[Federal Register Volume 79, Number 11 (Thursday, January 16, 2014)]
[Rules and Regulations]
[Pages 2789-2793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00547]


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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; Technical Amendments

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Direct final rule.

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[[Page 2790]]

SUMMARY: The Department of Health and Human Services (HHS) intends 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Disease Control and Prevention (CDC), to update outdated terminology 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 changes will not affect current practices.

DATES: This rule is effective April 16, 2014 without further action, 
unless significant adverse comment is received by March 17, 2014. If 
significant adverse comment is received, HHS will publish a withdrawal 
of the rule in the Federal Register within 30 days after the close of 
the comment period. If no significant adverse comment is received, HHS 
will publish a notice in the Federal Register confirming the effective 
date of the Direct Final Rule.

ADDRESSES: Written comments: You may submit comments by any of the 
following methods:
     Federal eRulemaking Portal: http://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 http://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 http://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 Final Rule
V. Regulatory Assessment Requirements

I. Executive Summary

A. Purpose of Regulatory Action

    The purpose of this direct final rule (DFR) 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. 
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

    Amendments are made to 42 CFR 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 ``Humans 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.''

C. Costs and Benefits

    Because there are no substantive changes to 42 CFR part 85a, there 
are no changes made to current practices. Therefore, there are no costs 
or benefits associated with this rulemaking.

II. Public Participation

    This DFR is being published 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. However, HHS is publishing a companion notice of proposed 
rulemaking in this issue of the Federal Register, in which the same 
amendments to Part 85a are proposed. If HHS does not receive any 
significant adverse comments on this 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 the notice of proposed rulemaking. 
Interested parties may participate in this rulemaking by submitting 
written views, opinions, recommendations, and data. If significant 
adverse comments are received, HHS will publish a notice in the Federal 
Register to withdraw this DFR. A final rule will subsequently be 
published, which will include the Agency's response to comments.
    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 DFR.

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 to improve working 
conditions [30 U.S.C. 813(a)] and 951, respectively].

IV. Summary of Final Rule

    The provisions in Part 85a govern procedures NIOSH follows in 
conducting safety and health investigations at places of employment. 
The amendments described below are all non-substantive and will have no 
practical effect on NIOSH procedures or practices, but are being made 
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

[[Page 2791]]

covered by HHS regulations in 42 CFR part 85. HHS is making no changes 
to this section.

Section 85a.2 Definitions

    Section 85a.2 offers definitions for terms used in this part. HHS 
is making a number of changes to this section. First, the paragraph 
designations are removed and the terms are listed alphabetically. Next, 
the definitions of BOM (Bureau of Mines) and NIOSH Regional Office are 
stricken 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 stricken 
from the definition of ``NIOSH,'' and the definition of ``FMSH Act,'' 
is teased apart from the existing definition of ``OSH Act'' and is made 
a stand-alone definition. None of the changes to this section are 
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 is making a minor change to this section to 
correct punctuation.

Section 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 is making 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 change is also made to Sec.  85a.4(a)(4) to 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 change is 
made to Sec.  85a.4(c) to add the term ``or organizations'' to specify 
that the investigating NIOSH official will notify the individuals or 
organizations referenced above. HHS is making 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 is 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 is making 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 is making 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 is making 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 is 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 is making 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 direct final rule has been determined not to be a 
``significant regulatory action'' under section 3(f) of E.O. 12866. The 
amendments in this notice 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.'' Because this DFR 
is entirely administrative and does not affect the economic impact, 
cost, or policies of the activities authorized by part 85a, HHS has not 
prepared an economic analysis and 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 rule has ``no significant economic 
impact upon a substantial number of small entities'' within the meaning 
of 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 
amendments in this rulemaking do 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

[[Page 2792]]

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 direct final 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 direct final 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 direct final 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 direct final 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 direct final 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 direct final 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.

Final Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 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 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

[[Page 2793]]

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. 2014-00547 Filed 1-15-14; 8:45 am]
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