Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Proposed Rules 2809 

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. 

Dated: December 23, 2013. 

Karl Brooks, 

Regional Administrator, Region 7. 

[FR Doc. 2014–00655 Filed 1–15–14; 8:45 am] 

BILLING CODE 6560–50–P 

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outdated terminology and strike 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: 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 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: § 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.’’ 

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]. 

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 § 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. 

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 § 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. 

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. 

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. 

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 

■ 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 

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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2812 Federal Register / Vol. 79, No. 11 / Thursday, January 16, 2014 / Proposed Rules 

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. 

(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 

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 

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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