Rules of Agency Practice and Procedure Concerning Occupational Safety and Health Administration Access to Employee Medical Records, 45780-45793 [2020-15562]
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Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations
Inspecting a harness takes about 0.25
work-hour, for an estimated cost of $21
per harness.
If required, replacing a harness takes
about 1 work-hour and parts cost about
$1,050 for an estimated replacement
cost of $1,135 per harness.
Authority for This Rulemaking
Regulatory Findings
This AD will not have federalism
implications under Executive Order
13132. This AD will not have a
substantial direct effect on the States, on
the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed above, I
certify that this AD:
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
2. Will not affect intrastate aviation in
Alaska, and
3. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
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List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
16:01 Jul 29, 2020
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certificate holding district office, before
operating any aircraft complying with this
AD through an AMOC.
1. The authority citation for part 39
continues to read as follows:
(g) Related Information
Bell Helicopter Textron Alert Service
Bulletin 204B–15–70 for Model 204B
helicopters, Bell ASB 205–15–113 for Model
205A and 205A–1 helicopters, Bell ASB
205B–15–66 for Model 205B helicopters, Bell
ASB 212–15–156 for Model 212 helicopters,
Bell ASB 412–15–170 for Model 412 and
412EP helicopters, and Bell ASB 412CF–15–
60 for Model 412CF helicopters, all dated
January 20, 2016, and Bell ASB 214–15–76,
dated January 11, 2016, for Model 214B and
214B–1 helicopters, all of which are not
incorporated by reference, contain additional
information about the subject of this AD. For
service information identified in this AD,
contact Bell Textron Inc., P.O. Box 482, Fort
Worth, TX 76101; telephone 817–280–3391;
fax 817–280–6466; or at https://
www.bellcustomer.com. You may view a
copy of the information at the FAA, Office of
the Regional Counsel, Southwest Region,
10101 Hillwood Pkwy., Room 6N–321, Fort
Worth, TX 76177.
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. Subtitle VII:
Aviation Programs, describes in more
detail the scope of the Agency’s
authority.
The FAA is issuing this rulemaking
under the authority described in
Subtitle VII, Part A, Subpart III, Section
44701: General requirements. Under
that section, Congress charges the FAA
with promoting safe flight of civil
aircraft in air commerce by prescribing
regulations for practices, methods, and
procedures the Administrator finds
necessary for safety in air commerce.
This regulation is within the scope of
that authority because it addresses an
unsafe condition that is likely to exist or
develop on helicopters identified in this
rulemaking action.
VerDate Sep<11>2014
PART 39—AIRWORTHINESS
DIRECTIVES
2020–16–10 Bell Textron Inc. (Type
Certificate Previously Held by Bell
Helicopter Textron Inc.): Amendment
39–21194; Docket No. FAA–2018–0598;
Product Identifier 2018–SW–030–AD.
(a) Applicability
This AD applies to Bell Textron Inc. (Bell)
Model 204B, 205A, 205A–1, 205B, 212, 214B,
214B–1, 412, 412CF, and 412EP helicopters,
certificated in any category, with a shoulder
harness seat belt comfort clip (comfort clip)
part numbers (P/Ns) D7LZ–6560286–A,
D7LZ–6560286–B, or 504636–401, installed.
(b) Unsafe Condition
This AD defines the unsafe condition as a
comfort clip interfering with the seat belt
inertia reel. The FAA is issuing this AD to
prevent the seat belt from locking. This
condition could result in injury to the
occupant during an emergency landing.
(c) Effective Date
This AD becomes effective September 3,
2020.
(d) Compliance
You are responsible for performing each
action required by this AD within the
specified compliance time unless it has
already been accomplished prior to that time.
(e) Required Actions
(1) Within 50 hours time-in-service:
(i) Remove from service each comfort clip
P/Ns D7LZ–6560286–A, D7LZ–6560286–B,
or 504636–401 from the shoulder harness
seat belt (harness).
(ii) Inspect each harness for a rip and an
abrasion. If there is a rip or any abrasion,
before further flight, remove from service the
harness.
(2) After the effective date of this AD, do
not install comfort clip P/Ns D7LZ–6560286–
A, D7LZ–6560286–B, or 504636–401 on any
helicopter.
(f) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, DSCO Branch, FAA, may
approve AMOCs for this AD. Send your
proposal to: Kuethe Harmon, Safety
Management Program Manager, DSCO
Branch, FAA, 10101 Hillwood Pkwy., Fort
Worth, TX 76177; telephone 817–222–5198;
fax: 817–222–4960; email: kuethe.harmon@
faa.gov.
(2) For operations conducted under a 14
CFR part 119 operating certificate or under
14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or
lacking a principal inspector, the manager of
the local flight standards district office or
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(h) Subject
Joint Aircraft Service Component (JASC)
Code: 2500, Cabin Equipment/Furnishings.
Issued on July 24, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives,
Compliance & Airworthiness Division,
Aircraft Certification Service.
[FR Doc. 2020–16490 Filed 7–29–20; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Part 1913
[Docket No. OSHA–2020–0005]
RIN 1218–AC95
Rules of Agency Practice and
Procedure Concerning Occupational
Safety and Health Administration
Access to Employee Medical Records
Occupational Safety and Health
Administration (OSHA); Labor.
ACTION: Final rule.
AGENCY:
OSHA is issuing a final rule
to amend the regulation addressing the
rules of agency practice and procedure
concerning OSHA access to employee
medical records. The final rule transfers
the approval of written medical access
orders (MAO) from the Assistant
Secretary for Occupational Safety and
Health (Assistant Secretary) to the
OSHA Medical Records Officer (MRO)
and makes the MRO responsible for
making determinations regarding inter-
SUMMARY:
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agency transfer and public disclosure of
personally identifiable medical
information in OSHA’s possession.
DATES: This final rule is effective on July
30, 2020.
ADDRESSES: In accordance with 29
U.S.C. 2112(a)(2), OSHA designates, Mr.
Edmund C. Baird, Associate Solicitor of
Labor for Occupational Safety and
Health, Office of the Solicitor, Room S–
4004, U.S. Department of Labor, 200
Constitution Avenue NW, Washington,
DC 20210, to receive petitions for
review of the final rule.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Mr. Frank Meilinger,
OSHA, Office of Communications;
telephone: (202) 693–1999; email:
Meilinger.francis2@dol.gov.
General and technical information:
Dr. Michael Hodgson, Director, OSHA
Office of Occupational Medicine and
Nursing; telephone: (202) 693–1768;
email: hodgson.michael@dol.gov.
SUPPLEMENTARY INFORMATION: The final
rule also amends § 1913.10 to clarify
that a written MAO does not constitute
an administrative subpoena, eliminates
outdated requirements for the removal
of direct personal identifiers when
OSHA personnel review medical
information away from a worksite, and
establishes new procedures for the
access and safeguarding of personally
identifiable employee medical
information in electronic form. The
revisions to § 1913.10 in the final rule
will increase employee privacy and
enhance OSHA’s ability to safeguard
personally identifiable medical
information.
Table of Contents
I. Background
II. Legal Authority
III. Summary and Explanation of the Final
Rule
IV. State Plans
V. Regulatory Flexibility Certification
VI. Environmental Impact Analysis
VII. Federalism
VIII. Unfunded Mandates
IX. Consultation and Coordination With
Indian Tribal Governments
X. Office of Management and Budget Review
Under the Paperwork Reduction Act of
1995
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I. Background
A. Introduction
In order to carry out its statutory
obligations, OSHA often reviews
employee medical records. For example,
OSHA may need to review employee
medical records during a compliance
inspection to determine whether an
employer is in compliance with OSHA
standards and regulations, or to verify
that an employer has taken steps to
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correct existing violations. Access to
employee medical records may also be
necessary during inspections to
determine the effectiveness of voluntary
employer safety and health programs.
OSHA also reviews medical records
when gathering information during
agency rulemaking to develop or revise
occupational safety and health
standards.
Several OSHA standards and
regulations mandate medical records
access, including 29 CFR 1910.1020,
Access to Employee Exposure and
Medical Records, which sets forth
procedures by which exposure and
medical records can be accessed by
employees, their designated
representatives, and OSHA. This
regulation, which applies to employers
with employees exposed to toxic
substances and harmful physical agents,
provides OSHA representatives with
prompt access to employee exposure
and medical records and to analysis
thereof using exposure or medical
records. See 29 CFR 1910.1020(e)(3). In
addition, several of OSHA’s substancespecific standards include provisions
for OSHA access to employee medical
records. (e.g., 29 CFR 1910.25(n)(4)
(Lead), and 29 CFR 1910.1028(k)
(Benzene)).
In many instances, OSHA must
examine and copy employee medical
information in personally identifiable
form. Personally identifiable employee
medical information as defined by 29
CFR 1913.10(b)(2) means employee
medical information accompanied by
either direct identifiers (name, address,
social security number, payroll number)
or by information which could
reasonably be used in particular
circumstances indirectly to identify
specific employees (e.g., date of birth,
race, sex, date of initial employment, job
title). An employee medical record may
include individual health histories as
well as medical opinions and
evaluations generated during diagnosis,
physical examinations, or medical
treatment by a health care professional.
Because of the substantial personal
privacy interests involved, OSHA
authority to access personally
identifiable employee medical
information is exercised only after the
agency has made a careful
determination of the need for the
information, and only when appropriate
safeguards are in place to prevent
unauthorized access. Once this
information is accessed, OSHA
examination and use is limited to only
that information needed to accomplish
a relevant statutory purpose. Also,
personally identifiable employee
medical information is retained by
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OSHA only for so long as needed to
accomplish the purpose for access, is
kept secured while being used, and is
not disclosed to other agencies or
members of the public except in
narrowly defined circumstances. In
addition, the examination and use of
personally identifiable employee
medical information is limited to only
OSHA personnel with a need to review
such information.
This rule is not an Executive Order
(E.O.) 13771 regulatory action because
this rule is not significant under E.O.
12866. Pursuant to the Congressional
Review Act (5 U.S.C. 801 et seq.), the
Office of Information and Regulatory
Affairs designated this rule not a ‘major
rule’, as defined by 5 U.S.C. 804(2).
B. OSHA’s Regulation at 29 CFR
1913.10
On May 25, 1980, OSHA issued a
final rule entitled Rules of Agency
Practice and Procedure Concerning
OSHA Access to Employee Medical
Records (45 FR 35284). The final rule
was developed and published in concert
with the promulgation of 29 CFR
1910.1020, Access to Employee
Exposure and Medical Records (45 FR
35212). During the rulemaking, there
was universal agreement that if OSHA
obtained access to employee medical
records, the access should be
accompanied by stringent internal
agency procedures to preclude abuse of
personally identifiable medical
information. Provided these procedures
were established, many participants in
the rulemaking endorsed OSHA access
to employee medical records without
the consent of the employee for
occupational safety and health purposes
(see 45 FR 35218).
Except as provided in 29 CFR
1913.10(b)(3) through (6), the rules of
agency practice and procedure apply to
all requests by OSHA personnel to
obtain access to records to examine and
copy personally identifiable employee
medical information, whether or not
access is mandated by 29 CFR
1910.1020. Among other things, the
regulation at 29 CFR 1913.10 establishes
certain responsibilities for specific
OSHA officials when the agency
accesses personally identifiable
employee medical information. The
regulation also includes provisions
addressing the internal use of employee
medical records by agency personnel, as
well as requirements for inter-agency
transfer and public disclosure of such
records. The regulation includes
security procedures for the use and
storage of employee medical records
while in the agency’s possession.
Finally, the regulation sets forth internal
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agency requirements for the retention
and destruction of records.
A key provision set forth in § 1913.10
is that, with few exceptions, each
request by an OSHA representative to
examine or copy personally identifiable
employee medical information must be
made pursuant to a written access order.
The written access order is an
authorization for specific OSHA
personnel to examine or copy
personally identifiable employee
medical information contained in
records held by an employer or other
record holder. The rules of agency
practice and procedure in § 1913.10
make clear that each written access
order must state the statutory purpose
for which access is sought, a general
description of the type of employee
medical information that will be
examined and why there is a need to
examine personally identifiable
information, whether the medical
information will be examined on-site,
what type of information will be copied
and removed off-site, and the
anticipated time during which OSHA
expects to retain the employee medical
information in personally identifiable
form.
In order to enhance employee privacy,
and clarify certain provisions, OSHA
has determined that it is necessary to
revise its regulation at § 1913.10. For
example, OSHA’s previous regulation at
§ 1913.10 used the term ‘‘written access
order.’’ However, this final rule revises
the regulatory text to include the more
commonly used term ‘‘medical access
order’’ or ‘‘MAO.’’
The final rule also amends the
regulation at 29 CFR 1913.10 to transfer
certain responsibilities from the
Assistant Secretary to the OSHA
Medical Records Officer (MRO).
Specifically, the MRO will now be
responsible for the overall
administration and implementation of
the procedures contained in § 1913.10.
These new responsibilities include
making determinations regarding (1)
OSHA access to personally identifiable
employee medical information pursuant
to a MAO, and (2) inter-agency transfer
and public disclosure of personally
identifiable employee medical
information. The final rule also transfers
responsibility from the Assistant
Secretary to the MRO for issuing written
directives that authorize OSHA
compliance personnel to review certain
information without obtaining a MAO.
The final rule clarifies that a MAO
does not constitute an administrative
subpoena, and eliminates requirements
for the removal of direct personal
identifiers when OSHA personnel
review medical information away from
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a workplace. The deletion of
requirements for the removal of direct
personal identifiers will be offset by
new provisions designed to strengthen
employee privacy. Finally, the final rule
establishes new internal OSHA
requirements, based on existing agency
policy, for the access and safeguarding
of personally identifiable employee
medical information maintained in
electronic form.
The procedures set forth in § 1913.10
are internal agency procedures and do
not affect employer compliance with
OSHA requirements. Employers and
employees will benefit from the
revisions to § 1913.10 in several ways.
First, since the process for determining
whether there is a need for OSHA to
review employee medical information
will be more efficient, employers will
know sooner if such a review is
authorized at their worksite. Second, the
elimination of the outdated requirement
to remove direct personal identifiers
before taking medical information offsite for review will reduce the amount
of an employer’s time and physical
space needed by OSHA personnel when
they visit a specific workplace. Third,
the revisions will benefit employees
because the procedures in § 1913.10 to
protect the security and privacy of
employee medical records will be
strengthened, especially with regard to
medical information in electronic form.
Fourth, the elimination of the
requirement to remove direct personal
identifiers before taking medical
information off-site will enhance
employee privacy because the removal
process always carries with it the
possibility that medical information will
be misidentified or mislabeled, which
could result in unauthorized staff
mistakenly reviewing that information.
Finally, deletion of the time-consuming
de-identification procedures will mean
that authorized OSHA personnel can
conduct follow-up consultations with
employees about their health more
quickly.
The notice and comment rulemaking
procedures of 5 U.S.C. 553 of the
Administrative Procedure Act (APA) do
not apply to ‘‘interpretive rules, general
statements of policy, or rules of agency
organization, procedure, or practice.’’ 5
U.S.C. 553(b)(A). The provisions in 29
CFR 1913.10 are rules of agency
procedure and practice within the
meaning of section 553(b)(A) of the
APA. Therefore, publication in the
Federal Register of a notice of proposed
rulemaking and request for comments is
not required. Furthermore, because this
rule is procedural rather than
substantive, the normal requirement of
5 U.S.C. 553(d) that a rule not be
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effective until at least 30 days after
publication in the Federal Register is
inapplicable. OSHA also finds good
cause to provide an immediate effective
date for this rule, because it imposes no
obligations on parties outside the
federal government and therefore no
advance notice is required to enable
employers or other private parties to
come into compliance.
II. Legal Authority
The Occupational Safety and Health
Act of 1970, 29 U.S.C. 651 et seq. (OSH
Act) authorizes the Secretary to issue
two types of occupational safety and
health rules: Standards and regulations.
Standards, which are authorized by
section 6 of the Act, specify remedial
measures to be taken to prevent and
control employee exposure to identified
occupational safety and health hazards,
while regulations are the means to
effectuate other statutory purposes,
including the maintaining of records.
For example, the OSHA requirements at
29 CFR 1910.95 are a ‘‘standard’’
because they include remedial measures
to address the specific and already
identified hazard of employee exposure
to occupational noise. In contrast, a
‘‘regulation’’ is a purely administrative
effort designed to uncover violations of
the Act and discover unknown dangers.
The procedural regulations in 29 CFR
1913.10 are necessary to enable the use
of employee medical records by OSHA
consistent with the employee’s right of
privacy.
In section 2(b) of the OSH Act,
Congress declared the overriding
purpose of the Act is ‘‘to assure so far
as possible every working man and
woman in the Nation safe and healthful
working conditions.’’ (29 U.S.C. 651.)
Congress also explicitly declared that
this must be accomplished, among other
ways, ‘‘by providing an effective
enforcement program . . .’’ (29 U.S.C.
651(b)(10)). For the Secretary of Labor to
conduct an effective enforcement
program, he or she must determine
whether occupational safety and health
hazards exist in the workplace. To that
end, the OSH Act authorizes the
Secretary to enter and inspect
workplaces and to conduct reasonable
investigations into working conditions.
Section 8(a) of the OSH Act
authorizes OSHA to enter, inspect, and
investigate places of employment, and
section 8(b) permits OSHA to subpoena
both witnesses and evidence when
conducting inspections and
investigations. (29 U.S.C. 657(a) and
(b)). As noted above, in some instances,
it may be necessary for OSHA to
examine personally identifiable
employee medical information. Section
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8 of the OSH Act recognizes OSHA’s
right of access to medical records, and
records access is mandated by OSHA
standards and regulations, including 29
CFR 1910.1020(e)(3) (access to
employee exposure and medical
records). OSHA relies on administrative
subpoenas to compel production of
medical records by employers and other
record holders.
OSHA is issuing the final rule
pursuant to authority expressly granted
in section 8 of the OSH Act. Section
8(c)(1) requires each employer to ‘‘make,
keep, 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’’ (29 U.S.C.
657(c)(1)). Employee medical records
are included within the type of records
addressed by this provision.
Section 8(g)(1) of the OSH Act
provides that the Secretary and
Secretary of Health and Human Services
are authorized to compile, analyze, and
publish, either in summary or detailed
from, all records or information
obtained under this section (29 U.S.C.
657(g)(1)). Section 8(g)(2) is the general
rulemaking authority of the OSH Act
and provides that the Secretary and the
Secretary of Health and Human Services
shall prescribe such rules and
regulations as he may deem necessary to
carry out their responsibilities under
this Act, including rules and regulations
dealing with the inspection of an
employer’s establishment.
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III. Summary and Explanation of the
Final Rule
Section 1913.10(b)—Scope and
Application
OSHA’s regulation at 29 CFR
1913.10(b), Scope and application,
defines the circumstances under which
the procedural regulations in § 1913.10
will apply. Except as provided in
paragraphs (b)(3) through (6), the
policies and procedures in § 1913.10
apply to all requests by OSHA
personnel to access personally
identifiable employee medical
information.
In general, 29 CFR 1913.10 requires
OSHA personnel to obtain a MAO
(previously ‘‘written access order,’’ but
referred to in this section as ‘‘MAO’’ as
it is in the final rule) when accessing
personally identifiable employee
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medical information. However, under
certain circumstances, the regulation
states that OSHA access may be
accomplished without obtaining a
MAO. For example, § 1913.10(d)(4)(i)
provides that a MAO is not needed
when an employee gives specific
written consent for OSHA to access
their medical records. Also,
§ 1913.10(b)(3) through (5) include
several categories of records that are not
subject to § 1913.10 and therefore may
be accessed without obtaining a MAO.
These categories of records include
medical information that is not in
personally identifiable form, injury and
illness records required by 29 CFR part
1904, death certificates, employee
exposure records, and medical
information obtained in the course of
litigation. In addition, previous
§ 1913.10(b)(6) provided that the
policies and procedures in § 1913.10 do
not apply when a written directive by
the Assistant Secretary authorizes
appropriately qualified personnel to
conduct limited review of specific
medical information mandated by an
OSHA standard or of specific biological
monitoring test results. This final rule
amends § 1913.10(b)(6) to state that the
MRO is now responsible for issuing
these written authorization directives.
OSHA Directive CPL 02–02–072,
Rules of agency practice and procedure
concerning OSHA access to employee
medical records, August 22, 2007,
includes authorization for review of
three categories of information based on
the provisions in § 1913.10(b)(6). The
directive authorizes OSHA compliance
personnel to review (1) medical
opinions mandated by OSHA standards,
(2) information required by a medical
surveillance program, and (3) certain
information used to verify compliance
with the injury and illness
recordkeeping requirements in 29 CFR
part 1904. OSHA personnel do not need
a MAO when they access the
information at a workplace pursuant to
a written directive under
§ 1913.10(b)(6). Instead, OSHA
personnel follow the procedures set
forth in the written directive. The 2007
directive includes provisions on how
OSHA personnel may access the
specific types of information and how
the information should be protected
once in the agency’s possession.
OSHA believes the MRO is in the best
position to make determinations
regarding written authorization under
§ 1913.10(b)(6). Section 1913.10(c)(2)
already provides that the MRO must
have experience or training in the
evaluation, use, and privacy protection
of medical records, and, as discussed
below in this preamble, paragraph (c) of
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§ 1913.10 has been amended to provide
that the MRO is now responsible for the
overall administration of the policies
and procedures in § 1913.10. Also, as
part of the final rule, paragraph (c) now
states that the MRO is specifically
responsible for making determinations
regarding the approval of MAOs, interagency transfer, and public disclosure of
identifiable employee medical records.
Given all the new MRO responsibilities
set forth in paragraph (c), as well as the
existing duties in the other paragraphs
of the regulation, it is appropriate to
also make the MRO responsible for
written authorization under paragraph
(b)(6). Accordingly, final § 1913.10(b)(6)
states that the provisions of 29 CFR
1913.10 do not apply where a written
directive by the MRO authorizes
appropriately qualified personnel to
conduct limited review of specific
medical information mandated by an
occupational safety and health standard
or of specific biological monitoring test
results. OSHA will also amend Directive
CPL 02–02–072 to reflect the new
regulatory text in paragraph (b)(6).
Section 1913.10(c)—Responsible
Persons
OSHA’s regulation at 29 CFR
1913.10(c) establishes certain
responsibilities for OSHA personnel
when the agency accesses personally
identifiable employee medical
information. Paragraph (c) is largely a
summary of duties established by other
paragraphs in § 1913.10 and sets forth
specific responsibilities for the Assistant
Secretary, MRO, and Principal OSHA
Investigator. The final rule amends
several provisions in paragraph (c) to
emphasize the responsibilities of the
MRO.
Under the previous regulation,
paragraph (c)(1) provided that the
OSHA Assistant Secretary was
responsible for the overall
administration and implementation of
the policies and procedures in
§ 1913.10. This responsibility included
making determinations regarding (1)
OSHA access to personally identifiable
employee medical information and (2)
interagency transfer or public disclosure
of personally identifiable employee
medical information. Also under the
previous regulation, § 1913.10(d)(1)
provided that each request by an OSHA
representative to access information
through a written access order must be
approved by the Assistant Secretary
upon the recommendation of the MRO.
Section 1913.10(c)(2) of the previous
regulation provided that the Assistant
Secretary was responsible for
designating an OSHA official with
experience or training in the evaluation,
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use, and privacy protection of medical
records to be the MRO. The MRO, who
reported directly to the Assistant
Secretary on matters related to
§ 1913.10, was responsible for making
recommendations to the Assistant
Secretary on whether to approve or
deny written access orders, and served
as the central reviewer of the sufficiency
and justification of these documents.
The MRO was also responsible for
responding to employee, collective
bargaining agent, and employer
objections to written access orders. In
addition, § 1913.10(c)(2) of the previous
regulation stated that the MRO was
responsible for controlling the use of
direct personal identifiers; controlling
internal agency use and security of
personally identifiable employee
medical information; assuring that the
results of agency analysis of personally
identifiable employee medical
information are, where appropriate,
communicated to employees; preparing
an annual report for the Assistant
Secretary on OSHA’s experience with
respect to § 1913.10; and assuring that
adequate notice is given of intended
inter-agency transfers or public
disclosures of personally identifiable
employee medical information.
The other OSHA official with
important responsibilities when the
agency accesses employee medical
information is the Principal OSHA
Investigator. Section 1913.10(c)(3)
provides that the Principal OSHA
Investigator is the OSHA employee
designated on the MAO who is
primarily responsible for ensuring that
OSHA examination and use of employee
medical information is in accordance
with the provisions of the MAO and
§ 1913.10. In most instances, the
Principal OSHA Investigator named on
a MAO is an employee from an OSHA
Regional or Area Office and determines
how and when employee medical
information will be accessed during an
OSHA inspection or investigation. In
practice, the Principal OSHA
Investigator is responsible for ensuring
that the provisions of the MAO and
§ 1913.10 are followed by OSHA
personnel when medical information is
accessed at a specific workplace. As
provided in § 1913.10(c)(3), the
Principal OSHA Investigator must be
professionally trained in medicine,
public health, or similar fields
(epidemiology, toxicology, industrial
hygiene, biostatistics, environmental
health) when access is made pursuant to
a MAO. The provisions in
§ 1913.10(c)(3) concerning the Principal
OSHA Investigator are unchanged by
the final rule.
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The final rule retains the Assistant
Secretary’s responsibility to designate
an OSHA official as MRO. However, this
responsibility is now set forth in
§ 1913.10(c)(1). Like the previous
regulation, § 1913.10(c)(1) of the final
rule states that the Assistant Secretary
shall designate an OSHA official with
experience or training in the evaluation,
use, and privacy protection of medical
records to be the OSHA Medical
Records Officer. The final rule also
states that the Assistant Secretary may
change the designation of the MRO at
will.
The final rule includes several
changes to paragraph (c)(2), OSHA
Medical Records Officer. Some of these
changes transfer specific responsibilities
from the Assistant Secretary to the MRO
while other responsibilities assigned to
the MRO in § 1913.10(c)(2) are carried
over from the previous regulation.
The final rule amends paragraph (c)(2)
to provide that the MRO is now
responsible for the overall
administration and implementation of
the procedures contained in § 1913.10.
OSHA believes there are two central
principles that form the basis of the
procedural requirements in § 1913.10:
(1) There should be a thorough review
of all efforts to examine or copy
personally identifiable employee
medical information before the
information is obtained and (2)
personally identifiable information must
be carefully protected once obtained.
OSHA also believes the MRO is in the
best position to ensure that the central
principles of § 1913.10 are carried out
by the agency.
As already noted, paragraph (c)(1) of
the final rule, like the previous
regulation, provides that the MRO must
have experience and training in the
evaluation, use, and privacy protection
of medical records. Historically, a
physician from OSHA’s Office of
Occupational Medicine and Nursing
(OOMN) has been designated as MRO,
and, in most cases, the person
designated has been the Director of
OOMN. As a result, the MRO has had
an extensive background in both
medicine and administration.
Additionally, under the previous
regulation, the MRO was already
responsible for ensuring the sufficiency
and justification of MAOs and making
recommendations to the Assistant
Secretary on whether to approve or
deny such documents. The MRO also
has several duties set forth throughout
the other paragraphs in § 1913.10 and
therefore has a good understanding of
the day-to-day implementation of the
regulation.
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Under the final rule, the MRO will
now be responsible for making
determinations regarding whether to
approve or deny MAOs, any interagency transfer, and public disclosures
of personally identifiable employee
medical information, as well as whether
to issue written directives authorizing
OSHA personnel to conduct limited
review of certain medical information
without an MAO. Accordingly, the
extensive medical and administrative
experience, the responsibilities under
the previous regulation, and the new
responsibilities assigned by this final
rule make the MRO the logical OSHA
official to have responsibility for the
overall administration and
implementation of the procedures in
§ 1913.10.
While the final rule limits the role of
the Assistant Secretary in the day-to-day
implementation of § 1913.10, the
Assistant Secretary still maintains an
important oversight responsibility. As in
the previous regulation, the Assistant
Secretary retains the responsibility for
naming an OSHA official as MRO, with
the ability to replace the MRO at will,
and the MRO must still report to the
Assistant Secretary on matters related to
§ 1913.10. In practice, the MRO will
continue to consult with the Assistant
Secretary on MAO approval, interagency transfers, and public disclosures
of personally identifiable employee
medical information. In addition,
paragraph (l) requires the MRO to
prepare an annual report for the
Assistant Secretary on matters related to
the approval and purpose of MAOs,
objections to MAOs, and inter-agency
transfers and public disclosures during
the previous year. The responsibility to
designate an OSHA official as MRO,
continued consultation, and receiving
reports from the MRO will keep the
Assistant Secretary informed about
OSHA’s overall implementation of
§ 1913.10. Accordingly, like the
previous regulation, the final rule at
paragraph (c)(2) provides that the MRO
is responsible for reporting directly to
the Assistant Secretary on matters
concerning § 1913.10.
Under the final rule, the MRO is also
now responsible for making
determinations concerning (1) access to
personally identifiable employee
medical information and (2) interagency
transfer or public disclosure of
personally identifiable employee
medical information. These two
responsibilities had been assigned to the
Assistant Secretary in previous
§ 1913.10(c)(1).
Section 1913.10(c)(2)(i) of the final
rule states that the MRO is responsible
for making determinations concerning
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OSHA access to personally identifiable
employee medical information under
§ 1913.10(d). Paragraph (d) addresses
OSHA access to personally identifiable
employee medical information by MAO.
With the exception of two
circumstances described at the end of
paragraph (d), each request by OSHA to
examine or copy personally identifiable
employee medical information is made
pursuant to an MAO. Paragraph (d)(2)
sets criteria the agency must follow
when it seeks access to identifiable
medical information, and paragraph
(d)(3) sets forth the content to be
included in the MAO. In order to be
valid, an MAO must be approved by the
MRO using the criteria in paragraph
(d)(2). First, the MRO must consider
whether the information to be examined
or copied is relevant to a statutory
purpose and whether there is a need to
gain access to the information. The
MRO has the responsibility, on a caseby-case basis, to ensure that access is
sought only where there is a genuine
need to do so. OSHA believes that a
finding of relevance and need by the
MRO is a significant safeguard against
excessive use of the agency’s authority
to access personally identifiable
employee medical information.
Paragraph (d)(2) next states that
consideration must be given to whether
the personally identifiable employee
medical information subject to the MAO
is limited to only that information
needed to accomplish the purpose for
access. This provision is aimed at
preventing OSHA access to extraneous
medical information unrelated to the
purpose for access. Lastly, paragraph
(d)(2) states that the MRO must
determine that the personnel authorized
to review the medical information are
limited to those who have a need for
access and have appropriate
professional qualifications. The limiting
of personnel that can review and
analyze information to only those who
have a need for access and who have
appropriate professional qualifications
is important for maintaining the
confidentiality of employee medical
records.
OSHA believes the MRO is in the best
position to evaluate the criteria in
paragraph (d) and make determinations
on whether to approve or deny MAOs.
Typically, the MRO has extensive
subject-matter clinical experience and
expertise in occupational medicine.
This allows the MRO to evaluate
whether, and to what extent, employee
medical information needs to be
accessed by OSHA. Accordingly,
paragraph (d)(2) has been amended to
state that, before approving an MAO, the
MRO must determine that the
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documents meet the criteria in that
paragraph.
For similar reasons, the MRO is also
now responsible for making
determinations concerning inter-agency
transfer and public disclosure of
personally identifiable employee
medical information. Section
1913.10(m) describes the circumstances
under which personally identifiable
employee medical information can be
transferred to another agency or
disclosed to the public. The
requirements in paragraph (m) remain
unchanged from the previous
regulation. However, the provisions in
paragraph (m), as well as paragraph
(c)(2), are amended by the final rule to
provide that the MRO, not the Assistant
Secretary, is now responsible for making
determinations regarding inter-agency
transfer and public disclosure of
personally identifiable employee
medical information. The individual
provisions in paragraph (m) are
amended to cross reference with the
new MRO responsibility established in
§ 1913.10(c)(2)(vii).
The following discussion of the
individual provisions in paragraph (m)
clarifies the MRO’s new responsibility
for making determinations concerning
inter-agency transfer and public
disclosure set forth in § 1913.10(c)(2).
The previous regulation at
§ 1913.10(m)(1) stated that personally
identifiable employee medical
information shall not be transferred to
another agency or office outside of
OSHA (other than the Office of the
Solicitor of Labor) or disclosed to the
public (other than to the affected
employee or the original recordholder)
except when required by law or when
approved by the Assistant Secretary.
The final rule amends paragraph
(c)(2)(vii) to make clear that the MRO is
now responsible for making these
determinations. The final rule also
amends paragraph (m) to provide that
the MRO must follow specific criteria
when making determinations
concerning inter-agency transfer and
public disclosure of personally
identifiable employee medical
information.
OSHA’s longstanding position is that
inter-agency transfer and public
disclosure of personally identifiable
employee medical information should
be carefully considered, and paragraph
(m) addresses these issues. Inter-agency
transfer and public disclosure of
personally identifiable employee
medical information are not
categorically prohibited by the
regulation for two reasons. OSHA
believes (1) it cannot legally make such
a commitment and (2) situations arise
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45785
where transfer or disclosure is
appropriate. Under certain
circumstances, as a matter of law, OSHA
is compelled to transfer information to
another agency or disclose it to a nongovernmental individual. For example,
OSHA might be required to provide the
information in response to a lawful
subpoena. In other circumstances,
disclosure may also be appropriate. For
example, in order to resolve a public
health problem, OSHA may need to
transfer employee medical information
to another federal or state agency. In
such situations, the transfer of employee
medical information may be critical in
identifying an emerging health issue,
compiling data on worker fatalities from
specific exposure, or evaluating the
effectiveness of workplace controls
designed to prevent occupational illness
at manufacturing facilities.
OSHA notes that inter-agency transfer
and public disclosure of personally
identifiable employee medical
information is not a common
occurrence. In the last five years, the
agency has made only three inter-agency
transfers of personally identifiable
employee medical information to
another federal or state agency. OSHA
also notes that inter-agency transfer and
public disclosure of employee medical
information not in personally
identifiable form is not subject to
provisions in § 1913.10.
Paragraph (m) of § 1913.10 includes
strict limitations on inter-agency sharing
and public disclosure of employee
medical information. Except when
required by law, all inter-agency transfer
or public disclosure of personally
identifiable employee medical
information must be approved by the
MRO in accordance with the criteria in
paragraph (m).
Paragraph (m)(2) states that, except as
provided for in paragraph (m)(3), the
MRO shall not approve a request for an
inter-agency transfer, which has not
been consented to by the affected
employee, unless the request is by a
public health agency. Under this
provision, transfer of medical
information is permitted only to a
public health agency for a substantial
public health purpose. The regulation
goes on to state that the MRO can
approve the transfer only if the public
health agency (1) needs the information
for substantial public health purposes,
(2) will not use the information to make
individual determinations concerning
affected employees which could be to
their detriment, (3) has regulations or
written established procedures
providing protection for personally
identifiable medical information
substantially equivalent to § 1913.10,
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and (4) satisfies an exemption to the
Privacy Act to the extent the Privacy Act
applies to the requested information.
Because OSHA collects medical
information only for a public health
purpose, OSHA believes it is
appropriate to restrict all subsequent
discretionary transfers to those agencies
with an equivalent public health
purpose. The MRO must review each
request for a transfer on a case-by-case
basis by taking into account each of the
listed criteria in paragraph (m)(2). Most
importantly, in order to protect
individual privacy, the MRO must be
satisfied that the recipient agency’s
privacy protections are equivalent to
OSHA’s.
Paragraph (m)(3) contains two
exceptions to the requirements of
paragraph (m)(2). First, upon the
approval of the MRO, personally
identifiable employee medical
information can be shared with the
National Institute for Occupational
Safety and Health (NIOSH). Like OSHA,
NIOSH is a public health agency and its
research activities complement OSHA’s
regulatory responsibilities. OSHA’s
ability to analyze employee medical
records is often improved by gaining
NIOSH assistance, and medical
information collected by OSHA may
have major research value for NIOSH.
Also, because of its frequent use of
medical information, and sensitivity to
individual privacy, NIOSH has
procedures in place that provide for the
protection of personally identifiable
medical information that are
substantially equivalent to § 1913.10. As
a result, employee medical information
may be transferred to NIOSH if
approved by the MRO without further
inquiry into the sufficiency of its
programs for protecting medical records.
Paragraph (m)(3) also permits, upon
the approval of the MRO, the interagency transfer of personally
identifiable employee medical
information to the U.S. Department of
Justice when necessary with respect to
a specific action under the OSH Act. For
example, the Justice Department
prosecutes criminal violations under the
OSH Act, as well as civil penalty
collection actions. The Justice
Department also represents OSHA in
Freedom of Information Act (FOIA)
lawsuits. Personally identifiable
employee medical information may be
relevant in these legal actions, and
OSHA must be able to share information
in these circumstances.
Paragraphs (m)(4) and (5) address
public disclosure of personally
identifiable employee medical
information which has not been
consented to by the affected employee.
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Paragraph (m)(4) provides that the MRO
shall not approve a request for public
disclosure of employee medical
information containing personal
identifiers unless there are compelling
circumstances affecting the health or
safety of an individual. Also, paragraph
(m)(5) states that the MRO shall not
approve a request for public disclosure
of employee medical information which
contains information which could
reasonably be used indirectly to identify
specific employees when the disclosure
would constitute a clearly unwarranted
invasion of personal privacy. Finally,
paragraph (m)(6) retains the provision
from the previous regulation that,
except as to inter-agency transfer to
NIOSH or the Department of Justice, the
MRO shall ensure that advance notice is
provided to any collective bargaining
agent representing affected employees
and to the employer on each occasion
OSHA intends to transfer personally
identifiable employee medical
information to another agency or
disclose it to a member of the public
other than to an affected employee.
When feasible, the MRO must take
reasonable steps to assure that advance
notice is provided to affected employees
when the employees’ medical
information to be transferred or
disclosed contains direct personal
identifiers.
Finally, the final rule at
§ 1913.10(c)(2) retains several
provisions from the previous regulation.
Specifically, paragraph (c)(2)(iii)
continues to provide that the MRO is
responsible for responding to MAO
objections, and paragraph (c)(2)(iv)
continues to provide that the MRO is
responsible for overseeing the internal
use and security of personally
identifiable employee medical
information. Two other MRO
responsibilities in paragraph (c)(2) have
been retained from the previous
regulation but have been renumbered
under the final rule. Paragraph (c)(2)(v),
formerly paragraph (c)(2)(vi), continues
to provide that the MRO is responsible
for assuring that the results of agency
analyses of personally identifiable
medical information are, where
appropriate, communicated to
employees. Paragraph (c)(2)(vi),
formerly paragraph (c)(2)(vii), retains
the provision that the MRO is
responsible for preparing an annual
report of OSHA’s experience under
§ 1913.10.
Section 1913.10(d)(1)—Requirements
for Medical Access Orders
OSHA’s previous regulation at
§ 1913.10(d)(1) stated that, except as
provided in paragraph (d)(4), each
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request by an OSHA representative to
examine or copy personally identifiable
employee medical information
contained in a record held by an
employer or other record holder shall be
made pursuant to a written access order
which has been approved by the
Assistant Secretary upon the
recommendation of the OSHA Medical
Records Officer. Paragraph (d)(1) went
on to state that, if deemed appropriate,
a written access order may constitute, or
be accompanied by, an administrative
subpoena.
As explained above, the MRO is now
responsible for the approval or denial of
MAOs, and paragraph (d)(1) has been
revised to reflect this change. The final
rule also amends paragraph (d)(1) to
make clear that a MAO does not
constitute an administrative subpoena.
An administrative subpoena is a
written order issued by OSHA to require
an employer, or any other person, to
produce listed records, documents,
testimony and/or other supporting
evidence relevant to an inspection or
investigation under the OSH Act. If the
person served with a subpoena refuses
to honor (or only partially honors) the
order, the subpoena is subject to judicial
review and enforcement by a U.S.
District Court. OSHA Regional
Administrators have authority to issue
administrative subpoenas and are also
authorized to delegate to Area Directors
the authority to issue routine
administrative subpoenas. OSHA’s
policies and procedures for issuing an
administrative subpoena are set forth in
OSHA Instruction ADM 01–00–002,
August 19, 1991.
In contrast, a MAO is an authorization
for specified OSHA personnel to
examine or copy personally identifiable
employee medical information
contained in a record held by an
employer or some other record holder.
Since an MAO relates to internal OSHA
procedures, it cannot be used to compel
the production of records, nor be
enforced in a U.S. District Court.
Historically, OSHA has not treated an
MAO as equivalent to an administrative
subpoena. OSHA’s longstanding
practice has been to rely on an
administrative subpoena to compel
production of medical records by
employers. See OSHA’s August 22,
2007, Instruction CPL 02–02–072, Rules
of agency practice and procedure
concerning OSHA access to employee
medical records. MAOs set forth
internal OSHA procedure for assuring
appropriate confidentiality of medical
records is observed by OSHA personnel.
As a result, except when reasonably
certain that the employer will grant
access to employee medical
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information, OSHA personnel present
an administrative subpoena to the
employer concurrently with an MAO.
The final rule amends § 1913.10(d)(1)
to state that except as provided in
paragraph (d)(4), each request by an
OSHA representative to examine or
copy personally identifiable employee
medical information contained in a
record held by an employer or other
recordholder shall be made pursuant to
a written medical access order which
has been approved by the OSHA
Medical Records Officer. A medical
access order does not constitute an
administrative subpoena.
Section 1913.10(g)—Removal of Direct
Personal Identifiers
OSHA’s previous regulation at
§ 1913.10(g) provided that all direct
personal identifiers (e.g., name, address,
Social Security Number, payroll
number) must be removed by OSHA
personnel whenever employee medical
information obtained pursuant to a
written access order is taken off-site,
unless otherwise directed by the MRO.
The regulation also required the
Principal OSHA Investigator to code the
medical information and the list of
direct personal identifiers with a unique
identifying number for each employee
and then hand deliver or mail the list of
identifiers to the MRO. The MRO
thereafter controlled the use and
distribution of the list of coded
identifiers to those with a need to know
its contents. In addition, the numerical
coded medical information was to be
used and kept secured as though still in
a directly identifiable form.
Paragraph (g) was originally
promulgated by OSHA when the rules
of agency practice and procedure were
issued in 1980. At that time, electronic
medical records did not exist, and the
employee records that did exist were
maintained almost entirely in paper
form. Since 1980, the number of
medical records maintained by
employers and other record holders has
substantially increased, and the majority
of these records are now maintained in
electronic form.
The final rule revises § 1913.10 by
deleting the outdated procedures set
forth in paragraph (g). OSHA is
eliminating this internal requirement for
several reasons. First, existing access
and safeguarding requirements in
§ 1913.10 already address privacy
concerns when OSHA takes medical
information away from a workplace for
off-site review. Specifically, paragraph
(h) of § 1913.10 provides that only
authorized personnel may examine or
copy personally identifiable employee
medical information. As explained
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below, OSHA experience is that this
process can result in coding and recoding errors in individual employee
medical records. Likewise, it provides
that, unless an exception applies, OSHA
personnel and contractors are
authorized to use information only for
the purpose for which it was obtained.
In addition, paragraph (h)(5) states that,
whenever practicable, the examination
of personally identifiable employee
medical information shall be conducted
on-site with a minimum of medical
information taken off-site in a
personally identifiable form.
Additionally, paragraph (i) of
§ 1913.10 includes security procedures
for handling personally identifiable
employee medical information. For
example, paragraph (i)(1) provides that
files containing personally identifiable
employee medical information shall be
segregated from other agency files and,
when not in active use, must be kept in
a locked cabinet or vault. In practice,
the locking requirement extends to
when medical information is
transported from the workplace, as
OSHA personnel place records in a
locked trunk during transport by
automobile.
Second, paragraph (n) of this final
rule establishes new requirements for
the access and safeguarding of
personally identifiable employee
medical information in electronic form.
As discussed more extensively below,
paragraph (n) of the final rule provides
that the Principal OSHA Investigator is
responsible for preventing any careless,
accidental, or unintentional disclosure
of, modification to, or destruction of
electronic medical records. Paragraph
(n)(3) of the final rule provides that the
transfer and/or duplication of medical
records in electronic form must be kept
to the minimum necessary to
accomplish the purpose for which it
was obtained. Also, paragraph (n)(4)
states that electronic files containing
personally identifiable employee
medical information shall be
downloaded only to a computer hard
drive or laptop that is secured (e.g.,
password protected). Paragraph (n)(4)
now includes the Government standards
that address secure access to
Government systems and the data they
contain: Federal Information Processing
Standards (FIPS) 201–2, ‘‘Personal
Identity Verification (PIV) of Federal
Employees and Contractors’’; and
HSPD–12, ‘‘Homeland Security
Presidential Directive 12: Policy for a
Common Identification Standard for
Federal Employees and Contractors
(HSPD–12).’’
In addition, paragraph (n)(5) provides
that electronic files containing
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45787
personally identifiable employee
medical information must be encrypted
before transferred to authorized
individuals. OSHA believes the
safeguards for electronic medical
records established by this final rule,
which are based on existing OSHA
practices and policy, enhance privacy
protection and reduces the need to
remove direct personal identifiers when
OSHA personnel take personally
identifiable employee medical
information off-site.
OSHA’s experience is that deidentification increases the risk of
mislabeling or misidentifying employee
medical records and places a burden on
agency resources by requiring additional
OSHA staff time to accurately conduct
de-identification and copying of
employee medical records. In some
cases, depending on the number of
employees at a specific facility, OSHA
employees may spend several hours
finding and removing each direct
personal identifier within each affected
employee’s medical record. The
deletion of paragraph (g) will reduce the
amount of time and physical space
needed by OSHA personnel at a
worksite.
Finally, the deletion of deidentification procedures in paragraph
(g) will simplify follow-up
communication from authorized OSHA
personnel with individual employees
after evaluation of their medical
information. For example, by not having
to complete a potentially extensive deidentification process, critical medical
information about an employee will be
reviewed by an OSHA physician sooner,
and this will allow the physician to
conduct follow-up consultation with the
employee in a timely manner. Also,
because personally-identifiable
information will remain in the medical
records taken from a workplace for offsite review, it will make it easier for the
OSHA physician to identify employees,
compare associated records, and contact
individual employees.
For all of the above reasons, OSHA
has concluded that the removal of direct
personal identifier requirements in
paragraph (g) should be deleted.
Section 1913.10(n)—Medical Records
Maintained in Electronic Form
In many cases, employers and other
record holders maintain personally
identifiable employee medical
information in electronic form. OSHA’s
regulation at 29 CFR 1910.1020 provides
that a ‘‘record’’ includes any item,
collection, or grouping of information
regardless of the form or process by
which it is maintained (e.g., paper,
document, microfilm, X-ray film, or
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automated data processing). Medical
records may also be maintained on
media such as magnetic tape, computer
disks, USB storage devices (e.g., thumb
drives), and online computer storage.
Historically, OSHA personnel have
followed the requirements in 29 CFR
1913.10 when accessing personally
identifiable employee medical
information maintained in electronic
form. However, the regulation did not
include provisions that specifically
addressed electronic medical records.
The final rule establishes new internal
policies and procedures in paragraph (n)
to § 1913.10 that specifically address
OSHA access, use, and safeguarding of
personally identifiable employee
medical information maintained in
electronic form.
Since the rules of agency practice and
procedure were first issued in 1980,
medical professionals have increasingly
relied on the use and storage of medical
records in electronic form. These
records tend to improve the quality of
health care and have several practical
advantages over paper records. For
example, electronic medical records can
be accessed by health care professionals
at any time from any given location.
Legible records can also lead to more
accurate diagnosis, treatment, and drug
prescription. Electronic medical records
are cost-effective because they take up
less storage space and can be stored
indefinitely. However, because they are
in electronic form, these records also
present unique challenges to security,
privacy, and data integrity.
OSHA believes the best way to protect
the security and confidentiality of
personally identifiable employee
medical information in electronic form
is to prevent unauthorized access to
such information. Several effective
administrative, technological, and
physical measures can be taken to
protect electronic medical information
from unauthorized access, use,
disclosure, disruption, modification, or
destruction. These methods include
establishing specific security roles and
responsibilities for OSHA officials,
technology safeguards such as
encryption or firewalls to protect against
electronic breaches, ID/password
protection for devices and information
systems, and the use of anti-virus and
intrusion detection software. The
establishment of new internal OSHA
policies and procedures in paragraph (n)
of this final rule will effectively protect
the security, privacy, and data integrity
of employee medical information in
electronic form.
Section 1913.10(n)(1) of the final rule
provides that, in general, when
accessing and/or copying personally
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identifiable employee medical
information in electronic form, OSHA
personnel shall follow the requirements
set forth in 29 CFR 1913.10. As noted
above, OSHA personnel have
historically followed the rules of agency
practice and procedure in § 1913.10
when accessing employee medical
information in electronic form, and
many of the provisions in § 1913.10 are
applicable regardless of the format used
to maintain information. As a result,
unless specifically addressed in
paragraph (n), OSHA personnel should
continue to follow the rules of agency
practice and procedure in paragraphs (a)
through (m) when accessing and
safeguarding electronic employee
medical information.
Section (n)(2) of the final rule
includes responsibilities for the
Principal OSHA Investigator when
OSHA personnel access personally
identifiable employee medical
information in electronic form.
Specifically, paragraph (n)(2) states that
when personally identifiable employee
medical information in electronic form
is taken off-site, the Principal OSHA
Investigator is primarily responsible for
ensuring that such information is
properly used and kept secured. This
provision is based on the requirement in
paragraph (h)(1) of § 1913.10, which
provides that the Principal OSHA
Investigator is responsible for ensuring
that medical information is used and
kept secured in accordance with
§ 1913.10. Other specific responsibilities
assigned to the Principal OSHA
Investigator in paragraph (n)(2) include
preventing any accidental or
unintentional disclosure of,
modification to, or destruction of
personally identifiable employee
medical information in electronic form
(paragraph (n)(2)(i)); controlling the
flow of data into, through, and from
agency computer operations (paragraph
(n)(2)(ii)); and ensuring that distribution
and review of medical information in
electronic form is limited to only those
OSHA personnel and contractors with a
need for access (paragraph (n)(2)(iii)).
The requirement in paragraph (n)(2)(iii)
is derived from § 1913.10(d)(2)(iii),
which provides that, before approving a
MAO, the MRO must determine that
personnel authorized to review and
analyze personally identifiable
employee medical information are
limited to those who have a need for
access and have appropriate
qualifications.
As discussed above, the Principal
OSHA Investigator is the OSHA
employee in the field with primary
responsibility for ensuring that the
examination and use of employee
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medical information is in accordance
with § 1913.10. As such, the Principal
OSHA Investigator is responsible for
ensuring that the provisions in
paragraph (n) are followed by OSHA
personnel when electronic medical
information is accessed from a specific
workplace. For example, this would
include ensuring that access to
personally identifiable employee
medical records in electronic form is
limited to only authorized personnel
with a need to review the information,
ensuring that employee medical
information is only downloaded to a
secured device (e.g., password
protected), and verifying that medical
information is deleted or destroyed
when no longer needed by the agency.
Section 1913.10(n)(3) of the final rule
provides that the transfer and/or
duplication of medical information in
electronic form shall be kept to the
minimum necessary to accomplish the
purpose for which it was obtained. This
provision is similar to paragraph (i)(3) of
§ 1913.10, which states that the
photocopying or other duplication of
personally identifiable employee
medical information shall be kept to the
minimum necessary to accomplish the
purpose for which the information was
obtained.
In some cases, personally identifiable
employee medical information in
electronic form needs to be transferred
or duplicated to facilitate internal
OSHA review. For example, in order to
conduct a proper workplace inspection
or investigation, it may be necessary for
OSHA personnel to transfer employee
medical records to another OSHA
employee with expertise on a specific
occupational health hazard. Paragraph
(n)(3) of the final rule permits the
transfer and duplication of electronic
medical information but only to
authorized individuals with a need to
review the information. Transfer and
duplication are also limited to the
minimum necessary to accomplish the
purpose for which it was obtained. An
example of this limitation might include
the review of a medical record to
determine whether an employee has
sustained a work-related injury or
illness. In such cases, review of a
medical record would extend only to
information about the employee’s injury
or illness. In this example, the transfer
and/or duplication of electronic medical
information unrelated to the injury or
illness would not be permitted.
Additionally, OSHA believes the
likelihood that medical information in
electronic form will be lost, altered, or
destroyed increases during transfer or
duplication. The duplication of
electronic medical information can also
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raise concern about data integrity. For
example, the copying or deleting of
employee medical information from one
document to another raises concern
about the accuracy of the information.
Accordingly, personally identifiable
electronic medical information should
be transferred only to authorized
individuals with a need to know the
information and should be duplicated
only to facilitate authorized internal
agency review.
Consistent with existing OSHA
policy, § 1913.10(n)(4) of the final rule
states that electronic files containing
personally identifiable employee
medical information shall be
downloaded only to a computer hard
drive or laptop that is in accordance
with Federal Information Processing
Standard (FIPS) 201–2, ‘‘Personal
Identity Verification (PIV) of Federal
Employees and Contractors,’’ and
‘‘Homeland Security Presidential
Directive 12: Policy for Common
Identification Standard for Federal
Employees and Contractors (HSPD–
12).’’ The use of secured technology
when downloading medical records will
help to ensure that information is (1)
accessed only by authorized individuals
with a need-to-know and (2) not
modified or deleted.
In accordance with current OSHA and
Federal Government policy, the use of
password protection is easy to
implement, cost-effective, and a reliable
method for securing electronic
information. By downloading employee
medical information to a secured hard
drive or laptop, OSHA personnel will be
able to ensure that only individuals that
know the password can open a
document and read its content. This
practice also provides a level of
protection that goes with the document
no matter where it is stored or sent.
Finally, because tampering with a
secured device takes time and effort,
providing this level of protection acts as
a deterrent to accessing document
content by unauthorized individuals.
Additionally, it is important for
OSHA personnel to follow proper
security practices when using password
protected devices containing personally
identifiable employee medical
information. Authorized individuals
must not share their ID with others,
should log-off when leaving a terminal,
and use their own ID to access employee
medical records. Also, authorized
individuals should not keep written
facsimiles of passwords or access codes.
Other security measures, such as the use
of firewalls, anti-virus software, and
intrusion detection software should also
be used to protect data integrity. Again,
the Principal OSHA Investigator is
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responsible for ensuring that proper
security measures are in place in the
field to protect the confidentiality of
personally identifiable employee
medical records in electronic form.
Moreover, it is critically important
that mobile devices be encrypted or use
password protection when used to
download, transfer, or store electronic
medical information. Mobile devices are
for individual use, and are not designed
for centralized IT management. These
devices can easily be manipulated,
damaged, or stolen. By encryption,
OSHA means the process of changing
plain text into cypher text for the
purpose of security. The use of
encryption results in the encoding of
information in such a way so that only
authorized individuals can access the
information.
Section 1913.10(n)(5) of the final rule
states that electronic files containing
personally identifiable employee
medical information shall not be
transferred to authorized personnel
through email attachment unless
appropriately encrypted. The transfer of
employee medical information by email
attachment increases the risk that such
information will be sent to an
unauthorized individual. The transfer of
personally identifiable employee
medical information in electronic form
must be made through secured means.
See § 1913.10(n)(4), discussed above
(‘‘Electronic files containing personally
identifiable employee medical
information shall only be downloaded
to a computer hard drive or laptop that
is secured.’’). Appropriate methods for
the transfer of personally identifiable
employee medical information in
electronic form may include the use of
password protected or encrypted files
on a secured agency website designed
for confidential information, the mailing
of encrypted computer disks or USB
drives, the emailing of password
protected medical records (Adobe
secured), and the printing and hand
delivery of paper records.
Paragraph (n)(6) provides that when
an employer or other record holder(s)
provides access to employee medical
information through a properly
encrypted email attachment, the
attachment shall be downloaded to a
secured hard drive or laptop. After the
attachment is downloaded, the email
shall be permanently deleted.
In some cases, employers and other
record holders provide OSHA with
access to employee medical information
through an encrypted email attachment.
As noted above, the use of email
attachments to transfer medical records
makes it more likely that the
information will be sent to unauthorized
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45789
individuals. Paragraph (n)(6) ensures
that medical information received in an
encrypted email attachment is
downloaded to a secured device.
After downloading the attachment
from the employer or other record
holder, the email must be permanently
deleted to prevent transfer to
unauthorized individuals. By
permanently deleted, OSHA means that
the email should be deleted so that it
cannot be retrieved. Some email
programs automatically delete trashed
emails after a certain amount of time.
Other programs retain emails until the
user runs out of space. However, the
intent of this provision is that, once the
attachment is downloaded, OSHA
personnel should immediately and
permanently delete the incoming email.
Most email programs have a ‘‘delete
forever’’ function that allows the user to
select emails in the trash folder for
permanent deletion.
Section 1913.10(n)(7) of the final rule
states that personally identifiable
employee medical information in
electronic form shall be secured when
not in use. This provision is based on
paragraph (i)(1) of § 1913.10, which
states that agency files containing
personally identifiable employee
medical information shall be segregated
from other agency files, and when not
in active use, files containing this
information shall be kept secured in a
locked cabinet or vault. Paragraph (n)(7)
is intended to prevent unauthorized
access or modification to employee
medical information in electronic form.
In addition to all of the procedures in
paragraph (n) addressing the use of
electronic information by OSHA
personnel, when not in use, such
information must be stored in a secured
manner. For example, when not in use,
personally identifiable employee
medical information should be stored
on a password protected hard drive or
laptop. Another example might be the
storing of information on a password
protected agency website designed to
store confidential information. Also, if
employee medical records are kept on
computer disk or other electronic
storage media, when not in use, the disk
or media should be stored under lock
and key. Paragraph (n)(7)(i) of the final
rule also emphasizes the importance of
proper storage by specifically stating
that medical information in electronic
form shall only be maintained or stored
where facilities and conditions are
designed to prevent unauthorized
access.
Paragraph (n)(7)(ii) provides that
personally identifiable employee
medical information in electronic form
shall be maintained only for so long as
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needed to accomplish the purpose for
access. This provision is derived from
paragraph (j)(1) of § 1913.10, which
provides that consistent with OSHA
records disposition programs,
personally identifiable employee
medical information shall be destroyed
or returned to the original record holder
when no longer needed for the purposes
for which they were obtained. In
OSHA’s view, maintaining medical
records only for so long as needed helps
to ensure that such information will not
be accessed by unauthorized
individuals.
In some cases, after its initial use by
the agency, personally identifiable
employee medical information may not
be used again until sometime in the
future. For example, medical
information used as the basis for an
OSHA citation may be used during the
hearing stage of an enforcement case
before the Occupational Safety and
Health Review Commission. The
medical information may not be used
while the case is on appeal, but there
may be a need for the information if the
case is remanded for further judicial
proceedings. Similarly, an investigation
of an apparently new health hazard may
produce uncertain results. Before
completely closing out this
investigation, it may be appropriate to
await the outcome of an ongoing
research study or parallel investigation
elsewhere in the country. In these cases,
§ 1913.10(j) provides that the medical
information should be transferred to the
MRO. Also, under § 1913.10(l)(2), the
MRO must conduct an annual review of
all centrally-held information to
determine which information is no
longer needed for the purposes for
which it was obtained. These
requirements apply equally to
personally identifiable employee
medical information stored in electronic
form.
Paragraph (n)(7)(iii) of the final rules
states that when no longer needed, the
Principal OSHA Investigator shall
ensure that all personally identifiable
employee medical information on
electric files has been deleted,
destroyed, or returned to the original
record holder. The requirement in
paragraph (n)(7)(iii) is intended to
ensure that the Principal OSHA
Investigator is responsible for OSHA
access and use of electronic medical
information from beginning to end.
When no longer needed, the Principal
OSHA Investigator must make sure that
authorized OSHA personnel follow
proper procedures for the deletion,
destruction and disposal of personally
identifiable employee medical
information. In practice, the Principal
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OSHA Investigator must ensure that
media containing employee medical
information is sanitized or destroyed
before disposal or release for reuse in
accordance with approved methods. In
addition, if electronic medical records
are returned to the original record
holder, the Principal OSHA Investigator
must ensure that all data is returned,
and no data remains in the possession
of OSHA personnel.
Paragraph (n)(7)(iv) states that the
disposal of personally identifiable
employee medical information
maintained in electronic form shall be
accomplished in such a manner as to
make the data unattainable by
unauthorized personnel. When no
longer needed, electronic media must be
handled and sanitized appropriately to
prevent unauthorized disclosure or
modification of personally identifiable
employee medical information.
OSHA personnel use several types of
electronic media to access, use, and
maintain personally identifiable
employee medical information,
including hard drives, laptops, USB
storage drives (e.g., thumb drives), CDs,
DVDs, and digital storage cards such as
camera cards. In order to meet the
requirement in paragraph (n)(7)(iv), and
depending on the type of electronic
media used, OSHA personnel may need
to re-use, recycle, or destroy the
electronic media containing medical
information. Also, when employee
medical information in electronic form
is no longer needed, it is important to
ensure that deleted data is not easily
recoverable. Residual data may allow
unauthorized individuals to reconstruct
data and thereby gain access to
personally identifiable employee
medical information. Sanitization is one
method that can be used to ensure that
deleted data cannot be reconstructed.
Sanitization is the general process of
removing data from storage media, such
that there is reasonable assurance that
the data may not be easily retrieved and
reconstructed. There are different types
of sanitization for each type of media,
including cleaning, purging, and
destroying. Cleaning is the removal of
data from devices in such a way that
there is assurance that the data cannot
be reconstructed using normal system
functions or software file/data recovery
utilities. For example, cleaning may
include using software or hardware
products to overwhelm media with nonsensitive data. Purging is generally done
before releasing media beyond control,
such as before discarding old media,
and includes degaussing or exposing
media to a strong magnetic field in order
to disrupt recorded magnetic domains.
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Destruction of media is the ultimate
form of sanitization.
In some cases, OSHA personnel
maintain employee medical information
on media that may not be able to be
reused such as computer disks and
camera cards. In these situations, when
no longer needed, electronic media
containing personally identifiable
employee medical information should
be disposed of using approved secure
data destruction. Several methods exist
to dispose of electronic media
containing medical information. For
example, computer disks can be
rendered unusable by shredding,
incinerating, or pulverizing. Many
OSHA Regional and Area Offices
already have equipment that can shred
or burn disks. Other offices contract
with private companies to perform this
task in a secure manner. As a reminder,
in order to address security and privacy
concerns, disposal operations should be
conducted in accordance with approved
DOL or OSHA methods. In addition,
OSHA is responsible for the
management of records pursuant to the
Federal Records Act of 1950, as
amended (44 U.S.C. Chapters 21, 29, 31,
33). The retention and destruction of
Federal records must be conducted in
accordance with the procedures
described in the Federal Records Act.
Finally, in the future, OSHA
personnel will be using media types not
specifically mentioned in this preamble.
The processes mentioned in this
document should guide media
sanitization and disposal decisions
regardless of the type of media in use.
In the future, OSHA will issue guidance
to agency staff as new technology is
developed.
IV. State Plans
The 28 states and U.S. territories with
their own OSHA-approved occupational
safety and health plans are encouraged,
but not required, to adopt these rules of
agency practice and procedure
concerning employee medical record
access that Federal OSHA is
promulgating to 29 CFR 1913.10 in this
final rule. The states and U.S. territories
with OSHA-approved occupational
safety and health plans covering private
employees and state and local
government employees are 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. In
addition, six states and U.S. territories
have OSHA-approved state Plans that
apply to state and local government
employees only: Connecticut, Illinois,
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Maine, New Jersey, New York, and the
Virgin Islands.
This final rule describes a Federal
program change for which State Plan
adoption is not required. However, State
Plans are required to have standards,
and an enforcement program, that are
‘‘at least as effective in providing safe
and healthful employment’’ as those of
Federal OSHA. In order to be ‘‘at least
as effective’’ as Federal OSHA, a State
Plan must appropriately utilize its
authority for access to medical records,
and must have effective procedures to
assure that the privacy of those records
is protected in a manner consistent with
applicable state and federal privacy
laws. Therefore, although adoption of
this rule is not required, State Plans
must have procedures covering this
issue that are at least as effective as
those of Federal OSHA and are
encouraged to adopt requirements
comparable to those in 29 CFR 1913.10.
Within 60 days of the effective date of
this final rule, a State Plan must submit
a notice of intent indicating whether
they already have a similar policy in
place, intend to adopt new policies and
procedures, or do not intend to adopt
this final rule. If a State Plan does not
adopt at first, but at some later point
decides to adopt this final rule or an at
least as effective version of this final
rule, the State Plan must notify OSHA
of this change in intent. Within 60 days
of adoption, the State Plan must provide
an electronic copy of the regulation or
policy, or a link to where their policy
is posted on the State Plan’s website.
The State Plan must also provide the
date of adoption and identify
differences, if any, between their policy
and this final rule. OSHA will provide
summary information on the State Plan
responses to this instruction on its
website at: www.osha.gov/dcsp/osp/
index.html.
V. Regulatory Flexibility Certification
The notice and comment procedures
of section 553 of the APA do not apply
‘‘to interpretative rules, general
statements of policy, or rules of agency
organization, procedure, or practice.’’ 5
U.S.C. 553(b)(A). Rules that are exempt
from APA notice and comment
requirements are also exempt from the
Regulatory Flexibility Act (RFA). See
SBA Office of Advocacy, A Guide for
Government Agencies: How to Comply
with the Regulatory Flexibility Act
(August 2017); also found at https://
www.sba.gov/sites/default/files/rfaguide
5F05125F0.pdf. This is a rule of agency
procedure, practice, and interpretation
within the meaning of that section; and
therefore, is exempt from both the
notice and comment rulemaking
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procedures of the APA and the
requirements of the RFA.
VI. Environmental Impact Analysis
In accordance with the requirements
of the National Environmental Policy
Act (NEPA) (42 U.S.C. 4231 et seq.),
Council on Environmental Quality
NEPA regulations (40 CFR parts 1500
through 1518), and the Department of
Labor NEPA regulations (29 CFR part
11), OSHA has determined that this
final rule will not have a significant
impact on the external environment.
VII. Federalism
OSHA reviewed this final rule in
accordance with the most recent
Executive order on federalism
(Executive Order 13132, 64 FR 43255,
August 10, 1999). This Executive order
requires Federal agencies, to the extent
possible, to refrain from limiting state
policy options, consult with states prior
to taking any action that would restrict
state policy options, and take such
actions only when clear constitutional
authority exists and the problem is
national in scope.
This rule does not have ‘‘federalism
implications.’’ The rule does not have
‘‘substantial direct effects on the States,
on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government’’ and therefore is
not subject to Executive Order 13132
(Federalism).
VIII. Unfunded Mandates
The Department has concluded that
this rule is not a ‘‘significant regulatory
action’’ within the meaning of Executive
Order 12866, reaffirmed by Executive
Order 13563, because it is not likely to
(1) have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
state, local, or Tribal governments or
communities; (2) create a serious
inconsistency or otherwise interfere
with an action taken or planned by
another agency; (3) materially alter the
budgetary impact of entitlements,
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the
President’s priorities, or the principles
set forth in Executive Order 12866.
Therefore, no economic impact analysis
under section 6(a)(3)(C) of Executive
Order 12866 has been prepared. For the
same reason, and because no notice of
proposed rulemaking was published, no
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45791
statement is required under section 202
of the Unfunded Mandates Reform Act
of 1995, 2 U.S.C. 1532. In any event, this
rulemaking is procedural and
interpretive in nature and is thus not
expected to have a significant economic
impact.
IX. Consultation and Coordination With
Indian Tribal Governments
OSHA reviewed this rule in
accordance with Executive Order 13175
(65 FR 67249, November 6, 2000) and
determined that it does not have ‘‘tribal
implications’’ as defined in that order.
The rule does not have substantial
direct effects on one or more Indian
tribes, on the relationship between the
Federal Government and Indian tribes,
or on the distribution of power and
responsibilities between the Federal
Government and Indian tribes.
X. Office of Management and Budget
Review Under the Paperwork
Reduction Act of 1995
The Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.) and OMB
regulations (5 CFR part 1320) require
agencies to obtain approval from OMB
before conducting any collection of
information. The PRA defines a
‘‘collection of information’’ as ‘‘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)). The PRA does not apply to
this final rule because it amends
existing internal agency procedures and
does not impose any new recordkeeping
or information collection requirements
that require OMB approval.
Authority and Signature
This document was prepared under
the direction of Loren Sweatt, Principal
Deputy Assistant Secretary for
Occupational Safety and Health. It is
issued under Section 8 of the
Occupational Safety and Health Act (29
U.S.C. 657), 5 U.S.C. 553, 5 U.S.C.
552a(e), 5 U.S.C. 301, and Secretary of
Labor’s Order No. 5–2012 (77 FR 3912).
Signed at Washington, DC, on July 14,
2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor
for Occupational Safety and Health.
Final Rule
Part 1913 of title 29 of the Code of
Federal Regulations is hereby amended
as follows:
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PART 1913—[AMENDED]
1. The authority citation for part 1913
is revised to read as follows:
■
Authority: 29 U.S.C. 657; 5 U.S.C. 553; 5
U.S.C. 301; Secretary of Labor’s Order No. 8–
76 (41 FR 25059), 5–2002 (67 FR 65008), or
1–2012 (77 FR 3912) as applicable.
2. Amend § 1913.10 by:
a. Revising paragraphs (b)(6), (c)(1)
and (2), and (d)(1) and (2);
■ b. Removing and reserving paragraph
(g);
■ c. Revising paragraph (m); and
■ d. Adding paragraph (n).
The revisions and addition read as
follows:
■
■
§ 1913.10 Rules of agency practice and
procedure concerning OSHA access to
employee medical records.
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*
*
*
*
*
(b) * * *
(6) This section does not apply where
a written directive by the OSHA
Medical Records Officer authorizes
appropriately qualified personnel to
conduct limited reviews of specific
medical information mandated by an
occupational safety and health standard,
or of specific biological monitoring test
results.
*
*
*
*
*
(c) * * *
(1) Assistant Secretary. The Assistant
Secretary of Labor for Occupational
Safety and Health (Assistant Secretary)
shall designate an OSHA official with
experience or training in the evaluation,
use, and privacy protection of medical
records to be the OSHA Medical
Records Officer. The Assistant Secretary
may change the designation of the
OSHA Medical Records Officer at will.
(2) OSHA Medical Records Officer.
The OSHA Medical Records Officer
shall be responsible for the overall
administration and implementation of
the procedures contained in this
section. The OSHA Medical Records
Officer shall report directly to the
Assistant Secretary on matters
concerning this section and be
responsible for:
(i) Making final determinations
concerning the approval or denial of
medical access orders (paragraph (d) of
this section);
(ii) Assuring that medical access
orders meet the requirements of
paragraphs (d)(2) and (3) of this section;
(iii) Responding to objections
concerning medical access orders
(paragraph (f) of this section);
(iv) Overseeing internal agency use
and security of personally identifiable
employee medical information
(paragraphs (g) through (j) of this
section);
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16:01 Jul 29, 2020
Jkt 250001
(v) Assuring that the results of agency
analyses of personally identifiable
medical information are, where
appropriate, communicated to
employees (paragraph (k) of this
section);
(vi) Preparing an annual report of
OSHA’s experience under this section
(paragraph (l) of this section); and
(vii) Making final determinations
concerning inter-agency transfer or
public disclosure of personally
identifiable employee medical
information (paragraph (m) of this
section). The Medical Records Officer
shall also assure that advance notice is
given of intended inter-agency transfers
or public disclosures.
*
*
*
*
*
(d) * * *
(1) Requirement for medical access
order. Except as provided in paragraph
(d)(4) of this section, each request by an
OSHA representative to examine or
copy personally identifiable employee
medical information contained in a
record held by an employer or other
recordholder shall be made pursuant to
a written medical access order which
has been approved by the OSHA
Medical Records Officer. A medical
access order does not constitute an
administrative subpoena.
(2) Approval criteria for medical
access order. Before approving a
medical access order, the OSHA
Medical Records Officer shall determine
that:
(i) The medical information to be
examined or copied is relevant to a
statutory purpose and there is a need to
gain access to this personally
identifiable information;
(ii) The personally identifiable
medical information to be examined or
copied is limited to only that
information needed to accomplish the
purpose for access; and
(iii) The personnel authorized to
review and analyze the personally
identifiable medical information are
limited to those who have a need for
access and have appropriate
professional qualifications.
*
*
*
*
*
(m) Inter-agency transfer and public
disclosure. (1) Personally identifiable
employee medical information shall not
be transferred to another agency or
office outside of OSHA (other than to
the Office of the Solicitor of Labor) or
disclosed to the public (other than to the
affected employee or the original
recordholder) except when required by
law or when approved by the OSHA
Medical Records Officer.
(2) Except as provided in paragraph
(m)(3) of this section, the OSHA
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Frm 00032
Fmt 4700
Sfmt 4700
Medical Records Officer shall not
approve a request for an inter-agency
transfer of personally identifiable
employee medical information, which
has not been consented to by the
affected employees, unless the request is
by a public health agency which:
(i) Needs the requested information in
a personally identifiable form for a
substantial public health purpose;
(ii) Will not use the requested
information to make individual
determinations concerning affected
employees which could be to their
detriment;
(iii) Has regulations or established
written procedures providing protection
for personally identifiable medical
information substantially equivalent to
that of this section; and
(iv) Satisfies an exemption to the
Privacy Act to the extent that the
Privacy Act applies to the requested
information (see 5 U.S.C. 552a(b); 29
CFR 70a.3).
(3) Upon the approval of the OSHA
Medical Records Officer, personally
identifiable employee medical
information may be transferred to:
(i) The National Institute for
Occupational Safety and Health
(NIOSH); and
(ii) The Department of Justice when
necessary with respect to a specific
action under the Occupational Safety
and Health Act.
(4) The OSHA Medical Records
Officer shall not approve a request for
public disclosure of employee medical
information containing direct personal
identifiers unless there are compelling
circumstances affecting the health or
safety of an individual.
(5) The OSHA Medical Records
Officer shall not approve a request for
public disclosure of employee medical
information which contains information
which could reasonably be used
indirectly to identify specific employees
when the disclosure would constitute a
clearly unwarranted invasion of
personal privacy (see 5 U.S.C. 552(b)(6);
29 CFR 70.26).
(6) Except as to inter-agency transfers
to NIOSH or the Department of Justice,
the OSHA Medical Records Officer shall
ensure that advance notice is provided
to any collective bargaining agent
representing affected employees and to
the employer on each occasion that
OSHA intends to either transfer
personally identifiable employee
medical information to another agency
or disclose it to a member of the public
other than to an affected employee.
When feasible, the OSHA Medical
Records Officer shall take reasonable
steps to assure that advance notice is
provided to affected employees when
E:\FR\FM\30JYR1.SGM
30JYR1
khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Rules and Regulations
the employee medical information to be
transferred or disclosed contains direct
personal identifiers.
(n) Medical records maintained in
electronic form. (1) In general, when
accessing and/or copying personally
identifiable employee medical
information in electronic form, OSHA
personnel shall follow all of the
requirements set forth in this section.
(2) When personally identifiable
employee medical information in
electronic form is taken off-site, the
Principal OSHA Investigator is
primarily responsible for ensuring that
such information is properly used and
kept secured.
(i) The Principal OSHA Investigator is
responsible for preventing any
accidental or unintentional disclosure
of, modification to, or destruction of
personally identifiable employee
medical information in electronic form.
(ii) The Principal OSHA Investigator
is responsible for controlling the flow of
data into, through, and from agency
computer operations.
(iii) The Principal OSHA Investigator
shall ensure the distribution and review
of medical information in electronic
form is limited to only those OSHA
personnel and contractors with a need
for access.
(3) The transfer and/or duplication of
medical information in electronic form
shall be kept to the minimum necessary
to accomplish the purpose for which it
was obtained.
(4) Electronic files containing
personally identifiable employee
medical information shall be
downloaded only to a computer hard
drive or laptop that is secured in
accordance with Federal Information
Processing Standard (FIPS) 201–2
‘‘Personal Identity Verification (PIV) of
Federal Employees and Contractors’’
and ‘‘Homeland Security Presidential
Directive 12: Policy for a Common
Identification Standard for Federal
Employees and Contractors (HSPD–
12).’’
(5) Electronic files containing
personally identifiable employee
medical information shall not be
transferred to authorized personnel
through email attachment unless
appropriately encrypted.
(6) When an employer or other record
holder(s) provides access to employee
medical information through a properly
encrypted email attachment, the
attachment shall be downloaded to a
secured hard drive or laptop. After the
attachment is downloaded, the email
shall be permanently deleted.
(7) Personally identifiable employee
medical information in electronic form
shall be secured when not in use.
VerDate Sep<11>2014
16:01 Jul 29, 2020
Jkt 250001
(i) Medical information in electronic
form shall only be maintained or stored
where facilities and conditions are
designed to prevent unauthorized
access.
(ii) Personally identifiable employee
medical information in electronic form
shall be maintained only for so long as
needed to accomplish the purpose for
access.
(iii) When no longer needed, the
Principal OSHA Investigator shall
ensure that all personally identifiable
employee medical information on
electronic files has been deleted,
destroyed, or returned to the original
record holder.
(iv) The disposal of personally
identifiable employee medical
information maintained in electronic
form shall be accomplished in such a
manner as to make the data unattainable
by unauthorized personnel.
[FR Doc. 2020–15562 Filed 7–29–20; 8:45 am]
BILLING CODE 4510–26–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 54
[WC Docket Nos. 18–143, 10–90, 14–58; FCC
19–95; FRS 16955]
The Uniendo a Puerto Rico Fund and
the Connect USVI Fund, Connect
America Fund, ETC Annual Reports
and Certifications
Federal Communications
Commission.
ACTION: Final rule; announcement of
effective date.
AGENCY:
In this document, the Federal
Communications Commission
(Commission) announces that the Office
of Management and Budget (OMB) has
approved, for a period of three years, an
information collection associated with
the rules for the Connect America Fund
contained in the Commission’s Uniendo
a Puerto Rico Fund and Connect USVI
Fund Order, FCC 19–95. This document
is consistent with the Uniendo a Puerto
Rico Fund and Connect USVI Fund
Order, which stated that the
Commission would publish a document
in the Federal Register announcing the
effective date of the new information
collection requirements.
DATES: The amendments to §§ 54.1505,
54.1508 and 54.1515 published at 84 FR
59937, November 7, 2019 are effective
July 30, 2020.
FOR FURTHER INFORMATION CONTACT:
Alexander Minard, Wireline
Competition Bureau at (202) 418–7400
SUMMARY:
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
45793
or TTY (202) 418–0484. For additional
information concerning the Paperwork
Reduction Act information collection
requirements contact Nicole Ongele at
(202) 418–2991 or via email:
Nicole.Ongele@fcc.gov.
SUPPLEMENTARY INFORMATION: The
Commission submitted revised
information collection requirements for
review and approval by OMB, as
required by the Paperwork Reduction
Act (PRA) of 1995, on May 20, 2020,
which were approved by OMB on July
9, 2020. The information collection
requirements are contained in the
Commission’s Uniendo a Puerto Rico
Fund and Connect USVI Fund Order,
FCC 19–95 published at 84 FR 59937,
November 7, 2019. The OMB Control
Number is 3060–1274. If you have any
comments on the burden estimates
listed in the following, or how the
Commission can improve the
collections and reduce any burdens
caused thereby, please contact Nicole
Ongele, Federal Communications
Commission, Room 1–A620, 445 12th
Street SW, Washington, DC 20554.
Please include the OMB Control
Number, 3060–1274, in your
correspondence. The Commission will
also accept your comments via email at
PRA@fcc.gov.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to fcc504@
fcc.gov or call the Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY).
Synopsis
As required by the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507),
the Commission is notifying the public
that it received OMB approval on July
9, 2020, for the information collection
requirements contained in 47 CFR
54.1505, 54.1508 and 54.1515 published
at 84 FR 59937, November 7, 2019.
Under 5 CFR part 1320, an agency may
not conduct or sponsor a collection of
information unless it displays a current,
valid OMB Control Number.
No person shall be subject to any
penalty for failing to comply with a
collection of information subject to the
Paperwork Reduction Act that does not
display a current, valid OMB Control
Number. The OMB Control Number is
3060–1274.
The foregoing notice is required by
the Paperwork Reduction Act of 1995,
Public Law 104–13, October 1, 1995,
and 44 U.S.C. 3507.
The total annual reporting burdens
and costs for the respondents are as
follows:
E:\FR\FM\30JYR1.SGM
30JYR1
Agencies
[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Rules and Regulations]
[Pages 45780-45793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15562]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1913
[Docket No. OSHA-2020-0005]
RIN 1218-AC95
Rules of Agency Practice and Procedure Concerning Occupational
Safety and Health Administration Access to Employee Medical Records
AGENCY: Occupational Safety and Health Administration (OSHA); Labor.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: OSHA is issuing a final rule to amend the regulation
addressing the rules of agency practice and procedure concerning OSHA
access to employee medical records. The final rule transfers the
approval of written medical access orders (MAO) from the Assistant
Secretary for Occupational Safety and Health (Assistant Secretary) to
the OSHA Medical Records Officer (MRO) and makes the MRO responsible
for making determinations regarding inter-
[[Page 45781]]
agency transfer and public disclosure of personally identifiable
medical information in OSHA's possession.
DATES: This final rule is effective on July 30, 2020.
ADDRESSES: In accordance with 29 U.S.C. 2112(a)(2), OSHA designates,
Mr. Edmund C. Baird, Associate Solicitor of Labor for Occupational
Safety and Health, Office of the Solicitor, Room S-4004, U.S.
Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210,
to receive petitions for review of the final rule.
FOR FURTHER INFORMATION CONTACT:
Press inquiries: Mr. Frank Meilinger, OSHA, Office of
Communications; telephone: (202) 693-1999; email:
[email protected].
General and technical information: Dr. Michael Hodgson, Director,
OSHA Office of Occupational Medicine and Nursing; telephone: (202) 693-
1768; email: [email protected].
SUPPLEMENTARY INFORMATION: The final rule also amends Sec. 1913.10 to
clarify that a written MAO does not constitute an administrative
subpoena, eliminates outdated requirements for the removal of direct
personal identifiers when OSHA personnel review medical information
away from a worksite, and establishes new procedures for the access and
safeguarding of personally identifiable employee medical information in
electronic form. The revisions to Sec. 1913.10 in the final rule will
increase employee privacy and enhance OSHA's ability to safeguard
personally identifiable medical information.
Table of Contents
I. Background
II. Legal Authority
III. Summary and Explanation of the Final Rule
IV. State Plans
V. Regulatory Flexibility Certification
VI. Environmental Impact Analysis
VII. Federalism
VIII. Unfunded Mandates
IX. Consultation and Coordination With Indian Tribal Governments
X. Office of Management and Budget Review Under the Paperwork
Reduction Act of 1995
I. Background
A. Introduction
In order to carry out its statutory obligations, OSHA often reviews
employee medical records. For example, OSHA may need to review employee
medical records during a compliance inspection to determine whether an
employer is in compliance with OSHA standards and regulations, or to
verify that an employer has taken steps to correct existing violations.
Access to employee medical records may also be necessary during
inspections to determine the effectiveness of voluntary employer safety
and health programs. OSHA also reviews medical records when gathering
information during agency rulemaking to develop or revise occupational
safety and health standards.
Several OSHA standards and regulations mandate medical records
access, including 29 CFR 1910.1020, Access to Employee Exposure and
Medical Records, which sets forth procedures by which exposure and
medical records can be accessed by employees, their designated
representatives, and OSHA. This regulation, which applies to employers
with employees exposed to toxic substances and harmful physical agents,
provides OSHA representatives with prompt access to employee exposure
and medical records and to analysis thereof using exposure or medical
records. See 29 CFR 1910.1020(e)(3). In addition, several of OSHA's
substance-specific standards include provisions for OSHA access to
employee medical records. (e.g., 29 CFR 1910.25(n)(4) (Lead), and 29
CFR 1910.1028(k) (Benzene)).
In many instances, OSHA must examine and copy employee medical
information in personally identifiable form. Personally identifiable
employee medical information as defined by 29 CFR 1913.10(b)(2) means
employee medical information accompanied by either direct identifiers
(name, address, social security number, payroll number) or by
information which could reasonably be used in particular circumstances
indirectly to identify specific employees (e.g., date of birth, race,
sex, date of initial employment, job title). An employee medical record
may include individual health histories as well as medical opinions and
evaluations generated during diagnosis, physical examinations, or
medical treatment by a health care professional.
Because of the substantial personal privacy interests involved,
OSHA authority to access personally identifiable employee medical
information is exercised only after the agency has made a careful
determination of the need for the information, and only when
appropriate safeguards are in place to prevent unauthorized access.
Once this information is accessed, OSHA examination and use is limited
to only that information needed to accomplish a relevant statutory
purpose. Also, personally identifiable employee medical information is
retained by OSHA only for so long as needed to accomplish the purpose
for access, is kept secured while being used, and is not disclosed to
other agencies or members of the public except in narrowly defined
circumstances. In addition, the examination and use of personally
identifiable employee medical information is limited to only OSHA
personnel with a need to review such information.
This rule is not an Executive Order (E.O.) 13771 regulatory action
because this rule is not significant under E.O. 12866. Pursuant to the
Congressional Review Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs designated this rule not a `major
rule', as defined by 5 U.S.C. 804(2).
B. OSHA's Regulation at 29 CFR 1913.10
On May 25, 1980, OSHA issued a final rule entitled Rules of Agency
Practice and Procedure Concerning OSHA Access to Employee Medical
Records (45 FR 35284). The final rule was developed and published in
concert with the promulgation of 29 CFR 1910.1020, Access to Employee
Exposure and Medical Records (45 FR 35212). During the rulemaking,
there was universal agreement that if OSHA obtained access to employee
medical records, the access should be accompanied by stringent internal
agency procedures to preclude abuse of personally identifiable medical
information. Provided these procedures were established, many
participants in the rulemaking endorsed OSHA access to employee medical
records without the consent of the employee for occupational safety and
health purposes (see 45 FR 35218).
Except as provided in 29 CFR 1913.10(b)(3) through (6), the rules
of agency practice and procedure apply to all requests by OSHA
personnel to obtain access to records to examine and copy personally
identifiable employee medical information, whether or not access is
mandated by 29 CFR 1910.1020. Among other things, the regulation at 29
CFR 1913.10 establishes certain responsibilities for specific OSHA
officials when the agency accesses personally identifiable employee
medical information. The regulation also includes provisions addressing
the internal use of employee medical records by agency personnel, as
well as requirements for inter-agency transfer and public disclosure of
such records. The regulation includes security procedures for the use
and storage of employee medical records while in the agency's
possession. Finally, the regulation sets forth internal
[[Page 45782]]
agency requirements for the retention and destruction of records.
A key provision set forth in Sec. 1913.10 is that, with few
exceptions, each request by an OSHA representative to examine or copy
personally identifiable employee medical information must be made
pursuant to a written access order. The written access order is an
authorization for specific OSHA personnel to examine or copy personally
identifiable employee medical information contained in records held by
an employer or other record holder. The rules of agency practice and
procedure in Sec. 1913.10 make clear that each written access order
must state the statutory purpose for which access is sought, a general
description of the type of employee medical information that will be
examined and why there is a need to examine personally identifiable
information, whether the medical information will be examined on-site,
what type of information will be copied and removed off-site, and the
anticipated time during which OSHA expects to retain the employee
medical information in personally identifiable form.
In order to enhance employee privacy, and clarify certain
provisions, OSHA has determined that it is necessary to revise its
regulation at Sec. 1913.10. For example, OSHA's previous regulation at
Sec. 1913.10 used the term ``written access order.'' However, this
final rule revises the regulatory text to include the more commonly
used term ``medical access order'' or ``MAO.''
The final rule also amends the regulation at 29 CFR 1913.10 to
transfer certain responsibilities from the Assistant Secretary to the
OSHA Medical Records Officer (MRO). Specifically, the MRO will now be
responsible for the overall administration and implementation of the
procedures contained in Sec. 1913.10. These new responsibilities
include making determinations regarding (1) OSHA access to personally
identifiable employee medical information pursuant to a MAO, and (2)
inter-agency transfer and public disclosure of personally identifiable
employee medical information. The final rule also transfers
responsibility from the Assistant Secretary to the MRO for issuing
written directives that authorize OSHA compliance personnel to review
certain information without obtaining a MAO.
The final rule clarifies that a MAO does not constitute an
administrative subpoena, and eliminates requirements for the removal of
direct personal identifiers when OSHA personnel review medical
information away from a workplace. The deletion of requirements for the
removal of direct personal identifiers will be offset by new provisions
designed to strengthen employee privacy. Finally, the final rule
establishes new internal OSHA requirements, based on existing agency
policy, for the access and safeguarding of personally identifiable
employee medical information maintained in electronic form.
The procedures set forth in Sec. 1913.10 are internal agency
procedures and do not affect employer compliance with OSHA
requirements. Employers and employees will benefit from the revisions
to Sec. 1913.10 in several ways. First, since the process for
determining whether there is a need for OSHA to review employee medical
information will be more efficient, employers will know sooner if such
a review is authorized at their worksite. Second, the elimination of
the outdated requirement to remove direct personal identifiers before
taking medical information off-site for review will reduce the amount
of an employer's time and physical space needed by OSHA personnel when
they visit a specific workplace. Third, the revisions will benefit
employees because the procedures in Sec. 1913.10 to protect the
security and privacy of employee medical records will be strengthened,
especially with regard to medical information in electronic form.
Fourth, the elimination of the requirement to remove direct personal
identifiers before taking medical information off-site will enhance
employee privacy because the removal process always carries with it the
possibility that medical information will be misidentified or
mislabeled, which could result in unauthorized staff mistakenly
reviewing that information. Finally, deletion of the time-consuming de-
identification procedures will mean that authorized OSHA personnel can
conduct follow-up consultations with employees about their health more
quickly.
The notice and comment rulemaking procedures of 5 U.S.C. 553 of the
Administrative Procedure Act (APA) do not apply to ``interpretive
rules, general statements of policy, or rules of agency organization,
procedure, or practice.'' 5 U.S.C. 553(b)(A). The provisions in 29 CFR
1913.10 are rules of agency procedure and practice within the meaning
of section 553(b)(A) of the APA. Therefore, publication in the Federal
Register of a notice of proposed rulemaking and request for comments is
not required. Furthermore, because this rule is procedural rather than
substantive, the normal requirement of 5 U.S.C. 553(d) that a rule not
be effective until at least 30 days after publication in the Federal
Register is inapplicable. OSHA also finds good cause to provide an
immediate effective date for this rule, because it imposes no
obligations on parties outside the federal government and therefore no
advance notice is required to enable employers or other private parties
to come into compliance.
II. Legal Authority
The Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et
seq. (OSH Act) authorizes the Secretary to issue two types of
occupational safety and health rules: Standards and regulations.
Standards, which are authorized by section 6 of the Act, specify
remedial measures to be taken to prevent and control employee exposure
to identified occupational safety and health hazards, while regulations
are the means to effectuate other statutory purposes, including the
maintaining of records. For example, the OSHA requirements at 29 CFR
1910.95 are a ``standard'' because they include remedial measures to
address the specific and already identified hazard of employee exposure
to occupational noise. In contrast, a ``regulation'' is a purely
administrative effort designed to uncover violations of the Act and
discover unknown dangers. The procedural regulations in 29 CFR 1913.10
are necessary to enable the use of employee medical records by OSHA
consistent with the employee's right of privacy.
In section 2(b) of the OSH Act, Congress declared the overriding
purpose of the Act is ``to assure so far as possible every working man
and woman in the Nation safe and healthful working conditions.'' (29
U.S.C. 651.) Congress also explicitly declared that this must be
accomplished, among other ways, ``by providing an effective enforcement
program . . .'' (29 U.S.C. 651(b)(10)). For the Secretary of Labor to
conduct an effective enforcement program, he or she must determine
whether occupational safety and health hazards exist in the workplace.
To that end, the OSH Act authorizes the Secretary to enter and inspect
workplaces and to conduct reasonable investigations into working
conditions.
Section 8(a) of the OSH Act authorizes OSHA to enter, inspect, and
investigate places of employment, and section 8(b) permits OSHA to
subpoena both witnesses and evidence when conducting inspections and
investigations. (29 U.S.C. 657(a) and (b)). As noted above, in some
instances, it may be necessary for OSHA to examine personally
identifiable employee medical information. Section
[[Page 45783]]
8 of the OSH Act recognizes OSHA's right of access to medical records,
and records access is mandated by OSHA standards and regulations,
including 29 CFR 1910.1020(e)(3) (access to employee exposure and
medical records). OSHA relies on administrative subpoenas to compel
production of medical records by employers and other record holders.
OSHA is issuing the final rule pursuant to authority expressly
granted in section 8 of the OSH Act. Section 8(c)(1) requires each
employer to ``make, keep, 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'' (29 U.S.C.
657(c)(1)). Employee medical records are included within the type of
records addressed by this provision.
Section 8(g)(1) of the OSH Act provides that the Secretary and
Secretary of Health and Human Services are authorized to compile,
analyze, and publish, either in summary or detailed from, all records
or information obtained under this section (29 U.S.C. 657(g)(1)).
Section 8(g)(2) is the general rulemaking authority of the OSH Act and
provides that the Secretary and the Secretary of Health and Human
Services shall prescribe such rules and regulations as he may deem
necessary to carry out their responsibilities under this Act, including
rules and regulations dealing with the inspection of an employer's
establishment.
III. Summary and Explanation of the Final Rule
Section 1913.10(b)--Scope and Application
OSHA's regulation at 29 CFR 1913.10(b), Scope and application,
defines the circumstances under which the procedural regulations in
Sec. 1913.10 will apply. Except as provided in paragraphs (b)(3)
through (6), the policies and procedures in Sec. 1913.10 apply to all
requests by OSHA personnel to access personally identifiable employee
medical information.
In general, 29 CFR 1913.10 requires OSHA personnel to obtain a MAO
(previously ``written access order,'' but referred to in this section
as ``MAO'' as it is in the final rule) when accessing personally
identifiable employee medical information. However, under certain
circumstances, the regulation states that OSHA access may be
accomplished without obtaining a MAO. For example, Sec.
1913.10(d)(4)(i) provides that a MAO is not needed when an employee
gives specific written consent for OSHA to access their medical
records. Also, Sec. 1913.10(b)(3) through (5) include several
categories of records that are not subject to Sec. 1913.10 and
therefore may be accessed without obtaining a MAO. These categories of
records include medical information that is not in personally
identifiable form, injury and illness records required by 29 CFR part
1904, death certificates, employee exposure records, and medical
information obtained in the course of litigation. In addition, previous
Sec. 1913.10(b)(6) provided that the policies and procedures in Sec.
1913.10 do not apply when a written directive by the Assistant
Secretary authorizes appropriately qualified personnel to conduct
limited review of specific medical information mandated by an OSHA
standard or of specific biological monitoring test results. This final
rule amends Sec. 1913.10(b)(6) to state that the MRO is now
responsible for issuing these written authorization directives.
OSHA Directive CPL 02-02-072, Rules of agency practice and
procedure concerning OSHA access to employee medical records, August
22, 2007, includes authorization for review of three categories of
information based on the provisions in Sec. 1913.10(b)(6). The
directive authorizes OSHA compliance personnel to review (1) medical
opinions mandated by OSHA standards, (2) information required by a
medical surveillance program, and (3) certain information used to
verify compliance with the injury and illness recordkeeping
requirements in 29 CFR part 1904. OSHA personnel do not need a MAO when
they access the information at a workplace pursuant to a written
directive under Sec. 1913.10(b)(6). Instead, OSHA personnel follow the
procedures set forth in the written directive. The 2007 directive
includes provisions on how OSHA personnel may access the specific types
of information and how the information should be protected once in the
agency's possession.
OSHA believes the MRO is in the best position to make
determinations regarding written authorization under Sec.
1913.10(b)(6). Section 1913.10(c)(2) already provides that the MRO must
have experience or training in the evaluation, use, and privacy
protection of medical records, and, as discussed below in this
preamble, paragraph (c) of Sec. 1913.10 has been amended to provide
that the MRO is now responsible for the overall administration of the
policies and procedures in Sec. 1913.10. Also, as part of the final
rule, paragraph (c) now states that the MRO is specifically responsible
for making determinations regarding the approval of MAOs, inter-agency
transfer, and public disclosure of identifiable employee medical
records. Given all the new MRO responsibilities set forth in paragraph
(c), as well as the existing duties in the other paragraphs of the
regulation, it is appropriate to also make the MRO responsible for
written authorization under paragraph (b)(6). Accordingly, final Sec.
1913.10(b)(6) states that the provisions of 29 CFR 1913.10 do not apply
where a written directive by the MRO authorizes appropriately qualified
personnel to conduct limited review of specific medical information
mandated by an occupational safety and health standard or of specific
biological monitoring test results. OSHA will also amend Directive CPL
02-02-072 to reflect the new regulatory text in paragraph (b)(6).
Section 1913.10(c)--Responsible Persons
OSHA's regulation at 29 CFR 1913.10(c) establishes certain
responsibilities for OSHA personnel when the agency accesses personally
identifiable employee medical information. Paragraph (c) is largely a
summary of duties established by other paragraphs in Sec. 1913.10 and
sets forth specific responsibilities for the Assistant Secretary, MRO,
and Principal OSHA Investigator. The final rule amends several
provisions in paragraph (c) to emphasize the responsibilities of the
MRO.
Under the previous regulation, paragraph (c)(1) provided that the
OSHA Assistant Secretary was responsible for the overall administration
and implementation of the policies and procedures in Sec. 1913.10.
This responsibility included making determinations regarding (1) OSHA
access to personally identifiable employee medical information and (2)
interagency transfer or public disclosure of personally identifiable
employee medical information. Also under the previous regulation, Sec.
1913.10(d)(1) provided that each request by an OSHA representative to
access information through a written access order must be approved by
the Assistant Secretary upon the recommendation of the MRO.
Section 1913.10(c)(2) of the previous regulation provided that the
Assistant Secretary was responsible for designating an OSHA official
with experience or training in the evaluation,
[[Page 45784]]
use, and privacy protection of medical records to be the MRO. The MRO,
who reported directly to the Assistant Secretary on matters related to
Sec. 1913.10, was responsible for making recommendations to the
Assistant Secretary on whether to approve or deny written access
orders, and served as the central reviewer of the sufficiency and
justification of these documents. The MRO was also responsible for
responding to employee, collective bargaining agent, and employer
objections to written access orders. In addition, Sec. 1913.10(c)(2)
of the previous regulation stated that the MRO was responsible for
controlling the use of direct personal identifiers; controlling
internal agency use and security of personally identifiable employee
medical information; assuring that the results of agency analysis of
personally identifiable employee medical information are, where
appropriate, communicated to employees; preparing an annual report for
the Assistant Secretary on OSHA's experience with respect to Sec.
1913.10; and assuring that adequate notice is given of intended inter-
agency transfers or public disclosures of personally identifiable
employee medical information.
The other OSHA official with important responsibilities when the
agency accesses employee medical information is the Principal OSHA
Investigator. Section 1913.10(c)(3) provides that the Principal OSHA
Investigator is the OSHA employee designated on the MAO who is
primarily responsible for ensuring that OSHA examination and use of
employee medical information is in accordance with the provisions of
the MAO and Sec. 1913.10. In most instances, the Principal OSHA
Investigator named on a MAO is an employee from an OSHA Regional or
Area Office and determines how and when employee medical information
will be accessed during an OSHA inspection or investigation. In
practice, the Principal OSHA Investigator is responsible for ensuring
that the provisions of the MAO and Sec. 1913.10 are followed by OSHA
personnel when medical information is accessed at a specific workplace.
As provided in Sec. 1913.10(c)(3), the Principal OSHA Investigator
must be professionally trained in medicine, public health, or similar
fields (epidemiology, toxicology, industrial hygiene, biostatistics,
environmental health) when access is made pursuant to a MAO. The
provisions in Sec. 1913.10(c)(3) concerning the Principal OSHA
Investigator are unchanged by the final rule.
The final rule retains the Assistant Secretary's responsibility to
designate an OSHA official as MRO. However, this responsibility is now
set forth in Sec. 1913.10(c)(1). Like the previous regulation, Sec.
1913.10(c)(1) of the final rule states that the Assistant Secretary
shall designate an OSHA official with experience or training in the
evaluation, use, and privacy protection of medical records to be the
OSHA Medical Records Officer. The final rule also states that the
Assistant Secretary may change the designation of the MRO at will.
The final rule includes several changes to paragraph (c)(2), OSHA
Medical Records Officer. Some of these changes transfer specific
responsibilities from the Assistant Secretary to the MRO while other
responsibilities assigned to the MRO in Sec. 1913.10(c)(2) are carried
over from the previous regulation.
The final rule amends paragraph (c)(2) to provide that the MRO is
now responsible for the overall administration and implementation of
the procedures contained in Sec. 1913.10. OSHA believes there are two
central principles that form the basis of the procedural requirements
in Sec. 1913.10: (1) There should be a thorough review of all efforts
to examine or copy personally identifiable employee medical information
before the information is obtained and (2) personally identifiable
information must be carefully protected once obtained. OSHA also
believes the MRO is in the best position to ensure that the central
principles of Sec. 1913.10 are carried out by the agency.
As already noted, paragraph (c)(1) of the final rule, like the
previous regulation, provides that the MRO must have experience and
training in the evaluation, use, and privacy protection of medical
records. Historically, a physician from OSHA's Office of Occupational
Medicine and Nursing (OOMN) has been designated as MRO, and, in most
cases, the person designated has been the Director of OOMN. As a
result, the MRO has had an extensive background in both medicine and
administration.
Additionally, under the previous regulation, the MRO was already
responsible for ensuring the sufficiency and justification of MAOs and
making recommendations to the Assistant Secretary on whether to approve
or deny such documents. The MRO also has several duties set forth
throughout the other paragraphs in Sec. 1913.10 and therefore has a
good understanding of the day-to-day implementation of the regulation.
Under the final rule, the MRO will now be responsible for making
determinations regarding whether to approve or deny MAOs, any inter-
agency transfer, and public disclosures of personally identifiable
employee medical information, as well as whether to issue written
directives authorizing OSHA personnel to conduct limited review of
certain medical information without an MAO. Accordingly, the extensive
medical and administrative experience, the responsibilities under the
previous regulation, and the new responsibilities assigned by this
final rule make the MRO the logical OSHA official to have
responsibility for the overall administration and implementation of the
procedures in Sec. 1913.10.
While the final rule limits the role of the Assistant Secretary in
the day-to-day implementation of Sec. 1913.10, the Assistant Secretary
still maintains an important oversight responsibility. As in the
previous regulation, the Assistant Secretary retains the responsibility
for naming an OSHA official as MRO, with the ability to replace the MRO
at will, and the MRO must still report to the Assistant Secretary on
matters related to Sec. 1913.10. In practice, the MRO will continue to
consult with the Assistant Secretary on MAO approval, inter-agency
transfers, and public disclosures of personally identifiable employee
medical information. In addition, paragraph (l) requires the MRO to
prepare an annual report for the Assistant Secretary on matters related
to the approval and purpose of MAOs, objections to MAOs, and inter-
agency transfers and public disclosures during the previous year. The
responsibility to designate an OSHA official as MRO, continued
consultation, and receiving reports from the MRO will keep the
Assistant Secretary informed about OSHA's overall implementation of
Sec. 1913.10. Accordingly, like the previous regulation, the final
rule at paragraph (c)(2) provides that the MRO is responsible for
reporting directly to the Assistant Secretary on matters concerning
Sec. 1913.10.
Under the final rule, the MRO is also now responsible for making
determinations concerning (1) access to personally identifiable
employee medical information and (2) interagency transfer or public
disclosure of personally identifiable employee medical information.
These two responsibilities had been assigned to the Assistant Secretary
in previous Sec. 1913.10(c)(1).
Section 1913.10(c)(2)(i) of the final rule states that the MRO is
responsible for making determinations concerning
[[Page 45785]]
OSHA access to personally identifiable employee medical information
under Sec. 1913.10(d). Paragraph (d) addresses OSHA access to
personally identifiable employee medical information by MAO.
With the exception of two circumstances described at the end of
paragraph (d), each request by OSHA to examine or copy personally
identifiable employee medical information is made pursuant to an MAO.
Paragraph (d)(2) sets criteria the agency must follow when it seeks
access to identifiable medical information, and paragraph (d)(3) sets
forth the content to be included in the MAO. In order to be valid, an
MAO must be approved by the MRO using the criteria in paragraph (d)(2).
First, the MRO must consider whether the information to be examined or
copied is relevant to a statutory purpose and whether there is a need
to gain access to the information. The MRO has the responsibility, on a
case-by-case basis, to ensure that access is sought only where there is
a genuine need to do so. OSHA believes that a finding of relevance and
need by the MRO is a significant safeguard against excessive use of the
agency's authority to access personally identifiable employee medical
information.
Paragraph (d)(2) next states that consideration must be given to
whether the personally identifiable employee medical information
subject to the MAO is limited to only that information needed to
accomplish the purpose for access. This provision is aimed at
preventing OSHA access to extraneous medical information unrelated to
the purpose for access. Lastly, paragraph (d)(2) states that the MRO
must determine that the personnel authorized to review the medical
information are limited to those who have a need for access and have
appropriate professional qualifications. The limiting of personnel that
can review and analyze information to only those who have a need for
access and who have appropriate professional qualifications is
important for maintaining the confidentiality of employee medical
records.
OSHA believes the MRO is in the best position to evaluate the
criteria in paragraph (d) and make determinations on whether to approve
or deny MAOs. Typically, the MRO has extensive subject-matter clinical
experience and expertise in occupational medicine. This allows the MRO
to evaluate whether, and to what extent, employee medical information
needs to be accessed by OSHA. Accordingly, paragraph (d)(2) has been
amended to state that, before approving an MAO, the MRO must determine
that the documents meet the criteria in that paragraph.
For similar reasons, the MRO is also now responsible for making
determinations concerning inter-agency transfer and public disclosure
of personally identifiable employee medical information. Section
1913.10(m) describes the circumstances under which personally
identifiable employee medical information can be transferred to another
agency or disclosed to the public. The requirements in paragraph (m)
remain unchanged from the previous regulation. However, the provisions
in paragraph (m), as well as paragraph (c)(2), are amended by the final
rule to provide that the MRO, not the Assistant Secretary, is now
responsible for making determinations regarding inter-agency transfer
and public disclosure of personally identifiable employee medical
information. The individual provisions in paragraph (m) are amended to
cross reference with the new MRO responsibility established in Sec.
1913.10(c)(2)(vii).
The following discussion of the individual provisions in paragraph
(m) clarifies the MRO's new responsibility for making determinations
concerning inter-agency transfer and public disclosure set forth in
Sec. 1913.10(c)(2). The previous regulation at Sec. 1913.10(m)(1)
stated that personally identifiable employee medical information shall
not be transferred to another agency or office outside of OSHA (other
than the Office of the Solicitor of Labor) or disclosed to the public
(other than to the affected employee or the original recordholder)
except when required by law or when approved by the Assistant
Secretary. The final rule amends paragraph (c)(2)(vii) to make clear
that the MRO is now responsible for making these determinations. The
final rule also amends paragraph (m) to provide that the MRO must
follow specific criteria when making determinations concerning inter-
agency transfer and public disclosure of personally identifiable
employee medical information.
OSHA's longstanding position is that inter-agency transfer and
public disclosure of personally identifiable employee medical
information should be carefully considered, and paragraph (m) addresses
these issues. Inter-agency transfer and public disclosure of personally
identifiable employee medical information are not categorically
prohibited by the regulation for two reasons. OSHA believes (1) it
cannot legally make such a commitment and (2) situations arise where
transfer or disclosure is appropriate. Under certain circumstances, as
a matter of law, OSHA is compelled to transfer information to another
agency or disclose it to a non-governmental individual. For example,
OSHA might be required to provide the information in response to a
lawful subpoena. In other circumstances, disclosure may also be
appropriate. For example, in order to resolve a public health problem,
OSHA may need to transfer employee medical information to another
federal or state agency. In such situations, the transfer of employee
medical information may be critical in identifying an emerging health
issue, compiling data on worker fatalities from specific exposure, or
evaluating the effectiveness of workplace controls designed to prevent
occupational illness at manufacturing facilities.
OSHA notes that inter-agency transfer and public disclosure of
personally identifiable employee medical information is not a common
occurrence. In the last five years, the agency has made only three
inter-agency transfers of personally identifiable employee medical
information to another federal or state agency. OSHA also notes that
inter-agency transfer and public disclosure of employee medical
information not in personally identifiable form is not subject to
provisions in Sec. 1913.10.
Paragraph (m) of Sec. 1913.10 includes strict limitations on
inter-agency sharing and public disclosure of employee medical
information. Except when required by law, all inter-agency transfer or
public disclosure of personally identifiable employee medical
information must be approved by the MRO in accordance with the criteria
in paragraph (m).
Paragraph (m)(2) states that, except as provided for in paragraph
(m)(3), the MRO shall not approve a request for an inter-agency
transfer, which has not been consented to by the affected employee,
unless the request is by a public health agency. Under this provision,
transfer of medical information is permitted only to a public health
agency for a substantial public health purpose. The regulation goes on
to state that the MRO can approve the transfer only if the public
health agency (1) needs the information for substantial public health
purposes, (2) will not use the information to make individual
determinations concerning affected employees which could be to their
detriment, (3) has regulations or written established procedures
providing protection for personally identifiable medical information
substantially equivalent to Sec. 1913.10,
[[Page 45786]]
and (4) satisfies an exemption to the Privacy Act to the extent the
Privacy Act applies to the requested information.
Because OSHA collects medical information only for a public health
purpose, OSHA believes it is appropriate to restrict all subsequent
discretionary transfers to those agencies with an equivalent public
health purpose. The MRO must review each request for a transfer on a
case-by-case basis by taking into account each of the listed criteria
in paragraph (m)(2). Most importantly, in order to protect individual
privacy, the MRO must be satisfied that the recipient agency's privacy
protections are equivalent to OSHA's.
Paragraph (m)(3) contains two exceptions to the requirements of
paragraph (m)(2). First, upon the approval of the MRO, personally
identifiable employee medical information can be shared with the
National Institute for Occupational Safety and Health (NIOSH). Like
OSHA, NIOSH is a public health agency and its research activities
complement OSHA's regulatory responsibilities. OSHA's ability to
analyze employee medical records is often improved by gaining NIOSH
assistance, and medical information collected by OSHA may have major
research value for NIOSH. Also, because of its frequent use of medical
information, and sensitivity to individual privacy, NIOSH has
procedures in place that provide for the protection of personally
identifiable medical information that are substantially equivalent to
Sec. 1913.10. As a result, employee medical information may be
transferred to NIOSH if approved by the MRO without further inquiry
into the sufficiency of its programs for protecting medical records.
Paragraph (m)(3) also permits, upon the approval of the MRO, the
inter-agency transfer of personally identifiable employee medical
information to the U.S. Department of Justice when necessary with
respect to a specific action under the OSH Act. For example, the
Justice Department prosecutes criminal violations under the OSH Act, as
well as civil penalty collection actions. The Justice Department also
represents OSHA in Freedom of Information Act (FOIA) lawsuits.
Personally identifiable employee medical information may be relevant in
these legal actions, and OSHA must be able to share information in
these circumstances.
Paragraphs (m)(4) and (5) address public disclosure of personally
identifiable employee medical information which has not been consented
to by the affected employee. Paragraph (m)(4) provides that the MRO
shall not approve a request for public disclosure of employee medical
information containing personal identifiers unless there are compelling
circumstances affecting the health or safety of an individual. Also,
paragraph (m)(5) states that the MRO shall not approve a request for
public disclosure of employee medical information which contains
information which could reasonably be used indirectly to identify
specific employees when the disclosure would constitute a clearly
unwarranted invasion of personal privacy. Finally, paragraph (m)(6)
retains the provision from the previous regulation that, except as to
inter-agency transfer to NIOSH or the Department of Justice, the MRO
shall ensure that advance notice is provided to any collective
bargaining agent representing affected employees and to the employer on
each occasion OSHA intends to transfer personally identifiable employee
medical information to another agency or disclose it to a member of the
public other than to an affected employee. When feasible, the MRO must
take reasonable steps to assure that advance notice is provided to
affected employees when the employees' medical information to be
transferred or disclosed contains direct personal identifiers.
Finally, the final rule at Sec. 1913.10(c)(2) retains several
provisions from the previous regulation. Specifically, paragraph
(c)(2)(iii) continues to provide that the MRO is responsible for
responding to MAO objections, and paragraph (c)(2)(iv) continues to
provide that the MRO is responsible for overseeing the internal use and
security of personally identifiable employee medical information. Two
other MRO responsibilities in paragraph (c)(2) have been retained from
the previous regulation but have been renumbered under the final rule.
Paragraph (c)(2)(v), formerly paragraph (c)(2)(vi), continues to
provide that the MRO is responsible for assuring that the results of
agency analyses of personally identifiable medical information are,
where appropriate, communicated to employees. Paragraph (c)(2)(vi),
formerly paragraph (c)(2)(vii), retains the provision that the MRO is
responsible for preparing an annual report of OSHA's experience under
Sec. 1913.10.
Section 1913.10(d)(1)--Requirements for Medical Access Orders
OSHA's previous regulation at Sec. 1913.10(d)(1) stated that,
except as provided in paragraph (d)(4), each request by an OSHA
representative to examine or copy personally identifiable employee
medical information contained in a record held by an employer or other
record holder shall be made pursuant to a written access order which
has been approved by the Assistant Secretary upon the recommendation of
the OSHA Medical Records Officer. Paragraph (d)(1) went on to state
that, if deemed appropriate, a written access order may constitute, or
be accompanied by, an administrative subpoena.
As explained above, the MRO is now responsible for the approval or
denial of MAOs, and paragraph (d)(1) has been revised to reflect this
change. The final rule also amends paragraph (d)(1) to make clear that
a MAO does not constitute an administrative subpoena.
An administrative subpoena is a written order issued by OSHA to
require an employer, or any other person, to produce listed records,
documents, testimony and/or other supporting evidence relevant to an
inspection or investigation under the OSH Act. If the person served
with a subpoena refuses to honor (or only partially honors) the order,
the subpoena is subject to judicial review and enforcement by a U.S.
District Court. OSHA Regional Administrators have authority to issue
administrative subpoenas and are also authorized to delegate to Area
Directors the authority to issue routine administrative subpoenas.
OSHA's policies and procedures for issuing an administrative subpoena
are set forth in OSHA Instruction ADM 01-00-002, August 19, 1991.
In contrast, a MAO is an authorization for specified OSHA personnel
to examine or copy personally identifiable employee medical information
contained in a record held by an employer or some other record holder.
Since an MAO relates to internal OSHA procedures, it cannot be used to
compel the production of records, nor be enforced in a U.S. District
Court. Historically, OSHA has not treated an MAO as equivalent to an
administrative subpoena. OSHA's longstanding practice has been to rely
on an administrative subpoena to compel production of medical records
by employers. See OSHA's August 22, 2007, Instruction CPL 02-02-072,
Rules of agency practice and procedure concerning OSHA access to
employee medical records. MAOs set forth internal OSHA procedure for
assuring appropriate confidentiality of medical records is observed by
OSHA personnel. As a result, except when reasonably certain that the
employer will grant access to employee medical
[[Page 45787]]
information, OSHA personnel present an administrative subpoena to the
employer concurrently with an MAO.
The final rule amends Sec. 1913.10(d)(1) to state that except as
provided in paragraph (d)(4), each request by an OSHA representative to
examine or copy personally identifiable employee medical information
contained in a record held by an employer or other recordholder shall
be made pursuant to a written medical access order which has been
approved by the OSHA Medical Records Officer. A medical access order
does not constitute an administrative subpoena.
Section 1913.10(g)--Removal of Direct Personal Identifiers
OSHA's previous regulation at Sec. 1913.10(g) provided that all
direct personal identifiers (e.g., name, address, Social Security
Number, payroll number) must be removed by OSHA personnel whenever
employee medical information obtained pursuant to a written access
order is taken off-site, unless otherwise directed by the MRO. The
regulation also required the Principal OSHA Investigator to code the
medical information and the list of direct personal identifiers with a
unique identifying number for each employee and then hand deliver or
mail the list of identifiers to the MRO. The MRO thereafter controlled
the use and distribution of the list of coded identifiers to those with
a need to know its contents. In addition, the numerical coded medical
information was to be used and kept secured as though still in a
directly identifiable form.
Paragraph (g) was originally promulgated by OSHA when the rules of
agency practice and procedure were issued in 1980. At that time,
electronic medical records did not exist, and the employee records that
did exist were maintained almost entirely in paper form. Since 1980,
the number of medical records maintained by employers and other record
holders has substantially increased, and the majority of these records
are now maintained in electronic form.
The final rule revises Sec. 1913.10 by deleting the outdated
procedures set forth in paragraph (g). OSHA is eliminating this
internal requirement for several reasons. First, existing access and
safeguarding requirements in Sec. 1913.10 already address privacy
concerns when OSHA takes medical information away from a workplace for
off-site review. Specifically, paragraph (h) of Sec. 1913.10 provides
that only authorized personnel may examine or copy personally
identifiable employee medical information. As explained below, OSHA
experience is that this process can result in coding and re-coding
errors in individual employee medical records. Likewise, it provides
that, unless an exception applies, OSHA personnel and contractors are
authorized to use information only for the purpose for which it was
obtained. In addition, paragraph (h)(5) states that, whenever
practicable, the examination of personally identifiable employee
medical information shall be conducted on-site with a minimum of
medical information taken off-site in a personally identifiable form.
Additionally, paragraph (i) of Sec. 1913.10 includes security
procedures for handling personally identifiable employee medical
information. For example, paragraph (i)(1) provides that files
containing personally identifiable employee medical information shall
be segregated from other agency files and, when not in active use, must
be kept in a locked cabinet or vault. In practice, the locking
requirement extends to when medical information is transported from the
workplace, as OSHA personnel place records in a locked trunk during
transport by automobile.
Second, paragraph (n) of this final rule establishes new
requirements for the access and safeguarding of personally identifiable
employee medical information in electronic form. As discussed more
extensively below, paragraph (n) of the final rule provides that the
Principal OSHA Investigator is responsible for preventing any careless,
accidental, or unintentional disclosure of, modification to, or
destruction of electronic medical records. Paragraph (n)(3) of the
final rule provides that the transfer and/or duplication of medical
records in electronic form must be kept to the minimum necessary to
accomplish the purpose for which it was obtained. Also, paragraph
(n)(4) states that electronic files containing personally identifiable
employee medical information shall be downloaded only to a computer
hard drive or laptop that is secured (e.g., password protected).
Paragraph (n)(4) now includes the Government standards that address
secure access to Government systems and the data they contain: Federal
Information Processing Standards (FIPS) 201-2, ``Personal Identity
Verification (PIV) of Federal Employees and Contractors''; and HSPD-12,
``Homeland Security Presidential Directive 12: Policy for a Common
Identification Standard for Federal Employees and Contractors (HSPD-
12).''
In addition, paragraph (n)(5) provides that electronic files
containing personally identifiable employee medical information must be
encrypted before transferred to authorized individuals. OSHA believes
the safeguards for electronic medical records established by this final
rule, which are based on existing OSHA practices and policy, enhance
privacy protection and reduces the need to remove direct personal
identifiers when OSHA personnel take personally identifiable employee
medical information off-site.
OSHA's experience is that de-identification increases the risk of
mislabeling or misidentifying employee medical records and places a
burden on agency resources by requiring additional OSHA staff time to
accurately conduct de-identification and copying of employee medical
records. In some cases, depending on the number of employees at a
specific facility, OSHA employees may spend several hours finding and
removing each direct personal identifier within each affected
employee's medical record. The deletion of paragraph (g) will reduce
the amount of time and physical space needed by OSHA personnel at a
worksite.
Finally, the deletion of de-identification procedures in paragraph
(g) will simplify follow-up communication from authorized OSHA
personnel with individual employees after evaluation of their medical
information. For example, by not having to complete a potentially
extensive de-identification process, critical medical information about
an employee will be reviewed by an OSHA physician sooner, and this will
allow the physician to conduct follow-up consultation with the employee
in a timely manner. Also, because personally-identifiable information
will remain in the medical records taken from a workplace for off-site
review, it will make it easier for the OSHA physician to identify
employees, compare associated records, and contact individual
employees.
For all of the above reasons, OSHA has concluded that the removal
of direct personal identifier requirements in paragraph (g) should be
deleted.
Section 1913.10(n)--Medical Records Maintained in Electronic Form
In many cases, employers and other record holders maintain
personally identifiable employee medical information in electronic
form. OSHA's regulation at 29 CFR 1910.1020 provides that a ``record''
includes any item, collection, or grouping of information regardless of
the form or process by which it is maintained (e.g., paper, document,
microfilm, X-ray film, or
[[Page 45788]]
automated data processing). Medical records may also be maintained on
media such as magnetic tape, computer disks, USB storage devices (e.g.,
thumb drives), and online computer storage. Historically, OSHA
personnel have followed the requirements in 29 CFR 1913.10 when
accessing personally identifiable employee medical information
maintained in electronic form. However, the regulation did not include
provisions that specifically addressed electronic medical records. The
final rule establishes new internal policies and procedures in
paragraph (n) to Sec. 1913.10 that specifically address OSHA access,
use, and safeguarding of personally identifiable employee medical
information maintained in electronic form.
Since the rules of agency practice and procedure were first issued
in 1980, medical professionals have increasingly relied on the use and
storage of medical records in electronic form. These records tend to
improve the quality of health care and have several practical
advantages over paper records. For example, electronic medical records
can be accessed by health care professionals at any time from any given
location. Legible records can also lead to more accurate diagnosis,
treatment, and drug prescription. Electronic medical records are cost-
effective because they take up less storage space and can be stored
indefinitely. However, because they are in electronic form, these
records also present unique challenges to security, privacy, and data
integrity.
OSHA believes the best way to protect the security and
confidentiality of personally identifiable employee medical information
in electronic form is to prevent unauthorized access to such
information. Several effective administrative, technological, and
physical measures can be taken to protect electronic medical
information from unauthorized access, use, disclosure, disruption,
modification, or destruction. These methods include establishing
specific security roles and responsibilities for OSHA officials,
technology safeguards such as encryption or firewalls to protect
against electronic breaches, ID/password protection for devices and
information systems, and the use of anti-virus and intrusion detection
software. The establishment of new internal OSHA policies and
procedures in paragraph (n) of this final rule will effectively protect
the security, privacy, and data integrity of employee medical
information in electronic form.
Section 1913.10(n)(1) of the final rule provides that, in general,
when accessing and/or copying personally identifiable employee medical
information in electronic form, OSHA personnel shall follow the
requirements set forth in 29 CFR 1913.10. As noted above, OSHA
personnel have historically followed the rules of agency practice and
procedure in Sec. 1913.10 when accessing employee medical information
in electronic form, and many of the provisions in Sec. 1913.10 are
applicable regardless of the format used to maintain information. As a
result, unless specifically addressed in paragraph (n), OSHA personnel
should continue to follow the rules of agency practice and procedure in
paragraphs (a) through (m) when accessing and safeguarding electronic
employee medical information.
Section (n)(2) of the final rule includes responsibilities for the
Principal OSHA Investigator when OSHA personnel access personally
identifiable employee medical information in electronic form.
Specifically, paragraph (n)(2) states that when personally identifiable
employee medical information in electronic form is taken off-site, the
Principal OSHA Investigator is primarily responsible for ensuring that
such information is properly used and kept secured. This provision is
based on the requirement in paragraph (h)(1) of Sec. 1913.10, which
provides that the Principal OSHA Investigator is responsible for
ensuring that medical information is used and kept secured in
accordance with Sec. 1913.10. Other specific responsibilities assigned
to the Principal OSHA Investigator in paragraph (n)(2) include
preventing any accidental or unintentional disclosure of, modification
to, or destruction of personally identifiable employee medical
information in electronic form (paragraph (n)(2)(i)); controlling the
flow of data into, through, and from agency computer operations
(paragraph (n)(2)(ii)); and ensuring that distribution and review of
medical information in electronic form is limited to only those OSHA
personnel and contractors with a need for access (paragraph
(n)(2)(iii)). The requirement in paragraph (n)(2)(iii) is derived from
Sec. 1913.10(d)(2)(iii), which provides that, before approving a MAO,
the MRO must determine that personnel authorized to review and analyze
personally identifiable employee medical information are limited to
those who have a need for access and have appropriate qualifications.
As discussed above, the Principal OSHA Investigator is the OSHA
employee in the field with primary responsibility for ensuring that the
examination and use of employee medical information is in accordance
with Sec. 1913.10. As such, the Principal OSHA Investigator is
responsible for ensuring that the provisions in paragraph (n) are
followed by OSHA personnel when electronic medical information is
accessed from a specific workplace. For example, this would include
ensuring that access to personally identifiable employee medical
records in electronic form is limited to only authorized personnel with
a need to review the information, ensuring that employee medical
information is only downloaded to a secured device (e.g., password
protected), and verifying that medical information is deleted or
destroyed when no longer needed by the agency.
Section 1913.10(n)(3) of the final rule provides that the transfer
and/or duplication of medical information in electronic form shall be
kept to the minimum necessary to accomplish the purpose for which it
was obtained. This provision is similar to paragraph (i)(3) of Sec.
1913.10, which states that the photocopying or other duplication of
personally identifiable employee medical information shall be kept to
the minimum necessary to accomplish the purpose for which the
information was obtained.
In some cases, personally identifiable employee medical information
in electronic form needs to be transferred or duplicated to facilitate
internal OSHA review. For example, in order to conduct a proper
workplace inspection or investigation, it may be necessary for OSHA
personnel to transfer employee medical records to another OSHA employee
with expertise on a specific occupational health hazard. Paragraph
(n)(3) of the final rule permits the transfer and duplication of
electronic medical information but only to authorized individuals with
a need to review the information. Transfer and duplication are also
limited to the minimum necessary to accomplish the purpose for which it
was obtained. An example of this limitation might include the review of
a medical record to determine whether an employee has sustained a work-
related injury or illness. In such cases, review of a medical record
would extend only to information about the employee's injury or
illness. In this example, the transfer and/or duplication of electronic
medical information unrelated to the injury or illness would not be
permitted.
Additionally, OSHA believes the likelihood that medical information
in electronic form will be lost, altered, or destroyed increases during
transfer or duplication. The duplication of electronic medical
information can also
[[Page 45789]]
raise concern about data integrity. For example, the copying or
deleting of employee medical information from one document to another
raises concern about the accuracy of the information. Accordingly,
personally identifiable electronic medical information should be
transferred only to authorized individuals with a need to know the
information and should be duplicated only to facilitate authorized
internal agency review.
Consistent with existing OSHA policy, Sec. 1913.10(n)(4) of the
final rule states that electronic files containing personally
identifiable employee medical information shall be downloaded only to a
computer hard drive or laptop that is in accordance with Federal
Information Processing Standard (FIPS) 201-2, ``Personal Identity
Verification (PIV) of Federal Employees and Contractors,'' and
``Homeland Security Presidential Directive 12: Policy for Common
Identification Standard for Federal Employees and Contractors (HSPD-
12).'' The use of secured technology when downloading medical records
will help to ensure that information is (1) accessed only by authorized
individuals with a need-to-know and (2) not modified or deleted.
In accordance with current OSHA and Federal Government policy, the
use of password protection is easy to implement, cost-effective, and a
reliable method for securing electronic information. By downloading
employee medical information to a secured hard drive or laptop, OSHA
personnel will be able to ensure that only individuals that know the
password can open a document and read its content. This practice also
provides a level of protection that goes with the document no matter
where it is stored or sent. Finally, because tampering with a secured
device takes time and effort, providing this level of protection acts
as a deterrent to accessing document content by unauthorized
individuals.
Additionally, it is important for OSHA personnel to follow proper
security practices when using password protected devices containing
personally identifiable employee medical information. Authorized
individuals must not share their ID with others, should log-off when
leaving a terminal, and use their own ID to access employee medical
records. Also, authorized individuals should not keep written
facsimiles of passwords or access codes. Other security measures, such
as the use of firewalls, anti-virus software, and intrusion detection
software should also be used to protect data integrity. Again, the
Principal OSHA Investigator is responsible for ensuring that proper
security measures are in place in the field to protect the
confidentiality of personally identifiable employee medical records in
electronic form.
Moreover, it is critically important that mobile devices be
encrypted or use password protection when used to download, transfer,
or store electronic medical information. Mobile devices are for
individual use, and are not designed for centralized IT management.
These devices can easily be manipulated, damaged, or stolen. By
encryption, OSHA means the process of changing plain text into cypher
text for the purpose of security. The use of encryption results in the
encoding of information in such a way so that only authorized
individuals can access the information.
Section 1913.10(n)(5) of the final rule states that electronic
files containing personally identifiable employee medical information
shall not be transferred to authorized personnel through email
attachment unless appropriately encrypted. The transfer of employee
medical information by email attachment increases the risk that such
information will be sent to an unauthorized individual. The transfer of
personally identifiable employee medical information in electronic form
must be made through secured means. See Sec. 1913.10(n)(4), discussed
above (``Electronic files containing personally identifiable employee
medical information shall only be downloaded to a computer hard drive
or laptop that is secured.''). Appropriate methods for the transfer of
personally identifiable employee medical information in electronic form
may include the use of password protected or encrypted files on a
secured agency website designed for confidential information, the
mailing of encrypted computer disks or USB drives, the emailing of
password protected medical records (Adobe secured), and the printing
and hand delivery of paper records.
Paragraph (n)(6) provides that when an employer or other record
holder(s) provides access to employee medical information through a
properly encrypted email attachment, the attachment shall be downloaded
to a secured hard drive or laptop. After the attachment is downloaded,
the email shall be permanently deleted.
In some cases, employers and other record holders provide OSHA with
access to employee medical information through an encrypted email
attachment. As noted above, the use of email attachments to transfer
medical records makes it more likely that the information will be sent
to unauthorized individuals. Paragraph (n)(6) ensures that medical
information received in an encrypted email attachment is downloaded to
a secured device.
After downloading the attachment from the employer or other record
holder, the email must be permanently deleted to prevent transfer to
unauthorized individuals. By permanently deleted, OSHA means that the
email should be deleted so that it cannot be retrieved. Some email
programs automatically delete trashed emails after a certain amount of
time. Other programs retain emails until the user runs out of space.
However, the intent of this provision is that, once the attachment is
downloaded, OSHA personnel should immediately and permanently delete
the incoming email. Most email programs have a ``delete forever''
function that allows the user to select emails in the trash folder for
permanent deletion.
Section 1913.10(n)(7) of the final rule states that personally
identifiable employee medical information in electronic form shall be
secured when not in use. This provision is based on paragraph (i)(1) of
Sec. 1913.10, which states that agency files containing personally
identifiable employee medical information shall be segregated from
other agency files, and when not in active use, files containing this
information shall be kept secured in a locked cabinet or vault.
Paragraph (n)(7) is intended to prevent unauthorized access or
modification to employee medical information in electronic form. In
addition to all of the procedures in paragraph (n) addressing the use
of electronic information by OSHA personnel, when not in use, such
information must be stored in a secured manner. For example, when not
in use, personally identifiable employee medical information should be
stored on a password protected hard drive or laptop. Another example
might be the storing of information on a password protected agency
website designed to store confidential information. Also, if employee
medical records are kept on computer disk or other electronic storage
media, when not in use, the disk or media should be stored under lock
and key. Paragraph (n)(7)(i) of the final rule also emphasizes the
importance of proper storage by specifically stating that medical
information in electronic form shall only be maintained or stored where
facilities and conditions are designed to prevent unauthorized access.
Paragraph (n)(7)(ii) provides that personally identifiable employee
medical information in electronic form shall be maintained only for so
long as
[[Page 45790]]
needed to accomplish the purpose for access. This provision is derived
from paragraph (j)(1) of Sec. 1913.10, which provides that consistent
with OSHA records disposition programs, personally identifiable
employee medical information shall be destroyed or returned to the
original record holder when no longer needed for the purposes for which
they were obtained. In OSHA's view, maintaining medical records only
for so long as needed helps to ensure that such information will not be
accessed by unauthorized individuals.
In some cases, after its initial use by the agency, personally
identifiable employee medical information may not be used again until
sometime in the future. For example, medical information used as the
basis for an OSHA citation may be used during the hearing stage of an
enforcement case before the Occupational Safety and Health Review
Commission. The medical information may not be used while the case is
on appeal, but there may be a need for the information if the case is
remanded for further judicial proceedings. Similarly, an investigation
of an apparently new health hazard may produce uncertain results.
Before completely closing out this investigation, it may be appropriate
to await the outcome of an ongoing research study or parallel
investigation elsewhere in the country. In these cases, Sec.
1913.10(j) provides that the medical information should be transferred
to the MRO. Also, under Sec. 1913.10(l)(2), the MRO must conduct an
annual review of all centrally-held information to determine which
information is no longer needed for the purposes for which it was
obtained. These requirements apply equally to personally identifiable
employee medical information stored in electronic form.
Paragraph (n)(7)(iii) of the final rules states that when no longer
needed, the Principal OSHA Investigator shall ensure that all
personally identifiable employee medical information on electric files
has been deleted, destroyed, or returned to the original record holder.
The requirement in paragraph (n)(7)(iii) is intended to ensure that the
Principal OSHA Investigator is responsible for OSHA access and use of
electronic medical information from beginning to end. When no longer
needed, the Principal OSHA Investigator must make sure that authorized
OSHA personnel follow proper procedures for the deletion, destruction
and disposal of personally identifiable employee medical information.
In practice, the Principal OSHA Investigator must ensure that media
containing employee medical information is sanitized or destroyed
before disposal or release for reuse in accordance with approved
methods. In addition, if electronic medical records are returned to the
original record holder, the Principal OSHA Investigator must ensure
that all data is returned, and no data remains in the possession of
OSHA personnel.
Paragraph (n)(7)(iv) states that the disposal of personally
identifiable employee medical information maintained in electronic form
shall be accomplished in such a manner as to make the data unattainable
by unauthorized personnel. When no longer needed, electronic media must
be handled and sanitized appropriately to prevent unauthorized
disclosure or modification of personally identifiable employee medical
information.
OSHA personnel use several types of electronic media to access,
use, and maintain personally identifiable employee medical information,
including hard drives, laptops, USB storage drives (e.g., thumb
drives), CDs, DVDs, and digital storage cards such as camera cards. In
order to meet the requirement in paragraph (n)(7)(iv), and depending on
the type of electronic media used, OSHA personnel may need to re-use,
recycle, or destroy the electronic media containing medical
information. Also, when employee medical information in electronic form
is no longer needed, it is important to ensure that deleted data is not
easily recoverable. Residual data may allow unauthorized individuals to
reconstruct data and thereby gain access to personally identifiable
employee medical information. Sanitization is one method that can be
used to ensure that deleted data cannot be reconstructed.
Sanitization is the general process of removing data from storage
media, such that there is reasonable assurance that the data may not be
easily retrieved and reconstructed. There are different types of
sanitization for each type of media, including cleaning, purging, and
destroying. Cleaning is the removal of data from devices in such a way
that there is assurance that the data cannot be reconstructed using
normal system functions or software file/data recovery utilities. For
example, cleaning may include using software or hardware products to
overwhelm media with non-sensitive data. Purging is generally done
before releasing media beyond control, such as before discarding old
media, and includes degaussing or exposing media to a strong magnetic
field in order to disrupt recorded magnetic domains. Destruction of
media is the ultimate form of sanitization.
In some cases, OSHA personnel maintain employee medical information
on media that may not be able to be reused such as computer disks and
camera cards. In these situations, when no longer needed, electronic
media containing personally identifiable employee medical information
should be disposed of using approved secure data destruction. Several
methods exist to dispose of electronic media containing medical
information. For example, computer disks can be rendered unusable by
shredding, incinerating, or pulverizing. Many OSHA Regional and Area
Offices already have equipment that can shred or burn disks. Other
offices contract with private companies to perform this task in a
secure manner. As a reminder, in order to address security and privacy
concerns, disposal operations should be conducted in accordance with
approved DOL or OSHA methods. In addition, OSHA is responsible for the
management of records pursuant to the Federal Records Act of 1950, as
amended (44 U.S.C. Chapters 21, 29, 31, 33). The retention and
destruction of Federal records must be conducted in accordance with the
procedures described in the Federal Records Act.
Finally, in the future, OSHA personnel will be using media types
not specifically mentioned in this preamble. The processes mentioned in
this document should guide media sanitization and disposal decisions
regardless of the type of media in use. In the future, OSHA will issue
guidance to agency staff as new technology is developed.
IV. State Plans
The 28 states and U.S. territories with their own OSHA-approved
occupational safety and health plans are encouraged, but not required,
to adopt these rules of agency practice and procedure concerning
employee medical record access that Federal OSHA is promulgating to 29
CFR 1913.10 in this final rule. The states and U.S. territories with
OSHA-approved occupational safety and health plans covering private
employees and state and local government employees are 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. In addition, six states and U.S. territories have OSHA-
approved state Plans that apply to state and local government employees
only: Connecticut, Illinois,
[[Page 45791]]
Maine, New Jersey, New York, and the Virgin Islands.
This final rule describes a Federal program change for which State
Plan adoption is not required. However, State Plans are required to
have standards, and an enforcement program, that are ``at least as
effective in providing safe and healthful employment'' as those of
Federal OSHA. In order to be ``at least as effective'' as Federal OSHA,
a State Plan must appropriately utilize its authority for access to
medical records, and must have effective procedures to assure that the
privacy of those records is protected in a manner consistent with
applicable state and federal privacy laws. Therefore, although adoption
of this rule is not required, State Plans must have procedures covering
this issue that are at least as effective as those of Federal OSHA and
are encouraged to adopt requirements comparable to those in 29 CFR
1913.10.
Within 60 days of the effective date of this final rule, a State
Plan must submit a notice of intent indicating whether they already
have a similar policy in place, intend to adopt new policies and
procedures, or do not intend to adopt this final rule. If a State Plan
does not adopt at first, but at some later point decides to adopt this
final rule or an at least as effective version of this final rule, the
State Plan must notify OSHA of this change in intent. Within 60 days of
adoption, the State Plan must provide an electronic copy of the
regulation or policy, or a link to where their policy is posted on the
State Plan's website. The State Plan must also provide the date of
adoption and identify differences, if any, between their policy and
this final rule. OSHA will provide summary information on the State
Plan responses to this instruction on its website at: www.osha.gov/dcsp/osp/.
V. Regulatory Flexibility Certification
The notice and comment procedures of section 553 of the APA do not
apply ``to interpretative rules, general statements of policy, or rules
of agency organization, procedure, or practice.'' 5 U.S.C. 553(b)(A).
Rules that are exempt from APA notice and comment requirements are also
exempt from the Regulatory Flexibility Act (RFA). See SBA Office of
Advocacy, A Guide for Government Agencies: How to Comply with the
Regulatory Flexibility Act (August 2017); also found at https://www.sba.gov/sites/default/files/rfaguide5F05125F0.pdf. This is a rule
of agency procedure, practice, and interpretation within the meaning of
that section; and therefore, is exempt from both the notice and comment
rulemaking procedures of the APA and the requirements of the RFA.
VI. Environmental Impact Analysis
In accordance with the requirements of the National Environmental
Policy Act (NEPA) (42 U.S.C. 4231 et seq.), Council on Environmental
Quality NEPA regulations (40 CFR parts 1500 through 1518), and the
Department of Labor NEPA regulations (29 CFR part 11), OSHA has
determined that this final rule will not have a significant impact on
the external environment.
VII. Federalism
OSHA reviewed this final rule in accordance with the most recent
Executive order on federalism (Executive Order 13132, 64 FR 43255,
August 10, 1999). This Executive order requires Federal agencies, to
the extent possible, to refrain from limiting state policy options,
consult with states prior to taking any action that would restrict
state policy options, and take such actions only when clear
constitutional authority exists and the problem is national in scope.
This rule does not have ``federalism implications.'' The rule does
not have ``substantial direct effects on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government'' and therefore is not subject to Executive Order 13132
(Federalism).
VIII. Unfunded Mandates
The Department has concluded that this rule is not a ``significant
regulatory action'' within the meaning of Executive Order 12866,
reaffirmed by Executive Order 13563, because it is not likely to (1)
have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or state, local, or Tribal governments or
communities; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in Executive Order
12866. Therefore, no economic impact analysis under section 6(a)(3)(C)
of Executive Order 12866 has been prepared. For the same reason, and
because no notice of proposed rulemaking was published, no statement is
required under section 202 of the Unfunded Mandates Reform Act of 1995,
2 U.S.C. 1532. In any event, this rulemaking is procedural and
interpretive in nature and is thus not expected to have a significant
economic impact.
IX. Consultation and Coordination With Indian Tribal Governments
OSHA reviewed this rule in accordance with Executive Order 13175
(65 FR 67249, November 6, 2000) and determined that it does not have
``tribal implications'' as defined in that order. The rule does not
have substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes.
X. Office of Management and Budget Review Under the Paperwork Reduction
Act of 1995
The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.)
and OMB regulations (5 CFR part 1320) require agencies to obtain
approval from OMB before conducting any collection of information. The
PRA defines a ``collection of information'' as ``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)). The PRA does not
apply to this final rule because it amends existing internal agency
procedures and does not impose any new recordkeeping or information
collection requirements that require OMB approval.
Authority and Signature
This document was prepared under the direction of Loren Sweatt,
Principal Deputy Assistant Secretary for Occupational Safety and
Health. It is issued under Section 8 of the Occupational Safety and
Health Act (29 U.S.C. 657), 5 U.S.C. 553, 5 U.S.C. 552a(e), 5 U.S.C.
301, and Secretary of Labor's Order No. 5-2012 (77 FR 3912).
Signed at Washington, DC, on July 14, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
Final Rule
Part 1913 of title 29 of the Code of Federal Regulations is hereby
amended as follows:
[[Page 45792]]
PART 1913--[AMENDED]
0
1. The authority citation for part 1913 is revised to read as follows:
Authority: 29 U.S.C. 657; 5 U.S.C. 553; 5 U.S.C. 301; Secretary
of Labor's Order No. 8-76 (41 FR 25059), 5-2002 (67 FR 65008), or 1-
2012 (77 FR 3912) as applicable.
0
2. Amend Sec. 1913.10 by:
0
a. Revising paragraphs (b)(6), (c)(1) and (2), and (d)(1) and (2);
0
b. Removing and reserving paragraph (g);
0
c. Revising paragraph (m); and
0
d. Adding paragraph (n).
The revisions and addition read as follows:
Sec. 1913.10 Rules of agency practice and procedure concerning OSHA
access to employee medical records.
* * * * *
(b) * * *
(6) This section does not apply where a written directive by the
OSHA Medical Records Officer authorizes appropriately qualified
personnel to conduct limited reviews of specific medical information
mandated by an occupational safety and health standard, or of specific
biological monitoring test results.
* * * * *
(c) * * *
(1) Assistant Secretary. The Assistant Secretary of Labor for
Occupational Safety and Health (Assistant Secretary) shall designate an
OSHA official with experience or training in the evaluation, use, and
privacy protection of medical records to be the OSHA Medical Records
Officer. The Assistant Secretary may change the designation of the OSHA
Medical Records Officer at will.
(2) OSHA Medical Records Officer. The OSHA Medical Records Officer
shall be responsible for the overall administration and implementation
of the procedures contained in this section. The OSHA Medical Records
Officer shall report directly to the Assistant Secretary on matters
concerning this section and be responsible for:
(i) Making final determinations concerning the approval or denial
of medical access orders (paragraph (d) of this section);
(ii) Assuring that medical access orders meet the requirements of
paragraphs (d)(2) and (3) of this section;
(iii) Responding to objections concerning medical access orders
(paragraph (f) of this section);
(iv) Overseeing internal agency use and security of personally
identifiable employee medical information (paragraphs (g) through (j)
of this section);
(v) Assuring that the results of agency analyses of personally
identifiable medical information are, where appropriate, communicated
to employees (paragraph (k) of this section);
(vi) Preparing an annual report of OSHA's experience under this
section (paragraph (l) of this section); and
(vii) Making final determinations concerning inter-agency transfer
or public disclosure of personally identifiable employee medical
information (paragraph (m) of this section). The Medical Records
Officer shall also assure that advance notice is given of intended
inter-agency transfers or public disclosures.
* * * * *
(d) * * *
(1) Requirement for medical access order. Except as provided in
paragraph (d)(4) of this section, each request by an OSHA
representative to examine or copy personally identifiable employee
medical information contained in a record held by an employer or other
recordholder shall be made pursuant to a written medical access order
which has been approved by the OSHA Medical Records Officer. A medical
access order does not constitute an administrative subpoena.
(2) Approval criteria for medical access order. Before approving a
medical access order, the OSHA Medical Records Officer shall determine
that:
(i) The medical information to be examined or copied is relevant to
a statutory purpose and there is a need to gain access to this
personally identifiable information;
(ii) The personally identifiable medical information to be examined
or copied is limited to only that information needed to accomplish the
purpose for access; and
(iii) The personnel authorized to review and analyze the personally
identifiable medical information are limited to those who have a need
for access and have appropriate professional qualifications.
* * * * *
(m) Inter-agency transfer and public disclosure. (1) Personally
identifiable employee medical information shall not be transferred to
another agency or office outside of OSHA (other than to the Office of
the Solicitor of Labor) or disclosed to the public (other than to the
affected employee or the original recordholder) except when required by
law or when approved by the OSHA Medical Records Officer.
(2) Except as provided in paragraph (m)(3) of this section, the
OSHA Medical Records Officer shall not approve a request for an inter-
agency transfer of personally identifiable employee medical
information, which has not been consented to by the affected employees,
unless the request is by a public health agency which:
(i) Needs the requested information in a personally identifiable
form for a substantial public health purpose;
(ii) Will not use the requested information to make individual
determinations concerning affected employees which could be to their
detriment;
(iii) Has regulations or established written procedures providing
protection for personally identifiable medical information
substantially equivalent to that of this section; and
(iv) Satisfies an exemption to the Privacy Act to the extent that
the Privacy Act applies to the requested information (see 5 U.S.C.
552a(b); 29 CFR 70a.3).
(3) Upon the approval of the OSHA Medical Records Officer,
personally identifiable employee medical information may be transferred
to:
(i) The National Institute for Occupational Safety and Health
(NIOSH); and
(ii) The Department of Justice when necessary with respect to a
specific action under the Occupational Safety and Health Act.
(4) The OSHA Medical Records Officer shall not approve a request
for public disclosure of employee medical information containing direct
personal identifiers unless there are compelling circumstances
affecting the health or safety of an individual.
(5) The OSHA Medical Records Officer shall not approve a request
for public disclosure of employee medical information which contains
information which could reasonably be used indirectly to identify
specific employees when the disclosure would constitute a clearly
unwarranted invasion of personal privacy (see 5 U.S.C. 552(b)(6); 29
CFR 70.26).
(6) Except as to inter-agency transfers to NIOSH or the Department
of Justice, the OSHA Medical Records Officer shall ensure that advance
notice is provided to any collective bargaining agent representing
affected employees and to the employer on each occasion that OSHA
intends to either transfer personally identifiable employee medical
information to another agency or disclose it to a member of the public
other than to an affected employee. When feasible, the OSHA Medical
Records Officer shall take reasonable steps to assure that advance
notice is provided to affected employees when
[[Page 45793]]
the employee medical information to be transferred or disclosed
contains direct personal identifiers.
(n) Medical records maintained in electronic form. (1) In general,
when accessing and/or copying personally identifiable employee medical
information in electronic form, OSHA personnel shall follow all of the
requirements set forth in this section.
(2) When personally identifiable employee medical information in
electronic form is taken off-site, the Principal OSHA Investigator is
primarily responsible for ensuring that such information is properly
used and kept secured.
(i) The Principal OSHA Investigator is responsible for preventing
any accidental or unintentional disclosure of, modification to, or
destruction of personally identifiable employee medical information in
electronic form.
(ii) The Principal OSHA Investigator is responsible for controlling
the flow of data into, through, and from agency computer operations.
(iii) The Principal OSHA Investigator shall ensure the distribution
and review of medical information in electronic form is limited to only
those OSHA personnel and contractors with a need for access.
(3) The transfer and/or duplication of medical information in
electronic form shall be kept to the minimum necessary to accomplish
the purpose for which it was obtained.
(4) Electronic files containing personally identifiable employee
medical information shall be downloaded only to a computer hard drive
or laptop that is secured in accordance with Federal Information
Processing Standard (FIPS) 201-2 ``Personal Identity Verification (PIV)
of Federal Employees and Contractors'' and ``Homeland Security
Presidential Directive 12: Policy for a Common Identification Standard
for Federal Employees and Contractors (HSPD-12).''
(5) Electronic files containing personally identifiable employee
medical information shall not be transferred to authorized personnel
through email attachment unless appropriately encrypted.
(6) When an employer or other record holder(s) provides access to
employee medical information through a properly encrypted email
attachment, the attachment shall be downloaded to a secured hard drive
or laptop. After the attachment is downloaded, the email shall be
permanently deleted.
(7) Personally identifiable employee medical information in
electronic form shall be secured when not in use.
(i) Medical information in electronic form shall only be maintained
or stored where facilities and conditions are designed to prevent
unauthorized access.
(ii) Personally identifiable employee medical information in
electronic form shall be maintained only for so long as needed to
accomplish the purpose for access.
(iii) When no longer needed, the Principal OSHA Investigator shall
ensure that all personally identifiable employee medical information on
electronic files has been deleted, destroyed, or returned to the
original record holder.
(iv) The disposal of personally identifiable employee medical
information maintained in electronic form shall be accomplished in such
a manner as to make the data unattainable by unauthorized personnel.
[FR Doc. 2020-15562 Filed 7-29-20; 8:45 am]
BILLING CODE 4510-26-P