```

[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Rules and Regulations]
[Pages 4801-4805]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01057]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

[Docket Number CDC-2015-0004; NIOSH-280]
RIN 0920-AA60

Closed-Circuit Escape Respirators; Extension of Transition Period

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Interim final rule.

-----------------------------------------------------------------------

SUMMARY: In March 2012, the Department of Health and Human Services 
(HHS) published a final rule establishing new standards for the 
certification of closed-circuit escape respirators (CCERs) by the 
National Institute for Occupational Safety and Health (NIOSH) within 
the Centers for Disease Control and Prevention (CDC). The new standards 
were designed to take effect over a 3-year transition period. HHS has 
determined that

[[Page 4802]]

extending the concluding date for the transition is necessary to allow 
sufficient time for respirator manufacturers to meet the demands of the 
mining, maritime, railroad, and other industries. Pursuant to this 
interim final rule, NIOSH will extend the phase-in period until 6 
months after the date that the first approval is granted to certain 
CCER models.

DATES: This rule is effective on January 29, 2015. Comments must be 
received by March 30, 2015.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA60,'' by 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, 
Cincinnati, OH 45226-1998.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All relevant comments will be posted without change to 
http://www.regulations.gov including any personal information provided. 
For detailed instructions on submitting comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090 
Tusculum Ave., MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 
(this is a toll-free number); email NIOSHregs@cdc.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Public Participation
II. Background
    A. History of Rulemaking
    B. Need for Rulemaking
    C. Scope
III. Issuance of an Interim Final Rule With Immediate Effective Date
IV. Summary of Interim Final Rule
V. Regulatory Assessment Requirements
    A. Executive Orders 12866 and 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act
    D. Small Business Regulatory Enforcement Fairness Act
    E. Unfunded Mandates Reform Act of 1995
    F. Executive Order 12988 (Civil Justice)
    G. Executive Order 13132 (Federalism)
    H. Executive Order 13045 (Protection of Children From 
Environmental Health Risks and Safety Risks)
    I. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    J. Plain Writing Act of 2010
    Interim Final Rule

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this rulemaking. HHS invites comments specifically on the following 
question related to this rulemaking:
    1. Will a compliance date 6 months after the date that the first 
approval is granted in each of three categories of CCER types provide 
sufficient time for respirator manufacturers to develop production 
capacity to meet expected market demand, while not causing undue loss 
of sales revenue that may be expected from achieving the first 
successful design for the given size?

II. Background

A. History of Rulemaking

    Under 42 CFR part 84--Approval of Respiratory Protective Devices, 
NIOSH approves respirators used by workers in mines and other 
workplaces for protection against hazardous atmospheres. The Mine 
Safety and Health Administration (MSHA) and the Occupational Safety and 
Health Administration (OSHA) require U.S. employers to supply NIOSH-
approved respirators to their employees whenever the employer requires 
the use of respirators.
    A closed-circuit escape respirator (CCER) is an apparatus in which 
the wearer's exhalation is rebreathed after the carbon dioxide in the 
exhaled breath has been effectively removed and a suitable oxygen 
supply has been restored from sources composed of compressed, chemical, 
or liquid oxygen. CCERs are used in certain industrial and other work 
settings during emergencies to enable users to escape from atmospheres 
that can be immediately dangerous to life and health. The CCER, known 
in the mining industry as a self-contained self-rescuer, is used by 
miners to escape dangerous atmospheres in mines. It is also used by 
certain Navy and Coast Guard personnel, such as crews working below 
decks on vessels, where it is referred to as an emergency escape 
breathing device, and in the railroad industry, where it is known as an 
emergency escape breathing apparatus. To a lesser extent, it is also 
used by other workers who work underground or in confined spaces, such 
as in tunneling operations in the construction industry.
    Standards for the certification of CCERs were updated in a 2012 
final rule, in which HHS codified a new Subpart O and removed only 
those technical requirements in 42 CFR part 84--Subpart H that were 
uniquely applicable to CCERs. All other applicable requirements of 42 
CFR part 84 were unchanged. The purpose of these updated requirements 
is to enable NIOSH and MSHA to more effectively ensure the performance, 
reliability, and safety of CCERs.
    The effective date for the new standards in Subpart O was April 9, 
2012. Beginning on that date, any new application for a certification 
of approval for a CCER would be required to meet the new standards in 
Subpart O. Manufacturers were allowed to continue to manufacture, 
label, and sell respirators certified to the prior Subpart H standard 
until April 9, 2015.

B. Need for Rulemaking

    HHS has determined that extending the concluding date for the 
transition is necessary to allow sufficient time for respirator 
manufacturers to meet the demands of the mining, maritime, railroad, 
and other industries. NIOSH has found that respirator manufacturers 
that have submitted applications under the Subpart O standards have not 
been successful in meeting those standards and obtaining approval of 
any large-capacity CCERs. While one manufacturer recently received 
NIOSH approval for a small-capacity non-mining respirator, large-
capacity units designed for underground coal mining and other 
industries are not likely to receive NIOSH approval before the April 9, 
2015 deadline. Mining industry and maritime stakeholders have expressed 
concern that an adequate number of new CCERs will not be available for 
purchase by April 2015, when the grandfather clause is set to expire, 
leaving miners, sailors, and other workers with insufficient 
protection.

C. Scope

    Pursuant to this interim final rule, which amends 42 CFR 84.301, 
NIOSH will extend the deadline for Subpart O compliance until 6 months 
after the date on which NIOSH approves the first CCER in each of the 
following three categories, described in 42 CFR 84.304: Cap 1 mining, 
Cap 3 mining, and Cap 3 non-mining.
    CCER Cap 1 non-mining and Cap 2 mining and non-mining categories 
are not included in this rulemaking. Approval TC-13G-0001 was issued to

[[Page 4803]]

Avon Protection Systems, Inc. on July 24, 2014 for its ER-2 emergency 
escape breathing device (EEBD). The ER-2 EEBD is certified by NIOSH as 
a Cap 1, 20-liter, CCER for use in non-mining applications. The current 
deadline for compliance (April 9, 2015) already provides for more than 
a 6-month period for the issuance of additional approvals for 
respirators in this category. Therefore, NIOSH has determined no 
further extension of the existing April 9, 2015 deadline is required 
for the Cap 1 non-mining category. The Cap 2 mining and non-mining 
categories are not included in this rulemaking because NIOSH never 
approved any respirators under the former Subpart H requirements that 
would be classified within either of these two categories.

III. Issuance of an Interim Final Rule With Immediate Effective Date

    Rulemaking under the Administrative Procedure Act (APA) generally 
requires a public notice and comment period and consideration of the 
submitted comments prior to promulgation of a final rule (5 U.S.C. 
553). However, the APA provides for exceptions to its notice and 
comment procedures when an agency finds that there is good cause for 
dispensing with such procedures on the basis that they are 
impracticable, unnecessary, or contrary to the public interest. In 
accordance with the provisions in 5 U.S.C. 553(b)(3)(B), HHS finds good 
cause to waive the use of prior notice and comment procedures for this 
IFR and to make this action effective immediately.
    This IFR amends 42 CFR 84.301 to extend the concluding date for the 
Subpart O transition to allow sufficient time for respirator 
manufacturers to meet the supply demands of the mining, maritime, 
railroad, and other industries. Pursuant to this interim final rule, 
NIOSH will extend the deadline for Subpart O compliance until 6 months 
after the date on which NIOSH approves the first CCER in each of three 
categories. HHS has determined that it is impracticable to use prior 
notice and comment procedures for this IFR because the transition 
period will end on April 9, 2015, and respirator manufacturers must 
have sufficient notice that they may be granted an extension. Thus, HHS 
is waiving the prior notice and comment procedures in the interest of 
protecting the health of coal miners and workers in other industries 
that use CCERs by offering extensions to manufacturers to ensure that 
the supply of new CCERs will not be depleted after April 9, 2015.
    Stakeholders were given an opportunity to comment on the CCER 
notice of proposed rulemaking, published on December 10, 2008 (73 FR 
75027), in which HHS proposed that all CCERs submitted to NIOSH for 
approval on or after the effective date would adhere to the new 
standards; all CCERs sold after 3 years would adhere to the new 
standards; and all certificates of approval under the former standard 
would be rescinded at 6 years. In response to stakeholder comments, HHS 
determined that the products certified under the former standard could 
remain in service through the service time indicated by the 
manufacturer (typically, 10-15 years), rather than those approvals 
being rescinded at 6 years, and that retaining the 3-year transition 
period would address the needs of workplace managers to have a 
sufficient supply of CCERs while ostensibly giving respirator 
manufacturers sufficient time to develop new products in accordance 
with the new standards. With the April 9, 2015 deadline approaching, 
manufacturers and other stakeholders have expressed concerns that no 
new products certified to the Subpart O requirements have yet become 
available. During a NIOSH status update at a MSHA meeting held on June 
19, 2014, participating stakeholders were given an additional 
opportunity to provide input to NIOSH and MSHA, where they expressed 
concern about the manufacturers' inability to submit respirators to 
NIOSH for approval prior to the concluding date of the transition 
period. A majority of manufacturers who have offered input to NIOSH 
indicate that they will not be able to build enough capacity of units 
submitted under Subpart O to meet market demands prior to the April 9, 
2015 deadline.
    Under 5 U.S.C. 553(d)(3), HHS finds good cause to make this IFR 
effective immediately. As stated above, in order to protect the health 
of coal miners and workers in other industries, it is necessary that 
HHS act quickly to amend 42 CFR 84.301 to allow NIOSH to offer 
transition period concluding date extensions on a case-by-case basis. 
While amendments to 42 CFR 84.301 are effective on the date of 
publication of this IFR, they are interim and will be finalized 
following the receipt and consideration of any substantive public 
comments. (See Section I. Public Participation, above.)

IV. Summary of Interim Final Rule

    This interim final rule amends 42 CFR 84.301 to allow NIOSH to 
extend the original 3-year period for continued manufacturing, 
labeling, and sale of CCERs approved under Subpart H to allow for the 
orderly implementation of the new testing and certification 
requirements of Subpart O. This provision allows NIOSH to extend the 
original transition period to allow manufacturers to obtain NIOSH 
certification, establish production capacity, and complete the 
modification of existing CCER designs, if necessary, or develop 
entirely new designs that respond to the new testing and certification 
requirements. An extension also ensures that a constant supply of 
approved CCERs will remain available for purchase. The new Subpart O 
standards will continue to be applied to all new CCER designs that are 
submitted for approval.
    Paragraph (a) of this section is new, and authorizes the continued 
manufacturing, labeling, and selling of CCERs approved under the former 
standards in Subpart H until either April 9, 2015 or 6 months after the 
date that NIOSH first approves a CCER model under the capacity rating 
categories Cap 1 (for mining applications) and Cap 3 (mining and non-
mining) described in 42 CFR 84.304, whichever date comes later. In 
particular, the compliance deadline may be extended for only those 
types of CCER that are currently approved under the former standards in 
Subpart H: 20-minute non-mining units and 10-minute and 1-hour units 
approved for mining pursuant to 42 CFR 84.100. As discussed in the 
final rule published on March 8, 2012, 10-minute units are considered 
comparable to Cap 1 devices, and 1-hour units are comparable to Cap 3 
devices (77 FR 14168).
    A new paragraph (b) clarifies that any non-major modifications to 
those approved devices must continue to meet the prior Subpart H 
standards. CCERs with major modifications that will result in a new 
NIOSH approval must conform to the new Subpart O standards.
    Paragraph (c) of this section is unchanged from the current 
requirement that Subpart O applies to all CCERs submitted to NIOSH for 
approval after the effective date of the final rule, April 9, 2012.

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

[[Page 4804]]

(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 interim final rule is not being treated as a ``significant'' 
action under E.O. 12866. It amends existing 42 CFR 84.301 to allow 
NIOSH to extend the deadline for respirator certification standards 
established in 2012, and does not result in any costs to affected 
stakeholders. Accordingly, HHS has not prepared an economic analysis 
and the Office of Management and Budget (OMB) has not reviewed this 
rulemaking.
    The rule does not interfere with State, local, or tribal 
governments in the exercise of their governmental functions.

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. The 
Department of Health and Human Services (HHS) certifies that this 
interim final rule will not have a significant economic impact on a 
substantial number of small entities, including both small 
manufacturers of CCERs and the small mining operators that are required 
to purchase them, within the meaning of the RFA.

C. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an 
agency to invite public comment on and to obtain OMB approval of any 
rule of general applicability that requires recordkeeping, reporting, 
or disclosure requirements.
    NIOSH has obtained approval from OMB to collect information from 
respirator manufacturers under ``Information Collection Provisions in 
42 CFR Part 84--Tests and Requirements for Certification and Approval 
of Respiratory Protective Devices'' (OMB Control No. 0920-0109, exp. 
November 30, 2017), which covers information collected under 42 CFR 
part 84. This rulemaking does not increase the reporting burden on 
respirator manufacturers.

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.), the Department 
will report the promulgation of this rule to Congress prior to its 
effective date. The report will state that the Department has concluded 
that this rule is not a ``major rule'' because it is not likely to 
result in an annual effect on the economy of $100 million or more.

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 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 2014, the inflation-adjusted threshold is 
$152 million.

F. Executive Order 12988 (Civil Justice)

    This rule has been drafted and reviewed in accordance with 
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly 
burden the Federal court system. NIOSH has provided clear deadline 
extension requirements that will be applied uniformly to all 
applications from manufacturers of CCERs. This rule has been reviewed 
carefully to eliminate drafting errors and ambiguities.

G. Executive Order 13132 (Federalism)

    The Department has reviewed this 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 rule on children. HHS 
has determined that the rule would have no 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 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 interim final rule consistent with the 
Federal Plain Writing Act guidelines.

List of Subjects in 42 CFR Part 84

    Incorporation by reference, Mine safety and health, Occupational 
safety and health, Personal protective equipment, Respirators.

Interim Final Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR part 84 as follows:

PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

0
1. The authority citation for Part 84 is revised to read as follows:

    Authority: 29 U.S.C. 651 et seq., 30 U.S.C. 3, 5, 7, 811, 
842(h), 844.

0
2. Revise Sec.  84.301 to read as follows:

Sec.  84.301  Applicability to new and previously approved CCERs.

    (a) The continued manufacturing, labeling, and sale of CCERs 
previously approved under Subpart H is authorized for units with 
durations comparable to Cap 1 (for mining applications) and Cap 3 
(mining and non-mining applications) until either April 9, 2015 or 6 
months after the date of the first NIOSH approval of a respirator model 
under each respective category specified, whichever date comes later.
    (b) Any manufacturer-requested modification to a device approved 
under the former subpart H standards must comply with the former 
subpart H standards and address an identified worker safety or health 
concern to be granted an extension of the NIOSH approval. Major 
modifications to the configuration that will result in a new approval 
number must meet and be

[[Page 4805]]

issued approvals under the requirements of this subpart O.
    (c) This subpart O applies to all CCERs submitted to NIOSH for a 
certificate of approval after April 9, 2012.

    Dated: January 14, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-01057 Filed 1-28-15; 8:45 am]
BILLING CODE 4163-18-P
```