[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Rules and Regulations]
[Pages 48268-48272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19750]


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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: Final rule.

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SUMMARY: In March 2012, the Department of Health and Human Services 
(HHS) published a final rule establishing a new standard 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 standard 
was originally designed to take effect over a 3-year transition period. 
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. Pursuant to this final action, NIOSH extends the 
phase-in period until 1 year after the date that the first approval is 
granted to certain CCER models.

DATES: This rule is effective on August 12, 2015.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090 
Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-
1629 (this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 48269]]

Table of Contents

I. Public Participation
II. Background
    A. History of Rulemaking
    B. Need for Rulemaking
    C. Scope
III. Response to Public Comments
IV. Summary of 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

I. Public Participation

    On January 29, 2015, HHS published an interim final rule to amend 
the transition deadline established in 42 CFR 84.301 (80 FR 4801), and 
invited interested persons or organizations to participate in this 
rulemaking by submitting written views, arguments, recommendations, and 
data. Comments were invited on any topic related to this rulemaking and 
specifically on the following question related to this rulemaking:
    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?
    We received four submissions to the docket: One from a respirator 
manufacturer, one from a mining association, one from a coal company, 
and one from three coal companies and another mining association. A 
summary of comments and HHS responses are found in Section III, below.

II. Background

A. History of Rulemaking

    Under Title 42 of the Code of Federal Regulations (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 a source within the device (e.g., 
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 non-mining workers who work in tunnels, 
underground, or in confined spaces.
    Requirements 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 standard in Subpart O was April 9, 
2012. Beginning on that date, any new application for a certificate of 
approval for a CCER would be required to meet the new Subpart O 
standard. Manufacturers were allowed to continue to manufacture, label, 
and sell respirators certified to the prior Subpart H standard until 
April 9, 2015.
    On January 29, 2015, HHS published an interim final rule to amend 
the compliance deadline established in 42 CFR 84.301 (80 FR 4801). The 
interim final rule amended 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. The amendments authorized the continued manufacturing, 
labeling, and selling of CCERs approved under the former standard 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 came later.

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. Two manufacturers recently received NIOSH 
approval for their small-capacity non-mining respirators; however, no 
large-capacity units designed for underground coal mining and other 
industries have received NIOSH approval to date. HHS published the 
interim final rule in response to concerns expressed by mining industry 
and maritime stakeholders that an adequate number of new CCERs would 
not be available for purchase by the Subpart O compliance deadline, 
leaving miners, sailors, and other workers with insufficient 
protection.

C. Scope

    Pursuant to this final rule, which amends 42 CFR 84.301, NIOSH will 
extend the deadline for Subpart O compliance until 1 year 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 
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. A second 
approval for a Cap 1 non-mining CCER was awarded to Ocenco Incorporated 
on December 2, 2014. The Cap 2 mining and non-mining categories are not 
included in this rulemaking because there are no units previously 
approved under Subpart H that are equivalent to the Cap 2 categories.
    Approval TC-13G-003 was issued to Avon Protection Systems on May 
13, 2015, for a Cap 1 unit for use in mining applications. The Avon 
approval triggered a 6-month transition for the category of Cap 1 
mining respirators, in accordance with the language of the interim 
final rule. With the publication of this final rule, that extension is

[[Page 48270]]

continued for an additional 6 months, until May 13, 2016.

III. Response to Public Comments

    As discussed above in the Public Participation section, HHS 
received four submissions to the rulemaking docket. Although the 
commenters were unanimous in their support of an extension, they cited 
a variety of reasons for the insufficiency of the 6-month extension 
established in the interim final rule.
    Comment: Six months is an arbitrary date and HHS should have 
consulted respirator manufacturers regarding the amount of time 
necessary for approved devices to be available to end-users. The phase-
in period should be extended from 6 to 16 months after the first 
approval to allow time for other manufacturers to obtain NIOSH approval 
and establish production capabilities, for the end-user to make 
procurement decisions, and for the manufacturer to finalize production 
activities after receiving procurement orders.
    Response: NIOSH works closely with respirator manufacturers and did 
consult with several regarding the implementation of Subpart O. We also 
reached out to end-users and other stakeholders to learn about their 
current and future respirator needs. Although we received anecdotal 
reports that user demand is greater than the availability of units 
capable of being produced under the new standard, users did not 
validate those reports. Consequently, after consulting with 
manufacturers and end-users, we originally determined that the 
compliance deadline, 3 years after publication of the new Subpart O 
standard, offered ample time for manufacturers to develop, produce, and 
deploy Subpart O CCERs. However, because only a handful of units were 
submitted to NIOSH for approval testing during the 3 years since the 
establishment of Subpart O, we decided to accommodate manufacturers by 
extending the transition period to 6 months after the first approval in 
each category. Based on our experience, we considered that the 6 month 
extension would allow for an estimated 8 weeks to begin production and 
another 8 weeks to develop sufficient capacity. We understand that this 
extension may still not be adequate for manufacturers to develop and 
produce CCERs in sufficient quantity to meet the needs of end-users. 
Accordingly, HHS agrees to extend the transition period further, as 
discussed below.
    Comment: The 6-month extension after a first approval could create 
a monopoly if the first manufacturer to receive approval receives the 
approval long before competitors and then saturates the market, thus 
disincentivizing competitors.
    Response: HHS has provided an extended implementation period for 
the development and provision of an adequate supply of Subpart O CCERs. 
This implementation period does not restrict the opportunity for 
competition but does provide substantial incentive for timely 
development of compliant new technology, which is in the interest of 
worker safety. We expect that manufacturers who have been in the CCER 
market have incentive to stay in the market. We are not amending the 
regulatory text based on this comment.
    Comment: HHS did not contact the two respirator manufacturers that 
have received approval for Cap 1 non-mining devices concerning the 
amount of time needed to produce units sufficient to meet demand.
    Response: We did communicate with both manufacturers that have 
units approved and asked for input on production times. However, we did 
not receive timely feedback on this point. Because both companies 
received approvals for Cap 1 non-mining devices prior to publication of 
the interim final rule, and because those approvals were granted many 
months before the April 9, 2015 Subpart O transition deadline, we did 
not find it appropriate to offer an extension for this category. 
Accordingly, we are not offering an extension for Cap 1 non-mining 
CCERs in this final rule.
    Comment: HHS could amend the rule text to allow the Subpart H 
standard to be extended until 6 months after the date of the NIOSH 
approval of ``two or more'' respirator models under each category. The 
extension of the transition period must be of sufficient duration to 
accommodate the approval of multiple devices, in order to give the 
mining industry a choice in the selection of CCERs.
    Response: The intent of this rulemaking is to permit the first 
awardee time to build a practical volume of inventory to meet market 
needs. We do not agree with the suggestion to amend the text to offer 
an extension after two or more models are approved because this would 
diminish the incentive of the remaining manufacturers (without an 
approved device) to be timely in the development of their Subpart O 
CCERs. Thus, we are not amending the regulatory text to offer an 
extension after two or more models are approved.
    Comment: The 6-month extension will not allow time for 
manufacturers to fill purchase orders and may result in mines not being 
able to obtain sufficient numbers of units to meet MSHA requirements. 
This could result in mines having to stop operations until additional 
units could be obtained. Further, if only one type of respirator is 
approved under Subpart O and is the only new device available on the 
market and that device utilizes a different technology from the types 
of respirator used in a particular mine, the mine might be forced to 
mix units. Mixing units would require additional training and could 
result in added stress and confusion during an emergency.
    Response: We agree to extend the Subpart O transition deadline 
beyond the 6 months offered in the interim final rule. This should 
alleviate concerns regarding the availability of units. Regarding the 
mixing of units of different technologies, underground mines have been 
permitted to co-mingle respirator types in the past. This can be done 
safely provided all persons are trained on the available respirator 
types. We are not aware that co-mingling of respirators has jeopardized 
worker safety and do not anticipate any such safety concerns as a 
result of this action.
    Comment: Significant delays in certification processing may occur 
because NIOSH is still refining the test equipment and training 
certification testing personnel and because there is no indication that 
any CCER will meet the Cap 3 requirements.
    Response: Respirator application processing comprises several 
different steps, including initial review, quality assurance review, 
laboratory testing, and final review; NIOSH is able to process multiple 
respirator applications simultaneously. Approval processing and testing 
typically takes between 4 and 6 months, depending on the completeness 
of the application and respirator complexity. Although our laboratory 
is only able to conduct certification testing on one CCER at a time, we 
do not anticipate any NIOSH-caused delays in the certification process 
as a result of equipment or personnel development. Nevertheless, HHS's 
interest is in ensuring at least one supplier of Subpart O CCERs in 
categories where Subpart H units currently exist. The extension offered 
in this final rule is designed to begin after NIOSH testing and 
approval of one application is complete.
    We do expect NIOSH approval of Cap 3 CCERs to occur in short order. 
Because two manufacturers have recently received approvals for Cap 1 
CCERs for non-mining applications, NIOSH expects that manufacturers 
will be able to meet the Cap 3 requirements, which require less of a 
performance increase from existing respirators in the

[[Page 48271]]

general class than did the development of respirators to meet the Cap 1 
requirements.
    Comment: HHS must consider the cumulative effect on coal companies 
of expected advancements in respirator technology. The mining industry 
will only be able to accommodate one technology change in the coming 
years--either CCERs that comply with the Subpart O standard or CCERs 
that have adopted new R&D developments for additional functionalities, 
such as seamless changeover between units and verbal communication.
    Response: HHS agrees that the scenario outlined in the comment is 
undesirable, but notes that Subpart O, as its forerunner, Subpart H, is 
a performance standard, not a design standard. HHS does not foresee any 
reason that desirable new technologies such as the ones identified in 
the comment cannot be incorporated into CCER designs which meet the 
Subpart O performance requirements. Although the schedule for adoption 
of additional functionalities is beyond the control of NIOSH and we 
cannot predict the timing of future R&D developments, extension of the 
transition deadline is one way to better accommodate any new 
technologies which may be imminently achievable in practical CCER 
designs.
    Comment: The rule should recognize the significant distinctions 
between the underground coal mining industry and the maritime, 
railroad, and other industries.
    Response: HHS agrees that this action should distinguish mining 
applications from non-mining and we did attempt to structure the 
extension to recognize the different needs of the different industries. 
For example, the maritime and railroad industries use Cap 1 non-mining 
devices; because two Cap 1 non-mining CCERs have already been approved, 
Cap 1 non-mining devices are not addressed in this rulemaking. We are 
not amending the regulatory text based on this comment.

IV. Summary of Final Rule

    This 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 approval, 
establish production capacity, and complete the modification of 
existing CCER designs, if necessary, or develop new designs that comply 
with 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 standard will continue to be applied to 
all new CCER designs that are submitted for approval. In accordance 
with this final rule, all types of CCERs approved under Subpart H that 
were manufactured and labeled as NIOSH-approved, and sold by April 9, 
2015, and including those units manufactured and labeled as NIOSH-
approved and sold during the extended periods established by this rule, 
may continue to be used as NIOSH-approved respirators until the end of 
their service life.
    In response to the public comments, HHS is amending Sec.  84.301(a) 
and thereby authorizes the continued manufacturing, labeling, and 
selling of CCERs approved under the former standard in Subpart H until 
1 year 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. This extension is 
in accordance with the comment requesting an increase in the duration 
of the extension from 6 to 16 months, as we understand that the 16-
month request includes at least 5 months for manufacturers to receive 
NIOSH approval after a first approval in a given category (leaving 11 
months, in the commenter's estimation, for completion of the 
manufacturing and procurement processes). We anticipate that most 
applications will have been submitted to NIOSH by the time a first 
approval is granted, and find that building additional time into the 
extension for the approval process will unnecessarily delay the Subpart 
O transition.
    We have also amended the paragraph to clarify that a Cap 1 device 
under Subpart O is comparable to a device with a rated service time of 
less than 20 minutes under Subpart H, and a Cap III device under 
Subpart O is comparable to a device with a rated service time of 
greater than 50 minutes under Subpart H. Finally, we have removed 
reference to April 9, 2015 in paragraph (a), as that date has passed.
    HHS received no comments on the provisions of paragraphs (b) or (c) 
and, accordingly, they are unchanged. Paragraph (b) clarifies that any 
non-major modifications to those approved devices must continue to meet 
the prior Subpart H standard. CCERs with major modifications that will 
result in a new NIOSH approval must conform to the new Subpart O 
standard. Paragraph (c) states 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 (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 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 a respirator certification standard established 
in 2012, and does not result in any costs to affected stakeholders; it 
does not raise any novel legal or policy issues. 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. HHS 
certifies that this 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

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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.

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 in certain categories. 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 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.

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 intended to 
be used in mining applications with durations comparable to Cap 1 (all 
CCERs with a rated service time <=20 minutes), and units intended to be 
used in mining and non-mining applications with durations comparable to 
Cap 3 (all CCERs with a rated service time >=50 minutes), until 1 year 
after the date of the first NIOSH approval of a respirator model under 
each respective category specified.
    (b) Any manufacturer-requested modification to a device approved 
under the former subpart H standard must comply with the former subpart 
H standard 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 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: August 5, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-19750 Filed 8-11-15; 8:45 am]
 BILLING CODE 4163-18-P