Occupational Safety and Health Investigations of Places of Employment, 2809-2812 [2014-00530]
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Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Proposed Rules
receives adverse comments on part of
this rule and if that part can be severed
from the remainder of the rule, EPA may
adopt as final those parts of the rule that
are not the subject of an adverse
comment. For additional information,
see the direct final rule which is located
in the rules section of this Federal
Register.
to https://www.regulations.gov. For
detailed instructions on submitting
public comments, see the ‘‘Public
Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket go to
https://www.regulations.gov.
Dated: December 23, 2013.
Karl Brooks,
Regional Administrator, Region 7.
Teresa Schnorr Ph.D., Director, NIOSH
Division of Surveillance, Hazard
Evaluations and Field Studies
(DSHEFS); 4676 Columbia Parkway,
Cincinnati, OH 45226; 513–841–4428
(this is not a toll-free number).
[FR Doc. 2014–00655 Filed 1–15–14; 8:45 am]
BILLING CODE 6560–50–P
FOR FURTHER INFORMATION CONTACT:
This
notice is organized as follows:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 85a
[Docket No. CDC–2014–0001; NIOSH–271]
RIN 0920–AA51
Occupational Safety and Health
Investigations of Places of
Employment
I. Executive Summary
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of proposed rulemaking;
technical amendments.
AGENCY:
The Department of Health and
Human Services (HHS) proposes to
amend its regulations pertaining to
occupational safety and health
investigations of places of employment
conducted by the National Institute for
Occupational Safety and Health
(NIOSH) in the Centers for Disease
Control and Prevention (CDC), to update
outdated terminology and strike
references to obsolete government
offices or divisions. These proposed
changes will not affect current practices.
DATES: Comments must be received by
March 17, 2014.
ADDRESSES: Written comments: You may
submit comments by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, OH
45226.
Instructions: All submissions received
must include the agency name (Centers
for Disease Control and Prevention,
HHS) and docket number (CDC–2014–
0001; NIOSH–271) or Regulation
Identifier Number (0920–AA51) for this
rulemaking. All relevant comments,
including any personal information
provided, will be posted without change
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SUMMARY:
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I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Statutory Authority
IV. Summary of Proposed Rule
V. Regulatory Assessment Requirements
A. Purpose of Regulatory Action
The purpose of this proposed rule is
to make minor technical changes to
HHS regulations in 42 CFR part 85a,
pertaining to occupational safety and
health investigations of places of
employment. Proposed amendments to
the existing rule include striking
references to obsolete government
offices or agencies, updating the proper
NIOSH office from which to request
specific reports of investigations, and
correcting outdated terms such as
‘‘motion pictures.’’ Obsolete terms and
outdated language in Part 85a were
identified during the agency’s
retrospective analysis of existing
regulations, in accordance with
Executive Order 13563.
B. Summary of Major Provisions
Proposed amendments to 42 CFR part
85a include the following: § 85a.2
(alphabetize definitions and strike
definitions of ‘‘NIOSH Regional Office,’’
and ‘‘BOM (Bureau of Mines)’’ and
remove reference to ‘‘Public Health
Service’’ within the definition of
‘‘NIOSH’’), § 85a.4 (clarify that the
union at the place of employment must
be notified of the investigation, and
strike reference to BOM), § 85a.5
(replace ‘‘motion pictures or
videotapes’’ with ‘‘video recordings’’
and ‘‘Human Subjects Review Board’’
with ‘‘Institutional Review Board’’), and
§ 85a.8 (replace ‘‘NIOSH Regional
Consultant for Occupational Safety and
Health’’ with ‘‘NIOSH Education and
Information Division.’’
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C. Costs and Benefits
Because HHS is proposing no
substantive changes to 42 CFR part 85a,
there would be no changes made to
current practices. Therefore, there are
no costs or benefits associated with this
rulemaking.
II. Public Participation
Interested parties may participate in
this rulemaking by submitting written
views, opinions, recommendations, and
data. This notice of proposed
rulemaking is published in conjunction
with a direct final rule (DFR) because
HHS finds that the updates to Part 85a
add clarity to the regulation and are
non-controversial; HHS does not expect
to receive any significant adverse
comments on this rulemaking. If
significant adverse comments are
received, HHS will publish a notice in
the Federal Register to withdraw the
companion DFR. A final rule will
subsequently be published, which will
include the Agency’s response to
comments. If HHS does not receive any
significant adverse comments on this
notice of proposed rulemaking or the
companion DFR within the specified
comment period, we will publish a
notice in the Federal Register
confirming the effective date of the final
rule within 30 days after the close of the
public comment period and withdraw
this notice of proposed rulemaking.
Comments received, including
attachments and other supporting
materials, are part of the public record
and subject to public disclosure. Do not
include any information in your
comment or supporting materials that
you do not wish to be disclosed. You
may submit comments on any topic
related to this notice of proposed
rulemaking.
III. Statutory Authority
Subsection 20(b) of the Occupational
Safety and Health (OSH) Act of 1970
authorizes the Secretary of Health and
Human Services to make inspections
and question employers and employees
as provided in section 8 of the OSH Act
in order to carry out the Secretary’s
functions and responsibilities under
section 20 [29 U.S.C. 669; 29 U.S.C.
657]. Section 8(g)(2) instructs the
Secretary to prescribe such regulations
as are deemed necessary to carry out the
responsibilities of the agency to conduct
inspections of an employer’s
establishment. Sections 103 and 501 of
the Federal Mine Safety and Health
(FMSH) Act of 1977 authorize the
Secretary to make inspections and
investigations at coal mines in order to
conduct research as may be appropriate
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to improve working conditions [30
U.S.C. 813(a)] and 951, respectively].
85a.4 Procedures for Initiating
Investigations of Places of Employment
IV. Summary of Proposed Rule
Section 85a.4 states that the NIOSH
authorized representative will contact
an official representative of the place of
employment prior to a site visit. The
NIOSH official will also notify a
representative of the appropriate State
agency, the local union at the place of
employment, the appropriate OSHA
Assistant Regional Director, and the
appropriate MSHA District Office. HHS
proposes minor changes to § 85a.4(a)(2)
to strike unnecessary language
specifying which union official must be
notified, thereby clarifying that the
union must be notified; a proposed
change to § 85a.4(a)(4) would remove
reference to the obsolete Bureau of
Mines. Section 85a.4(b) is edited to
correspond with the change in
paragraph (a)(2). One final proposed
change to § 85a.4(c) would add the term
‘‘or organizations’’ to specify that the
investigating NIOSH official would
notify the individuals or organizations
referenced above. HHS proposes no
further changes to this section.
The provisions in Part 85a govern
procedures NIOSH follows in
conducting safety and health
investigations at places of employment.
The proposed amendments described
below are all non-substantive and
would have no practical effect on
NIOSH procedures or practices, but are
being proposed in accordance with
Executive Order 13563, section 6, which
requires that Federal agencies conduct
retrospective analyses of existing rules.
In conducting the analysis, NIOSH
discovered that certain terms and
references in Part 85a were outdated.
Section 85a.1
Applicability
Section 85a.1 states that the
provisions in Part 85a pertain to
investigations of places of employment
conducted by NIOSH, pursuant to the
statutory authorities noted above. The
section also affirms that the provisions
in this part do not apply to activities
covered by HHS regulations in 42 CFR
part 85. HHS proposes no changes to
this section.
Section 85a.2
Definitions
Section 85a.2 offers definitions for
terms used in this part. HHS proposes
a number of changes to this section.
First, HHS proposes to remove the
paragraph designations and instead to
list the terms alphabetically. Next, HHS
proposes to strike the definitions of
BOM (Bureau of Mines) and NIOSH
Regional Office from § 85a.2, because
BOM is obsolete and because the
addresses of the regional offices
referenced here are no longer relevant to
this rule. The phrase ‘‘Public Health
Service’’ is proposed to be stricken from
the definition of ‘‘NIOSH,’’ and the
definition of ‘‘FMSH Act,’’ is teased
apart from the existing definition of
‘‘OSH Act’’ and is proposes as a standalone definition. None of the changes to
this section would be substantive.
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Section 85a.3 Authority for
Investigations of Places of Employment
Section 85a.3 establishes procedures
by which NIOSH authorized
representatives may enter a place of
employment for the purpose of
conducting investigations under the
OSH Act and the FMSH Act. This
section also establishes that
investigations will be conducted in a
reasonable manner. HHS proposes a
minor change to this section to correct
punctuation.
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Section 85a.5 Conduct of
Investigations of Places of Employment
Section 85a.5 establishes the
procedures NIOSH representatives will
follow to conduct a workplace
investigation. HHS proposes amending
this section to replace the outdated
terms ‘‘motion pictures or videotapes’’
with ‘‘video recordings’’ and ‘‘Human
Subjects Review Board’’ with
‘‘Institutional Review Board,’’ and
correcting ‘‘contact agreement,’’ which
should properly be ‘‘contract
agreement’’ in paragraph (b)(2). HHS
proposes no further changes to this
section.
Section 85a.6 Provision of Suitable
Space for Employee Interviews and
Examinations
Section 85a.6 requires that the
employer, owner, operator, or agent in
charge at the investigated place of
employment must provide a suitable
space for the NIOSH representative to
conduct private interviews. HHS
proposes no changes to this section.
Section 85a.7
Imminent Dangers
Section 85a.7 authorizes the NIOSH
representative to advise the employer,
owner, operator, or agent in charge, any
employees who appear to be in danger,
and any of the individuals or agencies
identified in § 85a.4 that an imminent
danger exists. HHS proposes no changes
to this section.
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Section 85a.8 Reporting of Results of
Investigations of Places of Employment
Section 85a.8 states that NIOSH will
make specific reports of investigations
available to the employer, owner,
operator, or agent in charge, as well as
to those individuals or agencies
identified in § 85a.4. HHS proposes
amending § 85a.8(a)(2) to strike
reference to ‘‘NIOSH Regional
Consultant for Occupational Safety and
Health’’ and replace it with the name of
the office that will make specific reports
available, the ‘‘NIOSH Education and
Information Division.’’ HHS proposes
no further changes to this section.
V. Regulatory Assessment
Requirements
A. Executive Order 12866 and Executive
Order 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility.
This proposed rule has been
determined not to be a ‘‘significant
regulatory action’’ under section 3(f) of
E.O. 12866. The proposed amendments
in this notice would alphabetize the
definitions section, strike reference to
the former Bureau of Mines and NIOSH
Regional Office, update where specific
reports of investigations may be
obtained, and update language used to
describe ‘‘motion pictures.’’ Further,
because this proposed rule is
administrative and would not affect the
cost of the activities authorized by Part
85a, HHS has not prepared an economic
analysis. Accordingly, the Office of
Management and Budget (OMB) has not
reviewed this rulemaking.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., requires each
agency to consider the potential impact
of its regulations on small entities
including small businesses, small
governmental units, and small not-forprofit organizations. Because no
substantive changes are being made to
42 CFR Part 85a as a result of this
action, HHS certifies that this proposed
rule has ‘‘no significant economic
impact upon a substantial number of
small entities’’ within the meaning of
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the Regulatory Flexibility Act (5 U.S.C.
601 et seq.).
C. Paperwork Reduction Act
The Paperwork Reduction Act (PRA),
44 U.S.C. 3501 et seq., requires an
agency to invite public comment on,
and to obtain OMB approval of, any
regulation that requires 10 or more
people to report information to the
agency or to keep certain records. Data
collection and recordkeeping
requirements for the health
investigations of places of employment
program receive OMB approval on an
as-needed basis. The proposed
amendments in this rulemaking would
not impact the collection of data.
D. Small Business Regulatory
Enforcement Fairness Act
As required by Congress under the
Small Business Regulatory Enforcement
Fairness Act of 1996 (5 U.S.C. 801 et
seq.), HHS will report the promulgation
of this rule to Congress prior to its
effective date.
E. Unfunded Mandates Reform Act of
1995
Title II of the Unfunded Mandates
Reform Act of 1995 (2 U.S.C. 1531 et
seq.) directs agencies to assess the
effects of Federal regulatory actions on
State, local, and Tribal governments,
and the private sector ‘‘other than to the
extent that such regulations incorporate
requirements specifically set forth in
law.’’ For purposes of the Unfunded
Mandates Reform Act, this proposed
rule does not include any Federal
mandate that may result in increased
annual expenditures in excess of $100
million by State, local or Tribal
governments in the aggregate, or by the
private sector. For 2013, the inflation
adjusted threshold is $150 million.
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F. Executive Order 12988 (Civil Justice)
This proposed rule has been drafted
and reviewed in accordance with
Executive Order 12988, ‘‘Civil Justice
Reform,’’ and will not unduly burden
the Federal court system. This rule has
been reviewed carefully to eliminate
drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
HHS has reviewed this proposed rule
in accordance with Executive Order
13132 regarding federalism, and has
determined that it 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.’’
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H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
In accordance with Executive Order
13045, HHS has evaluated the
environmental health and safety effects
of this proposed rule on children. HHS
has determined that the rule would have
no environmental health and safety
effect on children.
I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
In accordance with Executive Order
13211, HHS has evaluated the effects of
this proposed rule on energy supply,
distribution or use, and has determined
that the rule will not have a significant
adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111–274 (October
13, 2010), executive Departments and
Agencies are required to use plain
language in documents that explain to
the public how to comply with a
requirement the Federal Government
administers or enforces. HHS has
attempted to use plain language in
promulgating the proposed rule
consistent with the Federal Plain
Writing Act guidelines.
List of Subjects in 42 CFR Part 85a
Archives and records, Employee
management relations, Hazardous
substances, Health hazards, Health
records, Industry, Investigations, Labor,
Mine safety and health, Occupational
injury, Occupational safety and health,
Reporting and recordkeeping
requirements, Research, Respiratory
diseases, Right of entry, Toxic
substances, Unions.
Proposed Rule
For the reasons discussed in the
preamble, the Department of Health and
Human Services proposes to amend 42
CFR part 85a as follows:
PART 85a—OCCUPATIONAL SAFETY
AND HEALTH INVESTIGATIONS OF
PLACES OF EMPLOYMENT
1. The authority citation for part 85a
continues to read as follows:
■
Authority: Sec. 8(g), 84 Stat. 1600; 29
U.S.C. 657(g) and sec. 508, 83 Stat. 803; 30
U.S.C. 957.
■
2. Revise § 85a.2 to read as follows:
§ 85a.2
Definitions.
Any term defined in the Occupational
Safety and Health Act of 1970 or the
Federal Mine Safety and Health Act of
1977 and not defined below shall have
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2811
the meaning given it in the Acts. As
used in this part:
Assistant Regional Director means any
one of the ten Occupational Safety and
Health Administration Assistant
Regional Directors for Occupational
Safety and Health.
Employee has the same meaning as
stated in the OSH Act and for the
purposes of this part includes miner as
defined in the FMSH Act.
Employer has the same meaning as
stated in the OSH Act and for the
purposes of this part includes operator
as defined in the FMSH Act.
FMSH Act means the Federal Mine
Safety and Health Act of 1977 (30 U.S.C.
801 et seq.).
Informed consent means the knowing
consent of an individual or his legally
authorized representative, so situated as
to be able to exercise free power of
choice without undue inducement or
any element of force, fraud, deceit,
duress, or other form of constraint or
coercion. The basic elements of
information necessary to such consent
include:
(1) A fair explanation of the
procedures to be followed, and their
purposes, including identification of
any procedures which are experimental;
(2) A description of any attendant
discomforts and risks reasonably to be
expected;
(3) A description of any benefits
reasonably to be expected;
(4) A disclosure of any appropriate
alternative procedures that might be
advantageous for the subject;
(5) An offer to answer any inquiries
concerning the procedures; and
(6) An instruction that the person is
free to withdraw his consent and to
discontinue participation in the
investigation any time without
prejudice to the subject.
Investigation means research projects,
experiments, demonstrations, studies,
and similar activities of NIOSH which
are conducted under section 20 of the
OSH Act and section 501 of the FMSH
Act.
Legally authorized representative
means an individual or judicial or other
body authorized under applicable law to
consent on behalf of a prospective
subject to such subject’s participation in
the particular activity or procedure.
MSHA District Office means any one
of the Mine Safety and Health
Administration’s District Offices.
NIOSH means the National Institute
for Occupational Safety and Health of
the Centers for Disease Control and
Prevention, Department of Health and
Human Services.
NIOSH authorized representative
means a person authorized by NIOSH to
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conduct investigations of places of
employment, including any person that
is fulfilling a contract agreement with
NIOSH or is serving as an expert or
consultant to NIOSH pursuant to the
Act.
OSH Act means the Occupational
Safety and Health Act of 1970 (29 U.S.C.
651 et seq.).
Place of employment means any coal
or other mine, factory, plant,
establishment, construction site, or
other area, workplace or environment
where work is performed by any
employee of an employer.
■ 3. Amend § 85a.4 by revising
paragraphs (a)(2) and (4), (b), and (c) to
read as follows:
§ 85a.4 Procedures for initiating
investigations of places of employment.
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(a) * * *
(2) The local union at the place of
employment, if any;
*
*
*
*
*
(4) The appropriate MSHA District
Office when investigations are
conducted under the FMSH Act.
(b) Advance notice of site visits will
not be given to the place of employment
or local union at the place of
employment when, in the judgment of
the NIOSH authorized representatives,
giving such notice would adversely
affect the validity and effectiveness of
an investigation. Those individuals and
organizations specified in § 85a.4(a)(1),
(a)(3), and (a)(4) will be notified prior to
the initiation of such a site visit. After
the site visit has been initiated, and, as
soon as possible thereafter, the NIOSH
authorized representatives will contact
the organizations specified in
§ 85a.4(a)(2) concerning the nature and
details of the site visit.
(c) In those instances where site visits
are not necessary to the conduct of an
investigation, the NIOSH authorized
representatives will contact an official
representative of the place of
employment either verbally or through
a written communication and provide
the details of why an investigation of
the place of employment is being
conducted. If appropriate, the NIOSH
authorized representatives will contact
those individuals or organizations
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stipulated in paragraphs (a)(1) through
(4) of this section about the nature and
details of the investigation.
■ 4. Amend § 85a.5 by revising
paragraphs (b)(2) and (d) to read as
follows:
§ 85a.5 Conduct of investigations of
places of employment.
*
*
*
*
*
(b) * * *
(2) In those instances where the
NIOSH authorized representative is a
person fulfilling a contract agreement
with NIOSH or is serving as an expert
or consultant to NIOSH pursuant to the
Act, the employer, owner, operator or
agent in charge at the place of
employment may, after advising the
NIOSH contractor or consultant in
writing, elect to withhold information
deemed to be a trade secret from such
a NIOSH authorized representative or
prohibit entry into the area of the place
of employment where such entry will
reveal trade secrets. In those instances,
where the subject information is needed
or access to the area of the place of
employment is necessary, in the
judgment of NIOSH, to fulfill the goals
of the investigation, NIOSH regular
employees will then obtain the
information or enter the subject area of
the place of employment.
*
*
*
*
*
(d)(1) NIOSH authorized
representatives are authorized: To
collect environmental samples and
samples of substances; to measure
environmental conditions and employee
exposures (including measurement of
employee exposure by the attachment of
personal sampling devices to employees
with their consent); to take or obtain
photographs, video recordings related to
the purpose of the investigation; to
employ other reasonable investigative
techniques, including medical
examinations, anthropometric
measurements and standardized and
experimental functional tests of
employees with the informed consent of
such employees; to review, abstract, and
duplicate such personnel records as are
pertinent to mortality, morbidity, injury,
safety, and other similar studies; and to
question and interview privately any
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employer, owner, operator, agency, or
employee from the place of
employment. The employer, owner,
operator, or agency shall have the
opportunity to review photographs, and
video recordings taken or obtained for
the purpose of identifying those which
contain or might reveal a trade secret.
(2) Prior to the conduct of medical
examinations, anthropometric
measurements or functional tests of any
employees, the NIOSH authorized
representatives will obtain approval of
the procedures to be utilized from the
NIOSH Institutional Review Board and
no employee examination, measurement
or test will be undertaken without the
informed consent of such employee.
*
*
*
*
*
■ 5. Revise § 85a.7 to read as follows:
§ 85a.7
Imminent dangers.
Whenever, during the course of, or as
a result of, an investigation under this
part, the NIOSH authorized
representatives believe there is a
reasonable basis for an allegation of an
imminent danger, NIOSH will
immediately advise the employer,
owner, operator or agent in charge at the
place of employment and those
employees who appear to be in
immediate danger of such allegation and
will inform the agencies identified in
§ 85a.4(a) through (4).
■ 6. Amend § 85a.8 by revising
paragraph (a)(2) to read as follows:
§ 85a.8 Reporting of results of
investigations of places of employment.
(a) * * *
(2) All specific reports of
investigations of each place of
employment under this part will be
available to the public from the NIOSH
Education and Information Division,
4676 Columbia Parkway, Cincinnati,
Ohio 45226.
*
*
*
*
*
Dated: December 18, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2014–00530 Filed 1–15–14; 8:45 am]
BILLING CODE 4163–18–P
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Agencies
[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Proposed Rules]
[Pages 2809-2812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00530]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 85a
[Docket No. CDC-2014-0001; NIOSH-271]
RIN 0920-AA51
Occupational Safety and Health Investigations of Places of
Employment
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking; technical amendments.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) proposes to
amend its regulations pertaining to occupational safety and health
investigations of places of employment conducted by the National
Institute for Occupational Safety and Health (NIOSH) in the Centers for
Disease Control and Prevention (CDC), to update outdated terminology
and strike references to obsolete government offices or divisions.
These proposed changes will not affect current practices.
DATES: Comments must be received by March 17, 2014.
ADDRESSES: Written comments: You may submit comments by any of the
following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
Instructions: All submissions received must include the agency name
(Centers for Disease Control and Prevention, HHS) and docket number
(CDC-2014-0001; NIOSH-271) or Regulation Identifier Number (0920-AA51)
for this rulemaking. All relevant comments, including any personal
information provided, will be posted without change to https://www.regulations.gov. For detailed instructions on submitting public
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Teresa Schnorr Ph.D., Director, NIOSH
Division of Surveillance, Hazard Evaluations and Field Studies
(DSHEFS); 4676 Columbia Parkway, Cincinnati, OH 45226; 513-841-4428
(this is not a toll-free number).
SUPPLEMENTARY INFORMATION: This notice is organized as follows:
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Statutory Authority
IV. Summary of Proposed Rule
V. Regulatory Assessment Requirements
I. Executive Summary
A. Purpose of Regulatory Action
The purpose of this proposed rule is to make minor technical
changes to HHS regulations in 42 CFR part 85a, pertaining to
occupational safety and health investigations of places of employment.
Proposed amendments to the existing rule include striking references to
obsolete government offices or agencies, updating the proper NIOSH
office from which to request specific reports of investigations, and
correcting outdated terms such as ``motion pictures.'' Obsolete terms
and outdated language in Part 85a were identified during the agency's
retrospective analysis of existing regulations, in accordance with
Executive Order 13563.
B. Summary of Major Provisions
Proposed amendments to 42 CFR part 85a include the following: Sec.
85a.2 (alphabetize definitions and strike definitions of ``NIOSH
Regional Office,'' and ``BOM (Bureau of Mines)'' and remove reference
to ``Public Health Service'' within the definition of ``NIOSH''), Sec.
85a.4 (clarify that the union at the place of employment must be
notified of the investigation, and strike reference to BOM), Sec.
85a.5 (replace ``motion pictures or videotapes'' with ``video
recordings'' and ``Human Subjects Review Board'' with ``Institutional
Review Board''), and Sec. 85a.8 (replace ``NIOSH Regional Consultant
for Occupational Safety and Health'' with ``NIOSH Education and
Information Division.''
C. Costs and Benefits
Because HHS is proposing no substantive changes to 42 CFR part 85a,
there would be no changes made to current practices. Therefore, there
are no costs or benefits associated with this rulemaking.
II. Public Participation
Interested parties may participate in this rulemaking by submitting
written views, opinions, recommendations, and data. This notice of
proposed rulemaking is published in conjunction with a direct final
rule (DFR) because HHS finds that the updates to Part 85a add clarity
to the regulation and are non-controversial; HHS does not expect to
receive any significant adverse comments on this rulemaking. If
significant adverse comments are received, HHS will publish a notice in
the Federal Register to withdraw the companion DFR. A final rule will
subsequently be published, which will include the Agency's response to
comments. If HHS does not receive any significant adverse comments on
this notice of proposed rulemaking or the companion DFR within the
specified comment period, we will publish a notice in the Federal
Register confirming the effective date of the final rule within 30 days
after the close of the public comment period and withdraw this notice
of proposed rulemaking.
Comments received, including attachments and other supporting
materials, are part of the public record and subject to public
disclosure. Do not include any information in your comment or
supporting materials that you do not wish to be disclosed. You may
submit comments on any topic related to this notice of proposed
rulemaking.
III. Statutory Authority
Subsection 20(b) of the Occupational Safety and Health (OSH) Act of
1970 authorizes the Secretary of Health and Human Services to make
inspections and question employers and employees as provided in section
8 of the OSH Act in order to carry out the Secretary's functions and
responsibilities under section 20 [29 U.S.C. 669; 29 U.S.C. 657].
Section 8(g)(2) instructs the Secretary to prescribe such regulations
as are deemed necessary to carry out the responsibilities of the agency
to conduct inspections of an employer's establishment. Sections 103 and
501 of the Federal Mine Safety and Health (FMSH) Act of 1977 authorize
the Secretary to make inspections and investigations at coal mines in
order to conduct research as may be appropriate
[[Page 2810]]
to improve working conditions [30 U.S.C. 813(a)] and 951,
respectively].
IV. Summary of Proposed Rule
The provisions in Part 85a govern procedures NIOSH follows in
conducting safety and health investigations at places of employment.
The proposed amendments described below are all non-substantive and
would have no practical effect on NIOSH procedures or practices, but
are being proposed in accordance with Executive Order 13563, section 6,
which requires that Federal agencies conduct retrospective analyses of
existing rules. In conducting the analysis, NIOSH discovered that
certain terms and references in Part 85a were outdated.
Section 85a.1 Applicability
Section 85a.1 states that the provisions in Part 85a pertain to
investigations of places of employment conducted by NIOSH, pursuant to
the statutory authorities noted above. The section also affirms that
the provisions in this part do not apply to activities covered by HHS
regulations in 42 CFR part 85. HHS proposes no changes to this section.
Section 85a.2 Definitions
Section 85a.2 offers definitions for terms used in this part. HHS
proposes a number of changes to this section. First, HHS proposes to
remove the paragraph designations and instead to list the terms
alphabetically. Next, HHS proposes to strike the definitions of BOM
(Bureau of Mines) and NIOSH Regional Office from Sec. 85a.2, because
BOM is obsolete and because the addresses of the regional offices
referenced here are no longer relevant to this rule. The phrase
``Public Health Service'' is proposed to be stricken from the
definition of ``NIOSH,'' and the definition of ``FMSH Act,'' is teased
apart from the existing definition of ``OSH Act'' and is proposes as a
stand-alone definition. None of the changes to this section would be
substantive.
Section 85a.3 Authority for Investigations of Places of Employment
Section 85a.3 establishes procedures by which NIOSH authorized
representatives may enter a place of employment for the purpose of
conducting investigations under the OSH Act and the FMSH Act. This
section also establishes that investigations will be conducted in a
reasonable manner. HHS proposes a minor change to this section to
correct punctuation.
85a.4 Procedures for Initiating Investigations of Places of Employment
Section 85a.4 states that the NIOSH authorized representative will
contact an official representative of the place of employment prior to
a site visit. The NIOSH official will also notify a representative of
the appropriate State agency, the local union at the place of
employment, the appropriate OSHA Assistant Regional Director, and the
appropriate MSHA District Office. HHS proposes minor changes to Sec.
85a.4(a)(2) to strike unnecessary language specifying which union
official must be notified, thereby clarifying that the union must be
notified; a proposed change to Sec. 85a.4(a)(4) would remove reference
to the obsolete Bureau of Mines. Section 85a.4(b) is edited to
correspond with the change in paragraph (a)(2). One final proposed
change to Sec. 85a.4(c) would add the term ``or organizations'' to
specify that the investigating NIOSH official would notify the
individuals or organizations referenced above. HHS proposes no further
changes to this section.
Section 85a.5 Conduct of Investigations of Places of Employment
Section 85a.5 establishes the procedures NIOSH representatives will
follow to conduct a workplace investigation. HHS proposes amending this
section to replace the outdated terms ``motion pictures or videotapes''
with ``video recordings'' and ``Human Subjects Review Board'' with
``Institutional Review Board,'' and correcting ``contact agreement,''
which should properly be ``contract agreement'' in paragraph (b)(2).
HHS proposes no further changes to this section.
Section 85a.6 Provision of Suitable Space for Employee Interviews and
Examinations
Section 85a.6 requires that the employer, owner, operator, or agent
in charge at the investigated place of employment must provide a
suitable space for the NIOSH representative to conduct private
interviews. HHS proposes no changes to this section.
Section 85a.7 Imminent Dangers
Section 85a.7 authorizes the NIOSH representative to advise the
employer, owner, operator, or agent in charge, any employees who appear
to be in danger, and any of the individuals or agencies identified in
Sec. 85a.4 that an imminent danger exists. HHS proposes no changes to
this section.
Section 85a.8 Reporting of Results of Investigations of Places of
Employment
Section 85a.8 states that NIOSH will make specific reports of
investigations available to the employer, owner, operator, or agent in
charge, as well as to those individuals or agencies identified in Sec.
85a.4. HHS proposes amending Sec. 85a.8(a)(2) to strike reference to
``NIOSH Regional Consultant for Occupational Safety and Health'' and
replace it with the name of the office that will make specific reports
available, the ``NIOSH Education and Information Division.'' HHS
proposes no further changes to this section.
V. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
of reducing costs, of harmonizing rules, and of promoting flexibility.
This proposed rule has been determined not to be a ``significant
regulatory action'' under section 3(f) of E.O. 12866. The proposed
amendments in this notice would alphabetize the definitions section,
strike reference to the former Bureau of Mines and NIOSH Regional
Office, update where specific reports of investigations may be
obtained, and update language used to describe ``motion pictures.''
Further, because this proposed rule is administrative and would not
affect the cost of the activities authorized by Part 85a, HHS has not
prepared an economic analysis. Accordingly, the Office of Management
and Budget (OMB) has not reviewed this rulemaking.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities including small businesses, small
governmental units, and small not-for-profit organizations. Because no
substantive changes are being made to 42 CFR Part 85a as a result of
this action, HHS certifies that this proposed rule has ``no significant
economic impact upon a substantial number of small entities'' within
the meaning of
[[Page 2811]]
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
C. Paperwork Reduction Act
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires
an agency to invite public comment on, and to obtain OMB approval of,
any regulation that requires 10 or more people to report information to
the agency or to keep certain records. Data collection and
recordkeeping requirements for the health investigations of places of
employment program receive OMB approval on an as-needed basis. The
proposed amendments in this rulemaking would not impact the collection
of data.
D. Small Business Regulatory Enforcement Fairness Act
As required by Congress under the Small Business Regulatory
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will
report the promulgation of this rule to Congress prior to its effective
date.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
et seq.) directs agencies to assess the effects of Federal regulatory
actions on State, local, and Tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this proposed rule does not include any
Federal mandate that may result in increased annual expenditures in
excess of $100 million by State, local or Tribal governments in the
aggregate, or by the private sector. For 2013, the inflation adjusted
threshold is $150 million.
F. Executive Order 12988 (Civil Justice)
This proposed rule has been drafted and reviewed in accordance with
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly
burden the Federal court system. This rule has been reviewed carefully
to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
HHS has reviewed this proposed rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it 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.''
H. Executive Order 13045 (Protection of Children From Environmental
Health Risks and Safety Risks)
In accordance with Executive Order 13045, HHS has evaluated the
environmental health and safety effects of this proposed rule on
children. HHS has determined that the rule would have no environmental
health and safety effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this proposed rule on energy supply, distribution or use,
and has determined that the rule will not have a significant adverse
effect.
J. Plain Writing Act of 2010
Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
Government administers or enforces. HHS has attempted to use plain
language in promulgating the proposed rule consistent with the Federal
Plain Writing Act guidelines.
List of Subjects in 42 CFR Part 85a
Archives and records, Employee management relations, Hazardous
substances, Health hazards, Health records, Industry, Investigations,
Labor, Mine safety and health, Occupational injury, Occupational safety
and health, Reporting and recordkeeping requirements, Research,
Respiratory diseases, Right of entry, Toxic substances, Unions.
Proposed Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR part 85a as follows:
PART 85a--OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES
OF EMPLOYMENT
0
1. The authority citation for part 85a continues to read as follows:
Authority: Sec. 8(g), 84 Stat. 1600; 29 U.S.C. 657(g) and sec.
508, 83 Stat. 803; 30 U.S.C. 957.
0
2. Revise Sec. 85a.2 to read as follows:
Sec. 85a.2 Definitions.
Any term defined in the Occupational Safety and Health Act of 1970
or the Federal Mine Safety and Health Act of 1977 and not defined below
shall have the meaning given it in the Acts. As used in this part:
Assistant Regional Director means any one of the ten Occupational
Safety and Health Administration Assistant Regional Directors for
Occupational Safety and Health.
Employee has the same meaning as stated in the OSH Act and for the
purposes of this part includes miner as defined in the FMSH Act.
Employer has the same meaning as stated in the OSH Act and for the
purposes of this part includes operator as defined in the FMSH Act.
FMSH Act means the Federal Mine Safety and Health Act of 1977 (30
U.S.C. 801 et seq.).
Informed consent means the knowing consent of an individual or his
legally authorized representative, so situated as to be able to
exercise free power of choice without undue inducement or any element
of force, fraud, deceit, duress, or other form of constraint or
coercion. The basic elements of information necessary to such consent
include:
(1) A fair explanation of the procedures to be followed, and their
purposes, including identification of any procedures which are
experimental;
(2) A description of any attendant discomforts and risks reasonably
to be expected;
(3) A description of any benefits reasonably to be expected;
(4) A disclosure of any appropriate alternative procedures that
might be advantageous for the subject;
(5) An offer to answer any inquiries concerning the procedures; and
(6) An instruction that the person is free to withdraw his consent
and to discontinue participation in the investigation any time without
prejudice to the subject.
Investigation means research projects, experiments, demonstrations,
studies, and similar activities of NIOSH which are conducted under
section 20 of the OSH Act and section 501 of the FMSH Act.
Legally authorized representative means an individual or judicial
or other body authorized under applicable law to consent on behalf of a
prospective subject to such subject's participation in the particular
activity or procedure.
MSHA District Office means any one of the Mine Safety and Health
Administration's District Offices.
NIOSH means the National Institute for Occupational Safety and
Health of the Centers for Disease Control and Prevention, Department of
Health and Human Services.
NIOSH authorized representative means a person authorized by NIOSH
to
[[Page 2812]]
conduct investigations of places of employment, including any person
that is fulfilling a contract agreement with NIOSH or is serving as an
expert or consultant to NIOSH pursuant to the Act.
OSH Act means the Occupational Safety and Health Act of 1970 (29
U.S.C. 651 et seq.).
Place of employment means any coal or other mine, factory, plant,
establishment, construction site, or other area, workplace or
environment where work is performed by any employee of an employer.
0
3. Amend Sec. 85a.4 by revising paragraphs (a)(2) and (4), (b), and
(c) to read as follows:
Sec. 85a.4 Procedures for initiating investigations of places of
employment.
(a) * * *
(2) The local union at the place of employment, if any;
* * * * *
(4) The appropriate MSHA District Office when investigations are
conducted under the FMSH Act.
(b) Advance notice of site visits will not be given to the place of
employment or local union at the place of employment when, in the
judgment of the NIOSH authorized representatives, giving such notice
would adversely affect the validity and effectiveness of an
investigation. Those individuals and organizations specified in Sec.
85a.4(a)(1), (a)(3), and (a)(4) will be notified prior to the
initiation of such a site visit. After the site visit has been
initiated, and, as soon as possible thereafter, the NIOSH authorized
representatives will contact the organizations specified in Sec.
85a.4(a)(2) concerning the nature and details of the site visit.
(c) In those instances where site visits are not necessary to the
conduct of an investigation, the NIOSH authorized representatives will
contact an official representative of the place of employment either
verbally or through a written communication and provide the details of
why an investigation of the place of employment is being conducted. If
appropriate, the NIOSH authorized representatives will contact those
individuals or organizations stipulated in paragraphs (a)(1) through
(4) of this section about the nature and details of the investigation.
0
4. Amend Sec. 85a.5 by revising paragraphs (b)(2) and (d) to read as
follows:
Sec. 85a.5 Conduct of investigations of places of employment.
* * * * *
(b) * * *
(2) In those instances where the NIOSH authorized representative is
a person fulfilling a contract agreement with NIOSH or is serving as an
expert or consultant to NIOSH pursuant to the Act, the employer, owner,
operator or agent in charge at the place of employment may, after
advising the NIOSH contractor or consultant in writing, elect to
withhold information deemed to be a trade secret from such a NIOSH
authorized representative or prohibit entry into the area of the place
of employment where such entry will reveal trade secrets. In those
instances, where the subject information is needed or access to the
area of the place of employment is necessary, in the judgment of NIOSH,
to fulfill the goals of the investigation, NIOSH regular employees will
then obtain the information or enter the subject area of the place of
employment.
* * * * *
(d)(1) NIOSH authorized representatives are authorized: To collect
environmental samples and samples of substances; to measure
environmental conditions and employee exposures (including measurement
of employee exposure by the attachment of personal sampling devices to
employees with their consent); to take or obtain photographs, video
recordings related to the purpose of the investigation; to employ other
reasonable investigative techniques, including medical examinations,
anthropometric measurements and standardized and experimental
functional tests of employees with the informed consent of such
employees; to review, abstract, and duplicate such personnel records as
are pertinent to mortality, morbidity, injury, safety, and other
similar studies; and to question and interview privately any employer,
owner, operator, agency, or employee from the place of employment. The
employer, owner, operator, or agency shall have the opportunity to
review photographs, and video recordings taken or obtained for the
purpose of identifying those which contain or might reveal a trade
secret.
(2) Prior to the conduct of medical examinations, anthropometric
measurements or functional tests of any employees, the NIOSH authorized
representatives will obtain approval of the procedures to be utilized
from the NIOSH Institutional Review Board and no employee examination,
measurement or test will be undertaken without the informed consent of
such employee.
* * * * *
0
5. Revise Sec. 85a.7 to read as follows:
Sec. 85a.7 Imminent dangers.
Whenever, during the course of, or as a result of, an investigation
under this part, the NIOSH authorized representatives believe there is
a reasonable basis for an allegation of an imminent danger, NIOSH will
immediately advise the employer, owner, operator or agent in charge at
the place of employment and those employees who appear to be in
immediate danger of such allegation and will inform the agencies
identified in Sec. 85a.4(a) through (4).
0
6. Amend Sec. 85a.8 by revising paragraph (a)(2) to read as follows:
Sec. 85a.8 Reporting of results of investigations of places of
employment.
(a) * * *
(2) All specific reports of investigations of each place of
employment under this part will be available to the public from the
NIOSH Education and Information Division, 4676 Columbia Parkway,
Cincinnati, Ohio 45226.
* * * * *
Dated: December 18, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2014-00530 Filed 1-15-14; 8:45 am]
BILLING CODE 4163-18-P