
chance of viral infection or
transmission) between no face covering
and face covering groups (Chu et al.,
June 27, 2020).
Ueki et al. (June 25, 2020) evaluated
the effectiveness of cotton face
coverings, facemasks, and N95s (a
commonly used respirator) in
preventing transmission of SARS–CoV–
2 using a laboratory experimental
setting with manikins. The researchers
found that all offerings provided some
measure of protection as source control,
limiting droplets expelled from both
infected and uninfected wearers. For
instance, when spaced roughly 20
inches apart, an uninfected person can
reduce inhalation of infectious virus by
37% by wearing a cotton face covering.
If only the infected person wears a
cotton face covering, the amount
breathed in by the uninfected recipient
is reduced by 57%. However, if both
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individuals wear a cotton face covering,
the exposure is reduced 67%. If both are
wearing facemasks, exposure is reduced
by 76%. When an infected individual
wore an N95 respirator, exposure was
reduced by 96% or, when the seams
were taped, 99.7%.
As demonstrated by the studies above,
proper face covering usage leads to a
substantial reduction in the emission of
virus-containing droplets and
consequent transmission of the virus.
This is especially critical for
asymptomatic or pre-symptomatic
infected wearers who feel well and may
not be taking other preventative
measures—like self-isolation—because
they are unaware of their infectiousness
to others. Combined, these individuals
are estimated to account for more than
50% of COVID–19 transmissions
(Honein et al., December 11, 2020;
Moghadas et al., July 6, 2020; Johansson
et al., January 7, 2021). This figure could
be substantially reduced if face
coverings are required, even for
individuals who do not feel sick. Face
covering use is also especially important
in indoor spaces (Honein et al.,
December 11, 2020). The studies
reviewed above show that face
coverings reduce the release of droplets
but do not completely eliminate them.
CDC guidance affirms that COVID–19
pandemic control requires face covering
use (Honein et al., December 11, 2020;
CDC, May 7, 2021). Similarly, the WHO
advises face covering use as a critical
measure of a comprehensive package of
prevention and control measures to
limit the spread of COVID–19 (WHO,
December 1, 2020).
Although increasing COVID–19
vaccination coverage remains the most
effective means to achieve control of the
pandemic, additional layered
prevention strategies will be needed in
the short term to minimize preventable
morbidity and mortality among
unvaccinated individuals. Unvaccinated
individuals remain at substantial risk
for infection, severe illness, and death,
especially in areas where the level of
SARS–CoV–2 community transmission
is high (discussed in detail in Grave
Danger (Section III.A. of this preamble)).
Among strategies to prevent COVID–19,
CDC recommends all unvaccinated
individuals wear face coverings in
public indoor settings. A proven
effective strategy against SARS–CoV–2
transmission, beyond vaccination,
includes using face coverings
consistently and correctly (Christie et
al., July 30, 2021).
The agency is not requiring the use of
face coverings by workers who are fully
vaccinated because vaccination is
sufficient to reduce the grave danger to
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themselves or others. While vaccination
is sufficient to reduce grave danger to
the workers themselves, the agency
recognizes that there may still be
residual risk (e.g., breakthrough
infections); severe health outcomes
among vaccinated workers, however, are
unlikely. Vaccination is also sufficient
to reduce the grave danger that fully
vaccinated workers present to others
given the reduced likelihood of
transmission (see Grave Danger in
Section III.A. of this preamble).
Nonetheless, the use of face coverings
by fully vaccinated workers, while not
required by this ETS, is strongly
encouraged in a wide range of
circumstances to reduce the overall risk
of transmitting COVID–19, particularly
in areas of substantial or high
transmission, when indoors and when
in crowded outdoor areas. The use of
face coverings by customers and visitors
to workplaces is also beneficial in
reducing the overall risk of workplace
transmission of COVID–19.
OSHA has always considered
recognized consensus standards, with
design and construction specifications,
when determining the PPE requirements
of the agency’s standards. The OSH Act
(29 U.S.C. 655(b)(8)) requires the agency
to generally give deference to consensus
standards unless setting its own
specifications would better effectuate
the purposes of the Act. The agency’s
standards generally require PPE to
conform to the specifications in
consensus standards through
incorporation by reference (e.g., eye and
face protection, head protection, foot
protection). ASTM released a
specification standard on February 15,
2021, to establish a national standard
baseline for barrier face coverings
(ASTM F3502–21). OSHA considered,
as required, incorporation of ASTM
F3502–21 in this ETS. However, the
agency has determined that it is
infeasible for the timeframe of this ETS
to incorporate this consensus standard
or to otherwise establish additional
criteria for face coverings beyond that
already recommended by the CDC due
to the time needed to manufacture and
distribute any new product. OSHA
notes the CDC’s guidance on types of
masks, including those that meet ASTM
F3502–21 requirements, and respirators
as helpful to employers and workers in
selecting an appropriate product (CDC,
September 23, 2021).
Relatedly, OSHA has previously
established that medical facemasks are
essential PPE for workers in healthcare
and associated industries, and are
already used by workers under both the
general PPE standard (29 CFR
1910.132), and more specifically, the
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Bloodborne Pathogens standard (29 CFR
1910.1030). Facemasks are intended for
a medical purpose, such as prevention
of infectious disease transmission
(including uses related to COVID–19).
Facemasks can function as a barrier to
protect the wearer from hazards such as
splashes or large droplets of blood and
bodily fluids. Facemasks, such as
surgical masks, must be FDA-cleared or
authorized by FDA, including under an
EUA and provide a similar or greater
level of protection when serving the
purposes of a face covering. Respirators
are another type of personal protective
device that OSHA has regulated under
the Respiratory Protection standard (29
CFR 1910.134).
The best available experimental and
epidemiological data support consistent
use of face coverings by unvaccinated
workers in work settings to reduce the
spread of COVID–19 through droplet
transmission. As discussed in Need for
the ETS (Section III.B. of this preamble),
adopting face covering policies is
necessary, as part of a strategy combined
with testing, to protect employees from
exposure to COVID–19. Requiring
unvaccinated workers to wear face
coverings in the workplace will reduce
the likelihood that, in conjunction with
the testing (paragraph (g)) and removal,
of infected workers, (paragraph (h))
requirements, they will spread the virus
to others, including other unvaccinated
coworkers. Based on the proven
effectiveness of face covering use,
OSHA’s COVID–19 ETS includes
necessary provisions for required use of
face coverings by unvaccinated workers
and provisions to allow vaccinated
workers and customers and visitors to
wear face coverings or respirators as a
component of reducing the overall risk
of COVID–19 transmission in the
workplace.
The benefits that result from the use
of face coverings for preventing
transmission of COVID–19 are derived
from the combination of source control
(i.e., reducing the spread of large
respiratory droplets to others by
covering an infected person’s mouth
and nose) and some personal protection
for the wearer, as was discussed above
in the Need for Face Coverings section.
Face coverings are a vital layer of
protection, and the benefit to any given
individual increases with increasing
community use. Paragraph (i) contains
requirements for the use of face
coverings by each employee who is not
fully vaccinated, as well as alternatives
to face coverings (e.g., facemasks,
respirators) that may be acceptable in
some situations (described in detail
below). As defined in paragraph (c), a
face covering means a covering that
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completely covers the nose and mouth
of the wearer, excluding face shields,
which is made with two or more layers
of a breathable fabric that is tightly
woven, is secured to the wearer’s head
with ties, ear loops, or elastic bands that
go behind the head, and is a solid piece
of material without slits, exhalation
valves, visible holes, or other openings
in the material. This definition
encompasses face coverings that
otherwise meet the definition of face
covering under paragraph (c), but
include clear plastic windows, such as
those utilized by persons
communicating with those who are deaf
or hard-of-hearing or when seeing a
person’s mouth is otherwise important.
Face coverings can be manufactured or
homemade, and they can incorporate a
variety of designs, structures, and
materials. Face coverings can be
disposable or reusable. Face coverings
do not have to meet a consensus
standard, although they might. Apart
from any applicable FDA or NIOSH
regulatory requirements that might
otherwise apply, such requirements are
not required solely for the purposes of
meeting the requirements of this
standard.
As a general rule, OSHA has authority
to, and does, require employers to bear
the costs for protective equipment,
among other worker protections,
required by an OSHA standard. See,
e.g., 29 CFR 1910.1018(j) (requiring the
employer to provide protective clothing
at no cost to the employee). However, in
limited circumstances, OSHA has
chosen not to require employers to pay
for some forms of non-specialized
protective equipment, such as every-day
clothing, products providing weatherrelated protection, and non-specialized
equipment that the employee wears off
the job site. See 29 CFR 1910.132(h)(2)–
(5). Like the analogous situations listed
above, here employees may use their
personal face coverings in a variety of
circumstances on and off the job site as
part of their every-day protection.
Because the types of face coverings
permitted under this ETS are widely
used and readily available, (see
Technological Feasibility (Section IV.A.
of this preamble)), employees will have
no difficulty obtaining them. OSHA is
requiring employers to bear the costs for
employee vaccination, because it is the
more protective control, (Need for the
ETS (Section III.B. of this preamble).
OSHA does not believe it appropriate to
impose the costs of personal face
coverings on an employer where an
employee has made an individual
choice to pursue a less protective
option. For these reasons, OSHA has
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determined not to impose the costs of
face coverings on the employer as a
requirement under this ETS.
Paragraph (i)(1) requires employers to
ensure that each employee who is not
fully vaccinated wears a face covering
when indoors or when occupying a
vehicle with another person for work
purposes, except (i) when an employee
is alone in a room with floor to ceilings
windows and a closed door. However, if
that employee exits the room or another
individual enters the room, they are
required to wear a face covering. The
second exception is (ii) for a limited
time while an employee is eating or
drinking at the workplace or for
identification purposes in compliance
with safety and security requirements.
Under this exception, employees are not
required to wear face coverings during
the limited time while eating or
drinking at the workplace. Employers
may also let employees eat or drink
outside where there may be more space
and reduced risk of transmission.
Additionally, under the exception in
paragraph (i)(1)(ii), employees are not
required to wear a face covering for a
limited time for identification purposes
in compliance with safety and security
requirements. This means that an
unvaccinated employee can temporarily
remove their face covering when at a
security checkpoint within their
worksite and when identification is
otherwise required.
Another exception for required face
coverings is under paragraph (i)(1)(iii)
for when an employee is wearing a
respirator or facemask in accordance
with other OSHA standards (e.g.,
1910.134, 1910.504, 1910.1030,
1910.502). Facemask or respirator use in
accordance with other OSHA standards
takes precedence over face covering use
in this ETS. For example, OSHA
standard 1910.1030 has requirements
for facemasks in healthcare settings and
requires that workers should continue to
use the required facemask appropriate
for that setting. Another example may
include a worker who is required to use
a respirator under 1910.134 for
workplace exposure to harmful dusts,
where effective engineering controls are
not feasible; that worker should
continue to use the required respirator.
Employees must resume wearing a face
covering when not engaged in the
activity where a facemask or respirator
is required as an essential part of their
job. The last exception, contained in
paragraph (i)(1)(iv), is for a very limited
set of circumstances where employers
can show that the use of the face
covering is infeasible or creates a greater
hazard. Situations where it is important
to see an employee’s mouth for reasons
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related to their job duties, or their job
requires the use of their uncovered
mouth, or when the use of a face
covering presents a risk of serious injury
or death to the employee, would also be
covered under this provision. As has
been previously discussed in Summary
and Explanation for paragraph (d)
(Section VI.D. of this preamble), OSHA
recognizes that there may be certain
workers who may not be able to wear a
face covering due to a disability or
sincerely held religious belief and are
entitled to an accommodation.
If employers receive accommodation
requests relating to face coverings or
other protective gear, for example due to
disability or religious garb or grooming,
they should evaluate those requests
under applicable laws (EEOC, October
25, 2021).
Paragraph (i)(2) requires that
employers ensure that any face covering
required to be worn by this section is:
(i) Worn by the employee to fully cover
the employee’s nose and mouth; and (ii)
replaced when wet, soiled, or damaged
(e.g., is ripped, has holes, or has broken
ear loops). To be worn properly, face
coverings must completely cover the
wearer’s mouth and nose and must fit
snugly against the sides of the face
without gaps. Gaps can let air with
respiratory droplets leak in and out
around the edges of the mask. Face
coverings with a nose wire help to avoid
issues with glasses fogging and create a
snug fit. Workers can also use a mask
fitter or brace over a disposable mask or
a cloth mask to prevent air from leaking
around the edges of the mask. To ensure
face coverings are worn properly, an
employer might appoint a manager or
senior employee to check that each
unvaccinated employee is properly
wearing a face covering at the start of
and throughout each shift. Many aspects
of proper mask use are easily observable
(e.g., covering the mouth and nose, as
well as no observable gaps).
Additionally, employers may consider
utilizing workplace announcements
(email messages, safety talks, etc.) or
displaying signs or posters throughout
the facility about proper face covering
usage.
The employer must ensure that
employees replace face coverings when
wet, soiled, or damaged (paragraph
(i)(2)(ii)). Face coverings can become
soiled by splashes, sprays, or splatters,
from contact with a contaminated
surface, or by touching/adjusting them
with contaminated hands. Damaged face
coverings may not fit properly and thus
will have reduced effectiveness.
Employees who work where there is
potential for spills, sprays, or splashes
may need to change or replace their face
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coverings more frequently (e.g., in food,
meat, or poultry processing plants;
water, sanitation, or wastewater
treatment facilities; or restaurants). As
note 1 to paragraph (i) addresses, face
shields may be worn in addition to face
coverings to prevent them from getting
wet and soiled. For work where face
coverings are expected to become dirty
or soiled less frequently, employees may
only need to replace their face coverings
daily (e.g., in retail or office buildings).
Regardless of work location, reusable
face coverings can become soiled after
each use and may be contaminated with
bacteria and viruses, including the virus
that causes COVID–19. To ensure
performance and minimize the risk of
contaminating employees after contact
with a soiled face covering, as described
previously, the CDC recommends
washing them whenever they get dirty,
but at least once a day. The CDC also
has guidance on the selection, proper
wearing, cleaning, and storage of face
coverings (CDC, August 13, 2021).
The employer must not prevent any
employee, regardless of vaccination
status, from voluntarily wearing a face
covering or facemask unless the
employer can demonstrate that doing so
would create a hazard (paragraph (i)(3)).
While vaccination greatly reduces the
risk of the most severe consequences of
COVID–19 (e.g. hospitalizations and
fatalities) to workers, it does not reduce
the risk to zero and thus workers must
be permitted to wear face coverings or
facemasks even when not required to in
order to allow the workers to further
address residual risk. The agency has
determined this provision is necessary
because employees may themselves
have additional medical risk factors that
employers may or may not be aware of,
and which require enhanced
precautions. Similarly, employees may
live with or have frequent contact with
family members or others who have
enhanced risk if infected with COVID–
19 and thus justify assuring the
employees’ ability to take reasonable
precautions to protect their own health
and safety or that of loved ones.
Paragraph (i)(4) states that the
employer must permit the employee to
wear a respirator instead of a face
covering whether required or not (i.e.,
without regard to vaccination status),
and the employer may provide
respirators to the employee, even if not
required. This means that when a face
covering is not required by paragraph
(i)(1), the employer must permit the
employee to wear a respirator or the
employer may even provide a respirator;
in such circumstances, the employer
must also comply with 1910.504 (the
mini respiratory protection program).
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Respirators, as defined in paragraph (c),
are a type of PPE that are certified by
NIOSH or authorized under an
Emergency Use Authorization (EUA) by
the FDA, and protect against airborne
hazards by removing specific air
contaminants from the ambient
(surrounding) air or by supplying
breathable air from a safe source.
Respirator use can provide an additional
level of comfort and protection beyond
that provided by face coverings for
employees in circumstances that do not
require a respirator to be used. As
discussed previously, the agency has
determined that workers need the
ability to wear PPE, even when it is not
required, in order to address residual
risk and due to health conditions that
either they or their close contacts may
have that warrant enhanced
precautions. For a more in-depth
description of the mini respiratory
protection program, see the preamble to
the Healthcare ETS (86 FR 32615–
32617). OSHA intends the mini
respirator protection program to be
preserved for the duration of this ETS,
and any references relied upon by
OSHA in those sections of the
Healthcare ETS are also incorporated
explicitly into the rulemaking docket for
this ETS.
The mini respiratory protection
program is designed to strengthen
employee protections with a small set of
provisions for the safe use of respirators
designed to be easier and faster to
implement than the more
comprehensive respiratory protection
program under 29 CFR 1910.134. This
ETS is addressing an emergency health
crisis, so it is critical for employers to
be able to get more employee protection
in place quickly. OSHA expects that this
approach will facilitate additional
employee choice for the additional
protection provided by respirators while
reducing disincentives that may have
discouraged employers from allowing or
voluntarily providing respirators. A
mini respirator program is therefore an
important control to protect employees
from the hazard posed by COVID–19.
The mini respiratory protection
program is primarily intended to be
used for addressing circumstances
where employees are not exposed to
suspected or confirmed sources of
COVID–19, but where respirator use
could offer enhanced protection to
employees. Examples include when a
respirator could offer enhanced
protection in circumstances where a less
protective (in terms of filtering and fit)
face covering is required under the ETS
(See 29 CFR 1910.501(i)(1)). The
decision to use a respirator in place of
a face covering could be due to the
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higher filter efficiency and better sealing
characteristics of respirators when
compared to face coverings. For
additional discussion, the rationale for
the mini respiratory protection program
was addressed in detail in Need for
Specific Provisions in the agency’s prior
rulemaking on 1910.504, and the
requirements of the mini respiratory
protection program section are
discussed in Summary and Explanation
in the agency’s prior rulemaking on
1910.504.
As required by paragraph (i)(5), the
employers must not prohibit customers
or visitors from wearing face coverings.
Face coverings are a vital layer of
protection against the risk of COVID–19.
(See the discussion earlier in this
section on the benefits to individuals
associated with increased community
use.) This provision is necessary
because increased use of face coverings
also reduces the overall risk of COVID–
19 transmission from the customers and
visitors to workers, both unvaccinated
and vaccinated alike. Additionally, it
allows customers and visitors to protect
their own health and safety. Employers
may even want to create a policy
encouraging the use of face coverings by
anyone who enters the business; they
are encouraged to coordinate with state
and local health officials to obtain and
respond appropriately to timely and
accurate information (e.g., level of
community transmission, health system
capacity, vaccination coverage, capacity
for early detection of increases in
COVID–19 cases, and populations at
risk for severe outcomes from COVID–
19). Local conditions will influence the
decisions that public health officials
make regarding community-level
strategies. Additionally, workers and
their representatives may also negotiate
additional face covering measures not
required by the ETS through collective
bargaining agreements or other
collectively negotiated agreements.
Lastly, for the reasons explained
above, note 2 to paragraph (i) clarifies
that this section does not require the
employer to pay for any costs associated
with face coverings. However, the note
also makes clear that this section does
not prohibit the employer from paying
for costs associated with face coverings
required by this section. OSHA notes
that employer payment for face
coverings may be required by other
laws, regulations, or collective
bargaining agreements or other
collectively negotiated agreements.
Additionally, workers and their
representatives may also negotiate
employer payment for face coverings
not required by the ETS through
collective bargaining agreements or
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other collectively negotiated
agreements.
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(Siegel et al., 2007)
Ueki H et al. (2020, October 21). Effectiveness
of Face Masks in Preventing Airborne
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Transmission of SARS–CoV–2. mSphere
5: e00637–20. https://doi.org/10.1128/
mSphere.00637-20. (Ueki et al., October
21, 2020)
Verma S et al. (2020, June 30). Visualizing
the effectiveness of face masks in
obstructing respiratory jets. Physics of
Fluids, 32(6), 061708. doi: https://
doi.org/10.1063/5.0016018. (Verma et al.,
June 30, 2020)
Wang X et al. (2020, July 14). Association
between universal masking in a health
care system and SARS–CoV–2 positivity
among health care workers. Journal of
the American Medical Association,
324(7), 703–704. doi: 10.1001/
jama.2020.12897. (Wang et al., July 14,
2020)
Wang Y et al. (2020, May 11). Reduction of
secondary transmission of SAR–CoV–2
in households by face mask use,
disinfection and social distancing: A
cohort study in Beijing, China. BMJ
Global Health, 5, e002794. doi: 10.1136/
bmjgh–2020–002794. (Wang et al., May
11, 2020)
World Health Organization (WHO). (2020,
December 1). Mask use in the context of
COVID–19. https://www.who.int/
emergencies/diseases/novel-coronavirus2019/advice-for-public/when-and-howto-use-masks. (WHO, December 1, 2020)
J. Information Provided to Employees
In order to successfully implement
the provisions of the ETS, it is critical
that employers provide relevant
information to employees. Employers
must provide employees with the
information specified in paragraph (j),
an essential part of this ETS, because it
helps to ensure that employees
understand both their rights and
responsibilities under the ETS and their
employer’s policies and procedures. The
ETS cannot be effective if employees do
not have sufficient knowledge and
understanding of the requirements of
the ETS, their employers’ policies and
procedures, information about available
COVID–19 vaccines, their protections
against retaliation and discrimination,
and the potential penalties for
knowingly providing false information
to their employer.
Paragraph (j) provides that employers
must provide the required information
to each employee in a language and at
a literacy level the employee
understands. This means that if an
employer has employees that speak
different languages or are at different
literacy levels, the employer must
present information in a way that
ensures each employee can understand
it. This may require an employer to
create different materials for different
groups of employees (e.g., materials in
different languages). When information
must be translated into different
languages, employers must ensure the
translation is one the employees can
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understand. When an employer
provides employees with the required
information in a manner employees
understand, they help ensure that their
implementation of this ETS is
successful.
The manner in which employers
provide the required information to
employees may vary based on the size
and type of workplace. Employers have
flexibility to communicate this
information to employees using any
effective methods that are typically used
in their workplaces, and may choose
any method of informing employees so
long as each employee receives the
information specified in the standard in
a language and at a literacy level they
understand. For example, an employer
may provide this information to
employees through email
communications, printed fact sheets, or
during a discussion at a regularly
scheduled team meeting. To ensure
comprehension of the information
provided, employers can identify a
point-of-contact for employees who
have questions about the information
provided.
Paragraphs (j)(1)–(4) specify the
information that employers must
provide to employees. Paragraph (j)(1)
requires employers to provide each
employee with information regarding
the requirements of § 1910.501 and any
policies and procedures the employer
establishes to implement this ETS. The
information provided to employees
must cover any employer policies under
paragraph (d), including the details of
the employer’s vaccination policy.
Employers must also inform employees
about the process that will be used to
determine employee vaccination status,
as required under paragraph (e). In
addition, employers must inform
employees about the time and pay/leave
they are entitled to for vaccinations and
any side effects experienced following
vaccinations, as required by paragraph
(f). And employers must also inform
employees about the procedures they
need to follow to provide notice of a
positive COVID–19 test or diagnosis of
COVID–19 by a licensed healthcare
provider, as required under paragraph
(h), as well as the procedures to be used
for requesting records under paragraph
(l). Employers must provide additional
information to unvaccinated employees,
including information about the
employer’s policies and procedures for
COVID–19 testing and face coverings, as
required by paragraphs (g) and (i),
respectively.
Some employers may have informed
employees about their COVID-related
workplace-specific policies, e.g.,
policies on vaccination, testing, and face
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coverings, prior to the effective date of
this ETS. Employers may rely on any
such prior communications for purposes
of complying with paragraph (j)(1) to the
extent that the prior communications
meet the relevant requirements of
paragraph (j) and there have been no
changes to the relevant policies.
Employers must review and evaluate the
information already provided to
determine whether it covers all of the
information necessary under paragraph
(j)(1). If previous information provided
to employees did not cover all of the
required elements, the employer must
provide employees the information on
those missing elements to come into
compliance with the ETS. For example,
if an employer has a mandatory
vaccination policy and has already
provided information to the employees
on the policies and procedures the
employer has established to implement
that policy, and provided that
information in a language and at a
literacy level each employee can
understand, the employer would not
need to expend resources to provide
that information again to meet the
requirements under this ETS. However,
the employer would still need to
provide information to its employees
about other new policies and
procedures established to implement
the ETS.
When an employer’s policies or
procedures change, the employer must
provide any updated or supplemental
information to employees. For example,
an employer may initially opt to allow
only paper copies as proof of COVID–19
test results. Over time, however, the
employer may decide that it wants to
accept electronic proof of test results. If
that employer modifies its policy to
permit employees to submit electronic
proof of test results, the employer must
inform employees of any new or altered
policies and procedures that the
employer implements as a result.
Paragraph (j)(2) requires employers to
provide information to each employee
about COVID–19 vaccine efficacy,
safety, and the benefits of being
vaccinated. To meet this requirement,
employers must provide the CDC’s
document, ‘‘Key Things to Know About
COVID–19 Vaccines,’’ available at
https://www.cdc.gov/coronavirus/2019ncov/vaccines/keythingstoknow.html
(CDC, October 7, 2021), to each
employee. The employer may choose to
provide this information to employees
in either an electronic or print format.
The CDC currently provides this
document in multiple languages;
however, employers may need to
provide additional translations if
necessary to inform each employee of
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the contents of the document in a
language they understand. Employers
do not have any further obligations to
create or provide information on
vaccine efficacy, safety, or the benefits
of being vaccinated beyond providing
the aforementioned CDC document to
each employee.
Paragraph (j)(3) requires employers to
inform each employee about the
requirements of 29 CFR
1904.35(b)(1)(iv) and section 11(c) of the
OSH Act. These two provisions work
together to protect employees from
retaliation for engaging in activities
protected by OSHA statute or
regulation. The first of these provisions,
section 1904.35(b)(1)(iv), prohibits
employers from discharging or in any
manner discriminating against any
employee for reporting a work-related
injury or illness. The second provision,
section 11(c) of the OSH Act, prohibits
employers from discriminating against
employees for exercising rights under,
or as a result of actions required by, the
ETS. Section 11(c) also protects
employees from retaliation for filing an
occupational safety or health complaint,
reporting a work-related injury or
illness, or otherwise exercising any
rights afforded by the OSH Act.
Retaliation takes many forms; it
occurs when an employer (through a
manager, supervisor, or administrator)
fires an employee or takes any other
type of adverse employment action
against an employee for engaging in a
protected activity. Adverse employment
actions include discipline, reducing pay
or hours, reassignment to a less
desirable position, denying overtime or
promotion, intimidation or harassment,
and any other action that would
dissuade a reasonable employee from
raising a concern about a possible
violation or engaging in other protected
activity (see Burlington Northern &
Santa Fe Railway Co. v. White, 548 U.S.
53, 57 (2006) holding, in the Title VII
context, that the test for determining
whether a particular employment action
is materially adverse is whether it
‘‘could well dissuade’’ a reasonable
person from engaging in protected
activity).
The ETS does not change employers’
substantive obligations under either 29
CFR 1904.35(b)(1)(iv) or section 11(c) of
the OSH Act. Rather, it simply requires
employers to make employees aware of
these provisions and their requirements.
By increasing awareness, OSHA
believes that paragraph (j)(3) will
prevent acts of retaliation from
occurring in the workplace, encourage
employees to exercise their right to the
protections of the ETS, and engage
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employees in actions required by the
ETS.
It is critically important for employees
to be aware of, and to be able to
exercise, their rights under the ETS.
Employee participation is essential to
mitigating the spread of COVID–19 in
the workplace, and fear of retaliation
would undermine the effectiveness of
the ETS. For example, per paragraph (f)
of this ETS, employers must provide
employees up to 4 hours of paid time at
the employee’s regular rate of pay for
each vaccination dose, as well as
reasonable time and paid sick leave for
employees to recover from side effects
experienced following any vaccination
dose. If an employer fails to comply
with paragraph (f) and then retaliates
against employees who object,
employees may be deterred from being
vaccinated. Similarly, if employees fear
retaliation, they will be less likely to
voice concerns about unvaccinated coworkers who do not wear required face
coverings (see paragraph (i)(1)). A
workplace free from the threat of
retaliation promotes collaboration
between employers and employees and
allows employers to more effectively
implement the various requirements of
this ETS.
OSHA has received a record number
of complaints of retaliation during the
COVID–19 pandemic. The agency’s
website shows that, as of September 26,
2021, OSHA had received 5,788
complaints of retaliation related to
workplace protections from COVID–19
(OSHA, September 29, 2021). These
figures indicate that some employers
need to be reminded that they are
legally prohibited from engaging in
retaliatory actions. Additionally,
employees likely need reassurance of
their legal right to engage in protected
activity without fear of suffering from
adverse employment actions. As such, it
is critical for employers to inform
employees of the prohibitions against
retaliation in 29 CFR 1904.35(b)(1)(iv)
and section 11(c) after the effective date
of the ETS, without regard to any
information they may have provided
previously on these anti-retaliation
provisions. As with the other parts of
paragraph (j), employers have flexibility
regarding how they will provide the
required information.
Paragraph (j)(4) requires employers to
provide each employee with
information regarding the prohibitions
of 18 U.S.C. 1001 and Section 17(g) of
the OSH Act, which provide for
criminal penalties associated with
knowingly supplying false statements or
documentation. The first of these two
provisions, 18 U.S.C. 1001(a) is
described earlier in this preamble and
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provides for fines or imprisonment for
persons who ‘‘knowingly and willfully’’
(1) falsifies, conceals, or covers up by
any trick, scheme, or device a material
fact; (2) makes any materially false,
fictitious, or fraudulent statement or
representation; or (3) makes or uses any
false writing or document knowing the
same to contain any materially false,
fictitious, or fraudulent statement or
entry. And section 17(g) of the OSH Act
provides for fines up to $10,000, and
imprisonment for not more than six
months, or both, for anyone who
‘‘knowingly makes any false statement,
representation, or certification’’ in any
application, record, report, plan, or
other document ‘‘filed or required to be
maintained pursuant to this chapter.’’
False statements or documents made or
submitted for purposes of complying
with policies required by this ETS could
fall under either or both of these
statutory provisions.
This ETS requires that each employee
provide their employer either COVID–
19 vaccination documentation
(paragraph (e)), or, if applicable, regular
COVID–19 test results (paragraph (g)).
There is a significant public health
interest in ensuring employees provide
this information truthfully to the
employer. Employers cannot effectively
implement the requirements of this ETS
based on false information. By
increasing awareness of the possible
penalties an employee may face for
misrepresenting their vaccination status
or test results, OSHA intends to
discourage such behavior. Employers
can satisfy the requirement of paragraph
(j)(4) by providing each employee with
the text of the two statutory provisions
in hard copy or via electronic
communication (e.g., email), translated
as necessary into other languages,
emphasizing the importance of
providing truthful information about
vaccine status and test results, and
explaining that providing false
information could be punishable under
the two provisions. Employers are not
required to provide further explanation
of the statutory provisions or to provide
legal advice.
Information requirements are routine
components of OSHA standards. The
inclusion of information requirements
in this ETS reflects the agency’s
conviction, as noted above, that
informed employees are essential to the
implementation of any effective
occupational safety and health policy or
procedure. OSHA believes that
informing employees about their rights
and responsibilities under the ETS; the
employer’s policies and procedures; and
the safety, efficacy, and benefits of
vaccination will help increase the
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number of employees vaccinated and
will facilitate effective implementation
of the standard by employers.
References
Centers for Disease Control and Prevention
(CDC). (2021, October 7). Key Things to
Know About COVID–19 Vaccines.
https://www.cdc.gov/coronavirus/2019ncov/vaccines/keythingstoknow.html.
(CDC, October 7, 2021).
Occupational Safety and Health
Administration (OSHA). (2021,
September 29). COVID–19 Response
Summary: Summary Data for Federal
Programs—Whistleblower Data. https://
www.whistleblowers.gov/covid-19-data.
(OSHA, September 29, 2021).
K. Reporting COVID–19 Fatalities and
Hospitalizations to OSHA
OSHA has required employers to
report work-related fatalities and certain
work-related hospitalizations under its
recordkeeping regulation since 1971.
These requirements have been an
important part of the agency’s statutory
mission to assure safe and healthful
working conditions for all working
people. All employers covered by the
OSH Act, including employers who are
partially exempt from maintaining
injury and illness records, are required
to comply with OSHA reporting
requirements at 29 CFR 1904.39. Under
OSHA’s current reporting regulation,
employers are required to report each
work-related fatality to OSHA within 8
hours of the event, and each workrelated in-patient hospitalization,
amputation, and loss of an eye within
24 hours of the event.
The purpose of the reporting
requirement in § 1904.39 is to provide
OSHA with information to determine
whether it is necessary for the agency to
conduct an immediate investigation at a
specific establishment. Employer
reports of work-related COVID–19
fatalities and in-patient hospitalizations
are an important element of the agency’s
efforts to reduce occupational exposure
to the virus. After receiving an employer
report, OSHA decides whether an
inspection is needed to determine the
cause of a work-related COVID–19
fatality or in-patient hospitalization, and
whether any OSHA standards may have
been violated. These reports are critical
for the agency to respond quickly to
COVID–19 exposure that may pose an
ongoing risk to other employees at the
worksite. Timely investigation also
allows OSHA to view evidence at a
workplace soon after a work-related
COVID–19 fatality or in-patient
hospitalization has occurred, and can
make it easier for the agency to gather
relevant information from others at the
worksite that might be useful in
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protecting other employees. Moreover,
prompt inspection enables OSHA to
gather information to evaluate whether
its current standards adequately address
the workplace hazard presented from
COVID–19. The information gathered
from employer reports is also used by
the agency to form the basis of statistical
data on the causes and remediation of
work-related COVID–19 fatalities and
in-patient hospitalizations.
In order to address the unique
circumstances presented by COVID–19,
and to facilitate OSHA investigation and
better workplace health surveillance,
paragraph (k)(1) requires covered
employers to report each work-related
COVID–19 fatality to OSHA within 8
hours of the employer learning about
the fatality, and each work-related
COVID–19 in-patient hospitalization to
OSHA within 24 hours of the employer
learning about the in-patient
hospitalization. As described in more
detail in the following discussion,
OSHA is adding these additional
COVID–19 reporting requirements
because the delay in the manifestation
and progression of symptoms of
COVID–19 can lead to hospitalization or
fatality outside the normal window for
reporting those workplace events.
Paragraph (k)(1)(i) provides that
employers must report each workrelated COVID–19 fatality to OSHA
within 8 hours of the employer learning
about the fatality. Under this paragraph,
an employer must make a report to
OSHA within 8 hours of learning both
(1) that an employee has died from a
confirmed case of COVID–19, and (2)
that the cause of death was the result of
a work-related exposure to COVID–19.
Employers are only required to report
confirmed cases of COVID–19 as
defined by the Centers for Disease
Control and Prevention (CDC) (CDC,
May 20, 2020). Typically, the cause of
death is determined by the physician
who was responsible for a patient who
died in a hospital, although the cause of
death can also be determined by others
such as medical examiners or coroners
(Pappas, May 19, 2020).
The requirement in paragraph (k)(1)(i)
is similar to the fatality reporting
requirement in OSHA’s regulation at 29
CFR 1904.39(a)(1), which requires an
employer to report to OSHA within 8
hours after the death of any employee as
the result of a work-related incident.
However, 29 CFR 1904.39(b)(6) requires
employers to report a work-related
fatality to OSHA only if the fatality
occurs within 30 days of ‘‘the workrelated incident.’’ Prior to this ETS, for
purposes of reporting events involving
COVID–19, OSHA interpreted the
phrase ‘‘the work-related incident’’ to
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mean ‘‘exposure’’ in the work
environment. Therefore, in order to be
reportable under 29 CFR 1904.39(a)(1),
a work-related fatality due to COVID–19
needed to have occurred within 30 days
of an employee’s exposure in the work
environment. Given the possibility of
long-term illness before death, the 30day limitation for reporting fatalities to
OSHA could restrict OSHA’s ability to
receive information about work-related
COVID–19 fatalities.
To address these issues, OSHA has
chosen not to apply the 30-day
limitation period from 29 CFR
1904.39(b)(6) to the reporting provision
in paragraph (k) (see paragraph (k)(2)).
Therefore, the requirement to report
these fatalities is not limited by the
length of time between workplace
exposure and death. The reporting of
work-related COVID–19 fatalities that
occur beyond 30 days from the time of
exposure will enable the agency to
evaluate more work-related COVID–19
fatalities to determine whether
immediate investigations are needed to
prevent other employees at the same
worksite from being exposed to the
virus. The report of these fatalities to
OSHA facilitates the agency’s timely
tracking of this data. Accordingly,
paragraph (k)(1)(i) requires employers to
report each work-related COVID–19
fatality to OSHA within 8 hours of the
employer learning about the fatality
regardless of when the exposure in the
work environment occurred.
Paragraph (k)(1)(ii) of the standard
requires an employer to report each
work-related COVID–19 in-patient
hospitalization to OSHA within 24
hours of the employer learning about
the in-patient hospitalization. Under
this paragraph, and similar to OSHA’s
reporting regulation at 29 CFR 1904.39,
an employer must make a report to
OSHA within 24 hours of learning that
(1) an employee has been in-patient
hospitalized due to a confirmed case of
COVID–19, and (2) the reason for the
hospitalization was the result of a workrelated exposure to the illness.
OSHA’s current reporting regulation
at 29 CFR 1904.39(a)(2) provides that,
within 24 hours after the in-patient
hospitalization of one or more
employees, as the result of a workrelated incident, an employer must
report the in-patient hospitalization to
OSHA. 29 CFR 1904.39(b)(6) requires
employers to only report in-patient
hospitalizations to OSHA if the
hospitalization occurs within 24 hours
of the work-related incident. For
example, if an employee trips in the
workplace and sustains an injury on
Monday, but is not hospitalized until
Thursday, the employer does not need
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61545
to report the event. In this example, ‘‘the
work-related incident’’ occurred on
Monday when the employee tripped
and was injured in the workplace. Also,
under § 1904.39, employers must report
in-patient hospitalizations to OSHA
within 24 hours of knowing both that
the employee has been in-patient
hospitalized and that the reason for the
hospitalization was the result of ‘‘the
work-related incident’’ (see 29 CFR
1904.39(a)(2), (b)(7)–(b)(8)). In nonCOVID cases, the work-relatedness of
the injury is typically apparent
immediately.
Since the beginning of the pandemic,
the reporting of work-related COVID–19
in-patient hospitalizations under 29
CFR 1904.39 has presented unique
challenges. As noted above, for
purposes of reporting COVID–19
fatalities and in-patient hospitalizations,
OSHA has interpreted the phrase ‘‘the
work-related incident’’ in 29 CFR
1904.39(b)(6) to mean an employee’s
‘‘exposure’’ to COVID–19 in the work
environment. Thus, in order to be
reportable, an in-patient hospitalization
needed to occur within 24 hours of an
employee’s exposure to COVID–19 in
the work environment. Given the
incubation period of the virus, and the
typical timeframe between exposure and
the emergence of symptoms serious
enough to require hospitalization, it is
extremely unlikely for an in-patient
hospitalization to occur within 24 hours
of an employee’s exposure to the virus.
To address these issues, paragraph
(k)(1)(ii) does not limit the COVID–19
reporting requirement to only those
hospitalizations that occur within 24
hours of exposure, as in 29 CFR
1904.39(b)(6). This change in the
reporting requirement will result in
OSHA making more determinations as
to whether immediate investigations are
needed at additional worksites. Given
the severity of the disease, and how
quickly it can spread, it is essential that
remediation efforts at a workplace be
undertaken immediately. As noted
above, it is critical for OSHA to respond
quickly to hazardous conditions where
employees have been hospitalized. The
elimination of the 24-hour limitation
period will not only allow OSHA to
receive more employer reports about
work-related COVID–19 in-patient
hospitalizations and, as a result, shed
light on where severe COVID–19 events
are occurring, but it will also enable the
agency to respond more quickly and
effectively to these situations.
Accordingly, employers must report
each work-related COVID–19 in-patient
hospitalization to OSHA regardless of
when the employee’s exposure in the
workplace occurred (paragraph
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(k)(1)(ii)). But consistent with OSHA’s
normal reporting requirements, when
hospitalization for a work-related case
of COVID–19 does occur, the employer
must report it within 24 hours of
learning about the hospitalization.
Additionally, for purposes of this
section, OSHA defines in-patient
hospitalization as a formal admission to
the in-patient services of a hospital or
clinic for care or treatment (see 29 CFR
1904.39(b)(9) and (b)(10)). The
determination as to whether an
employee is formally admitted into the
in-patient service is made by the
hospital or clinic. Treatment in an
Emergency Room only is not reportable.
I. Work-Relatedness Determinations
Given the nature of the disease, and
the extent of community spread, in
some cases, it may be difficult for an
employer to determine whether an
employee’s COVID–19 illness is workrelated, especially when an employee
has experienced potential exposure both
in and out of the workplace. For
purposes of this ETS, when evaluating
whether a fatality or in-patient
hospitalization is the result of a workrelated case of COVID–19, employers
must follow the criteria in OSHA’s
recordkeeping regulation at 29 CFR
1904.5 for determining workrelatedness. Applying the criteria in 29
CFR 1904.5 under paragraph (k) of this
ETS is consistent with how employers
make work-relatedness determinations
when reporting fatalities and other
serious events under 29 CFR 1904.39.
Under § 1904.5, employers must
consider an injury or illness to be workrelated if an event or exposure in the
work environment either caused or
contributed to the resulting condition,
or significantly aggravated a pre-existing
injury or illness. An injury or illness is
presumed work-related if it results from
events or exposures occurring in the
work environment, unless an exception
in § 1904.5(b)(2) specifically applies.
Under this language, an injury or illness
is presumed work-related if an event or
exposure in the work environment is a
discernable cause of the injury or illness
(see 66 FR 66,943 (December 27, 2001)).
According to 29 CFR 1904.5(b)(3), the
‘‘work environment’’ includes the
employer’s establishment and any other
location where work is performed or
where employees are present as a
condition of their employment. Under
29 CFR 1904.5(b)(3), employers should
evaluate the employee’s work duties
and environment and determine
whether it is more likely than not that
exposure at work caused or contributed
to the illness (see 66 FR 5958–59
(January 19, 2001)).
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Because of the typical incubation
period of 3 to 14 days, an employee’s
exposure to COVID–19 will usually be
determined after the fact. Employers
must make reasonable efforts to acquire
the necessary information to make goodfaith work-relatedness determinations
under this section. In addition, the
employer should rely on information
that is reasonably available at the time
of the fatality or in-patient
hospitalization.
A work-related exposure in the work
environment would likely include close
contact with a person known to be
infected with COVID–19. For example,
although work-relatedness must be
determined on a case-by-case basis, if a
number of COVID–19 illnesses develop
among coworkers who work closely
together without an alternative
explanation, it is reasonable to conclude
that an employee’s fatality or in-patient
hospitalization is work-related. On the
other hand, if there is not a known
exposure to COVID–19 that would
trigger the presumption of workrelatedness, the employer must evaluate
the employee’s work duties and
environment to determine whether it is
more likely than not that the employee
was exposed to COVID–19 during the
course of their employment. Employers
should consider factors such as:
• The type, extent, and duration of
contact the employee had at the work
environment with other people,
particularly the general public.
• Physical distancing and other
controls that impact the likelihood of
work-related exposure.
• The extent and duration of time
spent in a shared indoor space with
limited ventilation.
• Whether the employee had workrelated contact with anyone who
exhibited signs and symptoms of
COVID–19.
Since 1971, under OSHA’s
recordkeeping system, employers have
been making work-relatedness
determinations regarding workplace
fatalities, injuries, and illnesses. In
general, employers are in the best
position to obtain information, both
from the employee and the workplace,
necessary to make a work-relatedness
determination. Although employers may
rely on experts and healthcare
professionals for guidance, the
determination of work-relatedness
ultimately rests with the employer.
Finally, OSHA wishes to emphasize
that, under OSHA’s recordkeeping
regulation at 29 CFR 1904, employers
must record on the OSHA 300 log each
work-related fatality, injury, and illness
reported to OSHA under § 1904.39. The
work-relatedness determination for
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fatality and in-patient hospitalization is
no different than the requirement to
determine work-relatedness when
entering fatalities, injuries and illness
on the OSH 300 log. Accordingly, the
work-relatedness determination for
reporting COVID–19 fatalities and inpatient hospitalizations is a
determination that is already required to
be made by the employer.
II. Time Periods for Reporting COVID–
19 Fatalities and In-Patient
Hospitalizations
As noted above, under paragraph (k),
employers must report each workrelated COVID–19 fatality or
hospitalization to OSHA within the
specified timeframes based on when any
agent or employee of the employer
becomes aware of the reportable event.
For example, an employer ‘‘learns’’ of a
COVID–19 fatality or in-patient
hospitalization when a supervisor,
receptionist, or other employee at the
company receives information from a
family member or medical professional
about an employee fatality or in-patient
hospitalization. It is the employer’s
responsibility to ensure that appropriate
instructions and procedures are in place
so that managers, supervisors, medical
personnel, as well as other employees or
agents of the company, who learn of an
employee’s death or in-patient
hospitalization due to COVID–19 know
that the company must make a report to
OSHA.
Consistent with OSHA’s regulation at
29 CFR 1904.39, the reporting clock
begins to run with the occurrence of the
reportable event. Under paragraph (k),
in situations where the employer or the
employer’s agent does not learn about
the work-related COVID–19 fatality or
in-patient hospitalization right away,
the employer must make the report to
OSHA within 8 hours for a fatality, or
24 hours for an in-patient
hospitalization, from the time the
employer (or the employer’s agent)
learns about the reportable event. For
example, if an employee dies from a
work-related case of COVID–19 on
Sunday at 6:00 a.m., but the employer
does not learn about the death until
Monday at 8:00 a.m., the employer has
until 4:00 p.m. that day to make the
report to OSHA. Similarly, if an
employee is in-patient hospitalized for a
work-related case of COVID–19 at 8:30
p.m. on Monday, but the employer or
the employer’s agent(s) does not learn
about the hospitalization until 9:00 a.m.
the next day (Tuesday), then the
employer would be required to make the
report to OSHA within 24 hours of
learning of the in-patient hospitalization
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(i.e., by 9:00 a.m. on Wednesday) (see 29
CFR 1904.39(b)(7)).
Likewise, if an employer does not
learn right away that a reportable
fatality or in-patient hospitalization is
work-related, the employer must make
the report to OSHA within 8 hours or
24 hours of learning that the death or inpatient hospitalization was the result of
a work-related COVID–19 exposure. For
example, if an employee is in-patient
hospitalized for a case of COVID–19 at
9:00 a.m. on Monday, but the employer
does not have enough information to
make a work-relatedness determination
until 11:00 a.m. on Monday, then the
employer would be required to report
the hospitalization within 24 hours of
learning that the hospitalization was
work-related (i.e., by 11:00 a.m. on
Tuesday) (see 29 CFR 1904.39(b)(8)).
Finally, if an employer makes a report
to OSHA concerning a work-related
COVID–19 in-patient hospitalization
and that employee subsequently dies
from the illness, the employer does not
need to make an additional fatality
report to OSHA.
III. How To Report COVID–19 Fatalities
and In-Patient Hospitalizations and
What Information Must Be Included in
the Report
Paragraph (k)(2) of the standard
provides that when reporting workrelated COVID–19 fatalities and inpatient hospitalizations to OSHA in
accordance with paragraph (k)(1), the
employer must follow the requirements
in 29 CFR 1904.39, except for 29 CFR
parts 1904.39(a)(1)–(2) and (b)(6). As
explained above, OSHA has included
specific provisions for the reporting of
work-related COVID–19 fatalities and
in-patient hospitalizations that differ
from 29 CFR 1904.39. However, when
making COVID–19 fatality and inpatient hospitalization reports to OSHA,
employers must follow the other
reporting procedures set forth in
§ 1904.39. Specifically, under
§ 1904.39(a)(3), employers have three
options for reporting work-related
fatalities and in-patient hospitalizations
to OSHA:
1. By telephone to the OSHA Area
Office that is nearest to the site of the
incident;
2. by telephone to the OSHA toll-free
central telephone number, 1–800–321–
OSHA (1–800–321–6742);
3. by electronic submission using the
reporting application located on
OSHA’s public website at
www.osha.gov.
Section 1904.39(a)(3) also allows
employers to report work-related
fatalities and in-patient hospitalizations
to OSHA in person to the OSHA Area
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Office that is nearest to the site of the
incident. However, because many
OSHA Area Offices are closed to the
public during the COVID–19 pandemic,
employers must use one of the three
options listed above. In addition,
§ 1904.39(b)(1) makes clear that, if the
OSHA Area Office is closed, an
employer may not report a work-related
fatality or in-patient hospitalization by
leaving a message on OSHA’s answering
machine, faxing the Area Office, or
sending an email. Instead, the employer
must make the report by using the 800
number or the reporting application
located on OSHA’s public website at
www.osha.gov.
The other provisions in 29 CFR
1904.39 (except for 29 CFR
1904.39(a)(1)–(2) and (b)(6)) also apply
to the reports required by paragraph (k).
For example, employers should consult
29 CFR 1904.39(b)(2) to determine what
information employers must give to
OSHA when making COVID–19 fatality
or in-patient hospitalization reports. Per
that provision, employers must give
OSHA the following information for
each fatality or in-patient
hospitalization: The establishment
name, the location of the work-related
incident, the time of the work-related
incident, the type of reportable event
(i.e., fatality or in-patient
hospitalization), the number of
employees who suffered a fatality or inpatient hospitalization, the names of the
employees who suffered a fatality or inpatient hospitalization, the employer’s
contact person and his or her phone
number, and a brief description of the
work-related incident.
References
Centers for Disease Control and Prevention.
(2020, May 20). Reporting and Coding
Deaths Due to COVID–19. https://
www.cdc.gov/nchs/covid19/coding-andreporting.htm. (CDC, May 20, 2020).
Pappas, S. (2020, May 19). How COVID–19
Deaths are Counted. Scientific American.
https://www.scientificamerican.com/
article/how-covid-19-deaths-arecounted1/. (Pappas, May 19, 2020).
L. Availability of Records
Section 8(c)(1) of the Act requires
employers to ‘‘make, keep and preserve,
and make available to the Secretary [of
Labor] or the Secretary of Health and
Human Services, such records regarding
his activities relating to this Act as the
Secretary, in cooperation with the
Secretary of Health and Human
Services, may prescribe by regulation as
necessary or appropriate for the
enforcement of this Act or for
developing information regarding the
causes and prevention of occupational
accidents and illnesses.’’ Section 8(c)(2)
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of the Act specifically directs the
Secretary of Labor to promulgate
regulations requiring employers to
maintain accurate records of workrelated injuries and illnesses. Section
8(c)(3) of the Act requires employers to
‘‘maintain accurate records of employee
exposures to potentially toxic materials
or harmful physical agents which are
required to be monitored or measured
under section 6 [of the Act.]’’ In
accordance with section 8(c), paragraph
(l) of the ETS includes availability of
records requirements for certain
COVID–19-related records required to
be created and maintained by the ETS.
This paragraph provides a right of
access to records by employees,
employee representatives, and OSHA.
Paragraph (l)(1) specifies that the
employer must make available, for
examination and copying, the
individual COVID–19 vaccine
documentation and any COVID–19 test
results required by the ETS for a
particular employee to that employee
and to anyone having written
authorized consent of that employee by
the end of the next business day after a
request. Prompt employee access to this
information ensures that employees
have the information necessary to take
an active role in their employers’ efforts
to prevent COVID–19 transmission in
the workplace. In particular, in
circumstances where employers or
employees choose to have the
employee’s COVID–19 test results go
directly to the employer, paragraph
(l)(1) gives the employee access to their
own records. Access to COVID–19 test
results may be helpful for a requesting
employee in evaluating information
relevant to COVID–19 exposure,
including if that exposure occurred at
the workplace. Prompt production of
these records can also assist employees
in making personal medical decisions
and seeking care from a licensed
healthcare provider if necessary.
Employers should note that employee
privacy is protected under the access to
records provisions in paragraph (l)(1).
Specifically, as noted above, paragraph
(l)(1) requires employers to provide
access to the vaccination records or
COVID–19 test results for a particular
employee to that employee or to anyone
having that employee’s written
permission. However, it does not
authorize employers to allow anyone
other than the particular employee to
access their records or results without
the written consent of that employee
(except as provided for under paragraph
(l)(3)).
Paragraph (l)(2) requires the employer
to make the following information
available to an employee or an
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employee representative on request: (1)
The aggregate number of fully
vaccinated employees at a workplace
and (2) the total number of employees
at that workplace. This information
must be made available to these
individuals by the end of the next
business day after a request. Employers
will be able to utilize the roster of each
employee’s vaccination status they are
required to maintain under paragraph
(e)(4) of this section to provide this
information promptly to a requester.
Since the aggregate totals of fully
vaccinated employees and total
employees made available by request in
paragraph (l)(2) do not contain any
personal identifiable information or
personal medical information, OSHA
does not believe that access to these
records raises any serious
confidentiality or privacy concern if
disclosed to employees or their
representatives.
OSHA believes that access to this
information will allow employees and
employee representatives to calculate a
percentage of fully vaccinated
employees at a workplace, evaluate the
efficacy of the employer’s vaccination
policy, raise any concerns identified to
OSHA, and actively participate in the
employer’s vaccination efforts. Without
the provision of this information to
employees and their representatives, the
only potential check on whether the
employer is complying with the
requirements of the ETS would be
OSHA inspections. The agency believes
that making this information available
to employee representatives will help
ensure compliance with the
requirements of the ETS and thereby
protect workers.
Consistent with 29 CFR 1904.35(a)(3),
OSHA interprets the term ‘‘employee’’
as used in paragraph (l) to include
former employees. In addition, for
purposes of paragraph (l)(2), the term
‘‘representative’’ is intended to have the
same meanings as in 29 CFR
1904.35(b)(2), which encompasses two
types of employee representatives. The
first is a personal representative of the
employee, who is a person the employee
designates, in writing, as his or her
personal representative, or is a legal
representative of a deceased or legally
incapacitated employee. The second is
an authorized representative, which is
defined as an authorized collective
bargaining agent of one or more
employees working at the employer’s
worksite. In accordance with these
interpretations, OSHA also interprets
the phrase ‘‘employee representative,’’
as used in paragraph (l)(2), to include
the personal and authorized
representatives of former employees.
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These interpretations are limited to
these provisions.
Under paragraphs (l)(1) and (l)(2),
requesters are entitled to one free copy
of each requested record, which is
consistent with OSHA’s recordkeeping
regulation at 29 CFR 1904.35. The cost
of providing one free copy to
employees, former employees, and/or
their representatives is minimal, and
these individuals are more likely to
access the records if it is without cost.
Allowing the employer to charge for a
copy of the record would only delay the
production of the information. After
receiving an initial, free copy of a
requested record or document, an
employee, former employee, or
representative may be charged a
reasonable fee for copying duplicative
records. However, no fee may be
charged for an update to a previously
requested record. It should be noted that
each COVID–19 test is a separate record,
and, as such, the employee or the
representative is entitled to one free
copy of each COVID–19 test record.
Paragraph (l)(3) provides OSHA with
a specific right of access. Under
paragraph (l)(3)(i), employers must
provide the written policy required by
paragraph (d), and the aggregate
numbers described in paragraph (l)(2) of
this section (both the aggregate number
of fully vaccinated employees at a
workplace and the total number of
employees at that workplace), to the
Assistant Secretary for examination and
copying within 4 business hours of a
request. Consistent with the
requirements in 29 CFR 1904.40(b)(2), if
the records are maintained at a location
in a different time zone, the employer
may use the business hours of the
establishment at which the records are
located when calculating the deadline.
Providing OSHA with prompt access
to the written policy and the aggregate
numbers allows the agency to more
rapidly focus inspections on employers
that may not be in compliance with the
requirements of this ETS. In addition,
this information will help OSHA
determine what to focus on in an
investigation. For example, if an
employer has established, implemented,
and is enforcing a written mandatory
vaccination policy under paragraph
(d)(1) and their aggregate numbers
indicate that their entire workforce is
fully vaccinated against COVID–19, the
agency might approach the investigation
differently than in a workplace where
the employer’s written policy (under
paragraph (d)(2)) allows employees to
provide proof of regular testing for
COVID–19 in accordance with
paragraph (g) and wear a face covering
in accordance with paragraph (i),
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instead of being fully vaccinated. This
information also provides OSHA
representatives with the ability to
quickly check any vaccination claims
made by an employer without
undertaking an employee-by-employee
assessment and assists OSHA
representatives in their evaluation of the
effectiveness of the employer’s written
policy.
Having this information within 4
business hours of the request helps the
agency act more quickly to protect
employees and preserves agency
resources. In addition, the 4-hour
response time is consistent with similar
obligations under other OSHA
recordkeeping requirements, such as the
recordkeeping requirement in 29 CFR
1904.40(a).
Paragraph (l)(3)(ii) requires employers
to provide all other records and other
documents that are required to be
maintained by this section to the
Assistant Secretary for examination and
copying by the end of the next business
day after a request. This means that
employers must allow OSHA
representatives to examine and copy
each employee’s COVID–19 vaccine
documentation (required to be
maintained under paragraph (e)(4)), the
roster of employee vaccination status
(required to be maintained under
paragraph (e)(4)), and each employee’s
COVID–19 test results (required to be
maintained under paragraph (g)(4)),
upon request.
As indicated in paragraph (c), the
term Assistant Secretary includes the
Assistant Secretary’s designees.
Consequently, the records and
information required to be provided to
the Assistant Secretary under paragraph
(l)(3) must be given to the Assistant
Secretary or their representatives, such
as OSHA’s Compliance Safety and
Health Officers.
As noted above, section 8 of the OSH
Act recognizes OSHA’s right of access to
records relating to employer compliance
with occupational safety and health
standards and regulations, including
access to relevant employee medical
records. OSHA does not believe that its
inspectors need to obtain employee
permission to access and review
personally identifiable information.
Gaining this permission would
essentially make it impossible to obtain
full access to the records in a timely
manner, which is needed by OSHA to
perform a meaningful workplace
investigation. OSHA also has policies
and procedures in place to ensure the
privacy and confidentiality of employee
records it accesses during inspections.
Finally, without complete and timely
access to the vaccine and testing
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records, agency efforts to conduct
immediate interventions to ensure
employees are protected from COVID–
19 at a specific workplace would be
limited.
OSHA does not prescribe specific
methods for requests for records in this
ETS. Employees, employee
representatives, and the Assistant
Secretary and designees can submit
requests in any manner that provides
adequate notice of the request to the
employer. This may include requests by
in writing (e.g., email, fax, letter), by
phone, or in person.
M. Dates
To minimize transmission of COVID–
19 in the workplace, it is essential that
employers ensure that the provisions of
this ETS are implemented as quickly as
possible, but no later than the dates
outlined in paragraph (m). This
paragraph sets forth the effective date of
the section and the compliance dates for
specific requirements of the standard.
The effective date for this ETS, as
required by section 6(c)(1) of the OSH
Act (29 U.S.C. 655(c)(1)), is the date of
publication in the Federal Register. The
compliance date for all provisions in the
ETS is 30 days after the effective date,
except for paragraph (g) (COVID–19
testing for employees who are not fully
vaccinated), which requires compliance
within 60 days of the effective date.
Given the grave danger to employees
from occupational exposure to COVID–
19, as previously described, the effective
date and compliance dates provided for
this ETS are reasonable and appropriate.
For over a year and a half—since at
least January 2020, when the Secretary
of Health and Human Services declared
COVID–19 to be a public health
emergency for the entire United States—
all employers have been made acutely
aware of the importance of minimizing
employees’ exposure to COVID–19 and
many have willingly joined the global
response to stop the spread of COVID–
19 and to protect their employees.
Therefore, many employers have
already been encouraging their
employees to get vaccinated against
COVID–19. Many employers have also
instituted vaccination mandates (see
Technological Feasibility, Section IV.A.
of this preamble, for more information).
OSHA has published this ETS
because there is great urgency in
instituting the workplace protections
OSHA has found to be necessary as
quickly as possible. Unvaccinated
workers are being hospitalized with
COVID–19 every day, and many are
dying, so it is particularly critical to
remove obstacles as soon as possible for
those who wish to be vaccinated. At the
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same time, OSHA has set the
compliance dates to allow enough time
for employers to obtain and read the
standard, become knowledgeable about
the standard’s requirements, and
undertake the necessary steps for
compliance.
OSHA anticipates that employers will
be able to implement measures to
comply with most provisions of the ETS
well within 30 days, pursuant to
paragraph (m)(2)(i). Even in situations
where an employer has not previously
taken the required actions to address
COVID–19 hazards in the workplace,
steps such as developing a vaccination
policy, determining employee
vaccination status, providing support
for employee vaccination, ensuring
employees who are not fully vaccinated
wear face coverings, and most other
measures required under the standard
can readily be completed within the 30day time period. These measures do not
require extensive lead times for large
employers to implement. The scope of
the standard is limited to employers
with more than 100 employees largely
because OSHA is especially confident
that these employers will have the
ability to implement the standard.
Paragraph (m)(2)(ii) of the ETS
provides a longer period of time—60
days—for employers to comply with the
requirements for COVID–19 testing in
paragraph (g). Paragraph (g) requires
employers to implement COVID–19
testing and reporting of results for
employees who are not fully vaccinated.
One reason for this extended period of
time for testing is that employers may
need additional time to develop policies
and procedures regarding COVID–19
testing and associated recordkeeping.
Perhaps more critically, this ETS is
intended to incentivize vaccination, so
this delayed compliance date was
established to allow sufficient time for
employees to complete a COVID–19
primary vaccination before it is
necessary to comply with the testing
requirements in paragraph (g). The 60day compliance period in paragraph
(m)(2)(ii) provides employees with
sufficient time to receive one dose of a
single-dose primary vaccination (e.g.,
Janssen (Johnson & Johnson)) or both
doses of a two-dose primary vaccination
series (e.g., Pfizer-BioNTech, Moderna).
For the Janssen COVID–19 vaccine, the
primary vaccination takes 1 day to
complete (CDC, August 10, 2021).
Employees who receive the Janssen
vaccine could therefore begin their
primary vaccination at any time up to
and including the 60th day from the
date of publication in the Federal
Register in order to be exempt from the
testing requirements of paragraph (g).
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61549
For the Pfizer-BioNTech COVID–19
vaccine, the primary vaccination series
takes 21 days to complete (CDC, August
25, 2021). Employees receiving the
Pfizer-BioNTech series could begin their
primary vaccination series up to 39 days
from the date of publication in the
Federal Register. Finally, for the
Moderna COVID–19 vaccine, the
primary vaccination series takes 28 days
to complete (CDC, August 23, 2021).
Employees receiving the Moderna series
could therefore begin their primary
vaccination series up to 32 days from
the date of publication in the Federal
Register.
As specified in paragraph (m)(2)(ii), if
an employee completes the entire
primary vaccination within 60 days
following publication in the Federal
Register, that employee does not have to
be tested under paragraph (g), even if
they have not yet completed the two
week waiting period that is required to
meet the definition of fully vaccinated
in paragraph (c). Employers must begin
compliance with the testing
requirements of paragraph (g) only for
employees who have not yet completed
primary vaccination (i.e., employees
who have not received any doses,
employees who have received only one
dose of a two-dose series) within 60
days from the date of publication in the
Federal Register. And because
employers must have their vaccination
support processes (as required by
paragraph (f)) in place before employees
would need to initiate their primary
vaccination in time to avoid testing
under this section, employees will be
able to avoid all testing costs required
by this ETS.
Compliance with the requirements of
the ETS within the specified dates is
achievable. Many employers are likely
already in compliance with at least
some of the provisions of the ETS.
Resources are also readily available to
help employers achieve compliance.
These resources include guidance
issued by OSHA, the CDC, state and
local governments, trade associations,
and other organizations to help
employers successfully implement
vaccination, testing, and face covering
requirements to minimize the
transmission of COVID–19 in the
workplace. OSHA therefore concludes
that the compliance dates in this ETS
strike a reasonable balance between
incentivizing vaccination and allowing
enough time for employers to comply.
Although employers are not required
to comply with the requirements of this
ETS until 30 days from the date of
publication in the Federal Register (60
days for paragraph (g)), OSHA strongly
encourages employers to implement the
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required measures to support employee
vaccination as soon as practicable.
Providing support for employees to
receive the COVID–19 vaccine and
recover from side effects, as required in
paragraph (f) of the ETS, prior to the
compliance date may encourage
employees to receive a COVID–19
vaccination at the earliest possible date.
This would not only reduce the grave
danger of COVID–19 in the workplace
but also reduce burdens on both
employers and employees when the
compliance dates for the additional
requirements for employees who are not
fully vaccinated arrive.
References
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Centers for Disease Control and Prevention
(CDC). (2021, August 10). Janssen
COVID–19 Vaccine (Johnson & Johnson).
https://www.cdc.gov/vaccines/covid-19/
info-by-product/moderna/.
(CDC, August 10, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, August 23). Moderna
COVID–19 Vaccine. https://
www.cdc.gov/vaccines/covid-19/info-byproduct/moderna/. (CDC,
August 23, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, August 25). PfizerBioNTech COVID–19 Vaccine. https://
www.cdc.gov/vaccines/covid-19/info-byproduct/pfizer/. (CDC, August
25, 2021)
N. Severability
OSHA’s amendment to its COVID–19
ETS, Part 1910, Subpart U, includes a
republication of § 1910.505,
Severability. Section 1910.505 contains
a severability clause, the primary
purpose of which is to express OSHA’s
intent that if any section or provision of
the COVID–19 ETS is held invalid or
unenforceable or is stayed or enjoined
by any court of competent jurisdiction,
the remaining sections or provisions
should remain effective and operative.
OSHA is including 29 CFR 1910.505 as
part of this ETS for the same reasons the
agency included the provision in the
Healthcare ETS, and OSHA intends for
it to have the same purposes and effects
as those expressed in the preamble to
the Healthcare ETS (86 FR 32617–
32618), which is hereby included in the
record for this ETS.
Because subpart U is the result of two
separate ETSs published at different
times and subject to different time
frames, but OSHA intends for both ETSs
to be subject to the same principles of
severability, OSHA has relied on the
same centralized severability section for
both for efficiency. For the benefit of the
reader and for administrative
convenience, this centralized
severability section is located in the
same subpart as the other provisions of
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the ETS. While either ETS remains in
effect, it is OSHA’s intent that 29 CFR
1910.505 remain in subpart U and
operative as to either ETS still in effect.
If both ETSs are not made permanent,
29 CFR 1910.505 will cease to have
effect along with the rest of subpart U.
If either ETS is made permanent, OSHA
will provide notice at that time of the
agency’s intended application of 29 CFR
1910.505 to the newly permanent
standard. For example, if 29 CFR
1910.502 becomes permanent because it
has been finalized, but 29 CFR 1910.501
remains a temporary requirement
because it is not yet finalized, 29 CFR
1910.505 would remain in subpart U
and operative as to 29 CFR 1910.501
and the agency would separately
provide notice of how severability is
intended to apply to the newly
permanent 29 CFR 1910.502.
O. Incorporation by Reference
OSHA’s amendment to its COVID–19
ETS, Part 1910, Subpart U, includes the
addition of § 1910.501, Vaccination,
Testing, and Face Coverings. This
section incorporates by reference CDC’s
‘‘Isolation Guidance.’’
This document, listed below, will be
fixed in time and made publicly
available. OSHA had previously
incorporated this same document into
29 CFR 1910.502 and listed it in subpart
U’s incorporation by reference (IBR)
section, 29 CFR 1910.509. Because
subpart U is the result of two separate
ETSs published at different times and
subject to different time frames, but both
incorporate documents by reference,
OSHA has relied on the same
centralized IBR section for both. For the
benefit of the reader and for
administrative convenience, this
centralized IBR section is located in the
same subpart as the other provisions of
the ETS.
While either ETS remains in effect, it
is OSHA’s intent that 29 CFR 1910.509
remain in subpart U. If both ETSs are
not made permanent, 29 CFR 1910.509
will cease to have effect along with the
rest of subpart U. If either ETS is made
permanent, OSHA intends to recodify
the relevant standards for that ETS from
29 CFR 1910.509 into 29 CFR 1910.6,
the centralized IBR section for part
1910. For example, if 29 CFR 1910.502
becomes permanent because it has been
finalized, but 29 CFR 1910.501 remains
a temporary requirement because it is
not yet finalized, OSHA would relocate
all of 29 CFR 1910.502’s incorporated
documents into 29 CFR 1910.6, but 29
CFR 1910.509 would remain in subpart
U and would list the one document
incorporated by reference into 29 CFR
1910.501.
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In this section, OSHA includes a list
of the titles, editions/versions, and years
of the incorporated documents.
Stakeholders may consult 29 CFR
1910.509 both to locate all of the
documents incorporated by reference in
subpart U (the paragraph in which the
document is incorporated is listed there)
and to find more details regarding how
to locate the specific consensus
standard and guidelines that have been
incorporated by reference in the ETS.
OSHA recognizes that the Centers for
Disease Control and Prevention (CDC)
may update their guidelines based on
the most current available scientific
evidence, but OSHA is only requiring
compliance with CDC’s ‘‘Isolation
Guidance’’ as incorporated by reference,
which is fixed in time as of February 18,
2021.
As discussed in the preamble of the
Healthcare ETS at 86 FR 32619, CDC’s
guidance, including its ‘‘Isolation
Guidance,’’ is not expressed in
mandatory terms. As such, OSHA has
determined it is not sufficiently
protective or a meaningful alternative to
a mandatory standard. OSHA has
reviewed this guidance and determined
that compliance with the safety
measures and specific instructions in
CDC’s ‘‘Isolation Guidance’’ is
important to protect workers who work
for employees with over 100 employees.
For the same reasons as described in the
Healthcare ETS (86 FR 32619), OSHA is
incorporating this guidance by
reference, and compliance with the
recommendations will be mandatory.
OSHA will be able to cite employers
who do not follow them. Compliance
with all applicable provisions of the
incorporated document is required
where the provisions into which they
are incorporated are mandatory,
whether the incorporated document sets
out its directions in mandatory language
or recommendations. OSHA recognizes
that this document incorporated by
reference into the ETS may become
outdated when newer versions are
published or other entities revise those
documents. In that case, OSHA will
work quickly to update the ETS through
a new rulemaking or issue enforcement
guidance, as appropriate. But OSHA
also has a longstanding de minimis
enforcement policy to allow employers
to rely on documents that are at least as
protective.
OSHA is incorporating by reference
(in 29 CFR 1910.509) the material
below. A brief description of the
guidance is provided in the text below.
A description of its use can be found in
the Regulatory Text, and Summary and
Explanation (Section VI. of this
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preamble), where the guidance is
referenced.
PART 1910—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS
Regulatory Text—§§ 1910.501(h);
1910.502(l)
Subpart U—COVID–19
CDC’s Isolation Guidance (2021): This
guidance provides steps to take when
someone is experiencing COVID–19
symptoms and/or tested positive for
COVID–19. This document is available
at www.osha.gov/coronavirus/ets/ibr.
The CDC document is available at no
cost through the contact information
listed above. In addition, in accordance
with § 1910.509(a)(1), this guidance is
available for inspection at any Regional
Office of the Occupational Safety and
Health Administration (OSHA), or at the
OSHA Docket Office, U.S. Department
of Labor, 200 Constitution Avenue NW,
Room N–3508, Washington, DC 20210;
telephone: 202–693–2350 (TTY number:
877–889–5627). Due to copyright issues,
OSHA cannot post consensus standards
on the OSHA website or through
www.regulations.gov.
List of Subjects
29 CFR Part 1910
COVID–19, Disease, Health, Health
care, Health facilities, Incorporation by
reference, Occupational safety and
health, Public health, Quarantine,
Reporting and recordkeeping
requirements, Respirators, SARS–CoV–
2, Telework, Vaccines, Viruses.
29 CFR Parts 1915, 1917, 1918, 1926,
and 1928
COVID–19, Disease, Health, Health
care, Health facilities, Occupational
safety and health, Public health,
Quarantine, Reporting and
recordkeeping requirements,
Respirators, SARS–CoV–2, Telework,
Vaccines, Viruses.
Authority and Signature
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James S. Frederick, Acting Assistant
Secretary of Labor for Occupational
Safety and Health, U.S. Department of
Labor, authorized the preparation of this
document pursuant to the following
authorities: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); Secretary
of Labor’s Order 8–2020 (85 FR 58393
(Sept. 18, 2020)); 29 CFR part 1911; and
5 U.S.C. 553.
James S. Frederick,
Acting Assistant Secretary of Labor for
Occupational Safety and Health.
For the reasons set forth in the
preamble, chapter XVII of title 29 of the
Code of Federal Regulations is amended
as follows:
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1. Revise the heading for Subpart U to
read as set forth above.
■ 2. The authority citation for subpart U
continues to read as follows:
■
Authority: 29 U.S.C. 653, 655, and 657;
Secretary of Labor’s Order No. 8–2020 (85 FR
58393); 29 CFR part 1911; and 5 U.S.C. 553.
3. Add § 1910.501 to subpart U to read
as follows:
■
§ 1910.501 Vaccination, testing, and face
coverings.
(a) Purpose. This section is intended
to establish minimum vaccination,
vaccination verification, face covering,
and testing requirements to address the
grave danger of COVID–19 in the
workplace, and to preempt inconsistent
state and local requirements relating to
these issues, including requirements
that ban or limit employers’ authority to
require vaccination, face covering, or
testing, regardless of the number of
employees.
Note 1 to paragraph (a): This section
establishes minimum requirements that
employers must implement. Nothing in this
section prevents employers from agreeing
with workers and their representatives to
additional measures not required by this
section and this section does not supplant
collective bargaining agreements or other
collectively negotiated agreements in effect
that may have negotiated terms that exceed
the requirements herein. The National Labor
Relations Act of 1935 (NLRA) protects the
right of most private-sector employees to take
collective action to improve their wages and
working conditions.
(b) Scope and application. (1) This
section covers all employers with a total
of 100 or more employees at any time
this section is in effect.
(2) The requirements of this section
do not apply to:
(i) Workplaces covered under the
Safer Federal Workforce Task Force
COVID–19 Workplace Safety: Guidance
for Federal Contractors and
Subcontractors; or
(ii) Settings where any employee
provides healthcare services or
healthcare support services when
subject to the requirements of
§ 1910.502.
(3) The requirements of this section
do not apply to the employees of
covered employers:
(i) Who do not report to a workplace
where other individuals such as
coworkers or customers are present;
(ii) While working from home; or
(iii) Who work exclusively outdoors.
(c) Definitions. The following
definitions apply to this section.
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Assistant Secretary means the
Assistant Secretary of Labor for
Occupational Safety and Health, U.S.
Department of Labor, or designee.
COVID–19 (Coronavirus Disease 2019)
means the disease caused by SARS–
CoV–2 (severe acute respiratory
syndrome coronavirus 2). For clarity
and ease of reference, this section also
uses the term ‘‘COVID–19’’ when
describing exposures or potential
exposures to SARS–CoV–2.
COVID–19 test means a test for SARS–
CoV–2 that is:
(i) Cleared, approved, or authorized,
including in an Emergency Use
Authorization (EUA), by the FDA to
detect current infection with the SARS–
CoV–2 virus (e.g., a viral test);
(ii) Administered in accordance with
the authorized instructions; and
(iii) Not both self-administered and
self-read unless observed by the
employer or an authorized telehealth
proctor. Examples of tests that satisfy
this requirement include tests with
specimens that are processed by a
laboratory (including home or on-site
collected specimens which are
processed either individually or as
pooled specimens), proctored over-thecounter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer.
Face covering means a covering that:
(i)(A) completely covers the nose and
mouth;
(B) Is made with two or more layers
of a breathable fabric that is tightly
woven (i.e., fabrics that do not let light
pass through when held up to a light
source);
(C) Is secured to the head with ties,
ear loops, or elastic bands that go
behind the head. If gaiters are worn,
they should have two layers of fabric or
be folded to make two layers;
(D) Fits snugly over the nose, mouth,
and chin with no large gaps on the
outside of the face; and
(E) Is a solid piece of material without
slits, exhalation valves, visible holes,
punctures, or other openings.
(ii) This definition includes clear face
coverings or cloth face coverings with a
clear plastic panel that, despite the noncloth material allowing light to pass
through, otherwise meet this definition
and which may be used to facilitate
communication with people who are
deaf or hard-of-hearing or others who
need to see a speaker’s mouth or facial
expressions to understand speech or
sign language respectively.
Facemask means a surgical, medical
procedure, dental, or isolation mask that
is FDA-cleared, authorized by an FDA
EUA, or offered or distributed as
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described in an FDA enforcement
policy. Facemasks may also be referred
to as ‘‘medical procedure masks.’’
Fully vaccinated means:
(i) A person’s status 2 weeks after
completing primary vaccination with a
COVID–19 vaccine with, if applicable,
at least the minimum recommended
interval between doses in accordance
with the approval, authorization, or
listing that is:
(A) Approved or authorized for
emergency use by the FDA;
(B) Listed for emergency use by the
World Health Organization (WHO); or
(C) Administered as part of a clinical
trial at a U.S. site, if the recipient is
documented to have primary
vaccination with the active (not
placebo) COVID–19 vaccine candidate,
for which vaccine efficacy has been
independently confirmed (e.g., by a data
and safety monitoring board) or if the
clinical trial participant at U.S. sites had
received a COVID–19 vaccine that is
neither approved nor authorized for use
by FDA but is listed for emergency use
by WHO; or
(ii) A person’s status 2 weeks after
receiving the second dose of any
combination of two doses of a COVID–
19 vaccine that is approved or
authorized by the FDA, or listed as a
two-dose series by the WHO (i.e., a
heterologous primary series of such
vaccines, receiving doses of different
COVID–19 vaccines as part of one
primary series). The second dose of the
series must not be received earlier than
17 days (21 days with a 4-day grace
period) after the first dose.
Mandatory Vaccination Policy is an
employer policy requiring each
employee to be fully vaccinated. To
meet this definition, the policy must
require: Vaccination of all employees,
including vaccination of all new
employees as soon as practicable, other
than those employees:
(i) For whom a vaccine is medically
contraindicated;
(ii) For whom medical necessity
requires a delay in vaccination; or
(iii) Who are legally entitled to a
reasonable accommodation under
federal civil rights laws because they
have a disability or sincerely held
religious beliefs, practices, or
observances that conflict with the
vaccination requirement.
Respirator means a type of personal
protective equipment (PPE) that is
certified by the National Institute for
Occupational Safety and Health
(NIOSH) under 42 CFR part 84 or is
authorized under an EUA by the FDA.
Respirators protect against airborne
hazards by removing specific air
contaminants from the ambient
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(surrounding) air or by supplying
breathable air from a safe source.
Common types of respirators include
filtering facepiece respirators (e.g., N95),
elastomeric respirators, and powered air
purifying respirators (PAPRs). Face
coverings, facemasks, and face shields
are not respirators.
Workplace means a physical location
(e.g., fixed, mobile) where the
employer’s work or operations are
performed. It does not include an
employee’s residence.
(d) Employer policy on vaccination.
(1) The employer must establish,
implement, and enforce a written
mandatory vaccination policy.
(2) The employer is exempted from
the requirement in paragraph (d)(1) of
this section only if the employer
establishes, implements, and enforces a
written policy allowing any employee
not subject to a mandatory vaccination
policy to choose either to be fully
vaccinated against COVID–19 or provide
proof of regular testing for COVID–19 in
accordance with paragraph (g) of this
section and wear a face covering in
accordance with paragraph (i) of this
section.
Note 1 to paragraph (d): Under federal law,
including the Americans with Disabilities
Act (ADA) and Title VII of the Civil Rights
Act of 1964, workers may be entitled to a
reasonable accommodation from their
employer, absent undue hardship. If the
worker requesting a reasonable
accommodation cannot be vaccinated and/or
wear a face covering because of a disability,
as defined by the ADA, the worker may be
entitled to a reasonable accommodation. In
addition, if the vaccination, and/or testing for
COVID–19, and/or wearing a face covering
conflicts with a worker’s sincerely held
religious belief, practice or observance, the
worker may be entitled to a reasonable
accommodation. For more information about
evaluating requests for reasonable
accommodation for disability or sincerely
held religious belief, employers should
consult the Equal Employment Opportunity
Commission’s regulations, guidance, and
technical assistance including at: https://
www.eeoc.gov/wysk/what-you-should-knowabout-covid-19-and-ada-rehabilitation-actand-other-eeo-laws.
(e) Determination of employee
vaccination status. (1) The employer
must determine the vaccination status of
each employee. This determination
must include whether the employee is
fully vaccinated.
(2) The employer must require each
vaccinated employee to provide
acceptable proof of vaccination status,
including whether they are fully or
partially vaccinated. Acceptable proof of
vaccination status is:
(i) The record of immunization from
a health care provider or pharmacy;
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(ii) A copy of the COVID–19
Vaccination Record Card;
(iii) A copy of medical records
documenting the vaccination;
(iv) A copy of immunization records
from a public health, state, or tribal
immunization information system; or
(v) A copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s);
(vi) In instances where an employee is
unable to produce acceptable proof of
vaccination under paragraphs (e)(2)(i)
through (v) of this section, a signed and
dated statement by the employee:
(A) Attesting to their vaccination
status (fully vaccinated or partially
vaccinated);
(B) Attesting that they have lost and
are otherwise unable to produce proof
required by this section; and
(C) Including the following language:
‘‘I declare (or certify, verify, or state)
that this statement about my vaccination
status is true and accurate. I understand
that knowingly providing false
information regarding my vaccination
status on this form may subject me to
criminal penalties.’’
Note 1 to paragraph (e)(2)(vi): An
employee who attests to their vaccination
status should, to the best of their recollection,
include the following information in their
attestation: The type of vaccine administered;
date(s) of administration; and the name of the
health care professional(s) or clinic site(s)
administering the vaccine(s).
(3) Any employee who does not
provide one of the acceptable forms of
proof of vaccination status in paragraph
(e)(2) of this section to the employer
must be treated as not fully vaccinated
for the purpose of this section.
(4) The employer must maintain a
record of each employee’s vaccination
status and must preserve acceptable
proof of vaccination for each employee
who is fully or partially vaccinated. The
employer must maintain a roster of each
employee’s vaccination status. These
records and roster are considered to be
employee medical records and must be
maintained as such records in
accordance with § 1910.1020 and must
not be disclosed except as required or
authorized by this section or other
federal law. These records and roster are
not subject to the retention requirements
of § 1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
(5) When an employer has ascertained
employee vaccination status prior to the
effective date of this section through
another form of attestation or proof, and
retained records of that ascertainment,
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the employer is exempt from the
requirements in paragraphs (e)(1)
through (3) of this section only for each
employee whose fully vaccinated status
has been documented prior to the
effective date of this section. For
purposes of paragraph (e)(4) of this
section, the employer’s records of
ascertainment of vaccination status for
each such person constitute acceptable
proof of vaccination.
(f) Employer support for employee
vaccination. The employer must
support COVID–19 vaccination as
described in this paragraph.
(1) Time for vaccination. The
employer must:
(i) Provide a reasonable amount of
time to each employee for each of their
primary vaccination dose(s); and
(ii) Provide up to 4 hours paid time,
including travel time, at the employee’s
regular rate of pay for this purpose.
(2) Time for recovery. The employer
must provide reasonable time and paid
sick leave to recover from side effects
experienced following any primary
vaccination dose to each employee for
each dose.
(g) COVID–19 testing for employees
who are not fully vaccinated. (1) The
employer must ensure that each
employee who is not fully vaccinated
complies with paragraph (g)(1)(i) or (ii)
of this section:
(i) An employee who reports at least
once every 7 days to a workplace where
other individuals such as coworkers or
customers are present:
(A) Must be tested for COVID–19 at
least once every 7 days; and
(B) Must provide documentation of
the most recent COVID–19 test result to
the employer no later than the 7th day
following the date on which the
employee last provided a test result.
(ii) An employee who does not report
during a period of 7 or more days to a
workplace where other individuals such
as coworkers or customers are present
(e.g., teleworking for two weeks prior to
reporting to a workplace with others):
(A) Must be tested for COVID–19
within 7 days prior to returning to the
workplace; and
(B) Must provide documentation of
that test result to the employer upon
return to the workplace.
Note 1 to paragraph (g)(1): This section
does not require the employer to pay for any
costs associated with testing; however
employer payment for testing may be
required by other laws, regulations, or
collective bargaining agreements or other
collectively negotiated agreements. This
section also does not prohibit the employer
from paying for costs associated with testing
required by paragraph (g)(1) of this section.
(2) If an employee does not provide
documentation of a COVID–19 test
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result as required by paragraph (g)(1) of
this section, the employer must keep
that employee removed from the
workplace until the employee provides
a test result.
(3) When an employee has received a
positive COVID–19 test, or has been
diagnosed with COVID–19 by a licensed
healthcare provider, the employer must
not require that employee to undergo
COVID–19 testing as required under
paragraph (g) of this section for 90 days
following the date of their positive test
or diagnosis.
(4) The employer must maintain a
record of each test result provided by
each employee under paragraph (g)(1) of
this section or obtained during tests
conducted by the employer. These
records are considered to be employee
medical records and must be
maintained as such records in
accordance with § 1910.1020 and must
not be disclosed except as required or
authorized by this section or other
federal law. These records are not
subject to the retention requirements of
§ 1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
(h) Employee notification to employer
of a positive COVID–19 test and
removal. Regardless of COVID–19
vaccination status or any COVID–19
testing required under paragraph (g) of
this section, the employer must:
(1) Require each employee to
promptly notify the employer when
they receive a positive COVID–19 test or
are diagnosed with COVID–19 by a
licensed healthcare provider; and
(2) Immediately remove from the
workplace any employee who receives a
positive COVID–19 test or is diagnosed
with COVID–19 by a licensed healthcare
provider and keep the employee
removed until the employee:
(i) Receives a negative result on a
COVID–19 nucleic acid amplification
test (NAAT) following a positive result
on a COVID–19 antigen test if the
employee chooses to seek a NAAT test
for confirmatory testing;
(ii) meets the return to work criteria
in CDC’s ‘‘Isolation Guidance’’
(incorporated by reference, § 1910.509);
or
(iii) Receives a recommendation to
return to work from a licensed
healthcare provider.
(i) Face coverings. (1) The employer
must ensure that each employee who is
not fully vaccinated wears a face
covering when indoors and when
occupying a vehicle with another
person for work purposes, except:
(i) When an employee is alone in a
room with floor to ceiling walls and a
closed door.
(ii) For a limited time while the
employee is eating or drinking at the
workplace or for identification purposes
in compliance with safety and security
requirements.
(iii) When an employee is wearing a
respirator or facemask.
(iv) Where the employer can show
that the use of face coverings is
infeasible or creates a greater hazard
that would excuse compliance with this
paragraph (e.g., when it is important to
see the employee’s mouth for reasons
related to their job duties, when the
work requires the use of the employee’s
uncovered mouth, or when the use of a
face covering presents a risk of serious
injury or death to the employee).
(2) The employer must ensure that
any face covering required to be worn
by this section:
(i) Is worn by the employee to fully
cover the employee’s nose and mouth;
and
(ii) Is replaced when wet, soiled, or
damaged (e.g., is ripped, has holes, or
has broken ear loops).
(3) The employer must not prevent
any employee from voluntarily wearing
a face covering or facemask unless the
employer can demonstrate that doing so
would create a hazard of serious injury
or death, such as interfering with the
safe operation of equipment.
(4) The employer must permit the
employee to wear a respirator instead of
a face covering whether required or not.
In addition, the employer may provide
respirators to the employee, even if not
required. In such circumstances, the
employer must also comply with
§ 1910.504.
(5) The employer must not prohibit
customers or visitors from wearing face
coverings.
Note 1 to paragraph (h)(2): This section
does not require employers to provide paid
time to any employee for removal as a result
of a positive COVID–19 test or diagnosis of
COVID–19; however, paid time may be
required by other laws, regulations, or
collective bargaining agreements or other
collectively negotiated agreements.
Note 2 to paragraph (i): This section does
not require the employer to pay for any costs
associated with face coverings; however
employer payment for face coverings may be
required by other laws, regulations, or
collective bargaining agreements or other
collectively negotiated agreements. This
section also does not prohibit the employer
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Note 1 to paragraph (i)(5): Nothing in this
section precludes employers from requiring
customers or visitors to wear face coverings.
Note 1 to paragraph (i): Face shields may
be worn in addition to face coverings to
prevent them from getting wet and soiled.
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from paying for costs associated with face
coverings required by this section.
(j) Information provided to employees.
The employer must inform each
employee, in a language and at a literacy
level the employee understands, about:
(1) The requirements of this section as
well as any employer policies and
procedures established to implement
this section;
(2) COVID–19 vaccine efficacy, safety,
and the benefits of being vaccinated, by
providing the document, ‘‘Key Things to
Know About COVID–19 Vaccines,’’
available at https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/
keythingstoknow.html;
(3) The requirements of 29 CFR
1904.35(b)(1)(iv), which prohibits the
employer from discharging or in any
manner discriminating against an
employee for reporting a work-related
injuries or illness, and section 11(c) of
the OSH Act, which prohibits the
employer from discriminating against an
employee for exercising rights under, or
as a result of actions that are required
by, this section. Section 11(c) also
protects the employee from retaliation
for filing an occupational safety or
health complaint, reporting a workrelated injuries or illness, or otherwise
exercising any rights afforded by the
OSH Act; and
(4) The prohibitions of 18 U.S.C. 1001
and of section 17(g) of the OSH Act,
which provide for criminal penalties
associated with knowingly supplying
false statements or documentation.
(k) Reporting COVID–19 fatalities and
hospitalizations to OSHA. (1) The
employer must report to OSHA:
(i) Each work-related COVID–19
fatality within 8 hours of the employer
learning about the fatality.
(ii) Each work-related COVID–19 inpatient hospitalization within 24 hours
of the employer learning about the inpatient hospitalization.
(2) When reporting COVID–19
fatalities and in-patient hospitalizations
to OSHA in accordance with paragraph
(j)(1) of this section, the employer must
follow the requirements in 29 CFR part
1904.39, except for 29 CFR part
1904.39(a)(1) and (2) and (b)(6).
(l) Availability of records. (1) By the
end of the next business day after a
request, the employer must make
available, for examination and copying,
the individual COVID–19 vaccine
documentation and any COVID–19 test
results for a particular employee to that
employee and to anyone having written
authorized consent of that employee.
(2) By the end of the next business
day after a request by an employee or an
employee representative, the employer
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
must make available to the requester the
aggregate number of fully vaccinated
employees at a workplace along with
the total number of employees at that
workplace.
(3) The employer must provide to the
Assistant Secretary for examination and
copying:
(i) Within 4 business hours of a
request, the employer’s written policy
required by paragraph (d) of this
section, and the aggregate numbers
described in paragraph (l)(2) of this
section; and
(ii) By the end of the next business
day after a request, all other records and
other documents required to be
maintained by this section.
(m) Dates—(1) Effective date. This
section is effective as of November 5,
2021.
(2) Compliance dates. (i) Employers
must comply with all requirements of
this section, except for requirements in
paragraph (g) of this section, by
December 6, 2021.
(ii) Employers must comply with the
requirements of this section in
paragraph (g) by January 4, 2022, but
employees who have completed the
entire primary vaccination by that date
do not have to be tested, even if they
have not yet completed the 2-week
waiting period.
■ 4. Amend § 1910.504 by revising
paragraph (a) to read as follows:
§ 1910.504
Program.
Severability.
§ 1910.509
Incorporation by reference.
*
*
PO 00000
7. The authority citation for part 1915
is revised to read as follows:
■
Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754); 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393); 29 CFR part 1911; and 5
U.S.C. 553, as applicable.
Subpart Z—Toxic and Hazardous
Substances
8. Add § 1915.1501 to subpart Z to
read as follows:
■
§ 1915.1501
COVID–19.
The requirements applicable to
shipyard employment under this section
are identical to those set forth at 29 CFR
1910.501.
PART 1917—MARINE TERMINALS
9. The authority citation for part 1917
is revised to read as follows:
■
Each section of this subpart U, and
each provision within those sections, is
separate and severable from the other
sections and provisions. If any provision
of this subpart is held to be invalid or
unenforceable on its face, or as applied
to any person, entity, or circumstance,
or is stayed or enjoined, that provision
shall be construed so as to continue to
give the maximum effect to the
provision permitted by law, unless such
holding shall be one of utter invalidity
or unenforceability, in which event the
provision shall be severable from this
subpart and shall not affect the
remainder of the subpart.
■ 6. Amend § 1910.509 by revising
paragraph (b)(5) to read as follows:
*
PART 1915—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS FOR
SHIPYARD EMPLOYMENT
Mini Respiratory Protection
(a) Scope and application. This
section applies only to respirator use in
accordance with §§ 1910.501(i)(4) and
1910.502(f)(4).
*
*
*
*
*
■ 5. Republish § 1910.505 to read as
follows:
§ 1910.505
(b) * * *
(5) Isolation Guidance. COVID–19:
Isolation If You Are Sick; Separate
yourself from others if you have
COVID–19, updated February 18, 2021,
IBR approved for §§ 1910.501(h) and
1910.502(l).
*
*
*
*
*
Frm 00154
*
Fmt 4701
*
Sfmt 4700
Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393), as applicable; and 29 CFR part
1911.
Sections 1917.28 and 1917.31 also issued
under 5 U.S.C. 553.
Section 1917.29 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Subpart B—Marine Terminal
Operations
10. Add § 1917.31 to subpart B to read
as follows:
■
§ 1917.31
COVID–19.
The requirements applicable to
marine terminal work under this section
are identical to those set forth at 29 CFR
1910.501.
PART 1918—SAFETY AND HEALTH
REGULATIONS FOR LONGSHORING
11. The authority citation for part
1918 is revised to read as follows:
■
E:\FR\FM\05NOR2.SGM
05NOR2
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393), as applicable; and 29 CFR
1911.
Sections 1918.90 and 1918.110 also issued
under 5 U.S.C. 553.
Section 1918.100 also issued under 49
U.S.C. 5101 et seq. and 5 U.S.C. 553.
12. Add subpart K to part 1918 to read
as follows:
■
Subpart K—COVID–19.
Sec.
1918.107–1918.109 [Reserved]
1918.110 COVID–19.
1918.107 through 1918.109 [Reserved]
§ 1918.110
COVID–19.
The requirements applicable to
longshoring work under this section are
identical to those set forth at 29 CFR
1910.501.
PART 1926—SAFETY AND HEALTH
REGULATIONS FOR CONSTRUCTION
Subpart B—Applicability of Standards
16. Amend § 1928.21 by adding
paragraph (a)(8) to read as follows:
■
§ 1928.21 Applicable standards in 29 CFR
part 1910.
(a) * * *
(8) COVID–19—§ 1910.501, but only
with respect to—
(i) Agricultural establishments where
eleven (11) or more employees are
engaged on any given day in hand-labor
operations in the field; and
(ii) Agricultural establishments that
maintain a temporary labor camp,
regardless of how many employees are
engaged on any given day in hand-labor
operations in the field.
*
*
*
*
*
[FR Doc. 2021–23643 Filed 11–4–21; 8:45 am]
■
13. The authority citation for part
1926 is revised to read as follows:
BILLING CODE 4510–26–P
Authority: 40 U.S.C. 3704; 29 U.S.C. 653,
655, and 657; and Secretary of Labor’s Order
No. 12–71 (36 FR 8754), 8–76 (41 FR 25059),
9–83 (48 FR 35736), 1–90 (55 FR 9033), 6–
96 (62 FR 111), 3–2000 (65 FR 50017), 5–
2002 (67 FR 65008), 5–2007 (72 FR 31159),
4–2010 (75 FR 55355), 1–2012 (77 FR 3912),
or 8–2020 (85 FR 58393), as applicable; and
29 CFR part 1911.
Sections 1926.58, 1926.59, 1926.60, and
1926.65 also issued under 5 U.S.C. 553 and
29 CFR part 1911.
Section 1926.61 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Section 1926.62 also issued under sec.
1031, Public Law 102–550, 106 Stat. 3672 (42
U.S.C. 4853).
Section 1926.65 also issued under sec. 126,
Public Law 99–499, 100 Stat. 1614 (reprinted
at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Subpart D—Occupational Health and
Environmental Controls
■
COVID–19.
The requirements applicable to
construction work under this section are
identical to those set forth at 29 CFR
1910.501 Subpart U.
PART 1928—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS FOR
AGRICULTURE
15. The authority citation for part
1928 is revised to read as follows:
■
Authority: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
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22:27 Nov 04, 2021
Jkt 256001
Centers for Medicare & Medicaid
Services
42 CFR Parts 416, 418, 441, 460, 482,
483, 484, 485, 486, 491 and 494
[CMS–3415–IFC]
RIN 0938–AU75
Medicare and Medicaid Programs;
Omnibus COVID–19 Health Care Staff
Vaccination
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
AGENCY:
This interim final rule with
comment period revises the
requirements that most Medicare- and
Medicaid-certified providers and
suppliers must meet to participate in the
Medicare and Medicaid programs.
These changes are necessary to help
protect the health and safety of
residents, clients, patients, PACE
participants, and staff, and reflect
lessons learned to date as a result of the
COVID–19 public health emergency.
The revisions to the requirements
establish COVID–19 vaccination
requirements for staff at the included
Medicare- and Medicaid-certified
providers and suppliers.
SUMMARY:
14. Add § 1926.58 to read as follows:
§ 1926.58
jspears on DSK121TN23PROD with RULES2
(29 U.S.C. 653, 655, 657); Secretary of Labor’s
Order No. 12–71 (36 FR 8754), 8–76 (41 FR
25059), 9–83 (48 FR 35736), 1–90 (55 FR
9033), 6–96 (62 FR 111), 3–2000 (65 FR
50017), 5–2002 (67 FR 65008), 4–2010 (75 FR
55355), or 8–2020 (85 FR 58393), as
applicable; and 29 CFR 1911.
Section 1928.21 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
PO 00000
Frm 00155
Fmt 4701
Sfmt 4700
61555
DATES:
Effective date: These regulations are
effective on November 5, 2021.
Implementation dates: The
regulations included in Phase 1 [42 CFR
416.51(c) through (c)(3)(i) and (c)(3)(iii)
through (x), 418.60(d) through (d)(3)(i)
and (d)(3)(iii) through (x), 441.151(c)
through (c)(3)(i) and (c)(3)(iii) through
(x), 460.74(d) through (d)(3)(i) and
(d)(3)(iii) through (x), 482.42(g) through
(g)(3)(i) and (g)(3)(iii) through (x),
483.80(d)(3)(v) and 483.80(i) through
(i)(3)(i) and (i)(3)(iii) through (x),
483.430(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 483.460(a)(4)(v), 484.70(d)
through (d)(3)(i) and (d)(3)(iii) through
(x), 485.58(d)(4), 485.70(n) through
(n)(3)(i) and (n)(3)(iii) through (x),
485.640(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 485.725(f) through (f)(3)(i)
through (f)(3)(iii) through (x), 485.904(c)
through (c)(3)(i) and (c)(3)(iii) through
(x), 486.525(c) through (c)(3)(i) and
(c)(3)(iii) through (x), 491.8(d) through
(d)(3)(i) and (d)(3)(iii) through (x),
494.30(b) through (b)((3)(i) and (b)(3)(iii)
through (x) must be implemented by
December 6, 2021.
The regulations included in Phase 2
[42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii),
441.151(c)(3)(ii), 460.74(d)(3)(ii),
482.42(g)(3)(ii), 483.80(i)(3)(ii),
483.430(f)(3)(ii), 484.70(d)(3)(ii),
485.70(n)(3)(ii), 485.640(f)(3)(ii),
485.725(f)(3)(ii), 485.904(c)(3)(ii),
486.525(c)(3)(ii), 491.8(d)(3)(ii),
494.30(b)(3)(ii)] must be implemented
by January 4, 2022. Staff who have
completed a primary vaccination series
by this date are considered to have met
these requirements, even if they have
not yet completed the 14-day waiting
period required for full vaccination.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
January 4, 2022.
ADDRESSES: In commenting, please refer
to file code CMS–3415–IFC.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3415–IFC, P.O. Box 8016,
Baltimore, MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
E:\FR\FM\05NOR2.SGM
05NOR2
Agencies
[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Rules and Regulations]
[Pages 61402-61555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23643]
[[Page 61401]]
Vol. 86
Friday,
No. 212
November 5, 2021
Part II
Department of Labor
-----------------------------------------------------------------------
Occupational Safety and Health Administration
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
29 CFR Parts 1910, 1915, 1917, et al.
42 Parts 416, 418, 441, et al.
-----------------------------------------------------------------------
COVID-19 Vaccination and Testing; Emergency Temporary Standard;
Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff
Vaccination; Interim Final Rules
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 /
Rules and Regulations
[[Page 61402]]
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, 1917, 1918, 1926, and 1928
[Docket No. OSHA-2021-0007]
RIN 1218-AD42
COVID-19 Vaccination and Testing; Emergency Temporary Standard
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Interim final rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Occupational Safety and Health Administration (OSHA) is
issuing an emergency temporary standard (ETS) to protect unvaccinated
employees of large employers (100 or more employees) from the risk of
contracting COVID-19 by strongly encouraging vaccination. Covered
employers must develop, implement, and enforce a mandatory COVID-19
vaccination policy, with an exception for employers that instead adopt
a policy requiring employees to either get vaccinated or elect to
undergo regular COVID-19 testing and wear a face covering at work in
lieu of vaccination.
DATES: The rule is effective November 5, 2021. The incorporation by
reference of certain publications listed in the rule is approved by the
Director of the Federal Register as of November 5, 2021.
Compliance dates: Compliance dates for specific provisions are in
29 CFR 1910.501(m).
Comments: Written comments, including comments on any aspect of
this ETS and whether this ETS should become a final rule, must be
submitted by December 6, 2021 in Docket No. OSHA-2021-0007. Comments on
the information collection determination described in Additional
Requirements (Section V.K. of this preamble) (OMB review under the
Paperwork Reduction Act of 1995) may be submitted by January 4, 2022 in
Docket No. OSHA-2021-0008.
ADDRESSES: In accordance with 28 U.S.C. 2112(a), the Agency designates
Edmund C. Baird, the Associate Solicitor for Occupational Safety and
Health, Office of the Solicitor, U.S. Department of Labor, to receive
petitions for review of the ETS. Service can be accomplished by email
to zzSOL-Covid19-[email protected].
Written comments. You may submit comments and attachments,
identified by Docket No. OSHA-2021-0007, electronically at
www.regulations.gov, which is the Federal e-Rulemaking Portal. Follow
the online instructions for making electronic submissions.
Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2021-0007). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public,
or submitting materials that contain personal information (either about
themselves or others), such as Social Security Numbers and birthdates.
Docket: To read or download comments or other material in the
docket, go to Docket No. OSHA-2021-0007 at www.regulations.gov. All
comments and submissions are listed in the www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that website. All comments and
submissions, including copyrighted material, are available for
inspection through the OSHA Docket Office. Documents submitted to the
docket by OSHA or stakeholders are assigned document identification
numbers (Document ID) for easy identification and retrieval. The full
Document ID is the docket number plus a unique four-digit code. OSHA is
identifying supporting information in this ETS by author name and
publication year, when appropriate. This information can be used to
search for a supporting document in the docket at https://www.regulations.gov. Contact the OSHA Docket Office at 202-693-2350
(TTY number: 877-889-5627) for assistance in locating docket
submissions.
FOR FURTHER INFORMATION CONTACT:
General information and press inquiries: Contact Frank Meilinger,
OSHA Office of Communications, U.S. Department of Labor; telephone
(202) 693-1999; email [email protected].
For technical inquiries: Contact Andrew Levinson, OSHA Directorate
of Standards and Guidance, U.S. Department of Labor; telephone (202)
693-1950; email [email protected].
SUPPLEMENTARY INFORMATION: The preamble to the ETS on COVID-19
vaccination and testing follows this outline:
Table of Contents
I. Executive Summary and Request for Comment
A. Executive Summary
B. Request for Comment
II. Pertinent Legal Authority
III. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
IV. Feasibility
A. Technological Feasibility
B. Economic Analysis
V. Additional Requirements
VI. Summary and Explanation
A. Purpose
B. Scope and Application
C. Definitions
D. Employer Policy on Vaccination
E. Determination of Employee Vaccination Status
F. Employer Support for Employee Vaccination
G. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
H. Employee Notification to Employer of a Positive COVID-19 Test
and Removal
I. Face Coverings
J. Information Provided to Employees
K. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
L. Availability of Records
M. Dates
N. Severability
O. Incorporation by Reference
VII. Authority and Signature
I. Executive Summary and Request for Comment
A. Executive Summary
This ETS is based on the requirements of the Occupational Safety
and Health Act (OSH Act or Act) and legal precedent arising under the
Act. Under section 6(c)(1) of the OSH Act, 29 U.S.C. 655(c)(1), OSHA
shall issue an ETS if the agency determines that employees are subject
to grave danger from exposure to substances or agents determined to be
toxic or physically harmful or from new hazards, and an ETS is
necessary to protect employees from such danger. These legal
requirements are more fully discussed in Pertinent Legal Authority
(Section II. of this preamble). This ETS does not apply to workplaces
subject to E.O. 14042 on Requiring Coronavirus Disease 2019 Vaccination
for Federal Contractors. In addition, OSHA will treat federal agencies'
compliance with E.O. 14043, and the Safer Federal Workforce Task Force
guidance issued under section 4(e) of Executive Order 13991 and section
2 of Executive Order 14043, as sufficient to meet their obligations
under the OSH Act and E.O. 12196.
COVID-19 has killed over 725,000 people in the United States in
less than two years, and infected millions more (CDC, October 18,
2021--Cumulative US Deaths). The pandemic continues to affect workers
and workplaces. While COVID-19 vaccines authorized or
[[Page 61403]]
approved by the U.S. Food and Drug Administration (FDA) effectively
protect vaccinated individuals against severe illness and death from
COVID-19, unvaccinated individuals remain at much higher risk of severe
health outcomes from COVID-19. Further, unvaccinated workers are much
more likely to contract and transmit COVID-19 in the workplace than
vaccinated workers. OSHA has determined that many employees in the U.S.
who are not fully vaccinated against COVID-19 face grave danger from
exposure to SARS-CoV-2 in the workplace. This finding of grave danger
is based on the severe health consequences associated with exposure to
the virus along with evidence demonstrating the transmissibility of the
virus in the workplace and the prevalence of infections in employee
populations, as discussed in Grave Danger (Section III.A. of this
preamble).
OSHA has also determined that an ETS is necessary to protect
unvaccinated workers from the risk of contracting COVID-19 at work, as
discussed in Need for the ETS (Section III.B. of this preamble). At the
present time, workers are becoming seriously ill and dying as a result
of occupational exposures to COVID-19, when a simple measure,
vaccination, can largely prevent those deaths and illnesses. The ETS
protects these workers through the most effective and efficient control
available--vaccination--and further protects workers who remain
unvaccinated through required regular testing, use of face coverings,
and removal of all infected employees from the workplace. OSHA also
concludes, based on its enforcement experience during the pandemic to
date, that continued reliance on existing standards and regulations,
the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1), and
workplace guidance, in lieu of an ETS, is not adequate to protect
unvaccinated employees from the grave danger of being infected by, and
suffering death or serious health consequences from, COVID-19.
OSHA will continue to monitor trends in COVID-19 infections and
death as more of the workforce and the general population become fully
vaccinated against COVID-19 and the pandemic continues to evolve. Where
OSHA finds a grave danger from the virus no longer exists for the
covered workforce (or some portion thereof), or new information
indicates a change in measures necessary to address the grave danger,
OSHA will update this ETS, as appropriate.
This ETS applies to employers with a total of 100 or more employees
at any time the standard is in effect. In light of the unique
occupational safety and health dangers presented by COVID-19, and
against the backdrop of the uncertain economic environment of a
pandemic, OSHA is proceeding in a stepwise fashion in addressing the
emergency this rule covers. OSHA is confident that employers with 100
or more employees have the administrative capacity to implement the
standard's requirements promptly, but is less confident that smaller
employers can do so without undue disruption. OSHA needs additional
time to assess the capacity of smaller employers, and is seeking
comment to help the agency make that determination. Nonetheless, the
agency is acting to protect workers now in adopting a standard that
will reach two-thirds of all private-sector workers in the nation,
including those working in the largest facilities, where the most
deadly outbreaks of COVID-19 can occur.
The agency has also evaluated the feasibility of this ETS and has
determined that the requirements of the ETS are both economically and
technologically feasible, as outlined in Feasibility (Section IV. of
this preamble). The specific requirements of the ETS are outlined and
described in Summary and Explanation (Section VI. of this preamble).
B. Request for Comment
Although this ETS takes effect immediately, it also serves as a
proposal under Section 6(b) of the OSH Act (29 U.S.C. 655(b)) for a
final standard. Accordingly, OSHA seeks comment on all aspects of this
ETS and whether it should be adopted as a final standard. OSHA
encourages commenters to explain why they prefer or disfavor particular
policy choices, and include any relevant studies, experiences,
anecdotes or other information that may help support the comment. In
particular, OSHA seeks comments on the following topics:
1. Employers with fewer than 100 employees. As noted above and
fully discussed in the Summary and Explanation for Scope and
Application (Section VI.B. of this preamble), OSHA has implemented a
100-employee threshold for the requirements of this standard to focus
the ETS on companies that OSHA is confident will have sufficient
administrative systems in place to comply quickly with the ETS. The
agency is moving in a stepwise fashion on the short timeline
necessitated by the danger presented by COVID-19 while soliciting
stakeholder comment and additional information to determine whether to
adjust the scope of the ETS to address smaller employers in the future.
OSHA seeks information about the ability of employers with fewer than
100 employees to implement COVID-19 vaccination and/or testing
programs. Have you instituted vaccination mandates (with or without
alternatives), or requirements for regular COVID-19 testing or face
covering use? What have been the benefits of your approach? What
challenges have you had or could you foresee in implementing such
programs? Is there anything specific to your industry, or the size of
your business, that poses particular obstacles in implementing the
requirements in this standard? How much time would it take, what types
of costs would you incur, and how much would it cost for you to
implement such requirements?
2. Significant Risk. If OSHA were to finalize a rule based on this
ETS, it would be a standard adopted under 6(b) of the OSH Act, which
requires a finding of significant risk from exposure to COVID-19. As
discussed more fully in Pertinent Legal Authority (Section II. of this
preamble), this is a lower showing of risk than grave danger, the
finding required to issue a 6(c) emergency temporary standard. How
should the scope of the rule change to address the significant risk
posed by COVID-19 in the workplace? Should portions of the rule, such
as face coverings, apply to fully vaccinated persons?
3. Prior COVID-19 infections. OSHA determined that workers who have
been infected with COVID-19 but have not been fully vaccinated still
face a grave danger from workplace exposure to SARS-CoV-2. This is an
area of ongoing scientific inquiry. Given scientific uncertainty and
limitations in testing for infection and immunity, OSHA is concerned
that it would be infeasible for employers to operationalize a standard
that would permit or require an exception from vaccination or testing
and face covering based on prior infection with COVID-19. Is there
additional scientific information on this topic that OSHA should
consider as it determines whether to proceed with a permanent rule?
In particular, what scientific criteria can be used to determine
whether a given employee is sufficiently protected against reinfection?
Are there any temporal limits associated with this criteria to account
for potential reductions in immunity over time? Do you require
employees to provide verification of infection with COVID-19? If so,
what kinds of verification do you accept (i.e., PCR testing, antigen
testing, etc.)? What challenges have you
[[Page 61404]]
experienced, if any, in operationalizing such an exception?
4. Experience with COVID-19 vaccination policies. Should OSHA
impose a strict vaccination mandate (i.e., all employers required to
implement mandatory vaccination policies as defined in this ETS) with
no alternative compliance option? OSHA seeks information on COVID-19
vaccination policies that employers have implemented to protect
workers. If you have implemented a COVID-19 vaccination policy:
(a) When did you implement it, and what does your policy require?
Was vaccination mandatory or voluntary under the policy? Do you offer
vaccinations on site? What costs associated with vaccination did you
cover under the policy? What percentage of your workforce was
vaccinated as a result? Do you offer paid leave for receiving a
vaccination? If vaccination is mandatory, have employees been resistant
and if so what steps were required to enforce the policy?
(b) How did you verify that employees were vaccinated? Are there
other reliable means of vaccination verification not addressed by the
ETS that should be included? Did you allow attestation where the
employee could not find other proof, and if so, have you experienced
any difficulties with this approach? Have you experienced any issues
with falsified records of vaccination, and if so, how did you deal with
them?
(c) Have you experienced a decrease in infection rates or outbreaks
after implementing this policy?
(d) If you have received any requests for reasonable accommodation
from vaccination, what strategies did you implement to address the
accommodation and ensure worker safety (e.g., telework, working in
isolation, regular testing and the use of face coverings)?
5. COVID-19 testing and removal. OSHA seeks information on COVID-19
testing and removal practices implemented to protect workers.
(a) Do you have a testing and removal policy in your workplace and,
if so, what does it require? How often do you require testing and what
types of testing do you use (e.g., at-home tests, tests performed at
laboratories, tests performed at your worksites)? What costs have you
incurred as part of your testing and removal policies? Do you have
difficulty in finding adequate availability of tests? How often? Have
you experienced any issues with falsified test results, and if so, how
did you deal with them? Have you experienced other difficulties in
implementing a testing and removal scheme, including the length of time
to obtain COVID-19 test results? Do you offer paid leave for testing?
(b) How often have you detected and removed COVID-19 positive
employees from the workplace under this policy? Do you provide paid
leave and job protection to employees you remove for this reason?
(c) Should OSHA require testing more often than on a weekly basis?
6. Face coverings. As discussed in the Summary and Explanation for
Face Coverings (Section VI.I. of this preamble), ASTM released a
specification standard on February 15, 2021, to establish a national
standard baseline for barrier face coverings (ASTM F3502-21). Should
OSHA require the use of face coverings meeting the ASTM F3502-21
standard instead of the face coverings specified by the ETS? If so,
should OSHA also require that such face coverings meet the NIOSH
Workplace Performance or Workplace Performance Plus criteria (see CDC,
September 23, 2021)? Are there particular workplace settings in which
face coverings meeting one standard should be favored over another? Are
there alternative criteria OSHA should consider for face coverings
instead of the F3502-21 standard or NIOSH Workplace Performance or
Workplace Performance Plus criteria? Is there sufficient capacity to
supply face coverings meeting F3502-01 and/or NIOSH Workplace
Performance or Workplace Performance Plus criteria to all employees
covered by the ETS? What costs have you incurred as part of supplying
employees with face coverings meeting the appropriate criteria?
7. Other controls. This ETS requires employees to either be fully
vaccinated against COVID-19 or be tested weekly and wear face
coverings, based on the type of policy their employer adopts. It stops
short of requiring the full suite of workplace controls against SARS-
CoV-2 transmission recommended by OSHA and the CDC, including
distancing, barriers, ventilation, and sanitation. As OSHA explained in
Need for the ETS (Section III.B. of this preamble), OSHA has determined
that it needs more information before imposing these requirements on
the entire scope of industries and employers covered by the standard.
OSHA is interested in hearing from employers about their experience in
implementing a full suite of workplace controls against COVID-19.
What measures have you taken to protect employees against COVID-19
in your workplace? Are there controls that you attempted to employ but
found ineffective or infeasible? What are they? Why did you conclude
that they were they ineffective or infeasible; for example, are there
particular aspects of your workplace or industry that make certain
controls infeasible? Do you require both fully vaccinated and
unvaccinated employees to comply with these controls? Have you
experienced a reduction in infection rates or outbreaks since
implementing these controls?
8. Educational materials. Have you implemented any policies or
provided any information that has been helpful in encouraging an
employee to be vaccinated?
9. Feasibility and health impacts. Do you have any experience or
data that would inform OSHA's estimates in its economic feasibility
analysis or any of the assumptions or estimates used in OSHA's
identification of the number of hospitalizations prevented and lives
saved from its health impacts analysis (see OSHA, October 2021c)?
References
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
23). Types of Masks and Respirators. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html.
(CDC, September 23, 2021)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
II. Pertinent Legal Authority
The purpose of the Occupational Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. 651 et seq., is ``to assure so far as possible every
working man and woman in the Nation safe and healthful working
conditions and to preserve our human resources.'' 29 U.S.C. 651(b). To
this end, Congress authorized the Secretary of Labor (Secretary) to
promulgate and enforce occupational safety and health standards under
sections 6(b) and (c) of the OSH Act.\1\ 29 U.S.C. 655(b). These
provisions provide bases for issuing occupational safety and health
standards under the Act. Once OSHA has established as a threshold
matter that a health standard is necessary under section 6(b) or (c)--
i.e., to reduce
[[Page 61405]]
a significant risk of material health impairment, or a grave danger to
employee health--the Act gives the Secretary ``almost unlimited
discretion to devise means to achieve the congressionally mandated
goal'' of protecting employee health, subject to the constraints of
feasibility. See United Steelworkers of Am. v. Marshall, 647 F.2d 1189,
1230 (D.C. Cir. 1981). A standard's individual requirements need only
be ``reasonably related'' to the purpose of ensuring a safe and
healthful working environment. Id. at 1237, 1241; see also Forging
Indus. Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1447 (4th Cir. 1985).
OSHA's authority to regulate employers is hedged by constitutional
considerations and, pursuant to section 4(b)(1) of the OSH Act, the
regulations and enforcement policies of other federal agencies. See,
e.g., Chao v. Mallard Bay Drilling, Inc., 534 U.S. 235, 241 (2002).
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\1\ The Secretary has delegated most of his duties under the OSH
Act to the Assistant Secretary of Labor for Occupational Safety and
Health. Secretary's Order 08-2020, 85 FR 58393 (Sept. 18, 2020).
This section uses the terms Secretary and OSHA interchangeably.
---------------------------------------------------------------------------
The OSH Act in section 6(c)(1) states that the Secretary ``shall''
issue an emergency temporary standard (ETS) upon a finding that the ETS
is necessary to address a grave danger to workers. See 29 U.S.C.
655(c). In particular, the Secretary shall provide, without regard to
the requirements of chapter 5, title 5, United States Code, for an
emergency temporary standard to take immediate effect upon publication
in the Federal Register if the Secretary makes two determinations: That
employees are exposed to grave danger from exposure to substances or
agents determined to be toxic or physically harmful or from new
hazards, and that such emergency standard is necessary to protect
employees from such danger. 29 U.S.C. 655(c)(1). A separate section of
the OSH Act, section 8(c), authorizes the Secretary to prescribe
regulations requiring employers to make, keep, and preserve records
that are necessary or appropriate for the enforcement of the Act. 29
U.S.C. 657(c)(1). Section 8(c) also provides that the Secretary shall
require employers to keep records of, and report, work-related deaths
and illnesses. 29 U.S.C. 657(c)(2).
The ETS provision, section 6(c)(1), exempts the Secretary from
procedural requirements contained in the OSH Act and the Administrative
Procedure Act, including those for public notice, comments, and a
rulemaking hearing. See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C. 552, 553.
The Secretary must issue an ETS in situations where employees are
exposed to a ``grave danger'' and immediate action is necessary to
protect those employees from such danger. 29 U.S.C. 655(c)(1); Pub.
Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156 (D.C. Cir.
1983). The determination of what exact level of risk constitutes a
``grave danger'' is a ``policy consideration that belongs, in the first
instance, to the Agency.'' Asbestos Info. Ass'n, 727 F.2d at 425
(accepting OSHA's determination that eighty lives at risk over six
months was a grave danger); Indus. Union Dep't, AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 655 n.62 (1980). However, a ``grave
danger'' represents a risk greater than the ``significant risk'' that
OSHA must show in order to promulgate a permanent standard under
section 6(b) of the OSH Act, 29 U.S.C. 655(b). Int'l Union, United
Auto., Aerospace, & Agr. Implement Workers of Am., UAW v. Donovan, 590
F. Supp. 747, 755-56 (D.D.C. 1984), adopted, 756 F.2d 162 (D.C. Cir.
1985); see also Indus. Union Dep't, AFL-CIO, 448 U.S. at 640 n.45
(noting the distinction between the standard for risk findings in
permanent standards and ETSs).
In determining the type of health effects that may constitute a
``grave danger'' under the OSH Act, the Fifth Circuit emphasized ``the
danger of incurable, permanent, or fatal consequences to workers, as
opposed to easily curable and fleeting effects on their health.'' Fla.
Peach Growers Ass'n, Inc. v. U. S. Dep't of Labor, 489 F.2d 120, 132
(5th Cir. 1974). Although the findings of grave danger and necessity
must be based on evidence of ``actual, prevailing industrial
conditions,'' see Int'l Union, 590 F. Supp. at 751, when OSHA
determines that exposure to a particular hazard would pose a grave
danger to workers, OSHA can assume an exposure to a grave danger
wherever that hazard is present in a workplace. Dry Color Mfrs. Ass'n,
Inc. v. Dep't of Labor, 486 F.2d 98, 102 n.3 (3d Cir. 1973).
In demonstrating whether OSHA had shown that an ETS is necessary,
the Fifth Circuit considered whether OSHA had another available means
of addressing the risk that would not require an ETS. Asbestos Info.
Ass'n, 727 F.2d at 426 (holding that necessity had not been proven
where OSHA could have increased enforcement of already-existing
standards to address the grave risk to workers from asbestos exposure).
Additionally, a standard must be both economically and technologically
feasible in order to be ``reasonably necessary and appropriate'' under
section 3(8) and, by inference, ``necessary'' under section 6(c)(1)(B)
of the Act. Cf. Am. Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490,
513 n.31 (1981) (noting ``any standard that was not economically or
technologically feasible would a fortiori not be `reasonably necessary
or appropriate' '' as required by the OSH Act's definition of
``occupational safety and health standard'' in section 3(8)); see also
Florida Peach Growers, 489 F.2d at 130 (recognizing that the
promulgation of any standard, including an ETS, must account for its
economic effect). However, given that section 6(c) is aimed at enabling
OSHA to protect workers in emergency situations, the agency is not
required to make a feasibility showing with the same rigor as in
ordinary section 6(b) rulemaking. Asbestos Info. Ass'n, 727 F.2d at 424
n.18.
On judicial review of an ETS, OSHA is entitled to great deference
on the determinations of grave danger and necessity required under
section 6(c)(1). See, e.g., Pub. Citizen Health Research Grp., 702 F.2d
at 1156; Asbestos Info. Ass'n, 727 F.2d at 422 (judicial review of
these legislative determinations requires deference to the agency); cf.
Am. Dental Ass'n v. Martin, 984 F.2d 823, 831 (7th Cir. 1993) (``the
duty of a reviewing court of generalist judges is merely to patrol the
boundary of reasonableness''). These determinations are ``essentially
legislative and rooted in inferences from complex scientific and
factual data.'' Pub. Citizen Health Research Grp., 702 F.2d at 1156.
The agency is not required to support its conclusions ``with anything
approaching scientific certainty,'' Indus. Union Dep't, AFL-CIO, 448
U.S. at 656, and has the ``prerogative to choose between conflicting
evidence.'' Asbestos Info. Ass'n, 727 F.2d at 425.
The determinations of the Secretary in issuing standards under
section 6 of the OSH Act, including ETSs, must be affirmed if supported
by ``substantial evidence in the record considered as a whole.'' 29
U.S.C. 655(f). The Supreme Court described substantial evidence as
``such relevant evidence as a reasonable mind might accept as adequate
to support a conclusion.'' Am. Textile Mfrs. Inst., 452 U.S. at 522-23
(quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951)). The
Court also noted that ``the possibility of drawing two inconsistent
conclusions from the evidence does not prevent an administrative
agency's finding from being supported by substantial evidence.'' Id. at
523 (quoting Consolo v. FMC, 383 U.S. 607, 620 (1966)). The Fifth
Circuit, recognizing the size and complexity of the rulemaking record
before it in the case of OSHA's ETS for organophosphorus pesticides,
stated that a court's function in reviewing an ETS to determine whether
it meets the substantial evidence standard is ``basically [to]
determine whether the
[[Page 61406]]
Secretary carried out his essentially legislative task in a manner
reasonable under the state of the record before him.'' Fla Peach
Growers Ass'n, 489 F.2d at 129.
Although Congress waived the ordinary rulemaking procedures in the
interest of ``permitting rapid action to meet emergencies,'' section
6(e) of the OSH Act, 29 U.S.C. 655(e), requires OSHA to include a
statement of reasons for its action when it issues any standard. Dry
Color Mfrs., 486 F.2d at 105-06 (finding OSHA's statement of reasons
inadequate). By requiring the agency to articulate its reasons for
issuing an ETS, the requirement acts as ``an essential safeguard to
emergency temporary standard-setting.'' Id. at 106. However, the Third
Circuit noted that it did not require justification of ``every
substance, type of use or production technique,'' but rather a
``general explanation'' of why the standard is necessary. Id. at 107.
ETSs are, by design, temporary in nature. Under section 6(c)(3), an
ETS serves as a proposal for a permanent standard in accordance with
section 6(b) of the OSH Act (permanent standards), and the Act calls
for the permanent standard to be finalized within six months after
publication of the ETS. 29 U.S.C. 655(c)(3); see Fla. Peach Growers
Ass'n, 489 F.2d at 124. The ETS is effective ``until superseded by a
standard promulgated in accordance with'' section 6(c)(3). 29 U.S.C.
655(c)(2).
Section 6(c)(1) states that the Secretary ``shall'' provide for an
ETS when OSHA makes the prerequisite findings of grave danger and
necessity. See Pub. Citizen Health Research Grp., 702 F.2d at 1156
(noting the mandatory language of section 6(c)). OSHA is entitled to
great deference in its determinations, and it must also account for
``the fact that `the interests at stake are not merely economic
interests in a license or a rate structure, but personal interests in
life and health.' '' Id. (quoting Wellford v. Ruckelshaus, 439 F.2d
598, 601 (D.C. Cir. 1971)).
When OSHA issues a standard pursuant to section 6--whether
permanent or an ETS--section 18 of the OSH Act provides that OSHA's
standard preempts any state occupational safety or health standard
``relating to [the same] occupational safety or health issue'' as the
Federal standard. 29 U.S.C. 667(b); see also Gade v. Nat'l Solid Wastes
Mgmt. Ass'n, 505 U.S. 88, 97 (1992). A state can avoid preemption only
if it submits, and receives Federal approval for, a state plan for the
development and enforcement of standards pursuant to section 18 of the
Act, which must be ``at least as effective'' as the Federal standards.
29 U.S.C. 667; Indus. Truck Ass'n v. Henry, 125 F.3d 1305, 1311 (9th
Cir. 1997). However, the OSH Act does not preempt state laws of
``general applicability'' that regulate workers and non-workers alike,
so long as they do not conflict with an OSHA standard. Gade, 505 U.S.
at 107.
As discussed in detail elsewhere in this preamble, OSHA has
determined that a grave danger exists necessitating a new ETS (see
Grave Danger and Need for the ETS, Sections III.A. and III.B. of this
preamble), and that compliance with this ETS is feasible for covered
employers (see Feasibility, Section IV. of this preamble). OSHA has
also provided a more detailed explanation of each provision of this ETS
in Summary and Explanation (Section VI. of this preamble). In addition,
OSHA wishes to provide here some general guidance on its legal
authority to regulate COVID-19 hazards, and for particular provisions
of this ETS.
As a threshold matter, OSHA's authority to regulate workplace
exposure to biological hazards like SARS-CoV-2 is well-established.
Section 6(b)(5) of the OSH Act uses similar language to section
6(c)(1)(A): The former sets forth requirements for promulgating
permanent standards addressing ``toxic materials or harmful physical
agents,'' and the latter authorizes OSHA to promulgate an ETS
addressing ``substances or agents determined to be toxic or physically
harmful'' (as well as ``new hazards''). OSHA has consistently
identified biological hazards similar to SARS-CoV-2, as well as SARS-
CoV-2 itself, to be ``toxic materials or harmful physical agents''
under the Act. Indeed, in its exposure and medical records access
regulation, OSHA has defined ``toxic materials or harmful physical
agents'' to include ``any . . . biological agent (bacteria, virus,
fungus, etc.)'' for which there is evidence that it poses a chronic or
acute health hazard. 29 CFR 1910.1020(c)(13). And in addition to
previously regulating exposure to SARS-CoV-2 as a new and physically
harmful agent in the Healthcare ETS (see, e.g., 86 FR at 32381), OSHA
has also previously regulated biological hazards like SARS-CoV-2 as
health hazards under section 6(b)(5), for example in the Bloodborne
Pathogens (BBP) standard, 29 CFR 1910.1030, which addresses workplace
exposure to HIV and Hepatitis B. The BBP standard was upheld (except as
to application in certain limited industries) in American Dental
Association, which observed that ``the infectious character'' of the
regulated bloodborne diseases might warrant ``more regulation than
would be necessary in the case of a noncommunicable disease.'' 984 F.2d
at 826. In addition, in the preamble to the respiratory protection
standard, 29 CFR 1910.134, which was also promulgated under section
6(b)(5), ``OSHA emphasize[d] that [the] respiratory protection standard
does apply to biological hazards.'' Respiratory Protection, 63 FR 1152-
01, 1180 (Jan. 8, 1998) (citing Mahone Grain Corp., 10 BNA OSHC 1275
(No. 77-3041, 1981)).
In addition to being a physically harmful agent covered by section
6(c)(1)(A), SARS-CoV-2 is also, without question, a ``new hazard''
covered by this provision, as discussed in more detail in Grave Danger
(Section III.A. of this preamble). SARS-CoV-2 was not known to exist
until January 2020, and since then more than 725,000 people have died
from COVID-19 in the U.S. alone (CDC, October 18, 2021--Cumulative US
Deaths).
Turning to specific provisions of this standard, the vaccination
requirements in this ETS are also well within the bounds of OSHA's
authority. Vaccination can be a critical tool in the pursuit of health
and safety goals, particularly in response to an infectious and highly
communicable disease. See, e.g., Jacobson v. Commonwealth of Mass., 197
U.S. 11, 27-28 (1905) (recognizing use of smallpox vaccine as a
reasonable measure to protect public health and safety); Klaassen v.
Trustees of Ind. Univ., 7 F.4th 592, 593 (7th Cir. 2021) (citing
Jacobson and noting that vaccination may be an appropriate safety
measure against SARS-CoV-2 as ``[v]accination protects not only the
vaccinated persons but also those who come in contact with them''). And
the OSH Act itself explicitly acknowledges that such treatments might
be necessary, in some circumstances. 29 U.S.C. 669(a)(5) (providing in
the Act's provisions on research and related activities conducted by
the Secretary of Health and Human Services to aid OSHA in its
formulation of health and safety standards that ``[n]othing in this or
any other provision of this Act shall be deemed to authorize or require
medical examination, immunization, or treatment for those who object
thereto on religious grounds, except where such is necessary for the
protection of the health or safety of others.'' (emphasis added)). In
recognition of the health and safety benefits provided by vaccination,
OSHA has previously exercised its authority to promulgate vaccine-
related requirements in the COVID-19 Healthcare ETS (29 CFR
1910.502(m))
[[Page 61407]]
and the BBP standard (29 CFR 1910.1030(f)). The BBP standard
illustrates congressional understanding that the statutory delegation
of authority to OSHA to issue standards includes authority for vaccine
provisions, where appropriate. See Public Law 102-170, Title I, Section
100, 105 Stat. 1107 (1991) (directing OSHA to complete the BBP
rulemaking by a date certain, and providing that if OSHA did not do so,
the proposed rule, which included a vaccine provision, would become the
final standard).
Additionally, OSHA's authority to require employers to bear the
costs of particular provisions of a standard is solidly grounded in the
OSH Act. The Act reflects Congress's determination that the costs of
compliance with the Act and OSHA standards are part of the cost of
doing business and OSHA may foreclose employers from shifting those
costs to employees. See Am. Textile Mfrs. Inst., 452 U.S. at 514;
Phelps Dodge Corp. v. OSHRC, 725 F.2d 1237, 1239-40 (9th Cir. 1984);
see also Sec'y of Labor v. Beverly Healthcare-Hillview, 541 F.3d 193
(3d Cir. 2008). Consistent with this authority, OSHA has largely
required employers to bear the costs of the provisions of this ETS,
including the typical costs associated with vaccination. The allocation
of vaccination costs to employers in this ETS is similar to OSHA's
treatment of vaccine-related costs in the COVID-19 Healthcare ETS and
the BBP standards. See 29 CFR 1910.502(m), (p); 29 CFR
1910.1030(f)(1)(ii)(A).
The OSH Act provides OSHA with discretion, however, to decide
whether to impose certain costs--such as those related to medical
examinations or other tests--on employers ``[w]here [it determines that
such costs are] appropriate.'' 29 U.S.C. 655(b)(7). OSHA has determined
that for purposes of this ETS, it would not be ``appropriate'' to
impose on employers any costs associated with COVID-19 testing for
employees who choose not to be vaccinated. For most of the agency's
existing standards containing medical testing and removal provisions,
OSHA has found it necessary to impose the costs of such provisions on
employers in order to remove barriers to employee participation in
medical examinations that are critical to effectuating the standards'
safety and health protections. See United Steelworkers of Am., 647 F.2d
at 1229-31, 1237-38. However, as explained in greater detail elsewhere
in this preamble (see Need for the ETS, Section III.B. of this
preamble), the ETS's safety and health protections are best effectuated
by employee vaccination, not testing. Accordingly, OSHA only requires
employers to bear the costs of employee compliance with the preferred,
and more protective, vaccination provision, but not costs associated
with testing. The agency does not believe it appropriate to impose the
costs of testing on an employer where an employee has made an
individual choice to pursue a less protective option. For the same
reasons, OSHA has also determined that it is not appropriate to require
employers to pay for face coverings for employees who choose not to be
vaccinated.\2\
---------------------------------------------------------------------------
\2\ OSHA notes that while the ETS does not impose these testing
or face covering costs on employers, in some circumstances employers
may be required to pay for the costs related to testing and/or face
coverings by other laws, regulations, or collectively negotiated
agreements. OSHA has no authority under the OSH Act to determine
whether such obligations under other laws, regulations, or
agreements might exist.
---------------------------------------------------------------------------
Finally, the Act and its legislative history ``both demonstrate
unmistakably'' OSHA's authority to require employers to temporarily
remove workers from the workplace to prevent exposure to a health
hazard. United Steelworkers of Am., 647 F.2d at 1230. And again, this
is an authority OSHA has repeatedly exercised in prior standards,
including in: COVID-19 Healthcare ETS (29 CFR 1910.502); Lead (29 CFR
1910.1025); Cadmium (29 CFR 1910.1027); Benzene (29 CFR 1910.1028);
Formaldehyde (29 CFR 1910.1048); Methylenedianiline (29 CFR 1910.1050);
Methylene Chloride (29 CFR 1910.1052); and Beryllium (29 CFR
1910.1024). It is equally appropriate to impose that obligation here.
For all of these reasons, as well as those explained more fully in
other areas of this preamble, OSHA has the authority--and obligation--
to promulgate this ETS.
References
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
III. Rationale for the ETS
A. Grave Danger
I. Introduction
Section 6(c)(1) of the OSH Act requires the Secretary to issue an
ETS in situations where employees are exposed to a ``grave danger'' and
immediate action is necessary to protect those employees from such
danger (29 U.S.C. 655(c)(1)). Consistent with its legal duties, OSHA is
issuing this ETS to address the grave danger posed by occupational
exposure to SARS-CoV-2, the virus that causes COVID-19.\3\ OSHA has
determined that occupational exposure to SARS-CoV-2, including the
Delta variant (B.1.617.2 and AY lineages), presents a grave danger to
unvaccinated workers in the U.S., with several exceptions explained
below.\4\ This finding of grave danger is based on the science of how
the virus spreads, the transmissibility of the disease in workplaces,
and the serious adverse health effects, including death, that can be
suffered by those who are diagnosed with COVID-19. The protections of
this ETS--which will apply, with some limitations, to a broad range of
workplace settings where exposure to SARS-CoV-2 may occur--are designed
to protect employees from infection with SARS-CoV-2 and from the dire,
sometimes fatal, consequences of such infection.
---------------------------------------------------------------------------
\3\ OSHA is defining the grave danger as workplace exposure to
SARS-CoV-2, the virus that causes the development of COVID-19.
COVID-19 is the disease that can occur in people exposed to SARS-
CoV-2, and that leads to the health effects described in this
section. This distinction applies despite OSHA's use of the terms
SARS-CoV-2 and COVID-19 interchangeably in some parts of this
preamble.
\4\ OSHA refers to the grave danger from occupational exposure
to SARS-CoV-2 throughout this document. Those references are
intended to encompass exposure to SARS-CoV-2 and all variants of
SARS-CoV-2, including the Delta variant.
---------------------------------------------------------------------------
The fact that COVID-19 is not a uniquely work-related hazard does
not change the determination that it is a grave danger to which
employees are exposed, nor does it excuse employers from their duty to
protect employees from the occupational transmission of SARS-CoV-2. The
OSH Act is intended to ``assure so far as possible every working man
and woman in the Nation safe and healthful working conditions'' (29
U.S.C. 651(b)), and there is nothing in the Act to suggest that its
protections do not extend to hazards which might occur outside of the
workplace as well as within. Indeed, COVID-19 is not the first hazard
that OSHA has regulated that occurs both inside and outside the
workplace. For example, the hazard of noise is not unique to the
workplace, but the Fourth Circuit has upheld OSHA's Occupational Noise
Exposure standard (29 CFR 1910.95) (Forging Industry Ass'n v. Sec' of
Labor, 773 F.2d 1437, 1444 (4th Cir. 1985)). Diseases caused by
bloodborne pathogens, including HIV/AIDS and hepatitis B, are also not
unique to the workplace, but the Seventh Circuit upheld the majority of
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) (Am. Dental
Ass'n v. Martin, 984 F.2d 823 (7th Cir. 1993)). OSHA's Sanitation
[[Page 61408]]
standard, 29 CFR 1910.141, which requires measures such as cleaning,
waste disposal, potable water, toilets, and washing facilities,
addresses hazards that exist everywhere--both within and outside of
workplaces. Moreover, employees have more freedom to control their
environment outside of work, and to make decisions about their behavior
and their contact with others to better minimize their risk of
exposure. However, during the workday, while under the control of their
employer, workers may have little ability to limit contact with
coworkers, clients, members of the public, patients, and others, any
one of whom could represent a source of exposure to SARS-CoV-2. OSHA
has a mandate to protect employees from hazards they are exposed to at
work, even if they may be exposed to similar hazards outside of work.
As described above in Pertinent Legal Authority (Section II. of
this preamble), ``grave danger'' indicates a risk that is more than
``significant'' (Int'l Union, United Auto., Aerospace, & Agr. Implement
Workers of Am., UAW v. Donovan, 590 F. Supp. 747, 755-56 (D.D.C. 1984);
Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 640
n.45, 655 (1980) (stating that a rate of 1 worker in 1,000 workers
suffering a given health effect constitutes a ``significant'' risk)).
``Grave danger,'' according to one court, refers to ``the danger of
incurable, permanent, or fatal consequences to workers, as opposed to
easily curable and fleeting effects on their health'' (Fla. Peach
Growers Ass'n, Inc. v. U.S. Dep't of Labor, 489 F.2d 120, 132 (5th Cir.
1974)). Fleeting effects were described as nausea, excessive
salivation, perspiration, or blurred vision and were considered so
minor that they often went unreported; these effects are in stark
contrast with the adverse health effects of COVID-19 infections, which
are formally referenced as ranging from ``mild'' to ``critical,'' \5\
but which can involve significant illness, hospital stays, ICU care,
death, and long-term health complications for survivors. Beyond this,
however, ``the determination of what constitutes a risk worthy of
Agency action is a policy consideration that belongs, in the first
instance, to the Agency'' (Asbestos Info. Ass'n/N. Am. v. OSHA, 727
F.2d 415, 425 (5th Cir. 1984)).
---------------------------------------------------------------------------
\5\ See the definitions for the different levels of severity of
COVID-19 illness in the National Institutes of Health's COVID-19
treatment guidelines (NIH, October 12, 2021).
---------------------------------------------------------------------------
In the context of ordinary 6(b) rulemaking, the Supreme Court has
said that the OSH Act is not a ``mathematical straitjacket,'' nor does
it require the agency to support its findings ``with anything
approaching scientific certainty,'' particularly when operating on the
``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
Am. Petroleum Inst., 448 U.S. 607, 655-56 (1980)). Courts reviewing
OSHA's determination of grave danger do so with ``great deference''
(Pub. Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156
(D.C. Cir. 1983)). In one case, the Fifth Circuit, in reviewing an OSHA
ETS for asbestos, declined to question the agency's finding that 80
worker lives at risk nationwide over six months constituted a grave
danger (Asbestos Info. Ass'n/N. Am., 727 F.2d at 424). OSHA estimates
that this ETS would save over 6,500 worker lives and prevent over
250,000 hospitalizations over the course of the next six months (OSHA,
October 2021c). Here, the mortality and morbidity risk to employees
from COVID-19 is so dire that the grave danger from exposures to SARS-
CoV-2 is clear.
SARS-CoV-2 is both a physically harmful agent and a new hazard (see
29 U.S.C. 655(c)(1)(A)). The majority of OSHA's previous ETSs addressed
toxic substances that had been familiar to the agency for many years
prior to issuance of the ETS. OSHA's Healthcare ETS, issued in response
to COVID-19 earlier this year, is one notable exception. In most cases,
OSHA's ETSs were issued in response to new information about substances
that had been used in workplaces for decades (e.g., Vinyl Chloride (39
FR 12342 (April 5, 1974)); Benzene (42 FR 22516 (May 3, 1977)); 1,2-
Dibromo-3-chloropropane (42 FR 45536 (Sept. 9, 1977))). In some cases,
the hazards of the toxic substance were already so well established
that OSHA promulgated an ETS simply to update an existing standard
(e.g., Vinyl cyanide (43 FR 2586 (Jan. 17, 1978))). The COVID-19
Healthcare ETS, which was issued in June 2021, was the sole instance in
which OSHA issued an ETS to address a grave danger from a substance
that had only recently come into existence. Although that action by the
agency was challenged, the case has not gone to briefing (see United
Food & Commercial Workers Int'l Union, AFL-CIO, CLC and AFL-CIO v.
OSHA, Dep't of Labor, D.C. Circuit No. 21-1143). Thus, no court has had
occasion to examine OSHA's authority under section (6)(c) of the OSH
Act (29 U.S.C. 655(c)) to address a grave danger from a ``new hazard.''
Yet by any measure, SARS-CoV-2 is a new hazard. Unlike any of the
hazards addressed in previous ETSs, there were no documented cases of
SARS-CoV-2 infections in the United States until January 2020. Since
then, more than 725,000 people have died in the U.S. alone (CDC,
October 18, 2021--Cumulative US Deaths). The pandemic continues to
affect workers and workplaces, with workplace exposures leading to
further exposures among workers' families and communities. Clearly,
SARS-CoV-2 is both a physically harmful agent and a new hazard that
presents a grave danger to workers in the U.S.
Published on June 21, 2021, OSHA's Healthcare ETS (86 FR 32376) was
written in response to the grave danger posed to healthcare workers in
the United States who faced a heightened risk of infection from COVID-
19. In the healthcare ETS, OSHA described its finding of grave danger
for healthcare and healthcare support service workers (see 86 FR 32381-
32412). OSHA now finds that all unvaccinated workers, with some
exceptions, face a grave danger from the SARS-CoV-2 virus.\6\
---------------------------------------------------------------------------
\6\ When OSHA refers to ``unvaccinated'' individuals in its
grave danger finding, it means all individuals who are not fully
vaccinated against COVID-19, i.e., those who are completely
unvaccinated and those who are partially vaccinated.
---------------------------------------------------------------------------
II. Nature of the Disease
The health effects of symptomatic COVID-19 illness can range from
mild disease consisting of fever or chills, cough, and shortness of
breath to severe disease. Severe cases can involve respiratory failure,
blood clots, long-term cardiovascular and neurological effects, and
organ damage, which can lead to hospitalization, ICU admission, and
death (see 86 FR 32383-32388; NINDS, September 2, 2021). Even in the
short time since the Healthcare ETS's publication in June 2021, the
risk posed by COVID-19 has changed meaningfully. Since OSHA considered
the impact of COVID-19 when promulgating the Healthcare ETS, over
135,000 additional Americans have died from COVID-19, and over 933,000
have been hospitalized, (CDC, October 18, 2021--Cumulative US Deaths;
CDC, May 28, 2021; CDC, October 18, 2021--Weekly Review). In August
2021, COVID-19 was the third leading cause of death in the United
States, trailing only heart disease and cancer (Ortaliza et al., August
27, 2021). By September 20, 2021, COVID-19 had killed as many Americans
as the 1918-1919 flu pandemic (Johnson, September 20, 2021).
While the Healthcare ETS addresses the risk of illness and death
from
[[Page 61409]]
COVID-19 as the SARS-CoV-2 virus continues to change over time, it does
not specifically address the increases in infectiousness and
transmission, and the potentially more severe health effects, related
to the Delta variant. The rapid rise to predominance of the Delta
variant in the U.S. occurred shortly after the ETS was published. At
this time, the widespread prevalence of the Delta variant and its
increased transmissibility have resulted in increased risk of exposure
and disease relative to the previously-dominant strains of the SARS-
CoV-2 virus. Adding to the information covered in the Healthcare ETS,
the following sections provide a brief review of SARS-CoV-2 and
describe the characteristics of the Delta variant that are different
from previous versions of SARS-CoV-2 and have changed the risks posed
by COVID-19. The agency specifically references the material presented
in the Healthcare ETS, which is still relevant to this analysis, to
support OSHA's finding of grave danger. Taken together, the information
available to OSHA demonstrates that SARS-CoV-2 poses a grave danger to
unvaccinated workers across all industry sectors.
a. Variants of SARS-CoV-2
Viral mutations have been a serious concern of scientists, public
health experts, and policymakers from the beginning of the COVID-19
pandemic. Viral mutations can affect how a virus interacts with a
cell--altering the virus's transmissibility, infection severity, and
sensitivity to vaccines. The U.S. government's SARS-CoV-2 Interagency
Group has a variant classification scheme that defines four classes of
SARS-CoV-2 variants: Variants Being Monitored (VBM), Variants of
Interest (VOI), Variants of Concern (VOC), and Variants of High
Consequence (VOHC). These variant designations are based on their
``proportions at the national and regional levels and the potential or
known impact of the constellation of mutations on the effectiveness of
medical countermeasures, severity of disease, and ability to spread
from person to person'' (CDC, October 4, 2021), with VOIs considered
less serious than VOCs and VOCs considered less serious than VOHCs. As
of early October 2021, the CDC was monitoring 10 VBMs--Alpha (B.1.1.7,
Q.1-Q.8), Beta (B.1.351, B.1.351.2, B.1.351.3), Gamma (P.1, P.1.1,
P.1.2), Epsilon (B.1.427 and B.1.429), Eta (B.1.525), Iota (B.1.526),
Kappa (B.1.617.1), B.1.617.3, Mu (B.1.621, B.1.621.1), and Zeta (P.2)--
and one VOC--Delta (B.1.617.2 and AY.1 sublineages)--in the U.S. (CDC,
October 4, 2021). CDC defines a VOC as ``[a] variant for which there is
evidence of an increase in transmissibility, more severe disease (e.g.,
increased hospitalizations or deaths), significant reduction in
neutralization by antibodies generated during previous infection or
vaccination, reduced effectiveness of treatments or vaccines, or
diagnostic detection failures'' (CDC, October 4, 2021).
While the proportions of SARS-CoV-2 variants in the United States
have shifted over time (CDC, May 24, 2021c; CDC, October 18, 2021--
Variant Proportions, July through October 2021), the primary variant
that drove COVID-19 transmission in the late Winter and Spring of 2021
was the Alpha variant. The CDC noted that Alpha is associated with an
increase in transmission, as well as potentially increased incidences
of hospitalization and death, compared to the predominant variants
before its emergence (CDC, October 4, 2021; Pascall et al., August 24,
2021; Julin et al., September 22, 2021). As Alpha transmission subsided
in the United States during the late Spring and early Summer of 2021,
Delta emerged and quickly became the predominant variant in the U.S. by
July 3, 2021 (CDC, October 18, 2021--Variant Proportions, July through
October 2021). Delta now accounts for more than 99% of circulating
virus nationwide (CDC, October 18, 2021--Variant Proportions, July
through October 2021).
FDA authorized and approved COVID-19 vaccines currently work well
against all of these variants; however, there are differences in
various variants' ability to spread and the likelihood of infection to
cause severe illness. Data on the Beta and Gamma variants do not
indicate that infections from these variants caused more severe illness
or death than other VOCs. Data on the Alpha variant does indicate its
ability to cause more severe illness and death in infected individuals.
And some data on the Delta variant suggests that the Delta variant may
cause more severe illness than previous variants, including Alpha, in
unvaccinated individuals (CDC, October 4, 2021).
The emergence of the Delta variant, along with other VOCs, has
resulted in a more deadly pandemic (Fisman and Tuite, July 12, 2021).
While the Delta variant is the most transmissible SARS-CoV-2 variant to
date, the possibility remains for the rise of future VOCs, and even
more dangerous VOHCs, as the virus continues to spread and mutate.
Inadequate vaccination rates and the abundance of transmission create
an environment that can foster the development of new variants that
could be similarly, or even more, disruptive (Liu and Rocklov, August,
4, 2021). In this context, it is critical that OSHA address the grave
danger from COVID-19 that unvaccinated workers are currently facing by
requiring vaccination and the other measures included in this rule, in
order to significantly slow the transmission of COVID-19 in workers and
workplaces and mitigate the rise of future variants.
b. Transmission
SARS-CoV-2 is a highly transmissible virus, regardless of variant.
Since the first case was detected in the U.S., there have been close to
45 million reported cases of COVID-19, affecting every state and
territory, with thousands more infected each day (CDC, October 18,
2021--Cumulative US Cases), and some indication that these numbers
continue to underestimate the full burden of disease (CDC, July 27,
2021). According to the CDC, the primary way the SARS-CoV-2 virus
spreads from an infected person to others is through the respiratory
droplets that are produced when an infected person coughs, sneezes,
sings, talks, or breathes (CDC, May 7, 2021). Infection could then
occur when another person breathes in the virus. Most commonly this
occurs when people are in close contact with one another in indoor
spaces (within approximately six feet for at least fifteen minutes)
(CDC, August 13, 2021). Additionally, airborne transmission may occur
in indoor spaces without adequate ventilation where small respiratory
particles are able to remain suspended in the air and accumulate (CDC,
May 7, 2021; Fennelly, July 24, 2020). While scientists' understanding
of the Delta variant's virology is evolving and remains at the frontier
of science, current data shows that the routes of transmission remain
the same for all currently-identified SARS-CoV-2 variants. In addition,
all variants can be transmitted by people who are pre-symptomatic
(i.e., people who are infected but do not yet feel sick) or
asymptomatic (i.e., people who are infected but never feel any symptoms
of COVID-19), as well as those who are symptomatic. Pre-symptomatic and
asymptomatic transmission continue to pose serious challenges to
containing the spread of COVID-19. For more extensive information on
transmission routes, as well as pre-symptomatic and asymptomatic
transmission, see the preamble to the Healthcare ETS (86 FR
[[Page 61410]]
32392-32396), which is hereby included in the record of this ETS.\7\
---------------------------------------------------------------------------
\7\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------
The Delta variant is transmitted from infectious individuals via
the same routes as previous variants, but is much more transmissible.
Specifically, Delta differs from previous dominant variants of SARS-
CoV-2 in terms of the amplification of viral particles expelled from
infected individuals. Testing of Delta-infected individuals indicates
that their viral loads are--on average--approximately 1,000x greater
than those of the SARS-CoV-2 variants from the first COVID-19 wave in
early 2020. This finding suggests much faster replication of viral
particles during early infection with the Delta variant, resulting in
greater infectiousness (contagiousness) when compared to earlier
versions of SARS-CoV-2 (Li et al., July 12, 2021).
The transmissibility of viruses is measured in part by the average
number of subsequently-infected people (or secondary cases) that are
expected to occur from each existing case (often referred to as
R0). Several comparisons of the transmissibility of the
initial SARS-CoV-2 variants to the Delta variant have shown that Delta
is approximately twice as transmissible (contagious) as previous
versions of SARS-CoV-2 (CDC, August 26, 2021; Riou and Althaus, January
30, 2020; Li et al., July 12, 2021; Liu and Rocklov, August, 4, 2021),
likely the result of higher initial viral loads during the pre-
symptomatic phase (Li et al., July 12, 2021). In addition, as described
further below, data on Delta shows that both unvaccinated and
vaccinated individuals are more likely to transmit Delta than previous
variants (Liu and Rocklov, August, 4, 2021; Eyre et al., September 29,
2021), making it especially dangerous to those who remain unvaccinated.
c. Health Effects
COVID-19 infections can lead to death. As reported in the
Healthcare ETS, by May 24, 2021, there had been 587,432 deaths and
32,947,548 million infections in the U.S. alone (CDC, May 24, 2021a;
CDC, May 24, 2021b). At that point in the pandemic, 1.8 out of every
1,000 people in the U.S. had died from COVID-19 (CDC, May 24, 2021a).
Since then, reported cases have increased to 44,857,861 and the number
of deaths has increased to 723,205 (CDC, October 18, 2021- Cumulative
US Cases; Cumulative US Deaths). By September 2021, an astounding 1 in
500 Americans had died from COVID-19 (Keating, September 15, 2021).
Updated mortality data \8\ currently indicate that people of working
age (18-64 years old) now have a 1 in 202 chance of dying when they
contract the disease, with the risk much higher (1 in 72) for those
aged 50-64 (CDC, October 18, 2021--Demographic Trends, Cases by Age
Group; CDC, October 18, 2021--Demographic Trends, Deaths by Age Group).
For a more in-depth description of the health effects resulting from
SARS-CoV-2 infection, see the preamble to the Healthcare ETS (86 FR
32383-32392), which is hereby included in the record of this ETS.\9\
---------------------------------------------------------------------------
\8\ Risk of death is based on averages from reported CDC data.
Risks of hospitalization and death are much higher in unvaccinated
individuals, as discussed further in Grave Danger, Section III.A.IV.
Vaccines Effectively Reduce Severe Health Outcomes from and
Transmission of SARS-CoV-2.
\9\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------
Apart from fatal cases, COVID-19 can cause serious illness,
including long-lasting effects on health. Many patients who become ill
with COVID-19 require hospitalization. Indeed, updated CDC
hospitalization and mortality data indicate that working age Americans
(18-64 years old) now have a 1 in 14 chance of hospitalization when
infected with COVID-19 (CDC, October 18, 2021--Demographic Trends,
Cases by Age; Total Hospitalizations, by Age). Those who are
hospitalized frequently need supplemental oxygen and treatment for the
disease's most common complications, which include pneumonia,
respiratory failure, acute respiratory distress syndrome (ARDS), acute
kidney injury, sepsis, myocardial injury, arrhythmias, and blood clots.
One study, which included 35,502 inpatients nationwide, determined that
the median length of hospital stay was 6 days, unless the cases
required ICU treatment. For those cases, ICU stays were on median 5
days in addition to the time spent hospitalized outside of the ICU
(Rosenthal et al., December 10, 2020). Another study that assessed
hospital length of stay for COVID-19 patients in England estimated that
a non-ICU hospital stay averaged between 8 and 9 days, but those
estimates ranged from approximately 12 to 18 days when patients were
admitted to the ICU (Vekaria et al., July 22, 2021). Moreover, given
that SARS-CoV-2 is still a novel virus, the severity of long-term
health effects--such as ``post-COVID conditions''--are not yet fully
understood.
Many members of the workforce are at increased risk of death and
severe disease from COVID-19 because of their age or pre-existing
health conditions. The comorbidities that further exacerbate COVID-19
infections are common among adults of working age in the U.S. For
instance, 46.1% of individuals with cancer are in the 20-64 year old
age range (NCI, April 29, 2015), and over 40% of working age adults are
obese (Hales et al., February 2020). Disease severity is also likely
exacerbated by long-standing healthcare inequities experienced by
members of many racial and economic demographics (CDC, April 19, 2021).
Recent data suggests that Delta variant infections may result in
even more severe illness and a higher frequency of death than previous
COVID-19 variants due to Delta's increased transmissibility, virulence,
and immune escape (Fisman and Tuite, July 12, 2021). Symptomatic Delta
variant infections do occur in fully vaccinated people (Mlcochova et
al., June 22, 2021; Musser et al., July 22, 2021); however, as reported
by the CDC (CDC, August 26, 2021), the vast majority of the continuing
instances of severe and fatal COVID-19 infections are occurring in
unvaccinated persons (discussed further in Grave Danger, Section
III.A.IV. Vaccines Effectively Reduce Severe Outcomes from and
Transmission of SARS-CoV-2). An assessment of Delta-related hospital
admissions in Scotland found that hospitalizations were approximately
doubled in patients with the Delta variant when compared to the Alpha
variant (Sheikh et al., June 4, 2021). A similar study conducted using
a retrospective cohort in Ontario, Canada compared the virulence of
novel SARS-CoV-2 variants and found that the incidences of
hospitalization, ICU admission, and death were more pronounced with the
Delta variant than any other SARS-CoV-2 variant (Fisman and Tuite, July
12, 2021). A large national cohort study that included all Alpha and
Delta SARS-CoV-2 patients in England between March 29 and May 23, 2021
found a ``higher hospital admission or emergency care attendance risk
for patients with COVID-19 infected with the Delta variant compared
with the Alpha variant,'' suggesting that Delta outbreaks--especially
amongst unvaccinated populations--may lead to more severe health
consequences and an equivalent or greater burden on healthcare services
than the Alpha variant (Twohig et al., August 27, 2021). However, one
more recent study examining data from several U.S. states demonstrated
a significant increase in hospitalization from the pre-Delta to the
Delta period, which may be related to increased transmissibility of
Delta rather than
[[Page 61411]]
more severe health outcomes (Taylor et al., October 22, 2021).
III. Impact on the Workplace
SARS-CoV-2 is readily transmissible in workplaces because they are
areas where multiple people come into contact with one another, often
for extended periods of time. When employees report to their workplace,
they may regularly come into contact with co-workers, the public,
delivery people, patients, and any other people who enter the
workplace. Workplace factors that exacerbate the risk of transmission
of SARS-CoV-2 include working in indoor settings, working in poorly-
ventilated areas, and spending hours in close proximity with others.
Full-time employees typically spend 8 hours or more at work each shift,
more time than they spend anywhere else but where they live. Employees
work in proximity to others in workplaces that were not originally
designed to keep people six feet away from other people and that may
make it difficult for employees to perform work tasks while maintaining
a six-foot distance from others. Even in the cases where workers can do
most of their work from, for example, a private office within a
workplace, they share common areas like hallways, restrooms, lunch
rooms and meeting rooms. Furthermore, many work areas are poorly
ventilated (Allen and Ibrahim, May 25, 2021; Lewis, March 30, 2021). An
additional factor that exacerbates the risk of transmission of SARS-
CoV-2 is interacting with or caring for people with suspected or
confirmed COVID-19; this was a primary driver of OSHA's determination
of grave danger for healthcare workers in the Healthcare ETS (see 86 FR
32381-32383). In recent weeks, the majority of states in the U.S. have
experienced what CDC defines as ``high or substantial community
transmission,'' indicating that there is a clear risk of the virus
being introduced into and circulating in workplaces (CDC, October 18,
2021--Community Transmission Rates).
Although COVID-19 is not exclusively an occupational disease, it is
evident from research accrued since the beginning of the pandemic that
SARS-CoV-2 transmission can and does occur in workplaces, affecting
employees and their lives, health, and livelihoods. This continues to
be true for the Delta variant, with its increased transmissibility and
potentially more severe health effects. This section describes some of
the clusters, outbreaks, and other occurrences of workplace COVID-19
cases that government agencies, researchers, and journalists have
described, and the widespread effects of SARS-CoV-2 in industry sectors
across the national economy. While the focus is on more recent data
reflecting the impact of the Delta variant, evidence of workplace
transmission that occurred prior to the emergence of the Delta variant
is also presented.
The workplace-based clusters described below provide evidence that
workplaces in a wide range of industries have been affected by COVID-
19, that many employees face exposure to infected people in their
workspaces, and that SARS-CoV-2 transmission is occurring in the
workplace, including during the recent period where the Delta variant
has predominated. Although the presence of a cluster on its own does
not necessarily establish that the cluster is work-related (i.e., a
result of transmission at the worksite), many state investigation
reports and published studies provide evidence that transmission is
work related by documenting that infections at a workplace occurred
within 14-days (the incubation period for the virus) of each other and
ruling out the possibility that transmission occurred outside the
workplace. In addition, the information below demonstrates that
exposures to SARS-CoV-2 happen regularly in a wide variety of different
types of workplaces.
The basis for OSHA's grave danger finding is that employees can be
exposed to the virus in almost any work setting; that exposure to SARS-
CoV-2 can lead to infection (CDC, September 21, 2021); and that
infection in turn can cause death or serious impairment of health,
especially in those who are unvaccinated (see Section III.A.IV.
Vaccines Effectively Reduce Severe Health Outcomes from and
Transmission of SARS-CoV-2). The information described in this section
supports OSHA's finding that employees who work in spaces shared by
others are at risk of exposure to SARS-CoV-2. The degree of risk from
droplet-based transmission may vary based on the duration of close
proximity to a person infected with SARS-CoV-2, including the Delta
variant, but the simple and brief act of sneezing, coughing, talking,
or even breathing can significantly increase the risk of transmission
if controls are not in place. SARS-CoV-2, including the Delta variant,
might also be spread through airborne particles under certain
conditions, particularly in enclosed settings with inadequate
ventilation, which are common characteristics of some workplaces.
The peer-reviewed scientific journal articles, government reports,
and news articles described below establish the widespread prevalence
of COVID-19 among employees, beginning with a description of the recent
impact from the Delta variant. OSHA's findings are based primarily on
the evidence from peer-reviewed scientific journal articles and
government reports. However, peer review for scientific journal
articles and the assembly of information for government reports and
other official sources of information take time, and therefore those
sources do not always reflect the most up-to-date information (Chan et
al., December 14, 2010). In addition, while state and local health
departments can report workplace outbreaks to CDC, the agency does not
provide summary statistics by workplace so that those outbreaks can be
tracked on a national level. In the context of the COVID-19 pandemic,
given the recent impacts due to the Delta variant and the emergence of
new information on a daily basis, it is critical for OSHA to rely on
the most up-to-date information available. Therefore, OSHA has
occasionally supplemented peer-reviewed data and government reports
with additional information on occupational outbreaks contained in
other sources of media (e.g., newspapers, digital media, and
information submitted to or obtained by private organizations).\10\ The
reported information from other sources can provide further evidence of
the impact of an emerging and changing disease, especially for
industries that are not well represented in the peer-reviewed
scientific literature. Together, these sources of information represent
the best available evidence of the impact on employees of the pandemic
thus far.
---------------------------------------------------------------------------
\10\ OSHA did not make findings based solely on non-peer-
reviewed sources such as news articles, but the agency found that
those sources can sometimes provide useful information when
considered with more robust sources.
---------------------------------------------------------------------------
The information described herein illustrates a significant number
of infections among employees in a variety of industries, with
virtually every state continuing to experience what CDC defines as high
or substantial community transmission related to the recent surge of
the Delta variant. The industries and types of workplaces described are
not the only ones in which a grave danger exists. The science of
transmission does not vary by industry or by type of workplace. OSHA
therefore expects transmission to occur in diverse workplaces all
across the country (see Dry Color Mfrs. Ass'n, Inc. v. Dep't of Labor,
486 F.2d 98, 102 n.3 (3d Cir. 1973) (holding that when OSHA determines
a substance poses a grave
[[Page 61412]]
danger to workers, OSHA can assume an exposure to a grave danger exists
wherever that substance is present in a workplace)). In addition, the
severity of COVID-19 does not depend on where an employee is infected;
an employee exposed to SARS-CoV-2 might die whether exposed while
working at a meat packing facility, a retail establishment, or an
office (see Grave Danger, Section III.A.V.b. Employees Who Work
Exclusively Outside, below, for a discussion of the risk of exposure in
outdoor workplaces).
a. General Impact on Workers
Data on SARS-CoV-2 infections, illnesses, and deaths among
employees in general industry, agriculture, construction, and maritime
support OSHA's finding that COVID-19 poses a grave danger to employees
in these sectors across the U.S. economy. This section summarizes
studies and reports of COVID-19 illness and fatalities in a wide range
of workplaces across those industry sectors. Not all workplace settings
are discussed; nor is the data available to do so. However, the
characteristics of the various affected workplaces--such as indoor work
settings; contact with coworkers, clients, or members of the public;
and sharing space with others for prolonged periods of time--indicate
that exposures to SARS-CoV-2 are occurring in a wide variety of work
settings across all industries. Therefore, most employees who work in
the presence of other people (e.g., co-workers, customers, visitors)
need to be protected.
While there is no comprehensive source of nationwide workplace
infection data, reports from states and communities on outbreaks
related to workplaces provide key, up-to-date data that illustrate the
likelihood of employee exposure to SARS-CoV-2 at workplaces throughout
the U.S. OSHA identified a number of recent reports from various
regions of the country that together demonstrate the impact that SARS-
CoV-2 can have on a variety of workplaces, including in service
industries (e.g., restaurants, grocery and other retail stores, fitness
centers, hospitality, casinos, salons), corrections, warehousing,
childcare, schools, offices, homeless shelters, transportation, mail/
shipping/delivery services, cleaning services, emergency services/
response, waste management, construction, agriculture, food packaging/
processing, and healthcare. Deaths are reported in many studies
performed prior to the emergence of the Delta variant but, because the
Delta outbreak is so recent and deaths can occur weeks after infection,
the number of deaths from recent infections might be underestimated.
Some of the reports include cumulative data representing various phases
of the pandemic, beginning prior to the availability of vaccines and
continuing through the recent surge of the Delta variant. In addition,
some studies report investigations of recent outbreaks, which provide
insight on the impact of the Delta variant as well as impacts
associated with the current vaccination status of workers.
The Washington State Department of Health (WSDH) reports outbreaks
occurring in non-healthcare workplaces (WSDH, September 8, 2021). In
non-healthcare workplaces, outbreaks are defined as two or more
laboratory confirmed cases of COVID-19, with at least two cases
reporting symptom onset within 14 days of each other, and plausible
epidemiological evidence of transmission in a shared location other
than a household. As of September 4, 2021, WSDH reported 5,247
outbreaks in approximately 40 different types of non-healthcare work
settings. During the week of August 29 through September 4, 2021, WSDH
identified 137 separate workplace outbreaks. The types of non-medical
workplace settings that represented more than 5% of the total outbreaks
during that week included food service/restaurants, childcare, schools,
retail, grocery, and shelter/homeless services. Other types of non-
healthcare settings where outbreaks occurred recently included non-food
and food manufacturing, construction, professional services/office
based, agriculture/produce packing, transportation/shipping delivery,
government agencies/facilities, leisure hospitality/recreation,
corrections, utilities, warehousing, facility/domestic cleaning
services, youth sports/activities, camps, and public safety. Over the
course of the pandemic, outbreaks have also been observed at bars/
nightclubs, hotels, and fishing/commercial seafood vessels.
The Oregon Health Authority (OHA) publishes a weekly report
detailing outbreaks directly related to work settings. OHA
epidemiologists consider cases to be part of a workplace outbreak when
clusters form with respect to space and time, within a plausible
incubation period for the virus, and their investigation does not
uncover an alternative source for the outbreak. For privacy reasons,
OHA only reports outbreaks with 5 or more cases in workplaces with 30
or more people. OHA reported a total of 26,013 cases and 135 deaths
related to workplace outbreaks as of September 1, 2021. As of September
1, 2021, OHA was investigating more than 124 active workplace outbreaks
(OHA, September 1, 2021). Those outbreaks occurred in a wide variety of
industries including correctional facilities, emergency services, waste
management, schools and child care, retail and grocery stores,
restaurants, warehousing, agriculture, food processing/packaging,
construction, healthcare, mail and delivery services, office locations,
utilities, transportation, and others.
Tennessee Department of Health was investigating 557 active COVID-
19 clusters as of September 8, 2021 (TDH, September 8, 2021). Clusters
are defined as two or more laboratory confirmed COVID-19 cases linked
to the same location or event that is not a household exposure. The
clusters occurred in 13 types of settings, 10 of which were workplace
settings. Outbreaks at workplaces represented more than half of the
total active outbreaks in the state at that time. Settings comprising
more than 5% of total clusters included assisted care living
facilities, nursing homes, and correctional facilities. Other types of
workplaces where outbreaks occurred included bars, construction, farms,
homeless shelters, and industrial settings.
The North Carolina Department of Health and Human Services reports
cumulative numbers of clusters, cases, and deaths for workers in
poultry processing facilities (beginning in April of 2020) and other
types of workplaces (beginning in May of 2020) (NCDHHS, August 30,
2021). Clusters are defined as a minimum of 5 cases with illness onset
or initial positive results within a 14-day period and plausible
epidemiological linkage between the cases. Plausible epidemiological
linkage means that multiple cases were in the same general setting
during the same time period (e.g., same shift, same physical area) and
that a more likely source of exposure is not identified (e.g.,
household contact or close contact to a confirmed case in another
setting). During that time period of April/May 2020 through August 30,
2021, workplaces \11\ were associated with nearly 80% of the 1,969
clusters and 27,097 cases observed and nearly 40% of the 167 deaths
related to the clusters. Cumulative numbers of cluster-associated
deaths were highest in meat and poultry processing (25 of 5,351 cases),
followed by healthcare (10 of 1,036 cases), government services and
manufacturing (5 of 1,048 cases and 5 of
[[Page 61413]]
1,856 cases, respectively), and restaurants and childcare (3 of 421
cases and 3 of 1,943 cases, respectively). Recently, in July of 2021,
the number of cases associated with workplace clusters began increasing
in several different types of work settings, including meat processing,
manufacturing, retail, restaurants, childcare, schools, and higher
education.
---------------------------------------------------------------------------
\11\ NCDHHS identifies a ``workplace'' category in their report
(e.g., agriculture, construction), but OSHA includes other settings
where employees would be present (e.g., retail, restaurants,
childcare, healthcare).
---------------------------------------------------------------------------
Colorado Department of Public Health & Environment/Colorado State
Emergency Operations Center (CDPHE/CSEOC, September 8, 2021) reported
5,584 resolved workplace-related outbreaks involving 40,156 employee
cases and 79 employee deaths since May of 2020. The agency's current
investigations, as of September 8, 2021 included 291 active outbreaks
(not defined), with 2,865 staff cases (assumed to be cases in
employees). The majority of active outbreaks were reported in
childcare, schools, healthcare, and corrections. Active outbreaks were
also reported in construction, retail, homeless shelters, casinos,
restaurants, hotels, offices, law enforcement, manufacturing, delivery
services, and warehouses. Other types of work settings that were
affected in resolved outbreaks included warehouses, bars, government
locations, waste management, utilities, salons, emergency services,
meat processing/packaging, and postal services. From June 21, 2021 (the
date the healthcare ETS was published) through September 8, 2021, 1,469
staff cases associated with outbreaks were reported, for an average of
approximately 19 cases per day.
Similar reporting is available from Louisiana's Department of
Health (LDH, August 24, 2021), with 1,347 outbreaks and 9,130 cases
reported as of August 24, 2021. LDH defines an outbreak as 2 or more
cases among unrelated individuals who visited a site within a 14-day
period. More than three quarters of outbreaks through that date were
associated with workplaces. Workplace settings in Louisiana that
experienced more than 5% of outbreaks included day care facilities,
bars, restaurants, retail settings, industrial settings, and office
spaces. Other types of workplace settings or industries where outbreaks
occurred included casinos, gyms/fitness centers, banks, automotive
services, construction, and ships/boats.
In addition to the state data above, some published studies and
government reports provide information on recent workplaces outbreaks.
For example, 47 people, including 3 of 11 staff members, 23 gymnasts,
and 21 household contacts, contracted COVID-19 from an outbreak linked
to an Oklahoma gymnastics facility during April 15 through May 3, 2021
(Dougherty et al., July 16, 2021). All 21 of the virus samples
sequenced were determined to be the Delta variant. The majority of the
infected individuals (85%) were unvaccinated. Infections were reported
in 16 adults aged 20 years or older; two adults were hospitalized and
one required intensive care.
The state of Hawaii defines clusters as three or more confirmed or
probable cases linked to a site or event within 14 days, with no
outside exposure of cases to each other (Hawaii State, August 19,
2021). The state reported a COVID-19 cluster in July associated with a
concert at a bar that affected 16 people, including employees, band
members, and concert attendees; infections also spread to 7 household
members. Band members had performed while sick. Four of the initial 16
people and none of the household members who tested positive for COVID-
19 were fully vaccinated. The concert cluster was linked to clusters at
another workplace and another concert. The report lists additional
clusters investigated in the two weeks prior to the report; those
clusters were observed in workplace locations such as correctional
facilities, bars and nightclubs, restaurants, construction/industrial
sites, travel/lodging/tourism, schools, food suppliers, and gyms.
Additional evidence that employees are at risk of exposure to SARS-
CoV-2 in the workplace is available from published, peer-reviewed
studies that were conducted before the Delta variant emerged. Those
studies demonstrate that employees have been at risk of infection,
illness, and death throughout the COVID-19 pandemic. Because the Delta
variant is more transmissible and likely causes more severe disease
than previous variants, there is even greater potential for
unvaccinated employees to become seriously ill or die as a result of
exposure to the Delta variant.
Contreras et al. (July, 2021) examined workplace outbreaks
(excluding healthcare settings, homelessness services, and emergency
medical services) in Los Angeles county from March 19 through September
30, 2020. Workplace outbreaks were defined as 5 or more suspected or
laboratory confirmed COVID-19 cases (prior to May 29) or 3 or more
laboratory confirmed cases (after May 29) occurring within 14 days.
Nearly 60% of the 698 identified outbreaks occurred in three sectors--
manufacturing (184, 26.4%), retail trade (137, 19.6%), and
transportation and warehousing (73, 10.5%). Also notable were the 71
outbreaks in the accommodation and food services industry, which
represented 10.2% of the outbreaks. The study authors concluded that
outbreaks were larger and lasted longer at facilities with more onsite
staff.
Outbreaks in Wisconsin from March 4 through November 16, 2020 were
also examined (Pray et al., January 29, 2021). Non-household outbreaks
were defined as two or more confirmed COVID-19 cases that occurred
within 14 days in persons who attended the same facility or event and
did not share a household. During the period from March 4 through
November 16, 2020, the largest percentages of cases were associated
with outbreaks in long-term care facilities (26.8% of cases),
correctional facilities (14.9% of cases), and colleges or universities
(15% of cases). Also notable were the substantial number of cases
associated with outbreaks in food production or manufacturing
facilities (including meat processing and warehousing; 14.5% of cases)
and schools and childcare facilities (10.6% of cases).
Bui et al. (August 17, 2020) analyzed data from the Utah Department
of Health's COVID-19 case surveillance system, which included data on
workplace outbreaks. Outbreaks were defined as two or more laboratory
confirmed cases occurring within a 14 day period among coworkers in a
common workplace (e.g., same facility). During the time period between
March 6 and June 5, 2020, 277 COVID-19 outbreaks were reported, of
which 210 (76%) occurred in workplaces. The 210 workplace outbreaks
occurred in 15 of 20 industry sectors, and the industry sectors of
manufacturing (43 outbreaks, 20%), construction (32 outbreaks, 15%),
and wholesale trade (29 outbreaks, 14%) together represented nearly
half of workplace outbreaks. Other sectors that represented more than
10% of total outbreaks were retail trade (28 outbreaks, 13%) and
accommodation and food services (25 outbreaks, 12%). Incidence rates of
COVID-19 over the period of March 6 through June 5, 2020 were 339/
100,000 workers in manufacturing, 122/100,000 workers in construction,
377/100,000 workers in wholesale trade, 68/100,000 workers for retail
trade, and 78/100,000 workers for accommodation and food services. For
COVID-19 cases associated with workplace outbreaks in which
hospitalization and severity status were known (1,382 and 1,155,
respectively), the number in all sectors who were admitted to the
hospital was 85 (6%) and the number with severe outcomes (intensive
care unit admission, mechanical ventilation, or death) was 40 (3%).
[[Page 61414]]
The impact of SARS-CoV-2 exposures on employee infection, illness,
and death has also been demonstrated in studies focusing on specific
types of industries, such as those where employees have frequent
contact with each other and the public (e.g., grocery stores, bars,
fitness facilities, schools, and law enforcement/corrections). For
example, a study by Lan et al. (September 26, 2020) demonstrates the
risk of infection in service industries. The cross-sectional study
examined the risks of SARS-CoV-2 exposure and infection for employees
in a Boston, Massachusetts-area retail grocery store market. The study
tested 104 grocery store employees, of whom 20% (21 employees) were
positive for COVID-19; 76% of confirmed cases did not have symptoms.
After adjusting for gender, smoking, age, and the prevalence of COVID-
19 in the employees' residential communities, employees who had direct
customer exposure (e.g., cashiers, sales associates, cart attendants)
were 5.1 times more likely to have a positive test for COVID-19 than
employees without direct face-to-face customer exposure (e.g.,
stockers, backroom, receiving and maintenance). The infection rate of
20% among all employees was significantly higher than the rate in the
surrounding community.
In February of 2021, an event at an Illinois bar that accommodates
approximately 100 people resulted in a COVID-19 outbreak that affected
46 people, including 3 (10%) staff members, 26 (90%) patrons, and 17
secondary cases (Sami et al., April 9, 2021). People at the event
included an asymptomatic person diagnosed with COVID-19 on the previous
day and 4 symptomatic people who were later diagnosed with COVID-19.
The outbreak resulted in a school closure and the hospitalization of a
resident at a long-term care facility.
In Minnesota, 47 COVID-19 outbreaks were detected at fitness
facilities from August through November of 2020 (Suhs et al., July 23,
2021). One outbreak at a fitness facility during October through
November of 2020 resulted in 23 COVID-19 cases including 5 (22%)
employees and 18 (78%) members. A genetic analysis of specimens from 3
employees and 10 members identified 2 distinct genetic subclusters,
indicating two distinct chains of transmission among members and
employees.
School-related outbreaks were examined from December 1, 2020
through January 22, 2021 in eight public elementary schools of a
Georgia school district (Gold et al., February 26, 2021). A COVID-19
case was determined to be school-related if (1) symptom onset or a
positive test was consistent with the incubation period of the virus
following contact with an index case or a school-associated case, (2)
close contact occurred with the index case or school-associated case
while that person was infected, and (3) no known contact occurred with
an infected community or household contact in the two weeks prior to a
positive test for COVID-19. The investigators identified nine clusters
of three or more epidemiologically linked COVID-19 cases that involved
13 educators and 32 students in six of the eight elementary schools.
Approximately half of the school-associated cases involved two clusters
that began with probable transmission between educators, followed by
educator to student transmission. Eighteen of 69 household members
tested received positive results.
A number of studies demonstrate the impact of COVID-19 in law
enforcement and related fields such as corrections. For example, a
study examining COVID-19 antibodies in employees from public service
agencies in the New York City area from May through July of 2020, found
that 22.5% of participants had COVID-19 antibodies (Sami et al., March,
2021). The percentage of correctional officers found to have COVID-19
antibodies (39.2%) was the highest observed among all the occupations.
The percentages of police dispatchers, traffic officers, security
guards, and dispatchers found to have COVID-19 antibodies (29.8 to
37.3%) were among the highest levels observed in all the occupations.
The study authors noted that those jobs involve frequent or close
contact with the public or are done in places where employees work in
close proximity to their coworkers.
Wallace et al. (May 15, 2020) evaluated data on COVID-19 cases and
deaths among correctional facility employees and inmates from January
21 to April 21, 2020. Data were reported to CDC by 37 (69%) of 54 state
and territorial health department jurisdictions. Of these 37
jurisdictions, 32 (86%) reported at least one COVID-19 case from a
correctional facility. Of the 420 facilities with a case, 221 (53%)
reported cases only among staff members. In total, 4,893 COVID-19 cases
among incarcerated or detained persons and 2,778 cases among staff
members were reported (total tested not provided). Among staff member
cases, 79 hospitalizations (3%) and 15 deaths (1%) were reported. The
study authors noted that ``correctional and detention facilities face
challenges in controlling the spread of infectious diseases because of
crowded, shared environments and potential introductions by staff
members and new intakes.''
Ward et al. (June 2021) analyzed COVID-19 prevalence among
prisoners and staff in 45 states from March 31, 2020 through November
4, 2020. During that time period, COVID-19 cases in staff were 3 to 5
times higher compared to the U.S. population. Average daily increases
in cases were 42 per 100,000 prison employees, 61 per 100,000
prisoners, and 13 per 100,000 U.S. residents. On November 4, 2020,
COVID-19 prevalence for prison staff was 9,316 cases per 100,000
employees, which was 3.2 times greater than prevalence in the U.S.
population (2,900 cases per 100,000).
Kirbiyik et al. (November 6, 2020) analyzed movement through a
network-informed approach to identify likely high points of
transmission within the Cook County Jail in Chicago, IL. At that
facility, over 900 COVID-19 cases were reported across 10 housing
divisions in 13 buildings from March 1-April 30, 2020. Staff members
were required to report symptoms of COVID-19 (probable cases) or
receipt of a positive test result (confirmed cases). A total of 2,041
staff members (77% of staff) were included in the network analysis
because information was available about their shift and division
assignments, and 198 (9.7%) of those staff members had COVID-19 during
the two-month study period. Connections between staff members who had
COVID-19 were higher than expected, suggesting likely transmission
among staff members. Fewer connections than expected were observed
among detained persons with SARS-CoV-2 infections, suggesting the
effectiveness of medical isolation at reducing transmission.
The Officer Down Memorial Page, which tracks police officer
fatalities determined to be occupationally related, reported that the
majority of officer deaths for 2021 (157 of 269) were related to COVID-
19 (ODMP, September 14, 2021). For the 269 officers who died, causes of
death were not reported for each month, but the highest numbers of
monthly deaths, 52 in January and 65 in August (compared to 16 to 34
deaths on other reported months), were consistent with the winter surge
of COVID-19 and, more recently, the surge caused by the Delta variant.
The risk of COVID-19 has also been examined in industries where
employees have little contact with the public, such as construction,
and food processing, and where most exposure to
[[Page 61415]]
SARS-CoV-2 likely comes from other workers. Pasco et al. (October 29,
2020) examined the association between construction work during the
COVID-19 pandemic and community transmission and construction worker
hospitalization rates in Austin, Texas from March 13 to August 20,
2020. A ``Stay Home-Work Safe'' order enacted on March 24, 2020,
limited construction to only critical infrastructure and excluded
commercial and residential work. One week later, the Texas governor
lifted the restriction for essential workers and allowed all types of
construction work to resume, while keeping the order in place for other
workers. The authors found that resuming construction during the
shelter-in-place order led to an increase in community transmission, an
increase in hospitalizations among community members, and an increase
in hospitalizations of construction workers. By mid-July, Austin Public
Health identified at least 42 clusters (not defined) of COVID-19 cases
in the construction industry; 515 individuals were hospitalized for
COVID-19 illnesses acquired as part of these clusters, and 77 of those
reported working in construction. The study found that construction
workers had a nearly 5-fold increased risk of hospitalization in
central Texas compared with workers in other occupations. The authors'
model predicted that allowing unrestricted construction work would be
associated with an increase in COVID-19 hospitalization rates from 0.38
per 1,000 residents to 1.5 per 1,000 residents overall, and from 0.22
per 1,000 construction workers to 9.3 per 1,000 construction workers
for the construction industry specifically. The authors concluded that
stringent workplace safety measures could significantly mitigate risks
related to COVID-19 in the industry.
The meat packing and processing industries and related agricultural
and food processing sectors have also been impacted by COVID-19.
Waltenburg et al. (January, 2021) reported COVID-19 cases in employees
from meat and poultry processing facilities in 31 states from March 1
through May 31, 2020. As reported in Table 2 of that report, 28,364
employees in those facilities were confirmed to have COVID-19 by
laboratory testing and 132 died. Among the 20 states that reported
total numbers of employees, 11.4% of the workers were diagnosed with
COVID-19 (with a range of 3.1 to 27.7% of workers in individual
states). For states that reported at least one COVID-19-related death,
the percentages of employees who died in each state ranged from 0.1 to
2.4% of those with COVID-19. The authors found a high burden of disease
in persons employed at these facilities who were racial or ethnic
minorities. Higher incidence in these populations might be due to the
likelihood of these employees working in areas in the plant where
transmission risk is higher. Steinberg et al. (August 7, 2020) reported
that attack rates (i.e., the number of individuals who are infected in
comparison to the total number at risk) among production employees in
the Cut (30.2%), Conversion (30.1%), and Harvest (29.4%) departments of
a meat processing plant (where spacing between employees is less than 6
feet) were double that of salaried employees (14.8%) whose workstations
had been modified to increase physical distancing from others.
Waltenburg et al. (January, 2021) also evaluated COVID-19 incidence
in food manufacturing and agricultural settings (e.g., manufacturing or
farming involving fruits, vegetables, dairy, baked goods, eggs,
prepared foods), as reported in 30 states from March through May 2020.
In food manufacturing and farming of fruits, vegetables, dairy, and
other items, 742 workplaces were affected, including 8,978 infections
and 55 fatalities. For states that reported total numbers of employees,
the proportion of employees who developed COVID-19 in each state ranged
from 2.0 to 43.5%. For states that reported at least one death, the
percentages of deaths among cases ranged from 0.1 to 3.8%.
Porter et al. (April 30, 2021) reported that 13 COVID-19 outbreaks
occurred at Alaska seafood processing facilities and vessels (both of
which were described as high density workplaces) during the Summer and
early Fall of 2020. The 13 outbreaks involved 539 COVID-19 cases, with
2-168 cases per outbreak. Attack rates in facilities and offshore
vessels ranged from less than 5% to 75%. Outbreaks were also reported
in entry quarantine groups. Because of these outbreaks, it was
determined that vaccination of these essential workers is important and
requirements for COVID-19 prevention were updated to include smaller
quarantine groups, serial testing, and testing before transfers from
one facility or vessel to another.
Finally, two published studies analyzed death records to determine
how mortality rates among individuals in various types of workplaces
had changed during the pandemic. Chen et al. (June 4, 2021) analyzed
records of deaths occurring on or after January 1, 2016 in California
and found that mortality rates in working aged adults (18-65 years)
increased 22% during the COVID-19 pandemic period of March through
November 2020 compared to pre-pandemic periods. Relative to pre-
pandemic periods, the groups of employees experiencing the highest,
statistically significant increases in relative excess mortality were
those in food/agriculture (39% increase), transportation/logistics (31%
increase), facilities (23% increase), and manufacturing (24% increase).
Other groups that also experienced excess, statistically significant
mortality compared to pre-pandemic periods were health or emergency
workers (17% increase), retail workers (21% increase), and government
and community workers (17% increase). The study authors concluded that
certain occupational sectors were impacted disproportionally by
mortality during the pandemic and that essential work conducted in-
person is a likely avenue of infection transmission.
Hawkins et al. (January 10, 2021) examined death certificates of
individuals who died in Massachusetts between March 1 and July 31,
2020. An age-adjusted mortality rate of 16.4 per 100,000 employees was
determined from 555 death certificates that had useable occupation
information. Employees in 11 occupational groups had particularly high
mortality rates: healthcare support; transportation and material
moving; food preparation and serving; building and grounds cleaning and
maintenance; production, construction and extraction; installation/
maintenance/repair; protective services; personal care services; arts/
design/entertainment; sports/media; and community and social services.
The study authors noted that occupational groups expected to have
frequent contact with sick people, close contact with the public, and
jobs that are not practical to do from home had particularly elevated
mortality rates.
b. Healthcare Workers
As explained in the Healthcare ETS, COVID-19 presents a grave
danger to workers in all U.S. healthcare settings where people with
COVID-19 are reasonably expected to be present (86 FR 32381).
Healthcare settings covered by the Healthcare ETS primarily include
settings where people with suspected or confirmed COVID-19 are treated,
exacerbating the risk present in most workplaces. To control the higher
level of risk in those settings, OSHA determined that a suite of
workplace controls was necessary to protect all employees, whether they
are vaccinated or unvaccinated. As explained further
[[Page 61416]]
below, OSHA now finds that unvaccinated healthcare workers in
healthcare settings not covered by the Healthcare ETS are also at grave
danger from exposure to SARS-CoV-2, just like unvaccinated workers in
other industries. Data continue to be collected and reported for
healthcare workers, and a small number of peer-reviewed studies
demonstrate the potential impact of the Delta variant on healthcare
workers.
CDC continues to provide updates for COVID-19 cases and deaths
among healthcare personnel. However, information on healthcare
personnel status continues to be reported for only a fraction (18.91%)
of total reported cases, and death status was reported for only 82.16%
of healthcare personnel cases as of October 18, 2021 (CDC, October 18,
2021--Healthcare Personnel). Given incomplete reporting, the data from
this source represent only a fraction of actual healthcare cases and
deaths. Nevertheless, CDC reported 666,707 healthcare personnel cases
among the 6,754,306 reported cases that included information on
healthcare personnel status (9.9%) and 2,229 fatalities among the
547,769 cases that included death status (0.4%) for healthcare
employees as of October 18, 2021. This is a 26% increase in the number
of cases and a 27% increase in the number of deaths since the May 24,
2021 data reported in the ETS (CDC, October 18, 2021--Healthcare
Personnel). The Delta variant is likely responsible for the majority of
those deaths. No healthcare worker deaths were reported by CDC during
the weeks of May 30 through June 13, 2021; however, as the Delta
variant's prevalence rose after June 20, healthcare worker deaths began
increasing; they peaked during the period of August 15 through
September 12, 2021, when 34 to 36 healthcare worker deaths were
reported per week (CDC October 18, 2021--Healthcare Personnel, Deaths
by Week). Independent reporting by Kaiser Health News and The Guardian
reported more than 3,600 fatalities in health care workers as of April
2021 (Spencer and Jewett, April 8, 2021). That number is expected to be
higher at this time since the earlier figure did not include the most
recent 5 months of the pandemic, which includes the period of Delta
variant predominance.
Published studies also demonstrate that healthcare workers,
especially those who are unvaccinated, remain at risk of being infected
with SARS-CoV-2 (see Section III.A.IV. Vaccines Effectively Reduce
Severe Health Outcomes from and Transmission of SARS-CoV-2). Routine
testing of health care personnel, first responders, and other frontline
workers in eight U.S. locations in six states from December 14, 2020
through August 14, 2021 revealed 194 infections in 4,136 unvaccinated
participants (89.7% symptomatic) and 34 infections in 2,976 fully
vaccinated participants (80.6% symptomatic) (Fowlkes et al., August 27,
2021). During time periods when the Delta variant represented more than
50% of viruses sequenced, 19 infections were detected in 488
unvaccinated participants (94.7% symptomatic) and 24 infections were
detected in 2,352 vaccinated participants (75% symptomatic).
Monthly COVID-19 cases in healthcare workers were reported during
the period from March 1 to July 31, 2021 at the University of
California San Diego (UCSD) health system, which is a healthcare
provider that includes primary care services such as family medicine
and pediatrics (Keehner et al., September 1, 2021; UCSD, 2021). During
that time period, a total of 227 health care workers tested positive
for COVID-19. One hundred and nine of 130 fully vaccinated workers who
tested positive (83.8%) were symptomatic and 80 of 90 unvaccinated
workers (88.9%) were symptomatic; one unvaccinated person was
hospitalized for COVID-19 symptoms. By July of 2021, after the end of
California's mask mandate on June 15 and after the Delta variant became
dominant, the number of cases detected dramatically increased; the
Delta variant accounted for more than 95% of SARS-CoV-2 viruses
sequenced by the end of that month. During July of 2021, symptomatic
infections were detected in 94 of 16,492 fully vaccinated workers and
31 of 1,895 unvaccinated workers. Attack rates in July of 2021 were 5.7
per 1,000 fully vaccinated workers and 16.4 per 1,000 unvaccinated
workers.
In Finland, a Delta variant infection from a hospitalized patient
spread throughout the hospital and to three primary care facilities,
infecting 103 individuals, including 45 healthcare workers
(Hetem[auml]ki et al., July 29, 2021). Twenty-six of the healthcare
workers were infected at the hospital and 19 were infected at primary
care facilities. The affected health care workers included 28 with
direct patient contact (11 who were not fully vaccinated), 8
unvaccinated healthcare worker students, and 9 other staff, including
hospital cleaners and secretaries (of whom 6 were not fully
vaccinated). According to study authors, ``There was high vaccine
coverage among permanent staff in the central hospital, but lower for
HCW in primary healthcare facilities. . .'' Study authors estimated
that vaccine effectiveness against the Delta variant in healthcare
workers was approximately 88-91%, suggesting how much more extensive
the outbreak could have been if a high percentage of healthcare workers
were not fully vaccinated.
In the UK, a Delta variant infection in a healthcare worker
resulted in an outbreak in a care home that affected 16 of 21 residents
and 8 of 21 staff (Williams et al., July 8, 2021). One staff member was
hospitalized. Attack rates were 35.7% in staff who were partially
vaccinated (i.e., received their second dose of vaccine on the day that
the index case was diagnosed with COVID-19 or had only received one
vaccine dose) and 40% in staff who were not vaccinated.
Recent news stories demonstrate that outbreaks affecting staff
members are still occurring in U.S. healthcare facilities. An outbreak
that began in August, 2021 at a Washington State nursing center
resulted in infections in 22 staff members and 52 residents. In an
unrelated outbreak, a nursing facility in Hawaii reported infections in
24 employees and 54 patients (Wingate, September 24, 2021). Vaccination
rates were reported at 64.5% of residents and 37.1% of staff in the
Washington State facility and 91% of staff and more than 80% of
patients at the Hawaii facility.
COVID-19 cases were also observed in staff at ambulatory care
settings prior to emergence of the Delta variant. Over an 11-week
period beginning on March 20, 2020, 254 tests for SARS-CoV-2 were
performed on employees who had potential exposures at an outpatient
urology center in New York State (Kapoor et al., 2020). Positive test
rates in employees correlated with rates in New York State, declining
over time, from 26.1% in the early stage to 7.3% in the late stage of
the study. According to study authors, the positive test results
coincided with the implementation of infection control procedures
(e.g., symptom screening, masking, distancing, and hygiene). Positivity
rates were similar in administrative and clinical staff and the study
authors concluded that ``administrative staff in an outpatient setting
were equally--if not more--vulnerable to SARS-CoV-2 transmission when
compared with clinical staff who were more directly exposed to
patients.'' The study authors speculated that possible reasons for the
findings were that clinical staff were more familiar with PPE and that
administrative staff, especially in check-in and check-out points, tend
to work close to each other.
[[Page 61417]]
c. Conclusion for Employee Impact
The evidence described above provides examples of the impact that
exposures from SARS-CoV-2, including those involving the Delta variant,
have had on employees in general industry, agriculture, construction,
maritime, and healthcare settings. It demonstrates that SARS-CoV-2 has
spread to employees in these industries and, in many cases, infection
was linked to exposure to infected persons at the worksite (WSDH,
September 8, 2021; OHA, September 1, 2021; TDH, September 8, 2021;
NCDHHS, August 30, 2021; Hawaii State, August 19, 2021; Pray et al.,
January 29, 2021; Sami et al., April 9, 2021; Suhs et al., July 23,
2021; Gold et al., February 26, 2021; Porter et al., April 30, 2021;
Hetem[auml]ki et al., July 29, 2021; Williams et al., July 8, 2021).
The documentation of so many workplace clusters suggests that exposures
to SARS-CoV-2 occur regularly in workplaces where employees come into
contact with others. This prevalence of clusters, combined with some
evidence that many infections occurred within the 14-day incubation
period for SARS-CoV-2 and that exposures to infected persons outside
the workplace were frequently ruled out, supports the proposition that
exposures to and transmission of SARS-CoV-2 occur frequently at work.
Multiple studies demonstrate high rates of COVID infections, illnesses,
and fatalities in the wide range of occupations that require frequent
or prolonged close contact with other people, indoor work, and work in
crowded and/or poorly ventilated areas The large numbers of infected
employees suggest that SARS-CoV-2 is likely to be present in a wide
variety of workplaces, placing unvaccinated workers at risk of serious
and potentially fatal health effects.
IV. Vaccines Effectively Reduce Severe Health Outcomes From and
Transmission of SARS-CoV-2
During the course of the SARS-CoV-2 pandemic, different variants
have emerged with different characteristics that better enable
transmission and potentially cause more severe outcomes. However,
vaccines remain very effective at reducing the occurrence of COVID-19-
related severe illness, disability and death.\12\ The Delta variant is
more transmissible than previous variants, might cause more severe
illness than previous variants in unvaccinated people, and has led to
hospitalization of individuals in numbers similar to those of the
November 2020 to February 2021 surge. These changes in characteristics
have provided a clearer realization of the continuing capacity for
SARS-CoV-2 to present a grave danger to workers. However, it is well
evident that even given these changed characteristics of Delta, serious
disease and death continue to occur overwhelmingly in unvaccinated
individuals while the vaccinated are afforded great protection.\13\
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\12\ A discussion of vaccination rates, as well as OSHA's
rationale for why vaccination is a critical means of protecting
workers from the grave danger described in this section, can be
found in Need for the ETS (Section III.B. of this preamble).
\13\ While mild cases of COVID-19 are included in the grave
danger presented by COVID-19, as stated in the Healthcare ETS (see
86 FR 32382), OSHA is focusing on the most severe health effects,
i.e., cases requiring hospitalization and cases resulting in death,
in this new rulemaking effort in order to prevent the gravest of
consequences to workers.
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a. Impact of Vaccination on Severe Health Outcomes
There are currently three vaccines that are approved or authorized
for the prevention of COVID-19 in the U.S.: The Pfizer-BioNTech COVID-
19 vaccine (FDA approved for ages 16 and above; authorized for ages 12
and above), the FDA-authorized Moderna COVID-19 vaccine (authorized for
ages 18 and above), and the FDA-authorized Janssen COVID-19 vaccine
(also known as the Johnson & Johnson vaccine; authorized for ages 18
and above.) Pfizer-BioNTech and Moderna are mRNA vaccines that require
two primary series doses administered three weeks and one month apart,
respectively. Janssen is a viral vector vaccine administered as a
single primary vaccination dose (CDC, September 15, 2021). The vaccines
were shown to greatly exceed minimum efficacy thresholds in preventing
COVID-19 in clinical trial participants (FDA, December 11, 2020; FDA,
December 18, 2020; FDA, February 26, 2021). Data from clinical trials
for all three vaccines and observational studies for the two mRNA
vaccines clearly establish that fully vaccinated persons have a greatly
reduced risk of SARS-CoV-2 infection compared to unvaccinated
individuals. This includes severe infections requiring hospitalization
and those resulting in death. For more information about the
effectiveness of vaccines as of late Spring 2021, see 86 FR 32397,
which OSHA hereby includes in the record for this ETS.\14\
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\14\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
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Vaccines remain highly effective against hospitalization and death.
A study evaluating vaccine effectiveness at preventing hospitalization
among those with SARS-CoV-2 infections in New York found that
effectiveness did not change from May 3 to July 25, 2021 as the Alpha
variant gave way to the Delta variant (91.9-96.2% range; Rosenberg et
al., August 27, 2021). Grannis et al. used data from 187 hospitals in
nine states from June to August 2021 to evaluate the efficacy of
vaccines against hospitalization when Delta had emerged as the
predominant variant causing SARS-CoV-2 infections (September 17, 2021).
This study found that vaccines were 89% effective at preventing
hospitalization in individuals aged 18 to 74. Similarly, vaccines were
also found to be 89% effective in preventing hospitalization in a study
collecting data from five Veteran Affairs Medical Centers from July 1
to August 6, 2021, a time when most transmission was attributed to the
Delta variant (Bajema et al., September 10, 2021).
Two other studies found that, although the level of protection
provided by vaccination has decreased somewhat with the emergence of
the Delta variant, vaccines continue to provide high levels of
protection against hospitalization. In a U.S. study, researchers found
that while the Moderna and Janssen vaccines mostly maintained their
effectiveness at preventing hospitalization (going from 93% to 92%
after more than 120 days post-vaccination and 71% to 68% after more
than 28 days post-vaccination, respectively) from March to August 2021,
the effectiveness of the Pfizer-BioNTech vaccine at preventing those
severe outcomes decreased from 91% to 77% after more than 120 days
post-vaccination (Self et al., September 17, 2021). An Israeli study on
infections documented between July 11 and July 31, 2021 found a
significant decrease in vaccine efficacy for the Pfizer-BioNTech
vaccine against severe outcomes in relation to when an individual was
vaccinated, but the absolute difference was much less than what was
observed in the U.S. study (e.g., 98% effective for 40-59 year olds
vaccinated in March versus 94% effective for those in the same age
group who were vaccinated in January) (Goldberg et al., August 30,
2021).
Vaccines also remain extremely effective at preventing death. A UK
study evaluated the effectiveness of the Pfizer-BioNTech vaccine
against death and found it to be 96.3% effective against the Alpha
strain and 95.2% protective against the Delta strain (Andrews et al.,
September 21, 2021). Two Israeli studies, Haas et al. and Saciuk et
al., performed during time periods where Alpha was predominant, found
the Pfizer-BioNTech vaccine to be 96.7% and 91.1% effective,
[[Page 61418]]
respectively, against death (Haas et al., May 15, 2021; Saciuk et al.,
June 25, 2021). A California study found that the Moderna vaccine was
97.9% effective against death (Bruxvoort et al., September 2, 2021). A
study on patients served by the Veterans Health Administration found
that Pfizer-BioNTech and Moderna vaccines provided 99% effectiveness
against death (Young-Xu et al., July 14, 2021).
The risks of hospitalization and death appear to have increased for
unvaccinated individuals since the Delta variant became a common source
of infections. A study of Los Angeles County SARS-CoV-2 infections
found that vaccinations reduced hospitalization risk by a factor of 10
on May 1, 2021, when the Alpha variant was dominant, but that the risk
of hospitalization was even more greatly reduced (by a factor of 29.2)
on July 25, 2021, when the Delta variant was dominant (Griffin et al.,
August 27, 2021). This difference suggests both that vaccines continue
to provide a high level of protection against disease that results in
hospitalization and that risk has increased for those who are
unvaccinated. Similar increased risk for unvaccinated individuals was
reported in a study that evaluated hospitalization and death data from
13 U.S. jurisdictions between June 20 and July 17, 2021, a period when
the Delta variant gained prominence (Scobie et al., September 17,
2021). For unvaccinated 18 to 49 year olds, the risk of hospitalization
was 15.2 times greater, and the risk of death was 17.2 times greater,
than the risks for vaccinated people in the same age range. For
unvaccinated 50 to 64 year olds, the risk of hospitalization was 10.9
times greater, and the risk of death was 17.9 times greater, than for
those who are vaccinated. These studies illustrate that vaccination is
an extremely effective control measure to minimize severe outcomes
resulting from Delta variant infections.
b. Impact of Vaccination on Infection and Transmission
Vaccines continue to provide robust protection for vaccinated
individuals against SARS-CoV-2 infections, even though several studies
indicate that vaccine efficacy against infection may have decreased
somewhat with the emergence of the Delta variant (Fowlkes et al.,
August 27, 2021; Rosenberg et al., August 27, 2021; Nanduri et al.,
August 27, 2021; Seppala et al., September 2, 2021; Bernal et al.,
August 12, 2021). For example, vaccination was observed to reduce the
risk of infection by a factor of 8.4 on May 1, 2021, when the Alpha
variant was predominant in Los Angeles county (Griffin et al., August
27, 2021). However, the level of protection had fallen to a factor of
4.9 by July 25, 2021, when Delta made up 88% of infections in the
county. The findings from this study indicate that while vaccines
maintain robust protection against severe outcomes, protection against
infection has fallen with the increased circulation of the Delta
variant. A broader study using data from 13 U.S. jurisdictions had
similar findings, observing that the protection vaccines afforded
against infection decreased from a factor of 11.1 (i.e., vaccinated
people were 11.1 times less likely than unvaccinated people to become
infected) between April 4 and June 19, 2021, to a factor of 4.6 between
June 20 and July 17, 2021 (Scobie et al., September 17, 2021). An
additional study noted, however, that the decrease in vaccine
protectiveness against symptomatic infection from the Delta variant
could be due to the waning of immunity specifically in older
populations. Andrews et al. (September 21, 2021) found that while the
Pfizer-BioNTech vaccine effectiveness decreased from 94.1% to 67.4% in
those 65 years old and older, vaccine effectiveness for those 40 to 64
years old only decreased from 92.9% to 80.6%.
While infections themselves do not normally result in serious
illness for those who are vaccinated, evidence shows that vaccinated
individuals who become infected with the Delta variant can transmit the
disease more easily to others than with previous variants. This
development poses a great concern for the unvaccinated, who generally
do not have the protections against severe outcomes that vaccination
affords. Before Delta, vaccinated individuals were shown to have lower
estimated viral loads when infected than those who were unvaccinated,
which suggested that infected vaccinated individuals were likely not a
major concern for transmission (Levine-Tiefenbrun et al., March 29,
2021). Transmission studies prior to the emergence of Delta appear to
bear this out. A Scottish study performed during a time period when the
Alpha variant was predominant in the region, showed that a fully
vaccinated individual was 3.2 times less likely than an unvaccinated
individual to transmit the virus to unvaccinated family members (Shah
et al., September 10, 2021; supplementary appendix). A population-based
study from the Netherlands found that vaccination decreased secondary
transmission to household members from 31% to 11% (de Gier et al.,
August 5, 2021). Additionally, a study from the UK found that household
transmission decreased by as much as 50% when the infected individual
was vaccinated (Harris et al., June 23, 2021).
More recent research suggests that the Delta variant may have
reduced the level of protection vaccination affords against
transmission of the virus to others, but still significantly reduces
transmission risk in comparison to infected unvaccinated individuals. A
UK study found that fully vaccinated individuals infected by the Delta
variant are able to transmit the virus to both vaccinated and, to a
greater degree, unvaccinated persons (Singanayagam et al., September 6,
2021). Still, the rate at which transmission to unvaccinated
individuals occurred was nearly double the rate of transmission to
vaccinated individuals (35.7% compared to 19.7%). Similarly, Eyre et
al., (September 29, 2021) found that during the predominance of Alpha,
full vaccination with the Pfizer-BioNTech vaccines resulted in a
significant reduction in transmission to others (an adjusted Odds Ratio
(aOR) of 0.18, meaning that being unvaccinated increased the odds of
transmission by over five times). With the rise of the Delta variant,
that reduction in transmission to others was less than with the Alpha
variant, but still significantly more than for unvaccinated individuals
(aOR of 0.35, meaning that being unvaccinated increased the odds of
transmission by almost three times).
The greater ability for vaccinated individuals to transmit the
Delta variant of SARS-CoV-2 to others (compared to previous variants)
appears to be linked to the generation of similar viral loads (as
estimated by Ct threshold) in the vaccinated compared to the
unvaccinated (Ct threshold is the number of RT-PCR cycles that need to
be run in order to amplify the RNA enough to be detected--fewer cycles
means a greater initial amount of virus was collected) (Singanayagam et
al., September 6, 2021). This observation has been made in several
studies. A study from Israel observed that viral loads among those
infected with the Delta variant were only decreased in people who had
been vaccinated recently (within the past two months) or in those who
had recently received a booster dose (Levine-Tiefenbrun et al.,
September 1, 2021). In a study of SARS-CoV-2 infections in Los Angeles
County, performed when the Delta variant was predominant, vaccination
status did not appear to affect the estimated viral loads, suggesting
that infected individuals who are vaccinated
[[Page 61419]]
may be just as likely to transmit the virus (Griffin et al., August 27,
2021). Additionally, estimated viral loads did not appear to be
significantly different with respect to vaccination status in a
Wisconsin study (Riemersma et al., July 31, 2021). Regardless of viral
loads in vaccinated and unvaccinated individuals, the fact remains
clear that unvaccinated people pose a higher risk of transmission to
others than vaccinated people, simply because they are much more likely
to get COVID-19 in the first place.
These studies, however, appear to overstate increases in
transmission risk from vaccinated individuals related to the Delta
variant. From May to July 2021, UK researchers tested individuals at
random to better characterize viral load estimates in people with
asymptomatic as well as symptomatic infections; they found that
vaccination was associated with a significantly lower estimated viral
load (Elliott et al., September 10, 2021). This more comprehensive
study (i.e., Elliott et al., September 10, 2021) may have been able to
better characterize the course of infection and to incorporate
vaccinated individuals whose viral loads were decreasing quickly. The
findings in Elliott et al. are consistent with studies observing that
viral load may fall more quickly in vaccinated individuals, resulting
in a shorter infectious period and possibly fewer transmission events
(Chia et al., July 31, 2021; Eyre et al., September 29, 2021).
c. Conclusion for the Impact of Vaccines
The studies discussed above indicate that vaccines continue to
effectively protect vaccinated individuals against SARS-CoV-2
infections, while the risk of infection, hospitalization, and death
increased among unvaccinated people as the Delta variant became
predominant in the U.S. The Delta variant is even more dangerous to
unvaccinated individuals than previous variants because of the higher
transmission potential from both unvaccinated and vaccinated people.
Because unvaccinated individuals are at much higher risk of severe
health outcomes from infection with SARS-CoV-2, and also pose a greater
transmission risk to those around them, it is critical to assure that
as many people as possible are fully vaccinated in order to prevent
transmission at work.
V. Coverage of OSHA's Grave Danger Finding
Based on the information discussed above, OSHA finds that many
unvaccinated workers across the U.S. economy are facing a grave danger
of severe health effects or death from exposure to SARS-CoV-2. Fully
vaccinated workers are not included in this grave danger finding
because, as described throughout this section, those who are fully
vaccinated are much better protected from the effects of SARS-CoV-2
and, in particular, the most severe effects, than are those who are
unvaccinated.\15\ Beyond that, OSHA's grave danger determination
exempts several categories of workers based on characteristics of their
work or workplace: (1) Workers who do not report to a workplace where
other individuals are present or who telework from home; and (2)
workers who perform their work exclusively outdoors. The basis for
these exemptions is explained below. In this section, OSHA also
addresses the basis for OSHA's grave danger finding for workers who are
unvaccinated yet had a prior COVID-19 infection, and explains the
Agency's more nuanced grave danger finding in the healthcare industry.
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\15\ The exclusion of vaccinated workers from this grave danger
finding does not mean that vaccinated workers face no risk from
exposure to SARS-CoV-2. The best available evidence clearly shows
that vaccination provides great protection from infection and severe
outcomes, but breakthrough infections do occur and vaccinated
individuals can still transmit the virus to others. In some cases,
the level of risk to vaccinated workers may even rise to the level
of a significant risk, the standard OSHA must meet for promulgation
of a permanent standard under section 6(b)(5) of the OSH Act (29
U.S.C. 655(b)(5)).
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a. Employees Who Telework and Employees Who Do Not Report to a
Workplace Where Other People Are Present.
Employees who report to workplaces where no other people are
present face no grave danger from occupational exposure to COVID-19
because such exposure requires the presence of other people. For those
who work from their homes, or from workplaces where no other people are
present (such as a remote worksite), the chances of being exposed to
SARS-CoV-2 through a work activity are negligible. Therefore, OSHA is
exempting those workers who do not come into contact with others for
work purposes from its grave danger finding as well as the scope of the
ETS (for more information, see the Summary and Explanation for Scope
and Application, Section VI.B. of this preamble).
b. Employees Who Work Exclusively Outside
Employees who work exclusively outside face a much lower risk of
exposure to SARS-CoV-2 at work, because their workplaces typically do
not include any of the characteristics that normally enable
transmission to occur (e.g., indoors, lack of ventilation, crowding).
Bulfone et al. attributed the lower risk of transmission in outdoor
settings (i.e., open air or structures with one wall) to increased
ventilation with fresh air and a greater ability to maintain physical
distancing (November 29, 2020). While the best available evidence
firmly establishes a grave danger in indoor settings, the CDC has
stated that the risk of outdoor transmission is ``low'' (CDC, September
1, 2021) and OSHA is unable to establish a grave danger in outdoor
settings from exposure during normal work activities.
OSHA recognizes that outdoor transmission has been identified in a
few specific incidents (e.g., 2 of 7,324 cases, Qian et al., October
27, 2020). However, general reviews of transmission studies that
include large-scale and high-density outdoor gatherings indicate that
indoor transmission overwhelmingly is responsible for SARS-CoV-2
transmission. Additionally, the lack of evidence tied to specific case
studies illustrating outdoor transmission in comparison to the bevy of
case studies on indoor transmission makes it difficult to support a
conclusion that outdoor transmission rises to the level of a grave
danger.
Bulfone et al. reviewed a collection of SARS-CoV-2 studies that
evaluated infections in outdoor and indoor settings (November 29,
2020), and found that transmission is significantly less likely to
occur in outdoor settings than in indoor settings. The studies overall
found that the risk of outdoor transmission was less than 10% of the
risk of transmission in indoor settings, with three of the studies
concluding risk was 5% or less of the risk of transmission in indoor
settings. While acknowledging significant gaps in knowledge, the
authors of a different study suggested that increases in transmission
related to large events such as the Sturgis motorcycle rally may be
related to lack of local efforts to prevent transmission indoors (e.g.,
requiring the wearing of masks, closing indoor dining), rather than the
outdoor setting for the rally (Dave et al., December 2, 2020). In
contrast, transmission rates did not increase as expected following the
Summer 2020 protests on racial injustice. This outcome was attributed,
in part, to participants having been less likely to enter indoor
commercial establishments.
[[Page 61420]]
Weed and Foad (September 10, 2020) found that transmission of SARS-
CoV-2 related to large scale outdoor gatherings could be largely
attributed to individual behaviors related to that event, such as
communal travel and indoor congregation at other facilities (e.g.,
restaurants, shared accommodations), rather than to the time spent
outdoors at those gatherings. Similarly, a Public Health England
evaluation of the literature on SARS-CoV-2 and surrogate respiratory
viruses (December 18, 2020) also concluded that when transmission does
occur at outdoor events, outdoor activities were mixed with indoor
setting use. Public Health England concluded that the vast majority of
transmission happens in indoor settings, with very little evidence for
outdoor transmission.
A systemic review of SARS-CoV-2 clusters identified 201 events
through May 26, 2020 (Leclerc et al., April 28, 2021), only 4 of which
occurred at predominantly outdoor settings. For those 4 clusters, the
authors noted that they were not able to evaluate specific transmission
events and attributed it to local health agencies being overwhelmed by
the pandemic. OSHA notes that the designations of settings in this
study are somewhat generic, as outdoor construction sites will often
have indoor locations, such as mobile offices, or locations with
reduced airflow, such as areas with a roof or ceiling and two or more
walls. Regardless, this study illustrates the comparable abundance of
evidence available to evaluate SARS-CoV-2 transmission in indoor
settings versus outdoor settings.
Cevik et al. (August 1, 2021) reviewed studies on the transmission
dynamics of SARS-CoV-2 infections from large scale, contact-tracing
studies. The authors recommended that, based on the evidence that
outdoor transmission dynamics resulted in significantly fewer
infections than in indoor settings, public health entities should
greatly encourage use of outdoor settings. The researchers highlighted
a study by Nishiura et al. (April 16, 2020), who evaluated 110 cases in
Japan at the beginning of the pandemic and found that outdoor settings
reduced transmission risk by 18.7 times and reduced the risk of super-
spreader events by 32.5 times.
Agricultural workplace settings have experienced significant SARS-
CoV-2 infections. However, transmission in these settings is difficult
to characterize because many jobs in this sector include both outdoor
and indoor activities. Miller et al. (April 30, 2021) evaluated an
outbreak among farmworkers in Washington State. The researchers found
that 28% of workers with predominantly indoor tasks where they were
unable to maintain physical distance were infected, compared to 6% of
workers who performed predominantly outdoors tasks in the orchards.
Conversely, a study on farmworkers in Monterey County, California found
a significant correlation between evidence of infection and individuals
who worked in the fields as opposed to indoor work (Mora et al.,
September 15, 2021). The paper noted that infections were predominant
in individuals who lived in crowded conditions, commuted together to
the fields, and spoke at home in indigenous languages, which is
important as written health messages are often not available in all
worker languages. These papers cannot identify where or when infections
occurred in order to discern causation. The associations observed may
indicate that SARS-CoV-2 infections may be more related to aspects
related to indoor exposures outside of the work activities (e.g.,
crowded living conditions) or potentially overlooked indoor aspects
connected to outdoor work (e.g., shared commuting).
Several studies discussed below in more detail have evaluated
outdoors on-field transmission from infected participants during
football, soccer, and rugby matches. These events include repeated
close physical contact between players, without PPE or physical
distancing, over the course of fairly long events, with increased
exertion leading to greater respiratory effort and production of
respiratory droplets. These events also include opposing cohorts who
only interact during on-field activities. Therefore, these studies
provide some evidence for the low likelihood of outdoor transmission in
other workplace activities greatly impacted by the pandemic, such as in
construction.
Mack et al. (January 29, 2021) detailed the National Football
League's complex program to assess and prevent transmission, which
included devices that recorded distance and duration of interactions
with others, for the purpose of improving identification of individuals
with high-risk exposures. Although 329 positive cases were identified
among roughly 11,400 players and staff, there were no reported cases of
on-field transmission by infected players. The results led the NFL to
focus more on reducing transmission in indoor settings, including
transportation.
Egger et al. (March 18, 2021) reviewed three soccer matches
involving 18 players who had SARS-CoV-2; one match involved a team
where 44% of the players were infected. Video analysis was used to
determine the type of contact between players, such as contact to face
or hand slaps. None of the existing cases were associated with on-field
play and no secondary transmission from on-the-field contacts was
observed. Jones et al. (February 11, 2021), evaluated four rugby Super
League matches involving eight players who were found to be infected
with SARS-CoV-2. Using video footage and global positioning data, the
researchers were able to identify 28 players as high-risk contacts with
the infected players. These high-risk players together had as many as
32 tackles and were within two meters of infected players as often as
121 times during the four matches. Of the 28 players noted as high-risk
contacts, one became infected with SARS-CoV-2. However, researchers
determined that the transmission resulted from internal team outbreaks
and not from exposure on the field.
OSHA acknowledges that the risk of transmission of SARS-CoV-2 in
outdoor settings is not zero, and that there may be some low risk to
workers performing general tasks exclusively in outdoor settings.
However, where studies have been able to differentiate between indoor
and outdoor exposures, they indicate that indoor exposures are the much
more significant drivers of SARS-CoV-2 infections. Therefore, the best
available evidence at this time does not provide OSHA with the
information needed to establish SARS-CoV-2 as a grave danger for
general work activities in outdoor settings (see Int'l Union, United
Auto., Aerospace, & Agr. Implement Workers of Am., UAW, 590 F. Supp. at
755-56, describing a ``grave danger'' as a risk that is more than
``significant''). Therefore, OSHA has excluded employees who work
exclusively outdoors from the scope of this ETS (see the Summary and
Explanation for Scope and Application, Section VI.B. of this preamble).
c. Employees in Healthcare
Because OSHA issued a separate grave danger determination several
months ago for some healthcare workers, some explanation of how its
current finding applies to healthcare workers is necessary. In June
2021, OSHA issued its Healthcare ETS (86 FR 32376) after determining
that some healthcare workers faced a grave danger of infection from
SARS-CoV-2. This grave danger determination, along with the protections
of the Healthcare ETS, applied to healthcare and healthcare support
workers in settings where
[[Page 61421]]
people with suspected or confirmed cases of COVID-19 are treated, and
was based on the increased potential for transmission of the virus in
such settings (see 86 FR 32411-32412). These workers are currently
covered by the protections of the Healthcare ETS (29 CFR 1910.502).
OSHA does not have data to demonstrate that unvaccinated workers in
settings covered by the Healthcare ETS face a grave danger from SARS-
CoV-2 when the requirements of that standard are followed. However, if
the Healthcare ETS were no longer in effect, OSHA would consider the
workers who were covered by it, and who remain unvaccinated, to be at
grave danger for the reasons described in this ETS.
OSHA's new finding of grave danger applies to healthcare and
healthcare support workers who are not covered by the Healthcare ETS,
to the extent they remain unvaccinated. In this ETS, as discussed in
this section, OSHA has made a broader determination of grave danger
that applies to most unvaccinated workers, regardless of industry.
OSHA's current finding of grave danger supporting this ETS does not
depend on whether a workplace is one where people with suspected or
confirmed COVID-19 are expected to be present. Therefore, the finding
of grave danger applies to unvaccinated workers in healthcare settings
that are not covered by 29 CFR 1910.502 to the same extent it applies
to unvaccinated workers in all other industry sectors.
d. Employees Who Were Previously Infected With SARS-CoV-2
OSHA has carefully evaluated the effectiveness of previous SARS-
CoV-2 infections in providing protection against reinfection. This
section provides a detailed description of the current scientific
information in order to ascertain what the best available scientific
evidence on this topic indicates regarding the risk to individuals with
previous COVID-19 infections from exposure to SARS-CoV-2. While the
agency acknowledges that the science is evolving, OSHA finds that there
is insufficient evidence to allow the agency to consider infection-
acquired immunity to allay the grave danger of exposure to, and
reinfection from, SARS-CoV-2.
To determine whether employees with infection-induced immunity from
SARS-CoV-2 (i.e., those who were infected with SARS-CoV-2 but have not
been vaccinated) face a grave danger, OSHA reviewed the scientific
evidence on the protective effects of vaccine-induced SARS-CoV-2
immunity versus infection-induced immunity. Individual immunity to any
infectious disease, including SARS-CoV-2, is achieved through a complex
response to exposure by the immune system. This response consists of
disease-specific antibody production guided and augmented by certain
types of immune cells, such as T and B cells, which work together to
neutralize or destroy the disease-causing agent. Immune responses to
viruses like SARS-CoV-2 can be measured in several ways. For instance,
blood serum can be taken and exposed to specific proteins found on the
SARS-CoV-2 virus, in order to measure the presence of antibodies in the
blood. Another antibody test, the neutralization test, measures the
ability of the antibodies present in a serum to neutralize infectivity
and prevent cells from being infected. T cell immunity can be measured
using techniques that target a specific biomolecule that is specific to
SARS-CoV-2.
A considerable number of individuals who were previously infected
with SARS-CoV-2 do not appear to have acquired effective immunity to
the virus (Psichogiou et al., September 13, 2021; Wei et al., July 5,
2021; Cavanaugh et al., August 13, 2021). The level of protection
afforded by infection-induced immunity appears to depend on the
severity of individuals' infections. In a study from Greece,
immunogenicity was compared between healthcare workers who were
vaccinated with Pfizer-BioNTech and unvaccinated patients who acquired
a natural infection (Psichogiou et al., September 13, 2021). The
researchers found that the immune response in unvaccinated individuals
correlated to the severity of their disease. Fully vaccinated
healthcare workers had immune responses (measured as antibody levels
specific to SARS-CoV-2) that were 1.3 times greater than patients who
had critical cases of COVID-19 cases, 2.5 times greater than patients
who had moderate to severe cases, and 10.5 times greater than patients
who had asymptomatic/mild illnesses. Similarly, another study found
that 24.0% (1,742 of 7,256) of individuals who had a previous SARS-CoV-
2 infection were seronegative (i.e., did not produce antibodies in
response to the virus), suggesting that the previous infection provided
insufficient protection against future infection (Wei et al., July 5,
2021). Individuals who were seronegative were typically older, had
lower viral burdens when infected, and were more likely to be
asymptomatic. The authors posited that the immunity of those who were
seropositive (i.e., did produce antibodies in response to the virus)
would provide some measure of protection, but that these individuals
would benefit from a vaccination booster. This position appears to be
validated by a study that compared the reinfection rates of individuals
in Kentucky based on their post-recovery vaccination status (Cavanaugh
et al., August 13, 2021). Unvaccinated individuals with previous
infection were found to be 2.3 times more likely to be reinfected than
those who were vaccinated after their prior infection. These studies
demonstrate not only that those with milder infections may not be
protected against future infection, but that it is difficult to tell,
on an individual level, which individuals might have had prior
infections that conveyed protection equivalent to that provided by
vaccination.
A number of other studies indicate that fully vaccinated
individuals may be better protected against future infection than those
with previous infections. A study in Massachusetts concluded that the
immunity conveyed from a previous SARS-CoV-2 infection was effectively
equivalent to the immunity of an uninfected individual who has had only
one dose of an mRNA vaccine (Naranbhai et al., October 13, 2021). The
authors found that fully vaccinated individuals have an immune response
(i.e., antibodies and neutralization) well above the levels observed in
unvaccinated, previously-infected individuals. German researchers found
that individuals who were fully vaccinated with Pfizer-BioNTech had a
significantly greater immune response (as measured by antibody levels)
than unvaccinated individuals who had infections, concluding that
vaccination would be needed for those unvaccinated individuals to have
similar protection against infection (Herzberg et al., June 13, 2021).
Similarly, a Dutch study observed that vaccination greatly improved the
immune response (as measured by antibodies and virus-specific T cells)
of individuals who had recovered from COVID-19 (Geers et al., May 25,
2021). Planas et al. (August 12, 2021) also noted that immune response
(as measured by neutralization) to the Alpha, Beta, and Delta
(B.1.617.2) variants in unvaccinated, previously-infected individuals
was considerably less than the immune response in individuals five
weeks after their second Pfizer-BioNTech dose. When unvaccinated,
previously-infected individuals were vaccinated, their immune response
(as measured by neutralization) increased by more than an order of
magnitude. Likewise, Wang
[[Page 61422]]
et al. (July 15, 2021) found that the immune response (as measured by
neutralization) of those with previous SARS-CoV-2 infection increased
by more than an order of magnitude against Alpha (B.1.1.7), Beta
(B.1.351), Iota (B.1.526), and Gamma (P.1) variants when they were
vaccinated. These studies show that infection-induced immunity may not
equal the protection afforded by vaccination and that vaccination
greatly improves the immune response of those who were previously
infected.
The aforementioned studies indicate that immunity acquired through
infection appears to be less protective than vaccination. There are
also a number of epidemiological studies that provide some evidence
that infection-acquired immunity has the potential to provide a
significant level of protection against reinfection. As OSHA discusses
in greater detail below, these studies suffer from methodological
limitations that render them inconclusive about the level of immunity
conferred by infection, and therefore OSHA is unable to establish that
such immunity eliminates grave danger. This determination is based in
three parts.
First, the epidemiological literature OSHA reviewed generally
suffers from selection bias to a degree that it serves as an unreliable
basis on which to reach a robust conclusion on whether previous
infection removes workers from grave danger. In general, the studies
described below do not account for people who had mild COVID-19
infections, leading to study findings regarding the level of protection
afforded by prior infection that are not generally applicable. Second,
the tests employed in the studies are being used in ways that they were
not originally designed to be employed. These tests are powerful tools,
but there are limitations to their use in determining if a specific
individual is, in fact, protected from the grave danger of SARS-CoV-2.
Particularly problematic is the lack of established thresholds to
determine full protection from reinfection or even a standardized
methodology to determine infection severity or immune response. Thus,
while these studies broadly establish some increase in protectiveness
against SARS-CoV-2 among the studied populations, they as yet are
unable to provide a reasonable degree of certainty on whether the
degree of protection afforded any particular individual from their
prior infection is sufficient to eliminate the grave danger from
reinfection (see Milne, et al., October 21, 2021.) Third, while the
research methodology itself creates difficulties in the context of
OSHA's grave danger inquiry, the implications of trying to apply
investigative research methodology to clinical practice are even more
challenging. The need for the development of standardized methods and
criteria for establishing sufficient immunity preclude the application
of the studies' findings to robust and reliable clinical practice.
These three rationales for OSHA's finding are described in more detail
below.
Several epidemiological studies used previous RT-PCR positive cases
to define previous infections (Hansen et al., March 27, 2021; Pilz et
al., February 11, 2021; Vitale et al., May 28, 2021; Pouwels et al.,
October 14, 2021; Braeye et al., September 15, 2021; Hall et al., April
17, 2021). RT-PCR tests, particularly in the beginning of the pandemic,
were given high priority to discern who seeking medical care was, in
fact, infected. For instance, the progression of testing from medical
needs to more of a community perspective is illustrated in Denmark
(Vrangbaek et al., April 29, 2021). Denmark, considered one of the gold
standard countries for its comprehensive testing program, missed five
infections for every one it identified in the spring of 2020 (Espenhaim
et al., August 22, 2021). Hansen et al. (March 27, 2021) depended
greatly on these first surge infection definitions to determine that
survivors had protection of 80.5% effectiveness during the second surge
in Denmark from September through December, 2020. By only noting RT-PCR
positives from the spring when testing was limited and highly focused
on health care needs, it seems apparent that the study excluded many
less severe cases (which are less likely to result in an effective
immune response against reinfection), leading to results that may
suggest greater protection is afforded by infection than in actuality.
Even by December of 2020, it appears Denmark's gold standard
comprehensive testing approach was only able to capture roughly half of
all infections. Similar systemic undercounts have also been determined
to be true in the United States where approximately three out of four
infections have never been reported (CDC, July 27, 2021b).
It is important to recognize that RT-PCR testing was not
implemented to find every infection, but was used instead to assist in
determining when medical and community interventions were necessary.
Infections without symptoms or with mild symptoms likely would not
require medical intervention and, therefore, would likely not be
identified via testing. The absence of this population that is more
vulnerable to reinfection, in these studies, undercuts their usefulness
in OSHA's grave danger analysis, because they may overestimate the
protectiveness of immunity acquired through infection.
Several other studies in regions less known for their sampling
approach than Denmark also were heavily dependent on early, limited
pandemic RT-PCR testing. An Austrian study found a roughly ten-fold
decrease in reinfection in survivors of reported infections from
February to April 30, 2020 in comparison with the general public (Pilz
et al., February 11, 2021). The authors noted that ``infections in the
first wave are likely to have been far more common than the documented
ones'' and referred to their results as a ``rough estimate.''
Researchers at the Cleveland Clinic also found a reduced rate of
reinfection in those who had a reported previous infection compared
with those with no prior infection (13.8% infection rate for those
previously uninfected and 4.9% infection rate for those previously
infected), but noted that testing was limited in that the ``Cleveland
Clinic did not test asymptomatic patients unless they were admitted to
hospital or undergoing a procedure/surgery'' (Sheehan et al., March 15,
2021). These criteria for testing create uncertainty in determining the
level of effectiveness previous infection provides against SARS-CoV-2
because many individuals with asymptomatic infections would not have
been tested. Similar issues are also found in studies on populations in
Italy, Belgium, and the UK (Vitale et al., May 28, 2021; Braeye et al.,
September 15, 2021; Pouwels et al., October 14, 2021).
To avoid the well-known problems with RT-PCRs defining previous
infection, other studies have defined previous infection as testing
positive for antibodies specific for SARS-CoV-2 (Lumley et al.,
February 11, 2021; Abu-Raddad et al., April 28, 2021; Hall et al.,
April 17, 2021). As noted above, previous infection does not
necessarily result in a seropositive outcome; one study indicated that
nearly a quarter (24%) of those infected with SARS-CoV-2 subsequently
showed no sign of an immune response in SARS-CoV-2-specific antibody
testing (Wei et al., July 5, 2021). Therefore, studies only considering
seropositive individuals are in essence studying only the individuals
most likely to have protection from reinfection. Lumley et al.
(February 11, 2021) found that those having a seropositive response had
almost an order of magnitude fewer infections (e.g., 0.11 adjusted
incidence rate ratio). Likewise, Abu-Raddad et al. (April 28,
[[Page 61423]]
2021) found that seropositive individuals were reinfected less (0.7%)
during their study period in comparison to seronegative individuals
(3.09%). In addition to the bias associated with using antibodies to
determine previous infection, the authors also noted that there may
have been issues with being able to document cases with mild or no
symptoms.
Hall et al. (April 17, 2021) cast a wider net by defining previous
infection to include both positive RT-PCR tests and seropositivity. The
researchers found that those who were considered previously infected
had an 84% lower risk of infection compared to those who were
unvaccinated with no record of infection. While the study does attempt
to capture as many previously-infected individuals as possible, this
does not actually address the weaknesses of each method. Those with
less severe infections were less likely to have sought out or been able
to get an RT-PCR test during the first surge, which is when an
overwhelming number of the previous infections were recorded in this
study (March through May, 2020). Additionally, the less severe
infections that are most likely underrepresented in the study appear to
be the ones that are less likely to produce seropositivity. Shenai et
al. (September 21, 2021) pooled several studies with the above issues
and concluded that immunity acquired through a previous infection from
SARS-CoV-2 may be as protective as, or more protective than, the
immunity afforded by vaccination to an individual without previous
infection. However, authors of several of those underlying studies used
in the analysis noted that their studies were limited by not having the
capability to fully account for asymptomatic infections (the
aforementioned Lumley et al., July 3, 2021; Gazit et al., August 25,
2021; Shrestha et al., June 19, 2021). As noted earlier, infection
severity appears to be correlated with the robustness of immunity
acquired through that infection, so the failure to account for
asymptomatic infections may mean that this finding is related to the
protection afforded by more severe disease. While pooled analyses can
be utilized to make powerful observations, those observations are
highly dependent upon the underlying studies not sharing the same
methodological weakness which, in this case, was the studies' exclusion
of asymptomatic infections.
Moreover, while the evidence suggests that severe infection may
provide significant protection against reinfection in some cases (Milne
et al., October 21, 2021), the level of protection cannot be determined
on an individual basis. The studies discussed above are based on tests
that show only whether a person was or was not infected and provide no
information about the severity of the infection. Because the studies
are likely biased towards those who had a relatively serious infection,
their findings cannot be generalized to all individuals with prior
infections.
RT-PCR and antibody testing are powerful tools with many clinical
and research applications. However, the application of these tools
cannot determine what degree of protection a particular individual has
against SARS-CoV-2 without a great deal of additional study concerning
thresholds establishing individual immunity. Therefore, these tools are
not yet able to assist OSHA in making more nuanced findings about which
workers who had COVID-19 previously are at grave danger. There is no
established threshold to determine full protection from reinfection or
a standardized methodology to determine infection severity or immune
response. Studies use Ct threshold to approximate viral loads and infer
disease severity, but that metric depends on many variables (e.g. time
of collection during infection, quality of collection, handling of
sample, specifics of the test protocol and materials, precision in
performing the protocol) that are often of far less importance when it
is used as a crude diagnostic to determine the presence of an
infection. In other words, it is reasonable to say that the lower the
Ct count, the greater the likelihood that an individual is at a lower
reinfection risk; however, the Ct count is greatly dependent on the RT-
PCR test used, and how different laboratories may run that test, which
cannot be discerned. Similarly, research needs to be done to better
identify the minimum protective threshold of anti-SARS-CoV-2 serum
neutralizing antibodies (Milne et al., October 21, 2021). Thus, these
studies currently do not allow OSHA to determine, with a reasonable
degree of certainty, how much protection employees with prior
infections have against reinfection.
Furthermore, while the research methodology itself raises
challenges in making the grave danger determination, the implications
of trying to apply investigative research methodology to clinical
practice are even more difficult. The lack of standardized methods and
standardized measures for immunity preclude their application to robust
and reliable clinical practice. One major drawback discussed above is
that, in contrast to vaccine studies where researchers know who was
vaccinated with a standardized dosing regime, scientific inquiries
likely will not be able to identify most individuals who were infected,
the degree of disease experienced for those with a confirmed infection,
and the immunity against reinfection. As of October 18, 2021, several
RT-PCR assays have been authorized without standardization or
assessment with respect to measuring disease severity (FDA, October 18,
2021). As noted above, the use of the Ct threshold to approximate viral
loads and infer disease severity is unreliable. As the FDA notes, the
same is true about antibody tests, which are considered to be poor
indicators for individuals to use to determine whether they are
protected from reinfection (FDA, May 19, 2021). There are many
different SARS-CoV-2-specific antibody tests that focus on different
specificity. Not only are the outcomes of these tests not directly
comparable to each other, but the specificity of these tests is not
related to any notion of protection against reinfection. It can be
reasonably said that a greater antibody response means a greater
likelihood of protection against infection, but, again, the science is
not clear what those thresholds are and whether a threshold would be
comparable between laboratories. At this point in time, even if OSHA
determined that some individuals with prior infections are not at grave
danger from exposure to SARS-CoV-2, there is no agreement on what
indicators of infection might be sufficient to confer this level of
immunity or how a healthcare provider or employer could document that a
certain level of immunity had been achieved.
Based on the best available evidence described above, OSHA
concludes that while some individuals who were infected with SARS-CoV-2
may have significant protection from subsequent infections, the level
of protection afforded by infection may be significantly impacted by
the severity of the infection and some previously infected individuals
may have no future protection at all. In addition, given the
limitations of the studies described above, there is considerable
uncertainty as to whether any given individual is adequately protected
against reinfection. Furthermore, the level of protection, if any,
provided by a given person's SARS-CoV-2 infection cannot be ascertained
based on currently-available testing methods. Therefore, OSHA finds
that the requirements of this ETS are necessary to protect unvaccinated
individuals who had prior SARS-CoV-2 infections from the grave danger
from exposure to SARS-CoV-2.
[[Page 61424]]
OSHA recognizes that its finding regarding infection-induced
immunity is being made in an area of inquiry that is currently on the
``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
Am. Petroleum Inst., 448 U.S. 607, 656 (1980)). For these reasons, OSHA
finds that those who have previously been infected with SARS-CoV-2 and
are not yet fully vaccinated are at grave danger from SARS-CoV-2
exposure and that it is necessary to protect these workers via
vaccination, or testing and the use of face coverings, under this
standard. OSHA will continue to follow developments on this issue,
however, and make appropriate adjustments to this ETS if the evidence
warrants.
VI. Conclusion.
OSHA finds that many employees in the U.S. who are not fully
vaccinated against COVID-19 face a grave danger from exposure to SARS-
CoV-2 in the workplace. OSHA's determination is based on the severe
health consequences of exposure to the virus, including death; powerful
lines of evidence demonstrating the transmissibility of the virus in
the workplace; and the prevalence of infections in employee
populations.
With respect to the grave health consequences of exposure to SARS-
CoV-2, OSHA has found that regardless of where and how exposure occurs,
COVID-19 can result in death. Even for those who survive a SARS-CoV-2
infection, the virus can cause serious, long-lasting, and potentially
permanent health effects. Serious cases of COVID-19 require
hospitalization and dramatic medical interventions, and might leave
employees with permanent and disabling health effects. Both death and
serious cases of COVID-19 requiring hospitalization provide independent
bases for OSHA's finding of grave danger. The evidence is clear that
the safe and effective vaccines authorized and/or approved for use in
the United States greatly reduce the likelihood of these severe
outcomes.
The best available evidence on the science of transmission of the
virus makes clear that SARS-CoV-2 is transmissible from person to
person in shared workplace settings. The likelihood of transmission can
be exacerbated by common characteristics of many workplaces, including
working indoors, working with others for extended periods of time, poor
ventilation, and close contact with potentially infectious individuals.
The likelihood of transmission in the workplace is also exacerbated by
the presence of unvaccinated workers, who are more likely than those
who are vaccinated to be infected and transmit the virus to others.
Every workplace SARS-CoV-2 exposure or transmission has the potential
to cause severe illness or even death, particularly in unvaccinated
workers. Taken together, the severe health consequences of COVID-19 and
the evidence of its transmission in environments characteristic of the
workplaces covered by this ETS demonstrate that exposure to SARS-CoV-2
represents a grave danger to unvaccinated employees in many workplaces
throughout the country.
The existence of a grave danger to employees from SARS-CoV-2 is
further supported by the toll the pandemic has already taken on the
nation as a whole and the number of workers who remain unvaccinated.
Although OSHA cannot state with precision the total number of workers
in our nation who have contracted COVID-19 at work and became sick or
died, COVID-19 has killed 723,205 people in the United States as of
October 18, 2021 (CDC, October 18, 2021--Cumulative US Deaths). That
death toll includes 131,478 people who were 18 to 64 years old, prime
working age (CDC, October 18, 2021--Demographic Trends, Deaths by Age
Group). OSHA estimates that there are over 26 million workers subject
to the rule who remain unvaccinated at present and therefore are in
grave danger. As a result of this ETS, the agency estimates that 72% of
them will be vaccinated (see OSHA, October 2021c).
Current mortality data shows that unvaccinated people of working
age have a 1 in 202 chance of dying when they contract COVID-19 (CDC,
October 18, 2021--Demographic Trends, Cases by Age Group; Demographic
Trends, Deaths by Age Group). As of October 18, 2021, close to 45
million people in the United States have been reported to have
infections, and thousands of new cases were being identified daily
(CDC, October 18, 2021--Daily Cases).One in 14 reported cases of COVID-
19 in people ages 18 to 64 becomes severe and requires hospitalization
(CDC, October 18, 2021--Demographic Trends, Cases by Age; Total
Hospitalizations, by Age). Moreover, public health officials agree that
these numbers fail to show the full extent of the deaths and illnesses
from this disease, and racial and ethnic minority groups are
disproportionately represented among COVID-19 cases, hospitalizations,
and deaths (CDC, December 10, 2020; CDC, May 26, 2021; Escobar et al.,
February 9, 2021; Gross et al., October 2020; McLaren, June 2020; CDC,
October 6, 2021). Given this context, OSHA is confident in its finding
that exposure to SARS-CoV-2 poses a grave danger to the employees
covered by this ETS.
The above analysis fully satisfies the OSH Act's requirements for
finding a grave danger. Although OSHA usually performs a quantitative
risk assessment based on extrapolations among exposure levels before
promulgating a health standard under section 6(b)(5) of the OSH Act (29
U.S.C. 655(b)(5)), that type of analysis is not necessary in this
situation. OSHA has most often invoked section 6(b)(5) authority to
regulate exposures to chemical hazards involving much smaller
populations, many fewer cases, extrapolations from animal evidence,
long-term exposure, and delayed effects. In those situations,
mathematical modelling is necessary to evaluate the extent of the risk
at different exposure levels. The gravity of the danger presented by a
disease with acute effects like COVID-19, on the other hand, is made
obvious by a straightforward count of deaths and illnesses caused by
the disease, which reach sums not seen in at least a century. The
evidence compiled above amply supports OSHA's finding that SARS-CoV-2
presents a grave danger in American workplaces. In the context of
ordinary 6(b) rulemaking, the Supreme Court has said that the OSH Act
is not a ``mathematical straitjacket,'' nor does it require the agency
to support its findings ``with anything approaching scientific
certainty,'' particularly when operating on the ``frontiers of
scientific knowledge'' (Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 655-56 (1980)). This is true a fortiori in the
current national crisis, where OSHA must act to ensure employees are
adequately protected from the hazard presented by the COVID-19 pandemic
(see 29 U.S.C 655(c)(1)).The grave danger from SARS-CoV-2 represents
the biggest threat to employees in OSHA's more than 50-year history.
The threat applies to employees in all sectors covered by OSHA,
including general industry, construction, maritime, agriculture, and
healthcare. Having made the determination of grave danger, as well as
the determination that an ETS is necessary to protect employees from
exposure to SARS-CoV-2 (see Need for the ETS, Section III.B. of this
preamble), OSHA is required to issue this standard to protect employees
from getting sick or dying from COVID-19 acquired at work (see 29
U.S.C. 655(c)(1)).
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Scobie HM et al. (2021, September 17). Monitoring Incidence of
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Self WH et al. (2021, September 17). Comparative effectiveness of
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Seppala E et al. (2021, September 2). Vaccine effectiveness against
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Shenai MB et al. (2021, September 21). Equivalency of protection
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Shrestha NK et al. (2021, June 19). Necessity of COVID-19
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Singanayagam A et al. (2021, September 6). Community transmission
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B. Need for the ETS
This ETS is necessary to protect unvaccinated workers from the risk
of contracting COVID-19, including its more contagious variants, such
as the B.1.617.2 (Delta), at work. The rule protects workers through
the most effective and efficient workplace control available:
Vaccination. Additionally, this ETS is necessary to protect workers who
remain unvaccinated through required regular testing, use of face
coverings, and removal of infected employees from the workplace.
I. Events Leading to the ETS
This section describes the evolution of OSHA's actions to protect
employees from the grave danger posed by COVID-19 and the agency's
reasons for issuing this ETS at this time.
a. OSHA's 2020 Actions Regarding COVID-19
Beginning in early 2020, OSHA began to monitor the growing cases of
the SARS-CoV-2 virus that were occurring around the country. Because
scientific information about the disease, its potential duration, and
ways to mitigate it were undeveloped, OSHA decided to monitor the
situation. As noted below, OSHA subsequently issued numerous guidance
documents advising interested employers of steps they could take to
mitigate the hazard arising from the virus.
Also beginning in early 2020, OSHA received numerous petitions and
supporting letters from members of Congress, unions, advocacy groups,
and one group of large employers urging the agency to take immediate
action by issuing an ETS to protect employees from exposure to the
virus that causes COVID-19 (Scott and Adams, January 30, 2020; NNU,
March 4, 2020; AFL-CIO, March 6, 2020; Menendez et al., March 9, 2020;
Wellington, March 12, 2020; DeVito, March 12, 2020; Carome, March 13,
2020; SMART, March 30, 2020; Blumenthal et al., April 8, 2020; Murray
et al., April 29, 2020; Luong, April 30, 2020; Novoa, June 24, 2020;
Solt, April 28, 2020; Castro et al., April 29, 2020; Talbott and Adely,
May 4, 2020; Public Citizen, March 13, 2020;
[[Page 61430]]
LULAC, March 31, 2020; Meuser, May 1, 2020; Raskin, April 29, 2020;
Cartwright et al., May 7, 2020; Frosh et al., May 12, 2020; Pellerin,
March 19, 2020; Yborra, March 19, 2020; Owen, March 19, 2020; Brown et
al., April 30, 2020; Price et al., May 1, 2020; ORCHSE, October 9,
2020). These petitions and supporting letters argued that many
employees had been infected because of workplace exposures to the virus
that causes COVID-19, and that immediate, legally enforceable action is
necessary for protection. OSHA quickly began issuing detailed guidance
documents and alerts beginning in March 2020 that helped employers to
determine employee risk levels of COVID-19 exposure and made
recommendations for appropriate controls. As explained in detail in
Section IV. of the Healthcare ETS, 86 FR 32376, 32412-13 (June 21,
2021) and hereby included in the record for this ETS,\16\ at the time,
OSHA leadership believed that implementing a combination of enforcement
tools, including guidance, existing OSHA standards, and the General
Duty Clause, would provide the necessary protection for workers. OSHA
also expressed concern that an ETS might unintentionally enshrine
requirements that are subsequently proven ineffective in reducing
transmission.
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\16\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------
When it decided not to issue an ETS in the spring of 2020, OSHA
determined that the agency could provide sufficient employee protection
against COVID-19 through enforcing existing workplace standards and the
General Duty Clause of the OSH Act, coupled with issuing industry-
specific, non-mandatory guidance. However, in doing so OSHA indicated
that its conclusion that an ETS was not necessary was specific to that
time, and that the agency would continue to monitor the situation and
take additional steps as appropriate (see, e.g., OSHA, March 18, 2020
Letter to Congressman Scott (stating ``[W]e currently see no additional
benefit from an ETS in the current circumstances relating to COVID-19.
OSHA is continuing to monitor this quickly evolving situation and will
take the appropriate steps to protect workers from COVID-19 in
coordination with the overall U.S. government response effort.''
(emphasis supplied); DOL May 29, 2020 at 20 (stating ``OSHA has
determined this steep threshold [of necessity] is not met here, at
least not at this time.'' (emphasis supplied))).
In addition to the various petitions for rulemaking that were
submitted to OSHA, the AFL-CIO filed a petition for a writ of mandamus
with the U.S. Court of Appeals for the D.C. Circuit, requesting that
the court compel OSHA to issue an ETS. (AFL-CIO, May 18, 2020). In its
administrative decision and filing in that case, OSHA explained that
the determination not to issue an ETS was based on the conditions and
information available to the agency at that time and was subject to
change as additional information indicated the need for an ETS. On June
11, 2020, the U.S. Court of Appeals for the D.C. Circuit issued a one
paragraph per curiam order denying the AFL-CIO's petition to require
OSHA to issue an ETS. To be clear, nothing in OSHA's prior position or
the D.C. Circuit's decision in In re Am. Fed'n of Labor & Cong. of
Indus. Orgs., No. 20-1158, 2020 WL 3125324 (D.C. Cir. June 11, 2020);
rehearing en banc denied (July 28, 2020) precludes OSHA's decision to
promulgate an ETS now. To the contrary, at an early phase of the
pandemic, when vaccines were not yet available and when it was not yet
known how extensive the impact would be on illness and death, the court
decided not to second-guess OSHA's decision to hold off on regulation
in order to see if its nonregulatory enforcement tools could be used to
provide adequate protection against the virus. ``OSHA's decision not to
issue an ETS is entitled to considerable deference,'' the court
explained, noting ``the unprecedented nature of the COVID-19 pandemic''
and concluding merely that ``OSHA reasonably determined that an ETS is
not necessary at this time.'' (Id., with emphasis added).
Employers do not have a reliance interest in OSHA's prior decision
not to issue an ETS on May 29, 2020, which did not alter the status quo
or require employers to change their behavior. See Dep't of Homeland
Security v. Regents of the Univ. of California, 140 S. Ct. 1891, 1913-
14 (2020). As OSHA indicated when it made the decision, the
determination was based on the conditions and information available to
the agency at that time and was subject to change as additional
information indicated the need for an ETS. In light of the agency's
express qualifications and the surrounding context, any employer
reliance would have been unjustified and cannot outweigh the
countervailing urgent need to protect workers covered by this ETS from
the grave danger posed by COVID-19.
b. OSHA's Decision To Promulgate a Healthcare ETS
OSHA subsequently issued the Healthcare ETS to protect healthcare
workers. 86 FR 32376. (June 21, 2021), codified at 29 CFR 1910.502.
Looking back on a year of experience, OSHA found that its enforcement
efforts had encountered significant obstacles, demonstrating that
existing standards, regulations, and the General Duty Clause were
inadequate to address the grave danger faced by healthcare employees.
86 FR 32415. In promulgating that ETS, OSHA recognized that ``the
impact of [COVID-19] has been borne disproportionately by the
healthcare and healthcare support workers tasked with caring for those
infected by this disease.'' 86 FR 32377. Furthermore, states and
localities had taken increasingly divergent approaches to workplace
protections against COVID-19, making it clear that a federal standard
was needed to ensure sufficient protection in all states. 86 FR 32377.
Therefore, OSHA focused on the unique situation experienced by
healthcare industry workers as the frontline caregivers and support
workers for those suffering from COVID-19. See 86 FR 32376, 32411-12.
The Healthcare ETS requires employers to institute a suite of
engineering controls, administrative controls, work practices, and
personal protective equipment to combat the COVID-19 hazard. In the
Preamble to the Healthcare ETS, OSHA observed that the development of
safe and highly effective vaccines is a critical milestone in the
nation's response to COVID-19, and that fully vaccinated persons have a
greatly reduced risk of death, hospitalization and other health
consequences. 86 FR 32396. The Healthcare ETS therefore includes
provisions intended to encourage employees to become vaccinated,
including a requirement for employers to provide reasonable paid leave
for vaccination and recovery from any side effects. 86 FR 32415, 29 CFR
1910.502(m).
In the Healthcare ETS OSHA found that employees who work in covered
healthcare workplaces are exposed to grave danger. 86 FR 32411. The
agency also stated that in light of the effectiveness of vaccines,
there was ``insufficient evidence in the record to support a grave
danger finding for non-healthcare workplaces where all employees are
vaccinated.'' 86 FR 32396 (emphasis supplied). OSHA made no finding at
that time regarding unvaccinated workers in non-healthcare workplaces.
[[Page 61431]]
No employer challenged the Healthcare ETS in court. The United Food
and Commercial Workers Union (UFCW) together with the AFL-CIO filed a
petition for review asserting that the rule should have gone further
and included more industries in its scope (UFCW and AFL-CIO, June 24,
2021). That case is being held in abeyance pending the issuance of this
ETS.
c. Subsequent Developments
The preamble to the Healthcare ETS notes that new COVID-19 variants
might emerge that are more transmissible and cause more severe illness,
but does not specifically mention the Delta Variant. See 86 FR 32384.
Since publication of the Healthcare ETS, the Delta Variant has become
the dominant form of the virus in the United States, causing large
spikes in transmission, and surges of hospitalizations, and deaths,
overwhelmingly among the unvaccinated (CDC, August 26, 2021; CDC,
October 18, 2021--Variant Proportions, July Through October, 2021). As
discussed in more detail in Grave Danger (Section III.A. of this
preamble), the Delta Variant is at least twice as contagious as
previous COVID-19 variants, and research suggests that it also causes
more severe illness in the unvaccinated population (CDC, August 26,
2021). More infections mean more potential for exposures, including in
workplaces (see Grave Danger, Section III.A. of this preamble, for
further discussion on workplace outbreaks, clusters, and the general
impact of transmission in the workplace.). More infections also mean
more opportunities for the virus to undergo mutations to its genetic
code, resulting in genetic variants with the potential to infect or re-
infect people.
Some variability in infection rates in a pandemic is to be
expected. While the curves of new infections and deaths can bend down
after peaks, they often reverse course only to reach additional peaks
in the future (Moore et al., April 30, 2020). Last year experts
expressed concern that one or more subsequent waves of COVID-19 were
possible in 2021 (Moore et al., April 30, 2020), especially with new
variants of COVID-19 in circulation (Doughton, February 9, 2021). That
potential tragically became a reality with the spread of the Delta
Variant.
In June 2021, when the Healthcare ETS was published, COVID-19
transmission rates in the United States were at a low point, with the
7-day moving average of reported cases to be about 12,000. (CDC, August
26, 2021) However, by the end of July, the 7-day moving average reached
over 60,000 as the Delta Variant spread across the country. (CDC,
August 26, 2021). The 7-day moving average of reported cases at the
beginning of September, 2021 exceeded 161,000 (CDC, October 18, 2021--
Daily Cases). The most recent 7-day moving average of reported cases,
while lower than the peak in late August and early September, is still
over 85,000. (CDC, October 18, 2021--Daily Cases). These rates are also
far higher than the rate when OSHA first declined to issue an ETS.
(CDC, August 27, 2020 (20,401 confirmed cases per day on May 29,
2020)). The jump in infections has resulted in increased
hospitalizations and deaths for unvaccinated workers, as discussed in
detail in Grave Danger (Section III.A. of this preamble). While the
most current data reflect a decline in new cases from the peak, the
level of new cases remains high. CDC data shows that, as of October 18,
2021, approximately 85% of U.S. counties were experiencing ``high''
rates of community transmission, and another 10% were experiencing
``substantial'' community transmission (CDC, October 18, 2021--Daily
Cases). Although the number of new detected cases is currently
declining nationwide (see CDC, October 18, 2021--Community Transmission
Rates), the agency cannot assume based on past experience that
nationwide case levels will not increase again. Indeed, many northern
states are currently experiencing increases in their rate of new cases
(see CDC, October 18, 2021--Cases, Deaths, and Laboratory Testing
(NAATS) by State; Slotnik, October 18, 2021), including Vermont, which
set a new record for new COVID-19 cases in mid-October 2021 (Murray,
October 18, 2021). Unless vaccination rates increase, the experience of
northern states during this fall could presage a greater resurgence in
cases this winter as colder weather drives more individuals indoors
(see Firozi and Dupree, October 18, 2021).
While it is important to recognize that the Delta Variant has
caused a spike in hospitalization and death in the United States, the
SARS-CoV-2 virus, and not just a particular variant of that virus, is
the hazard that workers face (see Grave Danger, Section III.A. of this
preamble). Like any virus, SARS-CoV-2 has the ability to mutate over
time and produce variants that may be more or less severe. Indeed, the
World Health Organization and the CDC both track new variants that have
continued to arise, such as the Lamda and Mu Variants (WHO, October 12,
2021; CDC, October 4, 2021). At this time, the CDC is tracking 11
different variants of COVID-19 (CDC, October 4, 2021). The World Health
Organization has classified the Lambda and Mu variants as ``variants of
interest,'' meaning that they have genetic changes that affect
transmissibility, disease severity, immune escape, diagnostic or
therapeutic escape; and have been identified to cause significant
community transmission or multiple COVID-19 clusters, in multiple
countries with increasing relative prevalence alongside increasing
number of cases over time, or other apparent epidemiological impacts to
suggest an emerging risk to global public health (WHO, October 12,
2021). Medical experts have also explained that vaccination reduces the
opportunities for the virus to continue to mutate by reducing
transmission and length of infection. And, there is no indication that
future variants of COVID-19 will not be equally or even more dangerous
than Delta without a higher rate of vaccination (Bollinger and Ray,
July 23, 2021).
Meanwhile, evidence on the power of vaccines to safely protect
individuals from infection and especially from serious disease has
continued to accumulate. (CDC, May 21, 2021). For example, as explained
in more detail in Grave Danger (Section III.A. of this preamble),
multiple studies have demonstrated that vaccines are highly effective
at reducing instances of hospitalization and death. In September the
CDC compiled data from various studies that demonstrated overall
authorized vaccines reduced death and severe case rates by 91 and 92%
respectively in the population studied between April and July (Scobie
et al., September 17, 2021, Table 1.). Additionally, the FDA granted
approval to the Pfizer-BioNTech COVID-19 Vaccine for individuals 16
years of age and older on August 23, 2021 (FDA, August 23, 2021). In
announcing the decision, the FDA Commissioner explained that ``[w]hile
this and other vaccines have met the FDA's rigorous, scientific
standards for emergency use authorization, as the first FDA-approved
COVID-19 vaccine, the public can be very confident that this vaccine
meets the high standards for safety, effectiveness, and manufacturing
quality the FDA requires of an approved product.'' (FDA, August 23,
2021.)
Despite this important milestone, and the demonstrated
effectiveness of the approved and authorized vaccines available to the
public, millions of employees remain unvaccinated, approximately 39% of
workers who are covered by this ETS (See Economic Analysis, Section
IV.B. of this ETS). The rate of vaccination in the United States
[[Page 61432]]
has slowed significantly from its peak in April, when the daily number
of vaccination doses administered exceeded three million at one point.
In recent months, daily vaccination rates have hovered around one
million doses administered, or lower (CDC, October 18, 2021--Daily
Vaccination Rate). The shortfall in vaccination leaves the nation's
working population vulnerable to sickness, hospitalization and death,
whether today under the Delta Variant, or under future variants that
may arise (CDC, October 18, 2021--Daily Vaccination Rate); see also
Grave Danger (Section III.A. of this preamble).
Moreover, in recent months, an increasing number of states have
promulgated Executive Orders or statutes that prohibit workplace
vaccination policies that require vaccination or proof of vaccination
status, thus attempting to prevent employers from implementing the most
efficient and effective method for protecting workers from the hazard
of COVID-19 (see, e.g., Texas Executive Order GA-40, October 11, 2021;
Montana H.B. 702, July 1, 2021; Arkansas S.B. 739, October 4, 2021 and
Arkansas H.B. 1977, October 1, 2021; AZ Executive Order 2021-18, August
16, 2021). While some States' bans have focused on preventing local
governments from requiring their public employees to be vaccinated or
show proof of vaccination, the Texas, Montana, and Arkansas
requirements apply to private employers as well. Other states have
banned local ordinances that require employers to ensure that customers
who enter their premises wear masks, thus endangering the employees who
work there, particularly those who are unvaccinated (see, e.g., Florida
Executive Order 21-102, May 3, 2021; Texas Executive Order GA-34, March
2, 2021).
In short, at the present time, workers are becoming sick and dying
unnecessarily as a result of occupational exposures, when there is a
simple and effective measure, vaccination, that can largely prevent
those deaths and illnesses (see Grave Danger, Section III.A. of this
preamble). Congress charged OSHA with responsibility for issuing
emergency standards when they are necessary to protect employees from
grave danger. 29 U.S.C. 655(c). In light of the current situation, OSHA
is issuing this emergency rule.
References
American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO). (2020, March 6). ``To Address the Outbreak
of COVID-19: A Petition for an OSHA Emergency Temporary Standard for
Infectious Disease.'' (AFL-CIO, March 6, 2020)
American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO). (2020, May 18). ``Emergency Petition For A
Writ Of Mandamus, and Request For Expedited Briefing And
Disposition, No. 19-1158.'' (AFL-CIO, May 18, 2020)
An Act Prohibiting Discrimination Based on a Person's Vaccination
Status or Possession of an Immunity Passport; Montana H.B. 702.
(2021, July 1). https://leg.mt.gov/bills/2021/billpdf/HB0702.pdf.
(Montana H.B. 702 July 1, 2021)
Arizona Executive Order 2021-18. (2021, August 16). https://azgovernor.gov/sites/default/files/eo_2021-18.pdf. (AZ Executive
Order 2021-18, August 16, 2021)
Arkansas H.B. 1977. (2021, October 1). To Provide Employee
Exemptions From Federal Mandates and Employer Mandates Related to
Coronavirus 2019 (COVID-19); and to Declare an Emergency. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FAMEND%2F2021R%2FPublic%2FHB1977-H1.pdf.
(Arkansas H.B. 1977, October 1, 2021)
Arkansas S.B. 739. (2021, October 4). An Act Concerning Employment
Issues Related to Coronavirus 2019 (COVID-19); To Provide Employee
Exemptions From Federal Mandates and Employer Mandates Related to
Coronavirus 2019 (COVID-19); To Declare and Emergency; and For Other
Purposes. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FBills%2F2021R%2FPublic%2FSB739.pdf. (Arkansas
S.B. 739, October 4, 2021)
Blumenthal R, Murray P, Duckworth T, Casey RP, Baldwin B, Brown S,
Menendez R. (2020, April 8). ``COVID-19 ETS Petition.'' (Blumenthal
et al., April 8, 2020)
Bollinger R and Ray R. (2021, July 23). New Variants of the
Coronavirus: What You Should Know. Johns Hopkins Medicine. https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/a-new-strain-of-coronavirus-what-you-should-know. (Bollinger and
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Brown S, Murray P, Baldwin T, Bennet MF, Casey Jr. RP, Whitehouse S,
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April 30). ``COVID-19 ETS Petition.'' (Brown et al., April 30, 2020)
Carome M. (2020, March 13). ``Letter requesting an immediate OSHA
emergency temporary standard for infectious disease.'' (Carome,
March 13, 2020)
Cartwright M, Kaptur M, Roybal-Allard L, Foster B. (2020, May 7).
``COVID-19 ETS Petition.'' (Cartwright et al., May 7, 2020)
Castro J, Espaillat A, C[aacute]rdenas T, Ocasio-Cortez A, Sablan
GKC, Garcia J, Gallego R, Escobar V, Vargas J, Trahan L, Torres NJ,
Correa L, Barrag[aacute]n ND, Serrano JE, Cisneros Jr. GR,
Napolitano GF, Velazquez NM, Garcia SR, Grijalva R. (2020, April
29). ``COVID-19 ETS Petition.'' (Castro et al., April 29, 2020)
Centers for Disease Control and Prevention (CDC). (2020, August 27).
Previous U.S. Covid-19 Case Data. https://www.cdc.gov/coronavirus/2019-ncov/covid-data/previouscases.html. (CDC, August 27, 2020)
Centers for Disease Control and Prevention (CDC). (2021, May 21).
Interim Estimates of Vaccine Effectivness of Pfizer-BioNTech and
Moderna COVID-19 Vaccines Among Health Care Personnel--33 U.S.
Sites, January-March 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e2.htm. (CDC, May 21, 2021)
Centers for Disease Control and Prevention (CDC). (2021, August 26).
Delta Variant: What We Know About the Science. https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html?s_cid=11512:cdc%20delta%20variant:sem.ga:p:RG:GM:gen:PTN:FY21. (CDC, August 26, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October 4).
SARS-CoV-2 Variant Classifications and Definitions. https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html. (CDC,
October 4, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
DeVito J. (2020, March 12). ``Grant OSHA emergency standard for
COVID-19 to protect frontline workers.'' (DeVito, March 12, 2020)
Doughton S. (2021, February 9). Can a fourth wave of COVID-19 be
prevented? Not likely, says Fred Hutch model--but the curve could be
flattened. The Seattle Times. https://www.seattletimes.com/seattle-news/health/can-a-fourth-wave-of-covid-19-be-prevented-not-likely-says-fred-hutch-model-but-the-curve-could-be-flattened/. (Doughton,
February 9, 2021)
Firozee P and Dupree J. (2021, October 18). Coronavirus numbers are
dropping. More vaccinations can prevent a winter surge, Fauci says.
The Washington Post. https://www.washingtonpost.com/health/2021/10/18/faucis-americans-can-prevent-winter-pandemic-surge/. (Firozee and
Dupree, October 18, 2021)
Florida Executive Order 21-102. (2021, May 3). https://www.flgov.com/wp-content/uploads/orders/2021/EO_21-102.pdf. (Florida
Executive Order 21-102, May 3, 2021)
Food and Drug Administration (FDA) (2021, August 23). FDA Approves
First COVID-19 Vaccine. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine. (FDA, August 23,
2021)
Frosh BE, Becerra X, Weiser PJ, Jennings K, Racine KA, Raoul K.,
Frey AM, Healey M., Nessel D, Ellison K, Ford AD, Grewal GS,
Balderas H, James L, Rosenblum EF, Shapiro J, Neronha P, Herring MP,
Ferguson B, Kaul JL. (2020, May 12).
[[Page 61433]]
``COVID-19 ETS Petition.'' (Frosh et al., May 12, 2020)
League of United Latin American Citizens (LULAC). (2020, March 31).
``COVID-19 ETS Petition.'' (LULAC, March 31, 2020)
Luong M. (2020, April 30). ``Petition for an OSHA Emergency
Temporary Standard for Airborne Infectious Diseases.'' (Luong, April
30, 2020)
Menendez R, Murray P, Baldwin T, Brown S, Duckworth T, Booker CA,
Warren E. (2020). ``Urge DOL to Direct OSHA to Issue Comprehensive
Emergency Temporary Standard (ETS) To Protect Workers Against COVID-
19.'' (Menendez et al., March 9, 2020)
Meuser D. (2020, May 1). ``COVID-19 ETS Petition.'' (Meuser, May 1,
2020)
Moore KA et al. (2020, April 30). COVID-19: The CIDRAP Viewpoint.
Part 1: The Future of the COVID-19 Pandemic: Lessons Learned from
Pandemic Influenza. University of Minnesota Center for Infectious
Disease Research and Policy. https://www.cidrap.umn.edu/sites/default/files/public/downloads/cidrap-covid19-viewpoint-part1_0.pdf.
(Moore et al., April 30, 2020)
Murray E. (2021, October 18). Vermont sets new positive COVID daily
case record as delta surge continues. Burlington Free Press. https://www.burlingtonfreepress.com/story/news/local/2021/10/18/covid-vermont-new-daily-positive-case-record-set/8505021002/. (Murray,
October 18, 2021)
Murray P, Brown S, Heinrich M, Brown S, Blumenthal R., Markey EJ,
Van Hollen C, Durbin RJ, Smith T, Whitehouse S, Wyden R, King Jr.
AS, Kaine T, Reed J, Menedez R, Gillibrand K, Duckworth T, Warren E,
Hassan MW, Casey Jr. RP, Sanders B, Udall T, Hirono MK, Harris KD,
Feinstein D, Klobuchar A, Booker CA, Shaheen J, Cardin B. (2020,
April 29). ``COVID-19 ETS Petition.'' (Murray et al., April 29,
2020)
National Nurses United (NNU). (2020, March 4). ``National Nurses
United Petitions OSHA for an Emergency Temporary Standard on
Emerging Infectious Diseases in Response to COVID-19.'' (NNU, March
4, 2020)
Novoa M. (2020, June 24). ``Direct OSHA to issue an emergency
temporary standard to protect all workers from COVID-19 now!''
(Novoa, June 24, 2020)
Occupational Safety and Health Administration (OSHA). Letter from
Loren Sweatt to Congressman Robert C. ``Bobby'' Scott. (OSHA, March
18, 2020)
ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
Department of Labor--Occupational Safety and Health Administration
(OSHA) for an Emergency Temporary Standard (ETS) for Infectious
Disease.'' (ORCHSE, October 9, 2020)
Owen M. (2020, March 19). ``Grant OSHA emergency standard to protect
frontline workers from COVID-19.'' (Owen, March 19, 2020)
Pellerin C. (2020, March 19). ``Grant OSHA emergency standard to
protect frontline workers from COVID-19.'' (Pellerin, March 19,
2020)
Price D, Pocan M, Schakowsky J, DeLauro RL. (2020, May 1). ``COVID-
19 ETS Petition.'' (Price et al., May 1, 2020)
Public Citizen. (2020, March 13). ``Support for AFL-CIO's Petition
for an OSHA Emergency Temporary Standard for Infectious Disease to
Address the Epidemic of Novel Coronavirus Disease.'' (Public
Citizen, March 13, 2020)
Raskin J. (2020, April 29). ``COVID-19 ETS Petition.'' (Raskin,
April 29, 2020)
Scobie HM et al. (2021, September 17). Monitoring Incidence of
COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination
Status--13 U.S. Jurisdictions, April 4-July 17, 2021. MMWR Morb
Mortal Wkly Rep 2021; 70: early release. https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm. (Scobie et al., September 17, 2021)
Scott RC and Adams AS. (2020, January 30). ``Prioritize OSHA's Work
on Infectious Diseases Standard/Immediate Issue of Temporary
Standard.'' (Scott and Adams, January 30, 2020)
Slotnik D. (2021, October 18). Coronavirus cases rise in the
northern U.S. amid lower temperatures. The New York Times. https://www.nytimes.com/live/2021/10/18/world/covid-delta-variant-vaccine#covid-cases-us-winter. (Slotnik, October 18, 2021)
International Association of Sheet Metal, Air, Rail and
Transportation Workers (SMART). (2020, March 30). ``Petition for
Emergency Standards.'' (SMART, March 30, 2020)
Solt BE. (2020, April 28). ``COVID-19 ETS Petition'' (Solt, April
28, 2020)
Talbott R and Adely R. (2020, May 4). ``Rulemaking Petition to the
United States Department of Labor Occupational Safety and Health
Administration.'' (Talbott and Adely, May 4, 2020)
Texas Executive Order GA-34. (2021, March 2). https://open.texas.gov/uploads/files/organization/opentexas/EO-GA-34-opening-Texas-response-to-COVID-disaster-IMAGE-03-02-2021.pdf.
(Texas Executive Order GA-34, March 2, 2021)
Texas Executive Order GA-40. (2021, October 11). https://gov.texas.gov/uploads/files/press/EO-GA-40_prohibiting_vaccine_mandates_legislative_action_IMAGE_10-11-2021.pdf. (Texas Executive Order GA-40, October 11, 2021)
United Food and Commercial Workers International Union (UFCW) and
American Federation of Labor and Congress of Industrial
Organizations (AFL-CIO). (2021, June 24). ``Petition for Review,
filed with the D.C. Circuit on June 24, 2021.'' (UFCW and AFL-CIO,
June 24, 2021)
Wellington M. (2020, March 12). ``Grant OSHA emergency standard for
COVID-19 to protect front-line workers'' (Wellington, March 12,
2020)
World Health Organization (WHO). (2021, October 12). Tracking SARS-
CoV-2 variants. https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/. (WHO, October 12, 2021)
Yborra G. (2020, March 19). ``Grant OSHA emergency standard to
protect frontline workers from COVID-19.'' (Yborra, March 19, 2020)
II. This ETS Is Necessary To Protect Unvaccinated Employees From Grave
Danger
As explained at length in the preceding section (Grave Danger,
Section III.A. of this preamble), OSHA has determined that most
unvaccinated workers across the U.S. economy are facing a grave danger
posed by the COVID-19 hazard.\17\ This new hazard has taken the lives
of more than 725,000 people--many of them workers--in the United States
since it was first detected in this country in early 2020. As the
federal agency tasked with protecting the safety and health of workers
in the United States, OSHA is required to act when it finds that
workers are exposed to a grave danger. 29 U.S.C. 655(c)(1). OSHA now
finds that this emergency temporary standard is necessary to protect
employees who are unvaccinated. Asbestos Info. Ass'n, 727 F.2d at 423
(``failure to act does not conclusively establish that a situation is
not an emergency . . . [when there is a grave danger to workers,] to
hold that because OSHA did not act previously it cannot do so now only
compounds the consequences of the Agency's failure to act.''). As
explained in detail below, OSHA has determined that vaccination is the
most effective control for abating the grave danger that unvaccinated
employees face from the COVID-19 hazard. And, for workers who are not
vaccinated, the use of testing, face coverings, and removal from the
workplace, while not as effective as vaccination, is still effective
and necessary.
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\17\ As explained in the Grave Danger section, this ETS focuses
on protecting unvaccinated workers from the grave danger that COVID-
19 poses in the workplace. OSHA did not include fully vaccinated
workers in its finding of grave danger because such workers are
generally much better protected from the effects of COVID-19, and,
in particular, the most severe effects, than workers who are
unvaccinated. OSHA's action in adopting this ETS for unvaccinated
workers does not mean that vaccinated workers do not face a
significant risk from COVID-19, or that the OSH Act's general duty
clause poses no obligation on employers to protect their vaccinated
workers from COVID-19. Indeed, symptomatic infections can occur in
fully vaccinated people, and COVID-19 therefore poses at least some
risk to vaccinated workers. OSHA has requested comment on the risks
faced by vaccinated workers from COVID-19, and what additional
measures, if any, should be taken to protect both vaccinated and
unvaccinated workers (see Request for Comments, Section I.B. of this
preamble).
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OSHA has determined that the best method for addressing the grave
danger that COVID-19 poses to unvaccinated workers is to strongly
encourage the use of the single most effective and efficient protection
available: Vaccination. OSHA
[[Page 61434]]
has long recognized the importance of vaccinating workers against
preventable illnesses to which they may be exposed on the job. See 56
FR 64004, 64152 (Dec. 6, 1991) (discussing requirement in Bloodborne
Pathogens standard for employer to make hepatitis B vaccine available
to any employees with occupational exposure to blood and other
potentially infectious materials). As explained in Grave Danger
(Section III.A. of this preamble), COVID-19 vaccines do not completely
eliminate the potential for infection, but significantly reduce the
likelihood of infection, and in turn, transmission of the virus to
others. Data from clinical trials for all three vaccines and
observational studies for the two mRNA vaccines clearly establish that
fully vaccinated persons have a greatly reduced risk of SARS-CoV-2
infection compared to unvaccinated individuals (see FDA, December 11,
2020; FDA, December 18, 2020; FDA, February 26, 2021).
More importantly, vaccination is the single most effective method
for protecting workers from the most serious consequences of a COVID-19
infection: Hospitalization and death. Although symptomatic infections
can occur in fully vaccinated people, they are less likely to occur,
and are far less likely to result in severe health outcomes or death.
As discussed in Grave Danger (Section III.A. of this preamble), studies
have established that the available COVID-19 vaccines are highly
effective at preventing hospitalization, and even more effective at
preventing death. For example, one study found that unvaccinated adults
age 18 to 49 were 15.2 times more likely to be hospitalized and 17.2
times more likely to die of COVID-19 than fully vaccinated people in
the same age range, and unvaccinated adults age 50 to 64 were 10.9
times more likely to be hospitalized and 17.9 times more likely to die
than their fully vaccinated peers (Scobie et al., September 17, 2021).
The New York Times reported on October 1, 2021, that of the
approximately 100,000 individuals who died of COVID-19 since mid-June
2021, less than 3% had been identified by the CDC as vaccinated
individuals (Boseman and Leatherby, October 1, 2021).
Vaccines are also uniquely effective when compared to non-
pharmaceutical methods for controlling exposure to COVID-19 at the
workplace. To be sure, non-pharmaceutical controls play an important
role in employers' efforts to prevent exposure to the virus; as
discussed in detail earlier, OSHA has, throughout the pandemic, advised
employers to implement various administrative, engineering, and other
controls to reduce workplace exposure to the virus. And, for certain
work settings in the healthcare industry where people with COVID-19 are
reasonably expected to be present, OSHA both encouraged vaccination and
mandated a suite of protections, many of which involve physical
controls (see 29 CFR 1910.502). Indeed, workers who work indoors and
near others are best protected from COVID-19 when they are fully
vaccinated and their exposure to COVID-19 is reduced (to the extent
possible) by non-pharmaceutical controls.
Non-pharmaceutical controls, however, focus on preventing employee
exposure to the virus, and do not directly affect an employee's immune
response if exposure to the virus does occur. Additionally, non-
pharmaceutical controls often rely on the actions of individuals and/or
the integrity of equipment to be effective; for example, to use PPE to
control exposure, a worker must correctly don appropriate PPE each time
there is potential exposure, must properly clean, store, and maintain
the PPE between uses, and must replace the PPE when it is no longer
effective (see, e.g., 29 CFR 1910.132 (general PPE requirements in
general industry workplaces)). Accordingly, OSHA standards have always
followed the principle of the hierarchy of controls, under which
employers must control hazards by means other than PPE whenever
feasible, and PPE is a supplementary control. See e.g., 29 CFR
1910.134(a); 29 CFR 1910.1030(d)(2).
Physical distancing requires workers to maintain constant awareness
of their environment in order to avoid coming into close proximity with
colleagues, customers, or other individuals, even though the realities
of their jobs and/or the design of the workplace may be unaccommodating
to that effort. Requiring employees to examine themselves for signs and
symptoms consistent with SARS-CoV-2 infection before reporting to work
is prone to human error and entirely ineffective when the employee is
infected but asymptomatic or pre-symptomatic.
In contrast, a worker is considered fully vaccinated after
completing primary vaccination with a COVID-19 vaccine, or the second
dose of any combination of two doses of a COVID-19 vaccine that is
approved, authorized, or listed as a two-dose primary vaccination by
the FDA or WHO (see the Summary and Explanation for paragraph (c),
Section VI.C. of this preamble). Once fully vaccinated, a worker enjoys
automatic and long-lasting benefits; namely, a drastic reduction in the
risk of severe health effects or death. The vaccine works by bolstering
the worker's immune system and does not depend on the worker's acumen
or actions to afford its protection. Moreover, where an employer
implements one or more non-pharmaceutical controls at the workplace,
vaccination provides workers with a backstop of protection that greatly
reduces their risk of serious health effects if they are exposed to the
virus despite the presence of other controls. Vaccination thus ensures
that workers need not rely on other factors, be it the workplace
environment, the effectiveness of equipment, or the actions of other
individuals, to be substantially protected from the worst potential
outcomes of a COVID-19 infection.
This ETS focuses on encouraging vaccination because it is the most
efficient and effective method for addressing the grave danger.
Vaccination is patently appropriate and feasible for almost every
worker in all industries, and will drastically reduce the risk that
unvaccinated workers will suffer the serious health outcomes associated
with SARS-CoV-2 infection. As described in Section III.A. of this
preamble (Grave Danger), employees who are unvaccinated are in grave
danger from the SARS-CoV-2 virus, but employees who are fully
vaccinated are not. Since it is the lack of vaccination that results in
grave danger, vaccination will best allay the grave danger. This ETS,
which is designed to strongly encourage vaccination, is thus
``necessary to protect employees'' from a grave danger. 29 U.S.C.
655(c).
OSHA continues to encourage employers to implement additional
controls that may be appropriate to eliminate exposure to the SARS-CoV-
2 virus at their workplace, but, as discussed further below, OSHA has
not required employers to implement a comprehensive and multilayered
set of COVID-19 exposure controls in this ETS. This decision reflects
the extraordinary and exigent circumstances have required OSHA to
immediately promulgate this emergency temporary standard. Although OSHA
was able to design a comprehensive infection prevention program for the
specific healthcare settings to which the June 2021 Healthcare ETS
applied, this rule encompasses all industries covered by the OSH Act,
and targets unvaccinated workers in any indoor work setting not covered
by the Healthcare ETS where more than one person is present. Crafting a
multi-layered standard that is comprehensive and feasible for all
[[Page 61435]]
covered work settings, including mixed settings of vaccinated and
unvaccinated workers, is an extraordinarily challenging and complicated
undertaking, yet the grave danger that COVID-19 poses to unvaccinated
workers obliges the agency to act as quickly possible. As discussed
above, OSHA has identified vaccination as the single most efficient and
effective means for removing an unvaccinated worker from the grave
danger.
Given the urgency of the rulemaking, and the singular effectiveness
of vaccination in removing unvaccinated workers from the grave danger,
OSHA is promulgating this ETS to immediately address the grave danger
that COVID-19 poses to unvaccinated workers by strongly encouraging
vaccination. As discussed in Pertinent Legal Authority (Section II. of
this preamble), a ``grave danger'' represents a risk greater than the
``significant risk'' that OSHA must show in order to promulgate a
permanent standard under section 6(b) of the OSH Act, 29 U.S.C. 655(b).
OSHA will consider whether it is necessary to require additional
controls to avert a significant risk of harm in the rulemaking
proceedings that follow this ETS. OSHA directs employers to its
website, www.osha.gov/coronavirus, and the CDC's website, www.cdc.gov/coronavirus, for guidance on the engineering, administrative, and other
exposure controls that may be effective and appropriate for their
workplace.
OSHA expects that, by strongly encouraging vaccination, this ETS
will have a positive impact on worker health. As discussed above,
millions of workers remain unvaccinated and are presently exposed to
risks of hospitalization and death many times higher than their
vaccinated coworkers. Although predicting the health impact of this ETS
is particularly challenging, given the ever-changing nature of the
pandemic and the many factors that may motivate workers to become fully
vaccinated, OSHA has attempted to quantify the potential number of
hospitalizations and fatalities that this ETS could avert by increasing
workforce vaccination rates (see OSHA, October 2021c). OSHA has
estimated that, as a result of the ETS, over 6,500 fewer currently
unvaccinated workers will die from COVID-19 over the next six months.
OSHA also estimates that this ETS will prevent over 250,000 currently
unvaccinated workers from being hospitalized during that same time
period. Even if OSHA's estimate does not prove to be precisely
accurate, OSHA is confident that this ETS will save hundreds of lives
and prevent thousands of workers from becoming severely ill.
a. OSHA Finds It Necessary To Strongly Encourage Vaccination
Despite the proven safety and efficacy of the available COVID-19
vaccines, many workers remain unvaccinated and are currently exposed to
a grave danger. As discussed in Grave Danger (Section III.A. of this
preamble), countless COVID-19 outbreaks have occurred in myriad work
settings where employees come into contact with others, and in recent
weeks, the majority of states in the U.S. have experienced what CDC
defines as high or substantial community transmission, indicating that
there is a clear risk of the virus being introduced into and
circulating in workplaces (CDC, October 18, 2021--Community
Transmission Rates). As of October 18, 2021, more than 184 million
people in the United States have been fully vaccinated, but only 68.5%
of people ages 18 years or older are fully vaccinated (CDC, October 18,
2021--Fully Vaccinated). OSHA has estimated that approximately 62.4%
percent of adults aged 18-74 within the scope of this ETS are either
fully vaccinated or received their first vaccine dose during the
previous two weeks, leaving approximately 31.7 million unvaccinated
(i.e., not fully vaccinated and did not receive a first dose with in
the past two weeks) (see Economic Analysis, Section IV.B. of this
preamble, Table IV.B.7). Meanwhile, the rate of new vaccinations has
slowed considerably; on October 15, 2021, the 7-day moving average
number of administered vaccine doses reported to the CDC per day was
841,731 doses, a steep reduction from the peak 3,448,156 dose average
that the CDC reported on April 11, 2021 (CDC, October 18, 2021--Weekly
Review).
Given the pervasiveness of the virus in workplaces across the
country and the unparalleled efficacy of vaccines at preventing serious
health effects, OSHA finds it necessary to strongly encourage
vaccination. Encouraging vaccination is principally necessary to reduce
the likelihood that workers who are infected by the SARS-CoV-2 virus
will suffer the worst outcomes of an infection (hospitalization and
death). Put simply, the single best method for protecting an
unvaccinated worker from the serious health consequences of a COVID-19
infection is for that worker to become fully vaccinated.
Additionally, encouraging vaccination is necessary to reduce the
overall prevalence of the SARS-CoV-2 virus at workplaces. Because
vaccinated workers are less likely than unvaccinated workers to be
infected by the virus, they are less likely to spread the virus to
others at their workplace, including to unvaccinated coworkers.
Increasing workforce vaccination rates will therefore reduce the risk
that unvaccinated workers will be infected by a coworker.
Evidence shows that mandating vaccination has proven to be an
effective method for increasing vaccination rates, and that vaccination
mandates have generally been more effective than merely encouraging
vaccination. Significant numbers of workers would get vaccinated if
their employers required it, and many workers who were vaccinated over
the last four months were motivated by their employer requiring
vaccination. The Kaiser Family Foundation (KFF) vaccine monitor, an
ongoing research project tracking the public's attitudes and
experiences with COVID-19 vaccinations, conducted a survey from
September 13 to September 22, 2021, among a nationally representative
random digit dial telephone sample of 1,519 adults ages 18 and older,
and found that those who received their first dose of a COVID-19
vaccine after June 1, 2021 were motivated by mandates of various sorts,
including one in five (19%) who say a major reason was that their
employer required it (KFF, September 2021). A survey conducted by
Change Research from August 30 to September 2, 2021 regarding
Americans' views on COVID-19 vaccines found that among the 1,775
respondents, ``one of the things that was most likely to lead someone
to get vaccinated was if their employer required it'' (Towey, September
27, 2021).
Vaccine mandates imposed by state governments and large employers
have also demonstrated the effectiveness of mandates in increasing
vaccination rates. For example, when Tyson Foods announced its
vaccination requirement in early August 2021, only 45% of its workforce
had received a vaccination dose, but as of September 30, 2021, the New
York Times reported that has increased to 91% (White House, October 7,
2021; Hirsch, September 30, 2021). Similarly, United Airlines reported
that 97% of its U.S.-based employees were fully vaccinated against
COVID-19 within a week of the deadline of the company's vaccination
mandate, and the 3% who were not fully vaccinated included several
employees who sought a medical or religious exemption from vaccination
(The Associated Press, September 22, 2021). In Washington State, the
weekly vaccination rate increased 34% after the Governor announced
vaccine requirements for
[[Page 61436]]
state workers (White House, October 7, 2021). The success of these
COVID-19 vaccination mandates comports with the National Safety
Council's recent finding that employers that instituted a COVID-19
vaccination mandate produced a 35% increase in employee vaccination
(NSC, September 2021). Similarly, the White House recently reported
that its analysis of vaccination requirements imposed by healthcare
systems, educational institutions, public-sector agencies, and private
businesses demonstrated that such requirements increased their
vaccination rates by more than 20 percentage points and have routinely
seen their share of fully vaccinated workers rise above 90 percent
(White House, October 7, 2021).
Given the effectiveness of vaccination mandates in increasing
vaccination rates, OSHA expects that, in most instances, an employer
implementing a policy that requires all employees to be vaccinated will
be the most effective approach for increasing the vaccination rate of
its employees and ensuring that they have the best protection available
against the worst consequences of a COVID-19 infection. Although OSHA
may well have the authority to impose a vaccination mandate, OSHA has
decided against pursuing strict vaccination requirement and has instead
crafted the ETS to strongly encourage vaccination. Employers are in the
best position to understand their workforces and the approach that will
work most effectively with them to secure employee cooperation and
protection. OSHA's traditional practice when including medical
procedures, such as medical surveillance testing and vaccinations, in
its health standards has been to require the employer to make the
medical procedure available to employees, and has viewed mandating
those procedures as a measure to avoid if possible. For example, when
the agency promulgated its standard regulating occupational exposure to
lead, OSHA considered mandating that employees participate in physical
examinations and biological monitoring, but ultimately required
employers to make them available to employees (see 43 FR 54354, 54450
(Nov. 21, 1978)). OSHA decided against mandating those procedures in
part because it believed a voluntary approach would elicit more
effective employee participation in the medical program and in part
because of the agency's concerns about the Government intruding into a
private and sensitive area of workers' lives (43 FR at 54450-51). OSHA
has followed that same approach of requiring employers to ``provide''
or ``make available'' medical procedures to employees in numerous
subsequent standards, such as the standards for asbestos (29 CFR
1910.1001), benzene (1910.1028), cotton dust (1910.1043), and
formaldehyde (1910.1048).
OSHA adhered to this approach when it promulgated the Bloodborne
Pathogens standard. The agency considered mandating a Hepatitis B
vaccination, but instead required employers to make the Hepatitis B
vaccination available to employees. 56 FR 64004, 64155 (Dec. 6, 1991);
29 CFR 1910.1030(f)(1)(i), (f)(2)(i). OSHA explained that the agency
may have the legal authority to mandate vaccination, but believed that,
under the circumstances, a voluntary vaccination program would ``foster
greater employee cooperation and trust in the system'' and ``enhance [
] compliance while respecting individuals' beliefs and rights to
privacy.'' 56 FR at 64155.
In keeping with this traditional practice, the agency has stopped
short of including a strict vaccination mandate with no alternative
compliance option in this ETS. OSHA has never done so, and if it were
to take that step, OSHA believes it more prudent to do so where the
agency has ample time to fully assess the potential ramifications of
imposing a vaccination mandate on covered employers and employees.
Here, exigent circumstances demand that OSHA take immediate action to
protect workers from the grave danger posed by COVID-19, but OSHA has
not had a full opportunity to study the potential spectrum of impacts
on employers and employees, including the economic and health impacts,
that would occur if OSHA imposed a strict vaccination mandate with no
alternative compliance option. Moreover, employers in their unique
workplace settings may be best situated to understand their workforce
and the strategies that will maximize worker protection while
minimizing workplace disruptions. These considerations persuade the
agency that this ETS should afford employers some flexibility in the
form of an alternative option to strictly mandating vaccination. In
light of the unique and grave danger posed by COVID-19, OSHA has
requested comment on whether a strict vaccination mandate is warranted
and the agency will consider all the information it receives as it
determines how to proceed with this rulemaking (see Request for
Comment, Section I.B. of this preamble).
Although this ETS does not impose a strict vaccination mandate,
OSHA has determined that, to adequately address the grave danger that
COVID-19 poses to unvaccinated workers, a more proactive approach is
necessary than simply requiring employers to make vaccination available
to employees. None of the standards that OSHA promulgated prior to this
year concerned an infectious agent as readily transmissible as COVID-
19. Standards like the Lead standard do not concern infectious agents
that can be transmitted between individuals at a workplace;
accordingly, the medical procedures that employers are required to make
available under those standards are solely aimed at protecting the
health of the worker who is undergoing the procedure. The Bloodborne
Pathogens standard concerned exposure to infectious biological agents
(Hepatitis B and HIV) that can be transmitted between individuals, but
the potential for those agents to be transmitted between workers is
minimal in comparison to the SARS-CoV-2 virus; Hepatitis B and HIV are
transmitted through blood and certain body fluids, whereas the SARS-
CoV-2 virus spreads through respiratory droplets that can travel
through the air from worker-to-worker (see Grave Danger, Section III.A.
of this preamble). Vaccination against COVID-19 is thus particularly
important in reducing the potential for workers to become infected and
spread the virus to others at the workplace, in addition to protecting
the worker from severe health outcomes if they are infected. Moreover,
the ease with which the SARS-CoV-2 virus spreads between workers makes
it more urgent for workers to be vaccinated, and this urgency
contributes to the agency's decision to strongly encourage vaccination.
Accordingly, to further the goal of increasing workforce
vaccination rates, this ETS requires employers to implement a mandatory
vaccination policy unless they adopt a policy in which employees may
either be fully vaccinated or regularly tested for COVID-19 and wear a
face covering in most situations when they work near other individuals.
Employers have the duty under the OSH Act to provide safe workplaces to
their employees, including protecting employees from known hazards by
complying with occupational safety and health standards (see 29 U.S.C.
654), and this ETS therefore provides employers with two compliance
options for protecting unvaccinated workers from the grave danger posed
by COVID-19. But while this ETS offers employers a choice in how to
comply, OSHA has presented implementation of a vaccination mandate as
the preferred compliance
[[Page 61437]]
option; as discussed above, vaccine mandates have proven to be
effective in increasing vaccination rates, and OSHA expects that, in
most instances, implementing a vaccination mandate will be the most
effective method for increasing a workforce's vaccination rate. As
discussed below, OSHA also recognizes that requiring that all employees
be vaccinated provides more protection to vaccinated workers than
regularly testing unvaccinated workers for COVID-19 and requiring them
to wear face coverings when they work near others. This ETS will
preempt inconsistent state and local requirements, including
requirements that ban or limit employers' authority to require
vaccination (see the Summary and Explanation for paragraph (a), Section
VI.A. of this preamble), and will therefore provide the necessary legal
authorization to covered employers to implement mandatory vaccination
policies, if they choose to comply in this preferred manner.
Although the ETS does not require all covered employers to
implement a mandatory vaccination policy, OSHA expects that employers
that choose that compliance option will enjoy advantages that employers
that opt out of the vaccination mandate option will not. Most
obviously, employers with a mandatory vaccination policy will enjoy a
dramatically reduced risk that their employees will become severely ill
or die of a COVID-19 infection. In addition, employers who implement a
vaccination mandate will likely have fewer workers temporarily removed
from the workplace due to a COVID-19 positive test; this rule requires
all covered employers to remove from the workplace any employee who
tests positive for COVID-19 or receives a diagnosis of COVID-19 (see
the Summary and Explanation for paragraph (h), Section VI.H. of this
preamble), and because vaccinated workers are less likely than
unvaccinated workers to be infected by the virus, OSHA expects
employers with a mandatory vaccination policy will be statistically
less likely to be obliged to remove a COVID-positive employee from the
workplace in accordance with paragraph (h)(2). Additionally, only
employers who decline to implement a mandatory vaccination program are
required by the rule to assume the administrative burden necessary to
ensure that unvaccinated workers are regularly tested for COVID-19 and
wear face coverings when they work near others.
Where employers opt out of implementing a mandatory vaccination
program, the ETS encourages employees to elect to be fully vaccinated.
As discussed in the Summary and Explanation for paragraph (f) (Section
VI.F. of this preamble), the ETS requires all covered employers to
support vaccination by providing employees with reasonable time,
including up to four hours of paid time, to receive each vaccination
dose, and reasonable time and paid sick leave to recover from
vaccination side effects. Many workers have been deterred from
receiving vaccination by fears of missing work and/or losing pay to
obtain vaccination and/or recover from side effects (see Section VI.F.
of this preamble; see, e.g., KFF, May 6, 2021; KFF, May 17, 2021), and
OSHA finds that this employer support is necessary to ensure that
employees can become fully vaccinated without concern that they will be
sacrificing pay or their jobs to do so.
All covered employers are required by the ETS to bear the cost of
providing up to four hours of paid time and reasonable paid sick leave
needed to support vaccination, but where an employee chooses to remain
unvaccinated, the ETS does not require employers to pay for the costs
associated with regular COVID-19 testing or the use of face coverings
(see the Summary and Explanation for paragraphs (g) and (i), Sections
VI.G. and VI.I. of this preamble). In some cases, employers may be
required to pay testing and/or face covering costs under other federal
or state laws or collective bargaining obligations, and some may choose
to do so even without such a mandate, but otherwise employees will be
required to bear the costs if they choose to be regularly tested and
wear a face covering in lieu of vaccination.
This ETS more strongly encourages vaccination than the June 2021
Healthcare ETS. OSHA designed the Healthcare ETS, which addresses the
grave danger that COVID-19 poses workers in specific health care
settings where COVID-19-positive individuals are reasonably likely to
be present, to encourage vaccination (see 86 FR at 32415, 32423, 32565,
32597). Specifically, the Healthcare ETS encourages vaccination by
requiring employers to provide employees reasonable and paid time to
receive vaccination doses and recover from side effects (29 CFR
1910.502(m)), and by exempting from its scope ``well-defined hospital
ambulatory care settings where all employees are fully vaccinated'' and
all non-employees are screened and denied entry if they are suspected
or confirmed to have COVID-19 (1910.502(a)(2)(iv)) and ``home
healthcare settings where all employees are fully vaccinated'' and all
nonemployees at that location are screened prior to employee entry so
that people with suspected or confirmed COVID-19 are not present
(1910.502 (a)(2)(v)).
Similar to the Healthcare ETS, this ETS requires employers to
support vaccination by providing employees with reasonable time,
including up to four hours of paid time, to receive vaccination, and
reasonable time and paid sick leave to recover from vaccination side
effects (see discussion above and the Summary and Explanation for
paragraph (f), Section VI.F. of this preamble). However, as discussed
above, this ETS goes further and expressly requires the implementation
of a mandatory vaccination policy, unless the employer implements an
alternative policy that requires unvaccinated workers to be regularly
tested for COVID-19 and to wear face coverings in most situations when
they work near others. While nothing in the Healthcare ETS prohibits
covered employers from implementing a mandatory vaccination policy,
this ETS presents the implementation of a mandatory vaccination policy
as a preferred compliance option, and will preempt inconsistent state
and local requirements that ban or limit employers' authority to
require vaccination. Additionally, where the employer opts out of
implementing a mandatory vaccination policy, and the employee opts out
of vaccination, this ETS places no obligation on the employer to pay
for costs associated with the regular testing of unvaccinated workers
for COVID-19 or their use of face coverings, which will provide a
financial incentive for some employees to be fully vaccinated.
OSHA finds it necessary to more strongly encourage vaccination in
this ETS than in the Healthcare ETS in the manner described above. The
Healthcare ETS's provisions that encouraged vaccination were packaged
with a comprehensive infection prevention program that was tailored to
the specific healthcare work settings to which the ETS applied,
including a suite of layered and overlapping controls. In contrast,
OSHA is promulgating this ETS to address the grave danger that COVID-19
now poses to all unvaccinated workers who work indoors and in the
presence of others. As mentioned above, crafting a comprehensive and
multi-layered standard that is comprehensive and feasible for the
myriad work settings to which this ETS will apply, including workplaces
as diverse as schools, restaurants, retail settings, offices, prisons,
and factories, is an
[[Page 61438]]
extraordinarily challenging and complicated undertaking.
Exigent circumstances require OSHA to immediately promulgate this
ETS to protect unvaccinated workers, and vaccination is the single most
efficient and effective method for removing unvaccinated workers from
the grave danger. Given the urgency of the rulemaking and the singular
efficacy of vaccination, OSHA has decided against including
comprehensive and multilayered exposure controls in this ETS, and is
instead focusing the ETS on strongly encouraging vaccination. Strongly
encouraging vaccination is thus critical to the effectiveness of this
ETS at protecting unvaccinated workers from the grave danger. In
Request for Comment (Section I.B. of this preamble), OSHA seeks
information on what additional measures, if any, should be required to
protect employees against COVID-19.
Moreover, stronger encouragement of vaccination is needed in this
ETS than in the Healthcare ETS because workers who are protected by the
Healthcare ETS are more likely to be vaccinated and/or subject to a
vaccination mandate. The Healthcare ETS, 29 CFR 1910.502, focused on
healthcare work settings where COVID-19 is reasonably expected to be
present, and, this ETS does not apply in settings where any employee
provides healthcare services or healthcare support services while they
are covered by the requirements of 29 CFR 1910.502 (see the Summary and
Explanation for paragraph (b), Section VI.B. of this preamble).
Evidence shows that workers in settings covered by Sec. 1910.502
already have a high rate of vaccination. As of July 2021, healthcare
workers had a higher rate of vaccination than non-healthcare workers
(Lazer et al., August, 2021), and many healthcare workers are currently
subject to vaccination mandates. Twenty-two states and the District of
Columbia have instituted vaccination mandates that are applicable to
healthcare workers (NASHP, October 1, 2021), and nearly 300 hospitals
and broader health systems have implemented vaccine mandates for their
employees (Renton et al., October 14, 2021). The White House reported
that almost 2,500 hospitals, 40% of all U.S. hospitals, across all 50
states, the District of Columbia, and Puerto Rico, have announced
vaccination requirements for their workforce, and noted numerous
examples of highly successful mandates in those workplaces (White
House, October 7, 2021). News reports attest that many of these
vaccination mandates have had great success in increasing the
vaccination rate of the targeted healthcare workers (Goldberg, July 9,
2021; Otterman and Goldstein, September 28, 2021; Hubler, September 30,
2021; Beer, October 4, 2021). Even more healthcare workers covered by
29 CFR 1910.502 will be subject to a vaccination mandate under the
Centers for Medicare & Medicaid Services (CMS) rule published elsewhere
in this issue of the Federal Register that requires COVID-19
vaccinations for workers in most healthcare settings that receive
Medicare or Medicaid reimbursement, including but not limited to
hospitals, dialysis facilities, ambulatory surgical settings, and home
health agencies. This CMS rule applies to at least 76,000 providers
(i.e., employers) and covers a majority of healthcare workers across
the country. OSHA expects that the combination of incentives to
vaccination in the Healthcare ETS and vaccination mandates applicable
to healthcare workers will leave few healthcare workers within the
scope of the Healthcare ETS unvaccinated.
b. Unvaccinated Workers Must Be Regularly Tested for COVID-19 and Use
Face Coverings
As discussed above, this ETS presumptively requires employers to
implement a mandatory vaccination policy, but permits employers to opt
out of that requirement. Nonetheless, the grave danger that COVID-19
poses to unvaccinated workers demands that alternative protective
measures be taken at workplaces where the employer does not implement a
mandatory vaccination policy. Given that the SARS-CoV-2 virus is highly
contagious, transmitted easily through the air, and can lead to severe
and/or fatal outcomes in unvaccinated workers, it is critical that
employers who do not require their employees to be vaccinated implement
controls to mitigate the potential for COVID-19 outbreaks to occur. As
discussed above, and in Grave Danger (Section III.A. of this preamble),
unvaccinated workers are more likely than vaccinated workers to be
infected with COVID-19 and transmit the virus to others, and thus pose
a heightened risk of spreading the virus at the workplace, including to
other unvaccinated workers.
To reduce the risk that unvaccinated workers will spread COVID-19
at the workplace, this rule requires employers that do not implement a
mandatory vaccination policy to ensure that unvaccinated workers who
report to a workplace where others are present are tested at least once
a week for COVID-19. As discussed in the Summary and Explanation for
paragraph (g) (Section VI.G. of this preamble), it is well-established
that, by identifying and isolating infected individuals, regularly
testing individuals for COVID-19 infection can be an effective method
for reducing virus transmission. Regularly testing unvaccinated workers
is essential because SARS-CoV-2 infection is often attributable to
asymptomatic or presymptomatic transmission (Bender et al., February
18, 2021; Byambasuren et al., December 11, 2020; Johansson et al.,
January 7, 2021; Klompas et al., September 2021). In accordance with
the CDC's recommendations, OSHA has set the minimum frequency of
testing at 7 days because the agency expects that it will be effective
in slowing the spread of COVID-19, while taking into account associated
cost considerations (see the Summary and Explanation for paragraph (g),
Section VI.G. of this preamble). As noted in the Request for Comment
(Section I.B. of this preamble), OSHA is gathering additional
information about whether OSHA should require testing more often than
on a weekly basis.
The requirement for unvaccinated workers to be regularly tested for
COVID-19 operates in tandem with paragraph (h)(2), which requires that
all employers remove from the workplace any employee who receives a
positive COVID-19 test, or a COVID-19 diagnosis (see the Summary and
Explanation for paragraph (h), Section VI.H. of this preamble).
Paragraph (h)(2) ensures that the COVID-19-positive employee will be
isolated from the workplace until it is safe for the employee to
return, and also allows the employee to seek medical care sooner and
reduce the likelihood that they will suffer the most severe
consequences of an infection (e.g., by seeking monoclonal antibody
treatment). The combination of the testing and medical removal
provisions will reduce the likelihood that an unvaccinated worker who
has been infected with COVID-19, including those who are not
experiencing symptoms of infection, will be permitted to spread the
virus to others at the workplace, including unvaccinated coworkers.
Additionally, OSHA finds it necessary to require employers that do
not implement a mandatory vaccination policy to ensure that
unvaccinated workers wear face coverings in most situations when they
are working near others. This reflects OSHA's recognition that
regularly testing unvaccinated workers for COVID-19 will not be 100%
effective in identifying infected workers before they enter the
workplace. Most obviously, testing employees once a week will not
prevent an unvaccinated
[[Page 61439]]
worker from exposing others at the workplace if the worker becomes
infected and reports to the workplace in between their weekly tests.
And, even if the rule required unvaccinated workers to be tested more
frequently than once a week, infected persons may still be missed,
particularly in areas with high community spread (Chin et al.,
September 9, 2020).
Accordingly, requiring unvaccinated workers to wear face coverings
in most situations when they are working near others will further
mitigate the potential for unvaccinated workers to spread the virus at
the workplace. As discussed in the Summary and Explanation for
paragraph (i) (Section VI.I. of this preamble), it is well-established
that face coverings provide effective source control; that is, they
largely prevent respiratory droplets emitted by the wearer of the face
covering from spreading to others, and thus make it significantly less
likely that the person wearing the mask will transmit the virus, if
they are infected. Face coverings are also believed to provide the
wearer some limited protection from exposure to the respiratory
droplets of co-workers and others (e.g., customers) (CDC, May 7, 2021),
but the principal benefit of face coverings is to significantly reduce
the wearer's ability to spread the virus. By requiring unvaccinated
workers to wear face coverings, this rule significantly reduces the
likelihood that an infected unvaccinated worker who enters the
workplace despite the testing requirements will spread the virus to
others, including unvaccinated coworkers.
OSHA acknowledges that regularly testing unvaccinated workers for
COVID-19 and requiring them to wear face coverings when they work near
others is less protective of unvaccinated workers than simply requiring
all workers to be vaccinated. To be sure, OSHA strongly prefers that
employers adopt a mandatory vaccination policy, as vaccination is
singularly effective at protecting workers from the severe consequences
that can result from a COVID-19 infection. And, where employers do not
adopt a mandatory vaccination policy, employers may also consider
alternative feasible measures that would remove employees who remain
unvaccinated from the scope of this ETS, such as increasing telework
(see the Summary and Explanation for paragraph (b), Section VI.B. of
this preamble). Nonetheless, as discussed above, OSHA has not imposed a
strict vaccination mandate on all covered employees who work in the
presence of others and not exclusively outdoors, given that the agency
has never previously used its authority to strictly mandate
vaccination, and the exigent and extraordinary circumstances driving
this emergency rulemaking have not afforded OSHA a full opportunity to
assess the potential ramifications of including a strict vaccination
mandate in this rule. Given these circumstances, and employers' unique
understanding of the compliance approaches that will best increase
vaccination rates among their workforce, OSHA has designed a rule that
preserves a limited degree of employer flexibility, and strongly
encourages, but does not strictly require, vaccination. OSHA has
requested comment in this ETS on whether a strict vaccination mandate
would be appropriate and the agency will consider those comments as it
determines how to proceed with this rulemaking.
References
Beer T. (2021, October 4). COVID-19 Vaccine Mandates Are Working--
Here's The Proof. Forbes. https://www.forbes.com/sites/tommybeer/2021/10/04/covid-19-vaccine-mandates-are-working-heres-the-proof/?sh=1a08d2e72305. (Beer, October 4, 2021)
Bender JK et al. (2021, February 18). Analysis of asymptomatic and
presymptomatic transmission in SARS-CoV-2 outbreak, Germany, 2020.
Emerging Infectious Diseases. 27(4). https://doi.org/10.3201/eid2704.204576. (Bender et al., February 18, 2021)
Boseman J and Leatherby L. (2021, October 1). U.S. Coronavirus Death
Toll Surpasses 700,000 Despite Wide Availability of Vaccines. The
New York Times. https://www.nytimes.com/2021/10/01/us/us-covid-deaths-700k.html. (Boseman and Leatherby, October 1, 2021)
Byambasuren O et al., (2020, December 11). Estimating the extent of
asymptomatic COVID-19 and its potential for community transmission:
Systematic review and meta-analysis. Official Journal of the
Association of Medical Microbiology and Infectious Disease Canada.
5(4): 223-234 doi:10.3138/jammi-2020-0030. (Byambasuren et al.,
December 11, 2020)
Centers for Disease Control and Prevention (CDC). (2021, May 7).
Science brief: Community use of cloth masks to control the spread of
SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/masking-science-SARS-cov2.html. (CDC, May 7, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
Chin E et al. (2020, September 9). Frequency of routine testing for
COVID-19 in high-risk healthcare environments to reduce outbreaks.
https://doi.org/10.1101/2020.04.30.20087015. (Chin et al., September
9, 2020)
Food and Drug Administration (FDA). (2020, December 11). Emergency
use authorization for an unapproved product review memorandum
(Pfizer-BioNTech COVID-19 vaccine/BNT 162b2 mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. (FDA, December 11,
2020)
Food and Drug Administration (FDA). (2020, December 18). Emergency
use authorization for an unapproved product review memorandum
(Moderna COVID-19 vaccine/mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine. (FDA, December 18, 2020)
Food and Drug Administration (FDA). (2021, February 26). Janssen
COVID-19 vaccine. Vaccines and Related Biological Products Advisory
Committee February 26, 2021 Meeting Briefing Document. https://www.fda.gov/media/146219/download. (FDA, February 26, 2021)
Goldberg C. (2021, July 9). Hospital Vaccine Mandates Suggest
Success in Boosting U.S. Shots. Bloomberg News. https://www.bloomberg.com/news/articles/2021-07-09/early-mandates-boost-worker-vaccine-rates-prompt-few-to-quit. (Goldberg, July 9, 2021)
Hirsch L. (2021, September 30). After Mandate, 91% of Tyson Workers
Are Vaccinated. https://www.nytimes.com/2021/09/30/business/tyson-foods-vaccination-mandate-rate.html. (Hirsch, September 30, 2021)
Hubler S. (2021, September 30). `Mandates Are Working': Employer
Ultimatums Life Vaccination Rates, So Far. The New York Times.
https://www.nytimes.com/2021/09/30/us/california-vaccine-mandate-health-care.html. (Hubler, September 30, 2021)
Johansson MA et al., (2021, January 7). SARS-CoV-2 transmission from
people without COVID-19 symptoms. JAMA Network Open. 4(1): e2035057.
doi:10.1001/jamanetworkopen.2020.35057. (Johansson et al., January
7, 2021)
Kaiser Family Foundation (KFF). (2021, May 6). KFF COVID-19 Vaccine
Monitor: April 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/. (KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May 17). How employer actions
could facilitate equity in COVID-19 vaccinations. https://www.kff.org/policy-watch/how-employer-actions-could-facilitate-equity-in-covid-19-vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021, September). Does The Public
Want To Get A COVID-19 Vaccine? When? https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/?utm_source=web&utm_medium=trending&utm_campaign=COVID-19-vaccine-monitor#messagesandinformation. (KFF, September 2021)
[[Page 61440]]
Klompas M et al. (2021, September). The case for mandating COVID-19
vaccines for health care workers. Annals of Internal Medicine.
https://doi.org/10.7326/M21-2366. (Klompas et al., September 2021)
Lazer D et al. (2021, August). The COVID States Project: A 50-State
COVID-19 Survey Report #62: COVID-19 Vaccine Attitudes Among
Healthcare Workers. https://news.northeastern.edu/uploads/COVID19%20CONSORTIUM%20REPORT%2062%20HCW%20August%202021.pdf. (Lazer
et al., August, 2021)
National Academy for State Health Policy (NASHP). (2021, October 1).
State Efforts to Ban or Enforce COVID-19 Vaccine Mandates and
Passports. https://www.nashp.org/state-lawmakers-submit-bills-to-ban-employer-vaccine-mandates/. (NASHP, October 1, 2021)
National Safety Council (NSC). (2021, September). A Year in Review,
and What's Next: COVID-19 Employer Approaches and Worker
Experiences. https://www.nsc.org/faforms/safer-year-one-final-report. (NSC, September 2021)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
Otterman S and Goldstein J. (2021, September 28). Thousands of N.Y.
Health Care Workers Get Vaccinated Ahead of Deadline. The New York
Times. https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html. (Otterman and Goldstein, September 28,
2021)
Renton B et al. (2021, October 14). New: Hospital Vaccine Mandate
Tracker. Global Epidemics, Brown School of Public Health. https://globalepidemics.org/2021/07/24/new-hospital-vaccine-mandate-tracker/
. (Renton et al., October 14, 2021)
Scobie HM et al. (2021, September 17). Monitoring Incidence of
COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination
Status--13 U.S. Jurisdictions, April 4-July 17, 2021. MMWR Morb
Mortal Wkly Rep 2021; 70: early release. https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm. (Scobie et al., September 17, 2021)
The Associated Press. (2021, September 22). United Airlines says 97%
of US employees have been vaccinated. https://www.wifr.com/2021/09/22/united-airlines-say-97-us-employees-have-been-vaccinated/. (The
Associated Press, September 22, 2021)
Towey R. (2021, September 27). CNBC poll shows very little will
persuade unvaccinated Americans to get Covid shots. https://www.cnbc.com/2021/09/10/cnbc-poll-shows-very-little-will-persuade-unvaccinated-americans-to-get-covid-shots.html. (Towey, September
27, 2021)
White House. (2021, October 7). White House Report: Vaccination
Requirements Are Helping Vaccinate More People, Protect Americans
from COVID-19, and Strengthen the Economy. https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf. (White House, October 7, 2021)
III. No Other Agency Action is Adequate To Protect Employees Against
Grave Danger
OSHA's experience to date shows that the agency's existing tools
are inadequate to meet the grave danger posed by COVID-19 to
unvaccinated workers not covered by the Healthcare ETS. OSHA has
determined that its existing standards, regulations, the OSH Act's
General Duty Clause, and non-mandatory guidance will not adequately
promote the most effective means to protect these workers: Vaccination.
The agency has determined that this ETS is necessary to address these
inadequacies. Multiple developments support this change in approach.
First, large numbers of employees are continuing to contract COVID-19
and die. (See Grave Danger, Section III.A. of this preamble). Further,
based on a thorough review of its existing approach to protecting
employees from COVID-19 and the current state of the pandemic, OSHA
finds that existing OSHA standards, regulations, the General Duty
Clause, and non-mandatory guidance are not adequate to protect
employees outside healthcare from COVID-19. The Preamble to the
Healthcare ETS includes a detailed analysis demonstrating the
inadequacy of existing tools in the healthcare industry. See 86 FR
32414-32423. In general, the same analysis applies here. The reasons
existing tools were inadequate to protect healthcare workers apply in
other industry sectors as well. The Healthcare ETS itself, while
necessary to protect healthcare workers, of course applies only to that
industry. Finally, the numerous guidance products published by other
entities, such as CDC, are not adequate to protect employees because
they are not enforceable; there is no penalty for noncompliance. 86 FR
at 32415. Even as the CDC has increasingly recommended vaccination to
protect from the dangers of transmission and severe illness related to
the SARS-CoV-2 virus, vaccination rates remain uneven around the
country. (CDC, September 9, 2021; Leonhardt, September 7, 2021; KFF,
October 6, 2021; McPhillips and Cohen, May 19, 2021).
The need for this ETS is also reflected in the number of states and
localities that have issued their own mandatory standards in
recognition that OSHA's existing measures (including non-mandatory
guidance, compliance assistance, and enforcement of existing standards)
have failed to prevent the spread of the virus in workplaces.
Additionally, as mentioned previously, other states have banned certain
employers from implementing workplace vaccination mandates or from
verifying an employee's vaccination status or from requiring face
coverings. A national standard is necessary to establish clear
requirements regarding vaccination, testing and face coverings that
will protect employees in all states and preempt state or local
ordinances that prevent employers from implementing necessary
protections.
a. The Current Standards and Regulations Are Inadequate
In the Healthcare ETS, OSHA considered its enforcement efforts with
regard to existing standards and regulations that OSHA had identified
as potentially applicable to occupational exposure to SARS-CoV-2.
OSHA's analysis in Section IV of the Healthcare ETS, 86 FR 32376,
32416-17 and hereby included in the record of this ETS,\18\ is
applicable here in considering the need for this ETS, which covers a
much broader set of employers in all industries. There OSHA found that
none of the existing OSHA standards could sufficiently abate the hazard
posed by COVID-19 in healthcare settings. Here again OSHA concludes
that the potentially applicable existing standards are insufficient to
address the grave danger faced by workers covered by this ETS. None of
the current standards, even if more rigorously enforced, can
sufficiently address this cross-industry hazard of national proportions
to abate the grave danger posed by COVID-19 or lead to the same
benefits that this ETS will achieve. See Asbestos Info. Ass'n/N. Am. v.
Occupational Safety & Health Admin., 727 F.2d 415, 427 (5th Cir. 1984)
(``[M]uch of the claimed benefit could be obtained simply by enforcing
the current standard.'').
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\18\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
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Through its enforcement guidance, OSHA identified a number of
current standards and regulations that might apply when workers have
occupational exposure to SARS-CoV-2, most of which are the same
standards OSHA considered in the Healthcare ETS. (Updated Interim
Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19))
(OSHA, July 7, 2021). OSHA has also cited the Hazard communication
standard (29 CFR 1910.1200) during COVID-19 investigations.
Accordingly, a list of
[[Page 61441]]
potentially applicable standards and regulations follows:
29 CFR part 1904, Recording and Reporting Occupational
Injuries and Illnesses. This regulation requires certain employers to
keep records of work-related fatalities, injuries, and illnesses and
report them to the government in specific circumstances.
29 CFR 1910.132, General requirements--Personal Protective
Equipment (PPE). This standard requires that appropriate PPE, including
PPE for eyes, face, head, and extremities, protective clothing,
respiratory devices, and protective shields and barriers, be provided,
used, and maintained in a sanitary and reliable condition.
29 CFR 1910.134, Respiratory protection. This standard
requires that employers provide, and ensure the use of, appropriate
respiratory protection when necessary to protect employee health.
29 CFR 1910.141, Sanitation. This standard applies to
permanent places of employment and contains, among other requirements,
general housekeeping and waste disposal requirements.
29 CFR 1910.145, Specification for accident prevention
signs and tags. This standard requires the use of biological hazard
signs and tags, in addition to other types of accident prevention signs
and tags.
29 CFR Subpart U--COVID-19 Emergency Temporary Standard.
The Healthcare ETS, promulgated on June 21, 2021 includes various
controls (patient screening and management, respirators and other PPE,
limiting exposure to aerosol-generating procedures, physical
distancing, physical barriers, cleaning, disinfection, ventilation,
health screening and medical management, access to vaccination, anti-
retaliation provisions, and medical removal protection) to address the
grave danger posed by COVID-19 to healthcare workers.
29 CFR 1910.1020, Access to employee exposure and medical
records. This standard requires that employers provide employees and
their designated representatives access to relevant exposure and
medical records.
29 CFR 1910.1200, Hazard communication. This standard
requires employers to keep Safety Data Sheets (SDS) for chemical
hazards, provide SDSs to employees and their representatives when
requested, and train employees about those hazards. The standard does
not apply to biological hazards, but hazard communication becomes an
issue for the SARS-CoV-2 virus when chemicals are used to disinfect
surfaces.
OSHA again finds that none of these existing standards provide for
the types of workplace controls that are necessary to combat the grave
danger addressed by this ETS. First, none of the listed potentially
applicable standards require vaccination against SARS-CoV-2, the most
efficient and effective control to combat the grave danger posed by the
virus. (The Bloodborne Pathogen Standard requires that the hepatitis B
vaccine be made available to certain employees, but that is not that is
not relevant here, since the hepatitis vaccine provides no protection
against COVID-19). Nor are the additional safety measures included in
this ETS--vaccination verification, screening testing, face coverings,
and medical removal of COVID-19 positive workers-- required by existing
standards other than OSHA's Healthcare ETS (covering employees exempted
from this new ETS while the Healthcare ETS is in effect).
Second, because existing standards do not contain provisions
specifically targeted at the COVID-19 hazard, it may be difficult for
employers and employees to determine what particular COVID-19 safety
measures are required by existing standards, or how the separate
standards are expected to work together as applied to COVID-19. An ETS
that contains provisions specifically addressing COVID-19 hazards in
covered workplaces will provide clear instructions. More certainty will
lead to more compliance, and more compliance will lead to improved
protection of employees covered by this standard.
Third, requirements in some standards may be appropriate for other
situations but simply do not contemplate COVID-19 and fail to address
important aspects of the hazard. For example, the general sanitation
standard requires employers to provide warm water, soap, and towels
that can be used in hand washing, but does not require disinfection or
provision of hand sanitizer where handwashing facilities cannot be made
readily available. See 86 FR 32417. Although the sanitation standard
might appear at first glance to be relevant here, it simply does not
require the types of controls that would, even if more rigorously
enforced, sufficiently reduce the threat of COVID-19 in the workplace.
As such, OSHA affirms its previous determination that some of the
above-listed standards--including the sanitation standard--are in
practice too difficult to apply to the COVID-19 hazard and have never
been cited in COVID enforcement. 86 FR 32416.
Fourth, existing recordkeeping and reporting regulations do not
adequately allow the employer or the agency to assess the full scope of
COVID-19 workplace exposures and protection. OSHA's general
recordkeeping regulations were not written with the nature of COVID-19
transmission or illness in mind. In order to adequately understand and
thereby control the spread of COVID-19 in the workforce, it is critical
that the employer has records of employees' vaccination status, and of
the testing undergone by employees who do not receive vaccination, and
that it knows of all cases of COVID-19 occurring among employees.
However, such information is outside of the scope of OSHA's existing
recordkeeping requirements, which are limited to injuries or illnesses
that the employer knows to be work-related.
Moreover, existing reporting regulations do not adequately ensure
that OSHA has the full picture of the impact of COVID-19 because those
regulations only require employers to report in-patient
hospitalizations that occur within 24 hours of the work-related
incident and to report fatalities that occur within thirty days of the
work-related incident. 86 FR at 32417. Many COVID-19 infections will
not result in hospitalization or death until well after these limited
reporting periods. Under existing regulations, such cases are not
required to be reported to OSHA, which limits the agency's ability to
fully understand the impact of COVID-19 on the workforce. 86 FR 32417.
This ETS includes a provision, paragraph (k), that removes the time
limitation on reporting for COVID-19 cases.
In conclusion, OSHA's experience has demonstrated that existing
standards and regulations are inadequate to address the current COVID-
19 hazard.
b. The General Duty Clause Is Inadequate To Meet the Current Crisis
Section 5(a)(1) of the OSH Act, or the General Duty Clause,
provides the general mandate that each employer ``furnish to each of
[its] employees employment and a place of employment which are free
from recognized hazards that are causing or are likely to cause death
or serious physical harm to [its] employees.'' 29 U.S.C. 654(a)(1). For
General Duty Clause citations to be upheld, OSHA must demonstrate
elements of proof that are supplementary to, and can be more difficult
to show than, the elements of proof required for violations of specific
standards, where a hazard is presumed. Specifically, to prove a
violation of the General Duty Clause, OSHA needs to
[[Page 61442]]
establish--in each individual case--that: (1) An activity or condition
in the employer's workplace presented a hazard to an employee; (2) the
hazard was recognized; (3) the hazard was causing or was likely to
cause death or serious physical harm; and (4) feasible means to
eliminate or materially reduce the hazard existed. BHC Nw. Psychiatric
Hosp., LLC v. Sec'y of Labor, 951 F.3d 558, 563 (D.C. Cir. 2020). OSHA
often relies on the General Duty Clause to fill gaps where specific
standards do not address a hazard and OSHA enforces it through case-by-
case adjudicative proceedings. See United States v. Strum, 84 F.3d 1, 5
(1st Cir. 1996).
OSHA has previously found the General Duty Clause to be inadequate
to protect employees from dangers posed by infectious agents. In
promulgating the bloodborne pathogens standard, OSHA explained that
enforcement under the General Duty Clause was insufficient to protect
employees from the serious hazards those pathogens present. 56 FR 64007
(December 6, 1991). In the recently promulgated Healthcare ETS, OSHA
found that the General Duty Clause was insufficient to protect
healthcare workers from the grave danger they faced as well. 86 FR
32418. While OSHA initially attempted to use the General Duty Clause to
protect employees across all industries from COVID-19-related hazards,
OSHA's experience has demonstrated that the Clause is grossly
inadequate to protect employees covered by this ETS from the grave
danger posed by COVID-19 in the workplace. As explained more fully
below, OSHA finds this ETS is necessary to protect employees from the
hazards of COVID-19.
As an initial matter, the General Duty Clause does not provide
employers with specific requirements to follow or a roadmap for
implementing appropriate abatement measures. The ETS, however, provides
a clear statement of what OSHA expects employers to do to protect
workers, thus facilitating better compliance. The General Duty Clause
is so named because it imposes a general duty to keep the workplace
free of recognized serious hazards; the ETS, in contrast, lays out
clear requirements for employers to implement vaccination policies
including vaccination verification, support for employee vaccination,
screening testing and face coverings for unvaccinated workers, and
medical removal of COVID-19 positive employees. Conveying obligations
as clearly and specifically as possible makes it much more likely that
employers will comply with those obligations and thereby protect
workers from COVID-19 hazards. See, e.g., Integra Health Mgmt., Inc.,
2019 WL 1142920, at *7 n.10 (No. 13-1124, 2019) (noting that standards
``give clear notice of what is required of the regulated community'');
56 FR 64007 (``because the standard is much more specific than the
current requirements [general standards and the general duty clause],
employers and employees are given more guidance in carrying out the
goal of reducing the risks of occupational exposure to bloodborne
pathogens'').
Moreover, several characteristics of General Duty Clause
enforcement actions make them an inadequate means to address hazards
associated with COVID-19. First, it would be virtually impossible for
OSHA to require and enforce the most important worker-protective
elements of the ETS (such as vaccination and testing) under the General
Duty Clause. Second, OSHA's burden of proof for establishing a General
Duty Clause violation is heavier than for standards violations. Third,
promulgating an ETS will enable OSHA to issue more meaningful penalties
for willful and egregious violations, thus creating effective
deterrence against employers who intentionally disregard their
obligations under the Act or demonstrate plain indifference to employee
safety. As discussed in more detail below, all of these considerations
demonstrate OSHA's need to promulgate this ETS in order to protect
unvaccinated workers covered by this standard from hazards posed by
COVID-19.
The General Duty Clause is ill-suited to requiring employers to adopt
vaccination and testing policies, like those required by the ETS
Because the General Duty Clause requires OSHA to establish the
existence and feasibility of abatement measures that can materially
reduce a hazard, it is difficult for OSHA to use the clause to require
specific control measures where an employer is doing something, but not
what the Secretary has determined is needed to fully address the
serious hazard. See, e.g., Waldon Health Care Center, 16 BNA OSHC 1052,
1993 WL 119662 at * (No. 89-2804, 1993) (vacating OSHA citation
requiring pre-exposure hepatitis B vaccination under General Duty
Clause by finding that although vaccination would more fully reduce the
hazard, the employer's chosen means of abatement were sufficient);
Brown & Root, Inc., Power Plant Div., 8 BNA OSHC 2140, 1980 WL 10668 at
*5 (No. 76-1296, 1980) (``[T]he employer may defend against a section
5(a)(1) citation by asserting that it was using a method of abatement
other than the one suggested by the Secretary.'').
Further, even where OSHA establishes a violation of the General
Duty Clause, the employer is under no obligation to implement the
feasible means of abatement proven by OSHA as part of its prima facie
case. Cyrus Mines Corp., 11 OSH Cas. (BNA) 1063, 1982 WL 22717, at *4
(No. 76-616, 1983) (``[The employer] is not required to adopt the
abatement method suggested by the Secretary, even one found feasible by
the Commission; it may satisfy its duty to comply with the standard by
using any feasible method that is appropriate to abate the
violation.''); Brown & Root, Inc., Power Plant Div., 1980 WL 10668 at
*5. Thus, even in cases where OSHA prevails, the employer need not
necessarily implement the specific abatement measure(s) OSHA
established would materially reduce the hazard. The employer could
select alternative controls and then it would be up to OSHA, if it
wished to cite the employer again, to establish that the recognized
hazard continued to exist and that its preferred controls could
materially reduce the hazard even further.
Given the severity and pervasiveness of the COVID-19 hazard, OSHA
has determined that the specific abatement measures provided in this
ETS are necessary to protect workers from grave danger. Under the
General Duty Clause alone, it would be nearly impossible to require
employers to provide these specific measures, and even then, it could
only be on a case-by-case enforcement basis. Considering the magnitude
and ubiquity of the danger that SARS-CoV-2 poses to workers across the
country, the case-by-case adjudicatory regime set up through the
General Duty Clause is simply not adequate to combat the risk of severe
illness and death caused by the virus.
General Duty Clause Citations Impose a Heavy Litigation Burden on OSHA
Under the General Duty Clause OSHA must prove that there is a
recognized hazard, i.e., a workplace condition or practice to which
employees are exposed, creating the potential for death or serious
physical harm to employees. See SeaWorld of Florida LLC v. Perez, 748
F.3d 1202, 1207 (D.C. Cir. 2014); Integra Health Management, 2019 WL
1142920, at *5. Whether a particular workplace condition or practice is
a ``recognized hazard'' under the General Duty Clause is a question of
fact that must be decided in each individual case. See SeaWorld of
Florida LLC, 748 F.3d at 1208. In the case of a COVID-19-related
citation, this means showing
[[Page 61443]]
not just that the virus is a hazard as a general matter--a fairly
indisputable point--but also that the specific conditions in the cited
workplace, such as unvaccinated, unmasked employees working in close
proximity to other employees for extended periods, create a COVID-19-
related hazard.
In contrast, an OSHA standard that requires or prohibits specific
conditions or practices establishes the existence of a hazard. See
Harry C. Crooker & Sons, Inc. v. Occupational Safety & Health Rev.
Comm'n, 537 F.3d 79, 85 (1st Cir. 2008); Bunge Corp. v. Sec'y of Labor,
638 F.2d 831, 834 (5th Cir. 1981). Thus, in enforcement proceedings
under OSHA standards, as opposed to the General Duty Clause, ``the
Secretary need not prove that the violative conditions are actually
hazardous.'' Modern Drop Forge Co. v. Sec'y of Labor, 683 F.2d 1105,
1114 (7th Cir. 1982). With OSHA's finding that the hazard of exposure
to COVID-19 can exist for unvaccinated workers in all covered
workplaces (see Grave Danger, Section III.A. of this preamble), the ETS
will eliminate the burden to repeatedly prove, workplace by workplace,
the existence of a COVID-19 hazard under the General Duty Clause.
One of the most significant advantages to standards like the ETS
that establish the existence of the hazard at the rulemaking stage is
that the Secretary can require specific abatement measures without
having to prove that a specific cited workplace is already
hazardous.\19\ In contrast, as discussed above, under the General Duty
Clause the Secretary cannot require abatement before proving in the
enforcement proceeding that an existing condition at the workplace is
hazardous. For example, in a challenge to OSHA's Grain Handling
Standard, which was promulgated in part to protect employees from the
risk of fire and explosion from accumulations of grain dust, the Fifth
Circuit acknowledged OSHA's inability to effectively protect employees
from these hazards under the General Duty Clause in upholding, in large
part, the standard. See Nat'l Grain & Feed Ass'n v. Occupational Safety
& Health Admin., 866 F.2d 717, 721 (5th Cir. 1988) (noting Secretary's
difficulty in proving explosion hazards of grain handling under General
Duty Clause). Although OSHA had attempted to address fire and explosion
hazards in the grain handling industry under the General Duty Clause,
``employers generally were successful in arguing that OSHA had not
proved that the specific condition cited could cause a fire or
explosion.'' Id. at 721 & n.6 (citing cases holding that OSHA failed to
establish a fire or explosion hazard under the General Duty Clause).
The Grain Handling Standard, in contrast, established specific limits
on accumulations of grain dust based on its combustible and explosive
nature, and the standard allowed OSHA to cite employers for exceeding
those limits without the need to prove at the enforcement stage that
each cited accumulation was likely to cause a fire or explosion. See
id. at 725-26.
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\19\ ``The Act does not wait for an employee to die or become
injured. It authorizes the promulgation of health and safety
standards and the issuance of citations in the hope that these will
act to prevent deaths and injuries from ever occurring.'' Whirlpool
Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also Arkansas-Best
Freight Sys., Inc. v. Occupational Safety & Health Rev. Comm'n, 529
F.2d 649, 653 (8th Cir. 1976) (noting that the ``[OSH] Act is
intended to prevent the first injury'').
---------------------------------------------------------------------------
The same logic applies to COVID-19 hazards. Given OSHA's burden
under the General Duty Clause to prove that conditions at the cited
workplace are hazardous, it is difficult for OSHA to ensure necessary
abatement before individual employee lives and health are unnecessarily
endangered by exposure to COVID-19, despite widespread evidence of the
grave danger posed by worker exposure to COVID-19. Indeed, despite
publishing a voluminous collection of COVID-19 guidance online and
receiving and investigating thousands of complaints, OSHA did not
believe it could justify the issuance of more than 20 COVID-19 related
General Duty Clause citations over the entire span of the pandemic so
far, because of the quantum of proof the Secretary must amass under the
General Duty Clause. Unlike enforcement under the General Duty Clause,
this ETS allows OSHA to cite employers for each protective requirement
they fail to implement without the need to wait for employee infection
or death to prove in an enforcement proceeding that the particular
cited workplace was hazardous without that particular measure in place.
Thus, this ETS, which covers millions of workers nation-wide, is
significantly preferable to the General Duty Clause with respect to
such a highly transmissible virus because the inability to prevent a
single exposure can quickly result in an exponential increase in
exposures and illnesses or fatalities even at a single worksite.
An additional limitation of the General Duty Clause is that proving
that there are feasible means to materially reduce a recognized hazard
typically requires testimony from an expert witness in each separate
case, which limits OSHA's ability to prosecute these cases as broadly
as needed to protect workers, in light of the expense involved. See,
e.g., Integra Health Management, 2019 WL 1142920, at *13 (requiring
expert witness to prove proposed abatement measures would materially
reduce hazard). In contrast, where an OSHA standard specifies the means
of compliance, the agency has already made the necessary technical
determinations in the rulemaking and therefore does not need to
establish feasibility of compliance as part of its prima facie case in
an enforcement proceeding. See, e.g., A.J. McNulty & Co. v. Sec'y of
Labor, 283 F.3d 328, 334 (D.C. Cir. 2002); S. Colorado Prestress Co. v.
Occupational Safety & Health Rev. Comm'n, 586 F.2d 1342, 1351 (10th
Cir. 1978). Preventing the initial exposure and protecting as many
workers as quickly as possible is especially critical in the context of
COVID-19 because, as explained in Grave Danger, Section III.A. of this
preamble, it can spread so easily in workplaces.
The ETS will also permit OSHA to achieve meaningful deterrence when
necessary to address willful or egregious failures to protect employees
against the COVID-19 hazard
As described above, in contrast to the broad language of the
General Duty Clause, this ETS will prescribe specific measures
employers covered by this standard must implement. This specificity
will make it easier for OSHA to determine whether an employer has
intentionally disregarded its obligations or exhibited a plain
indifference to employee safety or health. In such instances, OSHA can
classify the citations as ``willful,'' allowing it to propose higher
penalties, with increased deterrent effects. In promulgating the
Healthcare ETS, OSHA noted that early in the pandemic, shifting
guidance on the safety measures employers should take to protect their
employees from COVID-19 created ambiguity regarding employers' specific
obligations. Thus, OSHA could not readily determine whether a
particular employer had ``intentionally'' disregarded obligations that
were not yet clear. And, even as the guidance began to stabilize,
OSHA's ability to determine ``intentional disregard'' or ``plain
indifference'' was difficult, for example, when an employer took some
steps address the COVID-19 hazard. 86 FR 32420. The Healthcare ETS
largely resolved this issue for employers covered by that standard, by
laying out clearly what parameters to put in place to protect
healthcare workers. However, this general challenge persists in OSHA's
[[Page 61444]]
attempts at enforcement in other industries.
Further, OSHA has adopted its ``egregious violation'' policy to
impose sufficiently large penalties that achieve appropriate deterrence
against bad actor employers who willfully disregard their obligation to
protect their employees when certain aggravating circumstances are
present, such as a large number of injuries or illnesses, bad faith, or
an extensive history of noncompliance (OSHA Directive CPL 02-00-080
(October 21, 1990)). Its purpose is to increase the deterrent impact of
OSHA's enforcement activity. This policy utilizes OSHA's authority to
issue a separate penalty for each instance of noncompliance with an
OSHA standard, such as each employee lacking the same required
protections, or each workstation lacking the same required controls. It
can be more difficult to use this policy under the General Duty Clause
because the Fifth Circuit and the Occupational Safety and Health Review
Commission have held that, under the General Duty Clause, OSHA may only
cite a hazardous condition once, regardless of its scope or the number
of workers affected. Reich v. Arcadian Corp., 110 F.3d 1192, 1199 (5th
Cir. 1997). Thus, even where OSHA finds that an employer willfully
failed to protect a large number of employees from a COVID-19 hazard,
OSHA might not be able to cite the employer on a per-instance basis for
failing to protect each of its employees. The provisions of this ETS
have been intentionally drafted to make clear OSHA's authority to
separately cite employers for each instance of the employer's failure
to protect employees and for each affected employee, where appropriate.
By providing needed clarity, the ETS will facilitate ``willful''
and ``egregious'' determinations that are critical enforcement tools
OSHA can use to adequately address violations by employers who have
shown a conscious disregard for the health and safety of their workers
in response to the pandemic. Without the necessary clarity, OSHA has
been limited in its ability to impose penalties high enough to motivate
the very large employers who are unlikely to be deterred by penalty
assessments of tens of thousands of dollars, but whose noncompliance
can endanger thousands of workers. Indeed, OSHA has only been able to
issue two COVID-19-related ``willful'' citations and no ``egregious''
citations since the start of the pandemic because of the challenges
described above.
For all of the reasons described above, and after over a year of
attempting to use the General Duty Clause to address this widespread
hazard, OSHA finds that the General Duty Clause is not an adequate
enforcement tool to protect employees covered by this standard from the
grave danger posed by COVID-19.
c. OSHA and Other Entity Guidance Is Insufficient
OSHA has issued numerous non-mandatory guidance products to advise
employers on how to protect workers from SARS-CoV-2 infection (see
https://www.osha.gov/coronavirus). Even the most comprehensive guidance
makes clear, as it must, that the guidance itself imposes no new legal
obligations, and that its recommendations are ``advisory in nature.''
(See OSHA's online guidance, Protecting Workers: Guidance on Mitigating
and Preventing the Spread of COVID-19 in the Workplace (OSHA, Updated
August 13, 2021); and OSHA's earlier 35-page booklet, Guidance on
Preparing Workplaces for COVID-19, (OSHA, March 9, 2020)). This
guidance, as well as guidance products issued by other government
agencies and organizations, including the CDC, the Centers for Medicare
& Medicaid Services (CMS), the Institute of Medicine (IOM), and the
World Health Organization (WHO), help protect employees to the extent
that employers voluntarily choose to implement the practices they
recommend. Unfortunately, OSHA's experience and the continued spread of
COVID-19 throughout the country shows that does not happen consistently
or rigorously enough, resulting in inadequate protection for employees.
For example, the CDC has strongly recommended vaccination since
vaccines became widely available earlier in the year, but many
employees have yet to take this simple step, which would protect
themselves and their co-workers from the danger of COVID-19.
As documented in numerous peer-reviewed scientific publications,
CDC, IOM, and WHO have recognized a lack of compliance with non-
mandatory recommended infection-control practices (Siegel et al., 2007;
IOM, 2009; WHO, 2009). As noted in the preamble to the Healthcare ETS,
OSHA was aware of these findings when it previously concluded that an
ETS was not necessary, but at the time of that conclusion, the agency
erroneously believed that it would be able to effectively use the non-
mandatory guidance as a basis for establishing the mandatory
requirements of the General Duty Clause, and informing employers of
their compliance obligations under existing standards. 86 FR 32421. As
explained above, that has not proven to be an effective strategy.
Moreover, when OSHA made its initial necessity determination at the
beginning of the pandemic, it made an assumption that given the
unprecedented nature of the COVID-19 pandemic, there would be an
unusual level of widespread voluntary compliance by the regulated
community with COVID-19-related safety guidelines. (See, e.g., DOL, May
29, 2020 at 20 (observing that ``[n]ever in the last century have the
American people been as mindful, wary, and cautious about a health risk
as they are now with respect to COVID-19,'' and that many ``protective
measures are being implemented voluntarily, as reflected in a plethora
of industry guidelines, company-specific plans, and other sources'')).
Since that time, however, developments have led OSHA to conclude
that the same uneven compliance documented by CDC, IOM, and WHO is also
occurring for the COVID-19 guidance issued by OSHA and other agencies.
For example, rising ``COVID fatigue'' or ``pandemic fatigue'' has been
reported for nearly a year already--i.e., a decrease in voluntary use
of COVID-19 mitigation measures over time (Meichtry et al., October 26,
2020; Silva and Martin, November 14, 2020; Belanger and Leander,
December 9, 2020; Millard, February 18, 2021). Other reasons that
people have not followed COVID-19 guidance include fear of financial
loss; skepticism about the danger posed by COVID-19; and even a simple
human tendency, called ``psychological reactance,'' to resist curbs on
personal freedoms, i.e., an urge to do the opposite of what somebody
tells you to do (Belanger and Leander, December 9, 2020; Markman, April
20, 2020). OSHA is seeing evidence of these trends in its COVID-19
enforcement. For example, although OSHA has issued guidance since the
spring of 2020 encouraging the use of physical distancing and barriers
as a means of protecting employees at fixed work locations, there have
been a number of news reports indicating that employers ignore that
guidance (Romo, November 19, 2020; Richards, May 5, 2020; Lynch, July
9, 2020). This was evidenced by a cross-sectional study performed from
late summer to early fall of 2020 in New York and New Jersey that found
non-compliance and widespread inconsistencies in COVID-19 response
programs (Koshy et al., February 4, 2021). Indeed, OSHA continues to
receive complaints and referrals attesting to such workplace practices.
[[Page 61445]]
(OSHA, October 17, 2021). Worse, some employers must now deal with
employees who not only have yet to be vaccinated but compound the
danger by hiding their unvaccinated status and declining to wear source
protection that would identify them as unvaccinated, even though it
could provide some protection to their coworkers, in workplaces where
there is a stigma attached to being unvaccinated. (Ember and Murphy
Marcos, August 7, 2021). This ETS contains notification and vaccine
verification requirements that address these avoidant behaviors and
mitigate the hazard of undisclosed exposure and transmission (see the
Summary and Explanation for paragraphs (e), (g), and (h), Sections
VI.E., VI.G., and VI.H. of this preamble).
OSHA's more recent guidance update encourages employers to
facilitate employee vaccination by providing paid time off and
encourages testing and masks for unvaccinated workers. However, as
discussed previously, vaccination rates remain inconsistent across the
country and have slowed significantly since the spring of 2021. And
infection rates remain high, especially among the unvaccinated. It is
clear, as discussed previously, that voluntary self-regulation by
employers will not sufficiently reduce the danger that COVID-19 poses
in workplaces covered by this standard. As noted in the White House
Report on vaccination requirements released on October 7, at this time
only 25% of businesses have vaccine mandates in place (White House,
October 7, 2021). Since this ETS and other federal efforts to require
vaccination were announced more private and public sector institutions
have begun to prepare to implement vaccination requirements, further
demonstrating the need for this rule as an impetus for employer action
(White House, October 7, 2021).
The high number of COVID-19-related complaints and reports that
OSHA continues to receive on a regular basis suggests a lack of
widespread compliance with existing voluntary guidance: From March 2020
to October 2021, OSHA has continued to receive hundreds of COVID-19-
related complaints every month, including over 400 complaints during
the month of August 2021, and over 450 complaints to date in the month
of September (OSHA, October 11, 2021). And, as of October 17, OSHA has
received 223 additional COVID-19-related complaints. (OSHA, October 17,
2021). If guidance were followed more strictly, or if there were enough
voluntary compliance with steps to prevent illness, OSHA would expect
to see a significant reduction in COVID-19-related complaints from
employees.
The dramatic increases in the percentage of the population that
contracted the virus during the summer of 2021 indicates a continued
risk of COVID-19 transmission in workplace settings (for more
information on the prevalence of COVID-19 see Grave Danger, Section
III.A. of this preamble) despite OSHA's publication of numerous
specific and comprehensive guidance documents. OSHA has found that
neither reliance on voluntary action by employers nor OSHA non-
mandatory guidance is an adequate substitute for specific, mandatory
workplace standards at the federal level. Public Citizen v. Auchter,
702 F.2d 1150 at 1153 (voluntary action by employers ``alerted and
responsive'' to new health data is not an adequate substitute for
government action).
d. A Uniform Nationwide Response to the Pandemic Is Necessary To
Protect Workers
As the pandemic has continued in the United States, there has been
increasing recognition of the need for a more consistent national
approach (GAO, September, 2020; Budryk, November 17, 2020; Horsley, May
1, 2020; DOL OIG, February 25, 2021). Many employers have advised OSHA
that they would welcome a nationwide ETS. For example, in its October
9, 2020 petition for a COVID-19 ETS, ORCHSE Strategies, LLC explained
that it is ``imperative'' that OSHA issue an ETS to provide employers
one standardized set of requirements to address safety and health for
their workers (ORCHSE, October 9, 2020). This group of prominent
business representatives explained that an ETS would eliminate
confusion and unnecessary burden on workplaces that are struggling to
understand how best to protect their employees in the face of confusing
and differing requirements across states and localities.
The lack of a national standard on this hazard has led to
increasing imbalance in state and local regulation, a problem that OSHA
already identified as concerning in its Healthcare ETS. See 86 FR 32413
(``The resulting patchwork of state and local regulations led to
inadequate and varying levels of protection for workers across the
country, and has caused problems for many employees and businesses.'')
Since the Healthcare ETS was published, states and localities have
taken increasingly more divergent approaches to COVID-19 vaccination,
vaccination verification, screening testing, and the use of face
coverings in the workplace. Currently, the spectrum ranges from states
and localities requiring vaccine mandates and face coverings to states
prohibiting or restricting them, with many states falling somewhere in
between. Due to uneven approaches to vaccination across the country,
states with the lowest rates of vaccination have COVID-19 infection
rates four times as high as in states with the highest vaccine rates.
(Leonhardt, September 7, 2021). Given that thousands of working age
people continue to be infected with COVID-19 each week, many of whom
will become hospitalized or die, OSHA recognizes that a patchwork
approach to worker safety has not been successful in mitigating this
infectious disease outbreak (CDC, October 18, 2021--Cases, By Age). It
has become clear that a Federal standard, by way of this ETS, is
necessary to provide clear and consistent protection to employees
across the country. As explained in Pertinent Legal Authority (Section
II. of this preamble) and the Summary and Explanation for paragraph (a)
(Section VI.A. of this preamble), OSHA has the authority to
comprehensively address the issue(s) described in this ETS, and the
standard is intended to preempt conflicting state and local laws.
In sum, based on its enforcement experience during the pandemic to
date, OSHA concludes that continued reliance on existing standards and
regulations, the General Duty Clause, and guidance, in lieu of an ETS,
is not adequate to protect unvaccinated employees from the grave danger
of being infected by, and suffering death or serious health
consequences from, COVID-19.
References
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Rule Breakers? Scientific American. https://www.scientificamerican.com/article/what-motivates-covid-rule-breakers/. (Belanger and Leander, December 9, 2020)
Budryk Z. (2020, November 17). Fauci calls for `a uniform approach'
to coronavirus pandemic. The Hill. https://thehill.com/policy/healthcare/526378-fauci-calls-for-a-uniform-approach-to-the-coronavirus-pandemic?rl=1. (Budryk, November 17, 2020)
Centers for Disease Control and Prevention (CDC). (2021, September
9). Your COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/your-vaccination.html. (CDC, September 9, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)
[[Page 61446]]
Ember S and Murphy Marcos C. (2021, August 7). They Don't Want the
Shot. They Don't Want Colleagues to Know. The New York Times.
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2021)
Government Accountability Office (GAO). (2020, September). COVID-19:
Federal Efforts Could Be Strengthened by Timely and Concerted
Actions. https://www.gao.gov/assets/710/709934.pdf. (GAO, September
2020)
Horsley S. (2020, May 1). U.S. Workplace Safety Rules Missing in the
Pandemic. National Public Radio. https://www.npr.org/2020/05/01/849212026/it-s-the-wild-west-u-s-workplace-safety-rules-missing-in-the-pandemic. (Horsley, May 1, 2020)
Institute of Medicine (IOM). (2009). Respiratory Protection for
Healthcare Workers in a Workplace Against Novel H1N1 Influenza A: A
letter report. The National Academies Press. https://www.nap.edu/catalog/12748.html. (IOM, 2009)
Kaiser Family Foundation (KFF). (2021, October 6). Latest Data on
COVID-19 Vaccinations by Race/Ethnicity. https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-by-race-ethnicity/. (KFF, October 6, 2021)
Koshy K et al., (February 4, 2021). Perspectives of region II OSHA
authorized safety and health trainers about initial COVID-19
response programs. Safety Science 138. https://doi.org/10.1016/j.ssci.2021.105193. (Koshy et al., February 4, 2021)
Leonhardt D. (2021, September 7). One in 5,000. The New York Times.
https://www.nytimes.com/2021/09/07/briefing/risk-breakthrough-infections-delta.html. (Leonhardt, September 7, 2021)
Lynch R. (2020, July 9). Orange County to crack down on gyms that
ignore Covid-19 safety guidelines. Orlando Business Journal. https://www.bizjournals.com/orlando/news/2020/07/09/orange-county-gyms-could-face-scrutiny-for-not.html. (Lynch, July 9, 2020)
Markman A. (2020, April 20). Why are there still so many coronavirus
skeptics? Fast Company. https://www.fastcompany.com/90492518/why-are-there-still-so-many-coronavirus-skeptics. (Markman, April 20,
2020)
McPhillips D and Cohen E. (2021, May 19). Uneven vaccination rates
across the US linked to COVID-19 case trends, worry experts. CNN
Health. https://www.cnn.com/2021/05/19/health/uneven-vaccination-rates-covid-19-trends/. (McPhillips and Cohen, May 19,
2021)
Meichtry S et al. (2020, October 26). Pandemic Fatigue is Real--And
It's Spreading; Collective exhaustion with coronavirus restrictions
has emerged as a formidable adversary for governments. The Wall
Street Journal. https://www.wsj.com/articles/pandemic-fatigue-is-realand-its-spreading-11603704601. (Meichtry et al., October 26,
2020)
Millard E. (2021, February 18). How to not let pandemic fatigue turn
into pandemic burnout. Everyday Health. https://www.everydayhealth.com/coronavirus/how-to-not-let-pandemic-fatigue-turn-into-pandemic-burnout/. (Millard, February 18, 2021)
Occupational Safety and Health Administration (OSHA). (2020, March
9). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
March 9, 2020
Occupational Safety and Health Administration (OSHA). (2021, July
7). Updated Interim Enforcement Response Plan for Coronavirus
Disease 2019 (COVID-19). https://www.osha.gov/laws-regs/standardinterpretations/2021-07-07. (OSHA, July 7, 2021)
Occupational Safety and Health Administration (OSHA). (2021, August
13). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
August 13, 2021)
Occupational Safety and Health Administration (OSHA). (2021, August
13). Protecting Workers: Guidance on Mitigating and Preventing the
Spread of COVID-19 in the Workplace. https://www.osha.gov/coronavirus/safework. (OSHA, Updated August 13, 2021)
Occupational Safety and Health Administration (OSHA). (2021, October
17). Summary Data for Federal and State Programs--Enforcement.
https://www.osha.gov/enforcement/covid-19-data#complaints_referrals.
(OSHA, October 17, 2021)
ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
Department of Labor--Occupational Safety and Health Administration
(OSHA) for an Emergency Temporary Standard (ETS) for Infectious
Disease.'' (ORCHSE, October 9, 2020)
Richards C. (2020, May 5). 2 Utah County businesses told staff to
ignore COVID-19 guidelines, resulting in 68 positive cases. Daily
Herald. https://www.heraldextra.com/news/local/2-utah-county-businesses-told-staff-to-ignore-covid-19-guidelines-resulting-in-68-positive/article_d8426991-a693-5879-9d88-f9e094aef5b5.html.
(Richards, May 5, 2020)
Romo V. (2020, November 19). Tyson managers suspended after
allegedly betting if workers would contract COVID. National Public
Radio. https://www.npr.org/2020/11/19/936905707/tyson-managers-suspended-after-allegedly-betting-if-workers-would-contract-covid.
(Romo, November 19, 2020)
Siegel J, Rhinehart E, Jackson M, Chiarello L, and the Healthcare
Infection Control Practices Advisory Committee. (2007). 2007
Guideline for isolation precautions: Preventing transmission of
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et al., 2007)
Silva C and Martin M. (2020, November 14). U.S. Surgeon General
Blames ``Pandemic Fatigue'' for Recent COVID-19 Surge. NPR. https://www.npr.org/sections/coronavirus-live-updates/2020/11/14/934986232/u-s-surgeon-general-blames-pandemic-fatigue-for-recent-covid-19-surge. (Silva and Martin, November 14, 2020)
United States Department of Labor (DOL) and Office of the Inspector
General (OIG). (2021, February 25). COVID-19: Increased Worksite
Complaints and Reduced OSHA Inspections Leave U.S. Workers' Safety
at Increased Risk. https://www.oig.dol.gov/public/reports/oa/2021/19-21-003-10-105.pdf. (DOL OIG, February 25, 2021)
United States Department of Labor (DOL). (2020, May 29). In Re:
American Federation Of Labor And Congress Of Industrial
Organizations. Department Of Labor's Response to the Emergency
Petition for a Writ of Mandamus, No. 20-1158 (D.C. Cir., May 29,
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White House. (2021, October 7). White House Report: Vaccination
requirements are helping vaccinate more people, protect Americans
from COVID-19, and strengthen the economy. https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf. (White House, October 7, 2021)
World Health Organization (WHO). (2009). WHO Guidelines on Hand
Hygiene in Health Care: A Summary--First Global Patient Safety
Challenge Clean Care is Safer Care. https://www.ncbi.nlm.nih.gov/books/NBK144013/pdf/Bookshelf_NBK144013.pdf. (WHO, 2009)
IV. Conclusion
This pandemic continues to take a massive toll on American society,
and addressing it requires a comprehensive national response. This ETS
is part of that response. OSHA shares the nation's hope for the promise
of recovery created by the vaccines. But in the meantime, it recognizes
that we have not yet succeeded in defeating the virus, and that many
workers across the country are in grave danger. Therefore, this ETS,
with mitigation measures emphasizing worker vaccination, is necessary.
Although OSHA finds it necessary to institute specific mitigation
measures for the immediate future, the agency can adjust as conditions
change. Even after issuing an ETS, OSHA retains the flexibility to
update the ETS to adjust to the subsequent evolution of CDC workplace
guidance. This ETS addresses (and incorporates as a main component) the
major development in infection control over the last year--the
development and growing implementation of COVID-19 vaccines. Going
forward, further developments can be addressed through OSHA's
[[Page 61447]]
authority to modify the ETS if needed, or to terminate it entirely if
vaccination and other efforts end the current emergency. However, at
this point in time, the available evidence indicates that the ETS is
necessary to protect unvaccinated employees across the country from the
grave danger of COVID-19.
IV. Feasibility
A. Technological Feasibility
This section presents an overview of the technological feasibility
assessment for OSHA's Emergency Temporary Standard (ETS) for COVID-19
that requires all employers with 100 or more employees to ensure that
all employees are fully vaccinated unless they implement a policy
requiring employees to undergo testing for COVID-19 at least once every
seven days and wear face coverings.
Technological feasibility has been interpreted broadly to mean
``capable of being done'' (Am. Textile Mfrs. Inst. v. Donovan, 452 U.S.
490, 509-510 (1981)). A standard is technologically feasible if the
protective measures it requires already exist, can be brought into
existence with available technology, or can be created with technology
that can reasonably be expected to be developed, i.e., technology that
``looms on today's horizon'' (United Steelworkers of Am., AFL-CIO-CLC
v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980) (Lead I)); Amer. Iron
& Steel Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (Lead II);
American Iron and Steel Inst. v. OSHA, 577 F.2d 825 (3d Cir. 1978)).
Courts have also interpreted technological feasibility to mean that a
typical firm in each affected industry or application group will
reasonably be able to implement the requirements of the standard in
most operations most of the time (see Public Citizen v. OSHA, 557 F.3d
165 (3d Cir. 2009); Lead I, 647 F.2d at 1272; Lead II, 939 F.2d at
990).
OSHA issued an ETS in June 2021 to protect healthcare and
healthcare support employees in covered healthcare settings from
exposure to SARS-CoV-2. See 86 FR 32376 (June 21, 2021) (Healthcare
ETS). OSHA found the requirements in that ETS to be technologically
feasible, including a requirement for employers to pay for vaccination
of employees that is very similar to the requirement in this new ETS.
OSHA's finding that the Healthcare ETS was technologically feasible was
primarily based on available evidence showing that most healthcare
employers, and employers across all industry sectors, had already
implemented, or were in process of implementing, procedures similar to
those required by the Healthcare ETS. Similarly, OSHA's feasibility
findings for this ETS are based on evidence that vaccination and
testing policies, along with the use of face coverings consistent with
recommendations from the CDC, have been implemented in multiple
industry sectors as testing and vaccinations were made more widely
available during the course of the pandemic.
As discussed in Summary and Explanation (Section VI. of this
preamble), this ETS for vaccination and testing applies to all
employers with 100 or more employees, except as noted here. It does not
apply to workplaces covered under the Safer Federal Workforce Task
Force COVID-19 Workplace Safety: Guidance for Federal Contractors and
Subcontractors or settings where any employee provides healthcare
services or healthcare support services when subject to the
requirements of the Healthcare ETS (29 CFR 1910.502). It also does not
apply to employees who do not report to a workplace where other
individuals such as coworkers or customers are present, employees while
they are working from home, or employees who work exclusively outdoors.
As noted above, OSHA has the legal duty to demonstrate that the
average employer covered by this ETS can comply with that standard in
most operations most of the time. This legal analysis is therefore
focused solely on whether employers with 100 or more employees can
comply with the standard. OSHA's rationale for that scope threshold of
100 or more employees is explained in the Summary and Explanation for
paragraph (b), Section VI.B. of this preamble.
As discussed below, OSHA finds no technological feasibility
barriers related to compliance with the requirements in the ETS. These
requirements include establishing and implementing a written mandatory
COVID-19 vaccination policy or alternative policy requiring testing and
face coverings; determining employee vaccination status; supporting
employee vaccination by providing paid time for vaccination and time
off for recovery; ensuring that employees who are not fully vaccinated
are tested for COVID-19 at least once every seven days and wear face
coverings; and recordkeeping for employee vaccination status and
testing.
OSHA reviewed numerous large-scale employer surveys and vaccination
and testing policies developed by employers, public health
organizations, trade association, and local, state, and federal
governmental bodies. While OSHA discusses several examples of these
plans and policies below,\20\ OSHA's feasibility determination is based
on all evidence in the rulemaking record. The majority of the survey
data and other publicly available material that OSHA reviewed pertains
to large employers with 100 or more employees.
---------------------------------------------------------------------------
\20\ While OSHA references several employers' policies, this is
not intended to serve as an endorsement of those plans or an
indication that those plans comply with the ETS. Rather, the plans
and best practice documents show that developing and implementing
policies to address employee COVID-19 vaccination in various
workplaces is capable of being done in a variety of industries, and
therefore, compliance with the ETS is technologically feasible.
---------------------------------------------------------------------------
Additionally, OSHA thoroughly reviewed current and future
projections of the availability of COVID-19 tests, testing supplies,
and laboratory capacity. Based on a review of vaccination and testing
policies among large employers, OSHA has determined that most employers
covered by this standard across a wide range of industries have either
already implemented vaccination and testing programs and require
unvaccinated employees to wear face coverings, or are capable of
implementing programs that comply with the requirements in the ETS most
of the time. OSHA therefore finds that the standard is technologically
feasible.
I. Employer Policy on Vaccination
Paragraph (d)(1) of the ETS requires each covered employer to
establish and implement a written mandatory vaccination policy unless
the employer adopts an alternative policy requiring COVID-19 testing
and face coverings for unvaccinated employees, which is discussed
later. To meet the definition of ``mandatory vaccination policy'' under
paragraph (c), the policy must require: Vaccination of all employees,
including all new employees as soon as practicable, other than those
employees (1) for whom a vaccine is medically contraindicated, (2) for
whom medical necessity requires a delay in vaccination, or (3) those
legally entitled to a reasonable accommodation under federal civil
rights laws because they have a disability or sincerely-held religious
beliefs, practices, or observances that conflict with the vaccination
requirement.
OSHA requires employers to implement a mandatory vaccination
requirement, but provides an exemption for an alternative policy that
allows employees to choose either to be fully vaccinated or to be
regularly tested and wear a face covering. This compliance options mean
that the ETS is
[[Page 61448]]
technologically feasible if employers across various industries are
capable of implementing either policy, but nevertheless OSHA analyzes
both employer policy options to demonstrate that there are no
significant technological barriers to either approach.
OSHA reviewed several large-scale employer surveys related to
vaccination policies across the country covering a wide range of
industry sectors. Surveys conducted by Arizona State University (ASU)
and the World Economic Forum (WEF), called COVID-19 Workplace Commons--
Keeping Workers Well, show that most employers already have some type
of vaccination policy, with more than 60 percent of surveyed employers
requiring vaccinations for some or all employees. These survey results
further support OSHA's determination that the vaccination policy
requirement is feasible.
The ASU WEF workplace COVID-19 surveys collected information from
employers across industry sectors about their response to the COVID-19
pandemic. The results and responses from more than 1,400 companies are
publicly available through the ASU College of Health Solutions web page
COVID-19 Diagnostics Commons (ASU, October 5, 2021). Case studies from
employers are also available within the interactive dashboard on that
web page. The surveys consisted of numerous questions about workplace
pandemic response, including questions related to vaccination policies
and testing unvaccinated employees.
The most recent COVID-19 survey data was collected between August
2, 2021 and August 20, 2021 and reported in September 2021 (accessible
through the COVID-19 Workplace Commons). More than 1,400 companies
operating 1143 facilities in 23 industry sectors were part of the
survey, the majority of which are companies of the size covered by the
ETS. Ninety percent of facilities surveyed had 100 or more employees at
their facilities, and 56% had more than 100 but less than 1,000
employees at their facilities. The industry sectors surveyed include:
Technology and software; business and professional services;
manufacturing; construction; healthcare, hospitals, and clinics; retail
stores; retail food stores; consumer retail service; energy and
utilities; nonprofit organizations; education (colleges and
universities); education (pre-K to 12); real estate and property
management; agriculture and food production; healthcare services; media
and entertainment; government and quasi-public; biotech,
pharmaceuticals, and diagnostics; restaurants and food service; hotels
and casinos; transportation, distribution, and logistics; consumer
transportation; and recreation (ASU WEF, September 2021).
The survey responses related to vaccination policies support OSHA's
determination that it is feasible for covered employers to implement
mandatory COVID-19 vaccination policies. The survey results showed that
45% of employers surveyed require all employees to be vaccinated
against COVID-19, and an additional 16% require some of its employees
to be vaccinated against COVID-19. (ASU WEF, September 2021). Only
three percent of employers surveyed did not have a vaccination policy
at the time (ASU WEF, September 2021). While this survey covers a wide
range of industries it may not represent the percentage of companies
implementing mandatory vaccination policies in general populations but
for the feasibility purposes it demonstrates that it has and can be
done.
OSHA also reviewed slightly older survey data, which, even though
it shows somewhat lower rates of employer vaccination mandates, still
supports OSHA's finding that such vaccination polices are feasible. In
late June 2021, the National Safety Council (NSC) conducted three
national surveys, one organizational and two workforce, of private
companies, nonprofits, legal experts, public health professionals,
medical professionals and government agencies that have addressed
workforce COVID-19 vaccinations based on best practices and proven
workplace safety strategies. The survey results show that many
employers and organizations are currently requiring employees to be
vaccinated.
The three surveys were distributed to 300 employers and
organizations across the country and from a wide range of industries to
collect data on pandemic response, including implementation of COVID-19
vaccine policies and testing among their workforce. Of the employers
and organizations surveyed in June 2021, the NSC found that 20% were
implementing some form of a worker vaccination requirement. While OSHA
believes that the ASU WEF surveys (which included more employers and
are more recent) are better indicators of current employer vaccination
policies, the NSC surveys also support the feasibility of employer
vaccination mandates (NSC, September 2021)
The NSC, in partnership with the Health Action Alliance (HAA) and
the Centers for Disease Control and Prevention (CDC), have developed a
multifaceted, comprehensive effort called SAFER, aimed at helping
employers prioritize health and safety as they develop plans and
polices for their employees to return to the workplace (NSC, May 17,
2021). Through SAFER, the NSC and HAA developed a web-based decision
tool to guide employers on health, legal, and other considerations to
prioritize the health and safety of workers. Due to the Delta Variant
surge of new COVID-19 cases across the United States, the NSC and HAA
revised the SAFER resources, including the online tool, to include
information about employer requirements for COVID-19 vaccinations.
These include guides for developing plans and policies to support
employee vaccination through mandates and incentives; the collection
and maintenance of COVID-19 vaccination records; and various
considerations for testing unvaccinated workers. (HAA and NSC,
September 17, 2021). The availability of these publicly-accessible
tools to help employers develop vaccination policies further reduces
any potential barriers for covered employers to establish and implement
a written policy requiring each employee to be fully vaccinated against
COVID-19, or alternatively to establish a policy allowing employees to
choose whether to be fully vaccinated or tested for COVID-19 at least
every seven days and wear face coverings.
The HAA maintains an online list of large companies requiring
vaccinations for all or part of their workforce or customers. OSHA
reviewed the list of companies, drawn from news reports and employer
websites, with requirements for COVID-19 vaccination. Most of the
companies listed require some or all employees to be vaccinated against
COVID-19 while allowing medical exemptions or reasonable accommodations
for disability or religious reasons. There are currently 188 listed
companies across numerous industry sectors, including Amtrak, Deloitte,
Google, The Walt Disney Company, Walmart, and the U.S. Chamber of
Commerce.\21\
---------------------------------------------------------------------------
\21\ https://www.healthaction.org/resources/vaccines/covid-19-vaccines-employer-requirements-health-action-alliance?0405d6f4_page=1 (last visited October 2, 2021).
---------------------------------------------------------------------------
While healthcare employers subject to 29 CFR 1910.502 are not
covered by this ETS, a number of large healthcare employers have
implemented mandatory vaccine policies. This also shows the feasibility
of the employers implementing mandatory vaccination requirements, often
on large scales. According to the American Hospital Association (AHA),
over 1,800 hospitals
[[Page 61449]]
have one or more vaccination requirements in place (Becker's Hospital
Review, October 11, 2021). Large healthcare employers mandating that
their employees be vaccinated include Kaiser Permanente, the nation's
largest integrated, nonprofit health care organization with more than
216,000 employees and more than 23,000 physicians (Kaiser Permanente,
August 2, 2021); Trinity Health, one of the largest multi-institutional
Catholic health care delivery systems in the nation, with more than
123,000 employees and 90 hospitals in 22 states (Trinity Health, July
8, 2021); Sanford Health, which operates in 26 states and employs
nearly 50,000 people (Sanford Health, July 22, 2021); and Genesis
Health Care, a large U.S. nursing home chain with over 40,000 employees
working in more than 250 centers across 23 states (Genesis Health Care,
September 29, 2021).
Under paragraph (d)(2), if employers do not establish and implement
a written mandatory vaccination policy, the employer must establish and
implement a written policy allowing any employees not subject to a
mandatory vaccination policy to either choose to be fully vaccinated or
regularly tested for COVID-19 and wear a face covering. A substantial
number of employers already have such policies in place. For example,
the ASU WEF survey shows that 30% of employers surveyed require
unvaccinated employees to participate in mandatory COVID-19 testing and
30% of employers require face coverings for unvaccinated employees (ASU
WEF, September 2021).
OSHA also notes a number of state COVID-19 vaccination
requirements. In response to the Delta Variant surge, 19 states have
implemented written COVID-19 vaccination and testing policies for state
employees and 23 states have done so for healthcare employees (NASHP,
October 1, 2021). For example, on September 20, 2021, the Colorado
Department of Public Health and Environment (CDPHE) implemented
policies requiring state employees and personnel at health care
facilities and hospitals to be fully vaccinated against COVID-19. All
state employees must either be fully vaccinated against COVID-19 or
participate in twice-weekly testing. Employees are allowed work time to
get tested and administrative or Public Health Emergency Leave to get
vaccinated. Employees who are not fully vaccinated must wear masks
inside state facilities when they are around others. On August 30,
2021, the State Board of Health approved a vaccine requirement for
personnel in health care settings with high-risk patients. All
personnel affected by this rule needed to receive their first dose of
COVID-19 vaccine by September 30, 2021, and must be fully vaccinated by
October 31, 2021 (CDPHE, September 17, 2021).
A number of local governments have also implemented policies
requiring COVID-19 vaccination or testing for employees. For example,
the Fulton County Board of Commissioners in Georgia recently approved a
``Vax or Test'' policy requiring employees to get vaccinated or tested
for COVID-19 each week. Since September 6, 2021, Fulton County has
required all County employees, as a condition of employment, to either
be vaccinated against COVID-19 or be tested weekly for COVID-19 unless
an employee is granted a reasonable accommodation (Fulton County
Government, September 03, 2021). The multitude of local, state, and
employer vaccination or testing mandates across the country support
OSHA's finding that such policies are feasible.
II. Determining Employee Vaccination Status
Paragraph (e) of the ETS requires employers to determine the
vaccination status of each employee. Employers must require employees
to provide an acceptable proof of vaccination status, including whether
they are fully or partially vaccinated. As discussed in Summary and
Explanation (Section VI. of this preamble), acceptable proof of
vaccination status is: (i) The record of immunization from a health
care provider or pharmacy; (ii) a copy of the COVID-19 Vaccination
Record Card; (iii) a copy of medical records documenting the
vaccination; (iv) a copy of immunization records from a public health,
state, or tribal immunization information system; or a copy of any
other official documentation that contains the type of vaccine
administered, date(s) of administration, and the name of the health
care professional(s) or clinic site(s) administering the vaccine(s). A
signed and dated employee attestation is acceptable in instances when
an employee is unable to produce proof of vaccination. Given the
attestation option, there are no technological barriers to the
provision for proof of vaccination status. As discussed below, many
employers requiring proof of vaccination have successfully implemented
such policies even without allowing the flexibility of the attestation
option.
The employer must maintain a record and a roster of each employee's
vaccination status. This information is subject to applicable legal
requirements for confidentiality of medical information. These records
must be preserved while the ETS is in effect. OSHA is not aware of any
technological challenges that the large employers covered by this ETS
would face with respect to collecting and maintaining records. This is
a performance-based requirement, meaning that employers have the
flexibility to structure their systems to fit within current systems,
such as those relating to personnel records, tax records, and other
sensitive or confidential records gathered and maintained by large
employers.
A number of the surveys discussed above also show that most
employers with vaccine mandates require proof of vaccination. For
example, ASU WEF workplace COVID-19 survey from fall 2021 found that
60% of employers that required vaccinations also required proof of
vaccination from employees. The NSC study from June 2021 found that 45%
of employers with COVID-19 vaccination requirements required proof of
vaccination, such as submitting a copy of the COVID-19 vaccination
card. An additional 30% of employers surveyed verify employee
vaccination status through self-reporting based on the honor system.
Additionally, a large-scale survey conducted by the Willis Towers
Watson consulting firm between August 18 and 25, 2021, showed that a
majority of employers currently track their employees' vaccination
status. Nearly one thousand employers responded to this survey, and
they collectively employ 9.7 million workers from industries across the
public and private sectors including manufacturing, general services,
wholesale and retail, IT and telecom, healthcare, financial services,
energy and utilities, and public sector and education (Willis Towers
Watson, June 23, 2021). Nearly six in 10 (59%) currently track their
workers' vaccination status and another 19% are planning or considering
doing so later this year. A majority (62%) of those employers who
currently track their workers' vaccination status require proof of
vaccination, such as CDC vaccination cards, while 36% rely on employees
to self-report (Willis Towers Watson, September 1, 2021).
Other evidence in the record also supports the feasibility both of
gathering proof of vaccination and determining employees' vaccination
status. Many large employers with vaccination policies require
employees to submit proof of vaccination. For example, Tyson Foods
requires employees to submit proof of vaccination to Tyson
[[Page 61450]]
Foods Vaccination Verification Program in order to qualify for the
company's vaccination incentive (Tyson Foods, August 3, 2021).
Similarly, Capital One bank requires all employees, contractors,
vendors, and visitors to Capital One facilities to show proof of
vaccination. (Capital One, August 11, 2021). The International Union of
Painters and Allied Trades (IUPAT), which represents 140,000
craftspeople in the U.S. and Canada and has implemented vaccine
requirements for its members, also requires all of its own non-
bargaining unit office and field employees to show proof of
vaccination. (IUPAT, May 10, 2021).
CVS Health, a health conglomerate with more than 300,000 employees,
including more than 40,000 physicians, pharmacists, nurses and nurse
practitioners, has mandated COVID-19 vaccination for its nurses,
pharmacists and other employees who interact with patients and requires
proof of vaccination for those employees (CVS Health, August 23, 2021).
The surveys and employer policies reviewed by OSHA all support the
agency's finding that it is feasible for employers to determine their
employees' vaccination status and collect proof of vaccination.
III. Providing Support for Vaccination
Paragraph (f) of the ETS requires employers to support COVID-19
vaccination for each employee by providing a reasonable amount of time
to each employee for vaccination and reasonable time and paid sick
leave to each employee for side effects experienced following
vaccination. The feasibility of paying for the time is addressed in
OSHA's economic analysis.
This technological feasibility determination focuses on whether
employers would encounter obstacles in implementing payment policies
that would make this requirement infeasible for the large employers
covered by this ETS. OSHA has determined that there are no such
obstacles. Most significantly, OSHA has already required this type of
system for employers covered by the Healthcare ETS and nearly four
months after that ETS took effect, OSHA is not aware that employers
covered by that ETS experienced any technological compliance
difficulties with respect to that requirement. In addition, many
employers have already implemented policies such as those required to
comply with this new ETS as a way of incentivizing employee
vaccination. For example, the ASU WEF workplace COVID-19 survey from
fall 2021 found that 60% of employers surveyed offered incentives for
employees to be vaccinated. These incentives ranged from additional
paid time off, cash, the ability to bypass regular testing and/or daily
health screening requirements, and gifts. Eighteen percent of surveyed
employers already provide additional time off for COVID-19 vaccination.
Moreover, the NSC survey found that 86% of surveyed organizations had
implemented policies such as paid time off, assistance with scheduling
and transportation, and/or onsite vaccination.
OSHA's review of plans and best practice documents from the HAA
registry and from other publicly-available sources also inform OSHA's
finding that it is feasible for large employers to support employee
vaccination (HAA, October 10, 2021). As part of this review, OSHA
analyzed the ways that employers are currently supporting employee
vaccination. One employer in the restaurant industry, the Fifty/50
Group, a Chicago-based restaurant group comprised of 14 establishments
that requires employees to be fully vaccinated, offers paid time off
for anyone getting a vaccine or feeling the mild after-effects. (Fifty/
50 Group, May 18, 2021). Another employer in the animal slaughtering
and processing industry, Tyson Foods, requires COVID-19 vaccinations
for its U.S. workforce and also offers $200 and up to four hours of
regular pay if employees are vaccinated outside of their normal shift
or through an external source (Tyson Foods, August 3, 2021). In
addition, Tyson Foods supports onsite vaccination events in
collaboration with local health departments and healthcare providers to
improve accessibility to vaccination. Tyson Foods has hosted more than
100 vaccination events at its locations across the country.
The evidence in the record demonstrates that many employers are
already offering the types of vaccination support required by paragraph
(f). Combined with OSHA's previous finding for a similar provision in
the Healthcare ETS and the lack of compliance difficulties reported
while that ETS has been in effect, OSHA therefore finds this
requirement is technologically feasible.
IV. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
Paragraph (g) of the ETS requires employers to ensure that
employees who are not fully vaccinated and who report at least once
every seven days to a workplace where other individuals such as
coworkers or customers are present are: (1) Tested for COVID-19 at
least once every seven days; and (2) provide documentation of the most
recent COVID-19 test result to the employer no later than the seventh
day following the date the employee last provided a test result.
Employers must also ensure that employees who are not fully vaccinated
and do not report during a period of seven or more days to a workplace
where other individuals are present are: (1) Tested for COVID-19 within
seven days prior to returning to the workplace; and (2) provide
documentation of that test result upon return to the workplace.
Employees who are not fully vaccinated must be tested with a COVID-
19 test, which is a test for SARS-CoV-2 that is: (i) Cleared, approved,
or authorized, including in an Emergency Use Authorization (EUA) by the
U.S. Food and Drug Administration (FDA) to detect current infection
with the SARS-CoV-2 virus (e.g., a viral test); (ii) administered in
accordance with the authorized instructions; and (iii) not both self-
administered and self-read unless observed by the employer or an
authorized telehealth proctor. Examples of tests that satisfy this
requirement include tests with specimens that are processed by a
laboratory (including home or on-site collected specimens which are
processed either individually or as pooled specimens), proctored over-
the-counter tests, point of care tests, and tests where specimen
collection is either done or observed by an employer.
COVID-19 testing has become more widely available throughout the
pandemic and as of September 2021, the FDA has authorized approximately
250 tests and collection kits that diagnose current infection with the
SARS- CoV-2 virus and may be acceptable under the ETS (FDA, September
10, 2021), and by October 1, 2021, the number of EUAs issued had grown
to 324 (FDA, October 1, 2021). The ETS permits compliance through use
of a wide range of FDA-authorized tests that are readily available, so
there is little doubt that testing itself is technologically feasible.
This technological feasibility analysis therefore focuses on
whether testing will continue to be readily available in quantities
sufficient to meet the potential increase in testing demand while this
ETS is in place. Given the wide variety of tests that can be used to
comply with this ETS and OSHA's review of information about the
existing manufacturing and distribution capabilities of test
manufacturers, the agency does not anticipate feasibility issues
related to ensuring that
[[Page 61451]]
employees can get access to one of the acceptable tests within the time
frames required by the ETS.
a. Brief Overview of Testing and Administration
COVID-19 tests that are cleared, approved, or authorized, including
in an Emergency Use Authorization (EUA), by the FDA to detect current
infection with the SARS-CoV-2 virus (e.g., a viral test) satisfy the
ETS. FDA-cleared, approved, or authorized molecular diagnostic tests
and antigen tests are permitted under the ETS when used as authorized
by the FDA and with a Clinical Laboratory Improvement Amendments of
1988 (CLIA) certification when appropriate. As described in the Summary
and Explanation for paragraph (g) (Section VI.G. of this preamble),
NAATs are a type of molecular test that detect genetic material. As of
October 14, 2021, the FDA had issued EUAs for 264 molecular COVID-19
tests including tests specified to be used ``with certain conditions of
authorization required of the manufacturer and authorized
laboratories'', 81 of which are authorized for home collection.
Additionally, the FDA has issued EUAs for 2 OTC molecular COVID-19 test
kits available without a prescription (FDA, October 14, 2021b).
NAATs, such as real-time reverse transcription-polymerase chain
reaction (RT-PCR), have greater accuracy than antigen tests. However,
most FDA-authorized NAATs need to be processed in a laboratory
certified under the Clinical Laboratory Improvement Amendments of 1988
(referred to as a ``CLIA-certified laboratory'') with variable time to
results (~1-2 days). While the NAAT test is a more reliable test, the
antigen test is faster and less expensive.
An antigen test is an in vitro diagnostic test used to detect
active SARS-CoV-2 infection. As of October 14, 2021, the FDA had issued
37 EUAs for COVID-19 antigen tests, including eight EUAs for over-the-
counter (OTC) antigen tests that can be used without a prescription
(FDA, October 14, 2021a).
Administration of an antigen test that meets the definition of
COVID-19 test under this ETS falls into one of several categories: OTC
employee self-tests that are observed by employers or authorized
telehealth proctors; point-of-care (POC) or OTC tests performed by
employers with a CLIA certificate of waiver; and other FDA cleared,
approved, or authorized antigen tests that are analyzed in a CLIA
certified laboratory setting (FDA, October 14, 2021a). The FDA has
authorized POC tests that can be used at a place of employment when the
facility is operating under a CLIA certificate of waiver. A CLIA
certificate of waiver can be issued by CMS and may, when consistent
with FDA's authorization, allow a laboratory to run a SARS-CoV-2 test
outside a high or moderate complexity traditional clinical laboratory
setting (CDC, September 9, 2021). In accordance with the CLIA
certificate of waiver, the laboratory or POC testing site must use a
test authorized for that location, like an FDA EUA POC test, and must
adhere to the authorized test instructions to avoid human error.
Certain COVID-19 antigen diagnostic tests can be analyzed on-site
(where the person took the nasal swab) when that facility is operating
under a CLIA certificate of waiver, while others must be analyzed in a
CLIA certified high or moderate complexity laboratory setting. Some
COVID-19 antigen diagnostic tests are authorized for use at home,
without the need to send a sample to a laboratory. Antigen tests
generally return results in approximately 15-30 minutes. The CDC
provides training materials created by test manufacturers for POC
antigen testing and reading of results for SARS-CoV-2 (CDC, July 8,
2021).
COVID-19 antigen diagnostic tests are found at physician offices;
urgent care facilities; pharmacies, such as CVS or Walgreens; school
health clinics; long-term care facilities and nursing homes; temporary
locations, such as drive-through sites managed by local organizations;
and other locations across the country (CDC, July 8, 2021; CVS Health,
October 2021; Walgreens, October 8, 2021). The availability of
government-offered antigen tests varies by state, and may be free or
subsidized and accessible without a prescription or physician note
(RiteAid, October 2021; Walgreens, October 2021; HHS, June 11, 2021).
The Department of Health and Human Services (HHS) provides a publicly-
available list of community-based testing locations in each state that
offer free COVID-19 testing for insured and uninsured residents (HHS,
August 17, 2021). Pharmacies and other locations often provide antigen
tests by appointment, although some will allow testing for walk-ins
(CVS Health, September 2021; Walgreens, October 8, 2021). COVID test
kits are currently available from several on-line retailers (Amazon,
October 12, 2021).
b. Testing Frequency
The ASU WEF survey data also supports OSHA's finding that the
requirement for employees who are not fully vaccinated to be tested at
least every seven days is feasible. The ASU WEF found that 73% of
survey surveyed employers (797 employers) had testing policies for
their workforce, and 76% of those employers had implemented mandatory
testing requirements. Additionally, 25% of employers with testing
polices had implemented requirements for routine testing of a portion
of or the entire workforce, and 41% no longer require testing for fully
vaccinated employees. Of the employers that test employees, 27% of
those perform viral testing daily and 46% perform viral test once a
week. Finally, 38% of companies exclusively administer polymerase chain
reaction (PCR) tests (PCR tests are a type of NAAT), 17% exclusively
administer antigen tests, and 45% administer both. Companies administer
a range of COVID-19 tests and conduct testing at a variety of locations
(some companies use more than one location). Forty-two percent of
companies test workers at health testing laboratories, 35% test onsite
at work, 28% test at hospitals, 23% test at retail pharmacies, 13% test
at universities, 9% test at home to be sent a lab for evaluation, and
5% test at home for immediate results (ASU WEF, September 2021).
OSHA also evaluated evidence of employers' current testing efforts
by reviewing existing COVID-19 practices developed by employers, trade
associations, and other organizations. Based on its review, OSHA
concludes that it is feasible for most covered employees (and therefore
their employers) to be tested in compliance with the ETS requirements
for frequency of testing.
OSHA notes that there are several options for large employers to
consider if they want to help facilitate testing for employees who are
not vaccinated. Delta Airlines, for example, currently requires weekly
COVID-19 testing for all of its employees who are not vaccinated, and
the company has engaged the Mayo Clinic Laboratories to help design the
employee testing program, assist in administering diagnostic and
serology tests, and analyze the results to determine broader trends and
provide recommendations to Delta's existing policies and procedures
(Mayo Clinic Laboratories, June 30, 2020). Delta Airlines also operates
onsite testing in cities with large employee populations including
Atlanta, Minneapolis, and New York. It recently extended an at-home
specimen collection option to all U.S. employees, through which Quest
Diagnostics will send self-collection kits directly to an employee's
doorstep upon request and support complete laboratory confirmation for
results (Delta, August 25, 2021).
[[Page 61452]]
c. Availability of COVID-19 Tests
In the spring and early summer months of 2021, demand for tests
decreased as vaccinations began to increase and the number of COVID-19
cases declined before the Delta surge and some manufacturers slowed
production of COVID-19 tests. However, the number of tests performed
daily has grown considerably over the summer due to the Delta Variant
surge and re-openings of workplaces and schools. In parallel with the
Delta surge, COVID-19 testing has increased from a daily average of
about 450,000 in early July 2021 to about 1.8 million by mid-September
2021, or roughly 12.6 million per week (JHU, October 8, 2021). This
data does not include any self-administered OTC tests, which will be
discussed below.
OSHA's review of the evidence shows that the increasing rate of
production of COVID-19 tests is more than adequate to meet rising
demand related to compliance with the ETS testing option before the 60-
day delayed testing compliance date (see paragraph (m)(2)(ii)). This
determination is largely based on the number of tests with FDA EUAs
actively being produced through the National Institutes of Health (NIH)
Rapid Acceleration of Diagnostics (RADx) initiative described below.
According to the Johns Hopkins University of Medicine Coronavirus
Resource Center, the total tests administered in August 2021 was
approximately 44.4 million (or approximately 11.1 million per week).
Id. During that same month, the total tests produced by the NIH RADx
contracts was approximately 121 million (which would average to 30.25
million per week), resulting in a substantial surplus of available
tests (NIBIB, September 28, 2021). As discussed in Economic Analysis,
Section IV.B. of this preamble, Table IV.B.8, OSHA estimates that as
many as 7.2 million tests may be administered weekly under this
standard; however, 7.2 million is almost certainly an overestimate
because it does not exclude employees who are already required to be
tested by their employers and would continue to be tested at the same
frequency after the ETS. Even if testing is increased by 7.2 million
tests per week because of the ETS, that would still mean a surplus of
nearly 12 million tests per week beyond what would be need to continue
at current testing levels with the addition of ETS-related tests (30.25
- 11.1 - 7.2 = 11.95 million surplus per week).
The total number of tests administered during June, July, and
August 2021, the period of the summer including the Delta Variant surge
and other reasons for substantial testing increases such as re-opening
of schools, was approximately 87 million tests, an average of
approximately 6.7 million per week (JHU, October 8, 2021). During that
period, more than 400 million COVID-19 tests were produced through the
NIH RADx initiative, or roughly 33 million per week. OSHA anticipates
that this surplus of tests will continue to increase the availability
of tests that can be used to comply with the ETS.
The data from the Johns Hopkins Coronavirus Resource Center is
collected from state and county government sources, so it does not
include any self-administered OTC tests. Additionally, while all states
report PCR testing, not all states report antigen testing.
Nevertheless, the data from Johns Hopkins Coronavirus Resource Center
is the best available evidence from which to estimate the total number
of tests administered during a given period of time. Even though the
number of administered tests reported through the Johns Hopkins
Coronavirus Resource Center does not include unreported OTC tests, the
NIH RADx program data shows a large surplus and sufficient additional
COVID-19 test capacity relative to the number of administered tests
reported. Additionally, the NIH RADx program will further allow for
increased test distribution through retail markets and will address any
increase in demand due to companies that may stockpile tests. This
increased availability will strengthen test capacity, further enabling
compliance with the ETS testing provision (NIBIB, September 28, 2021).
OSHA has determined that even with an estimated additional 7.2 million
tests administered weekly due to the ETS (see Economic Analysis
(Section IV.B. of this preamble)), there are sufficient COVID-19 tests
available to allow for both employers and employees to obtain COVID-19
tests through a variety of retail sources (e.g., local pharmacies, on-
line purchasing as discussed above).
Determinations of testing capacity are aggregate measures of
domestic and global market and supply chains. Throughout the pandemic,
diagnostic testing capacity has been stressed by the increased demand,
as some products that are part of a global market cannot adapt by
simply increasing manufacturing in one country (e.g., laboratory
instruments), and other products manufactured domestically require
capital investments to address rising demands (e.g., extraction kits)
(CRS, February 25, 2021). As discussed below, because of the
substantial investments made, OSHA projects that the diagnostic testing
capacity can meet the increased demand due to this ETS.
OSHA evaluated multiple projections of current and future testing
capacity and determined that projections related to the NIH initiatives
discussed below are the most reliable estimates of current and future
testing capacity for its technological feasibility assessment. Test
manufacturers receiving NIH, FDA, and Biomedical Advanced Research and
Development Authority (BARDA) (a component of HHS) funding as part of
these programs undergo a submission and authorization process where
their production capacity and pipeline are assessed and production
quantities are validated. As explained below, as of August 2021, the
NIH data indicates testing capacity stands at about 30 million tests
per week, and capacity continues to grow (NIBIB, September 28, 2021).
OSHA notes that this number underestimates the total number of tests
available each week, as it only includes companies that have received
funding for tests and testing supplies through the NIH initiatives
described below.
The NIH has identified constraints on testing capacity as an area
of focus and investment since the beginning of the COVID-19 pandemic,
and OSHA examined potential constraints on testing capacity as part of
its feasibility analysis. As described below, massive investments in
testing capabilities, particularly in underserved areas, have largely
mitigated issues with the availability of COVID-19 tests. Further,
testing capacity continues to grow as new tests are developed and
brought to market and manufacturers can ramp up supply to meet any
future testing demands if need be.
The FDA has authorized more than 320 tests and collection kits that
diagnose current infection with the SARS-CoV-2 virus and may be
acceptable under the ETS (FDA, October 1, 2021). Among other criteria,
the standard allows for the use of tests with specimens that are
processed by a CLIA certified laboratory (including home or on-site
collected specimens which are processed either individually or as
pooled specimens), proctored over-the-counter tests, point of care
tests, and tests where specimen collection and processing is either
done or observed by an employer. As explained above, many employers
across various industry sectors have already implemented policies for
onsite testing. The use of FDA-authorized POC tests by these employers
would be compliant with the testing provision of the ETS if the entity
administering the test holds a CLIA
[[Page 61453]]
certificate as required by the EUA. COVID-19 OTC tests that are both
self-administered and self-read by employees do not satisfy the testing
requirement unless observed by the employer or an authorized telehealth
proctor. In the event that the employer is merely observing the
employee conduct a test, a CLIA certificate would not be needed.
There have been extensive investments, including by the federal
government, to help ensure that COVID-19 tests are widely available.
Section 2401 of the American Rescue Plan appropriated $47,800,000 to
the Secretary of the HHS, to remain available until expended, to carry
out activities to detect, diagnose, trace, and monitor SARS-CoV-2 and
COVID-19 infections and related strategies to mitigate the spread of
COVID-19. Funds were made available to implement a national testing
strategy; provide technical assistance, guidance, support, and awards
grants or cooperative agreements to State, local, and territorial
public health departments; and support the development, manufacturing,
procurement, distribution, and administration of tests to detect or
diagnose SARS-CoV-2 and COVID-19; and establish federal, state, local
and territorial testing capabilities.
On April 29, 2020, the NIH established the RADx initiative with a
$1.5 billion investment. The RADx initiative has used this funding to
speed development of rapid and widely-accessible COVID-19 testing (NIH,
April 29, 2020). On October 6, 2020, the NIH and BARDA established the
RADx Technology (RADx-Tech) and RADx Advanced Technology Platforms
(RADx-ATP) programs to speed innovation in the development,
commercialization, and implementation of technologies for COVID-19
testing specifically for late-stage scale-up projects. Through the RADx
Tech and RADx-ATP programs, the NIH and BARDA have awarded a total of
$476.4 million in manufacturing expansion contracts supporting a
combined portfolio of 22 companies in the U.S. (NIH, October 6, 2020).
These programs have significantly increased testing capacity
throughout the country. Since being established, RADx has worked
closely with the FDA, the CDC, and BARDA to move more advanced
diagnostic technologies swiftly through the development pipeline toward
commercialization and broad availability. On April 28, 2021, the
Institute of Electrical and Electronic Engineers (IEEE) dedicated a
special issue in the Journal of Engineering in Medicine and Biology
exploring the innovative structure and operation of the RADx Tech
program and determined that the initiatives had succeeded in
dramatically increasing COVID-19 testing capacity in the United States.
The IEEE report found that the RADx Tech/ATP programs, in conjunction
with BARDA and the FDA, had streamlined and bolstered the national
COVID-19 testing capacity. At the time of the report, the RADx Tech/ATP
programs had increased the number of testing makers to 150 companies
that, as a result of the NIH/BARDA investments, had the capacity to
produce up to 1.9 million tests per day (IEEE, April 28, 2021).
The NIH RADx-TECH/ATP initiative entered its second phase on
September 28, 2021, and at that time the supported companies had
collectively produced over 500 million tests, received 27 FDA
authorizations, and developed the first OTC COVID-19 test for use at
home. These September 2021 investments are supporting late stage
development of innovative point-of-care and home-based tests, as well
as improved clinical laboratory tests that will increase the capacity
of testing in the U.S. A full list of active contracts and supported
U.S. COVID-19 testing manufacturers can be found on the NIH RADx-TECH/
ATP programs: Phase 2 awards (NIBIB, October 14, 2021).
The following example shows the NIH RADx EUA pipeline process. On
May 9, 2020, the FDA authorized the first EUA for a COVID-19 antigen
test, a new category of tests for use in the ongoing pandemic. Quidel
was awarded a contract under the NIH RADx TECH/ATP phase 1 initiative
for the Sofia 2 SARS Antigen FIA for use in high and moderate
complexity laboratories certified by CLIA, as well as for point-of-care
testing by facilities operating under a CLIA certificate of waiver
(FDA, May 9, 2020). On July 31, 2020, Quidel announced that it had
received a contract for $71 million under the NIH RADx TECH/ATP
program, phase 1, to accelerate the expansion of its manufacturing
capacity for production of the SARS-CoV-2 rapid antigen test and
quickly exceeded that capacity (Quidel Corp., July 31, 2020). On March
31, 2021, the FDA then authorized a second EUA from Quidel under
contract with the NIH RADx initiative for the QuickVue At-Home OTC
COVID-19 Test, another antigen test where certain individuals can
rapidly collect and test their sample at home, without needing to send
a sample to a CLIA certifed laboratory for analysis (FDA, March 31,
2021). Furthermore, based on the success of the Quidel for the Sofia 2
SARS Antigen FIA increasing production capacity, the NIH granted
another $70 million contract for manufacturing Capacity Scale-Up for
Sofia SARS Antigen and Sofia Influenza A+B/SARS FIAs on June 11, 2021
(FDA, June 11, 2021).
The RADx-TECH/ATP initiative maintains a dashboard of manufacturer
testing data from supported U.S. firms. OSHA reviewed the data
available on the dashboard as part of its determination of feasibility.
In August 2021, the data showed that U.S. manufacturers supported by
the NIH RADx-TECH/ATP were producing approximately 30 million tests per
week (NIBIB, September 28, 2021).
While consumers in some parts of the country have encountered
difficulty obtaining rapid at-home tests, on October 4, 2021, the FDA
granted EUA for the ACON Laboratories Flowflex COVID-19 Home Test,
which is anticipated to double rapid at-home testing capacity in the
United States within weeks (and well before compliance dates for
testing required by this ETS) (FDA, October 4, 2021). By the end of the
2021 (ahead of the paragraph (g) compliance date), the manufacturer
plans to produce more than 100 million tests per month and plans to
produce more than 200 million tests per month by February 2022 (FDA,
October 4, 2021). On October 6, 2021, the Administration announced a
plan to buy $1 billion worth of rapid at-home COVID-19 tests; this
purchase, coupled with the October 4 authorization of the Flowflex
COVID-19 test, is expected to increase the number of available at-home
COVID-19 tests to 200 million per month by December 2021 (Washington
Post, October 6, 2021).
These investments have had a pronounced impact on the availability
of testing and employers' use of testing in the workplace. ASU's recent
report, How Work has Changed: The Lasting Impact of COVID-19 on the
Workplace, ascribed the jump in the percentage of employers that test
their employees from 17% in the fall of 2020 to 70% in the fall of 2021
in large part to the increased availability of testing. In particular,
the report noted that by the spring of 2021, ``it became relatively
easy to acquire tests and hire testing service providers. There are
more labs and companies with EUA's and most have enough capacity that
there are few shortages.'' (ASU WEF, September 2021).
Moreover, to ensure a broad, sustained capacity for COVID-19 test
production, multiple COVID-19 test manufacturers have been mobilized by
authority of the Defense Production Act. Under the Administration's
plan to increase COVID-19 testing, the federal
[[Page 61454]]
government will directly purchase and distribute 280 million- rapid
point-of-care and over-the-counter at-home COVID-19 tests, sending 25
million free at-home rapid tests to community health centers and food
banks. These actions will provide tests for use by communities to build
adequate stockpiles, as well as the sustained production to be able to
scale up production as needed in the future. Additionally, to ensure
convenient access to free testing, 10,000 pharmacies will be added to
the Department of Health and Human Services free testing program.
In response to rising demands for testing, U.S. manufacturers have
increased production of COVID-19 test kit, reagents, and supplies.
Advanced Medical Technology Association (AdvaMed), a trade group for
testing manufacturers, reported that its members are ramping up
production of rapid point-of-care test supplies to meet demand and that
laboratory-based testing capacity for test confirmation is strong.
AdvaMed has created a national COVID-19 Diagnostic Supply Registry of
COVID-19 test manufacturers that support state and federal governments
in their pandemic responses. Registry participants are thirteen leading
diagnostic manufacturers whose tests together comprise approximately
75-80% of the COVID-19 in vitro diagnostic devices (IVD) on the market
in the U.S. While these manufacturers produce a majority of molecular
COVID-19 tests, they do not produce a majority of the total COVID-19
tests manufactured. These COVID-19 test manufacturers collectively
shipped approximately 3.8 million tests in July 2021, 8.2 million tests
in August 2021, and 9.4 million molecular tests for the week ending
September 4th, 2021 (AdvaMed, September 10, 2021). While these figures
are not representative of the total weekly testing capacity in the
U.S., this data demonstrates that testing capacity has grown
significantly over the past few months and reflects the success
manufacturers have had in ramping up production of tests.
While current test availability is sufficient to meet the increased
testing demands due to the ETS, OSHA is also confident that the RADx-
TECH/ATP initiatives will continue to spur testing capacity and growth.
The RADx-TECH/ATP initiatives have focused on moving test makers'
products through the late stage pipeline and securing FDA authorization
for entry into the market. So far, there have been 27 such
authorizations. As of September 2021, there were 824 eligible late-
stage scale up proposals from various test makers up for review for
NIH/BARDA funding. Furthermore, 517 of these submissions are for the
authorization and production of multiple types of COVID-19 tests
including one or more of the following: Blood, sputum, nasal swab, oral
swab, fecal, saliva, or other types. OSHA considers this to be further
support for its determination that testing capacity will continue to
grow and that increased COVID-19 testing supplies are on the horizon
(NIBIB, September 28, 2021).
Based on data from the Johns Hopkins Coronavirus Resource Center,
which examined publicly-available data from multiple sources,
approximately 12.4 million tests were conducted during the week of
August 26-September 2, 2021. As noted earlier, in the economic analysis
of this ETS, OSHA projects testing rates to increase by approximately
7.2 million tests per week starting 60 days after publication of the
ETS. As described above, many employers are currently testing their
workforce. This 7.2 million is almost certainly an overestimate because
it does not exclude employees who are already required to be tested by
their employers and would continue to be tested at the same frequency
after the ETS. The data reviewed by OSHA on the RADx-TECH/ATP Dashboard
shows that the manufacturers supported by the initiative are producing
approximately 30 million tests per week, and capacity continues to
grow. As explained above, it is expected that roughly 50 million at-
home COVID-19 tests will be available each week by December 2021. OSHA
therefore finds that there are (and will continue to be) sufficient
COVID-19 tests available to meet the anticipated demand related to
compliance with paragraph (g) by the 60-day delayed compliance date.
d. Availability of COVID-19 Test Supplies
OSHA has also analyzed the availability of COVID-19 test supplies
for use by COVID-19 test kit manufacturers, diagnostic laboratories,
and determined that there are sufficient supplies to allow compliance
with the ETS testing option. The COVID-19 pandemic and recent Delta
Variant surge have caused some disruptions in the availability of
testing supplies such as swabs, viral transport medium, RNA extraction
kits, serology consumables, diagnostic reagents, plastic consumables,
and diagnostic instruments. The COVID-19 testing supply market is
driven by the need to rapidly screen large segments of the population
and deliver test results. The data presented throughout this assessment
has shown demand for laboratory COVID-19 tests is rising across the
country.
Testing for COVID-19 involves many different components that are
manufactured, transported, and used independently (e.g., bulk solvents,
extracting reagents, packaging) or semi-independently (e.g., test
kits). Most of the supplies used in COVID-19 testing are disposable,
requiring a constant sustained capacity for new supplies. Some
distribution channels move supplies directly to medical and laboratory
end-users and others move supplies through distributors. In either
case, the combination of increased testing demand and the established
supply chains indicate that testing kits will be available in
sufficient quantities throughout the country, including in rural areas
where large employers may be located.
There have been substantial investments from federal and state
programs and private industry to stimulate the production and
distribution of testing supplies to bolster testing capacity across the
country. Many products, such as swabs and reagents for RNA extraction
kits, exhibited rising demand and, at some point during the pandemic,
were subject to shortages that threatened continued testing capacity.
For example, there was only one domestic manufacturer of medical grade
flocked swabs, Puritan Medical Products Company of Guilford, Maine, and
the company's pre-pandemic capacity was insufficient to meet demand of
increased testing in the early period of the COVID-19 pandemic (Puritan
Products, April 20, 2020). On July 29, 2020, the Department of Defense
(DOD), in coordination with the Department of Health and Human
Services, awarded $51.15 million to Puritan to expand industrial
production capacity of flock tip testing swabs (DOD, July 31, 2020). On
March 26, 2021, Puritan was awarded another $146.77 million to increase
the company's total production capacity to 250 million foam tip swabs
per month at its Tennessee facility by February 2022 (DOD, March 29,
2021).
Other private sector companies were mobilized to change the
products they manufactured to accelerate production of COVID-19 test
components, such as swabs, reagents, and solvents for RNA extraction
kits. For example, Microbrush, a U.S.-based manufacturer of sterile
applicators for the dental industry, began production of a
nasopharyngeal test swab to meet the growing demand for COVID-19
testing requirements in July 2020. The Microbrush test swabs are
sterilized and individually packaged in a medical-
[[Page 61455]]
grade pouch intended for nasopharyngeal sample collection such as in
dental procedures and also COVID-19 testing (Microbrush, July 1, 2020).
RNA extraction kits are used by the majority of NAAT protocols.
These kits are sets of consumable plastic laboratory materials (small
centrifuge tubes, filters, and collection vials) and chemical reagents
(solutions for breaking the virus apart and purification) assembled by
a manufacturer. Each kit has enough materials to process several dozen
samples. The use of RNA extraction kits is not exclusive to COVID-19
testing, meaning that a market existed pre-COVID-19, and manufacturers
were able to adapt to fluctuations in demand spurred by the pandemic.
There are multiple companies with facilities in the United States
that produce RNA extraction kits for the domestic market that have been
awarded federal grants to increase the supply of COVID-19 test kits and
reagent supplies. For example, in December 2020, the DOD and HHS
identified several key reagents with the potential for supply chain
bottlenecks and awarded a $4.8 million Indefinite Delivery/Indefinite
Quantity contract to Anatrace Products, LLC to support increased
production of key reagents for sample processing; Polyadenylic Acid
(Poly A), Guanidinium Thiocyanate (GTC), and Proteinase K (Pro K) to
process samples (DOD, December 21, 2020). Additionally, QIAGEN (based
in Germany with U.S. manufacturing in Germantown, Maryland) produces
extraction kits for authorized COVID-19 tests and has responded to the
pandemic by scaling their production to around the clock production to
strengthen testing kit capacity (Qiagen, October 2, 2021). On August
23, 2021, DOD, on behalf of and in coordination with HHS, awarded a
$600,000 contract to QIAGEN to expand manufacturing capacity of
enzymatic reagents and reagent kits used in COVID-19 molecular
diagnostic tests, thereby allowing QIAGEN to increase its monthly
production of reagent kits by 7,000 and enzymes by 5,100 milligrams by
the end of February 2022 to support domestic laboratory testing for
COVID-19 (DOD, August 23, 2021).
Additionally, manufacturers of raw materials and solvents for
COVID-19 test kits have implemented strategies to strengthen their
portions of the COVID-19 test supply chain. Millipore Sigma, a large
producer of solvents and raw materials for tests, has created a global
task force to actively evaluate the overall supply chain of products
and key raw material suppliers to mitigate any potential disruption of
COVID-19 testing capacity (Millipore Sigma, October 2021). In light of
the foregoing, OSHA believes that there is sufficient--and increasing--
availability of COVID-19 testing supplies to enable compliance with the
ETS testing option.
e. Sufficiency of Laboratory Capacity
As noted above, a wide range of tests are acceptable under the ETS,
including those that can be observed by employers without laboratory
processing. Moreover, there has been rapid growth in the availability
of OTC tests that do not require laboratory processing. Authorized OTC
tests self-administered by employees and proctored by the employer do
not require a CLIA certificate of waiver.
The Association of Public Health Laboratories (APHL) has conducted
weekly surveys of its membership to monitor their current and projected
capability and capacity to test for COVID-19. Data from this survey is
used to inform HHS, FEMA, CDC, and other federal partners to support
public health laboratory supply and reagent needs. OSHA reviewed the
weekly COVID-19 survey results through the APHL COVID-19 Lab Testing
Capacity and Capability Data Dashboard. The data comes from voluntary
participation in the weekly surveys collected from approximately 100
state, local and territorial public health laboratories (PHLs) and
reported to the CDC. The APHL weekly survey data supports OSHA's
feasibility determination and demonstrates that COVID-19 testing demand
will be met. For example, from August 15, 2021 to September 12, 2021,
the APHL weekly survey data found that 96-100% of PHLs are meeting
their current testing demand since the Delta Variant surge began (APHL,
September 27, 2021).
Laboratory capacity for processing and confirmation of at-home
COVID-19 rapid tests provided by manufacturer retailers such as Walmart
has also increased. Laboratory and diagnostic service providers have
implemented parallel strategies to strengthen laboratory capacity for
confirmation of at-home COVID-19 rapid tests available on the market
for employers and employees to utilize. For example, Quest Diagnostics,
which is the laboratory processing the samples and delivering results
to those tested at Walmart's drive-through and curbside testing sites,
has scaled up laboratory testing capacity and rapid antigen test
inventory should demand increase (Walmart, July 9, 2021). Quest
Diagnostics has added COVID-19 testing platforms in laboratories in
regions where demand is comparatively high and has implemented an
online consumer-initiated test service for individuals and small
businesses to request COVID-19 testing. In August 2021, Quest
Diagnostics began to offer clinician-guided rapid COVID-19 antigen
testing to employers through a guided telehealth visit using a self-
administered, nasal swab antigen test that provides results in 15
minutes that is then shipped to a Quest Diagnostics lab for
confirmation (Quest Diagnostics, September 28, 2021).
Based on the evidence reviewed, OSHA has determined that there is
adequate laboratory capacity to enable compliance with the ETS testing
option.
f. Access to Testing in Underserved Communities
Individuals in underserved communities (including Black, Latino,
and Indigenous and Native American persons, Asian Americans and Pacific
Islanders and other persons of color; members of religious minorities;
lesbian, gay, bisexual, transgender, and queer persons; persons with
disabilities; persons who live in rural areas; and persons otherwise
adversely affected by persistent poverty or inequality) are
disproportionately burdened by the COVID-19 pandemic as many
individuals in these communities are essential workers who cannot work
from home, increasing their risk of being exposed to the virus. Access
to COVID-19 testing in these communities has been identified as
contributing factor to COVID-19 related health disparities in these
communities. For example, the NSC June 2021 survey found that the most
common barrier to testing for rural employers and workers is access to
vaccination and testing sites (NSC, September 2021).
Several federal efforts have recently been implemented to
strengthen testing capabilities in underserved communities. The NIH has
invested heavily to improve COVID-19 testing in underserved communities
throughout the COVID-19 pandemic. On September 30, 2020, the NIH
received nearly $234 million to improve COVID-19 testing for
underserved and vulnerable populations that have been
disproportionately affected by this pandemic and launched the RADx
Underserved Populations (RADx-UP) program (NIH, September 30, 2020).
The RADx-UP program has primary components supported by these NIH
grants to increase availability, accessibility, and acceptance of
testing among underserved and vulnerable populations. The RADx-UP
program also provides overarching support and
[[Page 61456]]
guidance on administrative operations and logistics, facilitating
effective use of COVID-19 testing technologies, supporting community
and health system engagement, and providing overall infrastructure for
data collection, integration, and sharing from a coordination and data
collection center (NIH, September 30, 2021). Through the RADx-UP
program, the NIH has continued to support the needs of underserved
populations and is currently funding 70 community-based projects across
the country (NIH, September 30, 2021).
The CDC has also focused its efforts to improve COVID-19 testing in
underserved communities throughout the COVID-19 pandemic. For example,
on September 20, 2021, Maine Health, the largest health care
organization in Maine and also serving northern New Hampshire, was
awarded nearly $1 million for COVID-19 testing in higher risk
communities (Maine Health, September 20, 2021). In March 2021, the CDC
implemented a plan to invest $2.25 billion over two years to address
COVID-19 related health disparities and advance health equity among
populations that are at high-risk and underserved, including racial and
ethnic minority groups and people living in rural areas. Since that
time, the CDC has awarded grants to public health departments to
improve testing capabilities; improve data collection and reporting;
and build, leverage, and expand infrastructure support for testing
(CDC, March 17, 2021). On September 30, 2021, the CDC awarded an $8.1
million grant to the Arizona Center for Rural Health (ACRH) to address
COVID-19 disparities across Arizona by improving the delivery of COVID-
19 testing to rural and underserved communities (ASU CRH, September 30,
2021). A number of other federal and state government agencies have
been expanding support for COVID-19 testing in underserved communities
as well. On June 11, 2021, HHS through the Health Resources and
Services Administration (HRSA) provided $424.7 million in American
Rescue Plan funding to over 4,200 Rural Health Clinics (RHCs) for
COVID-19 testing (HHS, June 11, 2021).
Private industry has also mobilized considerably to increase access
and testing capacity in rural and other underserved communities. The
NSC June 2021 survey found that a common barrier to employers and
employees in rural and other underserved communities is transportation
and access to vaccination and testing sites (NSC, September 2021). In
its final report, the NSC recommended employers in these communities
host on-site vaccinations to increase worker access. Applications for
mobile vaccination are available on most local and state health
department websites (NSC, September 2021; ASU WEF, September 2021).
CVS has collaborated with several organizations, including the
National Medical Association, to increase access to testing in
underserved communities and has developed mobile solutions that allow
health care professionals to bring testing capabilities to businesses
in these communities as they re-open (CVS Health, September 2021).
Walgreens has implemented efforts to increase access in underserved
communities such as rural and/or lower socioeconomic communities as
well, with now more than half of Walgreens testing sites currently
located in areas the CDC has identified as socially vulnerable and
underserved (Walgreens, October 2021). Because of these investments,
OSHA concludes that employers and their employees in underserved
communities, including those in rural areas, will have sufficient
access to COVID-19 tests and will be able to comply with the ETS's
testing requirements for employees who are not fully vaccinated.
V. Management of Confidential Medical Records, Including Employee
COVID-19 Vaccination and Testing Records
The ETS requires employers to maintain a record of each employee's
vaccination status. Employers must also maintain a record of each test
result provided by each employee. These records must be maintained as
confidential medical records and must not be disclosed except as
required or authorized by this ETS or other federal law. The records
are not subject to the retention requirements of 29 CFR
1910.1020(d)(1)(i) but must be maintained and preserved while the ETS
is in effect.
Other OSHA rules have a similar requirement to maintain employee
medical records, which could include vaccination records. See, e.g.,
Bloodborne Pathogens (29 CFR 1910.1030), Respiratory Protection (29 CFR
1910.134), Respirable Crystalline Silica (29 CFR 1910.1053), Beryllium
(29 CFR 1910.1024), Lead (29 CFR 1910.1025), and OSHA's requirements
for employee access to medical and exposure records (29 CFR 1910.1020).
OSHA is not aware of any potential technological feasibility issues
related to recordkeeping.
The requirement under this ETS to maintain records of employees'
COVID-19 vaccination status and COVID-19 test results is similar to
requirements in the aforementioned OSHA standards, and OSHA therefore
concludes that compliance is feasible. Employers subject to the ETS
will be able to comply with the provisions in the ETS using
straightforward recordkeeping systems that are already widely used by
large employers as part of their usual and customary business
practices. OSHA concludes that it is feasible for such employers to
comply with the requirements in the ETS for maintaining records related
to COVID-19 vaccination status and COVID-19 test results.
VI. Other Provisions
There are no technological feasibility barriers related to
compliance with other requirements in the ETS (e.g., face coverings,
employee notification). As explained above, many of the employer plans
and best practice documents reviewed by OSHA indicate that employers
have implemented the measures in these provisions across industry
sectors. OSHA highlights two of the ETS's other requirements below,
which are explored in more depth in other sections of this preamble.
Face Coverings. Paragraph (i) of the ETS requires the
employer to ensure that all employees who are not fully vaccinated wear
a face covering when indoors and when occupying a vehicle with another
person for work purposes, except: (i) When an employee is alone in a
room with floor to ceiling walls and a closed door; (ii) for a limited
time while the employee is eating or drinking at the workplace or for
identification purposes in compliance with safety and security
requirements; (iii) when employees are wearing respirators or face
masks; or (iv) where the employer can show that the use of face
coverings is infeasible or creates a greater hazard. The definition of
face covering allows various different types of masks, including clear
face coverings or cloth face coverings with a clear plastic panel which
may be used to facilitate communication with people who are deaf or
hard-of-hearing or others who need to see a speaker's mouth or facial
expressions to understand speech or sign language respectively. The
types of face coverings permitted under this ETS are widely used and
readily available. The results of the ASU WEF June 2021 survey found
that 30% of employers required face coverings for unvaccinated
employees, which demonstrates that this provision of the ETS is
currently being implemented by a substantial number of employers and is
``capable of being done.'' (ASU WEF, September 2021). OSHA identifies
no technological
[[Page 61457]]
feasibility issues with this provision of the ETS.
Notification. Paragraph (h) of the ETS contains COVID-19
notification requirements for both the employer and the employee. Under
this provision, the employer must require each employee to promptly
notify the employer if they receive a positive COVID-19 test or are
diagnosed with COVID-19 by a licensed healthcare provider and must
immediately remove any employee from the workplace who receives a
positive COVID-19 test or is diagnosed with COVID-19 by a licensed
healthcare provider. OSHA identifies no technological feasibility
issues in connection with the ETS's notification requirements. It is
the employer's responsibility to ensure that appropriate instructions
and procedures are in place so that designated representatives of the
employer (e.g., managers, supervisors) and employees conform to the
rule's requirements.
VII. Conclusion
OSHA has determined that complying with this ETS is technologically
feasible for typical firms covered by this standard, at least most of
the time (see Public Citizen v. OSHA, 557 F.3d 165 (3d Cir. 2009); Lead
I, 647 F.2d at 1272; Lead II, 939 F.2d at 990). OSHA reviewed extensive
evidence across industries and did not identify any industry-specific
compliance barriers. Evidence in the record that shows that the written
workplace COVID-19 vaccination policy requiring each employee to be
fully vaccinated against COVID-19 unless they establish and implement a
written policy that permits an employee to choose to be tested for
COVID-19 at least every seven days and wear a face covering is
feasible. In fact, such policies have already been implemented by
hundreds of large companies across industry sectors. OSHA has also
determined that there are sufficient COVID-19 tests available and
adequate laboratory capacity to meet the anticipated increased testing
demand related to compliance with the ETS testing option.
Additionally, the ETS's requirements to determine employee
vaccination status, support employee vaccination by providing time off
for vaccination and time off for recovery, and maintain records of
employee COVID-19 vaccination status and COVID-19 test results are also
technologically feasible. As discussed above, that many employers and
organizations have already implemented such requirements demonstrates
that they are ``capable of being done.'' Moreover, the recordkeeping
requirements in this ETS largely mirror the requirements for the
collection and maintenance of similar employee medical records in
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) and the
Respiratory Protection standard (29 CFR 1910.134). The ETS provides a
flexible compliance option for employers to tailor their procedures and
practices to the needs of their workplace. OSHA finds that employers in
typical firms in all industry sectors can comply with the requirements
of the ETS, and compliance with the ETS is therefore technologically
feasible.
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initiative advances six new COVID-19 testing technologies. https://www.nih.gov/news-events/news-releases/nih-radx-initiative-advances-six-new-covid-19-testing-technologies. (NIH, October 6, 2020)
National Institutes of Health (NIH). (2020, September 30). NIH to
assess and expand COVID-19 testing for underserved communities.
https://www.nih.gov/news-events/news-releases/nih-assess-expand-covid-19-testing-underserved-communities. (NIH, September 30, 2020)
National Institutes of Health (NIH). (2020, April 29). NIH mobilizes
national innovation initiative for COVID-19 diagnostics. https://www.nih.gov/news-events/news-releases/nih-mobilizes-national-innovation-initiative-covid-19-diagnostics. (NIH, April 29, 2020)
National Safety Council (NSC). (2021, May 17). SAFER: Safe Actions
For Employee Returns. https://www.nsc.org/getmedia/f5dfd05d-83bf-4753-8903-538a24157725/safer-framework-summary.pdf. (NSC, May 17,
2021)
National Safety Council (NSC). (2021, September). SAFER Report: A
Year in Review, and What's Next. https://www.nsc.org/workplace/safety-topics/safer/state-of-the-response-state-actions-to-address-the. (NSC, September 2021)
Puritan Products. (2020, April 20). Puritan Blog: Puritan at the
Epicenter of COVID-19 Testing. https://blog.puritanmedproducts.com/puritan-at-epicenter-of-covid-19-testing. (Puritan Products, April
20, 2020)
Qiagen. (2021, October 2). COVID-19 Latest News. https://www.qiagen.com/us/customer-stories/latest-news-on-the-fight-against-coronavirus. (Qiagen, October 2, 2021)
Quest Diagnostics. (2021, September 28). Quest Diagnostics Media
Statement about COVID-19 Testing. https://newsroom.questdiagnostics.com/COVIDTestingUpdates. (Quest
Diagnostics, September 28, 2021)
Quidel Corporation. (2020, July 31). Press release, Quidel Corp.
https://ir.quidel.com/news/news-release-details/2020/Quidel-Receives-Preliminary-Contract-Leading-to-Definitive-Agreement-for-71-Million-Under-NIHs-RADx-ATP-Program-to-Accelerate-the-Expansion-of-Its-Manufacturing-Capacity-for-Sofia-SARS-CoV-2-Antigen-Detection-Test-for-Rapid-Diagnosis-of-COVID-19/default.aspx. (Quidel
Corp., July 31, 2020)
RiteAid. (2021, October). Free* COVID-19 Testing. https://www.riteaid.com/pharmacy/services/covid-19-testing. (RiteAid,
October 2021)
Sanford Health. (2021, July 22). Sanford Health to require COVID-19
vaccine for employees. https://news.sanfordhealth.org/news-release/sanford-to-require-covid-19-vaccine-for-employees/. (Sanford Health,
July 22, 2021)
Trinity Health. (2021, July 8). Trinity Health Announces COVID-19
Vaccine Requirement for All Colleagues. https://www.trinity-
health.org/news/trinity-health-announces-covid-19-vaccine-
[[Page 61459]]
requirement-for-all-colleagues. (Trinity Health, July 8, 2021)
Tyson Foods. (2021, August 3) Tyson Foods to Require COVID-19
Vaccinations for its U.S. Workforce. https://www.tysonfoods.com/news/news-releases/2021/8/tyson-foods-require-covid-19-vaccinations-its-us-workforce. (Tyson Foods, August 3, 2021)
University of Arizona Center for Rural Health (ASU CRH). (2021,
September 30). ADHS-CDC COVID Disparities Initiative. https://crh.arizona.edu/programs/covid-disparities-initiative. (ASU CRH,
September 30, 2021)
U.S. Department of Defense (DOD). (2021, March 29) DOD Awards
$146.77 Million Contract to Puritan Medical Products to Increase
Domestic Production Capacity of Foam Tip Swabs. https://www.defense.gov/News/Releases/Release/Article/2554073/dod-awards-14677-million-contract-to-puritan-medical-products-to-increase-domes/. (DOD, March 29, 2021)
U.S. Department of Defense (DOD). (2021, July 31). DOD Awards $51.15
Million Undefinitized Contract Action to Puritan Medical Products
Company LLC to Increase Domestic Production Capacity of Flock Tip
Testing Swabs. https://www.defense.gov/News/Releases/Release/Article/2295387/dod-awards-5115-million-undefinitized-contract-action-to-puritan-medical-produc/. (DOD, July 31, 2021)
U.S. Department of Defense (DOD). (2021, August 23). DOD Awards $0.6
Million Contract to QIAGEN to Increase Domestic Production Capacity
of COVID-19 Diagnostic Test Kits and Reagents. https://www.defense.gov/News/Releases/Release/Article/2742967/dod-awards-06-million-contract-to-qiagen-to-increase-domestic-production-capaci/.
(DOD, August 23, 2021)
U.S. Department of Defense (DOD). (2021, December 21). DOD Awards
$4.8 Million Indefinite Delivery/Indefinite Quantity to a Calibre
Scientific Subsidiary, Anatrace, to Increase Domestic Production
Capacity of COVID-19 Testing Reagents. https://www.defense.gov/News/Releases/Release/Article/2454163/dod-awards-48-million-indefinite-deliveryindefinite-quantity-to-a-calibre-scien/. (DOD, December 21,
2020)
U.S. Department of Health and Human Services. (HHS). (2021, June
11). HHS Provides $424.7 Million to Rural Health Clinics for COVID-
19 Testing and Mitigation in Rural Communities. https://www.hhs.gov/about/news/2021/06/11/hhs-provides-424-million-to-rural-health-clinics-for-covid-19-testing.html. (HHS, June 11, 2021)
U.S. Department of Health and Human Services (HHS). (2021, August
17). Community based testing sites. https://www.hhs.gov/coronavirus/community-based-testing-sites/. (HHS, August 17, 2021)
Walgreens. (2021, October). Free Drive-Thru COVID-19 Testing for
Ages 3+. https://www.walgreens.com/findcare/covid19/testing?ban=covid_hp_cause2. (Walgreens, October 2021)
Walgreens. (2021, October 8). COVID-19 FAQs. https://news.walgreens.com/our-stories/covid-19-stories/covid-19-faq.htm#testinghome. (Walgreens, October 8, 2021)
Walmart. (2021, July 9). Supporting COVID-19 Testing. https://corporate.walmart.com/covid19testing. (Walmart, July 9, 2021)
Washington Post. (2021, October 6). White House announces $1 billion
purchase of rapid, at-home coronavirus tests. https://www.washingtonpost.com/health/2021/10/06/biden-rapid-at-home-covid-tests/. (Washington Post, October 6, 2021)
Willis Towers Watson. (2021, June 23) COVID-19 Vaccination and
Reopening the Workplace Survey press release. https://www.willistowerswatson.com/en-US/News/2021/09/workplace-vaccine-mandates-expected-to-accelerate-wtw-survey-finds. (Willis Towers
Watson, June 23, 2021)
Willis Towers Watson. (2021, September 1) Workplace vaccine mandates
expected to accelerate, Willis Towers Watson survey finds. https://www.willistowerswatson.com/en-US/News/2021/09/workplace-vaccine-mandates-expected-to-accelerate-wtw-survey-finds. (Willis Towers
Watson, September 1, 2021)
B. Economic Analysis
I. Introduction
This section presents OSHA's estimates of the costs and impacts,
anticipated to result from the COVID-19 Vaccination and Testing ETS, 29
CFR 1910.501. The purpose of this ETS is to address the grave danger of
COVID-19 in the workplace by promoting vaccination, while allowing an
alternative for face covering and testing requirements, and also to
remove COVID-19 positive workers from the workplace regardless of
vaccination status. The estimated costs are based on employers
achieving full compliance with the requirements of the ETS. They do not
include prior costs associated with firms whose current practices are
already in compliance with the ETS requirements. The purpose of this
analysis is to:
Identify the entities/establishments and industries
affected by the ETS;
Estimate and evaluate the costs and economic impacts that
regulated entities/establishments will incur to achieve compliance with
the ETS; and
Evaluate the economic feasibility of the rule for affected
industries.
In this analysis, OSHA is fulfilling the requirement under the OSH
Act to show the economic feasibility of this ETS. This analysis is
different from the cost portion of a regulatory impact analysis
prepared in accordance with Executive Order 12866 in that the agency is
focused only on costs to employers when evaluating economic
feasibility. In a regulatory impact analysis, the costs to all parties
(e.g., employers, employees, and governments) are included. While this
is not the case for an economic feasibility analysis, it does not
necessarily mean that the ETS imposes no costs or burdens on parties
other than employers. For example, the rule imposes certain costs on
employees who choose not to become vaccinated (e.g., for face coverings
and testing. While these costs are not relevant for the purpose of
establishing economic feasibility, these costs would be attributable to
the ETS in a regulatory impact analysis. In addition, these costs are
not mandatory because any employee who does not wish to pay them may
choose to become vaccinated or leave employment (see discussion below
on turnover), after which the costs would not be incurred. Some
employees may also be entitled to a reasonable accommodation that may
avoid additional cost (e.g., telework).
``[T]he Supreme Court has conclusively ruled that economic
feasibility [under the OSH Act] does not involve a cost-benefit
analysis.'' Pub. Citizen Health Research Grp. v. U.S. Dept. of Labor,
557 F.3d 165, 177 (3d Cir. 2009); see also Asbestos Info. Ass'n, 727
F.2d at 424 n.18 (noting that formal cost benefit is not required for
an ETS, and indeed may be impossible in an emergency). The OSH Act
``place[s] the `benefit' of worker health above all other
considerations save those making attainment of this `benefit'
unachievable.'' Cotton Dust, 452 U.S. at 509. Therefore, ``[a]ny
standard based on a balancing of costs and benefits by the Secretary
that strikes a different balance than that struck by Congress would be
inconsistent with the command set forth in'' the statute. Id. While
this case law arose with respect to health standards issued under
section 6(b)(5) of the Act, which specifically require feasibility,
OSHA finds the same concerns applicable to emergency temporary
standards issued under section 6(c) of the Act. An ETS ``serve[s] as a
proposed rule'' for a section 6(b)(5) standard, and therefore the same
limits on any requirement for cost-benefit analysis should apply.
Indeed, OSHA has also rejected the use of formal cost benefit analysis
for safety standards, which are not governed by section 6(b)(5). See 58
FR 16,612, 16,622-23 (Mar. 30, 1993) (``in OSHA's judgment, its
statutory mandate to achieve safe and healthful workplaces for the
nation's employees limits the role monetization of benefits and
analysis of extra-
[[Page 61460]]
workplace effects can play in setting safety standards.'').\22\ A
standard must be economically feasible in order to be ``reasonably
necessary and appropriate'' under section 3(8) and, by inference,
``necessary'' under section 6(c)(1)(B) of the OSH Act. Cf. Am. Textile
Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490, 513 n.31 (1981) (noting
``any standard that was not economically . . . feasible would a
fortiori not be `reasonably necessary or appropriate' '' as required by
the OSH Act's definition of ``occupational safety and health standard''
in section 3(8)); see also Florida Peach Growers, 489 F.2d at 130
(recognizing that the promulgation of any standard, including an ETS,
must account for its economic effect). A standard is economically
feasible when industries can absorb or pass on the costs of compliance
without threatening industry's long-term profitability or competitive
structure, Cotton Dust, 452 U.S. at 530 n.55, or ``threaten[ing]
massive dislocation to, or imperil[ing] the existence of, the
industry.'' United Steelworkers of Am. v. Marshall, 647 F.2d 1189, 1272
(D.C. Cir. 1981) (Lead I). Given that section 6(c) is aimed at enabling
OSHA to protect workers in emergency situations, the agency is not
required to make the showing with the same rigor as in ordinary section
6(b) rulemaking. Asbestos Info. Ass'n/N. Am. v. OSHA, 727 F.2d 415, 424
n.18 (5th Cir. 1984). In Asbestos Information Association, the Fifth
Circuit concluded that the costs of compliance were not unreasonable to
address a grave danger where the costs of the ETS did not exceed 7.2%
of revenues in any affected industry. Id. at 424.
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\22\ To support its Asbestos ETS, OSHA conducted an economic
feasibility analysis on these terms. 48 FR 51086, 51136-38 (Nov. 4,
1983). In upholding that analysis, the Fifth Circuit said that OSHA
was required to show that the balance of costs to benefits was not
unreasonable. Asbestos Info. Ass'n, 727 F.2d at 423. As explained
above, OSHA does not believe that is a correct statement of the
economic feasibility test. However, even under that approach this
ETS easily passes muster.
---------------------------------------------------------------------------
The scope of judicial review of OSHA's determinations regarding
feasibility (both technological and economic) ``is narrowly
circumscribed.'' N. Am.'s Bldg. Trades Unions v. OSHA, 878 F.3d 271,
296 (D.C. Cir. 2017) (Silica). ``OSHA is not required to prove economic
feasibility with certainty, but is required to use the best available
evidence and to support its conclusions with substantial evidence.''
Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 980-81 (D.C. Cir. 1991)
(Lead II); 29 U.S.C. 655(b)(5), (f). ``Courts, [moreover], `cannot
expect hard and precise estimates of costs.' '' Silica, 878 F.3d at 296
(quoting Lead II, 939 F.2d at 1006). Rather, OSHA's estimates must
represent ``a reasonable assessment of the likely range of costs of its
standard, and the likely effects of those costs on the industry.'' Lead
I, 647 F.2d at 1266. The ``mere `possibility of drawing two
inconsistent conclusions from the evidence,' or deriving two divergent
cost models from the data `does not prevent [the] agency's finding from
being supported by substantial evidence.' '' Silica, 878 F.3d at 296
(quoting Cotton Dust, 452 U.S. at 523).
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of the intended regulation and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, and public health and
safety effects; distributive impacts; and equity). Executive Order
13563 emphasized the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
Because of the continued impact of the pandemic on occupational safety
and health, OSHA has prepared this ETS and the accompanying economic
analysis on an extremely condensed timeline. Thus, in light of the
Secretary's conclusion that the COVID-19 pandemic constitutes an
emergency situation, the Secretary has notified OIRA that it is
necessary for OSHA to promulgate this regulation more quickly than
normal review procedures allow, pursuant to E.O. 12866 Sec. 6
(a)(3)(D). OIRA has waived compliance with Sec. 6(a)(3)(B) and (C) for
this economically significant rule.
II. COVID-19 ETS Industry Profile
a. Introduction
In this section, OSHA provides estimates of the number of affected
entities, establishments, and employees for the industries that have
settings covered by this ETS. The term ``entity'' describes a legal
for-profit business, a non-profit organization, or a local governmental
unit, whereas the term ``establishment'' describes a particular
physical site of economic activity. Some entities own and operate more
than one establishment.
Throughout this analysis, where estimates were derived from
available data those sources have been noted in the text. Estimates
without sources noted in the text are based on agency expertise.
b. Scope of the COVID-19 ETS
This ETS applies to all employers with a total of 100 or more
employees at any time this ETS is in effect. However, the requirements
of this ETS do not apply to: (1) Workplaces covered under the Safer
Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for
Federal Contractors and Subcontractors (Contractor Guidance); or (2)
settings where any employee provides healthcare services or healthcare
support services when subject to the requirements of 29 CFR 1910.502
(i.e., the Healthcare ETS). Furthermore, the requirements of this ETS
do not apply to the employees of covered employers: (1) Who do not
report to a workplace where other individuals, such as coworkers or
customers, are present; or (2) while working from home; or (3) who work
exclusively outdoors. Based on this scope, employers in nearly every
sector are expected to be covered by this ETS.
OSHA's assumptions may result in an overestimate of the number of
employees affected by the ETS. First, OSHA is not estimating the number
and type of workplaces covered by the Safer Federal Workforce Task
Force COVID-19 Workplace Safety: Guidance for Federal Contractors and
Subcontractors or removing them from the profile of employers affected
by this ETS. OSHA assumes for the purpose of this analysis that
employers covered under the Contractor Guidance will also have
contracts to perform work in workplaces where they are not covered
under that Guidance (i.e., where the employer contracts with an entity
other than the federal government), and so those employers are included
in the scope here.
Second, OSHA estimates that all employers in all private sector
industries are affected by this ETS to some extent. Although this ETS
imposes no compliance burden on employers whose employees work remotely
100 percent of the time, in OSHA's analysis, no employers with 100 or
more employees have all of their employees working remotely 100 percent
of the time (i.e., at least some employees in each affected firm do not
work remotely). Moreover, OSHA's analysis does not take into account
that some employees may engage in part-time telework (i.e., it assumes
that employees either work remotely full-time or do not work remotely
at all). Finally, OSHA's analysis does not fully take into account the
exemption for employees who do not report to a workplace where other
individuals are present, meaning that this analysis may overestimate
the number of employees affected by the rule.
As stated, the requirements of this ETS do not apply to the
employees of covered employers who work
[[Page 61461]]
exclusively outdoors. To determine the percentage of employees in
occupations for which the exception is relevant, the agency uses data
from the BLS's 2020 Occupational Requirements Survey (ORS) (BLS, 2020).
This survey looks at various aspects of job requirements. In
particular, the survey lists occupations where workers are outdoors
``constantly,'' which OSHA interprets as being nearly continuously
outdoors. Because the majority of workers who work outdoors
``constantly'' likely work indoors at least some of the time, the
agency judges that no more than 10 percent of the workers who are
primarily outdoors are actually there exclusively. See Table IV.B.1 for
the occupations, the ORS percentages, and final percentages for workers
OSHA estimates are exempt from the scope of this ETS based on the
outdoor work exemption.
[GRAPHIC] [TIFF OMITTED] TR05NO21.000
OSHA's estimate of employees who work exclusively outdoors does not
account for employers who only need to make slight adjustments to their
current work practices to ensure that their employees qualify for the
outdoor exemption, such as by holding tool box talks outdoors instead
of in a traditional indoor location. This may result in more employees
falling within the exemption than estimated by OSHA; therefore, OSHA's
cost analysis likely overestimates costs.
The requirements of the ETS also do not apply to settings where any
employee provides healthcare services or healthcare support services
when subject to the requirements of 29 CFR 1910.502 (the Healthcare
ETS). The Healthcare ETS is a temporary standard that may not remain in
effect for the entire period that 29 CFR 1910.501 remains in effect.
This means that some employers or employees covered by the Healthcare
ETS, those in firms that have 100 or more employees, may ultimately be
covered by 29 CFR 1910.501 (because the exception in 29 CFR 1910.501 is
limited to when employers are subject to the requirements of the
Healthcare ETS). This potentially impacts two types of costs: Employer-
based costs (e.g., employer policy on vaccination) and employee-based
(periodic) costs (e.g., recordkeeping).
Employer-Based Costs: For the purpose of the economic analysis
only, OSHA treats the Healthcare ETS as though it will no longer be in
effect after December, 2021, because at that point the Healthcare ETS
will have been in effect for the six months that OSHA had calculated
costs for that ETS. Therefore, OSHA estimates that some employers
including those with 100 or more employees subject to the 29 CFR
1910.502 exemption, will need to take employer-based costs because all
these employers will ultimately be subject to 29 CFR 1910.501 under
this assumption.
Employee-Based Costs: OSHA's estimates incorporate two assumptions
for the purposes of this analysis only. First, for the purposes of
assumptions for this analysis only, Sec. 1910.501 will remain in
effect for 6 months. Second, many employers and employees currently
covered only by the Healthcare ETS will be subject to the requirements
of 29 CFR 1910.501 for approximately 4 months (4 months of the 6 month
estimated lifespan of 29 CFR 1910.501). OSHA's estimate of those
employees exempted by the Healthcare ETS was based on the Industry
Profile of employees in firms with 100 employees or more covered by the
Healthcare ETS, as estimated in Table VI.B.3 in the economic analysis
for that rulemaking (see 86 FR 32488).
OSHA notes that some employees currently covered by the Healthcare
ETS might also be currently covered by 29 CFR 1910.501 (albeit at
different times or in different locations) because the Healthcare ETS
is settings-based. For example, a pharmacist would normally not need to
comply with the requirements of Sec. 1910.502 when just filling
prescriptions in a retail pharmacy store (see 29 CFR
1910.502(a)(2)(ii)), but would need to comply when administering
vaccinations within an embedded clinic inside that retail pharmacy.
Thus, there are a number of variables that could impact the extent to
which the pharmacist's employer might
[[Page 61462]]
incur any costs. However, even to the extent that such costs might
occur (e.g., recordkeeping for testing if the pharmacist works for an
employer covered by 29 CFR 1910.501 and is unvaccinated), OSHA judges
that they would be de minimis for several reasons. First, this pool of
workers is likely to be very small, especially when compared to the
population of workers covered by the Healthcare ETS. Second, most
employees subject to both standards will have been fully vaccinated
before OSHA takes costs for these employees under 29 CFR 1910.501 by
operation of the CMS rule mandating vaccination or as a result of the
voluntary vaccination incentives promoted by OSHA's Healthcare ETS
(therefore negating most of the costs associated with vaccination and
testing under 29 CFR 1910.501). Third, any underestimate of periodic
costs will only apply during the first two months after 29 CFR 1910.501
goes into effect and the standard has a delayed compliance date of 30
days after the effective date for most provisions, except for testing,
which has a delayed compliance date of 60 days. This will further
lessen the periodic costs associated with any potential underestimate.
In all respects (other than the \4/6\ share of employee-based
costs), OSHA is taking the same approach in the Industry Profile and
Cost Estimates for employers and employees currently covered by the
Healthcare ETS as it does for all other industries. These employers and
employees are fully integrated into Table IV.B.5, below, which contains
a summary of covered entities and employees. Moreover, the same
assumptions on outdoor work and other scope exemptions that OSHA
explains earlier holds for these employers and employees. In addition,
OSHA makes the same downward adjustment in telework for these employers
and employees in accordance with the methodology it sets out below.
Thus, the Healthcare ETS profile used in this ETS to account for
employees exempted by the Healthcare ETS into the Profile in the event
the Healthcare ETS expires (i.e., in Table IV.B.5, below) is an updated
version of Table VI.B.3 in the Healthcare ETS (see 86 FR 32488).\23\
OSHA notes that some firms may decide to proactively comply with
certain 29 CFR 1910.501 requirements (such as mandating vaccination for
all employees that were removed from the Industry Profile) before the
end date of the Healthcare ETS based on the conclusion that 29 CFR
1910.501 will ultimately apply in full to them. Since these costs still
occur due to 29 CFR 1910.501, OSHA is appropriately including them in
this cost analysis.
---------------------------------------------------------------------------
\23\ The CMS rule published elsewhere in this issue of the
Federal Register mandates vaccination for employees in facilities
that receive Medicare or Medicaid. OSHA is ignoring this for the
purpose of its cost analysis and taking costs into account as if the
CMS rule were not promulgated. This creates a substantial
overestimate.
---------------------------------------------------------------------------
There are 9.9 million employees who will newly be covered by 29 CFR
1910.501 starting in December whose employers will incur an additional
$318 million in costs. These costs are integrated into the agency's
main cost analysis, which is described later in this economic analysis.
Only some state- and local-government entities are included in this
analysis. State- and local-government entities are specifically
excluded from coverage under the OSH Act (29 U.S.C. 652(5)). Workers
employed by these entities only have OSH Act protections if they work
in states that have an OSHA-approved State Plan. (29 U.S.C. 667).
Consequently, this analysis excludes public entities in states that do
not have OSHA-approved State Plans. Table IV.B.2 presents the states
that have OSHA-approved State Plans and their public entities are
included in the analysis.
[GRAPHIC] [TIFF OMITTED] TR05NO21.001
OSHA notes, finally, that the percentage of employers mandating
vaccination, and hence the employee vaccination rate, would likely rise
to some degree absent this ETS due to other federal actions, such as
the vaccination mandate for federal contractors, the CMS rule published
elsewhere in this issue of the Federal Register, and as a result of
vaccination mandates that have been adopted at state and local levels.
This analysis does not account for increases in vaccination that would
occur absent the standard, resulting in a likely overestimate of the
costs.
c. Teleworking
Dingel-Neiman Approach for Estimating Who Can Work Remotely
OSHA uses the estimates in a paper by J.I. Dingel and B. Neiman,
``How Many Jobs Can be Done at Home?,'' published in July 2020, as a
starting point to determine the percentage of employees, by occupation,
who are not expected to work remotely (i.e., the percentage of workers
for whom employers have employee-based costs under this ETS) (Dingel
and Neiman, July 2020).
In Dingel and Neiman's paper, the authors estimate the number of
jobs in the U.S. economy that workers can feasibly perform remotely.
The authors use two different surveys from the
[[Page 61463]]
Occupational Information Network (O*Net) \24\ to evaluate which
occupations can be performed remotely and combine the O*Net estimates
with the Bureau of Labor Statistics' (BLS) Occupational Employment and
Wage Statistics (OEWS) data on employment by occupation to estimate the
total number of workers nationally who can work remotely.
---------------------------------------------------------------------------
\24\ 24 The O*Net Program is a major source of occupational
information for the U.S. The O*NET database surveys ask both
specific occupational experts and workers in those occupations
questions covering multiple aspects of almost 1,000 occupations
covering the entire U.S. economy. See https://www.onetonline.org/
for more information. The occupation definitions in the O*NET data
are Standard Occupation Codes--the same definitions that are used in
the BLS OEWS data. Dingel and Neiman use the responses to two
surveys included in release 24.2 of the database administered by
O*NET, the Worker Context Questionnaire and the Generalized Work
Activities Questionnaire. The occupation with the median number of
respondents had 26 respondents for each work context question and 25
respondents for each generalized work activities question per
detailed-level SOC occupation code.
In the O*Net Questionnaires, survey respondents responded to
statements about the nature and requirements of the daily tasks
associated with their job on a 1-5 ordinal scale, where 5 represents
the strongest agreement and 1 represents the strongest disagreement
(see Table IV.B.3). The O*Net data contain the average response to
each question for each occupation code. For instance, for occupation
``Chief Executives'' (SOC 11-1011), the average response to the
prompt ``Performing General Physical Activities is very important''
was 1.39, indicating that performing general physical activity is
not, on average, critical to the work of chief executives. The
average responses by occupation for other prompts in the relevant
surveys utilized by Dingel and Neiman are contained in those
surveys.
---------------------------------------------------------------------------
To evaluate the survey responses, Dingel and Neiman first
determined the occupations for which the average response to a given
prompt met a preset threshold. Table IV.B.3 presents the Dingel and
Neiman response threshold for each survey question as well as the
percent of occupations that meet each respective predetermined
threshold. For example, in 10.8 percent of occupations, the average
response to the ``Performing general physical activities'' (4.A.3.a.1)
question met the threshold, falling in the range of 4 to 5.
Dingel and Neiman determined that employees in a given occupation
can telework full time if they did not meet the predetermined threshold
for any of the questions highlighted in grey and denoted with a ``Yes''
in the column that reports whether that activity is used in determining
whether a job can be done remotely in Table IV.B.3.
[[Page 61464]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.002
Source: (Dingel and Neiman, July 2020).
[[Page 61465]]
Adjusting Dingel and Neiman To Reflect Current Conditions
While many employees can and are working remotely, many have
returned to their places of employment. This conclusion is borne out by
BLS's Current Population Survey (CPS) (BLS, 2021c). To address the
tendency toward employees returning to work on site and more accurately
reflect current remote work conditions, OSHA made two adjustments to
Dingel and Neiman's estimates. In the COVID-19 Healthcare ETS, OSHA
also used Dingel and Neiman's paper to estimate the number of workers
who teleworked in response to the pandemic and the ETS under the
assumption that anyone who could work remotely would do so in response
to the pandemic and the Healthcare ETS. Dingel and Neiman's estimates
are therefore framed as the upper-bound of potential teleworking.
The adjustments OSHA made reflect changing circumstances. First,
based on agency expertise, OSHA changed the status of certain
occupations in its occupational list from working remotely to not
working remotely. For example, when Dingel and Neiman published their
study, many schools were operating virtually so the Dingel and Neiman
finding that teachers were able to work remotely lined up with the
situation where teachers were working remotely. At this point in the
pandemic, on the other hand, in-person learning has mostly recommenced.
To this end, OSHA changed the status of teachers and other employees in
the education sector from working remotely to not working remotely in
this analysis. As another example, many activities that ceased or were
reduced significantly have now resumed and many locations that were
closed to the public have reopened (e.g., athletic events, shows, gyms,
casinos and places of worship), and, since more people have returned to
the office, there is more need for childcare. Therefore, OSHA also
changed the status of these employees and others from telework to non-
telework. This has the ultimate effect of increasing costs estimates
for the rule.
Appendix A (Table A-1), in the accompanying document in the docket,
``Vaccination, and Testing ETS: Economic Profile and Cost Chapter
Appendices'' (OSHA, October 2021b), presents Dingel and Neiman's (July
2020) unmodified percentages of workers that can work remotely in each
detailed occupation (based on BLS's Standard Occupation Code
(SOC)).\25\ Appendix A also presents, in separate columns, percentages
reflecting the modifications OSHA made in those occupations where OSHA
changed the results from telework to non-telework for the reasons
stated, as well as percentages reflecting the modifications made in
occupations where employees work exclusively outdoors.
---------------------------------------------------------------------------
\25\ Except for the adjustments to Dingel and Neiman discussed
above, OSHA used the Dingel and Neiman estimates for telework by
occupation without change. The agency recognizes that the authors'
methodology (i.e., the use of 0-1 thresholds) led to a small number
of results that may appear not to reflect real-world experiences
within an occupation. However, Dingel and Neiman represents the best
available evidence for determining the percentage of employees, by
occupation, who are expected to work remotely. OSHA is aware of no
other source for this information that contains the level of detail
necessary to conduct this analysis. Moreover, as explained above,
OSHA modified the results for individual occupations when it had a
reasoned basis for doing so. In any event, every NAICS industry is
comprised of many occupations, so for every occupation where OSHA
suspects remote work is overestimated in Dingel and Neiman's
results, there may be another where remote work is underestimated.
---------------------------------------------------------------------------
According to the OSHA-adjusted Dingel and Neiman estimates, 14
percent of the jobs in the United States are performed entirely at
home, with significant variation across cities and industries. It
should be noted that the Dingel and Neiman analysis does not specify a
proportion of jobs that can be performed at home part of the time;
under the analysis, employees are either working remotely full-time or
are working on site full time.
The second adjustment OSHA made used monthly COVID-specific
teleworking data from telework questions added during the pandemic to
the CPS to estimate the reduction in teleworking since its peak and
applied those estimates to further adjust downward the number of
workers currently teleworking (BLS, 2021c). Specifically, the CPS
questions asked respondents whether they were teleworking due to COVID-
19 (as opposed to teleworking for other reasons) and OSHA estimated the
difference in teleworking from the peak of COVID-related teleworking in
all industries, which occurred in May 2020, through August 2021 (see
Table IV.B.4).\26\ The reduction in teleworking was then applied as the
change in percentage points to the estimated overall level of employees
covered by the ETS in each NAICS code estimated based on data from
Dingel and Neiman (July 2020). OSHA's final teleworking estimates are
provided in Appendix B in the accompanying document in the docket,
``Vaccination, and Testing ETS: Economic Profile and Cost Chapter
Appendices'' (OSHA, October 2021b). Reductions due to employees working
exclusively outdoors were applied to reduce the percentage of covered
employees in Appendix B as well.
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\26\ The CPS data were available only at the 2-digit NAICS level
as shown in Table IV.B.4.
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[[Page 61466]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.003
Other Teleworking Literature
A number of companies have announced plans to allow employees to
work from home at least through the end of 2021--suggesting that the
levels of remote work will not be returning to pre pandemic levels in
the near future. Many technology and internet based companies, such as
Dropbox, Coinbase, VMWare, and Slack, have announced a complete,
permanent move to fully remote work (Courtney, September 27, 2021).
Large employers such as Facebook, Amazon, and Siemens plan to maintain
some physical workspace but now offer their employees who are telework
eligible the option to work from home at least part of the time on a
permanent basis (Id.). Google, Ford, Amazon, Apple and other large
employers are expecting their telework eligible workers to return to
on-site work (in some capacity) no earlier than January 2022 with Lyft
anticipating a February 2022 return (Cerullo, August 31, 2021). As a
final example, a survey of businesses in Massachusetts found that about
40 percent of teleworkers anticipate they will not be returning to the
office in January 2022 or earlier (Chesto, June 22, 2021).
Additional studies provide qualitative support for the conclusion
that a range of employees will ``predictably'' work from home both
during the pandemic and beyond. In Bick, Blandin, and Martens's paper,
``Work from Home Before and After the COVID-19 Outbreak'' the authors
use the following information to establish the physical location of
employment (home or workplace) of workers: Data from the Real-Time
Population Survey (RPS), a
[[Page 61467]]
national labor market survey of adults between ages 18-64 that mirrors
the Current Population Survey (CPS) and collects information used in
pandemic analysis, such as commuting behavior before and after the
World Health Organization declared a global pandemic; mobility data on
commuting; and information from the CPS since May 2020 on `pandemic-
related' telework (Bick et al., February 2021).
Based on these data, Bick et al., found that there was a sudden
decline in commuting trips in the U.S. after the initial COVID-19
outbreak, and that even when these trips subsequently began increasing
back toward the original number of commuting trips, the overall number
of trips did not return to normal at the end of 2020 because many
teleworking employees continued working from home. The authors found
that the surge in work from home came almost entirely from employees
working from home every workday in the reference week. The authors also
suggest that, for some occupations, especially those occupations with
more educated workers, the change to increased work from home appears
to be a long-term change; the data showed that, as of December 2020,
12.5 percent of these workers reported they expect to be working from
home full-time in the future, and 24.5 percent reported they expect to
be working from home part-time.
In ``COVID-19 and Remote Work: An Early Look At U.S. Data,''
Brynjolfsson et al., noted that some of the shift to working from home
seems to be a long-term phenomenon (Brynjolfsson et al., June 2020).
The authors found, using an online survey, that 35.2 percent of workers
had switched to working from home. Additionally, 15 percent of workers
reported they were already working from home before COVID-19.
Therefore, this study finds that about half of workers are now working
from home--an even greater percentage than estimated by Dingel and
Neiman.
Finally, in ``Why Working from Home Will Stick,'' Barrero et al.
predict that 22 percent of all full workdays will be performed from
home after the pandemic ends, compared to 5 percent before (Barrero et
al., April 2021). The authors highlight five factors contributing
towards the more permanent shift to telework: Diminished stigma,
better-than-expected experiences working from home, investments in
physical and human capital enabling work from home, reluctance to
return to pre-pandemic activities, and innovation supporting work from
home.
d. Affected Entities and Employees
OSHA used data from the U.S. Census' 2017 Statistics of U.S.
Businesses (SUSB) to identify private sector entities and employees
affected by this section of the ETS (U.S. Census Bureau, 2019), and
used the BLS 2017 Quarterly Census of Employment and Wages (QCEW) to
characterize state and local government entities (BLS, 2017). SUSB
provides estimates of entities and employees by employer size range,
which OSHA used to exclude employers with fewer than 100 employees.\27\
---------------------------------------------------------------------------
\27\ SUSB with revenue data is only collected every 5 years.
While OSHA could attempt to extrapolate these data to more recent
years, the results would be imprecise because they would change the
revenue-employee size distributions. Those distributions are crucial
for measuring impacts so the agency has opted to use the data as is.
The total number of employees in OSHA's estimate is fairly close to
that of SUSB. The 2017 SUSB data includes a total of 128.6 million
employees, while the more recent 2018 SUSB data includes a total of
130.9 million.
---------------------------------------------------------------------------
For rail transportation (NAICS 482), which is not included in SUSB
or QCEW data, OSHA relied on Federal Railroad Administration and
Association of American Railroads statistics reported in OSHA's 2020
final rule, Cranes and Derricks in Construction: Railroad Roadway Work.
See 85 FR 57109 (September 15, 2020). OSHA used these data sources to
identify public and private railroad employers with more than 100
employees. For agricultural NAICS (111 and 112), OSHA relies on the
National Agricultural Statistics Service, 2017 Census of Agriculture
(NASS, 2017) to obtain estimates of total entities, employees, and
revenues. Since these data do not indicate the number of entities with
more than 100 employees, OSHA assumes it is the same as the average
proportion as the support activity sectors for crop and animal
production (NAICS 114 and 115). OSHA similarly specifies teleworking
conditions for NAICS 111 and 112 using the average result for support
activities for agriculture (NAICS 114 and 115). For the postal service
industry, NAICS 491110, which is not included in SUSB, OSHA obtains
total entity and employment data for private postal services from the
QCEW. Since these data do not indicate the number of entities with more
than 100 employees, OSHA assumes it is the same as the average
proportion as the related industries, couriers and express delivery
(NAICS 492110), and local delivery (NAICS 492120).
OSHA used the BLS 2020 Occupational Employment and Wage Statistics
(OEWS), which provides NAICS-specific estimates of employment and wages
by occupation, along with the data in Appendix B (discussed earlier),
to determine the subset of non-teleworking employees affected by the
ETS.
Table IV.B.5 summarizes the set of entities covered by the ETS.
OSHA estimates a total of approximately 263,879 entities and
approximately 1.9 million establishments incur costs under the ETS.\28\
OSHA estimates these entities employ approximately 102.7 million
employees, and of these, OSHA estimates approximately 84.2 million
employees are covered by the ETS and are not excluded from coverage by
working remotely 100 percent of the time or exclusively outside.\29\
For the purpose of this analysis, OSHA estimates that all employees
that OSHA estimated will work remotely will continue to do so for the
duration of this ETS.\30\
---------------------------------------------------------------------------
\28\ This includes public entities only in states with an
approved OSHA State Plan. See Table IV.B.2 above for further
discussion of state plans.
\29\ OSHA's estimate of covered employees is based on the
discussion in the text. For example, as OSHA writes above: OSHA
assumes for the purpose of its analysis that employers covered under
the Contractor Guidance will conduct work at least some of the time
in workplaces not covered under that Guidance and so are fully
integrated into the scope of the ETS; and the employers and
employees covered by the Healthcare ETS are also fully integrated
into the scope of the ETS.
\30\ Conditions are changing rapidly, and though many firms are
planning to keep expanded telework to some extent, as the rate of
vaccinated workers increases, there may be increased movement back
to the workplace beyond what OSHA has estimated here.
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[[Page 61469]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.005
[[Page 61470]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.006
III. Baseline Vaccine Status for Covered Employees
To estimate the cost of the ETS, OSHA must first estimate the
baseline vaccination status for the 84.2m covered employees (those who
work for employers with 100 or more employees and are not otherwise
excluded from coverage). OSHA recognizes that employees' current
vaccination status continues to change on a daily basis. When
specifying baseline vaccination rates, OSHA used the most recently
available vaccination data from CDC, reflecting current conditions. For
the remaining set of unvaccinated employees covered by the ETS, after
accounting for baseline vaccinations, OSHA estimates the number of
these employees who will be vaccinated and the number who will test
under the ETS. OSHA's methodology for this analysis is detailed below.
a. Estimate the Current Vaccination Rate for Covered Employees
To estimate the current vaccinate rate for covered employees, OSHA
obtained recent vaccination data by age group from the CDC COVID Data
Tracker (CDC, October 4, 2021a).\31\ For age groups covering 18-74
years old, these data include the number of people who are fully-
vaccinated as well as the number of people of who have initiated their
first shot in the past two weeks (relative to the October 4, 2021
data).\32\ OSHA estimates the vaccination rate for each group (percent
of total population in the age group who are vaccinated) based on the
total number of people who are fully-vaccinated and had their first
shot in the past two weeks, as a fraction of the population in each age
group, obtained from the BLS Current Population Survey (CPS) (BLS,
2021d). Then, to estimate the overall average vaccination rate across
age groups 18-74 years old, OSHA weighted each group based on the
distribution of the labor force by age, also obtained from the BLS CPS
(BLS, 2021d). As shown in Table IV.B.6, OSHA estimates an overall
vaccination rate of 61.3 percent for covered employees (and 38.7
percent unvaccinated). The healthcare sector had an earlier push to get
healthcare workers vaccinated and has a higher current rate, estimated
to be 70 percent.\33\
---------------------------------------------------------------------------
\31\ The data from the CDC website was retrieved on October 4,
2021.
\32\ Age groups included: 18-24, 25-39, 40-49, 50-64, and 65-74.
OSHA had not included the group 65-74 in the economic analysis of
the Healthcare ETS this past spring because for the healthcare
sector, using the population wide average of workers in this age
bracket was felt would overcount the number of such workers in this
sector. OSHA is including this group now that more of the other age
populations have been vaccinated and those concerns are no longer as
relevant. This ETS will therefore indicate that a slightly higher
percentage of universe of covered employees is vaccinated than if
that age group of 65-74 was excluded altogether, but it also
increases the number of employees for which additional compliance
costs are factored in. OSHA interprets the ultimate result as a more
accurate reflection of the workplace and notes that more costs are
included than if the age group had been excluded from the analysis.
\33\ The agency takes a recent survey (Lazer et al., August 16,
2021) which breaks out rates for healthcare vaccination and non-
healthcare, and rather than replacing the CDC base vaccination rate
uses the CDC rate to make an adjustment upwards to the healthcare
rate of 70 percent.
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[[Page 61471]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.007
Based on the above, OSHA estimates that the 84.2m covered employees
includes 52.5 million (62 percent) vaccinated employees and 31.7
million unvaccinated employees (38 percent).
b. Adjust Baseline Vaccination for Continuing Trends
OSHA adjusts the current vaccination rate to account for continuing
trends in vaccinations among covered employees due to employers'
continued implementation of vaccine mandates and other policies
(described below), under the ETS. To make this adjustment, OSHA
requires 1) further characterization of the set of unvaccinated
employees in terms of their likelihood to receive the vaccine, and 2)
specification of the extent of employer-mandated and other employer
vaccination policies.
Based on vaccine confidence data from CDC (CDC, October 2021a),
13.8 percent of the population ``probably or definitely will not'' get
the vaccine; hereafter referred to as ``vaccine-hesitant''. Since this
group is by definition part of the currently unvaccinated, OSHA
characterizes the currently unvaccinated (37.6 percent) as being
comprised of those who are vaccine--hesitant (13.8 percent) and the
remainder, who while unvaccinated, are not hesitant because they are
not in the ``probably or definitely will not'' group (23.8 percent).
Among those who are vaccine-hesitant, OSHA estimates that 5 percent
of covered employees (or about 36 percent of the vaccine-hesitant), are
hesitant due to a religious (4 percent) or medical (1 percent)
exemption. The remaining 8.8 percent include those who are vaccine-
hesitant for other reasons. For the 4 percent estimate for religious
exemptions, OSHA relies on data from Vermont, which removed its vaccine
exemption for nonreligious personal beliefs in 2016 and saw the
proportion of kindergarten students with a religious exemption rise to
about 4 percent (Graham, September 15, 2021). In analyzing this issue,
the agency also reviewed other religious exemption data concerning
state workers in Oregon and Washington; the agency decided not to rely
on these data because the Vermont data is a more accurate measure of
the correct religious exemption rate, although the data does represent
parents deciding on whether to claim an exemption for their child, not
for themselves. This is because, unlike the Vermont data, the Oregon
and Washington data contain workers that have applied, but not yet been
accepted, for a religious exemption (O'Sullivan, September 18, 2021;
KEZI News, September 25, 2021). In Oregon, 5 percent and in Washington
8 percent of the employees have requested accommodations though only a
fraction so far have been accepted. However, the data are not
inconsistent with the Vermont data even though the process in both
Oregon and Washington are not yet complete. For the 1 percent estimate
for medical exemptions, OSHA relied on the Household Pulse Survey (HPS)
conducted by the U.S. Census (U.S. Census Bureau, 2021). In Table 6a of
the Health Tables for Week 31, September 1, 2021 through September 13,
2021, about 1% of the US population said they would not get the vaccine
because ``Doctor has not recommended it,'' and OSHA uses this response
as a proxy for all medical conditions.\34\
---------------------------------------------------------------------------
\34\ Table 6a presents that 3,884,902 of the population will not
take the vaccine because the ``doctor has not recommended it'' out
of a total of 38,936,606 who will not get the vaccine for any
reason. Medical reasons are then about 10% of the general population
that will not get the vaccine, and the ones who won't get the
vaccine are about 10% of the whole population, giving 1% (.10 *
.10).
---------------------------------------------------------------------------
Table IV.B.7 presents the number of employees in each vaccination
category, which informs OSHA's subsequent estimates of which currently
unvaccinated employees may be vaccinated by employer-mandates,
vaccinated under the ETS, or tested under the ETS.
[[Page 61472]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.008
Next, OSHA estimates the number of currently unvaccinated employees
that are likely to become vaccinated while the ETS is in effect, based
on their employers' policies. Based on limited data on current vaccine
mandate implementation and forecasts for future implementation (Mishra
and Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons,
October 6, 2021), OSHA estimates that 25 percent of firms in scope
currently have a mandate, and assumes that this will rise to 60 percent
of employers after the ETS is in place. The baseline of 25 percent is
based on recent surveys showing a range of approximately 13-45 percent
of employers currently requiring or planning to require vaccination
among employees (see Willis Towers Watson, June 23, 2021; Mishra and
Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons, October 6,
2021). Absent the ETS, OSHA assumes that the percentage of firms would
remain 25 percent (with some measure of upward adjustment due to other
federal vaccine mandates affecting select populations, as discussed
above). To the extent more firms than OSHA estimates would mandate
vaccination independent of the ETS and thereby increase the vaccination
rate (again because of factors such as other federal vaccine mandates),
then the agency's costs are overestimated because the agency's baseline
vaccination rate is too low. The assumption of an increase from 25 to
60 percent is based on the same set of surveys that indicate that the
share of employers who will mandate vaccinations after the ETS
(including those that already mandate vaccinations) range from 25-75
percent, see above references. The agency also assumes that employees
are distributed in the same proportion across employers with and
without a vaccine mandate (e.g., if 60 percent of firms mandate
vaccination, 60 percent of employees will be vaccinated due to the
mandate (less those who remain unvaccinated due to religious or medical
exemptions).
OSHA assumes that all unvaccinated employees subject to an employer
mandate will be vaccinated under that employer mandate, except for
those seeking a medical or religious exemption. For unvaccinated
employees not subject to an employer mandate, OSHA assumes that they
will also be vaccinated at their employer's request, except for
employees who are vaccine-hesitant, which includes not only those who
remain unvaccinated for medical and religious reasons, but also those
who are hesitant for any other reason. OSHA carries through its
assumptions and estimates into its total cost estimates. For example,
OSHA estimates that the 25 percent of firms in scope that currently
have a vaccination mandate will not need to implement a new written
policy on vaccination in response to the ETS since they will already
have implemented a policy that meets the requirements of the ETS.
In total, OSHA estimates that 27 percent of covered employees (22.7
million) will be vaccinated based on employer policies under the ETS;
or 72 percent of covered employees who are currently unvaccinated. The
resulting vaccination rate, adjusted for the ETS, is estimated based on
the total of those who are currently vaccinated and those who will be
vaccinated under employer policies, 89.4 percent as shown in Table
IV.B.8. Calculations of this nature, while not discussed in more detail
in this analysis, are contained fully in the spreadsheets supporting
this analysis (OSHA, October 2021a).\35\
---------------------------------------------------------------------------
\35\ OSHA notes that these estimates differ for employees
covered by the Healthcare ETS. OSHA calculated these estimates
separately because, as stated above, OSHA is only taking costs for
these employees in the last four months of the assumed 6-month
period while the ETS remains in effect. While OSHA does not describe
in detail how it derived estimates for employees covered by the
Healthcare ETS in this analysis, the derivation of those estimates
run parallel to those described above. For more information, please
see the spreadsheets supporting this analysis. (OSHA, October
2021a).
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[[Page 61473]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.009
From Table IV.B.8, OSHA estimates that approximately 75.3 million
(89.4 percent) of covered employees will be vaccinated when the ETS is
in full effect, and that approximately 8.9 million employees (10.6
percent, made up of approximately 6.3 million covered employees who
will be tested for COVID under the ETS and approximately 2.6 million
employees who return to telework (see next paragraph)) will remain
unvaccinated. This final set of unvaccinated employees includes all
employees not vaccinated because of religious or medical accommodations
or medical contraindication, plus the portion of those who are vaccine-
hesitant for any other reason, who were not vaccinated because their
employer has opted for a voluntary vaccination policy.
From the above, OSHA estimates that about 5 percent of all covered
employees will seek and receive religious or medical accommodations or
exemption for medical contraindication. While the agency encourages
employers to consider the most protective accommodations such as
telework, which would prevent the employee from being exposed at work
or from transmitting the virus at work, for cost analysis purposes the
agency assumes these workers will largely be tested in order for their
employers to comply with the ETS. Consistent with the overall average
22 percent of those who returned to work after teleworking earlier in
the pandemic (see teleworking discussion above), OSHA assumes for this
cost analysis that only 22 percent of workers needing a reasonable
accommodation will return to full time telework as a reasonable
accommodation. OSHA also assumes that the 78 percent remainder will
follow the testing/masking protocols in the ETS as a reasonable
accommodation.
For hesitant employees who will not seek a religious or medical
accommodation, and who work in a firm with a testing option, the agency
assumes as above that those who were teleworking before (again on
average 22 percent) will return to telework rather than being tested.
c. Cost of Absenteeism to Employers
Even mild cases of Covid-19 can be costly to employers as they can
induce productivity losses due to work absences, both among those
infected and their close contacts who may be subject to quarantine
requirements. While many workers were able to engage in telework in
March-April 2020, several occupational groups deemed essential,
including childcare workers, personal care aids, healthcare support
occupations, and food processing workers, exhibited significantly
higher rates of absenteeism during that period, which the authors
attributed to some workers contracting COVID-19 (Groenewold et al.,
July 10, 2020). Absenteeism can also affect the productivity of workers
who are present, similar to how turnover can impose costs on incumbent
workers (Kuhn and Yu, April 2021).
In aggregate, productivity losses from absences can be costly, as
evidenced by the economic losses from seasonal influenza. One estimate
found that the United States loses 20.1 million days of economic
productivity every year due to influenza, an ongoing loss equivalent to
80,400 full-time worker-years (Putri et al., June 22, 2018). Another
recent study found that higher influenza vaccination rates result in
both fewer deaths and significantly reduced illness-related work
absences (White, 2021).
OSHA recognizes that absenteeism has been a problem. However, as
explained in other sections of the preamble, the ETS vaccination and
testing and face covering requirements are necessary to reduce the
spread of COVID-19 in the workplace, which may in part reduce
absenteeism. The ETS might in a limited sense also increase absenteeism
because the rule requires employers to temporarily remove from the
workplace any employee who receives a positive COVID-19 test or is
diagnosed with COVID-19 by a licensed healthcare provider. However,
this provision will also help to further reduce absenteeism because,
when an
[[Page 61474]]
infected employee is promptly removed from the workplace, that can
prevent one employee from infecting other employees in the workplace
and potentially causing an outbreak or a super-spreader event. Thus,
OSHA concludes that the ETS may, on net, help ameliorate absenteeism by
reducing illnesses, but in any event will not increase absenteeism (see
OSHA, October 2021c).
d. The Effect of Employee Turnover
One of the primary concerns among employers in imposing vaccination
mandates is loss of staff, with 60 percent of employers selecting it as
a concern with regard to mandating COVID-19 vaccination, according to
one survey (Mishra and Hartstein, August 23, 2021).\36\ To this end,
employer vaccination mandates could lead to employee turnover;
employees could either leave on their own volition or employers who
have instituted strict vaccination policies may fire workers who are
not vaccinated, or place them on unpaid leave.
---------------------------------------------------------------------------
\36\ This survey done in August, 2021, has 1,630 responses,
reported by HR staff, attorneys, and executives. Described as being
``from a variety of industries,'' 83 percent of respondents were
from companies with more than 100 employees.
---------------------------------------------------------------------------
On the other hand, there is countervailing evidence to suggest that
employers who implement a vaccine mandate will be met with an influx of
potential workers. Many employees would prefer a mandate in place, and
would be more likely to stay with, or apply to, a firm that had a
vaccine mandate in place. For example, although Inova health system in
Northern Virginia, lost 89 workers for noncompliance with the system's
vaccination mandate, that loss amounted to less than 0.5 percent of its
workforce, (Portnoy, October 3, 2021), and, in any event, Inova's CEO
stated that the vaccine mandate has helped with recruitment, and that
its workers are concerned for their own safety and want to know they
are working with vaccinated colleagues. This same article listed some
other Virginia healthcare systems with higher rates of loss in
connection with vaccine mandates. Valley Health terminated 1 percent of
its employees, while Luminis Health had about 2 percent of its workers
still unvaccinated at the time of its mandate deadline. As another
example, although United Airlines had 593 employees (out of the
company's 67,000 U.S. employees) who had not complied with the
company's vaccination mandate at the end of September (a number that
dropped below 240 employees by October 1), the company reported it has
received 20,000 applications for 2,000 flight attendant positions, a
much higher ratio than before the pandemic (Chokshi and Scheiber,
October 2, 2021). In addition, one survey reports that among employee
resignations due to COVID-19 workplace policies, 42 percent reported
lack of workplace safety policies, 17 percent reported that existing
workplace policies were not stringent enough, and only 39 percent
reported overly restrictive workplace policies, suggesting that many
employees will welcome vaccine mandates (ASU COVID-19 Diagnostic
Commons, October 6, 2021).\37\
---------------------------------------------------------------------------
\37\ This August 2021 global survey (all results presented here
are for the US only) has 1,143 responses. It covers 28 industries,
including: Technology and Software, Business and Professional
Services, Manufacturing, Construction, and Healthcare. Ninety
percent of respondents were from companies with more than 100
employees.
---------------------------------------------------------------------------
While employee turnover is a natural part of business in any
industry, higher employee turnover rate than normal can have a direct
impact on profit and revenue. The normal range of employee turnover
differs widely by industry, with an average turnover rate of about 50
percent per year overall for the private sector.\38\ For example,
between 2016 and 2020, employee turnover ranged from 55 percent to 70
percent in the retail industry and from 40 percent to 60 percent in the
transportation industry (the industry sectors with the highest
employment).\39\
---------------------------------------------------------------------------
\38\ BLS (March 11, 2021).
\39\ Id.
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OSHA acknowledges that a vaccine mandate may result in increased
employee turnover, but one recent survey \40\ suggests it is very
unlikely that this potential increase in employee turnover will exceed
the ranges that industries have experienced over time. The survey,
though limited because many respondents did not have mandates in place
at that time, shows that there was no impact on turnover for 71 percent
of those with mandates in place. Only 25 percent saw a slight increase
in turnover (1 percent to 5 percent above normal) and only 4 percent
saw a significant increase (more than 5 percent above normal). As such,
OSHA does not anticipate that the potentially increased employee
turnover attributable to vaccine mandates will be substantial enough to
negate normal profit and revenue.
---------------------------------------------------------------------------
\40\ Umland, October 13, 2021. This October 2021 survey has
1,059 total respondents, though only 365 have implemented a
vaccination mandate and answered this turnover question.
---------------------------------------------------------------------------
To this end, an important factor to consider in examining turnover
in connection with vaccine mandates is the unquantified cost savings
and other positive economic impacts accruing to employers that
institute vaccine mandates. These include reduced absenteeism due to
fewer COVID-19 illnesses and quarantines, as discussed above. Other
positive economic impacts of a vaccine mandate are increased retail
trade from customers that feel less at risk and better relations with
suppliers and other business partners. These all would contribute to
improved business and increased profits.
The existence of these cost savings and other positive economic
impacts accruing to employers that comply with the ETS suggests that
the actual net costs of the ETS could be much lower than the costs
reported in this section of the economic analysis. As OSHA discusses
above, OSHA has provided evidence to support its estimate that 25
percent of covered employers already voluntarily require that their
employees be vaccinated and a much larger percentage are considering a
vaccine mandate. This supports the conclusion that these businesses
agree that doing so will ultimately save costs.
In addition, under the ETS, employers may implement a policy that
allows for testing and face covering instead. Firms will have a
tendency to self-select: If a large proportion of its work force has
indicated concern about a vaccine mandate, the firm is more likely to
choose the testing option to retain their workers. This is one factor
that led the agency to estimate that approximately 40 percent of
employers will allow employees to choose testing and face coverings in
lieu of vaccination. To the extent employers are concerned about
employee testing costs, employers can generally absorb testing costs or
help employees reduce those costs through low-cost assistance such as
employer proctoring of tests (even though that is not required by this
ETS). Departure of personnel because of vaccine mandates is also likely
to be less common when vaccine mandates are more prevalent across
employers in a region or industry. One survey reports that 65 percent
of employers state that actions of other companies in their industry
are very, or at least moderately, important in deciding to mandate
vaccination (Mishra and Hartstein, August 23, 2021).
Mandatory vaccinations for COVID-19 are still relatively new
because vaccines only became available in quantities sufficient to
support such mandates only about 6 months ago, and the FDA has only
recently moved past emergency clearance to final clearance. While there
is not an abundance of evidence about whether employees have actually
left or joined an employer based on a vaccine mandate,
[[Page 61475]]
particularly one with an alternative allowing for testing in lieu of
vaccination, OSHA has examined the best available evidence it could
locate in the timeline necessary to respond with urgency to the grave
danger addressed in this ETS. Based on that, OSHA is persuaded that the
net effect of the OSHA ETS on employee turnover will be relatively
small, given the option for employers to implement a testing and face
covering policy and the countervailing forces surrounding turnover that
will limit those effects, as discussed above.
Finally, OSHA finds one line of evidence particularly persuasive
because it involves data instead of polls: While different surveys may
suggest different levels of worker intentions (joining or remaining
with a safer employer versus leaving an employer to avoid
vaccination),\41\ the data suggests that the number of employees who
actually leave an employer is much lower than the number who claimed
they might: 1% to 3% or less actually leave, compared to the 48-50% who
claimed they would.\42\ As discussed earlier, this turnover number is
well below the average turnover rate in most industries. Thus, OSHA
concludes that whether or not the ETS proves helpful to recruitment
efforts for some employers, it will not, on balance, add significant
new costs to covered employers or threaten the economic feasibility of
any industry during a six month period.
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\41\ Two polls from June 2021, when the number of COVID-19 cases
had dropped dramatically just before the Delta Variant led to a
surge in cases, indicated that 50% of unvaccinated employees
surveyed said that they would leave their job rather than accept a
vaccination mandate from their employer. (KFF et al., June 30, 2021)
(the same percentage also responded that ``The number of cases is so
low that there is no need for more people to get the vaccine.''). A
separate poll from the same time also stated that 48% of ``vaccine
hesitant'' employees claimed they would quit their jobs rather than
be vaccinated. (Barry et al., September 24, 2021--citing yet
unpublished June 2021 poll). In a more recent poll, about 44% of
workers said that they would consider leaving their jobs if they
were forced to get vaccinated, while around 38% of workers would
consider leaving their current employer if the organization did not
enact a vaccine mandate. (Kelly August 12, 2021). Interestingly, in
that survey there was a direct correlation between the age of the
worker and the desire to have a vaccinated workplace: Younger
workers, usually the most mobile portion of the workforce, had a
much higher desire for a vaccinated workforce (50% of Generation Z
employees, as compared to 33% of Baby Boomers).
\42\ An article titled ``Unvaccinated Workers Say They'd Rather
Quit Than Get a Shot, but Data Suggest Otherwise'' noted the 48%-50%
threat to leave, but included hard data showing nothing close to
those levels actually occurred: Houston Methodist Hospital required
its 25,000 workers (including its 3,580 unvaccinated employees) to
get a vaccine by June 7, and only 153 resigned or were fired (4% of
the 3,580 unvaccinated employees; 0.6% of the total number of
employees); other examples of the numbers of employees who left in
response to their employers' mandatory vaccine policy involved 5 out
of 527 (0.9%), 2 out of 250 (0.8%), 6 out of 260 (3%), and 125 out
of 35,800 (0.3%). (Barry et al., September 24, 2021).
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OSHA seeks comments on these estimates and conclusions, as well as
further data that it could use to refine its estimates.
IV. Cost Analysis for COVID-19 Vaccination and Testing ETS, Sec.
1910.501
In this section, OSHA provides estimates of the per-entity and
total costs for the requirements of this ETS. Section 6(c)(3) of the
OSH Act states that the Secretary will publish a final standard ``no
later than six months after publication of the emergency standard.''
Costs are therefore estimated over a six-month time period. Note that
the estimates are presented in this section at the 3-digit NAICS level,
but the analysis was conducted at the 6-digit NAICS level and
aggregated to the 3-digit level for presentation purposes. The 6-digit
NAICS level data is accessible in the supporting spreadsheet. It should
be noted that this analysis deals strictly with averages. For any given
entity, actual costs may be higher or lower than the point estimate
shown here, but using an average allows OSHA to evaluate feasibility by
industry as required by the OSH Act. In addition, OSHA has limited data
on many of the parameters needed in this analysis and has estimated
them based on the available data, estimates for similar requirements
for other OSHA standards, consultation with experts in other government
agencies, and internal agency judgment where necessary. OSHA's
estimates are therefore based on the best evidence available to the
agency at the time this analysis of costs and feasibility was
performed.
As mentioned above, OSHA estimates that approximately 264,000
entities have employees who will be subject to the requirements of the
ETS, including approximately 84.2 million employees. Many ETS
requirements result in labor burdens that are monetized using the labor
rates described next.
a. Wage Rates
OSHA used occupation-specific wage rates from BLS 2020 OEWS data
(BLS, 2021a). Within each affected 6-digit NAICS industry, OSHA
calculated the employee-weighted average wage to be used in the
analysis. OSHA estimated loaded wages using the BLS' Employer Cost for
Employee Compensation data (BLS, 2021b), as well as OSHA's standard
estimate for overhead of 17 percent times the base wage.
Costs are estimated using three labor rates for each NAICS
industry: The average labor rate for all employees, the labor rate for
General and Operations Managers (SOC code 11-1021), and the labor rate
for Office Clerks, General (SOC 43-9060). Industry-specific wage rates
are presented in Appendix C in the accompanying document in the docket,
``Vaccination and Testing ETS: Economic Profile and Cost Chapter
Appendices (OSHA, October, 2021b).''
b. Rule Familiarization, Employer Policy on Vaccination, and
Information Provided to Employees
ETS Requirements
Section 1910.501(d)(1) of the ETS specifies that the employer must
establish and implement a written mandatory vaccination policy. The
employer is exempted from the requirement in paragraph (d)(1) only if
the employer establishes and implements a written policy allowing any
employee not subject to a mandatory vaccination policy to either choose
to be fully vaccinated against COVID-19 or to provide proof of regular
testing for COVID-19 in accordance with paragraph (g) of the ETS and to
wear a face covering in accordance with paragraph (i) of the ETS.\43\
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\43\ Note to paragraph (d): Under federal law, including the
Americans with Disabilities Act (ADA) and Title VII of the Civil
Rights Act of 1964, some workers may be entitled to a reasonable
accommodation from their employer, absent undue hardship. If the
worker requesting a reasonable accommodation cannot be vaccinated
against COVID-19 and/or wear a face covering because of a
disability, as defined by the ADA, or if the vaccination, testing,
and/or wearing a face covering conflicts with the worker's sincerely
held religious belief, practice or observance, the worker may be
entitled to a reasonable accommodation. For more information about
evaluating requests for these types of reasonable accommodations for
disability or sincerely held religious belief, employers should
consult the Equal Employment Opportunity Commission's regulations,
guidance, and technical assistance including at: https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
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In addition, under Sec. 1910.501(j), information provided to
employees, the ETS requires the employer to inform each employee, in a
language and at a literacy level the employee understand about: (1) The
requirements of the ETS as well as any employer policies and procedures
established to implement the ETS; (2) COVID-19 vaccine efficacy,
safety, and the benefits of being vaccinated; (3) the requirements of
29 CFR 1904.35(b)(1)(iv) and Section 11(c) of the OSH Act; and (4) the
prohibitions of 18 U.S.C. 1001 and Section 17(g) of the OSH Act.
As stated, the ETS face covering requirements are contained in
paragraph
[[Page 61476]]
(i) of the ETS. Under that paragraph, the employer, with certain
exceptions specified in the ETS, must ensure that each employee who is
not fully vaccinated wears a face covering when indoors and when
occupying a vehicle with another person for work purposes. The ETS does
not require, nor does it prohibit, the employer to pay for any costs
associated with face coverings (although employer payment for face
coverings may be required by other laws, regulations, or collective
bargaining agreements or other collectively negotiated agreements).
However, the employer must permit the employee to wear a respirator
instead of a face covering whether required or not. In addition, the
employer may provide respirators or face coverings to the employee,
even if not required. In such circumstances, where the employer
provides respirators, the employer must also comply with Sec.
1910.504, Mini respiratory protection program.
OSHA estimates no costs associated with an employee voluntarily
bringing in their own respirator to use instead of a face covering
other than those costs that OSHA is estimating below in connection with
29 CFR 1910.501(j), information provided to employees. That section
provides, again, that the employer must inform each employee, in a
language and at a literacy level the employee understands about the
requirements of the ETS as well as any employer policies and procedures
established to implement the ETS. One policy the employer would need to
establish to implement the ETS is a policy to comply with the
requirements of 29 CFR 1910.504 when an employee voluntarily brings in
their own respirator. Those requirements require only that the employer
provide certain information to the employee (see 29 CFR 1910.504(c)).
OSHA is also estimating no costs in connection with the employer
providing respirators to the employee. The ETS does not require the
employer to provide respirators to employees. Therefore, any such
provision is voluntary and not relevant to economic feasibility of this
rule.
The face covering provisions in paragraph (i) contain several other
requirements, none of which have costs associated with them.
Cost Analysis Assumptions
In this section, OSHA estimates the cost for establishing the
employer policy on vaccination, providing required information to
employees, and rule familiarization. OSHA assumes each entity will
require an average one-time labor burden of 1 hour of management labor
for rule familiarization. OSHA based this unit cost on that taken for
rule familiarization in the Healthcare ETS (86 FR at 32496), but
adjusted the time downward by a half-hour because this ETS is a simpler
standard than the Healthcare ETS.
To establish a written policy in accordance with paragraph (d) of
the ETS, OSHA assumes a one-time average labor burden of 5 hours of
manager time per firm. OSHA bases this estimate on its cost estimates
in the Healthcare ETS, where OSHA estimated that development of the
COVID-19 Plan required by that standard would take between 5 and 40
hours (see 86 FR at 32496-32497). OSHA concludes that 5 hours is a
reasonable estimate because the development of a written policy on
vaccination will be much simpler than the development of the written
COVID-19 Plan required by the Healthcare ETS (see 29 CFR
1910.502(c)).\44\ OSHA notes, that like the Healthcare ETS (id.), the
cost of implementing the plan for this ETS are included in the costs of
implementing the corresponding requirements in the ETS, which are
discussed below.
---------------------------------------------------------------------------
\44\ The estimates for the time to create the written vaccine
policy plan under this ETS may differ from the time to create the
various processes under the CMS rule published elsewhere in this
issue of the Federal Register since the requirements of what is
needed to be included in the plans differ. For example, the CMS plan
requires a process for ensuring the implementation of additional
precautions to mitigate the transmission and spread of COVID-19
while OSHA's vaccination policy requirements do not include this
requirement.
---------------------------------------------------------------------------
To provide information to employees in accordance with paragraph
(j) of the ETS, OSHA assumes a one-time average labor burden per firm
of 10 minutes of manager time. The agency expects activities like
posting the information on a community board, mass emailing, etc., will
satisfy this requirement.
The total cost for rule familiarization, establishing an employer
policy on vaccination and providing required information to employees
is calculated as the product of:
One-time labor burden for rule familiarization and
establishing a policy (a total of 6 hours of manager time per entity)
plus a one-time labor burden for providing information to employees (10
minutes of manager time per entity);
The labor rate for General and Operations Managers (SOC
code 11-1021, NAICS-specific wages); and,
The total number of covered entities.
Cost for Employer Policy on Vaccination and Information Provided to
Employees
Costs per entity and total costs for employer policy on vaccination and
information provided to employees are shown below in Table IV.B.9.
BILLING CODE 4120-01-P
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[[Page 61478]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.011
BILLING CODE 4120-01-C
c. Determining Employee Vaccination Status
ETS Requirements
Under Sec. 1910.501(e):
Paragraph (e)(1). The employer must determine the vaccination
status of each employee. This determination must include whether the
employee is fully vaccinated, which is 2 weeks after the full required
vaccine course is completed.
Paragraph (e)(2). The employer must require each vaccinated
employee to provide acceptable proof of vaccination status, including
whether they are fully or partially vaccinated. Acceptable proof of
vaccination status is:
The record of immunization from a health care provider or
pharmacy;
A copy of the COVID-19 Vaccination Record Card;
A copy of medical records documenting the vaccination;
A copy of immunization records from a public health,
state, or tribal immunization information system; or
[[Page 61479]]
A copy of any other official documentation that contains
the type of vaccine administered, date(s) of administration, and the
name of the health care professional(s) or clinic site(s) administering
the vaccine(s).
In instances where an employee is unable to produce acceptable
proof of vaccination, per above, a signed and dated statement by the
employee, subject to criminal penalties for knowingly providing false
information:
Attesting to their vaccination status (fully vaccinated or
partially vaccinated); and
Attesting that they have lost and are otherwise unable to
produce proof required by the ETS.
Paragraph (e)(3). Any employee who does not provide one of the
acceptable forms of proof of vaccination status in paragraph (e)(2) of
the ETS to the employer must be treated as not fully vaccinated for the
purpose of the ETS.
Paragraph (e)(4). The employer must maintain a record of each
employee's vaccination status and must preserve acceptable proof of
vaccination for each employee who is fully or partially vaccinated. The
employer must maintain a roster of each employee's vaccination status.
These records and roster are considered to be employee medical records
and must be maintained as such records in accordance with 29 CFR
1910.1020 and must not be disclosed except as required or authorized by
the ETS or other federal law. These records and roster are not subject
to the retention requirements of 29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while the ETS remains in effect.
Paragraph (e)(5). Finally, when an employer has ascertained
employee vaccination status prior to the effective date of this section
through another form of attestation or proof, and retained records of
that ascertainment, the employer is exempt from the requirements in
paragraphs (e)(1)-(e)(3) only for each employee whose fully vaccinated
status has been documented prior to the effective date of this section.
For purposes of paragraph (e)(4), the employer's records of
ascertainment of vaccination status for each such person constitute
acceptable proof of vaccination.
The full costs for these provisions are taken under the costs for
recordkeeping, discussed below, because determining vaccination status,
providing acceptable proof of vaccination status, and creating and
maintaining a roster of each employee's vaccination status will be part
and parcel of the recordkeeping process.
d. Employer Support for Employee Vaccination
ETS Requirements
Under 29 CFR 1910.501(f):
The employer must support COVID-19 vaccination by providing:
Time for vaccination. The employer must: (i) Provide a
reasonable amount of time to each employee for each of their primary
vaccination series dose(s); and (ii) provide up to 4 hours paid time,
including travel time, at the employee's regular rate of pay for this
purpose.
Time for recovery. The employer must provide reasonable
time and paid sick leave to recover from side effects experienced
following any primary vaccination series dose to each employee for each
dose.
Under the ETS, fully vaccinated means (i) a person's status 2 weeks
after completing primary vaccination with a COVID-19 vaccine with, if
applicable, at least the minimum recommended interval between doses in
accordance with the approval, authorization, or listing that is: (A)
Approved or authorized for emergency use by the FDA; (B) listed for
emergency use by the World Health Organization (WHO); or (C)
administered as part of a clinical trial at a U.S. site, if the
recipient is documented to have primary vaccination with the ``active''
(not placebo) COVID-19 vaccine candidate, for which vaccine efficacy
has been independently confirmed (e.g., by a data and safety monitoring
board), or if the clinical trial participant from the U.S. site had
received a COVID-19 vaccine that is neither approved nor authorized for
use by FDA but is listed for emergency use by WHO; or (ii) a person's
status 2 weeks after receiving the second dose of any combination of
two doses of a COVID-19 vaccine that is approved or authorized by the
FDA, or listed as a two-dose series by the WHO (i.e., heterologous
primary series of such vaccines, receiving doses of different COVID-19
vaccines as part of one primary series). The second dose of the series
must not be received earlier than 17 days (21 days with a 4-day grace
period) after the first dose.
Cost Analysis Assumptions
OSHA assumes there will be no costs to employers or employees
associated with the vaccine itself.\45\ However, to provide support for
vaccination of employees, OSHA estimates that it will take an average
of 15 minutes of travel time, each way, per employee to travel to a
vaccination site (for a total of 30 minutes). OSHA then estimates 5
minutes to wait, fill out any necessary paperwork, and receive the
shot, and a post-shot wait time of 20 minutes, per employee. Some
firms, particularly larger ones, will find it cheaper to have vaccines
administered on site. They may have an on-site health clinic or may
hire a 3rd party purveyor to come to the facility.\46\ This will
minimize travel and also allow the companies to mitigate some of the
logistical issues that may be preventing employees from receiving a
vaccine (finding a convenient appointment time, etc.). OSHA estimates
that 10 percent of firms with employees between 100 to 500 employees
will select this option, while, given decreased average costs
associated with economies of scale, 25 percent of firms with over 500
employees will select this option. OSHA was unable to obtain an
estimate of the cost savings associated with on-site vaccination in the
time allotted to issue this emergency standard, so it is assuming that
the costs for off-site vaccination are the same as the costs for on-
site vaccination. This results in a likely over-estimate of costs given
that the entities that choose the on-site option will do so as a cost-
saving measure.
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\45\ While there may be some administrative costs borne by the
government, such costs are not germane to this analysis of whether
the ETS is economically feasible for covered employers.
\46\ Prior to the effective date of this rule, some companies
offered on-site vaccination according to a limited survey. (Willis
Towers Watson, June 23, 2021). See also CDC on creating an on-site
program (CDC, March 25, 2021; CDC, October 4, 2021b).
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In OSHA's cost analysis, OSHA assumes that all employees will be
vaccinated during working hours and employers would adjust the employee
work schedule to ensure that the employee would not become eligible for
overtime pay as a result of the vaccination time. However, it should be
noted that, if an employee chooses to receive the vaccine outside of
work hours, OSHA does not require employers to grant paid time to the
employee for the time spent receiving the vaccine during non-work hours
(although other laws may include additional requirements for employers,
such as those addressing reasonable accommodations or exemptions).
OSHA's analysis may be an overestimate as it reflects an assumption
that all vaccinations are received during work hours.
CDC data indicated that 5 percent of employees vaccinated have
received the Johnson & Johnson vaccine, and 95 percent have received
either Pfizer or Moderna (CDC, October 2021b). OSHA applies the same
allocation to employees being vaccinated under the ETS. For those
receiving Pfizer or Moderna, the labor burden outlined
[[Page 61480]]
above occurs twice, since vaccination requires two shots.
The employer must provide reasonable time and paid sick leave to
recover from side effects experienced following any vaccination dose to
each employee for each vaccination dose. Employers may require
employees to use paid sick leave benefits otherwise provided by the
employer to offset these costs, if available. The average amount of
time off an employee may need for side effects while receiving the
vaccine doses necessary to achieve full vaccination (one or two doses,
depending on the vaccine) depends on several factors. First, the
percentage of people who will have side effects that are severe enough
to require time. Second, the average time duration for those who have
such a severe reaction. For estimates of these parameters OSHA is using
a recent study (Levi et al., September 29, 2021) which surveyed workers
at a state-wide health care system who had been vaccinated. The study
found that, for the first dose, 4.9% needed administrative leave, with
an average length of absence of 1.66 days. For the second dose, 19.79%
needed leave and their average length of absence was 1.39 days.
Together, the average time on leave is .36 days (.049 * 1.66 + .1979 *
1.39) for a person receiving two doses, which reflects the fact that
many people who receive the vaccine do not have any side effects for
either dose while others have more severe side effects.
In order to determine the amount of paid sick leave that would be
available to employees, OSHA relied on data from BLS (BLS, 2021e). BLS
estimates that for civilian workers in establishments with 100+
employees, 88% have access to paid sick leave (Table 33). BLS states
that the average number of paid sick leave available is 9 days (Table
36). Because there is the same number of days across all levels of
employee tenure (1 year, 5 years, 10 years, and 20 years), OSHA used 9
days for all covered employees. The agency assumes that 75% of the
available paid sick leave has been used by the current 4th quarter of
the calendar year. So the average number of days available is 1.98
days: 9 (days) * 88% (employees with available paid sick leave) * 25%
(amount of leave remaining in the year) = 1.98 days available. Given
that the average overall time out due to side effects is 0.36 days (see
above), OSHA concludes that, on average, employees should have
sufficient existing paid sick leave available to cover the time needed
as a result of vaccine-related side effects. As a result, OSHA is
taking no costs to employers in connection with the ETS's requirement
to provide time for recovery from vaccination (except as provided
below), as these costs will have been incurred by the employer
independent of the ETS.
While this analysis is entirely consistent with OSHA's standard
procedure of strictly using averages in cost analysis, it nonetheless
masks some significant effects resulting from the time for recovery
requirements. From the BLS data, OSHA knows there are 12% of
establishments that have 100+ employees and do not provide paid sick
leave. Correspondingly, there is a group of entities with no paid sick
leave that will obviously incur costs that result directly from these
requirements. In addition, some employees may not have, or some other
entities may not offer, sufficient paid sick leave to cover these
costs.
To account for the 12 percent of firms that do not offer paid sick
leave, the agency uses the above estimate of average days for two
doses, 0.36 days, and multiplies the average employee wage by NAICS to
calculate the cost per employee. Since OSHA does not know which firms
make up the 12 percent, the agency spreads this total cost across all
firms by employee. Since firms without any sick leave are likely to be
lower-wage firms, this will likely lead to a cost overestimate.
Therefore, the total cost for paid time off for vaccination is
based on the costs for providing paid sick leave for the 12 percent of
firms that do not offer paid sick leave and:
Travel time per employee of covered firms of 15 minutes
each way per vaccination dose (total of 30 minutes).
Pre-shot wait time per employee of covered firms of 5
minutes per vaccination dose.
Post-shot wait time per employee of covered firms of 20
minutes per vaccination dose.\47\
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\47\ According to the CDC, people with allergies require a wait
time of 30 minutes, but they are a small group, and, in any event,
the CDC recommends that routine wait time is 15 minutes, so the
agency considers that its average of 20 minutes is probably an
overestimate. (See CDC, October 4, 2021a; CDC, March 3,2021.)
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The average labor rate for employees (NAICS-specific
wages).
Total number of employees at covered firms getting
vaccinated due to the ETS with the Johnson & Johnson vaccine.
Total number of employees at covered firms getting
vaccinated due to the ETS with the Pfizer and Moderna vaccines,
multiplied by two to account for two shots.
Cost for Support for Employee Vaccination
Costs per firm and total costs for vaccination are shown below in
Table IV.B.10.
BILLING CODE 4120-01-P
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[[Page 61482]]
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[[Page 61484]]
BILLING CODE 4120-01-C
e. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
ETS Requirements
Section 1910.501(g)(1) of the ETS requires the employer to ensure
that each employee who is not fully vaccinated do the following:
An employee who reports at least once every 7 days to a workplace
where other individuals, such as coworkers or customers, are present:
Must be tested for COVID-19 at least once every 7 days;
and
Must provide documentation of the most recent COVID-19
test result to the employer no later than the 7th day following the
date on which the employee last provided a test result.
An employee who does not report during a period of 7 or more days
to a workplace where other individuals, such as coworkers or customers,
are present (e.g., teleworking for two weeks prior to reporting to a
workplace with others):
Must be tested for COVID-19 within 7 days prior to
returning to the workplace; and
Must provide documentation of that test result to the
employer upon return to the workplace.
Furthermore, if an employee does not provide documentation of a
COVID-19 test result as required by paragraph (g)(1) of the ETS, the
employer must keep that employee removed from the workplace until they
provide a test result. In addition, when an employee has received a
positive COVID-19 test, or has been diagnosed with COVID-19 by a
licensed healthcare provider, the employer must not require that
employee to undergo COVID-19 testing as required under paragraph (g) of
this section for 90 days following the date of their positive test or
diagnosis. Finally, the employer must maintain a record of each test
result provided by each employee under paragraph (g)(1) of this section
or obtained during tests conducted by the employer. These records are
considered to be employee medical records and must be maintained as
such records in accordance with 29 CFR 1910.1020 and must not be
disclosed except as required or authorized by this section or other
federal law. These records are not subject to the retention
requirements of 29 CFR 1910.1020(d)(1)(i) but must be maintained and
preserved while this section remains in effect.
OSHA addresses the costs associated with testing in the next
section. The remaining costs required by paragraph (g) are taken under
the costs for recordkeeping, discussed below, because providing
documentation of test results to the employer will be part and parcel
of the recordkeeping process.
Employees who are partially vaccinated are also required to be
tested weekly until they are fully vaccinated. Those receiving the J&J
vaccine will require two weeks of testing after the single shot,
employees who received the Pfizer-BioNTech Vaccine will require 5 weeks
of testing (3 weeks between shots and 2 weeks following the second
shot), and Moderna recipients require 6 weeks of testing (4 weeks
between shots and 2 weeks following the second shot) (CDC, October 4,
2021b). Notwithstanding this, in the agency's total cost estimate OSHA
accounts for the fact that employers need not comply with the
requirements of this section in paragraph (g) by 60 days after the
rule's effective date, and that employees who have completed the entire
primary vaccination series by that date do not have to be tested, even
if they have not yet completed the 2 week waiting period.
There is no requirement in the rule that the employer pay for this
testing so these testing-related costs are not included in the main
analysis (although, as discussed below OSHA takes into account costs
for testing in connection with the ETS's recordkeeping requirements).
The agency estimates that 6.3 million weekly tests will need to be
given due to this ETS (see Table IV.B.8). This 6.3 million is likely an
overestimate of new costs because it encompasses tests for employees
who were already required to conduct testing by their employers prior
to this ETS.
OSHA also notes that its cost estimates for testing do not take
into account the 90-day break in testing that occurs following the date
of a positive test or diagnosis. OSHA's cost estimates are also
potentially overcounting costs in that OSHA does not take into account
that not all employees for whom testing is required will report at
least once every 7 days to a workplace where other individuals, such as
coworkers or customers, are present. Thus, OSHA's estimate assumes that
employees for whom testing is required will need to be tested at least
once every 7 days and not less frequently as will often be the case.
OSHA notes, in addition, that there are no costs associated with
paragraph (g)'s removal provision. The ETS does not require the
employer to provide paid time off to any employee for removal as a
result of the employee's refusal/failure to provide documentation of a
COVID-19 test result as required by paragraph (g)(1) of the ETS.
Finally, OSHA notes that a COVID-19 test under the ETS is a test
for SARS-CoV-2 that is: (i) Cleared, approved, or authorized, including
in an Emergency Use Authorization (EUA), by the FDA to detect current
infection with the SARS-CoV-2 virus (e.g., a viral test); (ii)
Administered in accordance with the authorized instructions; and (iii)
Not both self-administered and self-read unless observed by the
employer or an authorized telehealth proctor. Examples of tests that
satisfy this requirement include tests with specimens that are
processed by a laboratory (including home or on-site collected
specimens which are processed either individually or as pooled
specimens), proctored over-the-counter tests, point of care tests, and
tests where specimen collection and processing is either done or
observed by an employer. Employers may have costs associated with
doing, observing or proctoring employee testing, if employers choose to
do so. However, for economic feasibility purposes, OSHA does not
account for these costs in its estimates because they are not required
for compliance with the ETS.
Costs Associated with Reasonable Accommodation: Testing, Face
Coverings, and Determinations
The ETS does not require the employer to pay for any costs
associated with testing; however employer payment for testing may be
required by other laws, regulations, or collective bargaining
agreements. Thus, while OSHA does not include any costs for reasonable
accommodation requests in its main cost analysis in recognition that
such costs would result from the application of other laws, OSHA notes
that even if employers were to agree to pay for COVID-19 testing as
part of a reasonable accommodation or some other reason required by
law, such costs would not alter OSHA's findings regarding the economic
feasibility of the rule.\48\ OSHA reached this conclusion after
conducting a separate analysis of reasonable accommodation costs that
an employer might assume if they do not represent an undue hardship for
the employer. This analysis is available in the docket at OSHA, October
2021d.
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\48\ OSHA notes that while the testing required under this
standard might be an option for employees who request a reasonable
accommodation to avoid vaccination, other alternatives such as
telework would be more protective to the employee by preventing
COVID-19 exposure. These alternatives may also be available at no
additional cost to the employer or employee.
---------------------------------------------------------------------------
OSHA notes that this separate analysis is limited to employees who
request accommodation, and accounts for costs of reviewing medical and/
or religious accommodation requests, as
[[Page 61485]]
well as costs for COVID-19 testing and face coverings that would
satisfy the requirements of this ETS. OSHA expects a reasonable
accommodation request could lead to a review of the employee's request
by a manager and then a conference between the manager and the
employee. OSHA concludes that the combination of these costs would not
alter OSHA's findings regarding the economic feasibility of the ETS.
f. Employee Notification to Employer of a Positive COVID-19 Test and
Removal
ETS Requirements
Under Sec. 1910.501(h):
Regardless of COVID-19 vaccination status or any COVID-19 testing
required under paragraph (g) of the ETS, the employer must:
Require each employee to promptly notify the employer when
they receive a positive COVID-19 test or are diagnosed with COVID-19 by
a licensed healthcare provider; and
Immediately remove from the workplace any employee who
receives a positive COVID-19 test or is diagnosed with COVID-19 by a
licensed healthcare provider and keep the employee removed until the
employee: (i) Receives a negative result on a COVID-19 nucleic acid
amplification test (NAAT) following a positive result on a COVID-19
antigen test if the employee chooses to seek a NAAT test for
confirmatory testing; (ii) meets the return to work criteria in CDC's
``Isolation Guidance'' (incorporated by reference, Sec. 1910.509); or
(iii) receives a recommendation to return to work from a licensed
healthcare provider.
Costs Analysis Assumptions
The ETS does not require employers to provide paid time off to any
employee for removal from the workplace as a result of a positive
COVID-19 test or diagnosis of COVID-19; however paid time off may be
required by other laws, regulations, or collective bargaining
agreements or other collectively negotiated agreements. Therefore,
there are no costs associated with paragraph (h)'s removal provision.
With respect to notification, to the extent employee notification
is connected to the ETS's testing and documentation requirements in
paragraph (g), those costs to the employer are taken under the costs
for recordkeeping, discussed below, because, as explained above,
receiving documentation of test results under paragraph (g) will be
part and parcel of the recordkeeping process.
OSHA notes also that the costs associated with employee
notification by vaccinated employees (not required by this ETS to
undergo testing) should also be negligible because it will not occur
with any real frequency. The very low breakthrough rates of infection
among vaccinated persons suggests that the overwhelming majority of
COVID-19 cases reported to a covered employer will be in the pool of
unvaccinated employees.
g. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
ETS Requirements
Under Sec. 1910.501(j):
The employer must report to OSHA:
Each work-related COVID-19 fatality within 8 hours of the
employer learning about the fatality.
Each work-related COVID-19 in-patient hospitalization
within 24 hours of the employer learning about the in-patient
hospitalization.
When reporting COVID-19 fatalities and in-patient hospitalizations
to OSHA in accordance with paragraph (j)(1) of the ETS, the employer
must follow the requirements in 29 CFR part 1904.39, except for 29 CFR
part 1904.39(a)(1) and (2) and (b)(6).
Cost Analysis Assumptions
OSHA estimates a total of 1,464 fatalities and 59,570
hospitalizations for employees of covered firms.\49\ This analysis is
broadly consistent, using updated data, with OSHA's analysis of a
nearly identical provision in 29 CFR 1910.502, the Healthcare ETS. OSHA
also estimates, based on the Healthcare ETS, that reporting of each
fatality and hospitalization will require 45 minutes of an employer's
time (86 FR at 32516). This includes hospitalizations and fatalities
for employees that remain unvaccinated, as well as a small percentage
of hospitalizations and fatalities of vaccinated employees due to
breakthrough cases. Because of the timing requirements in the rule, the
agency assumes that a hospitalization followed by a death will need two
reports from the employer (i.e., the agency assumes that reporting for
hospitalizations will occur within 8 hours, before reporting for
fatalities occurs, within 24 hours). This will result in a slight over-
estimate.
---------------------------------------------------------------------------
\49\ These counts represent hospitalizations and fatalities that
would occur to the in-scope labor force despite the ETS. The numbers
are derived using methodology similar to that used in Health Impacts
to generate hospitalizations and fatalities prevented. An infection
rate and case fatality rate are multiplied by the number of
unvaccinated workers to derive a total number of fatalities. That
number is used to derive hospitalizations. The number of
hospitalizations and fatalities to vaccinated employees is
calculated in a similar fashion, but with a lower infection rate
because vaccination makes it considerably less likely that an
individual will be tested and found to be infected. See (OSHA,
October 2021a and OSHA, October 2021c). One difference in
methodology between these counts and the Health Impacts analysis is
that these counts use a baseline of the last 19 months of CDC data
to estimate the case fatality rate (similar to Alternative C in the
Health Impacts analysis), rather than a baseline of the last 6
months (which OSHA used for the main Health Impacts analysis). This
results in an estimate toward the upper bound for these counts
(i.e., an overestimate of costs).
---------------------------------------------------------------------------
The total cost for reporting COVID-19 fatalities and
hospitalizations to OSHA is calculated as the product of:
One-time labor burden of 45 minutes per report of
hospitalization or fatality.
Wage range for General and Operations Managers (SOC code
11-1021, NAICS-specific wages).
Total number of fatalities for employees at covered firms.
Total number of hospitalizations for employees at covered
firms.
Cost for Reporting COVID-19 Fatalities and Hospitalizations to OSHA
Costs per entity and total costs for vaccination are shown below in
Table IV.B.11.
[[Page 61486]]
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[[Page 61487]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.016
h. Recordkeeping
ETS Requirements
As discussed above, the full costs for the requirements in
paragraph (e) of the ETS are taken under the costs for recordkeeping
because determining vaccination status, providing acceptable proof of
vaccination status, and creating and maintaining a roster of each
employee's vaccination status will be part and parcel of the
recordkeeping process. Under paragraph (e)(4) of the ETS, the employer
must maintain a record of each employee's vaccination status and must
preserve acceptable proof of vaccination for each employee who is fully
or partially vaccinated. The employer must also maintain a roster of
each employee's vaccination status. These records and roster are
considered to be employee medical records and must be maintained in
accordance with 29 CFR 1910.1020 as such records and must not be
disclosed except as required or authorized by the ETS or other federal
law. These records and roster are not subject to the retention
requirements of 29 CFR 1910.1020(d)(1)(i) but must be maintained and
preserved while the ETS remains in effect.
With respect to vaccination, it should be noted that, under
paragraph (e)(5) of the ETS, when an employer has ascertained employee
vaccination status prior to the effective date of this section through
another form of attestation or proof, and retained records of that
ascertainment, the employer is exempt from the determination of
vaccination requirements in paragraphs (e)(1)-(e)(3)
[[Page 61488]]
only for each employee whose fully vaccinated status has been
documented prior to the effective date of this section. For purposes of
the recordkeeping requirements in paragraph (e)(4), the employer's
records of ascertainment of vaccination status for each such person
constitute acceptable proof of vaccination. OSHA estimates, based on
this provision, that 60% of employees who were vaccinated prior to the
promulgation of the ETS will not need to document vaccination status in
connection with paragraph (e) (ASU COVID-19 Diagnostic Commons, October
6, 2021).
As also discussed above, the costs for the requirements for
documenting test results in paragraph (g), including the timing for
when recordkeeping costs for testing accrue under the ETS, are taken
under the costs for recordkeeping because providing documentation of
test results to the employer will be part and parcel of the
recordkeeping process. Under paragraph (g)(4) of the ETS, the employer
must maintain a record of each test result provided by each employee
under paragraph (g)(1) of the ETS or obtained during tests conducted by
the employer. These records must be maintained in accordance with 29
CFR 1910.1020 and must not be disclosed except as required or
authorized by this section or other federal law. These records are not
subject to the retention requirements of 29 CFR 1910.1020(d)(1)(i) but
must be maintained and preserved while this section remains in effect.
With respect to testing, it should be noted that, under paragraph
(m) of the ETS, employers are not required to comply with the
requirements in paragraph (g) of the ETS until 60 days after the
effective date of the ETS, meaning that for cost analysis purposes OSHA
assumes that employers would not receive any testing records until the
end of that 60-day period.
Finally, under paragraph 1910.501(l)(1) of the ETS, availability of
records, by the end of the next business day after a request, the
employer must make available, for examination and copying, the
individual COVID-19 vaccine documentation and any COVID-19 test results
for a particular employee to that employee and to anyone having written
authorized consent of that employee. In addition, under paragraph
1910.501(l)(2) of the ETS, by the end of the next business day after a
request by an employee or an employee representative, the employer must
make available to the requester the aggregate number of fully
vaccinated employees at a workplace along with the total number of
employees at that workplace. Under paragraph 1910.501(l)(3) of the ETS,
the employer must also provide to the Assistant Secretary for
examination and copying: (i) Within 4 business hours of a request, the
employer's written policy required by paragraph (d) of the ETS, and the
aggregate numbers described in paragraph (l)(2) of the ETS; and (ii) By
the end of the next business day after a request, all other records and
other documents required to be maintained by the ETS.
Cost Analysis Assumptions
To fulfill the recordkeeping requirements in the ETS, OSHA
estimates that it will take an average of 5 minutes of clerical time
per employee record. OSHA bases this cost estimate on the estimate for
recordkeeping in the Healthcare ETS (86 FR at 32515). While OSHA
estimated an average of 10 minutes of clerical time per employee record
in the Healthcare ETS, that standard includes more extensive
recordkeeping requirements than what is being required under this ETS.
See 29 CFR 1910.502(q)(2)(ii) (Healthcare ETS record must contain, for
each instance, the employee's name, one form of contact information,
occupation, location where the employee worked, the date of the
employee's last day at the workplace, the date of the positive test
for, or diagnosis of, COVID-19, and the date the employee first had one
or more COVID-19 symptoms, if any were experienced).
In addition, OSHA includes in this estimate 5 minutes of employee
time to provide documentation of vaccination status or testing, as
applicable, to the employer. OSHA notes that, for an employee who is
vaccinated, the employer will determine the vaccination status of that
employees and obtain acceptable proof of vaccination status at the same
time, thus negating the need to create two separate records for these
requirements.
OSHA notes that there will be a cost associated with setting up the
recordkeeping system (e.g., a spreadsheet) used to comply with the ETS.
OSHA takes these costs in connection with the costs for the employer
policy on vaccination, which are described above.
Given the relative complexity of recordkeeping in the Healthcare
ETS, OSHA has simplified its assumptions to reflect a variety of small
costs in a combined estimate. As in the Healthcare ETS, the cost
estimate of 5 minutes per event is likely much higher than necessary to
account for just the actions of receiving and maintaining copies of
records, so retaining this time will yield a tendency toward
overestimation. However, this cost also reflects a margin to encompass
additional outlier costs such as a second documentation of vaccination
status for all employees who need to submit documentation twice (first
for partial vaccination and then for full vaccination) under the ETS.
This 5 minutes for recordkeeping also encompasses the marginal time for
creating and maintaining a roster of each employee's vaccination status
(paragraph (e)) and making aggregate employee data available (paragraph
(l)). Since normally the system used for recordkeeping will be
electronic in businesses with more than 100 employees, the time to
create an aggregate report and a roster should be de minimis. Finally,
this inflated recordkeeping cost encompasses time for employee
notification to the employer of a positive COVID-19 test connected to
the ETS's testing and documentation requirements in paragraph (g),which
is a notification under paragraph (h). Finally, the burden of making
available, for examination and copying, the individual COVID-19 vaccine
documentation and any COVID-19 test results for a particular employee
are included in this estimate because this documentation will normally
be pulled from the electronic recordkeeping system described above.\50\
---------------------------------------------------------------------------
\50\ The cost of providing to the Assistant Secretary for
examination and copying the employer's written policy required by
paragraph (d) of the ETS will be de minimis.
---------------------------------------------------------------------------
[[Page 61489]]
The total cost for these requirements is calculated based on:
One-time labor burden of 5 minutes of employee labor to
provide documentation and 5 minutes of clerk labor per employee record
(one record per test administered and one record per documentation of
vaccination status).
The average labor rate for Office Clerks, General (SOC 43-
9060, NAICS-specific wages) and employees providing documentation
(average wage over all employees, NAICS-specific wages)
Total number of employees at covered firms getting
vaccinated due to the ETS with the Johnson & Johnson vaccine, who
receive one shot.
Total number of employees at covered firms getting
vaccinated due to the ETS with the Pfizer-BioNTech and Moderna
vaccines, multiplied by two to account for two shots.
Total number of tests for employees at covered firms who
are unvaccinated and will get vaccinated by receiving the Johnson and
Johnson vaccine.
Total number of tests for employees at covered firms who
are unvaccinated and will get vaccinated by receiving the Pfizer and
Moderna vaccines.
Total number of employees at covered firms who are
unvaccinated and will be tested weekly.
Cost for Recordkeeping
Costs per entity and total costs for recordkeeping are shown below
in Table IV.B.12.
[[Page 61490]]
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[[Page 61491]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.018
[[Page 61492]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.019
i. Summary of Total Cost
Total Cost and Total Cost per Entity
[[Page 61493]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.020
[[Page 61494]]
[GRAPHIC] [TIFF OMITTED] TR05NO21.021
j. Sensitivity Analysis
As stated above, based on limited data on current vaccine mandate
implementation and forecasts for future implementation (Mishra and
Hartstein, August 23, 2021; ASU COVID-19 Diagnostic Commons, October 6,
2021), OSHA estimates that 25 percent of firms in scope currently have
a vaccination mandate, and assumes that this will rise to 60 percent of
covered employers after the ETS is in place. Because the agency has no
historic reference on which to base its assumptions regarding vaccine
mandates, the agency adjusted the percentage of firms that will
institute a vaccine mandate because of the ETS as part of a sensitivity
analysis. Along with
[[Page 61495]]
the baseline estimate of 60 percent of firms having a mandate, the
agency looked at a vaccine mandate rate of 40 percent and 80 percent
for covered firms, which OSHA judged to be a reasonable range based on
the data available. The total costs associated with a 40 percent
vaccine mandate are $2.998 billion, and the total costs associated with
an 80 percent vaccine mandate are $2.964 billion. This compares to the
baseline costs associated with a 60 percent vaccine mandate of $2.981
billion. A higher vaccine mandate increases the share of employees who
get vaccinated while reducing the share that must get weekly testing.
It is this shift in shares that causes the costs to change because the
total costs associated with weekly testing (recordkeeping) are more
expensive than the total costs associated with vaccination under the
ETS (employer support for vaccination, recordkeeping).
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October). Analytical Spreadsheets in Support of the COVID-19
Vaccination and Testing ETS. (OSHA, October 2021a)
Occupational Safety and Health Administration (OSHA). (2021b,
October). COVID-19 Vaccination and Testing ETS: Economic Profile and
Cost Chapter Appendices. (OSHA, October 2021b)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
Occupational Safety and Health Administration (OSHA). (2021d,
October). Costs Associated with Reasonable Accommodation: Testing,
Face Coverings, and Determinations. (OSHA, October 2021d)
Portnoy J. (2021, October, 3). Several hundred Virginia health-care
workers have been suspended or fired over coronavirus vaccine
mandates. The Washington Post. https://www.washingtonpost.com/local/covid-vaccine-mandate-hospitals-virginia/2021/10/01/b7976d16-21ff-11ec-8200-5e3fd4c49f5e_story.html. (Portnoy, October 3, 2021)
Putri W et al. (2018, June, 22). Economic burden of seasonal
influenza in the United States. Vaccine 36(27), 3960-3966. https://www.sciencedirect.com/science/article/pii/S0264410X18306777?via%3Dihub. (Putri et al., June 22, 2018)
Umland B. (2021, October 13). Survey Looks at Vaccine Mandates and
Employee Turnover. Mercer. https://www.mercer.us/our-thinking/healthcare/survey-looks-at-vaccine-mandates-and-employee-turnover.html. (Umland, October 13, 2021)
U.S. Census Bureau. (2019). Statistics of U.S. Businesses (SUSB).
https://www.census.gov/programs-survey/susb.html. (U.S. Census
Bureau, 2019)
U.S. Census Bureau. (2021). Household Pulse Survey (HPS), Week 37
Table 6A. https://www.census.gov/programs-surveys/household-pulse-survey/data.html. (U.S. Census Bureau, 2021)
White C. (2021). Measuring Social and Externality Benefits of
Influenza Vaccination. Journal of Human Resources Vol 56 Number 3,
pp. 749-785. https://muse.jhu.edu/article/798143. (White, 2021)
Willis Towers Watson. (2021, June 23). COVID-19 Vaccination and
Reopening the Workplace Survey. https://www.willistowerswatson.com/en-US/Insights/2021/06/covid-19-vaccination-and-reopening-the-workplace-survey. (Willis Towers Watson, June 23, 2021)
V. ETS Economic Feasibility Determination
a. OSHA's Screening Tests for Economic Feasibility
As noted in the introduction to the economic analysis, an OSHA
standard is economically feasible when industries can absorb or pass on
the costs of compliance without threatening industry's long-term
profitability or competitive structure, Cotton Dust, 452 U.S. at 530
n.55, or ``threaten[ing] massive dislocation to, or imperil[ing] the
existence of, the industry.'' United Steelworkers of Am. v. Marshall
(Lead I), 647 F.2d 1189, 1272 (D.C. Cir. 1981).
To determine whether a rule is economically feasible, OSHA
typically begins by using two screening tests to determine whether the
costs of the rule are beneath the threshold level at which the economic
feasibility of an affected industry might be threatened. The first
screening test is a revenue test. While there is no hard and fast rule
on which to base the threshold, OSHA generally considers a standard to
be economically feasible for an affected industry when the annualized
costs of compliance are less than one percent of annual revenues. The
one-percent revenue threshold is intentionally set at a low level so
that OSHA can confidently assert that the rule is economically feasible
for industries that are below the threshold (i.e., industries for which
the costs of compliance are less than one percent of annual revenues).
To put the one-percent threshold into perspective, OSHA calculated the
average compounded annual rate of growth or decay in average revenues
over the 15-year period from 2002 to 2017 (inflated to 2005 to 2020
dollars) for firms with 100 or more employees in the 479 NAICS (out of
546) industries covered by this ETS for which Census data were
available and found that the average annual real rate of change in
revenues in absolute terms for the average firm was 2.2 percentage
points a year.\51\ In other words, revenues are generally observed to
change by well more than one percent per year, on average, for firms
with 100 or more employees in covered industries, indicating that
changes of this magnitude are normal in these industries and that
covered firms are typically able to withstand such changes over the
course of a year, much less six months. As discussed below, the average
percentage change due to this ETS for all covered NAICS is a fraction
of this fluctuation in revenues.
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\51\ These results are presented in the Excel ETS Revenue
Threshold Test Tables available in the Docket for this ETS. The data
used for six-digit NAICS were from the Bureau of the Census,
available every five years (2002, 2007, 2012, 2107).
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The second screening test that OSHA traditionally uses to consider
whether a standard is economically feasible for an affected industry is
if the costs of compliance are less than ten percent of annual profits
(see, e.g., OSHA's economic analysis of its Silica standard, 81 FR
16286, 16533 (March 25, 2016); upheld in N. Am.'s Bldg. Trades Unions
v. OSHA, 878 F.3d 271, 300 (D.C. Cir. 2017)). The ten-percent profit
test is also intended to be at a sufficiently low level so as to allow
OSHA to identify industries that might require further examination.
Specifically, the profit screen is primarily used to alert OSHA to
potential impacts on industries where the price elasticity of demand
does not allow for ready absorption of new costs in higher prices
(e.g., industries with foreign competition where the American firms
would incur costs that their foreign competitors would not because they
are not subject to OSHA requirements). In addition, setting the
threshold for the profit test low permits OSHA to reasonably conclude
that the rule would be economically feasible for industries below the
threshold. To put the ten-percent profit threshold test into
perspective, evidence used by OSHA in its 2016 OSHA silica rule
indicates that, for the combined affected manufacturing industries in
general industry and maritime from 2000 through 2012, the average year-
to-year fluctuation in profit rates (both up and
[[Page 61497]]
down) was 138.5 percent (81 FR 16545).\52\
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\52\ Profits are subject to the dynamics of the overall economy.
Many factors, including a national or global recession, a downturn
in a particular industry, foreign competition, or the increased
competitiveness of producers of close domestic substitutes are all
easily capable of causing a decline in profit rates in an industry
of well in excess of ten percent in one year or for several years in
succession (See OSHA, March 24, 2016).
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When an industry ``passes'' both the ``cost-to-revenue'' and
``cost-to-profit'' screening tests, OSHA is assured that the costs of
compliance with the rule are economically feasible for that industry.
The vast majority of the industries covered by the ETS fall into this
category.
A rule is not necessarily economically infeasible, however, for the
industries that do not pass the initial revenue screening test (i.e.,
those for which the costs of compliance with the rule are one percent
or more of annual revenues), the initial profit screening test (i.e,
those for which the costs of compliance are ten percent or more of
annual profits), or both. Instead, OSHA normally views those industries
as requiring additional examination as to whether the rule would be
economically feasible (see N. Am.'s Bldg. Trades Unions v. OSHA, 878
F.3d at 291). OSHA therefore conducts further analysis of the
industries that ``fail'' one or both of the screening tests in order to
evaluate whether the rule would threaten the existence or competitive
structure of those industries (see United Steelworkers of Am., AFL-CIO-
CLC v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980)).
Time Parameters for Analysis
OSHA's economic analyses almost always measure the costs of a
standard on an annual basis, conducting the screening tests by
measuring the cost of the standard against the annual profits and
annual revenues for a given industry. One year is typically the minimum
period for evaluating the status of a business; for example, most
business filings for tax or financial purposes are annual in nature.
Some compliance costs are up-front costs and others are spread over
the duration of the ETS; regardless, the costs of the rule overall will
not typically be incurred or absorbed by businesses all at once.
However, OSHA does not expect that the ETS will require employers to
incur initial capital costs for equipment to be used over many years
(which would typically be addressed through installments over a year or
a longer period to leverage loans or payment options to allow more time
to marshal revenue and minimize impacts on reserves).
The compliance costs for this ETS are for a temporary rule for a
period of six months (which, again, is the time period that OSHA
assumes this ETS will last, solely for economic purposes). While OSHA
believes the most appropriate screens would be based on annual profits
and revenue, it has followed the more cautious route of basing the
screens on 6 months of profits and revenues to avoid any potential
uncertainty about whether the ETS is economically feasible for the
industries covered by this ETS. Using one year of revenues and profits
as the denominators in the cost-to-revenue and cost-to-profit ratios
would have resulted in ratios that are half of the estimated ratios
presented in this analysis. It is therefore unsurprising that
businesses in some number of NAICs have edged above the profit-
thresholds using a 6 month screen (as will be discussed later), and
OSHA believes that edging above the screening thresholds is less of an
indicator of economic peril in this context than in the context of a
permanent rulemaking analysis. Nevertheless, OSHA has examined each of
the NAICS that did not clear either of these conservative screening
tests and has concluded that the ETS is economically feasible for each
one.
Data Used for the Screening Tests
The estimated costs of complying with the ETS, which OSHA relied
upon to examine feasibility is based on the two tests described above
(see OSHA, October 2021a). The revenue numbers used to determine cost-
to-revenue ratios were obtained from the 2017 Economic Census for firms
with 100 or more employees in covered industries. This is the most
current information available from this source, which OSHA considers to
be the best available source of revenue data for U.S. businesses.\53\
OSHA adjusted these figures to 2020 dollars using the Bureau of
Economic Analysis's GDP deflator, which is OSHA's standard source for
inflation and deflation analysis.
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\53\ For information regarding the standards and practices used
by the Census Bureau to ensure the quality and integrity of its
data, see (US Census Bureau, October 8, 2021a; US Census Bureau,
October 8, 2021b).
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The profit screening test for feasibility (i.e., the cost-to-profit
ratio) was calculated as ETS costs divided by profits. Profits were
calculated as profit rates multiplied by revenues. The before-tax
profit rates that OSHA used were estimated using corporate balance
sheet data from the Internal Revenue Service (IRS), 2013 Corporation
Source Book (IRS, 2013). The IRS discontinued the publication of these
data after 2013, and therefore the most current years available are
2000-2013.\54\ The most recent version of the Source Book represents
the best available evidence for these data on profit rates.\55\
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\54\ See IRS, 2013.
\55\ OSHA also investigated Bizminer and RMA as potential
sources of profit information and determined that they do not
represent adequate and random samples of the affected industries.
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For each of the years 2000 through 2013, OSHA calculated profit
rates by dividing the ``net income'' from all firms (both profitable
and unprofitable) by total receipts from all firms (both profitable and
unprofitable) for each NAICS.\56\ OSHA then averaged these rates across
the 14-year (2000 through 2013) period. Since some data provided by the
IRS were not available at disaggregated levels for all industries and
profit rates, data at more highly aggregated levels were used for some
industries; that is, where data were not available for each six-digit
NAICS code, data for the corresponding four- or five-digit NAICS codes
were used. Data were used for all firms in the NAICS (as opposed to
just firms with 100 or more employees) since data disaggregated by
employment size-class were not available. Profit rates are expressed as
a percentage (see OSHA, October 2021a). Profits themselves were used to
calculate the cost-to-profit estimates for all firms contained in a
particular NAICS code (see OSHA, October 2021a).
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\56\ There is one code reported per tax entity and it may not be
representative to the six-digit level. See Corporation Sourcebook on
limitations of the industry classification for details. (IRS, 2013).
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OSHA has estimated costs over a 6-month timeframe for this ETS. As
discussed above, OSHA has therefore used six months of revenue to
conduct the cost-to-revenue tests and six months of profit to conduct
the cost-to-profit tests.
General Use of Revenues and Profits To Measure Economic Feasibility
As with other OSHA rulemaking efforts, the agency relies on the two
screening tests (costs less than one percent of revenue and costs less
than ten percent of profit) as an initial indicator of economic
feasibility. OSHA has generally found that the cost-to-revenue test is
a more reliable indicator of feasibility simply because the revenue
data are more accurate than the profit data. There are several reasons
for this.
First, OSHA has been using corporate balance sheet data from the
IRS as the best available evidence for estimating
[[Page 61498]]
corporate profits for years.\57\ Nevertheless, because firms typically
have an incentive to minimize their tax burden, it is reasonable to
expect that some of the reported accounting data may have been
strategically adjusted to reduce reported profits and their associated
tax implications. Business profits are much more likely to reflect such
strategic accounting than business revenues; accordingly, revenues are
a more accurate measure than profits for evaluating economic
feasibility for a multitude of reasons.\58\
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\57\ OSHA funded and accepted a final report by Contractor Henry
Beale (Beale Report, 2003) that reviewed alternative financial data
sources and concluded that the IRS data were the best. Since then
OSHA has been relying on IRS data to provide the financial data to
support its rulemaking analyses. See, for example, Occupational
Safety and Health Administration (OSHA) (2016), Final Economic and
Regulatory Flexibility Analysis for OSHA's Rule on Occupational
Exposure to Respirable Crystalline Silica, Chapter VI, pp. VI-2 to
VI-3, Docket No. OSHA-2010-0034-4247 (OSHA, March 24, 2016), which
includes a more recent review of data sources for corporate
financial profit data and further support for OSHA's choice of IRS
data.
\58\ In fact, all other Department of Labor agencies rely solely
on revenues to assess economic impacts, such as Regulatory
Flexibility Act certifications, in their rulemakings (see, e.g.,
Employment and Training Administration, Final Rule on Strengthening
Wage Protections for the Temporary and Permanent Employment of
Certain Aliens in the United States, https://www.govinfo.gov/content/pkg/FR-2021-01-14/pdf/2021-00218.pdf; Wage and Hour
Division, Tip Regulations Under the Fair Labor Standards Act (FLSA),
https://www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/2020-28555.pdf).
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Second, because OSHA is using data from both profitable and
unprofitable firms, the average profit rate for a small number of
industries is negative (as described above, using 14 years of data that
predate the pandemic). This result could have occurred because of the
way profits are calculated, which unnaturally skews average profit
rates downward by including firms that have large losses (negative
profits) or subnormal profits and have already closed or are in the
process of closing, irrespective of any action by OSHA. The negative
rates could also be the result of macroeconomic fluctuations during the
14-year period used to determine the average, a period in which some of
these industries may have experienced unusually adverse financial
impacts (see, e.g., the explanation in Chapter VI, pp. VI-20 of the
Final Economic and Regulatory Flexibility Analysis for OSHA's Rule on
Occupational Exposure to Respirable Crystalline Silica, Docket No.
OSHA-2010-0034-4247, which notes the skew from negative impacts during
recession years (OSHA, March 24, 2016)). Or they could result from tax-
related incentives, as previously noted.
Whatever the reason, the cost-to-profit calculations for NAICS with
negative profit rates fail to provide reliable information about the
long-term profitability of these industries, independent of the ETS.
Companies and industries that consistently lose money do not typically
stay in business, and would almost certainly not still be in business
in 2021 if that loss continued at the same level for each of the 8
years since the profit data was published in 2012. Revenue streams are
a more dependable measure for those firms because those streams tend to
be more stable and more indicative of the actual capabilities of
sustainable firms than reported negative profit margins. As a result,
for the purposes of this analysis, OSHA has relied more heavily on its
cost-to-revenue estimates, in lieu of cost-to-profit estimates, as the
more reliable indicator for economic feasibility for the industries
with negative profit rates.
Third, and similarly, profit rates that are only slightly positive
(i.e., less than one percent) are inconclusive and not useful for the
purpose of OSHA's cost-to-profit test. In economics terms, profit
entails a reasonable rate of return on investment, and long-term
profits of less than one percent a year are not generally reasonable
for firms that expect to remain in business. Thus data showing
industry-wide profits in this range do not measure the true ability of
companies to pay for the ETS costs. As previously stated, revenue
streams tend to be more stable and more indicative of the actual
capabilities of sustainable firms. Therefore, where possible, OSHA
prefers to rely on the cost-to-revenue test to evaluate economic
feasibility for industries that have a less than one percent profit
rate.
The qualification, and by far the most important reason for the
general primacy of revenues versus profits as the appropriate metric
for determining economic feasibility, for most OSHA rules, is that the
regulated firms are able to pass on the costs of the rule in the form
of higher prices. When they cannot, the profit test functions primarily
as a screen for a limited purpose: Alerting OSHA to potential impacts
where unregulated competitors can prevent firms from passing costs
along to customers.
To understand this point, some economic background is needed. The
price elasticity of demand refers to the relationship between the price
charged for a product or service and the quantity demanded for that
product or service: The more elastic the relationship, the larger the
decrease in the quantity demanded for a product when the price goes up.
When demand is elastic, establishments have less ability to pass
compliance costs on to customers in the form of a price increase and
must absorb such costs in the form of reduced profits. In contrast,
when demand is relatively inelastic, the quantity demanded for the
product or service will be less affected by a change in price. In such
cases, establishments can recover most of the variable costs of
compliance (i.e., costs that are highly correlated with the amount of
output) by raising the prices they charge; under this scenario, if
costs are variable rather than fixed, business activity and profit
rates are largely unchanged for small changes in costs. Ultimately,
where demand is relatively inelastic, any impacts are primarily borne
by those customers who purchase the relevant product or service for a
slightly higher price. Most of the costs of this ETS are variable costs
because they depend primarily on the level of production or the number
of employees at an establishment. For example, under the ETS, a firm
with 500 employees must determine and record the vaccination status of
500 employees, while a firm with 250 employees need determine and
record the vaccination status of only 250 employees.\59\
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\59\ While fixed cost can be more limiting in terms of options
for businesses, most of the costs of this rule are not fixed.
Instead, most of the compliance costs vary with the level of output
or employment at a facility.
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In general, ``[w]hen an industry is subjected to a higher cost, it
does not simply swallow it; it raises its price and reduces its output,
and in this way shifts a part of the cost to its consumers and a part
to its suppliers'' (Am. Dental Ass'n v. Sec'y of Labor, 984 F.2d 823,
829 (7th Cir. 1993)). A reduction in output could happen in a variety
of ways: Individual establishments could reduce their levels of service
(e.g., retail firms) or production (e.g., manufacturing), both of which
could take the form of a reduction of worker hours; some marginal
establishments could close; or, in the case of an industry with high
turnover of establishments, new entry could be delayed until demand
equals supply. In many cases, a decrease in overall output for an
industry will be a combination of all three kinds of reductions. The
primary means of achieving the reduction in output most likely depends
on the rate of turnover in the industry and on the form that the costs
of the regulation take. Further, the temporary nature of the ETS and
its associated
[[Page 61499]]
costs suggests that firms may have more flexibility to respond than
when facing a permanent increase in costs. For example, firms may be
able to temporarily increase prices or temporarily defer planned
capital expenditures or other maintenance to cover compliance costs.
There are two situations typically mentioned when an industry
subject to regulatory costs might be unable to pass those costs on: (1)
Foreign competition not subject to the regulation, or (2) domestic
competitors in other industries, not subject to the regulation, that
produce goods or services that are close substitutes. Otherwise, when
all affected domestic industries are covered by a rule and foreign
businesses must also comply with the rule or are unable to compete
effectively, the ability of a competing industry to offer a substitute
product or service at a lower price is greatly diminished.
There is a third situation that is relevant to this ETS--when only
some firms in a domestic industry (in this case, only employers with
100 or more employees) are subject to the ETS and its regulatory costs.
In principle, competition from smaller employers in a NAICS could
prevent the larger employers from passing on their costs in the form of
higher prices and instead require them to absorb the costs in the form
of lost profits. There are, however, several important caveats:
1. As a practical matter, it is implausible to expect that covered
employers (with 100 or more employees) would feel constrained by
smaller competitors in their industry so as not to pass on costs for a
rule lasting 6 months that imposes costs equal to 0.02 percent of
revenues, on average across all NAICS, over that time period (see OSHA,
October 2021a). This time period would likely be too short for small
firms to expand to take business away from the larger firms or for new
firms to form to take advantage of such minor and transitory business
opportunities. Furthermore, smaller firms (particularly very small
firms--those with fewer than 20 employees) typically can't compete on
price with large firms that have cost advantages due to various
economies of scale; as a result, smaller firms often serve a
specialized niche market rather than compete directly with larger
firms. To the extent that this ETS creates new business opportunities
for these smaller uncovered firms, they would also be covered by the
ETS as soon as they reached 100 employees.\60\
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\60\ This cost advantage may be exaggerated or non-existent in
many cases (see the discussion directly below in the text in Caveat
2).
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2. An important factor to consider in calculating the costs and
impacts and economic feasibility of this ETS is the unquantified and
unmonetized cost savings and other positive economic impacts accruing
to employers that comply with the ETS. These include reduced
absenteeism due to COVID-19 illnesses \61\ and quarantine.\62\ Other
positive economic impacts that compliant employers would enjoy from a
safer business environment are increased retail trade from customers
that feel less at risk and better relations with suppliers and other
business partners. These all would contribute to improved business and
increased profits.
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\61\ Several occupational groups less able to avoid exposure to
SARS-CoV-2 infection exhibited significantly higher rates of
absenteeism in March-April 2020 compared to earlier periods
(Groenewold et al., July 10, 2020).
\62\ For a discussion of turnover (i.e. whether the ETS could
affect the likelihood that an employee will remain with an employer,
either because the imposition of a vaccine requirement will lead
some employees to leave and find employment at an establishment not
subject to the ETS, or, alternatively, to stay due to a preference
for enhanced COVID-19 safety procedures), please see the cost
section (Section III.d.) of this economic analysis.
---------------------------------------------------------------------------
3. The existence of these cost savings and other positive economic
impacts accruing to employers that comply with the ETS suggests that
the actual net costs of the ETS will be much lower than the costs
reported in the supporting economic analysis for this ETS used to
estimate cost impacts and demonstrate economic feasibility. In fact,
for some share of covered employers, the net costs of the ETS may well
be negative. Indeed, this is being confirmed by revealed preference in
the market. Elsewhere in the economic analysis for this ETS (Cost
Analysis section 4.2), OSHA has provided evidence to support its
estimate that 25 percent of covered employers already voluntarily
require that their employees be vaccinated and a much larger percentage
are considering a vaccine mandate. This strongly supports the
conclusion that these businesses agree that doing so will ultimately
save costs.
b. Economic Feasibility Analysis and Determination
This section summarizes OSHA's feasibility findings for industries
covered by the ETS. As stated previously, the agency uses two screening
tests (costs less than one percent of revenue and costs less than ten
percent of profit) as an initial indicator of economic feasibility. In
this section, OSHA discusses the industries that fall above the
threshold level for either screening test.
The overall effect of compliance with the general section of the
ETS on covered industries is very small (see OSHA, October 2021a). The
vast majority of the covered NAICS have very low cost-to-revenue and
cost-to-profit ratios, with the overall averages being 0.02 percent of
revenues and 0.49 percent of profits. To put this into perspective, if
the average firm decided to raise prices to cover the costs of the ETS,
the price of a $100 product or service, for example, would have to be
increased by 2 cents (during the six-month period).
Based on the information presented here, the costs of the ETS are
below both the threshold revenue test (1 percent of revenues) and the
threshold profit test (10 percent of profits) for the vast majority of
NAICS industries.\63\ This indicates that the average firm in these
industries will be able either to raise prices to cover ETS costs or to
absorb the costs of the ETS out of available profits. In either case,
OSHA concludes that the ETS is economically feasible for all of these
industries.
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\63\ By OSHA's calculation, 524 out of the 546 six-digit NAICS
covered by the ETS.
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Critically, there are no industries covered by the general section
of the ETS that are above OSHA's cost-to-revenue threshold level of one
percent and most are a small fraction of this level. Because OSHA is
using data from both profitable and unprofitable firms, the average
profit rate for a small number of industries is negative. There are 14
NAICS with negative cost-to-profit ratios, resulting from negative
average profit rates. These industries with negative profit rates are
domestic service industries that are not subject to international
competition.
There are eight six-digit NAICS industries, covering all
establishments in those industries covered by the general section of
the ETS, with cost-to-profit ratios above 10 percent:
1. NAICS 221118--Other Electric Power Generation, 23.97 percent;
2. NAICS 488119--Other Airport Operations, 18.41 percent;
3. NAICS 488410--Motor Vehicle Towing, 15.75 percent;
4. NAICS 488490--Other Support Activities for Road Transportation,
14.32 percent;
5. NAICS 713920--Skiing Facilities, 13.16 percent; and
[[Page 61500]]
6. NAICS 713940--Fitness and Recreational Sports Centers, 12.33
percent;
7. NAICS 713120--Amusement Arcades, 11.18 percent; and
8. NAICS 488320--Marine Cargo Handling, 10.03 percent.
The average profit rate reported over the 14 years for which OSHA
has profit data for all the NAICS affected by the ETS is 4.2 percent.
All of the eight NAICS industries with a cost-to-profit ratio above the
10 percent threshold report an annual profit rate below one percent--75
percent or more below the overall average for all NAICS covered by the
ETS. These eight industries all provide domestic services and are not
subject to international competition.
The fact that the covered firms in these 22 NAICS industries (the
14 with negative cost-to-profit ratios and the 8 with more sustainable
cost-to-profit ratios) exceeded the profit screen suggests that they
might in theory have difficulty paying for the costs of the ETS out of
profits gained over the six-month duration of the ETS if they had no
savings or access to capital, but even if that were true it would be
highly unlikely to place the firms in financial jeopardy. OSHA examines
these industries more closely below, but before even considering the
reasons in NAICs-specific analysis it is important to consider the
larger context. For the ETS to threaten the economic solvency of these
firms, the following 3 conditions must apply:
1. These firms must not enjoy certain cost savings and positive
economic impacts from the ETS that would partially or totally offset
their costs. This condition is questionable because of the estimated 25
percent of employers sampled that reported voluntarily imposing a
vaccine mandate and the substantial number more contemplating the
voluntary adoption of such a mandate. They can be expected to base
their decisions, partly or entirely, on anticipated cost savings or
positive economic impacts (which would reduce or eliminate their risk
of insolvency due to the ETS).
2. These firms (all with 100 or more employees) must not be able to
raise prices to cover ETS costs because of the threat that smaller
firms in their NAICS industry, not covered by the ETS, could underprice
them and take away their business. This condition is unlikely or
limited because of the economies of scale the larger firms enjoy and
the fact that the smaller firms out of necessity tend to serve a market
niche not in direct competition with the larger firms. Also, there is a
severe limit to the extent that firms with fewer than 100 employees can
take away significant portions of business from the larger firms
without becoming subject to the requirements of the rule themselves. If
the larger firms do not feel threatened by being underpriced by smaller
firms in these NAICS industries, then they could raise prices an
average of less than 0.05 percent \64\ to cover the cost of the ETS--a
small fraction of the 1.0 percent of revenues threshold (beneath which
OSHA has determined that economic feasibility is not a concern).
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\64\ If not underpriced by smaller firms, covered firms in the 8
NAICS industries reporting ETS costs above 10 percent of profits
could cover these costs by raising prices an average of 0.08 percent
(highest, 0.11 percent); covered firms in the 14 NAICS industries
reporting negative profits could cover ETS costs with a price
increase of 0.01 percent (highest, 0.02 percent).
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3. These firms must not generate sufficient profits or have
adequate borrowing capacity during the six months the ETS is in force
to cover the costs of the ETS. There are several reasons to doubt that
this condition broadly applies. First, the estimates of business
profits come from corporate balance sheet data that firms report to the
IRS. But, as previously noted, it is generally the case that firms have
an incentive to minimize their tax burden, and it is reasonable to
expect that some of the reported accounting data may have been
strategically adjusted to reduce reported profits and their associated
tax implications. Another point concerning the IRS data is that they
include the negative profits of firms that are going out of business or
have since gone out of business. To the extent that these points are
true, many or most of the covered firms in these NAICS industries
(still in business) actually would generate sufficient profit to cover
the cost of the ETS. A related point is that for this condition to
apply, the firms must not be able to borrow the money to pay for the
costs of the ETS. Recall, however, that these are all large firms with
100+ employees. It is reasonable to expect that many or most firms of
this size in the 22 NAICS industries at issue either have available
funds or could obtain a short-term loan to cover costs equal to the
0.01 to 0.11 percent of revenues that these firms would incur over the
six-month period that OSHA assumes the ETS will remain in effect. Firms
of this size normally have banking relationships and some unencumbered
assets. They also have access to national and international capital
markets. If these firms can borrow funds to pay for the ETS, then the
profit restriction doesn't matter.
Finally, OSHA anticipates concern that limiting the scope of the
ETS to employers with 100 or more employees will somehow put these
larger firms in economic jeopardy from the smaller firms to which the
ETS does not currently apply. This is highly improbable for several
reasons discussed earlier, including the fact that these are large
employers with advantages of economies of scale and access to capital
and the fact that this is a temporary standard that would result, at
most, in marginal impacts over 6 months (on average, equal to costs of
0.02 percent of revenues, which, again, translates to a cost increase
of a penny on a fifty dollar item).
But even that misses the main point: Economic feasibility refers to
the industry, not to the firm. OSHA must construct a reasonable
estimate of compliance costs and demonstrate a reasonable likelihood
that these costs will not threaten the existence or competitive
structure of an industry, even if it does portend disaster for some
marginal firms (Lead I, 647 F.2d at 1272). In the (again) highly
unlikely event that individual firms exit an industry and are replaced
by other firms in the industry, then the ETS would preserve the
economic feasibility of the covered industries. If an employer covered
by this standard actually had to increase its prices slightly to
account for the cost of this standard, there are two potential groups
of smaller businesses that could seek to supplant the covered firms.
The first group of businesses are much smaller than the covered firms.
Those businesses, however, will typically have higher costs and prices
to begin with due to their scale disadvantages to the larger firms. The
larger firm's small price increases attributable to this ETS would not
be likely to create an actionable competitive advantage for this group
of smaller businesses. The second group of businesses are those closer
in size to the 100-employee cutoff. If the marginal price increases did
actually cause some of the larger firms to fail and the slightly
smaller firms to take their place, the industry itself would not suffer
a massive dislocation or be imperiled. And, of course, if all of the
firms in an industry are large employers with 100 or more employees, no
competitive disadvantage from within the industry would exist (even
hypothetically), and there would be no question that they could cover
the cost of ETS by raising prices to customers accordingly.
Although the preceding discussion demonstrates that the ETS is
economically feasible, OSHA has provided an additional examination of
each of the NAICS that have crossed the profit screen (again noting
that none of
[[Page 61501]]
these failed the revenue screen): The eight NAICS industries with
positive profit ratios but profit rates below 1 percent.
1. NAICS 221118--Other Electric Power Generation, 23.97 Percent
This U.S. industry comprises establishments primarily engaged in
operating electric power generation facilities (except hydroelectric,
fossil fuel, nuclear, solar, wind, geothermal, biomass). These
facilities convert other forms of energy, such as tidal power, into
electric energy. The electric energy produced in these establishments
is provided to electric power transmission systems or to electric power
distribution systems.
Using tides to generate power is not yet economically viable,
according to one source, because ``[t]otal availability of tidal power
is restricted by its relatively high cost and limited number of sites
having high flow velocities and tidal ranges,'' although ``with [ ]
recent advancements in tidal technologies, the total availability of
tidal power in terms of turbine technology as well as design may be
higher than before, and the economic costs may be reduced significantly
to competitive levels.'' In support, in the same article, ``recent
reports state that the UK, which has the largest tidal and wave
resource in Europe, is capable of harnessing up to 153GW of tidal power
capacity with the help of three types of technologies and thus meeting
20% of current UK electricity demand and reducing carbon emissions.
Hence it is evident that wave and tidal energy could contribute more to
the increasing electricity demands across the globe.'' \65\
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\65\ See Walker, January 22, 2013.
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At the time OSHA obtained the most recent NAICS data, there were 7
affected entities in this NAICS industry. The entities in this NAICS
industry include firms like Berkshire Hathaway Energy Company, (with
annual sales of $19.8 billion, whose ``portfolio consists of locally
managed business that share a vision for a secure and sustainable
energy future''); Dominion Energy (with annual sales of $13.4 billion);
and other leading firms in this industry including some of the largest
power generation companies in the US (See NAICS Association, 2018a;
NAICS Association 2018d; and NAICS Association 2018e).
As this NAICS industry is not yet viable, (in the United States, at
least), it is to be expected that revenues and profits would be low. In
fact, OSHA believes the best way to view this industry is as a series
of incredibly well-funded start-up companies during the investment
phase of the business, where short-term losses are expected and offset
with the anticipation of enormous revenue growth potential (in an
acknowledged very limited energy market.) Given these factors, OSHA's
typical revenue and profit screen are a poor predictor of future
viability with respect to this NAICS industry (although, as pointed
out, this NAICS industry, like all other NAICS industries, falls well
below the revenue screen threshold). The estimated cost of this ETS per
firm is $866 in this NAICS industry, which equals about 11 cents per
hundred dollars of revenue over a limited six-month duration. OSHA
concludes that this industry will be able to withstand this small cost
in order to keep its workers protected during the pandemic.
2. NAICS 488119--Other Airport Operations, 18.41 Percent 66
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\66\ This U.S. industry comprises establishments primarily
engaged in (1) operating international, national, or regional
airports, or public flying fields or (2) supporting airport
operations, such as rental of hangar space, and providing baggage
handling and/or cargo handling services.
---------------------------------------------------------------------------
The services this industry offers are integrated into a particular
geographic location and entail specific tasks, such as parking and
baggage handling services, that must be done to ensure the proper
functioning of airports, thus negating the potential for substitution
during the 6 month period that OSHA is assuming the ETS will be in
effect for economic purposes. In addition, because these are services
that need to be done in particular domestic locations (i.e., airports),
there is no risk of international competition.
3. NAICS 488410--Motor Vehicle Towing, 15.75 Percent 67
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\67\ This industry comprises establishments primarily engaged in
towing light or heavy motor vehicles, both local and long-distance.
These establishments may provide incidental services, such as
storage and emergency road repair services.
---------------------------------------------------------------------------
The actual cost impacts on this industry are likely significantly
overstated to the extent that most employees performing towing services
ride alone in their trucks and their services do not typically require
exposure to others. In the event that individual large towing firms are
concerned about economic impacts, it would not be difficult to
structure their employee interactions with the company and customers to
take advantage of the scope restrictions. Moreover, the primary
services this industry offers involve the use of specialized vehicles
designed uniquely for towing, thus lowering the risk of substitution.
In addition, because these services are geographically based, there is
no risk of international competition.
4. NAICS 488490--Other Support Activities for Road Transportation,
14.32 Percent 68
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\68\ This industry comprises establishments primarily engaged in
providing services (except motor vehicle towing) to road network
users.
---------------------------------------------------------------------------
This industry offers services that must be done to ensure proper
operation of roadways (for example, bridge, tunnel, and highway
operations, pilot car services (i.e., wide load warning services),
driving services (e.g., automobile, truck delivery), and truck or
weighing station operations), thus negating the potential for
substitution. In addition, because these services need to be done in
particular domestic locations (i.e., roadways), there is no risk of
international competition.
5. NAICS 713920--Skiing Facilities, 13.16 Percent 69
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\69\ This industry comprises establishments engaged in (1)
operating downhill, cross country, or related skiing areas and/or
(2) operating equipment, such as ski lifts and tows. These
establishments often provide food and beverage services, equipment
rental services, and ski instruction services. Four season resorts
without accommodations are included in this industry.
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This industry caters to a wealthy clientele who ensure an inelastic
demand easily capable of absorbing any fractional increases
attributable to this ETS.\70\ In addition, skiing is done outdoors,
which will incentivize clientele to continue engaging in this
particular activity in lieu of indoor substitutions, during the
pandemic. Finally, there is little to no risk of international
competition from foreign ski resorts because the added and substantial
costs of international travel outweigh the costs associated with
marginally higher prices resulting from the ETS.
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\70\ See Brown, January 19, 2017, ``[o]f the 9.4 million skiers
in the U.S., more than half earn a salary higher than $100,000. For
some context, only 20 percent of American households have a combined
income of $100K. . . .'')
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6. NAICS 713940--Fitness and Recreational Sports Centers, 12.33 Percent
71
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\71\ This industry comprises establishments primarily engaged in
operating fitness and recreational sports facilities featuring
exercise and other active physical fitness conditioning or
recreational sports activities, such as swimming, skating, or
racquet sports.
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As these settings are generally located close to where clients live
or work, there is no risk of international competition. Some of the
largest employers in this industry have already responded to customer
feedback by not only requiring employees to be vaccinated, but also
[[Page 61502]]
members.\72\ This suggests both that the costs estimates attributed to
the ETS are overstated for these employers because higher levels of
compliance may have already occurred than projected in OSHA's analysis,
and that the ETS requirements reflect more of an industry trend than a
threat to the existence of the industry.
---------------------------------------------------------------------------
\72\ See Jackson, August 2, 2021 ``Equinox also noted in the
press release that `an overwhelming majority of members' have
expressed support for a vaccination requirement for entry to Equinox
clubs.''
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7. NAICS 713120--Amusement Arcades, 11.18 Percent 73
---------------------------------------------------------------------------
\73\ This industry comprises establishments primarily engaged in
operating amusement (except gambling, billiard, or pool) arcades and
parlors.
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This industry caters to a select clientele who have chosen to
engage in leisure activities in the unique settings offered by the
industry, thus negating the likelihood for substitution. In addition,
because these settings are localized, there is no risk of international
competition.
8. NAICS 488320--Marine Cargo Handling, 10.03 Percent 74
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\74\ This industry comprises establishments primarily engaged in
providing stevedoring and other marine cargo handling services
(except warehousing).
---------------------------------------------------------------------------
The services this industry offers are integrated into a particular
location and entail specific tasks, such as loading and unloading
services at ports and harbors, longshoremen services, marine cargo
handling services, ship hold cleaning services, and stevedoring
services, that must be done to ensure the proper movement of cargo off
of and onto ships, thus negating the potential for substitution. In
addition, because these are services that need to be done in particular
domestic locations (e.g., docks), there is no risk of international
competition.
As with towing, the actual cost impacts on this industry are likely
significantly overstated to the extent that some of the employees may
be able to perform their work exclusively outdoors.
The Fourteen NAICS Industries With Negative Profit Ratios
1. Air Transportation 75
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\75\ NAICS 481111 (Scheduled Passenger Air Transportation)
provides air transportation of passengers or passengers and freight
over regular routes and on regular schedules, including commuter and
helicopter carriers (except scenic and sightseeing). NAICS 481112
(Scheduled Freight Air Transportation) provides air transportation
of cargo without transporting passengers over regular routes and on
regular schedules, including scheduled air transportation of mail on
a contract basis. NAICS 481211 (Nonscheduled Chartered Passenger Air
Transportation) provides air transportation of passengers or
passengers and cargo with no regular routes and regular schedules.
NAICS 481212 (Nonscheduled Chartered Freight Air Transportation)
provides air transportation of cargo without transporting passengers
with no regular routes and regular schedules. NAICS 481219 (Other
Nonscheduled Air Transportation) provides air transportation with no
regular routes and regular schedules (except nonscheduled chartered
passenger and/or cargo air transportation). These establishments
provide a variety of specialty air transportation or flying services
based on individual customer needs using general purpose aircraft.
---------------------------------------------------------------------------
NAICS 481111 (Scheduled Passenger Air Transportation), NAICS 481112
(Scheduled Freight Air Transportation), NAICS 481211 (Nonscheduled
Chartered Passenger Air Transportation), NAICS 481212 (Nonscheduled
Chartered Freight Air Transportation), NAICS 481219 (Other Nonscheduled
Air Transportation).
This group of NAICS industries is comprised of U.S. industries that
primarily engage in providing air transportation. There is little to no
risk of substitution for this group of NAICS industries. Air
transportation provides unique and important benefits that cannot be
substituted via other forms of transportation (e.g., rail, freight,
bus). (See ATAG, September 2005). To this end, air transportation is
often the speediest means of transporting passengers and cargo, giving
it a unique purpose that cannot be met by other forms of transport. It
should be noted that the five NAICS in this group of industries are the
only NAICS in NAICS 4811 (Scheduled Air Transportation) and 4812
(Nonscheduled Air Transportation). The other industries in NAICS 48
(Transportation) do not provide air transportation (See NAICS
Association, 2018b). This further reduces the risk of substitution, as
all five NAICS at issue have a negative profit ratio and therefore face
similar challenges that appear to be endemic to air transportation.
Firms in this industry that have been able to weather the pandemic this
long are typically highly capitalized or have access to loans, so it is
highly likely that they could also weather the temporary marginal costs
of OSHA's ETS.
There is also no risk of international competition with respect to
this group of NAICS industries because any workers, whether they work
for an international company or not, who are in the US, are subject to
US laws, including the ETS, and foreign air carriers will need to
follow the ETS for those workers. In addition, OSHA suspects that any
smaller foreign air carriers will not have an incentive to expand their
routes significantly or change their routes to domestic US routes to
take advantage of the 100-employee cutoff in the ETS in the 6-months
the ETS is assumed to be in effect.
2. Telecommunications 76
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\76\ NAICS 517311 (Wired Telecommunications Carriers) comprises
establishments primarily engaged in operating and/or providing
access to transmission facilities and infrastructure that they own
and/or lease for the transmission of voice, data, text, sound, and
video using wired telecommunications networks. Establishments in
this industry use the wired telecommunications network facilities
that they operate to provide a variety of services, such as wired
telephony services, including VoIP services; wired (cable) audio and
video programming distribution; wired broadband internet services;
and, by exception, establishments providing satellite television
distribution services using facilities and infrastructure that they
operate are included in this industry. NAICS 517312 (Wireless
Telecommunications Carriers (except Satellite)) comprises
establishments primarily engaged in operating and maintaining
switching and transmission facilities to provide communications via
the airwaves. Establishments in this industry have spectrum licenses
and provide services using that spectrum, such as cellular phone
services, paging services, wireless internet access, and wireless
video services. NAICS 517410 (Satellite Telecommunications)
comprises establishments primarily engaged in providing
telecommunications services to other establishments in the
telecommunications and broadcasting industries by forwarding and
receiving communications signals via a system of satellites or
reselling satellite telecommunications. NAICS 517911
(Telecommunications Resellers) comprises establishments engaged in
purchasing access and network capacity from owners and operators of
telecommunications networks and reselling wired and wireless
telecommunications services (except satellite) to businesses and
households. Establishments in this industry resell
telecommunications; they do not operate transmission facilities and
infrastructure. NAICS 517919 (All Other Telecommunications)
comprises establishments primarily engaged in providing specialized
telecommunications services, such as satellite tracking,
communications telemetry, and radar station operation, and also
includes establishments primarily engaged in providing satellite
terminal stations and associated facilities connected with one or
more terrestrial systems and capable of transmitting
telecommunications to, and receiving telecommunications from,
satellite systems, as well as establishments providing internet
services or Voice over internet protocol (VoIP) services via client-
supplied telecommunications connections.
---------------------------------------------------------------------------
NAICS 517311 (Wired Telecommunications Carriers), NAICS 517312
(Wireless Telecommunications Carriers (except Satellite), NAICS 517410
(Satellite Telecommunications), NAICS 517911 (Telecommunications
Resellers), NAICS 517919 (All Other Telecommunications).
This group of NAICS industries is entirely comprised of U.S.
industries, except for NAICS 517410 (Satellite Telecommunications). All
of these industries provide specialized unique services in the
telecommunications industry that require specialized unique knowledge
and are thus resistant to substitution. While it is perhaps
[[Page 61503]]
possible that different forms of telecommunications might be
substituted for one another (e.g., the substitution of wired
telecommunications carriers for wireless telecommunications carriers),
the reality is that these different forms exist separately and feed
different markets and customer needs that are independent of the ETS.
Moreover, the five NAICS in this group of industries are the only NAICS
in NAICS 5173 (Wired and Wireless Telecommunications Carriers), NAICS
5174 (Satellite Telecommunications), and NAICS 5179 (Other
Telecommunications). The other industries in NAICS 51 (Information) are
not engaged in telecommunications (NAICS Association, 2018c). This
further reduces the risk of one industry substituting for the others,
as all five NAICS at issue have a negative profit ratio and therefore
face similar challenges that appear to be endemic to
telecommunications.
Moreover, three of the five NAICS industries in this group (NAICS
517311, 517312, 517410) operate or control the infrastructure needed
for engaging in the particular type of telecommunications in which
those industries engage. This not only fully negates the risk of
substitution, but also negates the risk of international competition
for these industries.
The other two industries in the group apparently do not operate or
control the infrastructure needed for telecommunications. However, the
telecommunications industry faces strict state and federal licensing
requirements, which severely limit the risk of competition both
internationally and from smaller firms seeking to take advantage of the
ETS's 100-employee cutoff. (See FCC, 2014; FCC, October 12, 2021a; FCC,
October 12, 2021b; Caltrans, October 12, 2021; and UTC, October 12,
2021).
3. Car and Equipment Rental 77
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\77\ NAICS 532111 (Passenger Car Rental) comprises
establishments primarily engaged in renting passenger cars without
drivers, generally for short periods of time. NAICS 532112
(Passenger Car Leasing) comprises establishments primarily engaged
in leasing passenger cars without drivers, generally for long
periods of time. NAICS 532120 (Truck, Utility Trailer, and RV
(Recreational Vehicle) Rental and Leasing comprises establishments
primarily engaged in renting or leasing, without drivers, one or
more of the following: Trucks, truck tractors, buses, semi-trailers,
utility trailers, or RVs (recreational vehicles). NAICS 532310
(General Rental Centers) comprises establishments primarily engaged
in renting a range of consumer, commercial, and industrial
equipment. Establishments in this industry typically operate from
conveniently located facilities where they maintain inventories of
goods and equipment that they rent for short periods of time. The
type of equipment that establishments in this industry provide often
includes, but is not limited to: Audio visual equipment,
contractors' and builders' tools and equipment, home repair tools,
lawn and garden equipment, moving equipment and supplies, and party
and banquet equipment and supplies.
---------------------------------------------------------------------------
NAICS 532111 (Passenger Car Rental), NAICS 532112 (Passenger Car
Leasing), NAICS 532120 (Truck, Utility Trailer), and RV (Recreational
Vehicle) Rental and Leasing) NAICS 532310 (General Rental Centers).
This group of industries rent motor vehicles (NAICS 532111, 532112,
532120) or equipment (NAICS 532310), for example, audio visual
equipment, contractors' and builders' tools and equipment, home repair
tools, lawn and garden equipment, moving equipment and supplies, and
party and banquet equipment and supplies, to individuals and
businesses, for personal and professional use. There is no risk of
substitution with respect to these industries, as these industries rent
specific items to those who want to use them. There is also no risk of
foreign competition with respect to these industries, as consumers and
businesses rent and pick up vehicles, as well as the type of equipment
offered for rent by NAICS 532310, from specific locations, including
car rental and other rental centers.
These industries have not been hard hit by the pandemic, as many
consumers have turned from group travel to individual transportation.
For example, RV rentals and leasing has soared during the pandemic,
which is not reflected in the pre-pandemic profit and revenue data
available for this analysis.\78\
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\78\ See Park, January 23, 2021.
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References
Air Transport Action Group (ATAG). (2005, September). The economic &
social benefits of air transport. https://www.icao.int/meetings/wrdss2011/documents/jointworkshop2005/atag_socialbenefitsairtransport.pdf. (ATAG, September 2005)
Beale HBR. (2003). Financial Data Sources. Microeconomic
Applications Inc. (Beale Report, 2003)
Brown J. (2017, January 19). Bring More Diversity to Skiing. https://www.powder.com/stories/opinion/extend-the-family/. (Brown, January
19, 2017)
Caltrans. (2021, October 12). Wireless Licensing Program, California
Department of Transportation. https://dot.ca.gov/programs/right-of-way/wireless-licensing-program. (Caltrans, October 12, 2021)
Federal Communications Commission (FCC). (2021, October 12a)
Licensing. https://www.fcc.gov/licensing-databases/licensing. (FCC,
October 12, 2021a)
Federal Communications Commission (FCC). (2021, October 12b)
Satellite. https://www.fcc.gov/general/satellite. (FCC, October 12,
2021b)
Groenewold M et al., (2020, July 10). Increases in Health-Related
Workplace Absenteeism Among Workers in Essential Critical
Infrastructure Occupations During the COVID-19 Pandemic--United
States, March-April 2020. Centers for Disease Control and Prevention
MMWR Vol. 69, No. 27. (Groenewold et al., July 10, 2020)
Internal Revenue Service (IRS). (2013). 2013 Corporation Source
Book. https://www.irs.gov/statistics/soi-tax-stats-corporation-source-book-us-total-and-sectors-listing. (IRS, 2013)
Jackson S. (2021, August 2). Gyms like Equinox and SoulCycle will
soon require members to show proof of vaccination to use their clubs
and studios. https://www.businessinsider.com/equinox-soulcycle-will-require-covid-19-vaccines-for-members-staff-2021-8. (Jackson, August
2, 2021)
NAICS Association. (2018a). NAICS Codes Description, 2018: 221118--
Other Electric Power Generation. https://www.naics.com/naics-code-description/?code=221118. Last accessed October 12, 2021. (NAICS
Association, 2018a)
NAICS Association. (2018b). Six Digit NAICS Codes and Titles, 2018:
Codes 48-49. https://www.naics.com/six-digit-naics/?code=48-49. Last
accessed October 12, 2021. (NAICS Association, 2018b)
NAICS Association. (2018c). Six Digit NAICS Codes and Titles, 2018:
Code 51. https://www.naics.com/six-digit-naics/?code=51. Last
accessed October 12, 2021. (NAICS Association, 2018c)
NAICS Association. (2018d). NAICS Profile Page, 2018: Berkshire
Hathaway Energy Co. https://www.naics.com/company-profile-page/?co=4973. Last accessed October 12, 2021. (NAICS Association, 2018d)
NAICS Association. (2018e). NAICS Profile Page, 2018: Dominion
Energy Inc. https://www.naics.com/company-profile-page/?co=11715.
Last accessed October 12, 2021. (NAICS Association, 2018e)
Occupational Safety and Health Administration (OSHA). (2016, March
24). Final Economic and Regulatory Flexibility Analysis for OSHA's
Rule on Occupational Exposure to Respirable Crystalline Silica,
Chapter VI, pp. VI-20. Docket No. OSHA-2010-0034-4247. (OSHA, March
24, 2016)
Occupational Safety and Health Administration (OSHA). (2021a,
October). Analytical Spreadsheets in Support of the COVID-19
Vaccination and Testing ETS. (OSHA, October 2021a)
Park S. (2021, January 23). RV sales soar during coronavirus
pandemic. https://www.foxbusiness.com/lifestyle/rv-sales-soar-during-pandemic-travel-road-trip. (Park, January 23, 2021)
U.S. Census Bureau. (2021, October 8a). Scientific Integrity.
https://www.census.gov/about/policies/quality/
[[Page 61504]]
scientific_integrity.html. (US Census Bureau, October 8, 2021a)
U.S. Census Bureau. (2021, October 8b). Statement of Commitment to
Scientific Integrity by Principal Statistical Agencies. https://www.census.gov/content/dam/Census/about/about-the-bureau/policies_and_notices/scientificintegrity/Scientific_Integrity_Statement_of_the_Principal_Statistical_Agencies.pdf. (US Census Bureau, October 8, 2021b)
Walker C. (2013, January 22). Is Tidal Power a Viable Source of
Energy? https://www.azocleantech.com/article.aspx?ArticleID=350.
(Walker, January 22, 2013)
Washington Utilities and Transportation Commission (UTC). (2021,
October 12). Eligible Telecommunications Carriers. https://www.utc.wa.gov/regulated-industries/utilities/telecommunications/federal-universal-service-funds/eligible-telecommunications-carriers. (UTC, October 12, 2021)
V. Additional Requirements
A. Regulatory Flexibility Act
Whenever an agency is required by the Administrative Procedure Act,
5 U.S.C. 553, or another law, to publish a general notice of proposed
rulemaking, the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires the agency to prepare an initial regulatory flexibility
analysis (IRFA). 5 U.S.C. 601(2), 603(a). Since this ETS ``shall serve
as a proposed rule'' for a final standard under section 6(c)(3) of the
OSH Act, it is treated as a general notice of proposed rulemaking under
the RFA. An agency may waive or defer the IRFA in the event a rule is
promulgated in response to an emergency that makes compliance with the
requirements of section 603 impracticable. 5 U.S.C. 608(a). The agency
hereby certifies that compliance with the IRFA requirement is
impracticable under the circumstances. OSHA prepared this ETS on an
expedited basis in response to a national emergency affecting the lives
and health of the nation's workers; the IRFA is inherently a relatively
lengthy process that would be impracticable to undertake for a standard
of such broad applicability in the limited time available. Because OSHA
is not preparing an IRFA for the ETS, the agency is also not required
to convene a small entity panel under section 609(b).
B. Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1501 et seq.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
U.S.C. 1532, requires agencies to assess the anticipated costs and
benefits of a rule before issuing ``any general notice of proposed
rulemaking'' that includes a Federal mandate that may result in
expenditures in any one year by state, local, or Tribal governments, or
by the private sector, of at least $100 million, adjusted annually for
inflation. The assessment requirement also applies to ``any final rule
for which a general notice of proposed rulemaking was published.''
Although no general notice of proposed rulemaking was published, the
agency has analyzed the ETS's economic feasibility and health impacts
in Section IV.B. of this preamble (Economic Analysis) and Health
Impacts Appendix (OSHA, October 2021c).
C. Executive Order 13175
Section 5 of E.O. 13175, on Consultation and Coordination with
Indian Tribal Governments, requires agencies to consult with tribal
officials early in the process of developing regulations that: (1) Have
tribal implications, that impose substantial direct compliance costs on
Indian governments, and that are not required by statute; or (2) have
tribal implications and preempt tribal law. 65 FR 67249, 67250 (Nov. 6,
2000). E.O. 13175 requires that such consultation occur to the extent
practicable. Given the expedited nature of issuing the ETS, it was not
practicable for OSHA to consult and incorporate non-federal input prior
to promulgation of the standard. OSHA commits to meaningful
consultation with tribal representatives after publication of the ETS
and during the comment period before finalizing any permanent standard.
Such consultation will be consistent with the Administrative Procedure
Act.
D. National Environmental Policy Act
OSHA has reviewed this ETS according to the National Environmental
Policy Act (NEPA) of 1969, 42 U.S.C. 4321 et seq., the regulations of
the Council on Environmental Quality, 40 CFR chapter V, subchapter A,
and the Department of Labor's NEPA procedures, 29 CFR part 11. As a
result of this review, the agency has determined that the rule will
have no significant impact on air, water, or soil quality; plant or
animal life; the use of land; or other aspects of the external
environment. Although the ETS contains testing requirements, and test
kits and supplies can generate some additional materials that will
enter the waste stream, the impact of this ETS will be minimal. As
discussed in more detail in Technological Feasibility (Section IV.A. of
this preamble), there is already a surplus of available tests, and
projected production of COVID-19 tests will be more than sufficient to
meet demands for testing created as a result of the rule. Therefore,
tests used for purposes of or for compliance with this ETS are not
being produced as a result of this standard, and the standard will not
generate significant new streams of waste beyond what would be
generated in the absence of the standard.
E. Congressional Review Act
This ETS is considered a major rule under the Congressional Review
Act (CRA), 5 U.S.C. 801 et seq. Section 801(a)(3) of the CRA normally
requires a 60-day delay in the effective date of a major rule. 5 U.S.C.
801(a)(3), 804(2). However, section 808(2) of the CRA allows the
issuing agency to make a rule effective sooner than otherwise provided
by the CRA if the agency makes a good cause finding that notice and
public procedure are impracticable, unnecessary, or contrary to the
public interest. 5 U.S.C. 808(2). OSHA finds that there is good cause
to make this rule effective upon publication because notice and public
procedure with respect to this ETS are both impracticable and contrary
to the public interest, given the expedited timeline on which this
standard was developed and the grave danger threatening workers' lives
and health (see Grave Danger and Need for the ETS, both in Section III.
of this preamble). Congress authorized OSHA to take swift action in
promulgating an ETS to address this type of grave danger, and provided
explicitly that an ETS is effective upon publication, 29 U.S.C.
655(c)(1); delaying the effective date of such an expedited process
would thwart that purpose. It is specifically because of the emergency
nature of this rulemaking that the OSH Act allows for OSHA to proceed
without the extensive public input the agency normally solicits in
issuing occupational safety and health standards. 29 U.S.C. 655(c)(1).
For rules to which section 808(2) applies, the agency may set the
effective date. In this case, consistent with the OSH Act requirement
cited above, the ETS takes immediate effect upon publication in the
Federal Register.
F. Administrative Procedure Act
The Administrative Procedure Act (APA) normally requires notice and
comment, and a 30-day delay of the effective date of a final rule, for
recordkeeping and reporting regulations promulgated under section 8(c)
of the OSH Act. 29 U.S.C. 657(c); 5 U.S.C. 553(b), (d). This ETS
contains recordkeeping and reporting requirements tailored to address
COVID-19 illness. To the extent that these requirements are not already
[[Page 61505]]
exempt from the APA's requirements for notice and comment under section
6(c) of the Act (29 U.S.C. 655(c)), OSHA invokes the ``good cause''
exemption to the APA's notice requirement because the agency finds that
notice and public procedure are impracticable and contrary to the
public interest under 5 U.S.C. 553(b)(B). As explained in more detail
in Grave Danger and Need for the ETS (both in Section III. of this
preamble), this finding is based on the critical importance of
implementing the requirements in this ETS, including the recordkeeping
and reporting provisions, as soon as possible to address the grave
danger that COVID-19 presents to workers.
As noted above, the ETS is required by the OSH Act to take
immediate effect upon publication. 29 U.S.C. 655(c)(1). For that
reason, and the underlying public health emergency that prompted this
ETS as discussed above, OSHA finds good cause to waive the normal 30-
day delay in the effective date of a final rule from the date of its
publication in the Federal Register. See 5 U.S.C. 553(d)(3). OSHA
notes, however, that OSHA does not require compliance with any
provision of the ETS within the first 30 days after it becomes
effective.
G. Consensus Standards
OSHA must consider adopting an existing national consensus standard
that differs substantially from OSHA's standard if the consensus
standard would better effectuate the purposes of the Act. See section
12(d)(1) of the National Technology Transfer and Advancement Act of
1995 (15 U.S.C.A. 272 Note); see also 29 U.S.C. 655(b)(8).
OSHA considered incorporation of ASTM F3502-21 in this ETS, as
required. However, the agency has insufficient evidence to make a
general finding of feasibility at this time. The agency notes that face
coverings that meet ASTM F3502-21 criteria also meet the definition of
``face coverings'' in this ETS (see the discussion of this issue in
Summary and Explanation, Section VI. of this preamble). The agency has
asked questions about this topic to gather additional information.
H. Executive Order 13045
Executive Order 13045, on Protection of Children from Environmental
Health Risks and Safety Risks, requires that Federal agencies
submitting covered regulatory actions to OIRA for review pursuant to
Executive Order 12866 must provide OIRA with (1) an evaluation of the
environmental health or safety effects that the planned regulation may
have on children, and (2) an explanation of why the planned regulation
is preferable to other potentially effective and reasonably feasible
alternatives considered by the agency (62 FR 19885 (April 23, 1997)).
Executive Order 13045 defines ``covered regulatory actions'' as rules
that may (1) be economically significant under Executive Order 12866,
and (2) concern an environmental health risk or safety risk that an
agency has reason to believe may disproportionately affect children.
Because OSHA has no reason to believe that the risk from COVID-19
disproportionately affects children, the ETS is not a covered
regulatory action and OSHA is not required to provide OIRA with further
analysis under section 5 of the executive order. However, to the extent
children are exposed to COVID-19 either as employees or at home as a
result of family members' workplace exposures to COVID-19, the ETS
should provide some protection for children.
I. Federalism
The agency reviewed this ETS according to Executive Order 13132, on
Federalism, which requires that Federal agencies, to the extent
possible, refrain from limiting State policy options, consult with
States before taking actions that would restrict States' policy
options, and take such actions only when clear constitutional authority
exists and the problem is of national scope. 64 FR 43255 (August 10,
1999). The Executive Order generally allows Federal agencies to preempt
State law only as provided by Congress or where State law conflicts
with Federal law. In such cases, Federal agencies must limit preemption
of State law to the extent possible.
The Occupational Safety and Health Act is an exercise of Congress's
Commerce Clause authority, and under Section 18 of the Act, 29 U.S.C.
667, Congress expressly provided that States may adopt, with Federal
approval, a plan for the development and enforcement of occupational
safety and health standards. OSHA refers to States that obtain Federal
approval for such plans as ``State Plans.'' Occupational safety and
health standards developed by State Plans must be at least as effective
in providing safe and healthful employment and places of employment as
the Federal standards. As discussed below, State Plans must submit to
Federal OSHA for approval, standards that differ from Federal standards
addressing the same issues, in order for such standards to become part
of the OSHA-approved State Plan. Subject to these requirements, State
Plans are free to develop and enforce their own occupational safety and
health standards.
This ETS complies with E.O. 13132. The problems addressed by this
ETS for COVID-19 are national in scope. As explained in Grave Danger
(Section III.A. of this preamble), employees face a grave danger from
exposure to COVID-19 in the workplace. Employees across the country
face the danger of exposure to COVID-19 at work, and as explained in
Need for the ETS (Section III.B. of this preamble), a national standard
is needed to protect workers from the grave danger of COVID-19 by
strongly encouraging vaccination and limiting the presence of COVID-19
positive workers in the workplace through testing and to ensure that a
clear and consistent baseline approach is taken across the country to
protect them. The SARS-CoV-2 virus is highly communicable and infects
workers without regard to state borders, making a national approach
necessary. Accordingly, the ETS establishes minimum requirements for
employers in every State to protect employees from the risks of
exposure to COVID-19.
In States without OSHA-approved State Plans, Congress provides for
OSHA standards to preempt State occupational safety and health
standards for issues addressed by the Federal standards. In these
States, this ETS limits State policy options in the same manner as
every standard promulgated by the agency. Furthermore, as discussed in
the Summary and Explanation for Purpose, nothing in the ETS is intended
to limit generally applicable public health measures instituted by
state or local governments that go beyond, and are not inconsistent
with, the requirements of the ETS. (See Summary and Explanation for
Purpose, Section VI.A. of this preamble); Gade v. National Solid Wastes
Management Ass'n, 505 U.S. 88, 107 (1992). In States with OSHA-approved
State Plans, this ETS does not significantly limit State policy
options. Any special workplace problems or conditions in a State with
an OSHA-approved State Plan may be dealt with by that State's standard,
provided the standard is at least as effective as this ETS.
As discussed in the Summary and Explanation for Purpose in this
preamble, OSHA has included a provision that states the purpose of this
ETS, as well as OSHA's intent to preempt all inconsistent State and
local requirements that relate to the issues addressed by this ETS.
(See section 1910.501(a); Summary and Explanation for Purpose, Section
VI.A. of this preamble). This includes State and local
[[Page 61506]]
requirements banning or limiting the authority of employers to require
vaccination, face covering, or testing. As discussed in that section,
such State and local bans would be preempted by this ETS, even in
States with OSHA-approved State Plans, because such bans are not
approved by federal OSHA as part of the State Plan and could not be
approved, because such bans are clearly not as effective--and, indeed,
are contrary to--the federal ETS. See Indust. Truck Ass'n v. Henry, 125
F.3d 1305, 1311 (9th Cir. 1997).
J. State Plans
When Federal OSHA promulgates an emergency temporary standard,
States and U.S. Territories with their own OSHA-approved occupational
safety and health plans (``State Plans'') must either amend their
standards to be identical or ``at least as effective as'' the new
standard, or show that an existing State Plan standard covering this
area is ``at least as effective'' as the new Federal standard. 29 CFR
1953.5(b). This ETS imposes new requirements to protect workers across
the nation from COVID-19. Adoption of this ETS, or an ETS that is at
least as effective as this ETS, by State Plans must be completed within
30 days of the promulgation date of the final Federal rule, and State
Plans must notify Federal OSHA of the action they will take within 15
days. The State Plan standard must remain in effect for the duration of
the Federal ETS. As noted above in Federalism (Section V.I. of this
preamble), this ETS preempts all State and local requirements,
including in States with State Plans, that ban or limit the authority
of employers to require vaccination, face covering, or testing. (See
also the Summary and Explanation for Purpose, Section VI.A. of this
preamble). As with all non-identical State Plan standards, OSHA will
review any comparable State standards to determine whether they are at
least as effective as this ETS. A State Plan standard that prohibits
employers from requiring vaccination would not be at least as effective
as this ETS because OSHA has recognized in this ETS that vaccination is
the most protective policy choice for employers to adopt to protect
their workplaces.
Of the 28 States and Territories with OSHA-approved State Plans, 22
cover both public and private-sector employees: Alaska, Arizona,
California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan,
Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico,
South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and
Wyoming. The remaining six States and Territories cover only state and
local government employees: Connecticut, Illinois, Maine, New Jersey,
New York, and the Virgin Islands.
K. Paperwork Reduction Act
I. Overview
The Emergency Temporary Standard (ETS) for COVID-19 Vaccination and
Testing contains collection of information requirements that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501, et seq., and
OMB's regulations at 5 CFR part 1320. The PRA defines a collection of
information to mean the obtaining, causing to be obtained, soliciting,
or requiring the disclosure to third parties or the public, of facts or
opinions by or for an agency, regardless of form or format (44 U.S.C.
3502(3)(A)). OSHA has determined an ETS is necessary to protect workers
from the grave danger posed by COVID-19 and is issuing an ETS that
amends 29 CFR 1910 subpart U to provide COVID-19 protections to workers
of employers with 100 or more employees. Section 1910.501 contains
collections of information necessary to effectuate the purpose of the
ETS. The collections of information appear in paragraphs 1910.501(d),
(e)(2), (e)(4), (f)(1), (g)(1), (g)(4), (h)(1), (j), (k)(1), (k)(2),
(l)(1), and (l)(2). For a more comprehensive discussion of these
provisions, see the sectional analysis earlier in this preamble. These
information collections are applied by cross reference to other
industries in regulations 29 CFR 1915.1501 (Shipyard Employment),
1917.31 (Marine Terminals), 1918.110 (Longshoring), 1926.58
(Construction), 1928.21 (Agriculture).\79\
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\79\ The ETS applies to agricultural establishments with 11 or
more employees engaged on any day in hand-labor occupations in the
field and agricultural establishments that maintain a temporary
labor camp, regardless of how many employees are engaged on any day
in hand-labor occupations in the field).
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Under the PRA, a Federal agency cannot conduct or sponsor a
collection of information unless OMB approves it and the agency
displays a currently valid OMB control number (44 U.S.C. 3507).
Notwithstanding any other provision of law, if a collection of
information does not display a currently valid control number, an
employer shall not be subject to penalty for failing to comply with the
collection of information (44 U.S.C. 3512). The PRA has special
provisions for emergency situations that are applicable to this ETS.
OMB may authorize a collection of information without regard to the
normal clearance procedures if either (a) the relevant agency
determines that the collection of information is essential to the
mission of the agency and public harm is reasonably likely to result if
normal clearance procedures are followed, or (b) the use of normal
clearance procedures is reasonably likely to cause a statutory or court
ordered deadline to be missed (44 U.S.C. 3507(j) and 5 CFR 1320.13).
Because COVID-19 presents an ongoing public health threat to workers
and American businesses, OSHA has requested the use of these emergency
procedures for this ETS. In accordance with 44 U.S.C. 3507(j)(1), OMB
approved the request and assigned this ETS an OMB control number that
is valid for 180 days. Therefore, the information collection provisions
contained within this ETS will take effect at the same time as all
other provisions.
II. Summary of Information Collection Requirements
This information collection is summarized as follows.
1. Title: COVID-19 Vaccination and Testing Emergency Temporary
Standard (29 CFR 1910, subpart U; 1915, subpart Z; 1917, subpart B;
1918, subpart K; 1926, subpart D; 1928, subpart B).
2. Type of Review: Emergency.
3. OMB Control Number: 1218-0278.
4. Affected Public: This rule applies to employers with a total of
100 or more employees except where the workplace is covered under the
Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance
for Federal Contractors and Subcontractors; or in setting where the
employee provides healthcare services or healthcare support services
that falls under the requirements of 29 CFR 1910.502. This rule does
not apply to employees of covered employers who work from home,
exclusively outdoors, or who do not report to a workplace where other
individuals such as coworkers or customers are present.
5. Description of the ICR. This ICR contains collections of
information requirements for employers with 100 or more employees. The
employer must establish, implement, and enforce a written mandatory
vaccination policy that requires each employee to be fully vaccinated
against COVID-19 unless the employer implements a policy that allows
employees to choose between being fully vaccinated or both tested and
wearing a face covering. Employers must determine employee vaccination
status, and must require than any employees who are not vaccinated be
tested for COVID-19 at least once every
[[Page 61507]]
7 days. Employers must provide specified information to employees
regarding COVID-19 vaccine efficacy, safety, and the benefits of being
vaccinated, and must maintain a record of the COVID-19 vaccination
status, proof of vaccination, and copies of employee COVID-19 test
results, and the aggregate number of fully vaccinated employees at a
workplace along with the total number of employees at that workplace.
6. Number of respondents: 1,858,935.
7. Frequency: Varies.
8. Number of Responses: 205,262,803.
9. Estimated Burden Hours: 79,720,444.
10. Estimated Cost (Capital-operation and maintenance):
$1,383,751,520.
These totals are explained and supported in the agency's Supporting
Statement as required by the PRA.
III. Request for Comment
Although the ETS takes effect immediately, with implementation
dates specified in the Dates provision of this publication, it also
serves as a temporary standard that can only be made permanent
following an opportunity for public notice and comment. OSHA therefore
invites the public to submit comments to OSHA on the proposed
collections of information with regard to the following.
Whether the proposed collections of information are
necessary for the proper performance of the Agency's functions,
including whether the information is useful.
The accuracy of OSHA's estimate of the burden (time and
cost) of the collections of information, including the validity of the
methodology and assumptions used.
The quality, utility, and clarity of the information
collected.
Ways to minimize the compliance burden on employers, for
example, by using automated or other technological techniques for
collecting and transmitting information.
Please submit comments related to the Paperwork Act analysis to
OSHA in the PRA docket (Docket Number OSHA-2021-0008). Comments related
to other parts of the ETS should be submitted to the rulemaking docket
(Docket Number OSHA-2021-0007). OSHA will accept comments for 60 days
on the information collection aspects of the rule. For instructions on
submitting these comments to the rulemaking and/or PRA docket, see the
sections of this Federal Register notice titled DATES and ADDRESSES.
References
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
VI. Summary and Explanation
A. Purpose
The ETS includes a sentence that states the purpose of the rule.
The first part of the sentence in the paragraph indicates that the
standard addresses the grave danger of COVID-19 in the workplace by
establishing workplace vaccination, vaccination verification, face
covering and testing requirements.
The second part of the sentence addresses the preemption of State
and local laws, regulations, executive orders, and other requirements,
by this Federal standard. It indicates OSHA's intention that the ETS
address comprehensively the occupational safety and health issues of
vaccination, wearing face coverings, and testing for COVID-19, and thus
that the standard is intended to preempt States, and political
subdivisions of States, from adopting and enforcing workplace
requirements relating to these issues, except under the authority of a
Federally-approved State Plan. In particular, OSHA intends to preempt
any State or local requirements that ban or limit an employer's
authority to require vaccination, face covering, or testing.
Preemption of such State and local requirements derives from
section 18 of OSH Act and general principles of conflict preemption.
See Gade v. National Solid Wastes Management Ass'n, 505 U.S. 88
(1992).\80\ Gade clarified two important principles. First, section 18
expresses Congress' intent to preempt State workplace safety or health
laws relating to issues on which Federal OSHA has promulgated
occupational safety and health standards. Under section 18, a State can
avoid preemption of such laws only if it submits and receives Federal
approval for a State Plan for the development and enforcement of
standards. OSHA-approved State Plans operate under authority of State
law and must adopt occupational safety and health standards which,
among other things, must be at least as effective in providing safe and
healthful employment and places of employment as Federal standards. 29
U.S.C. 667.
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\80\ The Court held that the dual impact licensing statutes were
preempted; however, no rationale commanded a majority. A four-
justice plurality found that supplementary State regulation is
impliedly preempted. Id. at 98-99. Justice Kennedy's concurrence
would have found express preemption rather than implied preemption,
Id. at 110-111, but otherwise agreed that ``in the OSH statute
Congress intended to pre-empt supplementary state regulation.'' Id.
at 113.
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Second, State and local laws that do not constitute occupational
safety or health laws because they are ``laws of general
applicability'' that regulate workers and nonworkers alike are
preempted only if they conflict with the federal standard. Laws of
general applicability that are consistent with the federal standard are
not preempted. Gade, 505 U.S. at 107.
While section 18 applies to every occupational safety and health
standard that OSHA promulgates, this ETS raises particular concerns
because of the current landscape of existing State and local
requirements that may overlap with, or directly conflict with, the
requirements of this ETS. As discussed in Need for the ETS (Section
III.B. of this preamble), OSHA is adopting this ETS in response to an
unprecedented health crisis that has resulted in a global pandemic
severely impacting the health and wellbeing of people in the United
States, and globally. This ETS is issued based on OSHA's determination
that employees in the United States face a grave danger from workplace
exposures to SARS-CoV-2, that the ETS is necessary to protect those
workers, and that the measures for vaccination, vaccine verification,
face coverings, and testing that this ETS requires will help ensure
that workers covered by the ETS are protected from severe illness and
death resulting from contracting COVID-19 in the workplace.
As explained in Need for the ETS (Section III.B. of this preamble),
the lack of a national standard on this hazard has led to disparate
State and local requirements, and this underscores the need for OSHA's
ETS to provide clear and consistent protection to employees across the
country. Over the past months, an increasing number of States have
passed laws or enacted other requirements banning workplace vaccination
policies that would mandate vaccination or require proof of vaccination
status, thus prohibiting employers operating in those jurisdictions
from implementing this proven method of protecting workers from the
hazard of COVID-19 that is at the core of this ETS (see, e.g., Texas
Executive Order GA-40, October 11, 2021; Montana H.B. 702, July 1,
2021; Arkansas S.B. 739, October 4, 2021 and Arkansas H.B. 1977,
October 1, 2021; AZ Executive Order 2021-18, Aug. 16, 2021). While some
States' bans have focused on preventing local governments from
requiring their public employees to be vaccinated or show proof of
vaccination, the Texas, Montana, and Arkansas requirements apply to
private employers as well. Likewise, some States and localities
[[Page 61508]]
have enacted requirements that prohibit businesses, government offices,
schools or other public spaces from requiring that face coverings be
worn (see, e.g., Florida Executive Order 21-102, May 3, 2021; Texas
Executive Order GA-34, March 2, 2021; Texas Executive Order GA-36, May
18, 2021). State and local requirements that prohibit employers from
implementing employee vaccination mandates, or from requiring face
coverings in workplaces, serve as a barrier to OSHA's implementation of
this ETS, and to the protection of America's workforce from this deadly
virus.
As discussed below, state restrictions of this kind are clearly
preempted whether they take the form of direct workplace regulation or
are part of a law of general applicability because they relate to the
issues addressed by this standard and conflict with it. Gade, 505 U.S.
at 99, 107. As is also discussed below, this is true even for State or
local requirements that may not prevent employers from compliance with
the ETS, but that prescribe or limit the employer's ability to mandate
vaccination for its workforce as the employer's chosen means of
compliance. See Gade, 505 at 107; see also Geier v. American Honda, 529
U.S. 861, 869, 875-886 (2000) (finding Department of Transportation
(DOT) regulations preempted a State tort action where the state action
``upset the careful regulatory scheme established by federal law'' and
placing weight on DOT's interpretation that such tort suit would be
``an obstacle to the accomplishment and execution'' of Agency
objectives). An employer's choice to mandate vaccination is a critical
aspect of this ETS, and state laws that remove that choice conflict
with it.
Thus, to ensure that the ETS supplants the existing State and local
vaccination bans and other requirements that could undercut its
effectiveness, and to foreclose the possibility of future bans, OSHA
has clearly defined the issues addressed by this section to encompass
vaccination, face covering, and testing needed to protect against
transmission of COVID-19 to employees in the workplace. To avoid
ambiguity, OSHA has stated expressly that it intends this ETS to
preempt all State and local workplace requirements that ``relate'' to
these issues, except pursuant to a State Plan. 29 U.S.C. 667(b).
The ``unavoidable implication'' of section 18 is that because OSHA
has adopted this ETS, States may no longer regulate these issues except
with OSHA's approval and the authority of a Federally-approved State
Plan. Gade, 505 U.S. at 99. As the Court explained, section 18 preempts
States without approved plans from adopting or enforcing any laws that
constitute, ``in a direct, clear and substantial way regulation of
worker health and safety'' relating to an issue addressed by an OSHA
standard. Id. at 107.
State and local requirements that ban or otherwise limit workplace
vaccination, face covering, or testing clearly ``relate'' to the
occupational safety and health ``issues'' that OSHA is regulating in
this ETS. 29 U.S.C. 667(b). Such bans regulate key workplace COVID-19
protections that are encompassed by this ETS ``in a direct, clear and
substantial way.'' Gade, 505 U.S. at 107. The direct effect of such
bans is to prohibit employers from requiring employees to implement
measures, such as vaccination requirements, face coverings, or testing.
These workplace protective measures are covered by, and, in many
circumstances required by, this ETS. For example, vaccination mandate
bans directed at employers specifically bar them from requiring
employee vaccination requirements for the purposes of protecting their
workforce. Prohibitions on face covering mandates likewise directly
prohibit individuals in positions of authority, including employers,
from requiring face covering use.
Although the expressly stated purposes for State and local
requirements banning or limiting employers from requiring vaccinations,
face coverings, or testing may not be occupational safety and
health,\81\ this does not control their preemption under section 18 of
the OSH Act. In assessing State and local requirements' impact on a
federal statutory scheme, courts ``have refused to rely solely on the
legislature's professed purpose and have looked as well to the effects
of the law.'' Gade, 505 U.S. at 105; see also, e.g., Perez v. Campbell,
402 U. S. 637, 651-652 (1971) (``[A]ny state legislation which
frustrates the full effectiveness of federal law is rendered invalid by
the Supremacy Clause''); Napier v. Atlantic Coast Line R. Co., 272 U.S.
605, 612 (1926) (pre-emption analysis does not depend on whether
federal and State laws ``are aimed at distinct and different evils''
but whether they ``operate upon the same object'').
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\81\ The express purposes of such requirements banning or
limiting employers from requiring vaccination, face coverings, or
testing may often not relate to occupational safety and health. For
example, Governor Greg Abbott's Texas face covering mandate ban in
Executive Order GA-16, is based on alleged decreasing COVID-19 rates
and the need to alleviate ``confusion,'' (Texas Executive Order GA-
36, May 18, 2021); the stated purpose of Montana's vaccination
mandate ban is to address health care privacy interests (Montana
H.B. 702, July 1, 2021).
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That a State has articulated a purpose other than, or in addition
to, workplace health and safety would not divest the OSH Act of its
preemptive force, because preemption law looks to the effects as well
as the purpose of a State law, and thus a dual-impact State law cannot
avoid OSH Act preemption simply because the regulation serves several
objectives. Gade, 505 U.S. at 107 (holding ``a law directed at
workplace safety is not saved from pre-emption simply because the State
can demonstrate some additional effect outside of the workplace'' and
``[t]hat such law may also have a nonoccupational impact does not
render it any less of an occupational standard for purposes of pre-
emption analysis''). Thus, to the extent that the stated purpose of a
requirement that bans or limits employers from requiring vaccinations,
face coverings, or testing is something other than, or in addition to,
occupational health, such laws, which have a specific and direct impact
on worker health, are nevertheless preempted.
Further, section 18 preempts even ``nonconflicting'' State and
local occupational safety and health requirements relating to the
issues addressed by this standard. Gade, 505 U.S. at 98-99, 103; see
id. at 100 (``state laws regulating the same issue as federal laws are
not saved, even if they merely supplement the federal standard''). This
is because OSHA ``'pre-empts the field' for any nonapproved State law
regulating the same safety and health issue.'' See Gade, 505 U.S. at
104, n. 2, citing English v. General Electric. Co., 496 U.S. 72, 79-80,
n.5 (``[F]ield preemption may be understood as a species of conflict
pre-emption: A State law that falls within a pre-empted field conflicts
with Congress' intent (either express or plainly implied) to exclude
state regulation''); see also id. at 105 (discussing effect of field
preemption). See generally Geier, 529 U.S. at 869, 875-886 (finding
State law preemption where it ``upset the careful regulatory scheme
established by federal law''); Williamson v. Mazda Motor of Am., Inc.,
562 U.S. 323, 330-36 (2011) (affirming the conflict pre-emption
principle that ``a state law that stands as an obstacle to the
accomplishment and execution of the full purposes and objectives of a
federal law is pre-empted'' and finding preemption where State law
interfered with ``significant objective'' of the federal regulation).
For example, the ETS would preempt State or local governments from
[[Page 61509]]
dictating that employers adopt a scheme of testing and face coverings
that complies with 1910.501(g) and (i) of the ETS, but that bars
employers from electing the preferred vaccine mandate alternative in
paragraph (d), because this interferes with OSHA's significant
regulatory objectives and its preemption of the field.\82\ (See Need
for the ETS (Section III.B. of this preamble) discussing that
vaccination is the preferred compliance option under this rule because
it is the most effective method of protecting workers from COVID-19).
Likewise, the ETS would preempt such State or local occupational
requirements, even to the extent that they may regulate employers with
fewer than 100 employees, notwithstanding that the requirements in this
ETS only apply to employers with more than 100 employees.
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\82\ OSHA is aware that some States have adopted or are
considering adopting such requirements, which this ETS would preempt
(see, e.g., Arkansas S.B. 739, October 4, 2021 and Arkansas H.B.
1977, October 1, 2021, which Arkansas Governor Asa Hutchinson
allowed to became law without his signature, and which require
employers in Arkansas to allow employees to opt out of vaccination
for purposes of complying with federal vaccination requirements; see
also Governor Hutchinson, October 13, 2021; Marr, October 7, 2021
(describing the Arkansas legislation and noting that other states
may contemplate similar legislation)).
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Case law is instructive on this point. In Gade, the Supreme Court
found regulations implementing a State statute that required training
for workers handling hazardous waste that went beyond, but did not
conflict with, OSHA's hazardous waste training requirements to be
preempted by the OSHA requirements. Id. Likewise, in Industrial Truck
Association Incorporated v. Henry, the Ninth Circuit found that OSHA's
hazard communication standard preempted California's Hazard
Communication regulations that were not submitted to OSHA for approval
through its State Plan, even to the extent that California's Hazard
Communication rule regulated manufacturers and distributers who were
excluded from coverage under federal OSHA's rule. Indust. Truck Ass'n
v. Henry, 125 F.3d 1305, 1311-14 (9th Cir. 1997). In the same way, the
ETS preempts all State and local requirements that bar or limit the
ability of an employer to require workplace vaccination, testing, and
face coverings to protected employees against COVID-19 in any respect,
since OSHA has occupied the entire field of regulation on these issues.
OSHA's definition of the ``issue'' in this rule should be afforded
weight, since the OSH Act vests OSHA with standard-setting
responsibility and, therefore, the authority to determine which
``issues'' to address with occupational safety and health standards.
See Indust. Truck, 125 F.3d at 1311 (relying on OSHA's regulation and
statements in the preamble to identify the relevant ``issue'' for
preemption purposes in OSHA's Hazard Communication standard).
Importantly, although OSHA's stated intention is to preempt
conflicting State and local requirements relating to the issues
addressed by this standard, OSHA recognizes that the OSH Act does not
allow, and OSHA does not intend, for the ETS to preempt non-conflicting
State or local requirements of general applicability. In Gade, the
Supreme Court qualified its ruling by saving from preemption non-
conflicting State and local ``laws of general applicability (such as
laws regarding traffic safety or fire safety) that do not conflict with
OSHA standards and that regulate the conduct of workers and nonworkers
alike.'' Gade, 505 U.S. at 107. The Majority reasoned that,
``[a]lthough some laws of general applicability may have a `direct and
substantial' effect on worker safety, they cannot fairly be
characterized as `occupational' standards, because they regulate
workers simply as members of the general public.'' Id.
During the pandemic, many States and municipal governments have
adopted requirements intended to protect public health by helping to
prevent the spread of COVID-19 in public spaces. These have included
requirements mandating face coverings in indoor public spaces,
including businesses, government buildings, and schools (see, e.g.,
Baltimore City Health Department, August 10, 2021; Illinois Executive
Order 2021-20, August 26, 2021; Hawai'i Emergency Proclamation, October
1, 2021). In addition, in recent months, some States and municipal
governments have adopted requirements mandating that members of the
public provide proof of vaccination or recent COVID-19 testing in order
to enter restaurants, bars, or other businesses or public spaces (see,
e.g., NYC Emergency Executive Order 225, August 16, 2021 (mandating
COVID-19 vaccination for most individuals for indoor entertainment,
recreation, dining and fitness settings)). Requirements such as these
apply to ``workers and nonworkers alike'' and ``regulate workers simply
as member of the general public'' and are accordingly not preempted.
Gade, 505 U.S.at 107.
Based on OSHA's observations and experience during the past year
and a half that the pandemic has been ongoing, OSHA is confident that
protective State and local regulations of general applicability that
mandate face coverings or vaccination will complement, rather than
interfere with OSHA's enforcement of the ETS, and also does not intend
to preempt such requirements. Indeed, OSHA believes that such measures
have significantly reduced the harmful effects of the pandemic and
total fatalities. See Steel Institute of NY v. The City of NY, 716 F.3d
31, 38 (affording some weight to OSHA's view that municipal regulations
governing construction cranes did not interfere with OSHA's regulatory
scheme in its crane standards and ultimately adopted OSHA's view in
finding these municipal regulations were not preempted by OSHA crane
standards).\83\
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\83\ OSHA's Cranes and Derricks in Construction rule directly
discussed its expectations and intent regarding the preemptive
effect of the rule, including that it was not intended to preempt
generally applicable municipal regulations, such as building codes,
which serve public safety purposes. Cranes and Derricks in
Construction, 75 FR 47,906, 48,128 (August 9, 2010). This rule also
includes a provision that requires employers to comply with State
crane operator licensing requirements that meet the federal floor
for crane operator certification in the rule. 29 CFR
1926.1427(c)(1). OSHA has also indicated that its rule would not
preempt State or local requirements in other rulemakings. See e.g.,
72 FR 7136, 7188 (Feb. 14, 2007) (Preamble to OSHA's most recent
electrical safety standard) (``State and local fire and building
codes, which are designed to protect a larger group of persons than
employees,'' are not preempted); 29 CFR 1910.134(e) (requiring
compliance with State and local laws by requiring ``a licensed
health care professional'' to perform a medical evaluation of an
employee's ability to use a respirator).
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In Steel Institute, the Second Circuit held that OSHA's crane
regulations did not preempt New York City municipal regulations
governing construction cranes, finding that such regulations were
requirements of general applicability, notwithstanding their direct
bearing on worker safety, because their primary purpose and effect was
to preserve the safety of the general public, and they regulated
workers and nonworkers alike. Id. The Steel Institute court noted the
``strong presumption against preemption when states and localities
``exercise[ ] their police powers to protect the health and safety of
their citizens.'' Id. at 36, citing Medtronic, Inc. v. Lohr, 518 U.S.
470, 475 (1996). The Second Circuit was also influenced by the clear
danger presented to the public by unsafe crane operation. This is
analogous to the situation here, because exposure to COVID-19 is a
hazard that directly impacts everyone. Thus, generally applicable State
and local mandates requiring face coverings or vaccination should not
be preempted and should
[[Page 61510]]
remain in effect, notwithstanding this ETS.\84\
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\84\ In addition, some State and local governments have adopted
vaccination mandates directed at State and/or local government
employees. The OSH Act and OSHA's standards would not preempt such
requirements since State or local government employers and employees
are exempt from OSHA coverage under the OSH Act. 29 U.S.C. 652 (5)
(defining employer to exclude ``any State or political subdivision
of a State''). However, many State and local government employers in
States with OSHA-approved State Plans will be covered by State
occupational safety and health requirements, and State Plans must
adopt requirements for State and local government employers, as well
as covered private sector employers, that are at least as effective
as federal OSHA's requirements; State Plans may also choose to adopt
more protective occupational safety and health requirements. 29
U.S.C. 667(c).
---------------------------------------------------------------------------
On the other hand, as noted above, this standard will preempt
requirements that conflict with it, regardless of whether the
requirements are part of a law of general applicability.\85\
---------------------------------------------------------------------------
\85\ As previously discussed, bans on mandating vaccinations or
face coverings have not typically been generally applicable, but
even the least workplace-specific, most generally applied bans will
not survive preemption because they directly interfere with the
ETS's regulatory scheme.
---------------------------------------------------------------------------
The effect of the ETS on State law requirements in State Plan
States works somewhat differently. As previously noted, under section
18 of the OSH Act States that wish to assume responsibility for the
development and enforcement of ``occupational safety and health
standards relating to any occupational safety or health issue with
respect to which a Federal standard has been promulgated'' may submit a
State Plan to OSHA for approval. Id. section 667(b); see also id.
section 667(c) (describing requirements for OSHA approval of State
Plans on issues for which OSHA has adopted standards). There are 22
States and territories that have OSHA-approved State Plans for private
employers, and 6 additional States and territories that have OSHA-
approved State Plans for public employers only.
Under section 18(c)(2) of the OSH Act, State Plans are required to
adopt and enforce occupational safety and health standards that are at
least as effective as federal OSHA's requirements. Id. section
667(c)(2). In addition, the OSH Act requires that State Plans must
cover State and local government employees (including, e.g., State and
local school systems within the scope of this rule), even though
federal OSHA does not have coverage over such employees in States
without OSHA-approved State Plans.
Once OSHA promulgates an ETS, OSHA's regulations provide that those
States have ``30 days after the date of promulgation of the Federal
standard to adopt a State emergency temporary standard,'' or to
demonstrate ``that promulgation of an emergency temporary standard is
not necessary because the State standard is already the same or at
least as effective as the Federal standard change.'' 29 CFR
1953.5(b)(1). The new ETS becomes part of the OSHA-approved State Plan
through the State Plan's submission to OSHA documentation showing it
adopted an identical ETS or a ``Plan Change Supplement'' showing that
it has adopted requirements that are ``at least as effective'' as
federal OSHA's ETS. 29 CFR 1953.5(b)(3); 1953.4.
Even in States with OSHA-approved State Plans, any State law
relating to an occupational safety and health issue that OSHA regulates
is preempted unless it is submitted for OSHA's approval as a supplement
to the State Plan. Indust. Truck Ass'n, 125 F.3d at 1311 (``If a State
wishes to regulate an issue of worker safety for which a federal
standard is in effect, its only option is to obtain the prior approval
of the Secretary of Labor . . . [and] [i]t would make the state plan
approval requirement superfluous if a state could pick and choose which
occupational health and safety regulations to submit to OSHA''). Thus,
a State or local requirement banning or limiting employer vaccine
mandates would similarly be preempted because it has not been approved
by federal OSHA as part of the State Plan. And, indeed, it could not be
approved by federal OSHA, because such bans or limitations undercut the
ETS's requirements and are clearly not as effective as the federal ETS.
See 29 U.S.C. 667(c)(2).\86\
---------------------------------------------------------------------------
\86\ For example, Arizona has an OSHA-approved State Plan, but
its vaccination ban, which is not part of its State Plan, is
preempted by this ETS (see AZ Executive Order 2021-18, Aug. 16,
2021).
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Finally, this provision includes a note that this section
establishes minimum requirements for employers, that nothing in this
section prevents employers from agreeing with their employees to
implement additional measures, and that this section does not supplant
collective bargaining agreements or other collectively negotiated
agreements in effect that may have negotiated terms that exceed the
requirements herein. It also references the National Labor Relations
Act of 1935, which protects most private-sector employees' right to
take collective action. The purpose of this note is to remind employers
and employees that OSHA's ETS establishes a floor for protections, and
that it does not preclude bargaining for additional protective
measures. For example, employers might agree to cover the costs of face
coverings or medical removal, or to a requirement that all employees,
regardless of vaccination status, wear face coverings while working
indoors.
References
An Act Prohibiting Discrimination Based on a Person's Vaccination
Status or Possession of an Immunity Passport; Montana H.B. 702.
(2021, July 1). https://leg.mt.gov/bills/2021/billpdf/HB0702.pdf.
(Montana H.B. 702, July 1, 2021)
Arizona Executive Order 2021-18. (2021, August 16). https://azgovernor.gov/sites/default/files/eo_2021-18.pdf. (AZ Executive
Order 2021-18, August 16, 2021)
Arkansas H.B. 1977. (2021, October 1). To Provide Employee
Exemptions From Federal Mandates and Employer Mandates Related to
Coronavirus 2019 (COVID-19); and to Declare an Emergency. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FAMEND%2F2021R%2FPublic%2FHB1977-H1.pdf.
(Arkansas H.B. 1977, October 1, 2021)
Arkansas S.B. 739. (2021, October 4). An Act Concerning Employment
Issues Related to Coronavirus 2019 (COVID-19); To Provide Employee
Exemptions From Federal Mandates and Employer Mandates Related to
Coronavirus 2019 (COVID-19); To Declare and Emergency; and For Other
Purposes. https://www.arkleg.state.ar.us/Bills/FTPDocument?path=%2FBills%2F2021R%2FPublic%2FSB739.pdf. (Arkansas
S.B. 739, October 4, 2021)
Arkansas Governor Asa Hutchinson. (2021, October 13). Press Release:
Governor Hutchinson Allows Vaccine Mandate, Redistricting Bills to
Become Law Without His Signature. https://governor.arkansas.gov/news-media/press-releases/governor-hutchinson-allows-vaccine-mandate-redistricting-bills-to-become-la. (Governor Hutchinson,
October 13, 2021)
Baltimore City Health Department. (2021, August 10). Health
Commissioner Updated Directive and Order for Face Coverings. https://www.baltimorecity.gov/sites/default/files/HEALTH%20COMMISSIONER%20AUGUST%2010,%202021%20DIRECTIVE%20AND%20ORDER%20FOR%20FACE%20COVERINGS_FINAL.pdf. (Baltimore City Health
Department, August 10, 2021)
Emergency Executive Order 225. (2021, August 16). Key to NYC:
Requiring COVID-19 Vaccination for Indoor Entertainment, Recreation,
Dining and Fitness Settings. https://www1.nyc.gov/office-of-the-mayor/news/225-001/emergency-executive-order-225. (NYC Emergency
Executive Order 225, August 16, 2021)
Florida Executive Order 21-102. (2021, May 3). https://
www.flgov.com/wp-content/
[[Page 61511]]
uploads/orders/2021/EO_21-102.pdf. (Florida Executive Order 21-102,
May 3, 2021)
Hawai'i Emergency Proclamation Related to the State's COVID-19 Delta
Response. (2021, October 1). https://governor.hawaii.gov/wp-content/uploads/2021/10/2109152-ATG_Emergency-Proclamation-Related-to-the-States-COVID-19-Delta-Response-distribution-signed.pdf. (Hawai'i
Emergency Proclamation, October 1, 2021)
Illinois Executive Order 2021-20. (2021, August 26). https://www.illinois.gov/government/executive-orders/executive-order.executive-order-number-20.2021.html. (Illinois Executive Order
2021-20, August 26, 2021)
Marr C. (2021, October 7). Workplace Vaccine Exemption Bills Sent to
Arkansas Governor. Bloomberg Law. https://news.bloomberglaw.com/daily-labor-report/workplace-vaccine-exemption-bills-sent-to-arkansas-governor. (Marr, October 7, 2021)
Texas Executive Order GA-34. (2021, March 2). Executive Order No.
GA-34 relating to the opening of Texas in response to the COVID-19
disaster. https://open.texas.gov/uploads/files/organization/opentexas/E.O.-GA-34-opening-Texas-response-to-COVID-disaster-IMAGE-03-02-2021.pdf. (Texas Executive Order GA-34, March 2, 2021)
Texas Executive Order GA-36. (2021, May 18). Executive Order No. GA-
36 relating to the prohibition of governmental entities and
officials from mandating face coverings or restricting activities in
response to the COVID-19 disaster. https://gov.texas.gov/uploads/files/press/E.O.-GA-36_prohibition_on_mandating_face_coverings_response_to_COVID-19_disaster_IMAGE_05-18-2021.pdf. (Texas Executive Order GA-36, May
18, 2021)
Texas Executive Order GA-40. (2021, October 11). Executive Order No.
GA-40 relating to prohibiting vaccine mandates, subject to
legislative action. https://gov.texas.gov/uploads/files/press/E.O.-GA-40_prohibiting_vaccine_mandates_legislative_action_IMAGE_10-11-2021.pdf. (Texas Executive Order GA-40, October 11, 2021)
B. Scope and Application
Paragraph (b)(1) of this ETS provides that the ETS applies to all
employers that have a total of at least 100 employees at any time the
ETS is in effect. OSHA has determined that the unvaccinated employees
of these employers face a grave danger of exposure to SARS-CoV-2,
including the Delta variant, while they are at work (see Grave Danger,
Section III.A. of this preamble). Because this grave danger finding
applies to all unvaccinated employees who come into contact with other
people in indoor work settings as part of their employment, this ETS is
not limited by industrial sector or NAICS code. Therefore, this
standard generally covers employers in all workplaces that are under
OSHA's authority and jurisdiction, including industries as diverse as
manufacturing, retail, delivery services, warehouses, meatpacking,
agriculture, construction, logging, maritime, and healthcare.
I. Decision To Limit Coverage of This ETS to Employers With 100 or More
Employees
This ETS applies to employers with a total of 100 or more employees
at any time the standard is in effect. In light of the unique
occupational safety and health dangers presented by COVID-19, and
against the backdrop of the uncertain economic environment of a
pandemic, OSHA established this coverage threshold for four reasons.
First, OSHA is confident that employers with 100 or more employees will
be able to meet the standard's requirements promptly, as the emergency
addressed by the standard necessitates. OSHA is less confident that
smaller employers can do so without undue disruption. Second, this
coverage threshold will enable the standard to reach two-thirds of all
private-sector workers in the nation, providing them with prompt
protection. Third, the standard will reach the largest facilities,
where the most deadly outbreaks of COVID-19 can occur. Fourth, the 100-
employee threshold in this standard is comparable with the size
thresholds established by congressional and agency decisions in
analogous contexts.
a. Challenges to Feasibility Analysis for Small Businesses
An OSHA standard, including an ETS, must be both economically and
technologically feasible. A standard is economically feasible under the
OSH Act if it neither threatens ``massive dislocation to'' nor upsets
the ``competitive stability of'' the regulated industries. United
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1265 (D.C.
Cir. 1980). Technological feasibility has been interpreted broadly to
mean ``capable of being done'' Am. Textile Mfrs. Inst. v. Donovan, 452
U.S. 490, 509-510 (1981).
As shown in Economic Analysis, Section IV.B. of this preamble, OSHA
is confident that this standard is feasible for employers with 100 or
more employees. OSHA is not at this time making any determination about
whether it would be appropriate to extend the ETS to cover smaller
employers. Put simply, the agency is requiring that employers it is
confident can implement the provisions of the standard without delay do
so. At the same time, the agency is soliciting public comment and
seeking additional information to assess the ability of smaller
employers to do so in the rulemaking commenced by this ETS. OSHA will
determine the issue on the basis of the record, after receiving public
comment.\87\ The SARS-CoV-2 virus continues to spread rapidly, and each
day that passes, tens of thousands more people are infected. The
employees of larger firms should not have to wait for the protections
of this standard while OSHA takes the additional time necessary to
assess the feasibility of the standard for smaller employers.
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\87\ If OSHA receives information suggesting that a broader
scope would be appropriate, the agency could expand the scope of the
ETS quickly through a supplemental action. Fla. Peach Growers Ass'n,
Inc. v. U. S. Dep't of Labor, 489 F.2d 120, 127 (5th Cir. 1974)
(``It is inconceivable that Congress, having granted the Secretary
the authority to react quickly in fast-breaking emergency
situations, intended to limit his ability to react to developments
subsequent to his initial response.'')
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The pandemic has presented special challenges for small businesses.
According to a survey conducted during its early stages, 66% of
businesses with fewer than 100 employees had suffered revenues losses
exceeding 30%. (SHRM, May 6, 2020a). By contrast, only 27% of larger
businesses with more than 100 employees had seen revenue drops of more
than 30% (SHRM, May 6, 2020b). More recently, 61% of the members of the
National Federation of Independent Businesses, mostly very small
businesses, responded to a survey reported that they were experiencing
staff shortages, with half of that group reporting a moderate to
significant loss of sales because of unfilled positions (NFIB, July 12,
2021).
The requirements of the ETS could have a differential impact on
small businesses compared with larger firms. Many small businesses lack
separate human resources departments and struggle to carry out HR
functions. A study found that some 70% of small businesses (with 5 to
49 employees) handle HR tasks in an ad hoc way. (ADP, December 2016).
Only 23% of ad hoc managers believed they had the tools and resources
necessary to perform HR tasks well, and only 19% were fully confident
in their ability to handle HR tasks without making mistakes (ADP,
December 2016). Another survey found that HR functions are
proportionally far more expensive for smaller firms than for larger
(small firms defined as up to 250 workers) (SHRM, 2015). The ETS
requires employers to establish new systems to track vaccination status
among workers, to keep related records, and for firms that allow the
testing option, to keep records of each test.
[[Page 61512]]
These records must be treated as confidential medical records subject
to detailed regulations, which is not something most smaller employers
typically need to do or have existing systems in place to address. 29
CFR 1910.1020. While OSHA has imposed similar requirements on smaller
employers before, it has typically done so in highly regulated
industries, such as healthcare, or in industries involving complicated
industrial processes, which already require a certain degree of
administrative capacity even when not responding to a grave danger,
through a rulemaking process that provides additional time for notice
and implementation, and when there is more time to assess the impact
that the standard would have on small business. This emergency standard
by contrast applies across the board to all industries, including less
regulated retail and service sectors.
Moreover, OSHA estimates that some 5% of employees may have a
medical contraindication or request an accommodation from the rule's
requirements for disability or sincerely held religious belief reasons.
(Please see Economic Analysis, Section IV.B. of this preamble).
Assessing these requests may require more resources for smaller firms
with less experience in this area, particularly if they lack HR staff.
By the same token, a delay in applying the ETS to businesses with fewer
than 100 employees would allow those businesses the benefit of learning
from the models established by larger businesses with respect to
accommodations. Similarly, implementing the ETS's testing provisions in
a stepwise fashion will allow OSHA the time necessary to assess any
impact the new requirements may have on the testing infrastructure and
related supply chains before considering extending those requirements
to additional employers.
b. The ETS Provides Prompt Protection for Most of America's Workforce
The 100 employee threshold means the ETS will reach two-thirds of
the nation's private sector workforce, providing protection to millions
of workers while issues regarding smaller firms are reviewed. OSHA
considered that a 100 employee threshold was superior to a 150 employee
threshold in this respect, because it would protect more employees: 67%
rather than 63%, which is a difference of 4.856 million workers. (U.S.
Census Bureau, May 2021). And while a 50 employee threshold would have
covered more employees (78%), it would have required additional
feasibility analysis, while still leaving many employees outside the
standard. (U.S. Census Bureau, May 2021).
c. The ETS Will Help Prevent Large Outbreaks of COVID-19
The ETS's focus on employers with more than 100 employees will also
help prevent large-scale outbreaks. As addressed in more detail in the
discussion of Grave Danger (Section III.A. of this preamble), all
unvaccinated employees who work in indoor settings face a grave danger
from COVID-19, which is why the scope of the ETS is not limited to
worksites of a specific size. The standard is based on employer size
primarily because administrative capacity is more closely related to
employer size. In addition, employer size provides a clear measure that
is easy for employers (and OSHA) to track, as opposed to an alternative
such as a workplace-based approach, which could fluctuate from day to
day and mean more places and information for the employer to track. But
OSHA also chose the 100 employee size threshold in recognition of the
fact that larger employers are more likely to have many employees
gathered in the same location. For employers with 100 or more
employees, the median number of employees at any one location is
approximately 50 (the average is also 50). (U.S. Census Bureau, May
2021). For employers with fewer than 100 employees, the median number
of any one location is approximately 2 (with an average number of 7)
(U.S. Census Bureau, May 2021).
Employees at larger locations are statistically more likely to be
exposed to someone with COVID-19 during the course of their shifts, and
thus face a heightened risk of virus transmission. Studies indicate
that introduction of infection and the risk of infection transmission
is increased with the size of a gathering (Champredon et al., April,
2021), and with larger populations (Shacham et al., July 5, 2021). See
also (Contreras et al., July, 2021) (concluding that outbreaks were
larger and lasted longer at facilities with more onsite staff). It is
therefore not surprising that significant COVID-19 outbreaks have
occurred at large facilities of employers with 100 or more employees
\88\ (Oregon Health Authority, October 6, 2021; CDPHE, October 6,
2021). A study of outbreaks in Los Angeles County found that the median
number of employees in an establishment in which an outbreak occurred
was 95, well above the 50 employee median for locations of employers
covered by this rule, indicating that the rule will protect employees
in the places where outbreaks are most likely to occur. (Contreras et
al., July, 2021). And those outbreaks occurred even before the
emergence of the SARS-CoV-2 Delta variant, which the CDC says ``causes
more infections and spreads faster than early forms of SARS-CoV-2.''
(CDC, August 26, 2021) In fact, the studies noted earlier in this
paragraph were published just as the Delta variant was emerging,
meaning that the risk of transmission cited in those studies has likely
increased.
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\88\ See, e.g., Oregon Health Authority, October 6, 2021,
(publishing data on outbreaks in large workplaces including two
Amazon facilities, several hospitals, and a Walmart distribution
center); CDPHE, Oct. 6, 2021, (identifying an active Covid outbreak
in Cargill's Fort Morgan, CO meat processing plant, which employs
more than 2,000 workers). While some have speculated that clusters
of infections among employees at the same facility might result
initially from shared exposures outside of work, the original source
of the infection would have little bearing on the statistical
probability of exposure and transmission once the infected people
are together in the workplace with unvaccinated co-workers. The most
effective way to prevent further transmission is to protect the
other workers through vaccination or, when that is not possible,
identify and remove the infected workers from the workplace as
quickly as possible.
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While virus transmission is certainly not limited to large
facilities, the potential scope of an outbreak is inherently more
limited when fewer employees are present. In limiting the scope of the
ETS to employers with 100 or more employees, OSHA is prioritizing
coverage of those businesses in which the spread of the virus could
potentially affect the largest number of employees and for which the
agency is most confident that it is feasible to apply the standard.
d. Analogous Regulatory Regimes Use Comparable Employee Size Thresholds
Congress and federal agencies have frequently recognized that an
employee size threshold may be appropriate in different regulatory
contexts. They have not settled on any one number as the most
appropriate, presumably because that depends on balancing different
considerations that are relevant to the particular context, as OSHA has
done here. But several analogous regulatory regimes use employee size
thresholds comparable to the one selected here, in light of similar
concerns about administrative feasibility.
For example, the EEOC has issued regulations requiring employers
with 100 or more employees to submit annual reports related to equal
employment opportunity in their workforce, in recognition that larger
employers are better equipped to absorb the types of administrative
burdens
[[Page 61513]]
imposed by surveying, tracking and recordkeeping requirements. See 42
U.S.C. 2000e-8(c), 29 CFR 1602.7-.14 and 41 CFR 60-1.7(a). In earlier
measures adopted in response to the COVID-19 pandemic, Congress adopted
special protections and exemptions based on employee counts. The
Families First Coronavirus Response Act, Public Law 116-127 (2020),
sections 7001 and 7003 provided tax credits to businesses with fewer
than 500 employees to assist compliance with the Act's expansion of
paid sick and family leave, in recognition of the challenges facing
smaller employers. Congress again relied on the same 500 employee
threshold when it later extended tax credits only to employers who
granted employees paid time off to be vaccinated, implicitly
acknowledging the financial obstacles that can exist for smaller
employers for the same activity that this ETS promotes (and without the
vaccine policy and verification requirement in this ETS). American
Rescue Plan Act, Public Law 117-2, Sec. 9641 (2021).
In the Affordable Care Act, Congress set the maximum size of a
``small employer'' at 100 employees for purposes of allowing greater
flexibility to these employers. 42 U.S.C.A. 18024(b)(3). Likewise,
private employers with fewer than 50 employees are exempt from
complying with the Family and Medical Leave Act, in recognition of
smaller employers' decreased administrative capacity, as well as their
inability to easily accommodate employee absences. 29 U.S.C.A.
2611(2)(b)(2).
e. The 100 Employee Coverage Provision Is a Reasonable Exercise of the
Secretary's Authority
OSHA's choice of a 100 employee threshold is based on balancing the
fundamentally incommensurable considerations described above. Under the
statute OSHA ``shall'' issue an ETS when employees are exposed to grave
danger, and is not to follow normal notice and comment procedures to
build a record. 29 U.S.C. 655(e). But OSHA may not issue an ETS unless
it shows that the rule is feasible for the employers covered, and it
has not yet made a feasibility determination for smaller employers. In
the circumstances of this case, OSHA considered that an ETS was
urgently needed to protect employees, that a 100 employee threshold
would protect the great majority of them and prevent the largest
outbreaks, that it would avoid the delays that would be needed if the
agency were required to gather information and analyze feasibility for
smaller employers, and that a comparable size threshold has been found
appropriate in similar contexts. Where employees are dying every day,
it is not unreasonable for the agency to prioritize doing what it can
to address the problem quickly, regardless of whether there are further
actions it might be able to take later.
Doing so implements the statutory delegation of authority to the
agency to establish priorities for issuing standards by giving ``due
regard to the urgency of the need'' for standards for particular
workplaces. 29 U.S.C. 655(g). The courts have recognized that this
provision authorizes the Secretary to make reasonable decisions
limiting the scope of a standard, particularly where as here the agency
has said it will address the reserved issue in subsequent rulemaking.
Forging Indus. Assoc. v. Donovan, 773 F.2d 1436, 1454 (4th Cir. 1985)
(hearing conservation standard); United Steelworkers of Am. v.
Marshall, 647 F.2d 1189, 1309-1310 (D.C. Cir. 1980) (lead standard).
Where competing considerations are in play and there is no clear
perfect choice, OSHA has a degree of discretion to draw a reasonable
line. Courts have consistently recognized that agencies have discretion
to draw reasonable lines. As the D.C. Circuit has explained: An agency
has ``wide discretion'' in making line-drawing decisions and ``[t]he
relevant question is whether the agency's numbers are within a zone of
reasonableness, not whether its numbers are precisely right.''
WorldCom, Inc. v. FCC, 238 F.3d 449, 462 (D.C. Cir. 2001) (quotation
marks omitted). An agency ``is not required to identify the optimal
threshold with pinpoint precision. It is only required to identify the
standard and explain its relationship to the underlying regulatory
concerns.'' Id. at 461-62. Nat'l Shooting Sports Found. v. Jones, 716
F.3d. 200, 214-215 (D.C. Cir 2013). See also Providence Yakima Med.
Ctr. v. Sebelius, 611 F.3d 1181, 1190-1191 (9th Cir. 2010).
For the reasons discussed above, the balance the agency struck here
falls well within this zone of reasonableness.
II. Explanation of Who Is Included in the 100-Employee Threshold
The applicability of this ETS is based on the size of an employer,
in terms of number of employees, rather than on the type or number of
workplaces. In determining the number of employees, employers must
include all employees across all of their U.S. locations, regardless of
employees' vaccination status or where they perform their work. Part-
time employees do count towards the company total, but independent
contractors do not. As discussed above, OSHA has not found that the
standard is feasible for firms with fewer than 100 employees, because
it needs additional time to assess the impact of the standard on these
employers, particularly as many smaller firms lack separate human
resources departments and may face additional challenges when carrying
out human resources functions. In contrast, OSHA has determined that
the standard is feasible for firms with 100 or more employees,
regardless of where those employees report to work. These firms
generally have greater administrative capacities, and including all
such employers in the scope of this ETS ensures that OSHA can cover
two-thirds of all workers in the private sector as quickly as possible.
For a single corporate entity with multiple locations, all
employees at all locations are counted for purposes of the 100-employee
threshold for coverage under this ETS. In a traditional franchisor-
franchisee relationship in which each franchise location is
independently owned and operated, the franchisor and franchisees would
be separate entities for coverage purposes, such that the franchisor
would only count ``corporate'' employees, and each franchisee would
only count employees of that individual franchise. In other situations,
two or more related entities may be regarded as a single employer for
OSH Act purposes if they handle safety matters as one company, in which
case the employees of all entities making up the integrated single
employer must be counted.
In scenarios in which employees of a staffing agency are placed at
a host employer location, only the staffing agency would count these
jointly employed workers for purposes of the 100-employee threshold for
coverage under this ETS. Although the staffing agency and the host
employer would normally share responsibility for these workers under
the OSH Act, this ETS raises unique concerns in that OSHA has set the
threshold for coverage based primarily on administrative capacity for
purposes of protecting workers as quickly as possible, as discussed
above, and the staffing agency would typically handle administrative
matters for these workers. Thus, for purposes of the 100-employee
threshold, only the staffing agency would count the jointly employed
employees. The host employer, however, would still be covered by this
ETS if it has 100 or more employees in addition to the employees of the
staffing agency. For enforcement purposes, traditional joint employer
principles would apply where both employers are covered by the ETS, as
[[Page 61514]]
illustrated further by the examples below. See also https://www.osha.gov/temporaryworkers/.
On a typical multi-employer worksite such as a construction site,
each company represented--the host employer, the general contractor,
and each subcontractor--would only need to count its own employees, and
the host employer and general contractor would not need to count the
total number of workers at each site. That said, each employer must
count the total number of workers it employs regardless of where they
report for work on a particular day. Thus, for example, if a general
contractor has more than 100 employees spread out over multiple
construction sites, that employer is covered under this ETS even if it
does not have 100 or more employees present at any one worksite.
Covering the employees of larger employers at multi-employer worksites
would mitigate the spread of COVID-19 at the workplace even where not
all employees are covered by this ETS because fully vaccinated
employees (or unvaccinated employees wearing face coverings and
submitting to weekly testing) would be less likely to spread the virus
to unvaccinated workers at the site who are not covered by this ETS.
The determination as to whether a particular employer is covered by
the standard should be made separately from whether individual
employees are covered by the standard's requirements, as described by
paragraph (b)(3) (e.g., some employers may be covered but have no
duties with respect to some of their employees under this standard).
Some additional examples include:
If an employer has 75 part-time employees and 25 full-time
employees, the employer would be within the scope of this ETS because
it has 100 employees.
If an employer has 150 employees, 100 of whom work from
their homes full-time and 50 of whom work in the office at least part
of the time, the employer would be within the scope of this ETS because
it has more than 100 employees.
If an employer has 102 employees and only 3 ever report to
an office location, that employer would be covered.
If an employer has 150 employees, and 100 of them perform
maintenance work in customers' homes, primarily working from their
company vehicles (i.e., mobile workplaces), and rarely or never report
to the main office, that employer would also fall within the scope.
If an employer has 200 employees, all of whom are
vaccinated, that employer would be covered.
If an employer has 125 employees, and 115 of them work
exclusively outdoors, that employer would be covered.
If a single corporation has 50 small locations (e.g.,
kiosks, concession stands) with at least 100 total employees in its
combined locations, that employer would be covered even if some of the
locations have no more than one or two employees assigned to work
there.
If a host employer has 80 permanent employees and 30
temporary employees supplied by a staffing agency, the host employer
would not count the staffing agency employees for coverage purposes and
therefore would not be covered. (So long as the staffing agency has at
least 100 employees, however, the staffing agency would be responsible
for ensuring compliance with the ETS for the jointly employed workers.)
If a host employer has 110 permanent employees and 10
temporary employees from a small staffing agency (with fewer than 100
employees of its own), the host employer is covered under this ETS and
the staffing agency is not.
If a host employer has 110 permanent employees and 10
employees from a large staffing agency (with more than 100 employees of
its own), both the host employer and the staffing agency are covered
under this standard, and traditional joint employer principles apply.
Generally, in a traditional franchisor-franchisee
relationship, if the franchisor has more than 100 employees but each
individual franchisee has fewer than 100 employees, the franchisor
would be covered by this ETS but the individual franchises would not be
covered.
As explained earlier, part of OSHA's rationale in adopting the 100-
employee threshold is to focus the ETS on companies that OSHA is
confident will have sufficient administrative systems in place to
comply quickly with the ETS. Thus, the ETS applies to all employers who
have the requisite number of employees at any time this ETS is in
effect. Along with employers that always have more than 100 employees,
OSHA intends to cover employers that fluctuate above and below the 100-
employee threshold during the term of the ETS because those employers
will typically have already developed systems and capabilities for
compliance; a decrease in the number of employees is therefore unlikely
to make them less capable of compliance.
The determination of whether an employer falls within the scope of
this ETS based on number of employees should initially be made as of
the effective date of the standard, as set out in paragraph (m)(1). If
the employer has 100 or more employees on the effective date, this ETS
applies for the duration of the standard. If the employer has fewer
than 100 employees on the effective date of the standard, the standard
would not apply to that employer as of the effective date. However, if
that same employer subsequently hires more workers and hits the 100-
employee threshold for coverage, the employer would then be expected to
come into compliance with the standard's requirements. Once an employer
has come within the scope of the ETS, the standard continues to apply
for the remainder of the time the standard is in effect, regardless of
fluctuations in the size of the employer's workforce. For example, an
employer that has 103 employees on the effective date of the standard,
but then loses four within the next month, would continue to be covered
by the ETS. OSHA is confident that employers with 100 or more employees
at any point while this ETS is in effect have the administrative
capacity to comply with the ETS, even if the number of employees
fluctuates somewhat above and below 100.
Paragraph (b)(2) of this ETS sets forth two exemptions to the
standard.\89\ Under paragraph (b)(2)(i), this ETS does not apply to
workplaces covered by the Safer Federal Workforce Task Force COVID-19
Workplace Safety: Guidance for Federal Contractors and Subcontractors
(see Safer Federal Workforce Task Force, September 24, 2021). With
limited exceptions, such as where a medical contraindication,
disability, or sincerely held religious belief would prevent an
employee from complying with certain provisions, those guidelines
require covered
[[Page 61515]]
contractors to ensure that all covered contractor employees (1) are
fully vaccinated by December 8, 2021; (2) follow CDC guidelines for
masks and physical distancing, including masking and distancing
requirements based on the employee's vaccination status and the level
of community transmission of COVID-19 where the workplace is located;
and (3) designate a person to coordinate COVID-19 workplace safety
efforts at covered workplaces. Because covered contractor employees are
already covered by the protections in those guidelines, OSHA has
determined that complying with this standard in addition to the federal
contractor guidelines is not necessary to protect covered contractor
employees from a grave danger posed by COVID-19. Although there may be
some respects in which the OSHA standard is somewhat more protective,
such as providing paid leave for vaccination, the federal contractor
guidelines are somewhat more protective in other respects, such as
requiring vaccination for everyone who does not have a right to an
accommodation rather than allowing employees to submit to testing in
lieu of vaccination. In essence, they are similar but slightly
different schemes that provide roughly equivalent protection, and OSHA
has determined that imposing a second set of similar protections on
covered federal contractors by subjecting them to this ETS in addition
to the federal contractor guidance is not necessary at this time to
reduce a grave danger to covered contractor employees from COVID-19.
---------------------------------------------------------------------------
\89\ Note that, in addition to the scope exceptions contained in
the ETS itself, which are discussed in this section, there may be
situations where the ETS does not apply by operation of the OSH Act.
For example, the OSH Act does not apply to working conditions of
employees with respect to which other Federal agencies have
exercised their statutory authority to prescribe or enforce
standards or regulations affecting occupational safety or health
(see 29 U.S.C. 653(b)(1)). Moreover, the ETS does not apply where
states with OSHA-approved occupational safety and health programs
(``State Plans'') have coverage (see 29 U.S.C. 667). State Plans
must adopt and enforce COVID-19 requirements that are at least as
effective as this ETS. Finally, the ETS does not apply to state and
local government employers in states without State Plans (see 29
U.S.C. 652(5)).
---------------------------------------------------------------------------
Under Executive Order 14043, every federal agency must implement a
program requiring each of its federal employees to be vaccinated
against COVID-19, except as required by law. 86 FR 50989. OSHA will
regard a federal agency's compliance with this requirement, and the
related Safer Federal Workforce Task Force guidance issued under
section 4(e) of Executive Order 13991 and section 2 of Executive Order
14043 (including guidance on employer support in the form of paid time
for vaccination and paid leave for post-vaccination recovery), as
sufficient to meet its obligation to comply with this ETS under Section
19 of the OSH Act and Executive Order 12196. In essence, the federal
government has chosen the mandatory vaccination option of this rule,
and all federal employees are required to be fully vaccinated by the
compliance date of this standard, except where entitled to a reasonable
accommodation. The Safer Federal Workforce Task Force's guidelines for
vaccination verification are consistent with the ETS's (see Safer
Federal Workforce Task Force, October 11, 2021). Note, however, that
under the OSH Act, the U.S. Postal Service is treated as a private
employer, see 29 U.S.C. 652(5), and it is therefore required to comply
with this ETS in the same manner as any other employer covered by the
Act.
For similar reasons, paragraph (b)(2)(ii) provides that this ETS
does not apply in settings where any employee provides healthcare
services or healthcare support services while they are covered by the
requirements of 29 CFR 1910.502. Section 1910.502 requires a multi-
layered suite of protections for employees covered by its requirements,
including patient screening and management, facemasks or respirators,
other personal protective equipment (PPE), limiting exposure to
aerosol-generating procedures, physical distancing, physical barriers,
cleaning, disinfection, ventilation, health screening and medical
management, access to vaccination, and medical removal protection.
Section 1910.502 was carefully tailored to the healthcare workplaces it
covers and, given the full suite of protections it requires, including
(like this ETS) the provision of paid time for vaccination, OSHA has
determined that it adequately protects the employees covered by its
requirements from the grave danger posed by COVID-19. Therefore,
complying with the additional requirements of this ETS is not necessary
to protect those employees while they are covered by that standard's
protections.
OSHA's intent was to leave no coverage gaps between section
1910.502 and this ETS. In other words, the purpose of paragraph
(b)(2)(ii) is to ensure that all workers in healthcare and healthcare
support jobs who are at grave danger from exposure to SARS-CoV-2 are
protected by either section 1910.502 or this ETS while performing their
jobs. Therefore, it will be necessary for employers with employees
covered by section 1910.502 to determine if they also have employees
covered by this ETS. For example, a healthcare employer with more than
100 employees that has non-hospital ambulatory care facilities that are
exempt under section 1910.502(a)(2)(iii) (for non-hospital ambulatory
care settings where all non-employees are screened prior to entry and
those with suspected or confirmed COVID-19 are prohibited from entry)
would be required to protect the employees in those ambulatory care
facilities under this ETS. Similarly, a retail pharmacy chain that
operates a series of ambulatory care clinics embedded in its stores,
where those embedded clinics are the only areas in the store that are
covered under 1910.502 (see section 1910.502(a)(3)(i)), would have to
ensure that the remainder of its employees in other parts of its stores
are protected under this ETS if the company has 100 or more employees
company-wide, including those covered under 1910.502.
Paragraph (b)(3) provides that, even where the standard applies to
a particular employer, its requirements do not apply to employees: (i)
Who do not report to a workplace where other individuals such as
coworkers or customers are present; (ii) while working from home; or
(iii) who work exclusively outdoors. OSHA intends these provisions to
exempt workplace settings where workers do not interact indoors with
other individuals, and to exempt work performed in the employee's home
regardless of whether other individuals may be present in the home.
OSHA has determined that the provisions of this ETS are not
necessary to protect employees from COVID-19 when they are working
alone, or when they are working from home (see Grave Danger, Section
III.A. of this preamble). These two provisions may overlap in some
cases, but also can apply to slightly different situations. Paragraph
(b)(3)(i) would apply to work in a solitary location, such as a
research station where only one person (the employee) is present at a
time. In that situation, the employee is not exposed to any potentially
infectious individuals at work. Paragraph (b)(3)(ii) would apply to
employees working in their homes, regardless of whether other
individuals who are not employees of the same employer are present. In
a home telework environment, many factors--such as the presence of
family members and other individuals unrelated to the employee's work,
who may not be fully vaccinated or wearing face coverings--may be
beyond the employer's control. Employees are typically in the best
position to manage COVID-19 risks in their homes. Note that the
exemption in paragraph (b)(3)(ii) only applies to employees while they
are working from home. An employee who switches back and forth from
teleworking to working in a setting where other people are present
(e.g., an office) is covered by this ETS and must be vaccinated if
required by the employer. If the employer does not require vaccination,
the teleworking employee must either be vaccinated or complete testing
and wear a face covering in accordance with their
[[Page 61516]]
employer's policy under paragraph (d). How often such an employee must
be tested for COVID-19 and wear a face covering, however, depends on
how often they report to the office (see, e.g., paragraph (g)(1)(ii)).
Paragraph (b)(3)(iii) provides that, even if a particular employer
is covered by the standard, the requirements of the standard do not
apply to employees who work exclusively outdoors. OSHA has determined
that COVID-19 does not pose a grave danger to employees who work
exclusively outdoors because of the significantly reduced likelihood of
transmission in outdoor settings. As discussed in more detail in Grave
Danger (Section III.A. of this preamble), the record contains very
little evidence of COVID-19 transmission in outdoor settings. And, in
studies where clusters were identified in worksites characterized as
being outdoors, the study authors were not able to identify specific
incidents that led to transmission. In addition, workplaces
characterized as ``outdoors'' may in fact involve significant time
spent indoors. For example, on a construction site, workers inside a
partially complete structure are not truly outdoors, and some
individuals on a construction site may spend significant amounts of
time in a construction trailer where other individuals are present.
Workers at outdoor locations may also routinely share work vehicles.
These indoor exposures could account for COVID-19 clusters among
employees at worksites otherwise characterized as being outdoors. And
employees whose outdoor time is interrupted by the indoor periods will
still be subject to the requirements in this ETS.
Studies of athletic teams further indicate that evidence of COVID-
19 clusters among workers characterized as working outdoors could
actually be caused by indoor exposures. Even where athletes were in
very close contact during outdoor exposures on the playing field, the
study authors could not identify a single case of COVID-19 transmission
between teams that occurred outdoors (see Mack et al., January 29,
2021; Egger et al., March 18, 2021; Jones et al., February 11, 2021).
For all of these reasons, and as discussed more fully in Grave Danger
(Section III.A. of this preamble), OSHA has determined that COVID-19
does not pose a grave danger to employees who work exclusively
outdoors.
As a practical matter, determining the applicability of paragraph
(b)(3)(iii) depends on the working conditions of individual employees.
For example, if a landscaping contractor has at least 100 employees and
is not covered by the exemptions in paragraph (b)(2), the standard
applies to that employer even if a majority of the company's employees
work exclusively outdoors. The standard's protections would only apply
to employees working in indoor settings around other individuals (other
than telework in their own homes), not to those employees working
exclusively outdoors. In some cases, it may be true that the standard
applies to an employer but the employer would not have to implement its
provisions at all because all of its employees fall within exemptions
in paragraph (b)(3). Going back to the example of the large landscaping
contractor, if all indoor workers either work from home or in locations
where no other individuals are present, and all outdoors workers work
exclusively outdoors and do not drive to worksites together in a
company vehicle, the employer would be covered by the ETS but not
required to comply with its provisions.
An employee will only be covered by the exemption in paragraph
(b)(3)(iii) if the employee works exclusively outdoors. Thus, an
employee who works indoors on some days and outdoors on other days
would not be exempt from the requirements of this ETS. Likewise, if an
employee works primarily outdoors but routinely occupies vehicles with
other employees as part of work duties, that employee is not covered by
the exemption in paragraph (b)(3)(iii). However, if an employee works
outdoors for the duration of every workday except for de minimis use of
indoor spaces where other individuals may be present--such as a multi-
stall bathroom or an administrative office--that employee would be
considered to work exclusively outdoors and covered by the exemption
under paragraph (b)(3)(iii) as long as time spent indoors is brief, or
occurs exclusively in the employee's home (e.g., a lunch break at
home). Extremely brief periods of indoor work would not normally expose
employees to a high risk of contracting COVID-19; however, OSHA will
look at cumulative time spent indoors to determine whether that time is
de minimis. Thus, if there are several brief periods in a day when an
employee goes inside, OSHA will total those periods of time when
determining whether the exception for exclusively outdoors work
applies.
Finally, to qualify for this exception, the employee's work must
truly occur ``outdoors,'' which would not include buildings under
construction where substantial portions of the structure are in place,
such as walls and ceiling elements that would impede the natural flow
of fresh air at the worksite. Workplaces that are truly outdoors
typically do not include any of the characteristics that normally
enable transmission of SARS-CoV-2 to occur, such as poor ventilation,
enclosed spaces, and crowding. As discussed in Bulfone et al. (November
29, 2020), the lower risk of transmission in outdoor settings (i.e.,
open air or structures with only one wall) is likely due to increased
ventilation with fresh air and a greater ability to maintain physical
distancing (see Grave Danger, Section III.A. of this preamble, for more
information on risk of transmission outdoors).
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C. Definitions
Paragraph (c) of the ETS provides definitions of terms used in the
section.
``Assistant Secretary'' means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.
This definition provides clarification about who can request and
receive records specified in paragraph (l)(3) of this section. A
designee includes a representative conducting an inspection or an
investigation.
``COVID-19 (Coronavirus Disease 2019)'' means the disease caused by
SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). SARS-CoV-
2 is a highly transmissible virus that spreads primarily through the
respiratory droplets that are produced when an infected person coughs,
sneezes, sings, talks, or breathes. The nature of the disease, variants
of SARS-CoV-2, disease transmission, and associated health effects are
all described in great detail in Grave Danger (Section III.A. of this
preamble). For clarity and ease of reference, the ETS also uses the
term ``COVID-19'' when describing exposures or potential exposures to
SARS-CoV-2. The requirements of the ETS are intended to address the
grave danger of exposure to COVID-19 in the workplace.
A ``COVID-19 test'' means a test for SARS-CoV-2 that is: (1)
Cleared, approved, or authorized, including in an Emergency Use
Authorization (EUA), by the U.S. Food and Drug Administration (FDA) to
detect current infection with the SARS-CoV-2 virus (e.g., a viral
test); (2) administered in accordance with the authorized instructions;
and (3) not both self-administered and self-read unless observed by the
employer or an authorized telehealth proctor. Examples of tests that
satisfy this requirement include tests with specimens that are
processed by a laboratory (including home or on-site collected
specimens which are processed either individually or as pooled
specimens), proctored over-the-counter tests, point of care tests, and
tests where specimen collection and processing is either done or
observed by an employer.
Under paragraph (g), employees who are not fully vaccinated must be
tested for COVID-19. When an employee must be tested, the test is
considered acceptable only if the test and the administration of the
test satisfy the definition of COVID-19 test in this standard.
COVID-19 tests can broadly be divided into two categories,
diagnostic tests and antibody tests. Diagnostic tests detect parts of
the SARS-CoV-2 virus and can be used to diagnose current infection. On
the other hand, antibody tests look for antibodies in the immune system
produced in response to SARS-CoV-2, and are not used to diagnose an
active COVID-19 infection. Antibody tests do not meet the definition of
COVID-19 test for the purposes of this ETS.
Diagnostic tests for current infection fall into two categories:
Nucleic acid amplification tests (NAATs) and antigen tests. NAATs are a
type of molecular test that detect genetic material (nucleic acids);
NAATs for COVID-19 identify the ribonucleic acid (RNA) sequences that
comprise the genetic material of the virus. NAATs can reliably detect
small amounts of SARS-CoV-2 and are unlikely to return a false-negative
result. NAATs use many different methods to detect the virus, including
reverse transcription-polymerase chain reaction (RT-PCR), which is a
high-sensitivity, high-specificity \90\ test for diagnosing SARS-CoV-2
infection. Other types of NAATs that use isothermal amplification
methods include nicking endonuclease amplification reaction (NEAR),
transcription mediated amplification (TMA), loop-mediated isothermal
amplification (LAMP), helicase-dependent amplification (HDA), clustered
regularly interspaced short palindromic repeats (CRISPR), and strand
displacement amplification (SDA) (CDC, June 14, 2021).
---------------------------------------------------------------------------
\90\ Test sensitivity indicates the ability of a test to
correctly identify people who have a disease. Test specificity
indicates the ability of a test to correctly identify people who do
not have a disease. A test with high sensitivity and high
specificity minimizes inaccurate results.
---------------------------------------------------------------------------
Most NAATs need to be processed in a laboratory with variable time
to receive results (approximately 1-2 days), but some NAATs are point-
of-care tests with results available in about 15-45 minutes. As of
October 14, 2021, 264 molecular tests (NAATs) and collection devices
have EUA from the FDA for COVID-19 (FDA, October 14, 2021b). These
tests may be acceptable under the ETS.
Antigen tests may also meet the definition of COVID-19 test under
this standard. Antigen tests indicate current infection by detecting
the presence of a specific viral antigen. Most can be processed at the
point of care with results available in about 1530 minutes. Antigen
tests generally have similar specificity to, but are less sensitive
than, NAATs (CDC, October 7, 2021). As of October 14, 2021, thirty-
seven antigen
[[Page 61518]]
tests have EUA from the FDA for COVID-19 (FDA, October 14, 2021a).
These tests may be acceptable under the ETS.
Most antigen tests and some NAATs are conducted at the point of
care, which means the test processing and result reading is performed
at or near the place where a specimen is collected so that results can
be obtained within minutes rather than hours or days. Rapid point-of-
care tests are administered in various settings operating under a
Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate
of waiver, such as physician offices, urgent care facilities,
pharmacies, school health clinics, workplace health clinics, long-term
care facilities and nursing homes, and at temporary locations, such as
drive-through sites managed by local health organizations (FDA,
November 16, 2020).
To be a valid COVID-19 test under this standard, a test may not be
both self-administered and self-read unless observed by the employer or
an authorized telehealth proctor. OSHA included the requirement for
some type of independent confirmation of the test result in order to
ensure the integrity of the result given the ``many social and
financial pressures for test-takers to misrepresent their results''
(Schulte et al., May 19, 2021). This independent confirmation can be
accomplished in multiple ways, including through the involvement of a
licensed healthcare provider or a point-of-care test provider. If an
over-the-counter (OTC) test is being used, it must be used in
accordance with the authorized instructions. The employer can validate
the test through the use of a proctored test that is supervised by an
authorized telehealth provider. Alternatively, the employer could
proctor the OTC test itself.
Employers have the flexibility to select the testing scenario that
is most appropriate for their workplace. Some employees and employers
may rely on testing that is conducted by a healthcare provider (e.g.,
doctor or nurse) who arranges for the specimen to be analyzed at a
laboratory or at a point-of-care testing location (e.g., a pharmacy).
The involvement of licensed or accredited healthcare providers allows
employers to have a high degree of confidence in the suitability of the
test and the test results. Some large employers who set up their own
on-site testing program may partner with a healthcare organization
(e.g., a local hospital or clinic) or rely on a licensed healthcare
provider to help obtain a CLIA certificate of waiver. Other employers
may simply require that employees perform and read their own OTC test
while an authorized employee observes the administration and reading of
the test to ensure that a new test kit was used and that the test was
administered properly (e.g., nostrils were swabbed), and to witness the
test result.
Due to the potential for employee misconduct (e.g., falsified
results), tests that are both self-administered and self-read are not
acceptable unless they are observed by the employer or an authorized
telehealth proctor. Some COVID-19 tests are authorized by the FDA to be
performed only with the supervision of a telehealth proctor, which is
someone who is trained to observe sample collection and provide
instructions and result interpretation assistance to individuals using
the test. The term ``authorized telehealth proctor'' refers to proctors
who follow the requirements for proctoring specified by the FDA
authorization. For a more detailed discussion on COVID-19 testing
requirements under this ETS, see the Summary and Explanation for
paragraph (g) (Section VI.G. of this preamble).
A ``face covering'' means a covering that: (1) Completely covers
the nose and mouth; (2) is made with two or more layers of a breathable
fabric that is tightly woven (i.e., fabrics that do not let light pass
through when held up to a light source); (3) is secured to the head
with ties, ear loops, or elastic bands that go behind the head. If
gaiters are worn, they should have two layers of fabric or be folded to
make two layers; (4) fits snugly over the nose, mouth, and chin with no
large gaps on the outside of the face; and (5) is a solid piece of
material without slits, exhalation valves, visible holes, punctures, or
other openings. This definition includes clear face coverings or cloth
face coverings with a clear plastic panel that, despite the non-cloth
material allowing light to pass through, otherwise meet this definition
and which may be used to facilitate communication with people who are
deaf or hard-of-hearing or others who need to see a speaker's mouth or
facial expressions to understand speech or sign language respectively.
Face coverings can be manufactured or homemade, and they can
incorporate a variety of designs, structures, and materials. Face
coverings provide variable levels of protection based on their design
and construction.
As explained in paragraph (i), face covering use is required based
on an employee's vaccination status. The criteria in the definition
help to ensure that face coverings that are worn by workers who are not
fully vaccinated will provide effective source control and some degree
of personal protection. Source control means reducing the spread of
large respiratory droplets to others by covering a person's mouth and
nose. The personal protection afforded by face coverings, as well as
the benefits and necessity, are described in the Summary and
Explanation for paragraph (i) (Section VI.I. of this preamble).
Face coverings differ from facemasks and respirators, which are
also defined in paragraph (c) of this section. Face coverings, unlike
facemasks and respirators, are not considered to be personal protective
equipment (PPE) under OSHA's general PPE standard (29 CFR 1910.132), as
discussed in the Summary and Explanation for paragraph (i) (Section
VI.I. of this preamble).
Lastly, face coverings as required by this standard do not have to
meet a consensus standard, although face coverings that adhere to such
consensus standards, with design and construction specifications, meet
the definition and may offer both greater protection and the confidence
that at least a minimum level of protection has been provided. The
National Institute for Occupational Safety and Health (NIOSH)
recommends that employers and workers who want a face covering that
provides a known level of protection use face coverings that meet a new
standard, called Workplace Performance and Workplace Performance Plus
masks, for workplaces. As discussed in the Summary and Explanation for
paragraph (i) (Section VI.I. of this preamble), the new NIOSH criteria
and the ASTM Specification for Barrier Face Coverings, F3502-21 (ASTM
Standard) provide a greater level of source control performance for
workers when wearing the face covering according to manufacturer's
instructions. The NIOSH criteria require that face coverings conform to
the ASTM Standard and meet additional quantitative leakage criteria.
Although not required by the standard, OSHA notes that face coverings
that meet ASTM F3502-21 requirements and the new NIOSH criteria may
offer a higher level of source control and wearer protection than those
face coverings that do not meet a consensus standard.
A ``facemask'' means a surgical, medical procedure, dental, or
isolation mask that is FDA-cleared, authorized by an FDA EUA, or
offered or distributed as described in an FDA enforcement policy.
Facemasks may also be referred to as ``medical procedure masks.'' This
definition provides clarification about the exception to the face
covering
[[Page 61519]]
requirement under paragraph (i)(1)(iii) that permits facemask use in
lieu of face coverings. OSHA notes that facemasks are not respirators,
which are also defined in this section.
Facemasks provide protection against exposure to splashes, sprays,
and spatter of body fluids. Facemasks offer both source control, as
defined in this section under face coverings, and protection for the
wearer. OSHA has previously established that facemasks are essential
PPE for employees in healthcare, under both the general PPE standard
(29 CFR part 1910.132) and the Bloodborne Pathogens standard (29 CFR
part 1910.1030). Although not required, the Summary and Explanation for
paragraph (i) (Section VI.I. of this preamble) addresses their
inclusion in this standard. Additional information on such facemasks
can be found in relevant FDA guidance.
``Fully vaccinated'' means (i) a person's status 2 weeks after
completing primary vaccination with a COVID-19 vaccine with, if
applicable, at least the minimum recommended interval between doses in
accordance with the approval, authorization, or listing that is: (A)
Approved or authorized for emergency use by the FDA; (B) listed for
emergency use by the World Health Organization (WHO); or (C)
administered as part of a clinical trial at U.S. site, if the recipient
is documented to have of primary vaccination with the ``active'' (not
placebo) COVID-19 vaccine candidate, for which vaccine efficacy has
been independently confirmed (e.g., by a data and safety monitoring
board) or if the clinical trial participant from the U.S. sites had
received a COVID-19 vaccine that is neither approved nor authorized for
use by the FDA but is listed for emergency use by the WHO. Currently-
authorized FDA vaccines include Janssen (Johnson & Johnson), which is a
single-dose primary vaccination, and Pfizer-BioNTech and Moderna, which
have a two-dose primary vaccination series. This definition is
consistent with the CDC definition of fully vaccinated (CDC, September
16, 2021).
The definition of ``fully vaccinated'' also means a person's status
2 weeks after receiving the second dose of any combination of two doses
of a COVID-19 vaccine that is approved or authorized by the FDA, or
listed as a two-dose series by the WHO (i.e., heterologous primary
series of such vaccines, receiving doses of different COVID-19 vaccines
as part of one primary series). The second dose of the series must not
be received earlier than 17 days (21 days with a 4-day grace period)
after the first dose (CDC, October 15, 2021). OSHA has included this
because people who have received a heterologous primary vaccination
series (including mixing of mRNA, adenoviral, and mRNA plus adenoviral
products) are considered by the CDC to also meet this definition. OSHA
considers a vaccination series that meets the definition in
subparagraph (ii) to be a primary vaccination for purposes of the
requirements to support vaccination in paragraph (f).
The employer obligations under the ETS differ based on whether each
employee is fully vaccinated. This definition is relevant to the
definition of mandatory vaccination policy, in this paragraph (c), as
well as the provisions under paragraph (d) regarding written
vaccination policy requirements and relevant procedures for workers who
are fully vaccinated. Paragraph (e)(2) also addresses fully vaccinated
employees, including the determination of vaccination status and
acceptable forms of proof. Lastly, the definition provides clarity with
regard to the requirements of paragraphs (g) and (i) respectively,
which contain requirements for regular COVID-19 testing and face
covering use among employees who are not fully vaccinated.
Paragraph (e) requires employers to determine each employee's
vaccination status, including whether they are fully or partially
vaccinated. By ``partially vaccinated,'' OSHA means someone who has
started a primary vaccination series but not completed it (e.g., has
received one dose of a two-dose series) or has completed their primary
vaccination and two weeks have not elapsed since the last dose of the
primary vaccination.
A ``mandatory vaccination policy'' is an employer policy requiring
each employee to be fully vaccinated. To meet the definition of a
mandatory vaccination policy, the policy must require: Vaccination of
all employees, including vaccination of all new employees as soon as
practicable, other than those employees (1) for whom a vaccine is
medically contraindicated, (2) for whom medical necessity requires a
delay in vaccination,\91\ or (3) who are legally entitled to a
reasonable accommodation under federal civil rights laws because they
have a disability or sincerely held religious beliefs, practices, or
observances that conflict with the vaccination requirement. OSHA
intends that ``employee,'' as used in this definition, includes only
employees that are covered by this ETS and does not include employees
who are excluded from coverage under paragraph (b)(3).
---------------------------------------------------------------------------
\91\ As defined by CDC's informational document, Summary
Document for Interim Clinical Considerations for Use of COVID-19
Vaccines Currently Authorized in the United States (CDC, September
29, 2021).
---------------------------------------------------------------------------
Paragraph (d)(1) of the standard requires an employer to establish,
implement, and enforce a written mandatory vaccination policy that
meets this definition. The benefits of vaccination, including the
effectiveness of vaccination mandates, are discussed in Grave Danger
(Section III.A. of this preamble) and Need for the ETS (Section III.B.
of this preamble).
OSHA recognizes that vaccination policies may vary, as indicated in
paragraph (d)(2). Any policy that permits the employee to choose
between vaccination and COVID-19 testing and face covering use would
not be considered a mandatory vaccination policy under paragraph
(d)(1), although such policy is permissible under paragraph (d)(2). In
some cases, employers may implement vaccination policies that differ by
location or type of business operation and thus the application of
paragraph (d)(2) might vary across an employer's workforce. This is
discussed in greater detail in the Summary and Explanation for
paragraph (d) (Section VI.D. of this preamble).
A ``respirator'' is a type of PPE that is certified by NIOSH under
42 CFR part 84 or is authorized under an EUA by the FDA. These
specifications are intended to ensure some consistent level of testing,
approval, and protection and to prevent the use of counterfeit
respirators that will not offer adequate protection, which is important
because respirators are intended to protect the wearer when directly
exposed to hazards. Respirators protect against airborne hazards by
removing specific air contaminants from the ambient (surrounding) air
or by supplying breathable air from a safe source. Common types of
respirators include filtering facepiece respirators (e.g., N95),
elastomeric respirators, and powered air-purifying respirators (PAPRs).
Face coverings, facemasks, and face shields are not respirators.
As stated above, there are various types of respirators that would
fall within this definition. A filtering facepiece respirator (FFR) is
a negative-pressure particulate respirator with a non-replaceable
filter as an integral part of the facepiece or with the entire
facepiece composed of the non-replaceable filtering medium. N95 FFRs
are the most common type of FFR and are the type of respirator most
often used to control exposures to infections transmitted via the
airborne route. When properly worn, N95 FFRs filter at least 95% of
airborne particles. An
[[Page 61520]]
elastomeric respirator is a tight-fitting respirator with a facepiece
that is made of synthetic or rubber material that permits it to be
disinfected, cleaned, and reused according to the manufacturer's
instructions. Elastomeric respirators are equipped with replaceable
cartridges, canisters, or filters. Lastly, a powered air-purifying
respirator (PAPR) is an air-purifying respirator that uses a blower to
force the ambient air through air-purifying elements to the inlet
covering.
This standard does not require the use of respirators. This
definition is included because it relates to paragraph (i)(1)(iii),
which exempts employees from wearing face coverings when they are
wearing respirators or facemasks. In addition, paragraph (i)(4)
requires employers to permit employees to wear a respirator instead of
a face covering and permits employers to provide respirators to their
employees, instead of face coverings. When respirators are used
pursuant to paragraph (i)(4), the employer must also comply with Sec.
1910.504, the Mini Respiratory Protection Program.
NIOSH has developed a set of regulations in 42 CFR part 84 for
testing and certifying non-powered, air-purifying, particulate-filter
respirators. To help address concerns about availability during the
COVID-19 pandemic, the FDA has issued EUAs for certain PPE products,
including respiratory protective devices such as respirators. For the
purposes of this standard, respirators certified by NIOSH, under 42 CFR
part 84 or authorized under an EUA by the FDA meet the definition.
Additional information on such respirators can be found in relevant FDA
and NIOSH guidance.
A ``workplace'' is a physical location (e.g., fixed, mobile) where
the employer's work or operations are performed. It does not include an
employee's residence, even if the employee is teleworking from their
residence. Examples of fixed locations include: Offices, retail
establishments, co-working facilities, and factories or manufacturing
facilities. A workplace includes the entire site (including outdoor and
indoor areas, a structure or a group of structures) or an area within a
site where work or any work-related activity occurs (e.g., taking
breaks, going to the restroom, eating, entering or exiting work). The
workplace includes the entirety of any space associated with the site
(e.g., workstations, hallways, stairwells, breakrooms, bathrooms,
elevators) and any other space that an employee might occupy in
arriving, working, or leaving. Examples of employees who have mobile
workplaces include maintenance and repair technicians who go to homes
or businesses to provide repair services, or those who provide delivery
services.
References
Centers for Disease Control and Prevention (CDC). (2021, June 14).
Nucleic Acid Amplification Tests. https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html. (CDC, June 14, 2021).
Centers for Disease Control and Prevention (CDC). (2021, September
16). When You've Been Fully Vaccinated: How to Protect Yourself and
Others. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html. (CDC, September 16, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
29). Summary Document for Interim Clinical Considerations for Use of
COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf. (CDC, September 29, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October 7).
Interim Guidance for SARS-CoV-2 Testing in Non-Healthcare
Workplaces. https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/testing-non-healthcare-workplaces.html. (CDC, October
7, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
15). Interim Public Health Recommendations for Fully Vaccinated
People. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html. (CDC, October 15, 2021)
Equal Employment Opportunity Commission (EEOC). (2021, October 25).
What You Should Know About COVID-19 and the ADA, the Rehabilitation
Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
(EEOC, October 25, 2021)
Food and Drug Administration (FDA). (2020, November 16). COVID-19
Test Settings: FAQs on Testing for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-settings-faqs-testing-sars-cov-2. (FDA, November 16, 2020)
Food and Drug Administration (FDA). (2021a, October 14). In Vitro
Diagnostics EUAs--Antigen Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021a)
Food and Drug Administration (FDA). (2021b, October 14)). In Vitro
Diagnostics EUAs--Molecular Diagnostic Tests for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2. (FDA, October 14, 2021b)
Schulte P et al. (2021, May 19). Proposed Framework for Considering
SARS-CoV-2 Antigen Testing of Unexposed Asymptomatic Workers in
Selected Workplaces. J Occup Environ Med. 2021 Aug; 63(8): 646-656.
Published online 2021, May 19. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8327768/. (Schulte et al., May 19, 2021)
D. Employer Policy on Vaccination
Vaccination is a vital tool to reduce the presence and severity of
COVID-19 cases in the workplace, in communities, and in the nation as a
whole. Despite the robust protection against COVID-19 that vaccination
affords, millions of eligible individuals have not yet been vaccinated.
Current efforts to increase the proportion of the U.S. population that
is fully vaccinated against COVID-19 are critical to ending the COVID-
19 pandemic (CDC, September 15, 2021). As described more fully in Need
for the ETS (Section III.B. of this preamble), mandatory vaccination
policies work. Therefore, OSHA has determined that requiring or
strongly encouraging vaccination--the most effective and efficient
control for reducing COVID-19--is key to ensuring the protection of
workers against the grave danger of exposure to SARS-CoV-2 in the
workplace (see Grave Danger, Section III.A. of this preamble).
Therefore, this ETS requires employers to adopt mandatory vaccination
policies for their workplaces, with an exception for employers that
instead adopt a policy allowing employees to elect to undergo regular
COVID-19 testing and wear a face covering at work in lieu of
vaccination. In Need for the ETS (Section III.B of this preamble), OSHA
explains its rationale for providing the exception.
Paragraph (d) of this ETS is a critical element in ensuring
employees' protection, as it requires covered employers to develop,
implement, and enforce written policies on COVID-19 vaccination for
their workforces. Paragraph (d)(1) requires the employer to establish,
implement, and enforce a written mandatory vaccination policy. As
defined in paragraph (c), a mandatory vaccination policy is an employer
policy requiring each employee to be fully vaccinated. Such a policy
must require vaccination of all employees, other than those employees
who fall into one of three categories: (1) Those for whom a vaccine is
medically contraindicated, (2) those for whom medical necessity
requires a delay in
[[Page 61521]]
vaccination, or (3) those who are legally entitled to a reasonable
accommodation under federal civil rights laws because they have a
disability or sincerely held religious beliefs, practices, or
observances that conflict with the vaccination requirement. The policy
must also require all new employees to be vaccinated as soon as
practicable.
Paragraph (d)(2) is a limited exemption from the mandatory
vaccination policy requirement. As discussed in Need for the ETS
(Section III.B. of this preamble), vaccination mandates are effective
at increasing overall vaccination rates and protecting employees and,
therefore, the agency encourages all employers to implement a mandatory
vaccination policy. Under paragraph (d)(2), however, employers can
avoid the mandate in paragraph (d)(1) if the employer establishes,
implements, and enforces a written policy allowing any employee not
subject to a mandatory vaccination policy to choose either to: (1) Be
fully vaccinated against COVID-19 or (2) provide proof of regular
testing for COVID-19 in accordance with paragraph (g) of this section
and wear a face covering in accordance with paragraph (i). An employer
who chooses to operate under paragraph (d)(2), however, must still
offer the support for vaccination required under paragraph (f) and may
not prevent employees from getting vaccinated. Adopting a policy under
paragraph (d)(2) simply means that employees themselves may choose not
to get vaccinated, in which case they must get tested and wear face
coverings per the requirements of the standard.
OSHA recognizes there may be employers who develop and implement
partial mandatory vaccination policies, i.e., that apply to only a
portion of their workforce. An example might be a retail corporation
employer who has a mixture of staff working at the corporate
headquarters, performing intermittent telework from home, and working
in stores serving customers. In this type of situation, the employer
may choose to require vaccination of only some subset of its employees
(e.g., those working in stores), and to treat vaccination as optional
for others (e.g., those who work from headquarters or who perform
intermittent telework). This approach would comply with the standard so
long as the employer complies in full with paragraph (d)(1) and (d)(2)
for the respective groups.
OSHA uses the terms establish, implement, and enforce in paragraph
(d) to emphasize that it is necessary for an employer to first
determine its policy and create a written record of that policy. After
determining the policy, an employer must then ensure that it is
following the policy, as laid out in its written plan. Finally,
employers must ensure that they enforce the requirements of their
policies with respect to their workforce, through training and the use
of such mechanisms as work rules and the workplace disciplinary system,
if necessary. These requirements apply to the written policy required
under paragraph (d), whether employers choose to implement the
mandatory vaccination policy under paragraph (d)(1) or utilize the
exemption under paragraph (d)(2) for all or a portion of their
workforce.
To ensure that employers' vaccination policies under paragraph (d)
are comprehensive and effective, the policies should address all of the
applicable requirements in paragraphs (e)-(j) of this standard,
including: Requirements for COVID-19 vaccination; applicable exclusions
from the written policy (e.g., medical contraindications, medical
necessity requiring delay in vaccination, or reasonable accommodations
for workers with disabilities or sincerely held religious beliefs);
information on determining an employee's vaccination status and how
this information will be collected (as described in paragraph (e));
paid time and sick leave for vaccination purposes (as described in
paragraph (f)); notification of positive COVID-19 tests and removal of
COVID-19 positive employees from the workplace (as described in
paragraph (h)); information to be provided to employees (pursuant to
paragraph (j)--e.g., how the employer is making that information
available to employees); and disciplinary action for employees who do
not abide by the policy. In addition to addressing the requirements of
paragraphs (e)-(j) of this standard, the employer should include all
relevant information regarding the policy's effective date, who the
policy applies to, deadlines (e.g., for submitting vaccination
information, for getting vaccinated), and procedures for compliance and
enforcement, all of which are necessary components of an effective
plan. Having a comprehensive written policy will provide a solid
foundation for an effective COVID-19 vaccination program, while making
it easier for employers to inform employees about the program-related
policies and procedures, as required under paragraph (j)(1).
If an employer utilizes the exemption under paragraph (d)(2), its
workplace may contain employees who are vaccinated and unvaccinated.
This might be the case even for employers who establish a mandatory
vaccination policy under paragraph (d)(1); for example, an employer
with a mandatory vaccination policy might have employees who cannot be
vaccinated for medical reasons. Given the additional safety protocols
under this standard for individuals who are not fully vaccinated (see
paragraphs (g) and (i)), an employer who has both vaccinated and
unvaccinated employees will have to develop and include the relevant
procedures for two sets of employees in the written policy. The
procedures for those who are fully vaccinated should contain all the
information previously discussed relevant to establishing,
implementing, and enforcing a comprehensive written policy. However,
the procedures applicable to employees who are not fully vaccinated
(i.e., those who decline vaccination, those who are unable to receive
vaccination and are, absent undue hardship to their employers, entitled
to reasonable accommodation) and those who are unable to provide proof
of vaccination as required by paragraph (e) (who must be treated as not
fully vaccinated), must include COVID-19 testing and face covering use
as required by paragraphs (g) and (i), respectively, unless the
reasonable accommodation from vaccination removes the employee from the
scope of Sec. 1910.501 (e.g., full time telework consistent with one
of the exceptions in Sec. 1910.501(b)(3)). OSHA intends that such an
employer will develop one written plan that includes different policies
and procedures for vaccinated and unvaccinated employees. The
requirements of paragraphs (e), (f), (h), and (j) should be addressed
in the policy regardless of the vaccination requirements adopted by the
employer.
As with all elements of the written plan, an effective written plan
will explain the testing requirements contained in paragraph (g) for
unvaccinated employees, and how the employer will implement and enforce
those policies. As described in paragraph (g)(1), the testing
requirements differ for employees who report at least once every 7 days
to a workplace compared to those who do not. Thus, the policy may
describe different testing procedures for those different groups of
employees, depending on how often they physically report to a workplace
where other individuals are present. As described in paragraph (g)(3),
the testing requirements are temporarily suspended for 90 days
following a positive COVID-19 test or diagnosis. Thus, the employer's
policy and procedures to implement this temporary suspension of
[[Page 61522]]
testing should be included in their written workplace policy. In
addition to the testing requirements in paragraph (g), an effective
policy must address mandatory face covering use as described in
paragraph (i), including procedures for employee compliance. Employers
can get more information on the requirements for paragraphs (e) through
(j), and what they must do to comply with those provisions of the
standard, in the relevant Summary and Explanation sections (see Section
VI. of this preamble).
As an employer develops their written policy, they must address how
the policy will apply to new employees. Although many new hires will be
fully vaccinated, there should be procedures within the plan to collect
information about the new employee's vaccination status, and determine
when an unvaccinated new hire must be vaccinated and, for employers
using a plan under paragraph (d)(2), when COVID-19 testing and face
covering use will commence if an employee remains unvaccinated. All new
hires should be treated similarly to any employee who has not entered
the workplace in the last seven days and will need to be fully
vaccinated or provide proof of a negative COVID-19 test within the last
seven days prior to entering the workplace for the first time. It is
not OSHA's intention to discourage employers from hiring new employees,
but rather to ensure that new employees are as well-protected from
COVID-19 hazards in the workplace as current employees and are less
likely to spread the virus to other employees.
An employer may have already developed and implemented a written
policy on vaccination, testing, and/or face covering use to protect
employees from COVID-19. It is not OSHA's intent for employers to
duplicate current effective policies covering the requirements of this
ETS; however, each employer with a current policy must evaluate that
policy to ensure it satisfies all of the requirements of this rule.
Employers with existing policies must modify and/or update their
current policies to incorporate any missing required elements, and must
provide information on these new updates or modifications to all
employees in accordance with paragraph (j)(1). Once the employer has
developed its policy pursuant to paragraph (d), the policy must be
reduced to writing in order to be compliant with paragraph (d).
The note to paragraph (d) was included in recognition that, under
federal law, some employees may be entitled to a reasonable
accommodation from their employer, absent undue hardship. If the worker
requesting a reasonable accommodation cannot be vaccinated and/or wear
a face covering because of a disability, as defined by the Americans
with Disabilities Act (ADA), that worker may be entitled to a
reasonable accommodation. In addition, if the vaccination, and/or
testing for COVID-19, and/or wearing a face covering conflicts with a
sincerely held religious belief, practice or observance, a worker may
be entitled to a reasonable accommodation. Such accommodations exist
independently of the Occupational Safety and Health Act and, therefore,
OSHA does not administer or enforce these laws. Examples of relevant
federal laws under which an accommodation can be requested include the
Americans with Disabilities Act (ADA) and Title VII of the Civil Rights
Act of 1964.
For more information, the note refers to a resource produced by the
Equal Employment Opportunity Commission (EEOC), which is responsible
for enforcing federal laws that prohibit employment-related
discrimination based on a person's race, color, religion, sex
(including pregnancy, gender identity, and sexual orientation),
national origin, age (40 or older), disability, or genetic information.
The EEOC resource listed in the note, What You Should Know About COVID-
19 and the ADA, the Rehabilitation Act, and Other EEO Laws, available
at https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws, should be helpful to
employers in navigating employees' requests for accommodations,
including the process for determining a reasonable accommodation and
information on undue hardship (EEOC, October 25, 2021). An additional
resource that might be helpful is the CDC's informational document,
Summary Document for Interim Clinical Considerations for Use of COVID-
19 Vaccines Currently Authorized in the United States (CDC, September
29, 2021), which lists the recognized clinical contraindications to
receiving a COVID-19 vaccine.
References
Centers for Disease Control and Prevention (CDC). (2021, September
15). Science Brief: Background rationale and evidence for public
health recommendations for fully vaccinated people. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. (CDC, September 15, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
29). Summary Document for Interim Clinical Considerations for Use of
COVID-19 Vaccines Currently Authorized in the United States. https://www.cdc.gov/vaccines/covid-19/downloads/summary-interim-clinical-considerations.pdf. (CDC, September 29, 2021)
Equal Employment Opportunity Commission (EEOC). (2021, October 25).
What You Should Know About COVID-19 and the ADA, the Rehabilitation
Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
(EEOC, October 25, 2021)
E. Determination of Employee Vaccination Status
To comply with the requirements of the standard, it is essential
that employers are aware of each employee's vaccination status. As
discussed in the Summary and Explanation for paragraph (d) (Section
VI.D. of this preamble), effective implementation and enforcement of a
written vaccination policy requires the employer to know the
vaccination status of all employees. Furthermore, the employer must
know each employee's vaccination status in order to ensure that the
vaccination, testing, and face covering requirements of the standard
are met. As such, paragraph (e) includes provisions for determining
each employee's vaccination status. The standard requires employers to
determine the vaccination status of each employee (paragraph (e)(1)),
and also to maintain records of each employee's vaccination status,
preserve acceptable proof of vaccination for each employee who is fully
or partially vaccinated, and maintain a roster of each employee's
vaccination status (paragraph (e)(4)). As discussed more fully below,
maintenance of records in accordance with this paragraph is subject to
applicable legal requirements for confidentiality of medical
information. Additional provisions in paragraph (e) define acceptable
proof of vaccination status for vaccinated employees (paragraph (e)(2))
and provide that any employee who does not submit an acceptable form of
proof of vaccination status must be treated as not fully vaccinated
(paragraph (e)(3)).
Paragraph (e)(1) requires the employer to determine the vaccination
status of each employee, including whether the employee is fully
vaccinated. Under paragraph (e)(2), the employer must require each
vaccinated employee to provide acceptable proof of vaccination status,
including whether they are fully or partially vaccinated. This is an
ongoing requirement for the employer (i.e., the employer needs to
update this information as employees proceed through the vaccination
process).
Paragraph (e)(2) defines what ``acceptable proof of vaccination
status'' means for purposes of the ETS, and
[[Page 61523]]
employers must accept any of the proofs listed in accordance with the
terms of the standard and as explained more fully below. Under
paragraph (e)(2), the following are acceptable for proof of
vaccination: (i) The record of immunization from a health care provider
or pharmacy; (ii) a copy of the U.S. CDC COVID-19 Vaccination Record
Card (CDC Form MLS-319813_r, published on September 3, 2020) (CDC,
October 5, 2021); (iii) a copy of medical records documenting the
vaccination; (iv) a copy of immunization records from a public health,
state, or tribal immunization information system; or (v) a copy of any
other official documentation that contains the type of vaccine
administered, date(s) of administration, and the name of the health
care professional(s) or clinic site(s) administering the vaccine(s).
To be acceptable as proof of vaccination, any documentation should
generally include the employee's name, type of vaccine administered,
date(s) of administration, and the name of the health care
professional(s) or clinic site(s) administering the vaccine(s). In some
cases, state immunization records may not include one or more of these
data fields, such as clinic site; in those circumstances, an employer
can still rely upon the State immunization record as acceptable proof
of vaccination. OSHA notes that clinic sites can include temporary
vaccination facilities used during large vaccine distribution
campaigns, such as schools, churches, or sports stadiums. Copies,
including digital copies, of the listed forms of proof are acceptable
means of documentation so long as they clearly and legibly display the
necessary information. Digital copies can include, for example, a
digital photograph, scanned image, or PDF of an acceptable form of
proof. Some state governments are utilizing digital COVID-19 vaccine
records showing the same information as the U.S. CDC COVID-19
Vaccination Record Card (CDC Form MLS-319813_r, published on September
3, 2020) and providing quick response (QR) codes that when scanned will
provide the same information (see, e.g., New York State Government,
n.d., Retrieved October 4, 2021). In certain states, the QR code
confirms the vaccine record as an official record of the state (see,
e.g., State of California, n.d., Retrieved October 7, 2021) and
therefore would provide acceptable proof of vaccination under the ETS
(see paragraph (e)(2)(iv)). However, as discussed later, the employer
must retain a copy of the vaccination information retrieved when the QR
code is scanned, not just the QR code itself, to comply with paragraph
(e)(4). In requesting proof of vaccination, the employer must take care
to comply with any applicable Federal laws, including requirements
under the Privacy Act, 5 U.S.C. 552a, and the Americans with
Disabilities Act (ADA), 42 U.S.C. 12101 et seq.
Each employee who has been partially or fully vaccinated should be
able to provide one of the forms of acceptable proof listed above
(paragraphs (e)(2)(i)-(e)(2)(v)). An employee who does not possess
their COVID-19 vaccination record (e.g., because it was lost or stolen)
should contact their vaccination provider (e.g., local pharmacy,
physician's office) to obtain a new copy or utilize their state health
department's immunization information system. In instances where an
employee is unable to produce acceptable proof of vaccination under
paragraphs (e)(2)(i)-(e)(2)(v), paragraph (e)(2)(vi) provides that a
signed and dated statement by the employee will be acceptable. The
employee's statement must: (A) Attest to their vaccination status
(fully vaccinated or partially vaccinated); (B) attest that they have
lost or are otherwise unable to produce proof required by the standard;
and (C) include the following language: ``I declare (or certify,
verify, or state) that this statement about my vaccination status is
true and accurate. I understand that knowingly providing false
information regarding my vaccination status on this form may subject me
to criminal penalties.'' The note to paragraph (e)(2)(vi) explains that
an employee who attests to their vaccination status should, to the best
of their recollection, include the following information in their
attestation: The type of vaccine administered; date(s) of
administration; and the name of the health care professional(s) or
clinic site(s) administering the vaccine(s). For example, some of the
information may be easier to recall, such as receiving a vaccine at a
mass vaccination site or local pharmacy, while the dates of
administration might only be remembered as falling within a particular
month or months. OSHA understands that employees may not be able to
recall certain information, such as the type of vaccine received.
Employees providing attestations should include as much of this
information as they can remember to the best of their ability.
Any statement provided under paragraph (e)(2)(vi) must include an
attestation that the employee is unable to produce another type of
proof of vaccination (paragraph (e)(2)(vi)(B)). Thus, before an
employee statement will be acceptable for proof of vaccination under
paragraph (e)(2)(vi), the employee must have attempted to secure
alternate forms of documentation via other means (e.g., from the
vaccine administrator or their state health department) and been
unsuccessful in doing so. The agency recognizes that securing
vaccination documentation may be challenging for some members of the
workforce, such as migrant workers, employees who do not have access to
a computer, or employees who may not recall who administered their
vaccines (e.g., if the vaccination was provided at a temporary
location, such as a church, or during a state or local mass vaccination
campaign). Thus, for employees who have no other means of obtaining
proof of vaccination, the standard permits employers to accept
attestations meeting the requirements in paragraph (e)(2)(vi) as proof
of vaccination. However, employers should explain to their employees
that they need to produce vaccination proof through the other means
listed in paragraph (e)(2), such as by contacting the vaccination
administrator, if they are able to do so. Once the employee has
provided a signed and dated attestation that meets the requirements of
paragraph (e)(2)(vi), the employer no longer needs to seek out one of
the other forms of vaccination proof for that employee and, depending
on the content of the attestation, the employer may consider that
employee either fully or partially vaccinated for purposes of the ETS.
Recently, there has been evidence of fraud associated with people
attesting to their vaccination status (Bergal, September 16, 2021).
While employers may not invite or facilitate fraud, the ETS does not
require employers to monitor for or detect fraud. By defining what
constitutes acceptable proof of vaccination under the ETS, OSHA is
ensuring that employers can accept proof meeting the requirements of
paragraph (e) for purposes of compliance with the standard. However,
the standard's requirements for proof of vaccination are integral to
ensuring that employees are protected appropriately, either through
vaccination (the preferred and most effective workplace control in this
ETS), or through regular testing and use of face coverings. Thus, it is
paramount that employees provide truthful information regarding their
vaccination status.
As discussed in more detail in the Summary and Explanation for
paragraph (j) (Section VI.J. of this section), 18 U.S.C. 1001(a), which
provides for fines or imprisonment of generally up to 5 years for any
person who ``in any matter within the
[[Page 61524]]
jurisdiction'' of the executive branch U.S. Government ``knowingly and
willfully'' engages in any of the following:
(1) Falsifies, conceals, or covers up by any trick, scheme, or
device a material fact;
(2) makes any materially false, fictitious, or fraudulent statement
or representation; or
(3) makes or uses any false writing or document knowing the same to
contain any materially false, fictitious, or fraudulent statement or
entry.
Similarly, the OSH Act recognizes that OSHA's ability to protect
workers' safety and health hinges on truthful reporting. For that
reason section 17(g) of the OSH Act subjects anyone who ``knowingly
makes any false statement, representation, or certification in any
application, record, report, plan, or other document filed or required
to be maintained pursuant to this chapter'' to criminal penalties. 29
U.S.C. 666(g). False statements made in any proof submitted under
paragraph (e)(2) of the standard could fall under either or both of 18
U.S.C. 1001 or section 17(g) of the OSH Act. And by requiring a
specific declaration about the truth and accuracy of employee
statements provided under paragraph (e)(2)(vi), employees who are
unable to provide any means of proof other than their own attestation
are being made aware that their words are being held to the same
standard of truthfulness as any other record presented for proof of
vaccination.
OSHA notes that these same prohibitions on false statements and
documentation can apply to employers. If an employer knows that proof
submitted by an employee is fraudulent, and even with this knowledge,
accepts and maintains the fraudulent proof as a record of compliance
with this ETS, it may be subject to the penalties in 18 U.S.C. 1001 and
17(g) of the OSH Act.
Paragraph (e)(3) provides the mechanism for employers to determine
vaccination status for employees who do not submit any of the
acceptable forms of proof of vaccination status. Under paragraph
(e)(3), any employee who does not provide their employer with one of
the acceptable forms of proof of vaccination status in paragraph (e)(2)
must be treated as not fully vaccinated for the purpose of the
standard. An unvaccinated employee does not need to provide any
documentation regarding vaccination status under this ETS; however,
failing to provide acceptable proof of vaccination status will signal
the employer to consider the employee as not fully vaccinated and to
note that as their status in the roster. For employers that include
COVID-19 testing in their written policies under paragraph (d),
employees without acceptable proof of vaccination status must submit to
weekly tests (as required by paragraph (g)) and wear a face covering
(as required by paragraph (i)).
Paragraph (e)(4) requires the employer to maintain a record of each
employee's vaccination status and preserve acceptable proof of
vaccination for each employee who is fully or partially vaccinated. As
discussed previously, the employer has various options for acquiring
proof of vaccination from each employee. An employer may allow
employees to provide a digital copy of acceptable records, including,
for example, a digital photograph, scanned image, or PDF of such a
record that clearly and legibly displays the necessary vaccination
information. However, to be in compliance with paragraph (e)(4), the
employer must ensure they are able to maintain a record of each
employee's vaccination status. Therefore, obtaining an employee's
vaccination information verbally would not comply with paragraph (e)(2)
or satisfy the record maintenance requirements of the standard.
Similarly, the record maintenance requirements of paragraph (e)(4)
cannot be fulfilled by an employee merely showing the employer their
vaccination status (e.g., by bringing the CDC COVID-19 vaccination card
to the workplace and showing it to an employer representative or
showing an employer representative a picture of the immunization
records on a personal cellphone). To satisfy paragraph (e)(4), the
employer must retain a copy of the documentation. As mentioned above,
some states and local governments utilize QR codes to facilitate proof
of vaccination. This can be an acceptable form of proof for compliance
with the standard so long as the employer retains a copy of the
information retrieved by scanning the QR code and maintains that
record. Required records of vaccination status can be maintained
physically or electronically, but the employer must ensure they have
access to the records at all times.
In addition to obtaining and maintaining individual records of each
employee's vaccination status and preserving acceptable proof of
vaccination for each employee who is partially or fully vaccinated,
under paragraph (e)(4) the employer must maintain a roster of each
employee's vaccination status, subject to applicable confidentiality
requirements. The roster must list all employees and clearly indicate
for each one whether they are fully vaccinated, partially (not fully)
vaccinated, not fully vaccinated because of a medical or religious
accommodation (see Note to paragraph (d)), or not fully vaccinated
because they have not provided acceptable proof of their vaccination
status. As noted previously, any employee that has not provided
acceptable proof of their vaccination status must be treated as not
fully vaccinated. Although unvaccinated employees will not have proof
of vaccination status, the standard requires the employer to include
all employees, regardless of vaccination status, on the roster.
The roster allows the employer to easily access the vaccination
status for any employee quickly and easily. This will be useful should
the employer need to respond to a request from an employee or employee
representative for the aggregate number of fully vaccinated employees
at a workplace (along with the total number of employees at that
workplace), as required under paragraph (l)(2). Additionally, the
roster will help the employer implement the written policy developed in
accordance with paragraph (d) and comply with other requirements of the
ETS. And finally, the roster, which must be provided to OSHA on request
(paragraph (l)(3)), will aid OSHA's ability to effectively and
efficiently enforce this ETS.
The records and roster required by paragraph (e)(4) are considered
to be employee medical records and must be maintained as such records
in accordance with 29 CFR 1910.1020 and must not be disclosed except as
required or authorized by this ETS or other federal law, including the
Americans with Disabilities Act (ADA), 42 U.S.C. 12101 et seq. These
records and roster are not subject to the retention requirements of 29
CFR 1910.1020(d)(1)(i) but must be maintained and preserved while this
ETS remains in effect. OSHA considers vaccination records required by
paragraphs (e)(2) and (e)(4) of the ETS to be employee medical records
concerning the health status of an employee and is requiring this
personally identifiable medical information to be maintained in a
confidential manner. OSHA notes that under paragraph (e)(4),
vaccination records and rosters are employee medical records, and must
be treated as employee medical records under 29 CFR 1910.1020, without
regard to whether the records satisfy the definition of employee
medical record at 29 CFR 1910.1020(c)(6)(i).
Paragraph (e) in 29 CFR 1910.1020 includes requirements for access
to employee medical records by
[[Page 61525]]
employees, their designated representatives, and OSHA. However, as
discussed in more detail below, paragraph (l) of the ETS includes
specific timeframes within which employers must make vaccine records
available to employees, OSHA, and other specified individuals.
Accordingly, the timeframes for providing access to employee medical
records in 29 CFR 1910.1020(e) do not apply, and employers must follow
the specific timeframes set forth in paragraph (l) of the ETS for
providing access to vaccination records.
Additionally, 29 CFR 1910.1020(d) addresses the preservation of
employee exposure and medical records. Paragraph (d)(1)(i) in section
1910.1020 generally provides that unless a specific occupational safety
and health standard provides a different period of time, each employer
must preserve and maintain employee medical records for at least the
duration of employment plus thirty (30) years. Paragraph (e)(4) of the
ETS specifically provides that the vaccination records required by the
ETS are not subject to the retention requirements of 29 CFR
1910.1020(d)(1)(i). Instead, paragraph (e)(4) states that vaccination
records must be maintained and preserved only so long as the ETS
remains in effect.
Finally, while the provisions on timeframes for access to records
and the retention provisions of 29 CFR 1910.1020 do not apply to
vaccine records required by the ETS, other provisions in that
regulation can still apply. For example, 29 CFR 1910.1020(h) includes
requirements for the transfer of employee medical records when an
employer ceases to do business.
OSHA recognizes the possibility that an employer may have already
collected information about the vaccination status of employees,
including proof of vaccination, prior to the effective date of this
ETS. Under paragraph (e)(5), when an employer has ascertained employee
vaccination status prior to the effective date of the ETS through
another form of attestation or proof, and retained records of that
ascertainment, the employer is exempt from the requirements in
paragraphs (e)(1)-(e)(3). The exemption applies only for each employee
whose fully vaccinated status has been documented prior to the
effective date of the standard. For example, an employer may have asked
each employee to self-report their vaccination status without requiring
the employee to provide any form of proof. If that self-reporting was
through oral conversation only, and not documented in some way, the
employer is not considered to have retained records of that
ascertainment for the purposes of this ETS. However, if, for example,
the employer had the employees provide their vaccine information on a
dated form, or through individual emails retained by the employer, or
on an employer portal specifically created for employees to provide
documentation status, or the employer created and retained some other
means of documentation, the employer is considered to have retained
records of ascertainment for the purposes of this ETS. Even if the
record does not have all of the elements of the acceptable forms of
proof listed in paragraph (e)(2), so long as the employer has
ascertained employee vaccination status prior to the effective date of
the ETS through another form of attestation or proof, and retained
records of that ascertainment, the employer does not need to re-
determine vaccination status (paragraph (e)(1)) or obtain proof of
vaccination status (paragraph (e)(2)) for fully vaccinated employees.
For purposes of paragraph (e)(4), the employer's records of vaccination
status for each employee whose fully vaccinated status was previously
documented constitute acceptable proof of vaccination. However, the
employer must still develop a roster of each employee's vaccination
status and include on that roster the employees for whom it had
previously determined and retained records of vaccination status. OSHA
notes that if the employer has not ascertained employee vaccination
status for employees prior to the effective date of the ETS, then all
requirements of paragraph (e) would apply. And all requirements of
paragraph (e) also apply with respect to employees for whom the
employer ascertained only partial vaccination status prior to the
effective date of the ETS.
References
Bergal J. (2021, September 16). Fake Vaccine Card Sales Have
Skyrocketed Since Biden Mandate. https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2021/09/16/fake-vaccine-card-sales-have-skyrocketed-since-biden-mandate. (Bergal, September 16,
2021).
Centers for Disease Control and Prevention (CDC). (2021, October 5).
Getting Your CDC COVID-19 Vaccination Record Card. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccination-card.html.
(CDC, October 5, 2021).
New York State Government. (n.d.) Excelsior Pass and Excelsior Pass
Plus. Retrieved October 4, 2021 from https://covid19vaccine.health.ny.gov/excelsior-pass-and-excelsior-pass-plus.
(New York State Government, n.d., Retrieved October 4, 2021).
State of California. (n.d.) Frequently Asked Questions. Retrieved
October 7, 2021 from https://myvaccinerecord.cdph.ca.gov/faq. (State
of California, n.d., Retrieved October 7, 2021).
F. Employer Support for Employee Vaccination
As discussed in the Summary and Explanation for paragraph (d)
(Section VI.D. of this preamble), as well as in Grave Danger and Need
for the ETS (Sections III.A. and III.B. of this preamble), vaccination
is the single most efficient and effective method for protecting
unvaccinated workers from the grave danger posed by COVID-19. This
emergency temporary standard is therefore designed to strongly
encourage vaccination. As discussed in detail below, paragraph (f)
requires employers to support vaccination by providing employees
reasonable time, including up to four hours of paid time, to receive
each primary vaccination dose, and reasonable time and paid sick leave
to recover from side effects experienced following each primary
vaccination dose. For purposes of the requirements to support
vaccination in paragraph (f), OSHA considers a vaccination series that
meets the criteria in subparagraph (ii) of the definition of ``fully-
vaccinated'' (i.e., a heterologous primary series of such vaccines,
receiving doses of different COVID-19 vaccines as part of one primary
series) to be a primary vaccination series, along with the primary
vaccination described in subparagraph (i) of that definition (see the
Summary and Explanation for paragraph (c), Section VI.C. of this
preamble, for more information on the definition of fully vaccinated).
Removing logistical barriers to obtaining vaccination is essential
to increasing workforce vaccination rates, and one such barrier for
many employees is their lack of time off of work to receive the vaccine
and recover from any potential side effects (SEIU Healthcare, February
8, 2021). Employees' concerns about missing work to obtain and recover
from a COVID-19 vaccination dose are well documented. In a McKinsey
survey, 12% of respondents stated that the time spent away from work to
get vaccinated or due to vaccine side effects was a barrier to
vaccination (Azimi et al., April 9, 2021). In a survey conducted of
unvaccinated adults in April 2021, a fifth of respondents said they
were very or somewhat concerned that they may need to take time off to
go and get the vaccine, and 48% of respondents said that they were very
or somewhat concerned that they might miss work if
[[Page 61526]]
the vaccine side effects make them feel sick (KFF, May 6, 2021). Black
and Hispanic adults were particularly worried about the potential time
necessary to receive the vaccine and to recover from vaccine side
effects; 64% of unvaccinated Hispanic adults and 55% of unvaccinated
Black adults expressed concern that they might have to miss work due to
the side effects of a COVID-19 vaccine, and 30% of Hispanic adults and
23% of Black adults were concerned that they might need to take time
off work to get a COVID-19 vaccine (KFF, May 6, 2021; KFF, May 17,
2021). News and journal articles further evince this concern (Roy et
al., December 29, 2020; Cleveland Documenters, 2021; Rosenberg and
Stein, August 18, 2021).
This concern reflects the fact that many workers do not have access
to paid time off to receive vaccination or to recover from side
effects. A KFF survey found that only half of all workers reported that
their employer provided them with paid time off either to get a COVID-
19 vaccine or to recover from any side effects (KFF, June 30, 2021). A
subsequent KFF survey found that only about one-third of workers were
sure that their employer offered them paid time off to get a COVID-19
vaccine and recover from side effects (KFF, September 28, 2021).
Although employee access to paid sick leave is less of a concern for
employers with 100 or more employees, approximately 12% of employees in
these situations do not have paid sick leave (BLS, September 2021) and
in some cases, employees may have already exhausted paid sick leave
they have received and would need additional time from their employers
to recover from vaccine side effects.
The scarcity of paid time off for vaccination and side effect
recovery is particularly acute for certain demographic groups. The June
2021 KFF survey found that only 38% of Black workers reported getting
either paid time off to get a COVID-19 vaccine or to recover from side
effects, and that only 41% of workers with household incomes less than
$40,000 annually had access to such paid time off (KFF, June 30, 2021).
Similarly, the September 2021 KFF survey found that lower-wage workers
were particularly unlikely to report access to paid time off for
vaccination or recovery, with only 23% of workers whose household
incomes was less than $40,000 reporting that they could take paid time
off to get vaccinated, and only 28% of that group reporting that they
could take paid time off to recover from side effects (KFF, September
28, 2021). Lower-wage workers' lack of access to paid time off for
vaccination comports with a different report indicating that, before
the pandemic, about 65% of the lowest-wage workers had no access to
paid sick leave, meaning that any time off for vaccination or recovery
would result in lost wages for those who can least afford those losses
(BLS, September 2021). The need for paid time off to receive
vaccination is also particularly important for workers with
disabilities and workers in rural areas because travel to and from
vaccination sites may take more time or be more logistically difficult
for those populations (National Safety Council, 2021).
Paying workers for the time spent to receive vaccination and to
recover from side effects has proven to be an effective method for
increasing vaccination rates. In June 2021, KFF found that
approximately 75% of employed adults surveyed who received paid time
off to get the vaccine or to recover from side effects had received at
least one dose of the vaccine compared to only 51% of those surveyed
who did not receive paid time off from their employer (KFF, June 30,
2021). KFF also found that employees who are provided paid time off and
are encouraged by their employers to get vaccinated are more likely to
get vaccinated, even after controlling for demographic characteristics
that may impact vaccination uptake (KFF, June 30, 2021). Another KFF
survey found that 28% of unvaccinated respondents who did not want to
get the vaccine as soon as possible said that they would be more likely
to obtain vaccination if their employer gave them paid time off to get
vaccinated and recover from any side effects (KFF, May 6, 2021). KFF
has also found that increasing access to paid leave for vaccination or
recovery from side effects can also help further reduce disparities in
vaccination by age and income (KFF, September 28, 2021).
In a different survey, paid time off for vaccination and the
recovery period post-vaccination was the single most-influential action
for encouraging employee vaccination, with 75% of respondents
indicating that such paid time off would significantly or moderately
increase the likelihood that they would get vaccinated (Azimi et al.,
April 9, 2021). Another survey of nearly 9,000 service workers across
large grocery, retail, food service, pharmacy, and delivery firms,
found that vaccination rates were lower than other frontline workers
who also regularly work in-person and indoors, and when employers
supported and facilitated vaccination, such as through providing paid
time off or paid sick leave for vaccination or for recovery from side
effects, employee vaccination rates were higher than if no support was
provided, and in May 2021, workers with paid sick leave were 15% more
likely to have gotten the vaccine than workers without such leave
(Bellew et al., June 2021).
To address this barrier to vaccination, paragraph (f) requires
employers to support COVID-19 vaccination by providing each employee
with reasonable time, including up to four hours of paid time, to
receive each primary vaccination dose, and reasonable time and paid
sick leave to recover from side effects experienced following any
primary vaccination dose. Providing this time is essential for all
unvaccinated employees who are covered by this rule to ensure that they
can receive primary vaccination dose(s) and recover from side effects
without sacrificing pay or their jobs. In workplaces where employers
implement a mandatory vaccination policy in accordance with paragraph
(d)(1) of this rule, the requirements of paragraph (f) ensure that
employees are able to comply with the mandatory vaccination policy
without concern about missing work to do so. In workplaces where the
employer opts out of implementing a mandatory vaccination policy in
accordance with paragraph (d)(2), the requirements of paragraph (f)
encourage employees to choose vaccination, and ensure that employees
who choose to obtain vaccination, rather than be regularly tested for
COVID-19 and wear a face covering in most situations when they work
near others, are not penalized for making that choice.
Paragraph (f)(1) requires employers to support COVID-19 vaccination
for each employee by providing reasonable time to each employee during
work hours for each of their primary vaccination dose(s), including up
to four hours of paid time, at the employee's regular rate of pay, for
the purposes of vaccination. Reasonable time may include, but is not
limited to, time spent during work hours related to the vaccination
appointment(s), such as registering, completing required paperwork, all
time spent at the vaccination site (e.g., receiving the vaccination
dose, post-vaccination monitoring by the vaccine provider), and time
spent traveling to and from the location for vaccination (including
travel to an off-site location (e.g., a pharmacy), or situations in
which an employee working remotely (e.g., telework) or in an alternate
location must travel to the workplace to receive the vaccine).
Employers are not, however, obligated by this ETS to reimburse
employees for transportation costs (e.g., gas money,
[[Page 61527]]
train/bus fare, etc.) incurred to receive the vaccination. This could
include the costs of travel to an off-site vaccination location (e.g.,
a pharmacy) or travel from an alternate work location (e.g., telework)
to the workplace to receive a vaccination dose.
Because employers are required to provide reasonable time for
vaccination during work hours, if an employee chooses to receive a
primary vaccination dose outside of work hours, employers are not
required to grant paid time to the employee for the time spent
receiving the vaccine during non-work hours. However, even if employees
receive a primary vaccination dose outside of work hours, employers
must still afford them reasonable time and paid sick leave to recover
from side effects that they experience during scheduled work time in
accordance with paragraph (f)(2).
An employer may make other efforts to facilitate vaccination of its
employees by, for example, hosting a vaccine clinic at the workplace
(e.g., mobile trailer) or partnering with another entity, such as a
pharmacy or healthcare provider, so that employees can be vaccinated at
the workplace or at an off-site location. If an employer chooses to
make the vaccine available to its employees, it must support full
vaccination (i.e., provide all doses in a primary vaccination, as
applicable), and assure the availability of reasonable time and paid
time to each employee to receive the full primary vaccination, and
reasonable time and paid sick leave to recover from side effects that
they may experience. Any additional costs incurred by the employer to
bring vaccination on-site would be covered by the employer, though such
an approach would likely reduce the amount of paid time needed for
vaccine administration (but not side effects) because of reduced
employee travel time.
Paragraph (f)(1) specifies that the amount of paid time that an
employer is required to provide each employee to receive each primary
vaccination dose is capped at four hours. OSHA has determined that four
hours would provide reasonable time for most employees to get each
vaccination dose. Vaccines are widely available to the public at
clinics, pharmacies, and other locations across the country (see CDC,
October 8, 2021). Providing four hours of paid time to receive each
primary vaccination dose is consistent with OSHA's presumption of the
amount of time needed to receive a vaccination dose in the June 2021
Healthcare ETS (86 FR 32598), and with the U.S. Office of Personnel
Management's guidance to federal government agencies on the use of the
emergency paid leave created for federal employees in the American
Rescue Plan Act of 2021 (Public Law 117-2), which encouraged agencies
to offer up to four hours of administrative leave per dose to cover
time spent getting a vaccine dose, plus additional time if reasonably
necessary, instead of having employees use emergency paid leave (OPM,
April 29, 2021). OSHA expects that most employees will need less than
four hours to receive a vaccination dose.
The maximum of four hours of paid time that employers must provide
under paragraph (f)(1)(ii) for the administration of each primary
vaccination dose cannot be offset by any other leave that the employee
has accrued, such as sick leave or vacation leave. OSHA is concerned
that employees forced to use their sick leave or vacation leave for
vaccination would have a disincentive to gaining the health protection
of vaccination. Employers must pay employees for up to four hours of
time at the employee's regular rate of pay. This may be achieved by
paying for the time to be vaccinated as work hours for up to four
hours. Requiring employers to pay for vaccine administration is
consistent with OSHA's normal approach of requiring employers to bear
the costs of compliance with safety and health standards.
OSHA understands that employees may need much less than four hours
to receive a primary vaccination dose, for example, if vaccinations are
offered on-site. However, OSHA also understands that, in some
circumstances, an employee may need more than four hours to receive a
primary vaccination dose, in which case the additional time, as long as
it is reasonable, would be considered unpaid but protected leave. The
employer cannot terminate the employee if they use a reasonable amount
of time to receive their primary vaccination doses. The employee may
use other leave time that they have available (e.g., sick leave or
vacation time) to cover the additional time needed to receive a
vaccination dose that would otherwise be unpaid.
Paragraph (f)(2) also requires employers to support COVID-19
vaccination for each employee by providing reasonable time and paid
sick leave to recover from side effects experienced following any
primary vaccination dose to each employee for each dose. The paid sick
leave can be in the form of an employee's accrued sick leave, if
available. If the employee does not have available sick leave, leave
must be provided for this purpose.
Although some individuals experience no side effects from COVID-19
vaccination doses, the CDC has identified a range of side effects that
other individuals may experience following a vaccination dose (CDC,
April 2, 2021; CDC, September 30, 2021). Side effects may affect
individuals' ability to engage in daily activities, are typically mild-
to-moderate in severity, and usually go away in a few days. Common side
effects include pain, redness, and swelling at the site of injection,
and systemic side effects throughout the body, including tiredness,
headache, muscle pain, chills, fever, and nausea. Side effects may be
sufficiently severe to require the employee to take sick leave from
work, but will rarely extend beyond a few days. One study found that
``unanticipated paid administrative leave was only required for 4.9%
and 19.79% of individuals after the first and second doses of vaccine,
respectively'' (Levi et al., September 25, 2021). Employees would not
typically be expected to need leave solely to address redness or
swelling at the site of injection, but it is not uncommon for vaccine
recipients to require some recovery time for many of the other side
effects. The CDC notes, however, that cough, shortness of breath, runny
nose, sore throat, or loss of taste or smell are not consistent with
post-vaccination symptoms and instead may be symptoms of COVID-19 or
another infection (CDC, April 2, 2021).
If an employee already has accrued paid sick leave, an employer may
require the employee to use that paid sick leave when recovering from
side effects experienced following a primary vaccination dose.
Additionally, if an employer does not specify between different types
of leave (i.e., employees are granted only one type of leave), the
employer may require employees to use that leave when recovering from
vaccination side effects. If an employer provides employees with
multiple types of leave, such as sick leave and vacation leave, the
employer can only require employees to use the sick leave when
recovering from vaccination side effects. Employers cannot require
employees to use advanced sick leave to cover reasonable time needed to
recover from vaccination side effects under paragraph (f)(2). An
employer may not require an employee to accrue negative paid sick leave
or borrow against future paid sick leave to recover from vaccination
side effects. In other words, the employer cannot require an employee
to go into the negative for paid sick leave if the employee does not
have accrued paid
[[Page 61528]]
sick leave when they need to recover from side effects experienced
following a primary vaccination dose. Neither the paid time required to
receive any vaccine dose(s) nor the paid sick leave required to recover
from side effects experienced following any vaccination dose are
retroactive requirements for vaccine dose(s) received prior to the
promulgation of this ETS.
Paragraph (f)(2) requires employers to provide reasonable time and
paid sick leave to employees to recover from side effects experienced
following a primary vaccination dose, but does not specify the amount
of paid sick leave that the employer is required to provide for that
purpose. Employers may set a cap on the amount of paid sick leave
available to employees to recover from any side effects, but the cap
must be reasonable. CDC notes that although some people have no side
effects, side effects, if experienced, should go away in a few days
(CDC, September 30, 2021). Another study found that the average
unanticipated paid administrative leave required by individuals
experiencing side effects was around two days (1.66 days for the first
dose and 1.39 days for the second dose) (Levi et al., September 25,
2021). Generally, OSHA presumes that, if an employer makes available up
to two days of paid sick leave per primary vaccination dose for side
effects, the employer would be in compliance with this requirement.
When setting the cap, an employer would not be expected to account for
the unlikely possibility of the vaccination resulting in a prolonged
illness in the vaccinated employee (e.g., a severe allergic reaction).
OSHA is aware that other federal, state, or local laws, or
collective bargaining agreements, may require employers to provide
employees additional paid time for vaccination and/or paid sick leave
to recover from vaccination side effects. Where such an overlap exists,
the requirements of this standard are satisfied so long as the employer
provides each employee reasonable time and four hours of paid time to
receive each primary vaccination dose, and reasonable time and paid
sick leave to recover from side effects experienced following a primary
vaccination dose.
References
Azimi T et al. (2021, April 9). Getting to work: Employers' role in
COVID-19 vaccination.\1\(Azimi et al., April 9, 2021)
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\1\ Azimi T et al. (2021, April 9). Getting to work: Employers'
role in COVID-19 vaccination. https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/getting-to-work-employers-role-in-covid-19-vaccination# (Azimi et al., April 9,
2021)
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Bellew E et al. (2021, June). Half of service sector workers are not
yet vaccinated for COVID-19: What gets in the way? The Shift
Project: Research Brief. https://shift.hks.harvard.edu/wp-content/uploads/2021/06/Vax_Brief_6.28.21-2.pdf. (Bellew et al., June 2021)
Centers for Disease Control and Prevention (CDC). (2021, April 2).
Post-vaccination considerations for workplaces. https://www.cdc.gov/coronavirus/2019-ncov/community/workplaces-businesses/vaccination-considerations-for-workplaces.html. (CDC, April 2, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
30). Possible side effects after getting a COVID-19 vaccine. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/after.html. (CDC,
September 30, 2021)
Centers for Disease Control and Prevention (CDC). (2021, accessed
October 8). We can do this: Vaccines.gov website. https://www.vaccines.gov/. (CDC, October 8, 2021)
Cleveland Documenters. (2021). Why some Clevelanders are still on
the fence or not getting vaccinated: Voices on the vaccine. The
Cleveland Observer. https://www.freshwatercleveland.com/street-level/VaccineVoice050521.aspx. (Cleveland Documenters, 2021)
Kaiser Family Foundation (KFF). (2021, May 6). KFF COVID-19 Vaccine
Monitor: April 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/. (KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May 17). How employer actions
could facilitate equity in COVID-19 vaccinations. https://www.kff.org/policy-watch/how-employer-actions-could-facilitate-equity-in-covid-19-vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021, June 30). KFF COVID-19
Vaccine Monitor: June 2021. https://www.kff.org/report-section/kff-covid-19-vaccine-monitor-june-2021-findings/. (KFF, June 30, 2021)
Kaiser Family Foundation (KFF). (2021, September 28). KFF COVID-19
Vaccine Monitor: September 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-september-2021/.
(KFF, September 28, 2021)
Levi ML et al. (2021, September 25). COVID-19 mRNA vaccination,
reactogenicity, work-related absences and the impact on operating
room staffing: A cross-sectional study. Perioperative Care and
Operating Room Management preprint. https://doi.org/10.1016/j.pcorm.2021.100220. (Levi et al., September 25, 2021)
National Safety Council. (2021). A Year in Review, and What's Next:
COVID-19 Employer Approaches and Worker Experiences. https://www.nsc.org/faforms/safer-year-one-final-report. (National Safety
Council, 2021)
Rosenberg E and Stein J. (2021, August 18). America's failure to pay
workers time off undermines vaccine campaign, according to surveys,
policy experts. Washington Post. https://www.washingtonpost.com/us-policy/2021/08/16/paid-leave-covid-vaccine/. (Rosenberg and Stein,
August 18, 2021)
Roy B et al. (2020, December 29). Health Care Workers' Reluctance to
Take the COVID-19 Vaccine: A Consumer-Marketing Approach to
Identifying and Overcoming Hesitancy.NEJM Catalyst. https://catalyst.nejm.org/doi/pdf/10.1056/CAT.20.0676. (Roy et al., December
29, 2020)
SEIU Healthcare. (2021, February 8). Research shows 81% of
healthcare workers willing to take COVID-19 vaccines but personal
financial pressures remain a significant barrier for uptake. https://www.newswire.ca/news-releases/research-shows-81-of-healthcare-workers-willing-to-take-covid-19-vaccines-but-personal-financial-pressures-remain-a-significant-barrier-for-uptake-888810789.html.
(SEIU Healthcare, February 8, 2021)
United States Bureau of Labor Statistics (BLS). (2021, September).
National Compensation Survey: Employee Benefits in the United
States, March 2021. https://www.bls.gov/ncs/ebs/benefits/2021/employee-benefits-in-the-united-states-march-2021.pdf. (BLS,
September, 2021)
United States Office of Personnel Management (OPM). (2021, April
29). American Rescue Plan: COVID-19 Emergency Paid Leave for Federal
Employees. https://chcoc.gov/sites/default/files/Attachment%205%20COVID-19%20Emergency%20Paid%20Leave%20Questions%20and%20Answers_0.pdf.
(OPM, April 29, 2021)
G. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
Paragraph (g) of this ETS addresses employers' obligations with
respect to employees who are not fully vaccinated, including the
requirement to ensure unvaccinated employees are tested for COVID-19.
As explained in Need for the ETS (Section III.B. of this preamble),
OSHA strongly prefers that employers implement written mandatory
vaccination policies because that is the most effective and efficient
workplace control available for preventing the spread of COVID-19.
However, this ETS is also necessary to protect workers who remain
unvaccinated through required regular testing, use of face coverings,
and removal of infected employees from the workplace, and to protect
other workers from the greater likelihood that unvaccinated workers may
spread COVID-19 in the workplace. People who are unvaccinated are at
increased risk of becoming infected with COVID-19 and are more likely
to spread the disease when compared to people who
[[Page 61529]]
are fully vaccinated (CDC, September 15, 2021). Additionally, people
who are unvaccinated are more likely to experience severe clinical
outcomes if they become infected than people who are vaccinated (Lopez
Bernal et al., July 21, 2021). Therefore, routine COVID-19 testing of
unvaccinated employees is necessary to identify employees with COVID-19
so they can be removed from the workplace to prevent transmission to
other employees and to facilitate early medical intervention for
infected employees when appropriate.
Routine testing of unvaccinated employees is necessary regardless
of whether the unvaccinated employees have symptoms because SARS-CoV-2
infection is often attributable to asymptomatic and/or pre-symptomatic
transmission (i.e., individuals who are not exhibiting symptoms)
(Bender et al., February 18, 2021; Klompas, September 2021; Johansson
et al., January 7, 2021; Byambasuren et al., December 11, 2020).
Although less effective and efficient than vaccination, the CDC has
recognized regularly testing unvaccinated employees for COVID-19 as a
useful tool for identifying asymptomatic and/or pre-symptomatic
infected individuals so that they can be isolated (CDC, May 4, 2021;
CDC, October 7, 2021). In contrast, the CDC recommends that fully
vaccinated employees with no symptoms and no known exposure should be
exempt from routine testing programs (CDC, May 4, 2021). Additional
information about the risks of COVID-19 transmission in vaccinated and
unvaccinated workers is discussed in Grave Danger (Section III.A. of
this preamble).
Testing for COVID-19 can broadly be divided into two categories:
diagnostic testing and screening testing. The purpose of diagnostic
testing is to identify current infection when a person has signs or
symptoms consistent with COVID-19, or when a person is asymptomatic but
has recent known or suspected exposure to SARS-CoV-2. The information
provided by diagnostic testing can be used by a healthcare provider to
diagnose or treat a patient. The purpose of screening testing is to
identify infected people who are asymptomatic and do not have known,
suspected, or reported exposure to COVID-19. Screening testing helps to
identify unknown cases both so that measures can be taken to prevent
further transmission to others (e.g., removal from the workplace and
home isolation) and also to allow infected, but asymptomatic, people to
begin medical treatment, as appropriate, so they can better avoid the
most severe outcomes of COVID-19 (e.g., high risk individuals seeking
monoclonal antibody treatment or anti-viral medication). Although the
testing required in paragraph (g)(1) of this ETS is screening testing,
both screening and diagnostic testing can help prevent the spread of
COVID-19. Paragraph (g) does not preclude additional diagnostic testing
if an employee shows signs or symptoms consistent with COVID-19 or has
recent known or suspected exposure to SARS-CoV-2.
Both screening and diagnostic testing involve the use of viral
COVID-19 tests to detect current infection, as opposed to antibody
COVID-19 tests, which are used to detect whether a person has
antibodies for COVID-19. A positive antibody test indicates someone has
antibodies to SARS-CoV-2, the virus that causes COVID-19, which could
either be the result of a prior infection with the virus or vaccination
against COVID-19 (FDA, May 19, 2021; CDC, September 10, 2021). Viral
tests for current infection fall into two categories: Nucleic acid
amplification tests (NAATs) and antigen tests. The Food and Drug
Administration (FDA) (October 6, 2021) has issued a number of Emergency
Use Authorizations (EUAs) for viral COVID-19 tests. It is important to
note that OSHA's definition of ``COVID-19 test'' requires that COVID-19
tests be cleared, approved, or authorized by the FDA and administered
in accordance with authorized instructions, with the noted exception of
not allowing tests that are both self-administered and self-read by the
employee unless observed by the employer or an authorized telehealth
proctor. In this regard, OSHA recognizes that it is within FDA's
authority and jurisdiction to help to assure the appropriate safety,
efficacy, and accuracy of COVID-19 tests. The definition of ``COVID-19
test'' has previously been discussed in the Summary and Explanation for
paragraph (c) (Section VI.C. of this preamble). Additional information
about the type of COVID-19 tests that would satisfy the requirements of
paragraph (g) are available in that section of this preamble.
As explained above, the most effective and efficient workplace
control for preventing the spread of COVID-19 is vaccination and OSHA
strongly prefers that employers implement written mandatory vaccination
policies. However, where employers have unvaccinated employees, regular
COVID-19 screening tests are necessary so infected employees can be
identified and removed from the workplace to prevent workplace
transmission and to facilitate early medical intervention, when
appropriate. In addition to being more likely to become infected with
COVID-19, people who are unvaccinated are more likely to experience
severe clinical outcomes from COVID-19 than fully vaccinated people
(see Grave Danger, Section III.A. of this preamble). In a recent CDC
Morbidity and Mortality Weekly Report (MMWR) out of Los Angeles County,
the SARS-CoV-2 infection rate among unvaccinated persons was 4.9 times
and the hospitalization rate was 29.2 times the rates among fully
vaccinated persons (Griffin et al., August 27, 2021). As explained
below, regular screening testing of individuals for COVID-19 is an
effective method of identifying asymptomatic and pre-symptomatic
infections. Screening testing of unvaccinated employees is necessary
because symptom and temperature checks will miss both asymptomatic and
pre-symptomatic infections, which is a serious problem because pre-
symptomatic and asymptomatic transmission are significant drivers of
the continued spread of COVID-19 (Johansson et al., January 7, 2021).
Once infected employees are identified, they can be removed from the
workplace, thereby reducing virus transmission to other employees.
Several studies have indicated that the time from exposure to
becoming contagious for COVID-19 is shorter than the time for symptoms
to develop (incubation period), meaning that individuals can transmit
SARS-CoV-2 before they begin to feel ill (i.e., pre-symptomatic
transmission) (Nishiura et al., March 4, 2020; Tindale et al., June 22,
2020). Pre-symptomatic individuals can transmit the virus to others
before they know they are sick. These individuals should isolate but
would not know to do so if they are unaware of their infection. It is
also possible for individuals to be infected and subsequently transmit
the virus without ever exhibiting symptoms. This is called asymptomatic
transmission. A meta-analysis of 351 studies from January 1, 2020, to
April 2, 2021, estimated that 42.8% of those infected with the SARS-
CoV-2 virus exhibited no symptoms at the time of testing and so had
either asymptomatic or pre-symptomatic infections (Sah et al., August
10, 2021). In another meta-analysis of studies, which included people
of all ages at risk of contracting COVID-19 who were tested regardless
of presence or absence of symptoms, seventeen percent of cases never
developed symptoms during entire COVID-19 infection (i.e., asymptomatic
infection). In those studies, a diagnosis was confirmed with
[[Page 61530]]
a positive result on a RT-PCR and all positive cases had a follow-up
period of at least seven days to distinguish asymptomatic cases from
pre-symptomatic cases (Byambasuren et al., December 11, 2020). In
another study, researchers used a decision analytical model to assess
the proportion of SARS-CoV-2 transmission from pre-symptomatic, never
symptomatic, and symptomatic individuals in the community. Based on
their modeling, they predicted that 59% of transmission came from
asymptomatic transmission, including 35% from pre-symptomatic
individuals and 24% from individuals who never develop symptoms
(Johansson et al., January 7, 2021).
The existence of pre-symptomatic and asymptomatic infections pose
serious challenges to containing the spread of SARS-CoV-2. Although the
risk of asymptomatic transmission is 42% lower than from symptomatic
COVID-19 patients (Byambasuren et al., December 11, 2020), asymptomatic
transmission may result in more transmissions than symptomatic cases
because asymptomatic persons are less likely to be aware of their
infection and can unknowingly continue to spread the disease to others
(Sah et al., August 10, 2021). The challenge of containing pre-
symptomatic and asymptomatic SARS-CoV-2 transmission is amplified among
unvaccinated individuals because, as explained above, they are more
likely to become infected with COVID-19 in the first place.
Because unvaccinated employees are at higher risk of COVID-19
infection and COVID-19 transmission among individuals without symptoms
is a significant driver of the spread of COVID-19, OSHA has determined
it is necessary to prevent the pre-symptomatic and asymptomatic
transmission of COVID-19 from unvaccinated workers, through a
requirement for weekly screening testing. Screening testing with
antigen tests is a rapidly evolving and important tool that can be used
to reduce the spread of SARS-CoV-2 in the workplace, particularly when
coupled with other COVID-19 prevention and control measures (e.g.,
workplace removal of infected persons, proper use of face coverings)
(Schulte et al., May 19, 2021). The CDC recommends screening testing of
unvaccinated asymptomatic workers as a useful tool to detect COVID-19
and stop transmission quickly. Screening testing is particularly useful
in areas with moderate to high community transmission of COVID-19,
which is currently the overwhelming majority of the United States (CDC,
October 7, 2021). In a study with a well-defined population of SARS-
CoV-2 infected individuals, researchers found that frequent testing
(i.e., at least twice per week) maximizes the likelihood of detecting
infected individuals. However, even when used weekly, rapid antigen
tests still had a 76% probability of detection (i.e., weekly rapid
antigen tests correctly identified 76% of true positive infected COVID-
19 individuals) (Smith et al., September 15, 2021). By identifying pre-
symptomatic and asymptomatic unvaccinated employees, employers can
remove them from the workplace to prevent those employees from
spreading SARS-CoV-2 to other employees. More information about the
removal requirements in this ETS is available in the Summary and
Explanation for paragraph (h) (Section VI.H. of this preamble).
Since the incubation period for COVID-19 can be up to 14 days, the
CDC recommends that screening testing be conducted at least weekly in
non-healthcare workplaces (CDC, October 7, 2021; CDC, May 4, 2021).
Other researchers also recognize the effectiveness of weekly screening
testing to control surges of COVID-19 infections (Larremore, January 1,
2021). Consequently, in workplaces with unvaccinated employees, OSHA
has set the minimum frequency of testing unvaccinated workers at seven
days because the agency expects that it will be effective in slowing
the spread of COVID-19 in those workplaces, when used in tandem with
face coverings (paragraph (i)) and removal of infected individuals
(paragraph (h)). OSHA emphasizes that each of these infection controls
provides some protection from COVID-19 by itself, but that they work
best when used together, layering their protective impact to boost
overall effectiveness. Although some studies have shown that more
regular screening testing (e.g., twice weekly) would identify even more
cases, OSHA has decided to require testing only on a weekly basis. This
is in line with the CDC recommendations, and as noted above the
evidence shows that this frequency is effective in detecting
asymptomatic and pre-symptomatic cases. A more frequent testing
schedule would result in significant additional costs, and OSHA is
hesitant to impose these costs and depart from CDC recommendations
without a fuller record generated through the benefit of notice and
comment rulemaking. OSHA seeks comment on this issue. Nonetheless, it
should be noted that nothing in this rule prevents screening testing
from being conducted more frequently based on factors such as the level
of community transmission, workplace experience with outbreaks, and
type of workplace (e.g., specific workplace factors such as high volume
retail or critical infrastructure sector).
Early detection of COVID-19-positive employees through screening
testing of unvaccinated employees also facilitates early medical
intervention, when appropriate, to avoid the most severe health
outcomes associated with COVID-19. Early effective treatment of disease
can help avert progression to more serious illness, especially for
patients at high risk of disease progression and severe illness, with
the additional benefit of reducing the burden on healthcare systems
(CDC, December 4, 2021). For example, anti-SARS-CoV-2 monoclonal
antibodies have been shown to reduce the risk of hospitalization and
death in the outpatient setting in those with mild to moderate COVID-19
symptoms and certain risk factors for disease progression. Treatment
should be started as soon as possible after the patient receives a
positive result on a COVID-19 test and within 10 days of symptom onset
(NIH, September 24, 2021). Any COVID-19 medical treatment should be
used in accordance with a licensed healthcare provider. The screening
tests required by this rule will facilitate such treatment.
Pursuant to paragraph (g)(1)(i), covered employers must ensure that
each employee who is not fully vaccinated and reports at least once
every seven days to a workplace where other individuals (e.g.,
coworkers, customers) are present: (A) Is tested for COVID-19 at least
once every seven days; and (B) provides documentation of the most
recent COVID-19 test result to the employer no later than the 7th day
following the date on which the employee last provided a test result.
Employers must ensure these unvaccinated employees are tested at least
once every seven calendar days, regardless of their work schedule. For
example, an unvaccinated part-time employee who is scheduled to work
only every Monday and Tuesday must still be tested at least once every
seven days. Because employees must provide documentation of their most
recent COVID-19 test results to their employers no later than the 7th
day following the date on which they last provided a test result,
employees may want to set a schedule for their testing (e.g., get a
COVID-19 test every Wednesday). A consistent testing day may help
employees ensure their documentation is provided every seven calendar
days.
[[Page 61531]]
Paragraph (g)(1)(ii) addresses situations where an employee does
not report to a workplace where other individuals, such as coworkers or
customers, are present during a period of seven or more days (e.g.,
when an employee is teleworking for an extended period of time). In
such cases, the employer must ensure the employee is tested for COVID-
19 within seven days prior to returning to the workplace and provides
documentation of that test result to the employer upon return to the
workplace. For example, if an unvaccinated office employee has been
teleworking for two weeks but must report to the office, where other
employees will be present (e.g., coworkers, security officers, mailroom
workers), on a specific Monday to copy and fax documents, that employee
must receive a COVID-19 test within the seven days prior to the Monday
and provide documentation of that test result to the employer upon
return to the workplace. The employee's test must occur within the
seven days before the Monday the employee is scheduled to report to the
office, but it also must happen early enough to allow time for the
results to be received before returning to the workplace. Similarly,
unvaccinated new hires would need to be tested for COVID-19 within
seven days prior to reporting to a workplace where other employees will
be present and provide documentation of their test results no later
than arrival on their first day of work. Since point-of-care testing
that uses an antigen test allows for results within minutes, OSHA does
not expect that scheduling tests or providing results to employers will
be an impediment.
OSHA chose the seven-day period for employees returning to work
after more than a week away from the workplace based on the evidence
noted above about the effectiveness of testing at seven-day intervals.
While it considered using a shorter time period in this situation, OSHA
concluded that it would be less confusing for employers to use a
uniform time period for both situations. OSHA was concerned that
requiring different time periods in the two situations would cause
confusion among both employees and supervisors implementing the program
that would undermine the effectiveness of the testing scheme. OSHA
seeks comment on this issue.
An employer has some discretion regarding how to satisfy its
obligations under paragraph (g)(1), but those policies and procedures
must be detailed in the employer's written policy pursuant to paragraph
(d)(2) of this ETS. For example, the employer must specify how testing
will be conducted (e.g., testing provided by the employer at the
workplace, employees independently scheduling tests at point-of-care
locations, etc.). The employer must also specify in their policy how
employees should provide their COVID-19 test results to the employer
(e.g., an online portal, to the human resources department). The
Summary and Explanation for paragraph (d) (Section VI.D. of this
preamble) provides additional information regarding the requirements of
paragraph (d)(2) of this ETS. Test results given to the employer must
contain information that identifies the worker (i.e., full name plus at
least one other identifier, such as date of birth), the specimen
collection date, the type of test, the entity issuing the result (e.g.,
laboratory, healthcare entity), and the test result.
If an employer is notified that an employee has a positive
screening test, the employer must remove that employee from the
workplace pursuant to paragraph (h)(2) of this ETS. The employee should
quarantine and the employer must not allow the employee to return to
the workplace until they meet the requirements in paragraphs (h)(2)(i)
through (iii). More discussion of employee notification to their
employer of a COVID-19 positive status and removal requirements is
available in the Summary and Explanation for paragraph (h) (Section
VI.H. of this preamble).
OSHA expects that most screening testing will be antigen testing
that is conducted at point-of-care locations due to the reduced cost
and faster processing time when compared to NAAT testing in
laboratories. Most NAATs need to be processed in a laboratory with
variable time to results (approximately 1-2 days). In contrast, most
antigen tests can be processed at the point of care with results
available in about 15-30 minutes (CDC, October 7, 2021). Rapid point-
of-care tests are administered in various settings, such as: Physician
offices, urgent care facilities, pharmacies, school health clinics,
workplace health clinics, long-term care facilities and nursing homes,
and at temporary locations, such as drive-through sites managed by
local organizations. As explained above, COVID-19 tests that are both
self-administered and self-read do not meet the definition of ``COVID-
19 test'' in this ETS (unless observed by the employer or an authorized
telehealth proctor) and therefore do not satisfy the testing
requirements of paragraph (g).
Because antigen testing in point-of-care locations will typically
produce results within minutes, the use of antigen testing should not
result in an inability to provide the employer with test results in a
timely fashion. However, the agency recognizes that where the employee
or employer uses an off-site laboratory for testing, there may be
delays beyond the employee's or employer's control. In the event that
there is a delay in the laboratory reporting results and the employer
permits the employee to continue working, OSHA will look at the pattern
and practice of the individual employee or the employer's testing
verification process and consider refraining from enforcement where the
facts show good faith in attempting to comply with the standard.
OSHA has determined that employers may use pooling procedures to
satisfy the requirements of screening testing under paragraph (g)(1).
Pooling (also referred to as pool testing or pooled testing) means
combining the same type of specimen from several people and conducting
one laboratory test on the combined pool of specimens to detect SARS-
CoV-2 (e.g., four samples may be tested together, using only the
resources needed for a single test). The advantages of pooling include
preserving testing resources, reducing the amount of time required to
test large numbers of specimens (increasing throughput), and lowering
the overall cost of testing (CDC, June 30, 2021).
If pooling procedures are used and a pooled test result comes back
negative, then all the specimens can be presumed negative with the
single test. In other words, all of the employees who provided
specimens for that pool test can be assumed to have a negative test
result for SARS-CoV-2 infection. Therefore, documentation of the
negative pooled test result would satisfy the paragraph (g)(1)
documentation requirement for each employee in the pool and no
additional testing is necessary. However, if the pooled test result is
positive, immediate additional testing would be necessary to determine
which employees are positive or negative. Each of the original
specimens collected in the pool must be tested individually to
determine which specimen(s) is (are) positive. If original specimens
from the workers in a pooled test with a positive result are
insufficient to be subsequently tested individually, those workers in
the positive pool would need to be immediately re-swabbed and tested.
The individual employee test results would be necessary to satisfy the
employee documentation requirements of paragraph (g)(1). Where pooled
testing is used (in accordance with paragraph (g)(1)), CDC and FDA
procedures and
[[Page 61532]]
recommendations for implementing screening pooled tests should be
followed (CDC, June 30, 2021; FDA, August 24, 2020). OSHA notes that
only some tests are authorized for pooled testing, and should be
performed per the authorization.
In a note to paragraph (g)(1), OSHA explains that this section does
not require the employer to pay for any costs associated with testing.
As explained in Pertinent Legal Authority, Section II. of this
preamble, the OSH Act authorizes OSHA to require employers to bear the
costs of compliance with occupational safety and health standards, but
OSHA has discretion to decide whether to impose certain costs--such as
those related to medical examinations or other tests--on employers
``[w]here [it determines that such costs are] appropriate.'' 29 U.S.C.
655(b)(7). OSHA has commonly required employers to bear the costs of
compliance with standards as a cost of doing business, including
requiring employers to bear the costs of medical examinations and
procedures (see, e.g., 29 CFR 1910.1018(n)(1)(i) (inorganic arsenic
standard requires employers to ensure that medical examinations and
procedures are provided ``without cost to the employee''); see also
United Steelworkers, 647 F.2d at 1229-31 (discussing Lead standard's
medical removal provisions and OSHA's authority for imposing cost of
medical removal on employers)). Requiring employers to bear the costs
of compliance makes it more likely that employees will take advantage
of workplace protections (see 86 FR 32605). For example, employees are
more likely to use personal protective equipment (PPE) when employers
provide the PPE to their employees at no cost (see 72 FR 64342, 64344).
In this ETS, OSHA has largely required employers to bear the costs
of compliance, including the typical costs associated with vaccination,
but has determined that it would not be appropriate to impose on
employers any costs associated with COVID-19 testing for employees who
choose not to be vaccinated. As explained in Need for the ETS, Section
III.B. of this preamble, this ETS is designed to strongly encourage
vaccination because vaccination is the most efficient and effective
control for protecting unvaccinated workers from the grave danger posed
by COVID-19. COVID-19 testing is only required under the ETS where an
employee has made an individual choice to forgo vaccination and pursue
a less protective option. Given the superior protectiveness of
vaccination, and OSHA's intent for this ETS to strongly encourage
vaccination, requiring employers to bear the costs of COVID-19 testing
would be counter-productive. As mentioned above, requiring employers to
pay for workplace protections makes it more likely that employees will
take advantage of that protection, and in this ETS, OSHA intends to
strongly encourage employees to choose vaccination, not regular COVID-
19 testing. Because employees who choose to remain unvaccinated will
generally be required to pay for their own COVID-19 testing, this
standard creates a financial incentive for those employees to become
fully vaccinated and avoid that cost.
Although this ETS does not require employers to pay for testing,
employer payment for testing may be required by other laws,
regulations, or collective bargaining agreements or other collectively
negotiated agreements. This section also does not prohibit the employer
from paying for costs associated with testing required by paragraph
(g)(1) of this section. Otherwise, the agency leaves the decision
regarding who pays for the testing to the employer. Because OSHA does
not specify who pays for the testing, OSHA expects that some workers
and/or their representatives will negotiate the terms of payment. OSHA
has also considered that some employers may choose to pay for some or
all of the costs of testing as an inducement to keep employees in a
tight labor market. Other employers may choose to put the full cost of
testing on employees in recognition of the employee's decision not to
become fully vaccinated. It is also possible that some employers may be
required to cover the cost of testing for employees pursuant to other
laws or regulations. OSHA notes, for instance, that in certain
circumstances, the employer may be required, under the Fair Labor
Standards Act, to pay for the time it takes an employee to be tested
(e.g., if employee testing is conducted in the middle of a work shift).
The subject of payment for the costs associated with testing pursuant
to other laws or regulations not associated with the OSH Act is beyond
OSHA's authority and jurisdiction. As explained in a note to paragraph
(d) of this ETS, under various anti-discrimination laws, workers who
cannot be tested because of a sincerely held religious belief may ask
for a reasonable accommodation from their employer. For more
information about evaluating requests for reasonable accommodation for
a sincerely held religious belief, employers should consult the Equal
Employment Opportunity Commission's website: https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
Pursuant to paragraph (g)(2), if an employee does not provide the
result of a COVID-19 test as required by paragraph (g)(1), the employer
must keep the employee removed from the workplace until the employee
provides a test result. This provision is imperative because workers
with asymptomatic or pre-symptomatic SARS-CoV-2 infection are
significant contributors to COVID-19 transmission, and screening
testing will help to identify and remove those individuals from the
workplace. Employees providing accurate and weekly test results to
their employer is of utmost importance for preventing and reducing the
transmission of COVID-19 in the workplace.
Paragraph (g)(3) provides that when an employee has received a
positive COVID-19 test, or has been diagnosed with COVID-19 by a
licensed healthcare provider, the employer must not require that
employee to undergo COVID-19 testing for 90 days following the date of
their positive test or diagnosis. This provision is specifically
intended to prohibit screening testing for 90 days because of the high
likelihood of false positive results that do not indicate active
infection but are rather a reflection of past infection. Studies of
patients who were hospitalized and recovered indicate that SARS-CoV-2
RNA can be detected in upper respiratory tract specimens for up to
three months (90 days) after symptom onset (CDC, August 2, 2021; CDC,
September 14, 2021). If employees were to be subjected to screening
tests in such a situation it would both undermine the confidence in the
COVID-19 screening tests and could result in a harm to the worker of
being unnecessarily removed from the workplace and subjected to the
additional burden of unnecessary tests. Where employers implement a
vaccination policy that allows employees to choose to provide proof of
regular testing and wear a face covering rather than getting
vaccinated, the employer's policy and procedures to implement this
temporary suspension of testing must be included in their written
workplace policy as required by paragraph (d)(2) of this ETS.
Paragraph (g)(4) provides that the employer must maintain a record
of each test result required to be provided by each employee under
paragraph (g)(1) of this ETS or obtained during tests conducted by the
employer. These records must be maintained in
[[Page 61533]]
accordance with 29 CFR 1910.1020 as an employee medical record and must
not be disclosed except as required by this ETS or other federal law.
However, these records are not subject to the retention requirements of
29 CFR 1910.1020(d)(1)(i) (Employee medical records), but must be
maintained and preserved while this ETS remains in effect.
Additionally, paragraph (l) of this ETS includes specific
timeframes for providing access to records, including the COVID-19 test
results required by paragraph (g)(1). As a result, the timeframes for
providing access to employee medical records in 29 CFR 1910.1020(e) do
not apply. Instead, when providing access to an employee, anyone with
written authorized consent from that employee, and OSHA, employers must
follow the access timeframes set forth in paragraph (l) of this ETS.
The Summary and Explanation for paragraph (l) (Section VI.L. of this
preamble) contains additional information about accessing records
gathered pursuant to paragraph (g)(1).
Finally, while the access timeframes in 29 CFR 1910.1020(e) and
retention requirements of 29 CFR 1910.1020(d)(1)(i) do not apply to
test result records required by this ETS, the other provisions in 29
CFR 1910.1020 do apply. For example, 29 CFR 1910.1020(h) includes
requirements for the transfer of employee medical records when an
employer ceases to do business. Like the vaccine records required by
paragraph (e)(4) of this ETS, and because they concern the health
status of an employee, test result records required by paragraph (g)(1)
are employee medical records for purposes of 29 CFR 1910.1020. These
test result records contain personally identifiable medical information
and must be maintained in a confidential manner. The Summary and
Explanation for paragraph (e) (Section VI.E. of this preamble) contains
additional information about the interplay between this ETS and OSHA's
regulation at 29 CFR 1910.1020.
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Centers for Disease Control and Prevention (CDC). (2021, September
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Interim Guidance. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html. (CDC, September 14, 2021).
Centers for Disease Control and Prevention (CDC). (2021, September
15). Science Brief: COVID-19 Vaccines and Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html. (CDC, September 15, 2021).
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7, 2021).
Food and Drug Administration (FDA). (2020, August 24). Pooled Sample
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(FDA, May 19, 2021).
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Griffin JB et al. (2021, August 27). SARS-CoV-2 infections and
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Johansson MA et al. (2021, January 7). SARS-CoV-2 transmission from
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Larremore DB et al. (2021, January 1). Test sensitivity is secondary
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(Larremore, January 1, 2021).
Lopez Bernal et al. (2021, July 21). Effectiveness of COVID-19
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Nishiura H et al. (2020, March 4). Serial interval of novel
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284-286. doi:10.1016/j.ijid.2020.02.060. Epub 2020 Mar 4. PMID:
32145466; PMCID: PMC7128842. (Nishiura et al., March 4, 2020).
Sah P et al. (2021, August 10). Asymptomatic SARS-COV-2 infection: A
systematic review and meta-analysis. Proceedings of the National
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Schulte P et al. (2021, May 19). Proposed Framework for Considering
SARS-CoV-2 Antigen Testing of Unexposed Asymptomatic Workers in
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Smith R et al. (2021, September 15). Longitudinal assessment of
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COVID-19 prior to symptom onset. Elife. 2020; 9: e57149. Published
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2020).
H. Employee Notification to Employer of a Positive COVID-19 Test and
Removal
Employers can substantially reduce disease transmission in the
workplace by removing employees who are confirmed to have COVID-19
based on a COVID-19 test or diagnosis by a healthcare provider. It is
necessary that employees who are confirmed to have COVID-19 be removed
from the workplace to prevent transmission to other employees. Several
studies have focused on the impact of isolating persons with COVID-19
from others during their likely known infectious period, and those
studies show that isolation is a strategy that reduces the transmission
of infections. For example, Kucharski et al. (2020) found that
transmission of SARS-CoV-2 would decrease by 29% with self-isolation
within the household, which would extend to 37% if the entire household
quarantined. Similarly, Wells et al. (2021) found that isolation of
individuals at symptom onset would decrease the reproductive rate (R0)
of COVID-19 from 2.5 to 1.6. Lastly, Moghadas et al. (2020) reported
results that highlight the role of silent transmission, from a
combination of the pre-symptomatic stage and asymptomatic infections,
as the primary driver of COVID-19 outbreaks and underscore the need for
mitigation strategies, including those that detect and isolate
infectious individuals prior to the onset of symptoms. Isolating
contagious employees from their co-workers can prevent further spread
at the workplace and safeguard the health of other employees.
Paragraph (h) provides that employers must require each employee to
promptly notify the employer when the employee receives a positive
COVID-19 test or is diagnosed with COVID-19 by a licensed healthcare
provider. This notification must occur regardless of employee
vaccination status. As discussed in Grave Danger (Section III.A. of
this preamble), exposure to SARS-CoV-2 in the workplace presents a
grave danger to employees; removing those who are confirmed to have
COVID-19 from the workplace mitigates that grave danger. This is true
even for fully vaccinated employees since they also have the potential
to transmit COVID-19 to other individuals, including other employees.
Because the goal of this ETS, and the notification requirements in this
paragraph, is to reduce transmission of COVID-19 in the workplace,
employees are required to notify the employer of any COVID-19 positive
test or diagnosis that they receive, not just positive results that are
received from testing required under paragraph (g) of this ETS.
Paragraph (h)(1) states that the employer must require each
employee who is COVID-19 positive to notify the employer of their
COVID-19 test result or diagnosis ``promptly.'' For employees who are
not at the workplace when they receive a positive COVID-19 test result
or diagnosis, ``promptly'' notifying the employer means notifying the
employer as soon as practicable before the employee is scheduled to
start their shift or return to work. In the event that the employee is
in the workplace when they receive a positive COVID-19 test result or
diagnosis of COVID-19, ``promptly'' notifying the employer means
notifying the employer as soon as safely possible while avoiding
exposing any other individuals in the workplace.
The employer should establish notification procedures and inform
employees about these procedures (see paragraph (j)(1)), so that
employees are aware of the appropriate method for providing this
notification to their employer. These notification procedures can be
based on the employer's current protocols for employees to notify the
employer if they are not able to come to work or need to leave work
because of illness or injury. However the employer chooses to implement
its notification procedures, it must ensure that an employee
notification of a positive COVID-19 test or diagnoses results in the
employee's immediate removal from the workplace, as required under
paragraph (h)(2). For example, the employer may require employees to
report any positive COVID-19 test or diagnosis to a company supervisor
with the authority to temporarily remove the employee from the
workplace. If an employer takes all steps required under this paragraph
but an employee fails to report required information, the ETS does not
dictate that any disciplinary action be taken against the employee. If
an employer is cited by OSHA under this provision under such
circumstances, the employer is entitled to contest the citation if it
can establish an employee misconduct defense in accordance with
applicable case law.
The notification requirement in paragraph (h)(1) is an important
measure to ensure employers can take adequate steps to protect their
employees from the hazard of COVID-19 because it is connected to a
parallel requirement in paragraph (h)(2) to remove, from the workplace,
any employee who receives a positive COVID-19 test or is diagnosed with
COVID-19. It is important to remove employees who test positive or are
diagnosed with COVID-19 from the workplace as soon as possible to
prevent the transmission of COVID-19 to other employees. Therefore, the
requirement that employees promptly inform their employer of a positive
COVID-19 test result or COVID-19 diagnosis is necessary because this
information allows the employer to take actions to protect other
employees, including most critically by removing employees whose
illness poses a direct threat of infection to other employees in the
workplace.
Paragraph (h)(2) requires employers to immediately remove from the
workplace any employee, regardless of vaccination status, who receives
a positive COVID-19 test or is diagnosed with COVID-19 by a licensed
healthcare provider. OSHA determined that directing an employee who
tests positive or is diagnosed with COVID-19 to stay home until return
to work criteria are achieved is critical to preventing the
transmission of COVID-19 in the workplace. Similar to the notification
required in paragraph (h)(1), this removal must occur regardless of
employee vaccination status since someone who is fully vaccinated can
still transmit COVID-19 to others, including other employees (see Grave
Danger, Section III.A. of this preamble).
OSHA notes that, in most circumstances, any positive COVID-19 test
would result in removal. However, this is not necessarily the case
where an employer uses pooled COVID-19 testing, a method where one
laboratory test is conducted using the specimens of several people to
detect the virus that causes COVID-19 (CDC, June 30, 2021). If an
employer conducts pooled testing for COVID-19, a positive pooled test
result would trigger a need to immediately re-test those employees in
the pool using an individual COVID-19 test because the positive pooled
result would not satisfy the requirements of paragraph (g). Only those
employees who test positive on their individual re-test would need to
be removed from the workplace.
OSHA intends ``removal'' under paragraph (h)(2) to refer only to
the temporary removal from the workplace of an employee while that
employee is infectious. The requirement in paragraph (h)(2) to
temporarily remove a COVID-19 positive employee from the workplace does
not mean permanent removal of an employee from their position. Any time
an employee is
[[Page 61535]]
required to be removed from the workplace under paragraph (h)(2) of
this section, the employer can require the employee to work remotely or
in isolation if suitable work is available and if the employee is not
too ill to work. In cases where working remotely or in isolation is not
possible, OSHA encourages employers to consider flexible and creative
solutions, such as a temporary reassignment to a different position
that can be performed by telework. However, if an employee is too ill
to work, remote work should not be required, and sick leave or other
leave should be made available as consistent with the employer's
general policies and practices, and as may be required under applicable
laws.
After an employee has been removed from the workplace as required
by paragraph (h)(2), the employer must ensure that they do not return
to the workplace until the employee meets one of three criteria
outlined in paragraphs (h)(2)(i) through (h)(2)(iii). The purpose of
these provisions is to ensure that an employee who has COVID-19 does
not return to work until the risk that they will transmit the disease
to others in the workplace has been minimized. Each of these provisions
is based on the best scientific evidence available on when a person
with COVID-19 is no longer likely to transmit the virus.
Under paragraph (h)(2)(i), the employee can return to work if they
receive a negative result on a COVID-19 nucleic acid amplification test
(NAAT) following a positive result on a COVID-19 antigen test (the most
common screening test). There is a small possibility for employees to
receive false positive test results when conducting regular screening
with an antigen test. Positive results are usually highly accurate at
moderate-to-high peak viral load, but false positives can occur,
depending on the course of infection (FDA, April 2021). OSHA recognizes
that an employee might choose to seek a NAAT test for confirmatory
testing. NAATs are considered the ``gold standard'' for clinical
diagnosis of SARS-CoV-2 and may have a higher sensitivity (i.e.,
ability to correctly generate a positive result) than antigen tests
(CDC, September 9, 2021). If an employee tested positive for COVID-19
via an antigen test, but then received follow-up confirmatory testing
via a NAAT and the NAAT was negative, the positive antigen test can be
considered a false positive and the employee can return to work (CDC,
September 9, 2021). For a more detailed discussion of COVID-19 tests,
see the Summary and Explanation for paragraph (c) (Section VI.C. of
this preamble).
The employee may also return to work if they meet the return to
work criteria in CDC's ``Isolation Guidance'' (incorporated by
reference, Sec. 1910.509) (CDC, February 18, 2021) as described in
paragraph (h)(2)(ii). CDC's guidance states that a COVID-19 positive
person can stop isolating when three criteria are met: (1) At least ten
days have passed since the first appearance of the person's symptoms;
(2) the person has gone at least 24 hours without a fever (without the
use of fever-reducing medication); and (3) the person's other symptoms
of COVID-19 are improving (excluding loss of taste and smell). If a
person has tested positive but never experiences symptoms, then the
person can stop isolating after ten days from the date of their
positive test. These recommendations are based on scientific evidence
reviewed by CDC, which indicates that levels of viral RNA in upper
respiratory tract samples begin decreasing after the onset of symptoms
(CDC, September 14, 2021). The rationale for including CDC's
``Isolation Guidance'' in the ETS was addressed in detail in Need for
Specific Provisions in the agency's prior rulemaking on 1910.502 (see
86 FR 32376, 32455).
Finally, the employee may return to work, per paragraph
(h)(2)(iii), if the employee receives a return-to-work recommendation
from a licensed healthcare provider. The appropriate duration of
removal from work for any given individual may differ depending on
factors such as disease severity or the health of the employee's immune
system. For this reason, the ETS permits employers to make decisions
about an employee's return to work in accordance with guidance from a
licensed healthcare provider (who would be better acquainted with a
particular employee's condition). If a licensed healthcare provider
recommends a longer period of isolation for a particular employee than
the CDC's ``Isolation Guidance'' would otherwise recommend, then the
employer would need to abide by that longer period rather than
returning the employee to work after ten days.
OSHA's removal requirements as outlined in paragraph (h)(2) are
intended to set the floor for what is required; however, OSHA
encourages employers who are able to do so to have a more robust
program of medical removal, as indeed some employers have already done.
In addition to removal from the workplace based on a positive COVID-19
test or diagnosis of COVID-19, employers may consider removal based on
COVID-19 symptoms or certain exposure or close contacts employees have
had outside of the workplace. Similarly, employers may consider
removing employees from the workplace if the employer learns that the
employee was notified by a state or local public health authority to
quarantine or isolate; the employer might even be contacted by such an
authority directly. Although this ETS does not require removal from the
workplace in those situations, the employer might choose to remove
employees from the workplace, above and beyond what is required by this
ETS.
Finally, the note to paragraph (h)(2) clarifies that this ETS does
not require employers to provide paid time to any employee for removal
as a result of a positive COVID-19 test or diagnosis of COVID-19;
however, paid time may be required by other laws, regulations, or
collective bargaining agreements or other collectively negotiated
agreements. On the other hand, the ETS does not preclude employers from
choosing to pay employees for time required for removal under this
standard. Additionally, employers should allow their employees to make
use of any accrued leave in accordance with the employer's policies and
practices on use of leave. This provision, while not placing the burden
on the employer to provide paid time, should not be read as depriving
employees of the benefits they are normally entitled to as part of
their employment.
Because it does not require employers to provide paid time to
employees who are removed for a positive COVID-19 test or diagnosis of
COVID-19, this ETS differs from OSHA's COVID-19 Healthcare ETS, which
applies to employees in the healthcare industry who are expected to be
exposed to COVID-19, and requires paid medical removal protection
benefits (Sec. 1910.502(l)(5)) for most employees. This difference
reflects the structure and focus of this ETS relative to the Healthcare
ETS. The Healthcare ETS requires employees to report symptoms of COVID-
19 to their employers, as well as positive COVID-19 tests or diagnoses
(see Sec. 1910.502(l)(2)), but does not require employees to be
regularly tested for COVID-19. A primary function of the payment for
medical removal in that standard is, therefore, to remove the potential
for financial disincentives that might deter employees from reporting
any signs or symptoms of COVID-19 that they experience. Because this
ETS already requires testing for unvaccinated workers, which should
result in employers learning of cases of COVID-19 in unvaccinated
workers, and does not otherwise require
[[Page 61536]]
employees to report signs and symptoms of COVID-19 to their employers,
OSHA found that requiring employer payment for removal was not
necessary in this standard.
As the note to paragraph (h) indicates, the employer may be
required to follow other laws or regulations that would require paid
medical removal. For example, if an employee covered by this ETS
believes they were exposed to COVID-19 in the workplace and then tested
positive, that employee may be entitled to workers' compensation
benefits. Workers' compensation is a system already in place to provide
benefits to employees who get sick or injured on the job from
occupational disease or a work-related injury. Some states have
expressly clarified or expanded their workers compensation rules to
allow for COVID-19 claims during the pandemic (see, e.g., Industrial
Commission of Arizona, May 15, 2020; Connecticut Executive Order No.
7JJJ, July 24, 2020; Minn. Stat. Ann. Sec. 176.011 Subd. (15)(f),
2020)).
Finally, the ETS does not contain specific requirements under this
paragraph for the employer to establish or maintain records of employee
notifications of a positive COVID-19 test or diagnosis of COVID-19 by a
licensed healthcare provider. However, should an employer determine
that a reported case of COVID-19 is work-related, the employer must
continue to record that information on the OSHA Forms 300, 300A, and
301, or on equivalent forms, if required to do so under 29 CFR part
1904. This also includes confirmed cases of COVID-19 identified under
paragraph (h) that an employer determines are work-related. Under 29
CFR part 1904, COVID-19 is a recordable illness and employers are
responsible for recording cases of COVID-19 if: (1) The case is a
confirmed case of COVID-19 as defined by the Centers for Disease
Control and Prevention (CDC); (2) the case is work-related as defined
by 29 CFR part 1904.5; and (3) the case involves one or more of the
general recording criteria in set forth in 29 CFR part 1904.7 (e.g.,
medical treatment beyond first aid, days away from work). Under 29 CFR
part 1904, employers must generally provide access to the 300 log to
employees, former employees, and their representatives with the names
of injured or ill employees included on the form. If, however, the
employee requests that their name not be entered on the 300 log, the
employer must treat their illness as a privacy concern case and may not
enter their name on the log (see 29 CFR 1904.29(b)(6), (b)(7)(vi)).
References
Centers for Disease Control and Prevention (CDC). (2021, February
18). Isolate if you are sick. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/isolation.html. (CDC, February 18, 2021).
Centers for Disease Control and Prevention (CDC). (2021, June 30).
Interim Guidance for Use of Pooling Procedures in SARS-CoV-2
Diagnostic and Screening Testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html. (CDC, June 30, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
9). Interim Guidance for Antigen Testing for SARS-CoV-2. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html. (CDC, September 9, 2021).
Centers for Disease Control and Prevention (CDC). (2021, September
14). Ending Isolation and Precautions for People with COVID-19:
Interim Guidance. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html. (CDC, September 14, 2021).
Connecticut Executive Order No. 7JJJ. (2020, July 24). Executive
Order No. 7JJJ Protection of public health and safety during COVID-
19 pandemic and response--rebuttable presumption regarding workers
compensation benefits related to contraction of COVID-19. https://portal.ct.gov/-/media/Office-of-the-Governor/Executive-Orders/Lamont-Executive-Orders/Executive-Order-No-7JJJ.pdf. (Connecticut
Executive Order No. 7JJJ, July 24, 2020).
Food and Drug Administration (FDA). (2021, April). Coronavirus
Disease 2019 Testing Basics. https://www.fda.gov/media/140161/download. (FDA, April 2021).
Industrial Commission of Arizona. (2020, May 15). COVID-19 Workers'
Compensation Claims. https://www.azica.gov/sites/default/files/SPS%20-COVID-19%20FINAL.pdf. (Industrial Commission of Arizona, May
15, 2020).
Kucharski AJ et al. (2020). Effectiveness of isolation, testing,
contact tracing, and physical distancing on reducing transmission of
SARS-CoV-2 in different settings: a mathematical modelling study.
The Lancet Infectious Disease. 2020 Oct; 20(10): 1151-1160.
doi:10.1016/S1473-3099(20)30457-6. Epub 2020 Jun 16. PMID: 32559451;
PMCID: PMC7511527. (Kucharski et al., 2020)
Minnesota Statutes Annotated, Section 176.011 Definitions. Subd.
15(f). (2020). https://www.revisor.mn.gov/statutes/cite/176.011/pdf.
(Minn. Stat. Ann. Sec. 176.011 Subd. (15)(f), 2020)
Moghadas S et al. (2020, July 6). The implications of silent
transmission for the control of COVID-19 outbreaks. Proceedings of
the National Academy of Sciences of the United States of America,
117(30), 17513-17515. doi:https://doi.org/10.1073/pnas.2008373117.
(Moghadas et al., July 6, 2020)
Wells CR et al. (2021). Optimal COVID-19 quarantine and testing
strategies. Nature Communications 2021 Jan 7; 12(1): 356.
doi:10.1038/s41467-020-20742-8. PMID: 33414470; PMCID: PMC7788536.
(Wells et al., 2021)
I. Face Coverings
Paragraph (i) of this standard addresses the use of face coverings.
As previously discussed in Grave Danger (Section III.A. of this
preamble), COVID-19 spreads when an infected person breathes out
droplets and very small particles that contain the virus. These
droplets and particles can be breathed in by other people or land on
their eyes, noses, or mouth. Face coverings reduce the risk of droplet
transmission of COVID-19. The CDC recommends that people who are not
fully vaccinated wear a face covering (e.g., a mask) in indoor public
places. (CDC, July 14, 2021). Additional discussion on the efficacy of
face coverings is provided below.
Face coverings are simple bi-directional barriers that tend to keep
droplets, and to a lesser extent airborne particulates, on the side of
the filter from which they originate. An explanation of the term ``face
covering'', as used in this ETS, can be found in the Summary and
Explanation for paragraph (c) (Section VI.C. of this preamble). The CDC
(August 13, 2021) recommends unvaccinated people wear face coverings
when indoors to prevent getting and spreading COVID-19 mostly by
blocking large respiratory droplets from either leaving the face
covering of the wearer (source control) or by preventing someone else's
droplets from reaching the wearer (personal protection). The need for
face coverings in workplaces applies particularly to unvaccinated
workers due to their increased potential for asymptomatic and pre-
symptomatic transmission of COVID-19.
The CDC Healthcare Infection Control Practices Advisory Committee's
(HICPAC) ``Isolation Guidance'' for healthcare settings has long
recommended facemasks, among other controls, to prevent the
transmission of viruses that cause respiratory illnesses (Siegel et
al., 2007). Face coverings play an important dual role in protecting
workers from droplet transmission of COVID-19. One of their key
purposes is to function as source control. In this role, the face
covering helps protect people around the wearer by reducing the number
of infectious droplets released into the air by the wearer and limiting
the distance traveled by any particles that are released. As a result,
anyone near the wearer is exposed to fewer (if any) droplets and the
transmission risk is lowered (OSHA,
[[Page 61537]]
January 28, 2021; Siegel et al., 2007). Face coverings also provide a
degree of particulate filtration to reduce the amount of inhaled
particulate matter, meaning face coverings can help protect the wearer
themselves, by reducing their inhalation of droplets produced by an
infected person nearby (CDC, May 7, 2021; Brooks et al., February 10,
2021).
The efficacy of any given face covering in either functioning as
source control or protecting the wearer will depend on the
construction, design, and material used for the face covering. The CDC
has stated that ``masks are primarily intended to reduce the emission
of virus-laden droplets (``source control''), which is especially
relevant for asymptomatic or presymptomatic infected wearers who feel
well and may be unaware of their infectiousness to others, and who are
estimated to account for more than 50% of transmissions'' (CDC, May 7,
2021). The CDC has also stated that: ``Multi-layer cloth masks block
release of exhaled respiratory particles into the environment, along
with the microorganisms these particles carry. Cloth masks not only
effectively block most large droplets (i.e., 20-30 microns and larger)
but they can also block the exhalation of fine droplets and particles
(also often referred to as aerosols) smaller than 10 microns; which
increase in number with the volume of speech and specific types of
phonation. Multi-layer cloth masks can both block up to 50-70% of these
fine droplets and particles and limit the forward spread of those that
are not captured. Upwards of 80% blockage has been achieved in human
experiments that have measured blocking of all respiratory droplets,
with cloth masks in some studies performing on par with surgical masks
as barriers for source control'' (CDC, May 7, 2021). Thus, the
construction of the face covering is a significant factor in
determining its efficacy at reducing COVID-19 transmission.
While face coverings are generally effective as source control,
because of the potential variations in protective properties, OSHA has
not considered face coverings that are not certified to a consensus
standard to be personal protective equipment (PPE) under OSHA's general
PPE standard (29 CFR 1910.132), as there is insufficient assurance that
any given face covering is of safe design and construction for the work
to be performed, which is required by the PPE standard. Despite these
limitations, many of the available face coverings have proven to be
effective at providing source control, and where a face covering is
also effective in providing personal protection, the wearer will be at
reduced risk of, and could be protected from, infection. Accordingly,
over the course of the pandemic, through its guidance, OSHA has
strongly encouraged workers to wear face coverings when they are in
close contact with others to reduce the risk of spreading COVID-19
despite the shortcomings that have prevented the agency from
considering them to be PPE that complies with the requirement of the
PPE standard. To enhance the effectiveness of any face covering
required by this standard, this ETS imposes certain minimum design
criteria, consistent with CDC recommendations. Thus, the face covering
must consist of at least two layers of material that is either tightly
woven or non-woven, and the face covering must not have visible holes
or openings. CDC has found face coverings that are tightly woven and
made with at least two layers are more effective at filtering droplets
than face coverings that are loosely woven or consist of a single layer
of fabric (CDC, May 7, 2021; Ueki et al., June 25, 2020).
OSHA's determination on the importance of face coverings is
supported by a substantial body of evidence. As described in further
detail below, consistent and correct use of face coverings is widely
recognized and scientifically supported as an important evidence-based
strategy for COVID-19 control. Accordingly, with specific exceptions
relevant to outdoor areas and vaccinated persons, the CDC recommends
everyone two years of age and older wear a face covering in public
settings and when around people outside of their household (CDC, August
13, 2021). And, on January 21, 2021, President Biden issued Executive
Order 13998, which recognizes the use of face coverings or facemasks as
a necessary, science-based public health measure to prevent the spread
of COVID-19, and therefore directed regulatory action to require that
they be worn in compliance with CDC guidance while traveling on public
transportation (e.g., buses, trains, subway) and while at airports
(Executive Order 13998, 86 FR 7205, 7205 (Jan. 21, 2021); CDC, February
2, 2021). Similarly, the World Health Organization (WHO) has recognized
face coverings as a key measure in suppressing COVID-19 transmission,
and thus, saving lives. The WHO observes that face coverings serve two
purposes, to both protect healthy people from acquiring COVID-19 and to
prevent sick people from further spreading it. Since December of 2020,
the WHO has recommended that the general public wear face coverings in
indoor settings and in outdoor settings where physical distancing
cannot be maintained (WHO, December 1, 2020).
In the United States, several states have imposed statewide face
covering mandates in order to mitigate the spread of COVID-19. One
study examined data on statewide face covering mandates during March 1-
October 22, 2020, and found that statewide face covering mandates were
associated with a decline in weekly COVID-19-associated hospitalization
growth rates by up to 5.6 percentage points for adults aged 18-64 years
after mandate implementation, compared with growth rates during the 4
weeks preceding implementation of the mandate (Joo et al., February 12,
2021). Similarly, another study examined the association of state-
issued face covering mandates with COVID-19 cases and deaths during
March 1-December 31, 2020, and found mandating face coverings was
associated with a decrease in daily COVID-19 case and death growth
rates within 20 days of implementation (Guy et al., March 12, 2021).
School face covering policies for students, staff members, faculty,
and visitors are associated with a reduction in COVID-19 outbreaks.
Between July 15 and August 31, 2021, schools in Arizona were analyzed
for school mask policies, which provided that all persons, regardless
of vaccination status, were required to wear a mask indoors. The odds
of a school-associated COVID-19 outbreak in schools without a mask
requirement were 3.5 times higher than those in schools with an early
mask requirement (Odds Ratio = 3.5; 95% Confidence Interval = 1.8-6.9)
(Jehn et al., October 1, 2021).
The effectiveness of face coverings in limiting the emission and
spread of droplets has also been demonstrated in numerous studies. For
example, multiple studies in which droplets were visualized while
individuals were talking or a manikin was used to simulate coughs and
sneezes demonstrated that two-layer face coverings limited the number
of droplets released into the air, and limited the forward spread of
those not captured (Fischer et al., September 2, 2020; Verma et al.,
June 30, 2020; CDC, May 7, 2021).
The effectiveness of face coverings in preventing infections was
also observed in a number of epidemiological studies. For example, in
June of 2020 an outbreak was studied aboard the USS Theodore Roosevelt,
an environment notable for congregate living quarters, close working
environments, and a sample of mostly young, healthy adults. The
investigation found that use of face
[[Page 61538]]
coverings on board was associated with a 70% reduced risk of
transmission, which demonstrates that the use of face coverings,
especially among asymptomatic cases, can help mitigate future
transmission (Payne et al., June 12, 2020). Another publication,
released in July of 2020, included an investigation of a high-exposure
event among 139 clients exposed to two symptomatic hair stylists with
confirmed cases of COVID-19. Both of the stylists and all of their
clients wore face coverings during their interactions. Among 67 clients
subsequently tested for COVID-19, all test results were negative; no
symptomatic secondary cases were reported by any clients, including
those who were not tested. The study concluded that the strict use of
face coverings likely mitigated the spread of COVID-19 (Hendrix et al.,
July 17, 2020).
Several other observational epidemiological studies have reviewed
data regarding the ``real-world'' effectiveness of face covering usage.
First, in a study of 124 Beijing households with one or more
laboratory-confirmed case of COVID-19, face covering use by both the
index patient and all family contacts before the index patient
developed symptoms reduced secondary transmission (i.e., infections
occurring within two weeks of symptom onset in the index case) within
the households by 79% (Wang et al., May 11, 2020). Second, a
retrospective case-control study from Thailand documented that, among
more than 1,000 persons interviewed as part of contact tracing
investigations, those who reported having always worn a face covering
during high-risk exposures experienced a greater than 70% reduced risk
of infection compared with persons who did not wear face coverings
under these circumstances. The risk for infection was not significantly
lower in those who reported only sometimes wearing face coverings
compared to those who did not wear face coverings at all. This evidence
supports the conclusion that face coverings must be worn consistently
and correctly to meaningfully reduce the risk of infection (Doung-ngern
et al., September 14, 2020).
Community-level analyses have also confirmed the benefit of
universal face covering use in: A unified hospital system (Wang et al.,
July 14, 2020); a German city (Mitze et al., June 1, 2020); a U.S.
state (Gallaway et al., October 6, 2020); a panel of 15 U.S. states and
Washington, DC (Lyu and Wehby, June 16, 2020; Hatzius et al., June 29,
2020); as well as both Canada (Karaivanov et al., October 1, 2020) and
the U.S. (Chernozhukov et al., September 15, 2020) nationally. Each
community analysis demonstrated that, following universal face covering
directives from both organizational and political leadership, new
infections were shown to fall significantly. These analyses have also
shown reductions in mortality and the need for lockdowns, with their
associated monetary/gross domestic product losses (Leffler et al.,
December 2, 2020; Hatzius et al., June 29, 2020). Additionally,
multiple investigations involving infected passengers aboard flights
longer than ten hours strongly suggest that face covering usage
prevented in-flight transmissions, as demonstrated by the absence of
infection developing in other passengers and crew in the 14 days
following exposure (Schwartz et al., April 14, 2020; Freedman and
Wilder-Smith, September 25, 2020).
Researchers from the COVID-19 Systematic Urgent Review Group Effort
investigated the effects of face coverings and eye protection on virus
transmission in both healthcare and non-healthcare settings. They
identified 172 observational studies for their systematic review and 44
comparative studies for their meta-analysis, including data on 25,697
COVID-19, SARS, or MERS patients. They concluded for the general
public, based mainly on evidence from face covering use within
households and among contacts of cases, that disposable surgical masks
or face coverings (reusable multi-layer cotton face coverings) are
associated with protection from viral transmission. Through the meta-
analysis, combining 39 of the studies' results, they found a 14.3%
reduction in the difference of anticipated absolute effect (e.g., the
chance of viral infection or transmission) between no face covering and
face covering groups (Chu et al., June 27, 2020).
Ueki et al. (June 25, 2020) evaluated the effectiveness of cotton
face coverings, facemasks, and N95s (a commonly used respirator) in
preventing transmission of SARS-CoV-2 using a laboratory experimental
setting with manikins. The researchers found that all offerings
provided some measure of protection as source control, limiting
droplets expelled from both infected and uninfected wearers. For
instance, when spaced roughly 20 inches apart, an uninfected person can
reduce inhalation of infectious virus by 37% by wearing a cotton face
covering. If only the infected person wears a cotton face covering, the
amount breathed in by the uninfected recipient is reduced by 57%.
However, if both individuals wear a cotton face covering, the exposure
is reduced 67%. If both are wearing facemasks, exposure is reduced by
76%. When an infected individual wore an N95 respirator, exposure was
reduced by 96% or, when the seams were taped, 99.7%.
As demonstrated by the studies above, proper face covering usage
leads to a substantial reduction in the emission of virus-containing
droplets and consequent transmission of the virus. This is especially
critical for asymptomatic or pre-symptomatic infected wearers who feel
well and may not be taking other preventative measures--like self-
isolation--because they are unaware of their infectiousness to others.
Combined, these individuals are estimated to account for more than 50%
of COVID-19 transmissions (Honein et al., December 11, 2020; Moghadas
et al., July 6, 2020; Johansson et al., January 7, 2021). This figure
could be substantially reduced if face coverings are required, even for
individuals who do not feel sick. Face covering use is also especially
important in indoor spaces (Honein et al., December 11, 2020). The
studies reviewed above show that face coverings reduce the release of
droplets but do not completely eliminate them. CDC guidance affirms
that COVID-19 pandemic control requires face covering use (Honein et
al., December 11, 2020; CDC, May 7, 2021). Similarly, the WHO advises
face covering use as a critical measure of a comprehensive package of
prevention and control measures to limit the spread of COVID-19 (WHO,
December 1, 2020).
Although increasing COVID-19 vaccination coverage remains the most
effective means to achieve control of the pandemic, additional layered
prevention strategies will be needed in the short term to minimize
preventable morbidity and mortality among unvaccinated individuals.
Unvaccinated individuals remain at substantial risk for infection,
severe illness, and death, especially in areas where the level of SARS-
CoV-2 community transmission is high (discussed in detail in Grave
Danger (Section III.A. of this preamble)). Among strategies to prevent
COVID-19, CDC recommends all unvaccinated individuals wear face
coverings in public indoor settings. A proven effective strategy
against SARS-CoV-2 transmission, beyond vaccination, includes using
face coverings consistently and correctly (Christie et al., July 30,
2021).
The agency is not requiring the use of face coverings by workers
who are fully vaccinated because vaccination is sufficient to reduce
the grave danger to
[[Page 61539]]
themselves or others. While vaccination is sufficient to reduce grave
danger to the workers themselves, the agency recognizes that there may
still be residual risk (e.g., breakthrough infections); severe health
outcomes among vaccinated workers, however, are unlikely. Vaccination
is also sufficient to reduce the grave danger that fully vaccinated
workers present to others given the reduced likelihood of transmission
(see Grave Danger in Section III.A. of this preamble). Nonetheless, the
use of face coverings by fully vaccinated workers, while not required
by this ETS, is strongly encouraged in a wide range of circumstances to
reduce the overall risk of transmitting COVID-19, particularly in areas
of substantial or high transmission, when indoors and when in crowded
outdoor areas. The use of face coverings by customers and visitors to
workplaces is also beneficial in reducing the overall risk of workplace
transmission of COVID-19.
OSHA has always considered recognized consensus standards, with
design and construction specifications, when determining the PPE
requirements of the agency's standards. The OSH Act (29 U.S.C.
655(b)(8)) requires the agency to generally give deference to consensus
standards unless setting its own specifications would better effectuate
the purposes of the Act. The agency's standards generally require PPE
to conform to the specifications in consensus standards through
incorporation by reference (e.g., eye and face protection, head
protection, foot protection). ASTM released a specification standard on
February 15, 2021, to establish a national standard baseline for
barrier face coverings (ASTM F3502-21). OSHA considered, as required,
incorporation of ASTM F3502-21 in this ETS. However, the agency has
determined that it is infeasible for the timeframe of this ETS to
incorporate this consensus standard or to otherwise establish
additional criteria for face coverings beyond that already recommended
by the CDC due to the time needed to manufacture and distribute any new
product. OSHA notes the CDC's guidance on types of masks, including
those that meet ASTM F3502-21 requirements, and respirators as helpful
to employers and workers in selecting an appropriate product (CDC,
September 23, 2021).
Relatedly, OSHA has previously established that medical facemasks
are essential PPE for workers in healthcare and associated industries,
and are already used by workers under both the general PPE standard (29
CFR 1910.132), and more specifically, the Bloodborne Pathogens standard
(29 CFR 1910.1030). Facemasks are intended for a medical purpose, such
as prevention of infectious disease transmission (including uses
related to COVID-19). Facemasks can function as a barrier to protect
the wearer from hazards such as splashes or large droplets of blood and
bodily fluids. Facemasks, such as surgical masks, must be FDA-cleared
or authorized by FDA, including under an EUA and provide a similar or
greater level of protection when serving the purposes of a face
covering. Respirators are another type of personal protective device
that OSHA has regulated under the Respiratory Protection standard (29
CFR 1910.134).
The best available experimental and epidemiological data support
consistent use of face coverings by unvaccinated workers in work
settings to reduce the spread of COVID-19 through droplet transmission.
As discussed in Need for the ETS (Section III.B. of this preamble),
adopting face covering policies is necessary, as part of a strategy
combined with testing, to protect employees from exposure to COVID-19.
Requiring unvaccinated workers to wear face coverings in the workplace
will reduce the likelihood that, in conjunction with the testing
(paragraph (g)) and removal, of infected workers, (paragraph (h))
requirements, they will spread the virus to others, including other
unvaccinated coworkers. Based on the proven effectiveness of face
covering use, OSHA's COVID-19 ETS includes necessary provisions for
required use of face coverings by unvaccinated workers and provisions
to allow vaccinated workers and customers and visitors to wear face
coverings or respirators as a component of reducing the overall risk of
COVID-19 transmission in the workplace.
The benefits that result from the use of face coverings for
preventing transmission of COVID-19 are derived from the combination of
source control (i.e., reducing the spread of large respiratory droplets
to others by covering an infected person's mouth and nose) and some
personal protection for the wearer, as was discussed above in the Need
for Face Coverings section. Face coverings are a vital layer of
protection, and the benefit to any given individual increases with
increasing community use. Paragraph (i) contains requirements for the
use of face coverings by each employee who is not fully vaccinated, as
well as alternatives to face coverings (e.g., facemasks, respirators)
that may be acceptable in some situations (described in detail below).
As defined in paragraph (c), a face covering means a covering that
completely covers the nose and mouth of the wearer, excluding face
shields, which is made with two or more layers of a breathable fabric
that is tightly woven, is secured to the wearer's head with ties, ear
loops, or elastic bands that go behind the head, and is a solid piece
of material without slits, exhalation valves, visible holes, or other
openings in the material. This definition encompasses face coverings
that otherwise meet the definition of face covering under paragraph
(c), but include clear plastic windows, such as those utilized by
persons communicating with those who are deaf or hard-of-hearing or
when seeing a person's mouth is otherwise important. Face coverings can
be manufactured or homemade, and they can incorporate a variety of
designs, structures, and materials. Face coverings can be disposable or
reusable. Face coverings do not have to meet a consensus standard,
although they might. Apart from any applicable FDA or NIOSH regulatory
requirements that might otherwise apply, such requirements are not
required solely for the purposes of meeting the requirements of this
standard.
As a general rule, OSHA has authority to, and does, require
employers to bear the costs for protective equipment, among other
worker protections, required by an OSHA standard. See, e.g., 29 CFR
1910.1018(j) (requiring the employer to provide protective clothing at
no cost to the employee). However, in limited circumstances, OSHA has
chosen not to require employers to pay for some forms of non-
specialized protective equipment, such as every-day clothing, products
providing weather-related protection, and non-specialized equipment
that the employee wears off the job site. See 29 CFR 1910.132(h)(2)-
(5). Like the analogous situations listed above, here employees may use
their personal face coverings in a variety of circumstances on and off
the job site as part of their every-day protection. Because the types
of face coverings permitted under this ETS are widely used and readily
available, (see Technological Feasibility (Section IV.A. of this
preamble)), employees will have no difficulty obtaining them. OSHA is
requiring employers to bear the costs for employee vaccination, because
it is the more protective control, (Need for the ETS (Section III.B. of
this preamble). OSHA does not believe it appropriate to impose the
costs of personal face coverings on an employer where an employee has
made an individual choice to pursue a less protective option. For these
reasons, OSHA has
[[Page 61540]]
determined not to impose the costs of face coverings on the employer as
a requirement under this ETS.
Paragraph (i)(1) requires employers to ensure that each employee
who is not fully vaccinated wears a face covering when indoors or when
occupying a vehicle with another person for work purposes, except (i)
when an employee is alone in a room with floor to ceilings windows and
a closed door. However, if that employee exits the room or another
individual enters the room, they are required to wear a face covering.
The second exception is (ii) for a limited time while an employee is
eating or drinking at the workplace or for identification purposes in
compliance with safety and security requirements. Under this exception,
employees are not required to wear face coverings during the limited
time while eating or drinking at the workplace. Employers may also let
employees eat or drink outside where there may be more space and
reduced risk of transmission. Additionally, under the exception in
paragraph (i)(1)(ii), employees are not required to wear a face
covering for a limited time for identification purposes in compliance
with safety and security requirements. This means that an unvaccinated
employee can temporarily remove their face covering when at a security
checkpoint within their worksite and when identification is otherwise
required.
Another exception for required face coverings is under paragraph
(i)(1)(iii) for when an employee is wearing a respirator or facemask in
accordance with other OSHA standards (e.g., 1910.134, 1910.504,
1910.1030, 1910.502). Facemask or respirator use in accordance with
other OSHA standards takes precedence over face covering use in this
ETS. For example, OSHA standard 1910.1030 has requirements for
facemasks in healthcare settings and requires that workers should
continue to use the required facemask appropriate for that setting.
Another example may include a worker who is required to use a
respirator under 1910.134 for workplace exposure to harmful dusts,
where effective engineering controls are not feasible; that worker
should continue to use the required respirator. Employees must resume
wearing a face covering when not engaged in the activity where a
facemask or respirator is required as an essential part of their job.
The last exception, contained in paragraph (i)(1)(iv), is for a very
limited set of circumstances where employers can show that the use of
the face covering is infeasible or creates a greater hazard. Situations
where it is important to see an employee's mouth for reasons related to
their job duties, or their job requires the use of their uncovered
mouth, or when the use of a face covering presents a risk of serious
injury or death to the employee, would also be covered under this
provision. As has been previously discussed in Summary and Explanation
for paragraph (d) (Section VI.D. of this preamble), OSHA recognizes
that there may be certain workers who may not be able to wear a face
covering due to a disability or sincerely held religious belief and are
entitled to an accommodation.
If employers receive accommodation requests relating to face
coverings or other protective gear, for example due to disability or
religious garb or grooming, they should evaluate those requests under
applicable laws (EEOC, October 25, 2021).
Paragraph (i)(2) requires that employers ensure that any face
covering required to be worn by this section is: (i) Worn by the
employee to fully cover the employee's nose and mouth; and (ii)
replaced when wet, soiled, or damaged (e.g., is ripped, has holes, or
has broken ear loops). To be worn properly, face coverings must
completely cover the wearer's mouth and nose and must fit snugly
against the sides of the face without gaps. Gaps can let air with
respiratory droplets leak in and out around the edges of the mask. Face
coverings with a nose wire help to avoid issues with glasses fogging
and create a snug fit. Workers can also use a mask fitter or brace over
a disposable mask or a cloth mask to prevent air from leaking around
the edges of the mask. To ensure face coverings are worn properly, an
employer might appoint a manager or senior employee to check that each
unvaccinated employee is properly wearing a face covering at the start
of and throughout each shift. Many aspects of proper mask use are
easily observable (e.g., covering the mouth and nose, as well as no
observable gaps). Additionally, employers may consider utilizing
workplace announcements (email messages, safety talks, etc.) or
displaying signs or posters throughout the facility about proper face
covering usage.
The employer must ensure that employees replace face coverings when
wet, soiled, or damaged (paragraph (i)(2)(ii)). Face coverings can
become soiled by splashes, sprays, or splatters, from contact with a
contaminated surface, or by touching/adjusting them with contaminated
hands. Damaged face coverings may not fit properly and thus will have
reduced effectiveness. Employees who work where there is potential for
spills, sprays, or splashes may need to change or replace their face
coverings more frequently (e.g., in food, meat, or poultry processing
plants; water, sanitation, or wastewater treatment facilities; or
restaurants). As note 1 to paragraph (i) addresses, face shields may be
worn in addition to face coverings to prevent them from getting wet and
soiled. For work where face coverings are expected to become dirty or
soiled less frequently, employees may only need to replace their face
coverings daily (e.g., in retail or office buildings). Regardless of
work location, reusable face coverings can become soiled after each use
and may be contaminated with bacteria and viruses, including the virus
that causes COVID-19. To ensure performance and minimize the risk of
contaminating employees after contact with a soiled face covering, as
described previously, the CDC recommends washing them whenever they get
dirty, but at least once a day. The CDC also has guidance on the
selection, proper wearing, cleaning, and storage of face coverings
(CDC, August 13, 2021).
The employer must not prevent any employee, regardless of
vaccination status, from voluntarily wearing a face covering or
facemask unless the employer can demonstrate that doing so would create
a hazard (paragraph (i)(3)). While vaccination greatly reduces the risk
of the most severe consequences of COVID-19 (e.g. hospitalizations and
fatalities) to workers, it does not reduce the risk to zero and thus
workers must be permitted to wear face coverings or facemasks even when
not required to in order to allow the workers to further address
residual risk. The agency has determined this provision is necessary
because employees may themselves have additional medical risk factors
that employers may or may not be aware of, and which require enhanced
precautions. Similarly, employees may live with or have frequent
contact with family members or others who have enhanced risk if
infected with COVID-19 and thus justify assuring the employees' ability
to take reasonable precautions to protect their own health and safety
or that of loved ones.
Paragraph (i)(4) states that the employer must permit the employee
to wear a respirator instead of a face covering whether required or not
(i.e., without regard to vaccination status), and the employer may
provide respirators to the employee, even if not required. This means
that when a face covering is not required by paragraph (i)(1), the
employer must permit the employee to wear a respirator or the employer
may even provide a respirator; in such circumstances, the employer must
also comply with 1910.504 (the mini respiratory protection program).
[[Page 61541]]
Respirators, as defined in paragraph (c), are a type of PPE that are
certified by NIOSH or authorized under an Emergency Use Authorization
(EUA) by the FDA, and protect against airborne hazards by removing
specific air contaminants from the ambient (surrounding) air or by
supplying breathable air from a safe source. Respirator use can provide
an additional level of comfort and protection beyond that provided by
face coverings for employees in circumstances that do not require a
respirator to be used. As discussed previously, the agency has
determined that workers need the ability to wear PPE, even when it is
not required, in order to address residual risk and due to health
conditions that either they or their close contacts may have that
warrant enhanced precautions. For a more in-depth description of the
mini respiratory protection program, see the preamble to the Healthcare
ETS (86 FR 32615-32617). OSHA intends the mini respirator protection
program to be preserved for the duration of this ETS, and any
references relied upon by OSHA in those sections of the Healthcare ETS
are also incorporated explicitly into the rulemaking docket for this
ETS.
The mini respiratory protection program is designed to strengthen
employee protections with a small set of provisions for the safe use of
respirators designed to be easier and faster to implement than the more
comprehensive respiratory protection program under 29 CFR 1910.134.
This ETS is addressing an emergency health crisis, so it is critical
for employers to be able to get more employee protection in place
quickly. OSHA expects that this approach will facilitate additional
employee choice for the additional protection provided by respirators
while reducing disincentives that may have discouraged employers from
allowing or voluntarily providing respirators. A mini respirator
program is therefore an important control to protect employees from the
hazard posed by COVID-19.
The mini respiratory protection program is primarily intended to be
used for addressing circumstances where employees are not exposed to
suspected or confirmed sources of COVID-19, but where respirator use
could offer enhanced protection to employees. Examples include when a
respirator could offer enhanced protection in circumstances where a
less protective (in terms of filtering and fit) face covering is
required under the ETS (See 29 CFR 1910.501(i)(1)). The decision to use
a respirator in place of a face covering could be due to the higher
filter efficiency and better sealing characteristics of respirators
when compared to face coverings. For additional discussion, the
rationale for the mini respiratory protection program was addressed in
detail in Need for Specific Provisions in the agency's prior rulemaking
on 1910.504, and the requirements of the mini respiratory protection
program section are discussed in Summary and Explanation in the
agency's prior rulemaking on 1910.504.
As required by paragraph (i)(5), the employers must not prohibit
customers or visitors from wearing face coverings. Face coverings are a
vital layer of protection against the risk of COVID-19. (See the
discussion earlier in this section on the benefits to individuals
associated with increased community use.) This provision is necessary
because increased use of face coverings also reduces the overall risk
of COVID-19 transmission from the customers and visitors to workers,
both unvaccinated and vaccinated alike. Additionally, it allows
customers and visitors to protect their own health and safety.
Employers may even want to create a policy encouraging the use of face
coverings by anyone who enters the business; they are encouraged to
coordinate with state and local health officials to obtain and respond
appropriately to timely and accurate information (e.g., level of
community transmission, health system capacity, vaccination coverage,
capacity for early detection of increases in COVID-19 cases, and
populations at risk for severe outcomes from COVID-19). Local
conditions will influence the decisions that public health officials
make regarding community-level strategies. Additionally, workers and
their representatives may also negotiate additional face covering
measures not required by the ETS through collective bargaining
agreements or other collectively negotiated agreements.
Lastly, for the reasons explained above, note 2 to paragraph (i)
clarifies that this section does not require the employer to pay for
any costs associated with face coverings. However, the note also makes
clear that this section does not prohibit the employer from paying for
costs associated with face coverings required by this section. OSHA
notes that employer payment for face coverings may be required by other
laws, regulations, or collective bargaining agreements or other
collectively negotiated agreements. Additionally, workers and their
representatives may also negotiate employer payment for face coverings
not required by the ETS through collective bargaining agreements or
other collectively negotiated agreements.
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J. Information Provided to Employees
In order to successfully implement the provisions of the ETS, it is
critical that employers provide relevant information to employees.
Employers must provide employees with the information specified in
paragraph (j), an essential part of this ETS, because it helps to
ensure that employees understand both their rights and responsibilities
under the ETS and their employer's policies and procedures. The ETS
cannot be effective if employees do not have sufficient knowledge and
understanding of the requirements of the ETS, their employers' policies
and procedures, information about available COVID-19 vaccines, their
protections against retaliation and discrimination, and the potential
penalties for knowingly providing false information to their employer.
Paragraph (j) provides that employers must provide the required
information to each employee in a language and at a literacy level the
employee understands. This means that if an employer has employees that
speak different languages or are at different literacy levels, the
employer must present information in a way that ensures each employee
can understand it. This may require an employer to create different
materials for different groups of employees (e.g., materials in
different languages). When information must be translated into
different languages, employers must ensure the translation is one the
employees can
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understand. When an employer provides employees with the required
information in a manner employees understand, they help ensure that
their implementation of this ETS is successful.
The manner in which employers provide the required information to
employees may vary based on the size and type of workplace. Employers
have flexibility to communicate this information to employees using any
effective methods that are typically used in their workplaces, and may
choose any method of informing employees so long as each employee
receives the information specified in the standard in a language and at
a literacy level they understand. For example, an employer may provide
this information to employees through email communications, printed
fact sheets, or during a discussion at a regularly scheduled team
meeting. To ensure comprehension of the information provided, employers
can identify a point-of-contact for employees who have questions about
the information provided.
Paragraphs (j)(1)-(4) specify the information that employers must
provide to employees. Paragraph (j)(1) requires employers to provide
each employee with information regarding the requirements of Sec.
1910.501 and any policies and procedures the employer establishes to
implement this ETS. The information provided to employees must cover
any employer policies under paragraph (d), including the details of the
employer's vaccination policy. Employers must also inform employees
about the process that will be used to determine employee vaccination
status, as required under paragraph (e). In addition, employers must
inform employees about the time and pay/leave they are entitled to for
vaccinations and any side effects experienced following vaccinations,
as required by paragraph (f). And employers must also inform employees
about the procedures they need to follow to provide notice of a
positive COVID-19 test or diagnosis of COVID-19 by a licensed
healthcare provider, as required under paragraph (h), as well as the
procedures to be used for requesting records under paragraph (l).
Employers must provide additional information to unvaccinated
employees, including information about the employer's policies and
procedures for COVID-19 testing and face coverings, as required by
paragraphs (g) and (i), respectively.
Some employers may have informed employees about their COVID-
related workplace-specific policies, e.g., policies on vaccination,
testing, and face coverings, prior to the effective date of this ETS.
Employers may rely on any such prior communications for purposes of
complying with paragraph (j)(1) to the extent that the prior
communications meet the relevant requirements of paragraph (j) and
there have been no changes to the relevant policies. Employers must
review and evaluate the information already provided to determine
whether it covers all of the information necessary under paragraph
(j)(1). If previous information provided to employees did not cover all
of the required elements, the employer must provide employees the
information on those missing elements to come into compliance with the
ETS. For example, if an employer has a mandatory vaccination policy and
has already provided information to the employees on the policies and
procedures the employer has established to implement that policy, and
provided that information in a language and at a literacy level each
employee can understand, the employer would not need to expend
resources to provide that information again to meet the requirements
under this ETS. However, the employer would still need to provide
information to its employees about other new policies and procedures
established to implement the ETS.
When an employer's policies or procedures change, the employer must
provide any updated or supplemental information to employees. For
example, an employer may initially opt to allow only paper copies as
proof of COVID-19 test results. Over time, however, the employer may
decide that it wants to accept electronic proof of test results. If
that employer modifies its policy to permit employees to submit
electronic proof of test results, the employer must inform employees of
any new or altered policies and procedures that the employer implements
as a result.
Paragraph (j)(2) requires employers to provide information to each
employee about COVID-19 vaccine efficacy, safety, and the benefits of
being vaccinated. To meet this requirement, employers must provide the
CDC's document, ``Key Things to Know About COVID-19 Vaccines,''
available at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html (CDC, October 7, 2021), to each employee. The
employer may choose to provide this information to employees in either
an electronic or print format. The CDC currently provides this document
in multiple languages; however, employers may need to provide
additional translations if necessary to inform each employee of the
contents of the document in a language they understand. Employers do
not have any further obligations to create or provide information on
vaccine efficacy, safety, or the benefits of being vaccinated beyond
providing the aforementioned CDC document to each employee.
Paragraph (j)(3) requires employers to inform each employee about
the requirements of 29 CFR 1904.35(b)(1)(iv) and section 11(c) of the
OSH Act. These two provisions work together to protect employees from
retaliation for engaging in activities protected by OSHA statute or
regulation. The first of these provisions, section 1904.35(b)(1)(iv),
prohibits employers from discharging or in any manner discriminating
against any employee for reporting a work-related injury or illness.
The second provision, section 11(c) of the OSH Act, prohibits employers
from discriminating against employees for exercising rights under, or
as a result of actions required by, the ETS. Section 11(c) also
protects employees from retaliation for filing an occupational safety
or health complaint, reporting a work-related injury or illness, or
otherwise exercising any rights afforded by the OSH Act.
Retaliation takes many forms; it occurs when an employer (through a
manager, supervisor, or administrator) fires an employee or takes any
other type of adverse employment action against an employee for
engaging in a protected activity. Adverse employment actions include
discipline, reducing pay or hours, reassignment to a less desirable
position, denying overtime or promotion, intimidation or harassment,
and any other action that would dissuade a reasonable employee from
raising a concern about a possible violation or engaging in other
protected activity (see Burlington Northern & Santa Fe Railway Co. v.
White, 548 U.S. 53, 57 (2006) holding, in the Title VII context, that
the test for determining whether a particular employment action is
materially adverse is whether it ``could well dissuade'' a reasonable
person from engaging in protected activity).
The ETS does not change employers' substantive obligations under
either 29 CFR 1904.35(b)(1)(iv) or section 11(c) of the OSH Act.
Rather, it simply requires employers to make employees aware of these
provisions and their requirements. By increasing awareness, OSHA
believes that paragraph (j)(3) will prevent acts of retaliation from
occurring in the workplace, encourage employees to exercise their right
to the protections of the ETS, and engage
[[Page 61544]]
employees in actions required by the ETS.
It is critically important for employees to be aware of, and to be
able to exercise, their rights under the ETS. Employee participation is
essential to mitigating the spread of COVID-19 in the workplace, and
fear of retaliation would undermine the effectiveness of the ETS. For
example, per paragraph (f) of this ETS, employers must provide
employees up to 4 hours of paid time at the employee's regular rate of
pay for each vaccination dose, as well as reasonable time and paid sick
leave for employees to recover from side effects experienced following
any vaccination dose. If an employer fails to comply with paragraph (f)
and then retaliates against employees who object, employees may be
deterred from being vaccinated. Similarly, if employees fear
retaliation, they will be less likely to voice concerns about
unvaccinated co-workers who do not wear required face coverings (see
paragraph (i)(1)). A workplace free from the threat of retaliation
promotes collaboration between employers and employees and allows
employers to more effectively implement the various requirements of
this ETS.
OSHA has received a record number of complaints of retaliation
during the COVID-19 pandemic. The agency's website shows that, as of
September 26, 2021, OSHA had received 5,788 complaints of retaliation
related to workplace protections from COVID-19 (OSHA, September 29,
2021). These figures indicate that some employers need to be reminded
that they are legally prohibited from engaging in retaliatory actions.
Additionally, employees likely need reassurance of their legal right to
engage in protected activity without fear of suffering from adverse
employment actions. As such, it is critical for employers to inform
employees of the prohibitions against retaliation in 29 CFR
1904.35(b)(1)(iv) and section 11(c) after the effective date of the
ETS, without regard to any information they may have provided
previously on these anti-retaliation provisions. As with the other
parts of paragraph (j), employers have flexibility regarding how they
will provide the required information.
Paragraph (j)(4) requires employers to provide each employee with
information regarding the prohibitions of 18 U.S.C. 1001 and Section
17(g) of the OSH Act, which provide for criminal penalties associated
with knowingly supplying false statements or documentation. The first
of these two provisions, 18 U.S.C. 1001(a) is described earlier in this
preamble and provides for fines or imprisonment for persons who
``knowingly and willfully'' (1) falsifies, conceals, or covers up by
any trick, scheme, or device a material fact; (2) makes any materially
false, fictitious, or fraudulent statement or representation; or (3)
makes or uses any false writing or document knowing the same to contain
any materially false, fictitious, or fraudulent statement or entry. And
section 17(g) of the OSH Act provides for fines up to $10,000, and
imprisonment for not more than six months, or both, for anyone who
``knowingly makes any false statement, representation, or
certification'' in any application, record, report, plan, or other
document ``filed or required to be maintained pursuant to this
chapter.'' False statements or documents made or submitted for purposes
of complying with policies required by this ETS could fall under either
or both of these statutory provisions.
This ETS requires that each employee provide their employer either
COVID-19 vaccination documentation (paragraph (e)), or, if applicable,
regular COVID-19 test results (paragraph (g)). There is a significant
public health interest in ensuring employees provide this information
truthfully to the employer. Employers cannot effectively implement the
requirements of this ETS based on false information. By increasing
awareness of the possible penalties an employee may face for
misrepresenting their vaccination status or test results, OSHA intends
to discourage such behavior. Employers can satisfy the requirement of
paragraph (j)(4) by providing each employee with the text of the two
statutory provisions in hard copy or via electronic communication
(e.g., email), translated as necessary into other languages,
emphasizing the importance of providing truthful information about
vaccine status and test results, and explaining that providing false
information could be punishable under the two provisions. Employers are
not required to provide further explanation of the statutory provisions
or to provide legal advice.
Information requirements are routine components of OSHA standards.
The inclusion of information requirements in this ETS reflects the
agency's conviction, as noted above, that informed employees are
essential to the implementation of any effective occupational safety
and health policy or procedure. OSHA believes that informing employees
about their rights and responsibilities under the ETS; the employer's
policies and procedures; and the safety, efficacy, and benefits of
vaccination will help increase the number of employees vaccinated and
will facilitate effective implementation of the standard by employers.
References
Centers for Disease Control and Prevention (CDC). (2021, October 7).
Key Things to Know About COVID-19 Vaccines. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html. (CDC, October
7, 2021).
Occupational Safety and Health Administration (OSHA). (2021,
September 29). COVID-19 Response Summary: Summary Data for Federal
Programs--Whistleblower Data. https://www.whistleblowers.gov/covid-19-data. (OSHA, September 29, 2021).
K. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
OSHA has required employers to report work-related fatalities and
certain work-related hospitalizations under its recordkeeping
regulation since 1971. These requirements have been an important part
of the agency's statutory mission to assure safe and healthful working
conditions for all working people. All employers covered by the OSH
Act, including employers who are partially exempt from maintaining
injury and illness records, are required to comply with OSHA reporting
requirements at 29 CFR 1904.39. Under OSHA's current reporting
regulation, employers are required to report each work-related fatality
to OSHA within 8 hours of the event, and each work-related in-patient
hospitalization, amputation, and loss of an eye within 24 hours of the
event.
The purpose of the reporting requirement in Sec. 1904.39 is to
provide OSHA with information to determine whether it is necessary for
the agency to conduct an immediate investigation at a specific
establishment. Employer reports of work-related COVID-19 fatalities and
in-patient hospitalizations are an important element of the agency's
efforts to reduce occupational exposure to the virus. After receiving
an employer report, OSHA decides whether an inspection is needed to
determine the cause of a work-related COVID-19 fatality or in-patient
hospitalization, and whether any OSHA standards may have been violated.
These reports are critical for the agency to respond quickly to COVID-
19 exposure that may pose an ongoing risk to other employees at the
worksite. Timely investigation also allows OSHA to view evidence at a
workplace soon after a work-related COVID-19 fatality or in-patient
hospitalization has occurred, and can make it easier for the agency to
gather relevant information from others at the worksite that might be
useful in
[[Page 61545]]
protecting other employees. Moreover, prompt inspection enables OSHA to
gather information to evaluate whether its current standards adequately
address the workplace hazard presented from COVID-19. The information
gathered from employer reports is also used by the agency to form the
basis of statistical data on the causes and remediation of work-related
COVID-19 fatalities and in-patient hospitalizations.
In order to address the unique circumstances presented by COVID-19,
and to facilitate OSHA investigation and better workplace health
surveillance, paragraph (k)(1) requires covered employers to report
each work-related COVID-19 fatality to OSHA within 8 hours of the
employer learning about the fatality, and each work-related COVID-19
in-patient hospitalization to OSHA within 24 hours of the employer
learning about the in-patient hospitalization. As described in more
detail in the following discussion, OSHA is adding these additional
COVID-19 reporting requirements because the delay in the manifestation
and progression of symptoms of COVID-19 can lead to hospitalization or
fatality outside the normal window for reporting those workplace
events.
Paragraph (k)(1)(i) provides that employers must report each work-
related COVID-19 fatality to OSHA within 8 hours of the employer
learning about the fatality. Under this paragraph, an employer must
make a report to OSHA within 8 hours of learning both (1) that an
employee has died from a confirmed case of COVID-19, and (2) that the
cause of death was the result of a work-related exposure to COVID-19.
Employers are only required to report confirmed cases of COVID-19 as
defined by the Centers for Disease Control and Prevention (CDC) (CDC,
May 20, 2020). Typically, the cause of death is determined by the
physician who was responsible for a patient who died in a hospital,
although the cause of death can also be determined by others such as
medical examiners or coroners (Pappas, May 19, 2020).
The requirement in paragraph (k)(1)(i) is similar to the fatality
reporting requirement in OSHA's regulation at 29 CFR 1904.39(a)(1),
which requires an employer to report to OSHA within 8 hours after the
death of any employee as the result of a work-related incident.
However, 29 CFR 1904.39(b)(6) requires employers to report a work-
related fatality to OSHA only if the fatality occurs within 30 days of
``the work-related incident.'' Prior to this ETS, for purposes of
reporting events involving COVID-19, OSHA interpreted the phrase ``the
work-related incident'' to mean ``exposure'' in the work environment.
Therefore, in order to be reportable under 29 CFR 1904.39(a)(1), a
work-related fatality due to COVID-19 needed to have occurred within 30
days of an employee's exposure in the work environment. Given the
possibility of long-term illness before death, the 30-day limitation
for reporting fatalities to OSHA could restrict OSHA's ability to
receive information about work-related COVID-19 fatalities.
To address these issues, OSHA has chosen not to apply the 30-day
limitation period from 29 CFR 1904.39(b)(6) to the reporting provision
in paragraph (k) (see paragraph (k)(2)). Therefore, the requirement to
report these fatalities is not limited by the length of time between
workplace exposure and death. The reporting of work-related COVID-19
fatalities that occur beyond 30 days from the time of exposure will
enable the agency to evaluate more work-related COVID-19 fatalities to
determine whether immediate investigations are needed to prevent other
employees at the same worksite from being exposed to the virus. The
report of these fatalities to OSHA facilitates the agency's timely
tracking of this data. Accordingly, paragraph (k)(1)(i) requires
employers to report each work-related COVID-19 fatality to OSHA within
8 hours of the employer learning about the fatality regardless of when
the exposure in the work environment occurred.
Paragraph (k)(1)(ii) of the standard requires an employer to report
each work-related COVID-19 in-patient hospitalization to OSHA within 24
hours of the employer learning about the in-patient hospitalization.
Under this paragraph, and similar to OSHA's reporting regulation at 29
CFR 1904.39, an employer must make a report to OSHA within 24 hours of
learning that (1) an employee has been in-patient hospitalized due to a
confirmed case of COVID-19, and (2) the reason for the hospitalization
was the result of a work-related exposure to the illness.
OSHA's current reporting regulation at 29 CFR 1904.39(a)(2)
provides that, within 24 hours after the in-patient hospitalization of
one or more employees, as the result of a work-related incident, an
employer must report the in-patient hospitalization to OSHA. 29 CFR
1904.39(b)(6) requires employers to only report in-patient
hospitalizations to OSHA if the hospitalization occurs within 24 hours
of the work-related incident. For example, if an employee trips in the
workplace and sustains an injury on Monday, but is not hospitalized
until Thursday, the employer does not need to report the event. In this
example, ``the work-related incident'' occurred on Monday when the
employee tripped and was injured in the workplace. Also, under Sec.
1904.39, employers must report in-patient hospitalizations to OSHA
within 24 hours of knowing both that the employee has been in-patient
hospitalized and that the reason for the hospitalization was the result
of ``the work-related incident'' (see 29 CFR 1904.39(a)(2), (b)(7)-
(b)(8)). In non-COVID cases, the work-relatedness of the injury is
typically apparent immediately.
Since the beginning of the pandemic, the reporting of work-related
COVID-19 in-patient hospitalizations under 29 CFR 1904.39 has presented
unique challenges. As noted above, for purposes of reporting COVID-19
fatalities and in-patient hospitalizations, OSHA has interpreted the
phrase ``the work-related incident'' in 29 CFR 1904.39(b)(6) to mean an
employee's ``exposure'' to COVID-19 in the work environment. Thus, in
order to be reportable, an in-patient hospitalization needed to occur
within 24 hours of an employee's exposure to COVID-19 in the work
environment. Given the incubation period of the virus, and the typical
timeframe between exposure and the emergence of symptoms serious enough
to require hospitalization, it is extremely unlikely for an in-patient
hospitalization to occur within 24 hours of an employee's exposure to
the virus.
To address these issues, paragraph (k)(1)(ii) does not limit the
COVID-19 reporting requirement to only those hospitalizations that
occur within 24 hours of exposure, as in 29 CFR 1904.39(b)(6). This
change in the reporting requirement will result in OSHA making more
determinations as to whether immediate investigations are needed at
additional worksites. Given the severity of the disease, and how
quickly it can spread, it is essential that remediation efforts at a
workplace be undertaken immediately. As noted above, it is critical for
OSHA to respond quickly to hazardous conditions where employees have
been hospitalized. The elimination of the 24-hour limitation period
will not only allow OSHA to receive more employer reports about work-
related COVID-19 in-patient hospitalizations and, as a result, shed
light on where severe COVID-19 events are occurring, but it will also
enable the agency to respond more quickly and effectively to these
situations. Accordingly, employers must report each work-related COVID-
19 in-patient hospitalization to OSHA regardless of when the employee's
exposure in the workplace occurred (paragraph
[[Page 61546]]
(k)(1)(ii)). But consistent with OSHA's normal reporting requirements,
when hospitalization for a work-related case of COVID-19 does occur,
the employer must report it within 24 hours of learning about the
hospitalization.
Additionally, for purposes of this section, OSHA defines in-patient
hospitalization as a formal admission to the in-patient services of a
hospital or clinic for care or treatment (see 29 CFR 1904.39(b)(9) and
(b)(10)). The determination as to whether an employee is formally
admitted into the in-patient service is made by the hospital or clinic.
Treatment in an Emergency Room only is not reportable.
I. Work-Relatedness Determinations
Given the nature of the disease, and the extent of community
spread, in some cases, it may be difficult for an employer to determine
whether an employee's COVID-19 illness is work-related, especially when
an employee has experienced potential exposure both in and out of the
workplace. For purposes of this ETS, when evaluating whether a fatality
or in-patient hospitalization is the result of a work-related case of
COVID-19, employers must follow the criteria in OSHA's recordkeeping
regulation at 29 CFR 1904.5 for determining work-relatedness. Applying
the criteria in 29 CFR 1904.5 under paragraph (k) of this ETS is
consistent with how employers make work-relatedness determinations when
reporting fatalities and other serious events under 29 CFR 1904.39.
Under Sec. 1904.5, employers must consider an injury or illness to
be work-related if an event or exposure in the work environment either
caused or contributed to the resulting condition, or significantly
aggravated a pre-existing injury or illness. An injury or illness is
presumed work-related if it results from events or exposures occurring
in the work environment, unless an exception in Sec. 1904.5(b)(2)
specifically applies. Under this language, an injury or illness is
presumed work-related if an event or exposure in the work environment
is a discernable cause of the injury or illness (see 66 FR 66,943
(December 27, 2001)).
According to 29 CFR 1904.5(b)(3), the ``work environment'' includes
the employer's establishment and any other location where work is
performed or where employees are present as a condition of their
employment. Under 29 CFR 1904.5(b)(3), employers should evaluate the
employee's work duties and environment and determine whether it is more
likely than not that exposure at work caused or contributed to the
illness (see 66 FR 5958-59 (January 19, 2001)).
Because of the typical incubation period of 3 to 14 days, an
employee's exposure to COVID-19 will usually be determined after the
fact. Employers must make reasonable efforts to acquire the necessary
information to make good-faith work-relatedness determinations under
this section. In addition, the employer should rely on information that
is reasonably available at the time of the fatality or in-patient
hospitalization.
A work-related exposure in the work environment would likely
include close contact with a person known to be infected with COVID-19.
For example, although work-relatedness must be determined on a case-by-
case basis, if a number of COVID-19 illnesses develop among coworkers
who work closely together without an alternative explanation, it is
reasonable to conclude that an employee's fatality or in-patient
hospitalization is work-related. On the other hand, if there is not a
known exposure to COVID-19 that would trigger the presumption of work-
relatedness, the employer must evaluate the employee's work duties and
environment to determine whether it is more likely than not that the
employee was exposed to COVID-19 during the course of their employment.
Employers should consider factors such as:
The type, extent, and duration of contact the employee had
at the work environment with other people, particularly the general
public.
Physical distancing and other controls that impact the
likelihood of work-related exposure.
The extent and duration of time spent in a shared indoor
space with limited ventilation.
Whether the employee had work-related contact with anyone
who exhibited signs and symptoms of COVID-19.
Since 1971, under OSHA's recordkeeping system, employers have been
making work-relatedness determinations regarding workplace fatalities,
injuries, and illnesses. In general, employers are in the best position
to obtain information, both from the employee and the workplace,
necessary to make a work-relatedness determination. Although employers
may rely on experts and healthcare professionals for guidance, the
determination of work-relatedness ultimately rests with the employer.
Finally, OSHA wishes to emphasize that, under OSHA's recordkeeping
regulation at 29 CFR 1904, employers must record on the OSHA 300 log
each work-related fatality, injury, and illness reported to OSHA under
Sec. 1904.39. The work-relatedness determination for fatality and in-
patient hospitalization is no different than the requirement to
determine work-relatedness when entering fatalities, injuries and
illness on the OSH 300 log. Accordingly, the work-relatedness
determination for reporting COVID-19 fatalities and in-patient
hospitalizations is a determination that is already required to be made
by the employer.
II. Time Periods for Reporting COVID-19 Fatalities and In-Patient
Hospitalizations
As noted above, under paragraph (k), employers must report each
work-related COVID-19 fatality or hospitalization to OSHA within the
specified timeframes based on when any agent or employee of the
employer becomes aware of the reportable event. For example, an
employer ``learns'' of a COVID-19 fatality or in-patient
hospitalization when a supervisor, receptionist, or other employee at
the company receives information from a family member or medical
professional about an employee fatality or in-patient hospitalization.
It is the employer's responsibility to ensure that appropriate
instructions and procedures are in place so that managers, supervisors,
medical personnel, as well as other employees or agents of the company,
who learn of an employee's death or in-patient hospitalization due to
COVID-19 know that the company must make a report to OSHA.
Consistent with OSHA's regulation at 29 CFR 1904.39, the reporting
clock begins to run with the occurrence of the reportable event. Under
paragraph (k), in situations where the employer or the employer's agent
does not learn about the work-related COVID-19 fatality or in-patient
hospitalization right away, the employer must make the report to OSHA
within 8 hours for a fatality, or 24 hours for an in-patient
hospitalization, from the time the employer (or the employer's agent)
learns about the reportable event. For example, if an employee dies
from a work-related case of COVID-19 on Sunday at 6:00 a.m., but the
employer does not learn about the death until Monday at 8:00 a.m., the
employer has until 4:00 p.m. that day to make the report to OSHA.
Similarly, if an employee is in-patient hospitalized for a work-related
case of COVID-19 at 8:30 p.m. on Monday, but the employer or the
employer's agent(s) does not learn about the hospitalization until 9:00
a.m. the next day (Tuesday), then the employer would be required to
make the report to OSHA within 24 hours of learning of the in-patient
hospitalization
[[Page 61547]]
(i.e., by 9:00 a.m. on Wednesday) (see 29 CFR 1904.39(b)(7)).
Likewise, if an employer does not learn right away that a
reportable fatality or in-patient hospitalization is work-related, the
employer must make the report to OSHA within 8 hours or 24 hours of
learning that the death or in-patient hospitalization was the result of
a work-related COVID-19 exposure. For example, if an employee is in-
patient hospitalized for a case of COVID-19 at 9:00 a.m. on Monday, but
the employer does not have enough information to make a work-
relatedness determination until 11:00 a.m. on Monday, then the employer
would be required to report the hospitalization within 24 hours of
learning that the hospitalization was work-related (i.e., by 11:00 a.m.
on Tuesday) (see 29 CFR 1904.39(b)(8)).
Finally, if an employer makes a report to OSHA concerning a work-
related COVID-19 in-patient hospitalization and that employee
subsequently dies from the illness, the employer does not need to make
an additional fatality report to OSHA.
III. How To Report COVID-19 Fatalities and In-Patient Hospitalizations
and What Information Must Be Included in the Report
Paragraph (k)(2) of the standard provides that when reporting work-
related COVID-19 fatalities and in-patient hospitalizations to OSHA in
accordance with paragraph (k)(1), the employer must follow the
requirements in 29 CFR 1904.39, except for 29 CFR parts 1904.39(a)(1)-
(2) and (b)(6). As explained above, OSHA has included specific
provisions for the reporting of work-related COVID-19 fatalities and
in-patient hospitalizations that differ from 29 CFR 1904.39. However,
when making COVID-19 fatality and in-patient hospitalization reports to
OSHA, employers must follow the other reporting procedures set forth in
Sec. 1904.39. Specifically, under Sec. 1904.39(a)(3), employers have
three options for reporting work-related fatalities and in-patient
hospitalizations to OSHA:
1. By telephone to the OSHA Area Office that is nearest to the site
of the incident;
2. by telephone to the OSHA toll-free central telephone number, 1-
800-321-OSHA (1-800-321-6742);
3. by electronic submission using the reporting application located
on OSHA's public website at www.osha.gov.
Section 1904.39(a)(3) also allows employers to report work-related
fatalities and in-patient hospitalizations to OSHA in person to the
OSHA Area Office that is nearest to the site of the incident. However,
because many OSHA Area Offices are closed to the public during the
COVID-19 pandemic, employers must use one of the three options listed
above. In addition, Sec. 1904.39(b)(1) makes clear that, if the OSHA
Area Office is closed, an employer may not report a work-related
fatality or in-patient hospitalization by leaving a message on OSHA's
answering machine, faxing the Area Office, or sending an email.
Instead, the employer must make the report by using the 800 number or
the reporting application located on OSHA's public website at
www.osha.gov.
The other provisions in 29 CFR 1904.39 (except for 29 CFR
1904.39(a)(1)-(2) and (b)(6)) also apply to the reports required by
paragraph (k). For example, employers should consult 29 CFR
1904.39(b)(2) to determine what information employers must give to OSHA
when making COVID-19 fatality or in-patient hospitalization reports.
Per that provision, employers must give OSHA the following information
for each fatality or in-patient hospitalization: The establishment
name, the location of the work-related incident, the time of the work-
related incident, the type of reportable event (i.e., fatality or in-
patient hospitalization), the number of employees who suffered a
fatality or in-patient hospitalization, the names of the employees who
suffered a fatality or in-patient hospitalization, the employer's
contact person and his or her phone number, and a brief description of
the work-related incident.
References
Centers for Disease Control and Prevention. (2020, May 20).
Reporting and Coding Deaths Due to COVID-19. https://www.cdc.gov/nchs/covid19/coding-and-reporting.htm. (CDC, May 20, 2020).
Pappas, S. (2020, May 19). How COVID-19 Deaths are Counted.
Scientific American. https://www.scientificamerican.com/article/how-covid-19-deaths-are-counted1/. (Pappas, May 19, 2020).
L. Availability of Records
Section 8(c)(1) of the Act requires employers to ``make, keep and
preserve, and make available to the Secretary [of Labor] or the
Secretary of Health and Human Services, such records regarding his
activities relating to this Act as the Secretary, in cooperation with
the Secretary of Health and Human Services, may prescribe by regulation
as necessary or appropriate for the enforcement of this Act or for
developing information regarding the causes and prevention of
occupational accidents and illnesses.'' Section 8(c)(2) of the Act
specifically directs the Secretary of Labor to promulgate regulations
requiring employers to maintain accurate records of work-related
injuries and illnesses. Section 8(c)(3) of the Act requires employers
to ``maintain accurate records of employee exposures to potentially
toxic materials or harmful physical agents which are required to be
monitored or measured under section 6 [of the Act.]'' In accordance
with section 8(c), paragraph (l) of the ETS includes availability of
records requirements for certain COVID-19-related records required to
be created and maintained by the ETS. This paragraph provides a right
of access to records by employees, employee representatives, and OSHA.
Paragraph (l)(1) specifies that the employer must make available,
for examination and copying, the individual COVID-19 vaccine
documentation and any COVID-19 test results required by the ETS for a
particular employee to that employee and to anyone having written
authorized consent of that employee by the end of the next business day
after a request. Prompt employee access to this information ensures
that employees have the information necessary to take an active role in
their employers' efforts to prevent COVID-19 transmission in the
workplace. In particular, in circumstances where employers or employees
choose to have the employee's COVID-19 test results go directly to the
employer, paragraph (l)(1) gives the employee access to their own
records. Access to COVID-19 test results may be helpful for a
requesting employee in evaluating information relevant to COVID-19
exposure, including if that exposure occurred at the workplace. Prompt
production of these records can also assist employees in making
personal medical decisions and seeking care from a licensed healthcare
provider if necessary.
Employers should note that employee privacy is protected under the
access to records provisions in paragraph (l)(1). Specifically, as
noted above, paragraph (l)(1) requires employers to provide access to
the vaccination records or COVID-19 test results for a particular
employee to that employee or to anyone having that employee's written
permission. However, it does not authorize employers to allow anyone
other than the particular employee to access their records or results
without the written consent of that employee (except as provided for
under paragraph (l)(3)).
Paragraph (l)(2) requires the employer to make the following
information available to an employee or an
[[Page 61548]]
employee representative on request: (1) The aggregate number of fully
vaccinated employees at a workplace and (2) the total number of
employees at that workplace. This information must be made available to
these individuals by the end of the next business day after a request.
Employers will be able to utilize the roster of each employee's
vaccination status they are required to maintain under paragraph (e)(4)
of this section to provide this information promptly to a requester.
Since the aggregate totals of fully vaccinated employees and total
employees made available by request in paragraph (l)(2) do not contain
any personal identifiable information or personal medical information,
OSHA does not believe that access to these records raises any serious
confidentiality or privacy concern if disclosed to employees or their
representatives.
OSHA believes that access to this information will allow employees
and employee representatives to calculate a percentage of fully
vaccinated employees at a workplace, evaluate the efficacy of the
employer's vaccination policy, raise any concerns identified to OSHA,
and actively participate in the employer's vaccination efforts. Without
the provision of this information to employees and their
representatives, the only potential check on whether the employer is
complying with the requirements of the ETS would be OSHA inspections.
The agency believes that making this information available to employee
representatives will help ensure compliance with the requirements of
the ETS and thereby protect workers.
Consistent with 29 CFR 1904.35(a)(3), OSHA interprets the term
``employee'' as used in paragraph (l) to include former employees. In
addition, for purposes of paragraph (l)(2), the term ``representative''
is intended to have the same meanings as in 29 CFR 1904.35(b)(2), which
encompasses two types of employee representatives. The first is a
personal representative of the employee, who is a person the employee
designates, in writing, as his or her personal representative, or is a
legal representative of a deceased or legally incapacitated employee.
The second is an authorized representative, which is defined as an
authorized collective bargaining agent of one or more employees working
at the employer's worksite. In accordance with these interpretations,
OSHA also interprets the phrase ``employee representative,'' as used in
paragraph (l)(2), to include the personal and authorized
representatives of former employees. These interpretations are limited
to these provisions.
Under paragraphs (l)(1) and (l)(2), requesters are entitled to one
free copy of each requested record, which is consistent with OSHA's
recordkeeping regulation at 29 CFR 1904.35. The cost of providing one
free copy to employees, former employees, and/or their representatives
is minimal, and these individuals are more likely to access the records
if it is without cost. Allowing the employer to charge for a copy of
the record would only delay the production of the information. After
receiving an initial, free copy of a requested record or document, an
employee, former employee, or representative may be charged a
reasonable fee for copying duplicative records. However, no fee may be
charged for an update to a previously requested record. It should be
noted that each COVID-19 test is a separate record, and, as such, the
employee or the representative is entitled to one free copy of each
COVID-19 test record.
Paragraph (l)(3) provides OSHA with a specific right of access.
Under paragraph (l)(3)(i), employers must provide the written policy
required by paragraph (d), and the aggregate numbers described in
paragraph (l)(2) of this section (both the aggregate number of fully
vaccinated employees at a workplace and the total number of employees
at that workplace), to the Assistant Secretary for examination and
copying within 4 business hours of a request. Consistent with the
requirements in 29 CFR 1904.40(b)(2), if the records are maintained at
a location in a different time zone, the employer may use the business
hours of the establishment at which the records are located when
calculating the deadline.
Providing OSHA with prompt access to the written policy and the
aggregate numbers allows the agency to more rapidly focus inspections
on employers that may not be in compliance with the requirements of
this ETS. In addition, this information will help OSHA determine what
to focus on in an investigation. For example, if an employer has
established, implemented, and is enforcing a written mandatory
vaccination policy under paragraph (d)(1) and their aggregate numbers
indicate that their entire workforce is fully vaccinated against COVID-
19, the agency might approach the investigation differently than in a
workplace where the employer's written policy (under paragraph (d)(2))
allows employees to provide proof of regular testing for COVID-19 in
accordance with paragraph (g) and wear a face covering in accordance
with paragraph (i), instead of being fully vaccinated. This information
also provides OSHA representatives with the ability to quickly check
any vaccination claims made by an employer without undertaking an
employee-by-employee assessment and assists OSHA representatives in
their evaluation of the effectiveness of the employer's written policy.
Having this information within 4 business hours of the request
helps the agency act more quickly to protect employees and preserves
agency resources. In addition, the 4-hour response time is consistent
with similar obligations under other OSHA recordkeeping requirements,
such as the recordkeeping requirement in 29 CFR 1904.40(a).
Paragraph (l)(3)(ii) requires employers to provide all other
records and other documents that are required to be maintained by this
section to the Assistant Secretary for examination and copying by the
end of the next business day after a request. This means that employers
must allow OSHA representatives to examine and copy each employee's
COVID-19 vaccine documentation (required to be maintained under
paragraph (e)(4)), the roster of employee vaccination status (required
to be maintained under paragraph (e)(4)), and each employee's COVID-19
test results (required to be maintained under paragraph (g)(4)), upon
request.
As indicated in paragraph (c), the term Assistant Secretary
includes the Assistant Secretary's designees. Consequently, the records
and information required to be provided to the Assistant Secretary
under paragraph (l)(3) must be given to the Assistant Secretary or
their representatives, such as OSHA's Compliance Safety and Health
Officers.
As noted above, section 8 of the OSH Act recognizes OSHA's right of
access to records relating to employer compliance with occupational
safety and health standards and regulations, including access to
relevant employee medical records. OSHA does not believe that its
inspectors need to obtain employee permission to access and review
personally identifiable information. Gaining this permission would
essentially make it impossible to obtain full access to the records in
a timely manner, which is needed by OSHA to perform a meaningful
workplace investigation. OSHA also has policies and procedures in place
to ensure the privacy and confidentiality of employee records it
accesses during inspections. Finally, without complete and timely
access to the vaccine and testing
[[Page 61549]]
records, agency efforts to conduct immediate interventions to ensure
employees are protected from COVID-19 at a specific workplace would be
limited.
OSHA does not prescribe specific methods for requests for records
in this ETS. Employees, employee representatives, and the Assistant
Secretary and designees can submit requests in any manner that provides
adequate notice of the request to the employer. This may include
requests by in writing (e.g., email, fax, letter), by phone, or in
person.
M. Dates
To minimize transmission of COVID-19 in the workplace, it is
essential that employers ensure that the provisions of this ETS are
implemented as quickly as possible, but no later than the dates
outlined in paragraph (m). This paragraph sets forth the effective date
of the section and the compliance dates for specific requirements of
the standard. The effective date for this ETS, as required by section
6(c)(1) of the OSH Act (29 U.S.C. 655(c)(1)), is the date of
publication in the Federal Register. The compliance date for all
provisions in the ETS is 30 days after the effective date, except for
paragraph (g) (COVID-19 testing for employees who are not fully
vaccinated), which requires compliance within 60 days of the effective
date. Given the grave danger to employees from occupational exposure to
COVID-19, as previously described, the effective date and compliance
dates provided for this ETS are reasonable and appropriate.
For over a year and a half--since at least January 2020, when the
Secretary of Health and Human Services declared COVID-19 to be a public
health emergency for the entire United States--all employers have been
made acutely aware of the importance of minimizing employees' exposure
to COVID-19 and many have willingly joined the global response to stop
the spread of COVID-19 and to protect their employees. Therefore, many
employers have already been encouraging their employees to get
vaccinated against COVID-19. Many employers have also instituted
vaccination mandates (see Technological Feasibility, Section IV.A. of
this preamble, for more information).
OSHA has published this ETS because there is great urgency in
instituting the workplace protections OSHA has found to be necessary as
quickly as possible. Unvaccinated workers are being hospitalized with
COVID-19 every day, and many are dying, so it is particularly critical
to remove obstacles as soon as possible for those who wish to be
vaccinated. At the same time, OSHA has set the compliance dates to
allow enough time for employers to obtain and read the standard, become
knowledgeable about the standard's requirements, and undertake the
necessary steps for compliance.
OSHA anticipates that employers will be able to implement measures
to comply with most provisions of the ETS well within 30 days, pursuant
to paragraph (m)(2)(i). Even in situations where an employer has not
previously taken the required actions to address COVID-19 hazards in
the workplace, steps such as developing a vaccination policy,
determining employee vaccination status, providing support for employee
vaccination, ensuring employees who are not fully vaccinated wear face
coverings, and most other measures required under the standard can
readily be completed within the 30-day time period. These measures do
not require extensive lead times for large employers to implement. The
scope of the standard is limited to employers with more than 100
employees largely because OSHA is especially confident that these
employers will have the ability to implement the standard.
Paragraph (m)(2)(ii) of the ETS provides a longer period of time--
60 days--for employers to comply with the requirements for COVID-19
testing in paragraph (g). Paragraph (g) requires employers to implement
COVID-19 testing and reporting of results for employees who are not
fully vaccinated. One reason for this extended period of time for
testing is that employers may need additional time to develop policies
and procedures regarding COVID-19 testing and associated recordkeeping.
Perhaps more critically, this ETS is intended to incentivize
vaccination, so this delayed compliance date was established to allow
sufficient time for employees to complete a COVID-19 primary
vaccination before it is necessary to comply with the testing
requirements in paragraph (g). The 60-day compliance period in
paragraph (m)(2)(ii) provides employees with sufficient time to receive
one dose of a single-dose primary vaccination (e.g., Janssen (Johnson &
Johnson)) or both doses of a two-dose primary vaccination series (e.g.,
Pfizer-BioNTech, Moderna). For the Janssen COVID-19 vaccine, the
primary vaccination takes 1 day to complete (CDC, August 10, 2021).
Employees who receive the Janssen vaccine could therefore begin their
primary vaccination at any time up to and including the 60th day from
the date of publication in the Federal Register in order to be exempt
from the testing requirements of paragraph (g). For the Pfizer-BioNTech
COVID-19 vaccine, the primary vaccination series takes 21 days to
complete (CDC, August 25, 2021). Employees receiving the Pfizer-
BioNTech series could begin their primary vaccination series up to 39
days from the date of publication in the Federal Register. Finally, for
the Moderna COVID-19 vaccine, the primary vaccination series takes 28
days to complete (CDC, August 23, 2021). Employees receiving the
Moderna series could therefore begin their primary vaccination series
up to 32 days from the date of publication in the Federal Register.
As specified in paragraph (m)(2)(ii), if an employee completes the
entire primary vaccination within 60 days following publication in the
Federal Register, that employee does not have to be tested under
paragraph (g), even if they have not yet completed the two week waiting
period that is required to meet the definition of fully vaccinated in
paragraph (c). Employers must begin compliance with the testing
requirements of paragraph (g) only for employees who have not yet
completed primary vaccination (i.e., employees who have not received
any doses, employees who have received only one dose of a two-dose
series) within 60 days from the date of publication in the Federal
Register. And because employers must have their vaccination support
processes (as required by paragraph (f)) in place before employees
would need to initiate their primary vaccination in time to avoid
testing under this section, employees will be able to avoid all testing
costs required by this ETS.
Compliance with the requirements of the ETS within the specified
dates is achievable. Many employers are likely already in compliance
with at least some of the provisions of the ETS. Resources are also
readily available to help employers achieve compliance. These resources
include guidance issued by OSHA, the CDC, state and local governments,
trade associations, and other organizations to help employers
successfully implement vaccination, testing, and face covering
requirements to minimize the transmission of COVID-19 in the workplace.
OSHA therefore concludes that the compliance dates in this ETS strike a
reasonable balance between incentivizing vaccination and allowing
enough time for employers to comply.
Although employers are not required to comply with the requirements
of this ETS until 30 days from the date of publication in the Federal
Register (60 days for paragraph (g)), OSHA strongly encourages
employers to implement the
[[Page 61550]]
required measures to support employee vaccination as soon as
practicable. Providing support for employees to receive the COVID-19
vaccine and recover from side effects, as required in paragraph (f) of
the ETS, prior to the compliance date may encourage employees to
receive a COVID-19 vaccination at the earliest possible date. This
would not only reduce the grave danger of COVID-19 in the workplace but
also reduce burdens on both employers and employees when the compliance
dates for the additional requirements for employees who are not fully
vaccinated arrive.
References
Centers for Disease Control and Prevention (CDC). (2021, August 10).
Janssen COVID-19 Vaccine (Johnson & Johnson). https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/. (CDC, August
10, 2021)
Centers for Disease Control and Prevention (CDC). (2021, August 23).
Moderna COVID-19 Vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/. (CDC, August 23, 2021)
Centers for Disease Control and Prevention (CDC). (2021, August 25).
Pfizer-BioNTech COVID-19 Vaccine. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/. (CDC, August 25, 2021)
N. Severability
OSHA's amendment to its COVID-19 ETS, Part 1910, Subpart U,
includes a republication of Sec. 1910.505, Severability. Section
1910.505 contains a severability clause, the primary purpose of which
is to express OSHA's intent that if any section or provision of the
COVID-19 ETS is held invalid or unenforceable or is stayed or enjoined
by any court of competent jurisdiction, the remaining sections or
provisions should remain effective and operative. OSHA is including 29
CFR 1910.505 as part of this ETS for the same reasons the agency
included the provision in the Healthcare ETS, and OSHA intends for it
to have the same purposes and effects as those expressed in the
preamble to the Healthcare ETS (86 FR 32617-32618), which is hereby
included in the record for this ETS.
Because subpart U is the result of two separate ETSs published at
different times and subject to different time frames, but OSHA intends
for both ETSs to be subject to the same principles of severability,
OSHA has relied on the same centralized severability section for both
for efficiency. For the benefit of the reader and for administrative
convenience, this centralized severability section is located in the
same subpart as the other provisions of the ETS. While either ETS
remains in effect, it is OSHA's intent that 29 CFR 1910.505 remain in
subpart U and operative as to either ETS still in effect. If both ETSs
are not made permanent, 29 CFR 1910.505 will cease to have effect along
with the rest of subpart U. If either ETS is made permanent, OSHA will
provide notice at that time of the agency's intended application of 29
CFR 1910.505 to the newly permanent standard. For example, if 29 CFR
1910.502 becomes permanent because it has been finalized, but 29 CFR
1910.501 remains a temporary requirement because it is not yet
finalized, 29 CFR 1910.505 would remain in subpart U and operative as
to 29 CFR 1910.501 and the agency would separately provide notice of
how severability is intended to apply to the newly permanent 29 CFR
1910.502.
O. Incorporation by Reference
OSHA's amendment to its COVID-19 ETS, Part 1910, Subpart U,
includes the addition of Sec. 1910.501, Vaccination, Testing, and Face
Coverings. This section incorporates by reference CDC's ``Isolation
Guidance.''
This document, listed below, will be fixed in time and made
publicly available. OSHA had previously incorporated this same document
into 29 CFR 1910.502 and listed it in subpart U's incorporation by
reference (IBR) section, 29 CFR 1910.509. Because subpart U is the
result of two separate ETSs published at different times and subject to
different time frames, but both incorporate documents by reference,
OSHA has relied on the same centralized IBR section for both. For the
benefit of the reader and for administrative convenience, this
centralized IBR section is located in the same subpart as the other
provisions of the ETS.
While either ETS remains in effect, it is OSHA's intent that 29 CFR
1910.509 remain in subpart U. If both ETSs are not made permanent, 29
CFR 1910.509 will cease to have effect along with the rest of subpart
U. If either ETS is made permanent, OSHA intends to recodify the
relevant standards for that ETS from 29 CFR 1910.509 into 29 CFR
1910.6, the centralized IBR section for part 1910. For example, if 29
CFR 1910.502 becomes permanent because it has been finalized, but 29
CFR 1910.501 remains a temporary requirement because it is not yet
finalized, OSHA would relocate all of 29 CFR 1910.502's incorporated
documents into 29 CFR 1910.6, but 29 CFR 1910.509 would remain in
subpart U and would list the one document incorporated by reference
into 29 CFR 1910.501.
In this section, OSHA includes a list of the titles, editions/
versions, and years of the incorporated documents. Stakeholders may
consult 29 CFR 1910.509 both to locate all of the documents
incorporated by reference in subpart U (the paragraph in which the
document is incorporated is listed there) and to find more details
regarding how to locate the specific consensus standard and guidelines
that have been incorporated by reference in the ETS.
OSHA recognizes that the Centers for Disease Control and Prevention
(CDC) may update their guidelines based on the most current available
scientific evidence, but OSHA is only requiring compliance with CDC's
``Isolation Guidance'' as incorporated by reference, which is fixed in
time as of February 18, 2021.
As discussed in the preamble of the Healthcare ETS at 86 FR 32619,
CDC's guidance, including its ``Isolation Guidance,'' is not expressed
in mandatory terms. As such, OSHA has determined it is not sufficiently
protective or a meaningful alternative to a mandatory standard. OSHA
has reviewed this guidance and determined that compliance with the
safety measures and specific instructions in CDC's ``Isolation
Guidance'' is important to protect workers who work for employees with
over 100 employees. For the same reasons as described in the Healthcare
ETS (86 FR 32619), OSHA is incorporating this guidance by reference,
and compliance with the recommendations will be mandatory. OSHA will be
able to cite employers who do not follow them. Compliance with all
applicable provisions of the incorporated document is required where
the provisions into which they are incorporated are mandatory, whether
the incorporated document sets out its directions in mandatory language
or recommendations. OSHA recognizes that this document incorporated by
reference into the ETS may become outdated when newer versions are
published or other entities revise those documents. In that case, OSHA
will work quickly to update the ETS through a new rulemaking or issue
enforcement guidance, as appropriate. But OSHA also has a longstanding
de minimis enforcement policy to allow employers to rely on documents
that are at least as protective.
OSHA is incorporating by reference (in 29 CFR 1910.509) the
material below. A brief description of the guidance is provided in the
text below. A description of its use can be found in the Regulatory
Text, and Summary and Explanation (Section VI. of this
[[Page 61551]]
preamble), where the guidance is referenced.
Regulatory Text--Sec. Sec. 1910.501(h); 1910.502(l)
CDC's Isolation Guidance (2021): This guidance provides steps to
take when someone is experiencing COVID-19 symptoms and/or tested
positive for COVID-19. This document is available at www.osha.gov/coronavirus/ets/ibr.
The CDC document is available at no cost through the contact
information listed above. In addition, in accordance with Sec.
1910.509(a)(1), this guidance is available for inspection at any
Regional Office of the Occupational Safety and Health Administration
(OSHA), or at the OSHA Docket Office, U.S. Department of Labor, 200
Constitution Avenue NW, Room N-3508, Washington, DC 20210; telephone:
202-693-2350 (TTY number: 877-889-5627). Due to copyright issues, OSHA
cannot post consensus standards on the OSHA website or through
www.regulations.gov.
List of Subjects
29 CFR Part 1910
COVID-19, Disease, Health, Health care, Health facilities,
Incorporation by reference, Occupational safety and health, Public
health, Quarantine, Reporting and recordkeeping requirements,
Respirators, SARS-CoV-2, Telework, Vaccines, Viruses.
29 CFR Parts 1915, 1917, 1918, 1926, and 1928
COVID-19, Disease, Health, Health care, Health facilities,
Occupational safety and health, Public health, Quarantine, Reporting
and recordkeeping requirements, Respirators, SARS-CoV-2, Telework,
Vaccines, Viruses.
Authority and Signature
James S. Frederick, Acting Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, authorized
the preparation of this document pursuant to the following authorities:
Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, 657); Secretary of Labor's Order 8-2020 (85 FR
58393 (Sept. 18, 2020)); 29 CFR part 1911; and 5 U.S.C. 553.
James S. Frederick,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
For the reasons set forth in the preamble, chapter XVII of title 29
of the Code of Federal Regulations is amended as follows:
PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS
Subpart U--COVID-19
0
1. Revise the heading for Subpart U to read as set forth above.
0
2. The authority citation for subpart U continues to read as follows:
Authority: 29 U.S.C. 653, 655, and 657; Secretary of Labor's
Order No. 8-2020 (85 FR 58393); 29 CFR part 1911; and 5 U.S.C. 553.
0
3. Add Sec. 1910.501 to subpart U to read as follows:
Sec. 1910.501 Vaccination, testing, and face coverings.
(a) Purpose. This section is intended to establish minimum
vaccination, vaccination verification, face covering, and testing
requirements to address the grave danger of COVID-19 in the workplace,
and to preempt inconsistent state and local requirements relating to
these issues, including requirements that ban or limit employers'
authority to require vaccination, face covering, or testing, regardless
of the number of employees.
Note 1 to paragraph (a): This section establishes minimum
requirements that employers must implement. Nothing in this section
prevents employers from agreeing with workers and their
representatives to additional measures not required by this section
and this section does not supplant collective bargaining agreements
or other collectively negotiated agreements in effect that may have
negotiated terms that exceed the requirements herein. The National
Labor Relations Act of 1935 (NLRA) protects the right of most
private-sector employees to take collective action to improve their
wages and working conditions.
(b) Scope and application. (1) This section covers all employers
with a total of 100 or more employees at any time this section is in
effect.
(2) The requirements of this section do not apply to:
(i) Workplaces covered under the Safer Federal Workforce Task Force
COVID-19 Workplace Safety: Guidance for Federal Contractors and
Subcontractors; or
(ii) Settings where any employee provides healthcare services or
healthcare support services when subject to the requirements of Sec.
1910.502.
(3) The requirements of this section do not apply to the employees
of covered employers:
(i) Who do not report to a workplace where other individuals such
as coworkers or customers are present;
(ii) While working from home; or
(iii) Who work exclusively outdoors.
(c) Definitions. The following definitions apply to this section.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.
COVID-19 (Coronavirus Disease 2019) means the disease caused by
SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). For
clarity and ease of reference, this section also uses the term ``COVID-
19'' when describing exposures or potential exposures to SARS-CoV-2.
COVID-19 test means a test for SARS-CoV-2 that is:
(i) Cleared, approved, or authorized, including in an Emergency Use
Authorization (EUA), by the FDA to detect current infection with the
SARS-CoV-2 virus (e.g., a viral test);
(ii) Administered in accordance with the authorized instructions;
and
(iii) Not both self-administered and self-read unless observed by
the employer or an authorized telehealth proctor. Examples of tests
that satisfy this requirement include tests with specimens that are
processed by a laboratory (including home or on-site collected
specimens which are processed either individually or as pooled
specimens), proctored over-the-counter tests, point of care tests, and
tests where specimen collection and processing is either done or
observed by an employer.
Face covering means a covering that:
(i)(A) completely covers the nose and mouth;
(B) Is made with two or more layers of a breathable fabric that is
tightly woven (i.e., fabrics that do not let light pass through when
held up to a light source);
(C) Is secured to the head with ties, ear loops, or elastic bands
that go behind the head. If gaiters are worn, they should have two
layers of fabric or be folded to make two layers;
(D) Fits snugly over the nose, mouth, and chin with no large gaps
on the outside of the face; and
(E) Is a solid piece of material without slits, exhalation valves,
visible holes, punctures, or other openings.
(ii) This definition includes clear face coverings or cloth face
coverings with a clear plastic panel that, despite the non-cloth
material allowing light to pass through, otherwise meet this definition
and which may be used to facilitate communication with people who are
deaf or hard-of-hearing or others who need to see a speaker's mouth or
facial expressions to understand speech or sign language respectively.
Facemask means a surgical, medical procedure, dental, or isolation
mask that is FDA-cleared, authorized by an FDA EUA, or offered or
distributed as
[[Page 61552]]
described in an FDA enforcement policy. Facemasks may also be referred
to as ``medical procedure masks.''
Fully vaccinated means:
(i) A person's status 2 weeks after completing primary vaccination
with a COVID-19 vaccine with, if applicable, at least the minimum
recommended interval between doses in accordance with the approval,
authorization, or listing that is:
(A) Approved or authorized for emergency use by the FDA;
(B) Listed for emergency use by the World Health Organization
(WHO); or
(C) Administered as part of a clinical trial at a U.S. site, if the
recipient is documented to have primary vaccination with the active
(not placebo) COVID-19 vaccine candidate, for which vaccine efficacy
has been independently confirmed (e.g., by a data and safety monitoring
board) or if the clinical trial participant at U.S. sites had received
a COVID-19 vaccine that is neither approved nor authorized for use by
FDA but is listed for emergency use by WHO; or
(ii) A person's status 2 weeks after receiving the second dose of
any combination of two doses of a COVID-19 vaccine that is approved or
authorized by the FDA, or listed as a two-dose series by the WHO (i.e.,
a heterologous primary series of such vaccines, receiving doses of
different COVID-19 vaccines as part of one primary series). The second
dose of the series must not be received earlier than 17 days (21 days
with a 4-day grace period) after the first dose.
Mandatory Vaccination Policy is an employer policy requiring each
employee to be fully vaccinated. To meet this definition, the policy
must require: Vaccination of all employees, including vaccination of
all new employees as soon as practicable, other than those employees:
(i) For whom a vaccine is medically contraindicated;
(ii) For whom medical necessity requires a delay in vaccination; or
(iii) Who are legally entitled to a reasonable accommodation under
federal civil rights laws because they have a disability or sincerely
held religious beliefs, practices, or observances that conflict with
the vaccination requirement.
Respirator means a type of personal protective equipment (PPE) that
is certified by the National Institute for Occupational Safety and
Health (NIOSH) under 42 CFR part 84 or is authorized under an EUA by
the FDA. Respirators protect against airborne hazards by removing
specific air contaminants from the ambient (surrounding) air or by
supplying breathable air from a safe source. Common types of
respirators include filtering facepiece respirators (e.g., N95),
elastomeric respirators, and powered air purifying respirators (PAPRs).
Face coverings, facemasks, and face shields are not respirators.
Workplace means a physical location (e.g., fixed, mobile) where the
employer's work or operations are performed. It does not include an
employee's residence.
(d) Employer policy on vaccination. (1) The employer must
establish, implement, and enforce a written mandatory vaccination
policy.
(2) The employer is exempted from the requirement in paragraph
(d)(1) of this section only if the employer establishes, implements,
and enforces a written policy allowing any employee not subject to a
mandatory vaccination policy to choose either to be fully vaccinated
against COVID-19 or provide proof of regular testing for COVID-19 in
accordance with paragraph (g) of this section and wear a face covering
in accordance with paragraph (i) of this section.
Note 1 to paragraph (d): Under federal law, including the
Americans with Disabilities Act (ADA) and Title VII of the Civil
Rights Act of 1964, workers may be entitled to a reasonable
accommodation from their employer, absent undue hardship. If the
worker requesting a reasonable accommodation cannot be vaccinated
and/or wear a face covering because of a disability, as defined by
the ADA, the worker may be entitled to a reasonable accommodation.
In addition, if the vaccination, and/or testing for COVID-19, and/or
wearing a face covering conflicts with a worker's sincerely held
religious belief, practice or observance, the worker may be entitled
to a reasonable accommodation. For more information about evaluating
requests for reasonable accommodation for disability or sincerely
held religious belief, employers should consult the Equal Employment
Opportunity Commission's regulations, guidance, and technical
assistance including at: https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
(e) Determination of employee vaccination status. (1) The employer
must determine the vaccination status of each employee. This
determination must include whether the employee is fully vaccinated.
(2) The employer must require each vaccinated employee to provide
acceptable proof of vaccination status, including whether they are
fully or partially vaccinated. Acceptable proof of vaccination status
is:
(i) The record of immunization from a health care provider or
pharmacy;
(ii) A copy of the COVID-19 Vaccination Record Card;
(iii) A copy of medical records documenting the vaccination;
(iv) A copy of immunization records from a public health, state, or
tribal immunization information system; or
(v) A copy of any other official documentation that contains the
type of vaccine administered, date(s) of administration, and the name
of the health care professional(s) or clinic site(s) administering the
vaccine(s);
(vi) In instances where an employee is unable to produce acceptable
proof of vaccination under paragraphs (e)(2)(i) through (v) of this
section, a signed and dated statement by the employee:
(A) Attesting to their vaccination status (fully vaccinated or
partially vaccinated);
(B) Attesting that they have lost and are otherwise unable to
produce proof required by this section; and
(C) Including the following language: ``I declare (or certify,
verify, or state) that this statement about my vaccination status is
true and accurate. I understand that knowingly providing false
information regarding my vaccination status on this form may subject me
to criminal penalties.''
Note 1 to paragraph (e)(2)(vi): An employee who attests to their
vaccination status should, to the best of their recollection,
include the following information in their attestation: The type of
vaccine administered; date(s) of administration; and the name of the
health care professional(s) or clinic site(s) administering the
vaccine(s).
(3) Any employee who does not provide one of the acceptable forms
of proof of vaccination status in paragraph (e)(2) of this section to
the employer must be treated as not fully vaccinated for the purpose of
this section.
(4) The employer must maintain a record of each employee's
vaccination status and must preserve acceptable proof of vaccination
for each employee who is fully or partially vaccinated. The employer
must maintain a roster of each employee's vaccination status. These
records and roster are considered to be employee medical records and
must be maintained as such records in accordance with Sec. 1910.1020
and must not be disclosed except as required or authorized by this
section or other federal law. These records and roster are not subject
to the retention requirements of Sec. 1910.1020(d)(1)(i) but must be
maintained and preserved while this section remains in effect.
(5) When an employer has ascertained employee vaccination status
prior to the effective date of this section through another form of
attestation or proof, and retained records of that ascertainment,
[[Page 61553]]
the employer is exempt from the requirements in paragraphs (e)(1)
through (3) of this section only for each employee whose fully
vaccinated status has been documented prior to the effective date of
this section. For purposes of paragraph (e)(4) of this section, the
employer's records of ascertainment of vaccination status for each such
person constitute acceptable proof of vaccination.
(f) Employer support for employee vaccination. The employer must
support COVID-19 vaccination as described in this paragraph.
(1) Time for vaccination. The employer must:
(i) Provide a reasonable amount of time to each employee for each
of their primary vaccination dose(s); and
(ii) Provide up to 4 hours paid time, including travel time, at the
employee's regular rate of pay for this purpose.
(2) Time for recovery. The employer must provide reasonable time
and paid sick leave to recover from side effects experienced following
any primary vaccination dose to each employee for each dose.
(g) COVID-19 testing for employees who are not fully vaccinated.
(1) The employer must ensure that each employee who is not fully
vaccinated complies with paragraph (g)(1)(i) or (ii) of this section:
(i) An employee who reports at least once every 7 days to a
workplace where other individuals such as coworkers or customers are
present:
(A) Must be tested for COVID-19 at least once every 7 days; and
(B) Must provide documentation of the most recent COVID-19 test
result to the employer no later than the 7th day following the date on
which the employee last provided a test result.
(ii) An employee who does not report during a period of 7 or more
days to a workplace where other individuals such as coworkers or
customers are present (e.g., teleworking for two weeks prior to
reporting to a workplace with others):
(A) Must be tested for COVID-19 within 7 days prior to returning to
the workplace; and
(B) Must provide documentation of that test result to the employer
upon return to the workplace.
Note 1 to paragraph (g)(1): This section does not require the
employer to pay for any costs associated with testing; however
employer payment for testing may be required by other laws,
regulations, or collective bargaining agreements or other
collectively negotiated agreements. This section also does not
prohibit the employer from paying for costs associated with testing
required by paragraph (g)(1) of this section.
(2) If an employee does not provide documentation of a COVID-19
test result as required by paragraph (g)(1) of this section, the
employer must keep that employee removed from the workplace until the
employee provides a test result.
(3) When an employee has received a positive COVID-19 test, or has
been diagnosed with COVID-19 by a licensed healthcare provider, the
employer must not require that employee to undergo COVID-19 testing as
required under paragraph (g) of this section for 90 days following the
date of their positive test or diagnosis.
(4) The employer must maintain a record of each test result
provided by each employee under paragraph (g)(1) of this section or
obtained during tests conducted by the employer. These records are
considered to be employee medical records and must be maintained as
such records in accordance with Sec. 1910.1020 and must not be
disclosed except as required or authorized by this section or other
federal law. These records are not subject to the retention
requirements of Sec. 1910.1020(d)(1)(i) but must be maintained and
preserved while this section remains in effect.
(h) Employee notification to employer of a positive COVID-19 test
and removal. Regardless of COVID-19 vaccination status or any COVID-19
testing required under paragraph (g) of this section, the employer
must:
(1) Require each employee to promptly notify the employer when they
receive a positive COVID-19 test or are diagnosed with COVID-19 by a
licensed healthcare provider; and
(2) Immediately remove from the workplace any employee who receives
a positive COVID-19 test or is diagnosed with COVID-19 by a licensed
healthcare provider and keep the employee removed until the employee:
(i) Receives a negative result on a COVID-19 nucleic acid
amplification test (NAAT) following a positive result on a COVID-19
antigen test if the employee chooses to seek a NAAT test for
confirmatory testing;
(ii) meets the return to work criteria in CDC's ``Isolation
Guidance'' (incorporated by reference, Sec. 1910.509); or
(iii) Receives a recommendation to return to work from a licensed
healthcare provider.
Note 1 to paragraph (h)(2): This section does not require
employers to provide paid time to any employee for removal as a
result of a positive COVID-19 test or diagnosis of COVID-19;
however, paid time may be required by other laws, regulations, or
collective bargaining agreements or other collectively negotiated
agreements.
(i) Face coverings. (1) The employer must ensure that each employee
who is not fully vaccinated wears a face covering when indoors and when
occupying a vehicle with another person for work purposes, except:
(i) When an employee is alone in a room with floor to ceiling walls
and a closed door.
(ii) For a limited time while the employee is eating or drinking at
the workplace or for identification purposes in compliance with safety
and security requirements.
(iii) When an employee is wearing a respirator or facemask.
(iv) Where the employer can show that the use of face coverings is
infeasible or creates a greater hazard that would excuse compliance
with this paragraph (e.g., when it is important to see the employee's
mouth for reasons related to their job duties, when the work requires
the use of the employee's uncovered mouth, or when the use of a face
covering presents a risk of serious injury or death to the employee).
(2) The employer must ensure that any face covering required to be
worn by this section:
(i) Is worn by the employee to fully cover the employee's nose and
mouth; and
(ii) Is replaced when wet, soiled, or damaged (e.g., is ripped, has
holes, or has broken ear loops).
(3) The employer must not prevent any employee from voluntarily
wearing a face covering or facemask unless the employer can demonstrate
that doing so would create a hazard of serious injury or death, such as
interfering with the safe operation of equipment.
(4) The employer must permit the employee to wear a respirator
instead of a face covering whether required or not. In addition, the
employer may provide respirators to the employee, even if not required.
In such circumstances, the employer must also comply with Sec.
1910.504.
(5) The employer must not prohibit customers or visitors from
wearing face coverings.
Note 1 to paragraph (i)(5): Nothing in this section precludes
employers from requiring customers or visitors to wear face
coverings.
Note 1 to paragraph (i): Face shields may be worn in addition to
face coverings to prevent them from getting wet and soiled.
Note 2 to paragraph (i): This section does not require the
employer to pay for any costs associated with face coverings;
however employer payment for face coverings may be required by other
laws, regulations, or collective bargaining agreements or other
collectively negotiated agreements. This section also does not
prohibit the employer
[[Page 61554]]
from paying for costs associated with face coverings required by
this section.
(j) Information provided to employees. The employer must inform
each employee, in a language and at a literacy level the employee
understands, about:
(1) The requirements of this section as well as any employer
policies and procedures established to implement this section;
(2) COVID-19 vaccine efficacy, safety, and the benefits of being
vaccinated, by providing the document, ``Key Things to Know About
COVID-19 Vaccines,'' available at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html;
(3) The requirements of 29 CFR 1904.35(b)(1)(iv), which prohibits
the employer from discharging or in any manner discriminating against
an employee for reporting a work-related injuries or illness, and
section 11(c) of the OSH Act, which prohibits the employer from
discriminating against an employee for exercising rights under, or as a
result of actions that are required by, this section. Section 11(c)
also protects the employee from retaliation for filing an occupational
safety or health complaint, reporting a work-related injuries or
illness, or otherwise exercising any rights afforded by the OSH Act;
and
(4) The prohibitions of 18 U.S.C. 1001 and of section 17(g) of the
OSH Act, which provide for criminal penalties associated with knowingly
supplying false statements or documentation.
(k) Reporting COVID-19 fatalities and hospitalizations to OSHA. (1)
The employer must report to OSHA:
(i) Each work-related COVID-19 fatality within 8 hours of the
employer learning about the fatality.
(ii) Each work-related COVID-19 in-patient hospitalization within
24 hours of the employer learning about the in-patient hospitalization.
(2) When reporting COVID-19 fatalities and in-patient
hospitalizations to OSHA in accordance with paragraph (j)(1) of this
section, the employer must follow the requirements in 29 CFR part
1904.39, except for 29 CFR part 1904.39(a)(1) and (2) and (b)(6).
(l) Availability of records. (1) By the end of the next business
day after a request, the employer must make available, for examination
and copying, the individual COVID-19 vaccine documentation and any
COVID-19 test results for a particular employee to that employee and to
anyone having written authorized consent of that employee.
(2) By the end of the next business day after a request by an
employee or an employee representative, the employer must make
available to the requester the aggregate number of fully vaccinated
employees at a workplace along with the total number of employees at
that workplace.
(3) The employer must provide to the Assistant Secretary for
examination and copying:
(i) Within 4 business hours of a request, the employer's written
policy required by paragraph (d) of this section, and the aggregate
numbers described in paragraph (l)(2) of this section; and
(ii) By the end of the next business day after a request, all other
records and other documents required to be maintained by this section.
(m) Dates--(1) Effective date. This section is effective as of
November 5, 2021.
(2) Compliance dates. (i) Employers must comply with all
requirements of this section, except for requirements in paragraph (g)
of this section, by December 6, 2021.
(ii) Employers must comply with the requirements of this section in
paragraph (g) by January 4, 2022, but employees who have completed the
entire primary vaccination by that date do not have to be tested, even
if they have not yet completed the 2-week waiting period.
0
4. Amend Sec. 1910.504 by revising paragraph (a) to read as follows:
Sec. 1910.504 Mini Respiratory Protection Program.
(a) Scope and application. This section applies only to respirator
use in accordance with Sec. Sec. 1910.501(i)(4) and 1910.502(f)(4).
* * * * *
0
5. Republish Sec. 1910.505 to read as follows:
Sec. 1910.505 Severability.
Each section of this subpart U, and each provision within those
sections, is separate and severable from the other sections and
provisions. If any provision of this subpart is held to be invalid or
unenforceable on its face, or as applied to any person, entity, or
circumstance, or is stayed or enjoined, that provision shall be
construed so as to continue to give the maximum effect to the provision
permitted by law, unless such holding shall be one of utter invalidity
or unenforceability, in which event the provision shall be severable
from this subpart and shall not affect the remainder of the subpart.
0
6. Amend Sec. 1910.509 by revising paragraph (b)(5) to read as
follows:
Sec. 1910.509 Incorporation by reference.
* * * * *
(b) * * *
(5) Isolation Guidance. COVID-19: Isolation If You Are Sick;
Separate yourself from others if you have COVID-19, updated February
18, 2021, IBR approved for Sec. Sec. 1910.501(h) and 1910.502(l).
* * * * *
PART 1915--OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD
EMPLOYMENT
0
7. The authority citation for part 1915 is revised to read as follows:
Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754); 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), 1-2012 (77 FR 3912), or 8-2020 (85 FR 58393); 29 CFR part
1911; and 5 U.S.C. 553, as applicable.
Subpart Z--Toxic and Hazardous Substances
0
8. Add Sec. 1915.1501 to subpart Z to read as follows:
Sec. 1915.1501 COVID-19.
The requirements applicable to shipyard employment under this
section are identical to those set forth at 29 CFR 1910.501.
PART 1917--MARINE TERMINALS
0
9. The authority citation for part 1917 is revised to read as follows:
Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), 1-2012 (77 FR 3912), or 8-2020 (85 FR 58393), as applicable;
and 29 CFR part 1911.
Sections 1917.28 and 1917.31 also issued under 5 U.S.C. 553.
Section 1917.29 also issued under 49 U.S.C. 1801-1819 and 5
U.S.C. 553.
Subpart B--Marine Terminal Operations
0
10. Add Sec. 1917.31 to subpart B to read as follows:
Sec. 1917.31 COVID-19.
The requirements applicable to marine terminal work under this
section are identical to those set forth at 29 CFR 1910.501.
PART 1918--SAFETY AND HEALTH REGULATIONS FOR LONGSHORING
0
11. The authority citation for part 1918 is revised to read as follows:
[[Page 61555]]
Authority: 33 U.S.C. 941; 29 U.S.C. 653, 655, 657; Secretary of
Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48
FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR
50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31160), 4-2010 (75 FR
55355), 1-2012 (77 FR 3912), or 8-2020 (85 FR 58393), as applicable;
and 29 CFR 1911.
Sections 1918.90 and 1918.110 also issued under 5 U.S.C. 553.
Section 1918.100 also issued under 49 U.S.C. 5101 et seq. and 5
U.S.C. 553.
0
12. Add subpart K to part 1918 to read as follows:
Subpart K--COVID-19.
Sec.
1918.107-1918.109 [Reserved]
1918.110 COVID-19.
1918.107 through 1918.109 [Reserved]
Sec. 1918.110 COVID-19.
The requirements applicable to longshoring work under this section
are identical to those set forth at 29 CFR 1910.501.
PART 1926--SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION
0
13. The authority citation for part 1926 is revised to read as follows:
Authority: 40 U.S.C. 3704; 29 U.S.C. 653, 655, and 657; and
Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR
25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-
2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-
2010 (75 FR 55355), 1-2012 (77 FR 3912), or 8-2020 (85 FR 58393), as
applicable; and 29 CFR part 1911.
Sections 1926.58, 1926.59, 1926.60, and 1926.65 also issued
under 5 U.S.C. 553 and 29 CFR part 1911.
Section 1926.61 also issued under 49 U.S.C. 1801-1819 and 5
U.S.C. 553.
Section 1926.62 also issued under sec. 1031, Public Law 102-550,
106 Stat. 3672 (42 U.S.C. 4853).
Section 1926.65 also issued under sec. 126, Public Law 99-499,
100 Stat. 1614 (reprinted at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553.
Subpart D--Occupational Health and Environmental Controls
0
14. Add Sec. 1926.58 to read as follows:
Sec. 1926.58 COVID-19.
The requirements applicable to construction work under this section
are identical to those set forth at 29 CFR 1910.501 Subpart U.
PART 1928--OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR AGRICULTURE
0
15. The authority citation for part 1928 is revised to read as follows:
Authority: Sections 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR
35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017),
5-2002 (67 FR 65008), 4-2010 (75 FR 55355), or 8-2020 (85 FR 58393),
as applicable; and 29 CFR 1911.
Section 1928.21 also issued under 49 U.S.C. 1801-1819 and 5
U.S.C. 553.
Subpart B--Applicability of Standards
0
16. Amend Sec. 1928.21 by adding paragraph (a)(8) to read as follows:
Sec. 1928.21 Applicable standards in 29 CFR part 1910.
(a) * * *
(8) COVID-19--Sec. 1910.501, but only with respect to--
(i) Agricultural establishments where eleven (11) or more employees
are engaged on any given day in hand-labor operations in the field; and
(ii) Agricultural establishments that maintain a temporary labor
camp, regardless of how many employees are engaged on any given day in
hand-labor operations in the field.
* * * * *
[FR Doc. 2021-23643 Filed 11-4-21; 8:45 am]
BILLING CODE 4510-26-P