```

[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Rules and Regulations]
[Pages 14168-14197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4691]

[[Page 14167]]

Vol. 77

Thursday,

No. 46

March 8, 2012

Part III

Department of Health and Human Services

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42 CFR Part 84

 Approval Tests and Standards for Closed-Circuit Escape Respirators; 
Final Rule

Federal Register / Vol. 77 , No. 46 / Thursday, March 8, 2012 / Rules 
and Regulations

[[Page 14168]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

[Docket NIOSH-005]
RIN 0920-AA10

Approval Tests and Standards for Closed-Circuit Escape 
Respirators

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

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SUMMARY: This final rule announces updated requirements that the 
National Institute for Occupational Safety and Health (NIOSH or 
Agency), located within the Centers for Disease Control and Prevention 
(CDC) in the Department of Health and Human Services (HHS or 
Department), will employ to test and approve closed-circuit respirators 
used for escaping atmospheres considered to be immediately dangerous to 
life and health, including such respirators required by the Mine Safety 
and Health Administration (MSHA) for use in underground coal mines. 
NIOSH and MSHA jointly review and approve this type of respirator used 
for mine emergencies under regulations concerning approval of 
respiratory protective devices. NIOSH also approves these respirators 
for use in other work environments where escape equipment may be 
provided to workers, such as on vessels operated by U.S. Navy and Coast 
Guard personnel. The purpose of these updated requirements is to enable 
NIOSH and MSHA to more effectively ensure the performance, reliability, 
and safety of CCERs.

DATES: This final rule is effective April 9, 2012. The incorporation by 
reference of certain publications listed in the rule is approved by the 
Director of the Federal Register as of April 9, 2012.

FOR FURTHER INFORMATION CONTACT: Tim Rehak, NIOSH National Personal 
Protective Technology Laboratory (NPPTL), P.O. Box 18070, 626 Cochrans 
Mill Road, Pittsburgh, PA, 15236; (412) 386-5200 (this is not a toll-
free number). Information requests can also be submitted by email to 
nioshdocket@cdc.gov.

SUPPLEMENTARY INFORMATION:

Preamble Table of Contents

I. Background
    A. Introduction
    B. Approval of CCERs
    C. Need for Rulemaking
    D. Scope of the Rulemaking
    E. Effects of Rulemaking on Federal Agencies
II. Summary of Public Comments
    A. Need
    B. Size
    C. Scope
    D. Feasibility
    E. State Stakeholders
    F. Railroads
    G. Training
    H. Section 84.300 Closed-Circuit Escape Respirator; Description
    I. Section 84.301 Applicability to New and Previously Approved 
CCERs
    J. Section 84.302 Required Components, Attributes, and 
Instructions
    1. Chemical Bed Physical Integrity Iindicator
    2. Instructions and Service Life Plan
    3. Labeling
    K. Section 84.303 General Testing Conditions and Requirements
    1. Breathing & Metabolic Simulator
    2. Carbon Dioxide
    3. Oxygen
    4. Peak Breathing Pressures
    5. Wet-Bulb Temperature
    L. Section 84.304 Capacity Test Requirements
    1. Man Test 4
    2. Duration Versus Capacity
    3. Capacity Ratings
    4. Achieved Capacity
    M. Section 84.305 Performance Test Requirements
    1. Performance Testing
    2. Work Rates
    3. Hypoxia
    N. Section 84.306 Wearability Test Requirements
    O. Section 84.307 Environmental Treatments
    1. Humidity
    2. Temperature
    3. Shock
    4. Vibration
    P. Section 84.308 Additional Testing
    Q. Section 84.309 Additional Testing and Requirements for 
Dockable CCERs
    R. Section 84.310 Post-Approval Testing
III. Summary of the Rule
    A. Subpart O--Closed-Circuit Escape Respirators
    1. Section 84.300 Closed-Circuit Escape Respirator, Description
    2. Section 84.301 Applicability to New and Previously Approved 
CCERs
    3. Section 84.302 Required Components, Attributes, and 
Instructions
    4. Section 84.303 General Testing Conditions and Requirements
    5. Section 84.304 Capacity Test Requirements
    6. Section 84.305 Performance Test Requirements
    7. Section 84.306 Wearability Test Requirements
    8. Section 84.307 Environmental Treatments
    9. Section 84.308 Additional Testing
    10. Section 84.309 Additional Testing and Requirements for 
Dockable CCERs
    11. Section 84.310 Post-Approval Testing
    12. Section 84.311 Registration of CCER Units Upon Purchase
    B. Subpart G--General Construction and Performance Requirements
    1. Sections 84.60, 84.63-84.65
    C. Subpart H--Self-Contained Breathing Apparatus
    1. Section 84.70 Self-Contained Breathing Apparatus; Description
IV. Regulatory Assessment Requirements
    A. Executive Order 12866 and 13563
    B. Regulatory Flexibility Act
    C. Paperwork Reduction Act of 1995
    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 Language in Government Writing
V. Final Rule

I. Background

A. Introduction

    A closed-circuit escape respirator (CCER) technically defined as a 
closed-circuit, self-contained breathing apparatus used for escape, is 
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.
    CCERs are commonly worn on workers' belts or stored in close 
proximity to be accessible in an emergency. They are relatively small 
respirators, typically the size of a water canteen, which employ either 
compressed oxygen with a chemical system for removing exhaled carbon 
dioxide from the breathing circuit, or a chemical that both provides a 
source of oxygen and removes exhaled carbon dioxide. Users re-breathe 
their exhalations after the oxygen and carbon dioxide levels have been 
restored to suitable levels, which distinguishes these ``closed-
circuit'' respirators from ``open-circuit'' respirators, which vent 
each exhalation. The total capacity for oxygen supply and carbon 
dioxide removal vary by respirator model to address different work and 
escape needs. The greater the oxygen supply capacity of a respirator, 
the larger the

[[Page 14169]]

respirator size and the less practical or comfortable it might be to 
wear during work tasks. Current models are encased in hard, water-
resistant cases to protect the respirators from damage by impact, 
puncture, or moisture.

B. Approval of CCERs

    NIOSH and MSHA jointly review and approve such respirators for use 
by miners to escape hazardous atmospheres generated during emergencies 
in underground coal mines (42 CFR 84.3). NIOSH currently approves or 
certifies CCERs under 42 CFR Part 84--Approval of Respiratory 
Protective Devices, Subpart H--Self-Contained Breathing Apparatus, as 
closed-circuit apparatus for ``escape only.'' Subpart H also specifies 
requirements for other related, but distinct, types of respirators, 
including open-circuit escape respirators and respirators (closed- and 
open-circuit) used by rescuers responding to an emergency (``entry'' 
and ``entry and escape'' apparatus); none of those other types of 
respirators are covered by this rulemaking.

C. Need for Rulemaking

    This final rule addresses problems that have been identified by 
NIOSH and users regarding CCERs and is intended to:
     Reduce reliance on human testing of devices, which is 
difficult to conduct precisely and consistently and to replicate, 
through the use of a machine-based testing regime that can be 
accurately and completely calibrated and produces replicable results;
     Establish new performance-based standards for the quality 
of the breathing supply produced by the CCER, based on the best 
available physiological research;
     Replace the measurement of the duration of breathing gas 
supplied with the measurement of the volume of breathing gas supplied 
(in liters of oxygen) as a principal certification parameter. CCERs are 
presently approved as providing a specified duration of breathing gas 
based on the performance of test subjects, but this can be misleading 
since the actual durations of breathing gas received by users during 
escapes can differ substantially from those received by test subjects;
     Require design features, as necessary, to allow users to 
check the material integrity of a deployed unit. This will make it 
easier for employers and users to detect suspect units through 
inspection and remove them from service;
     Establish performance-based testing requirements for 
durability since CCERs are often used in relatively harsh environmental 
and handling conditions, such as in coal mining; and
     Provide for the approval of new ``dockable'' CCER designs 
that would allow the user to replenish the breathing gas supply of the 
CCER safely, reliably, and quickly under escape conditions.
    The final rule will result in the approval of CCERs that provide 
improved protection over those currently approved under the existing 
regulatory provisions and will facilitate the introduction of new 
technologies.

D. Scope of the Rulemaking

    This rulemaking applies only to closed-circuit escape respirators. 
It will establish a new Subpart O codifying new testing and approval 
requirements for these respirators, replacing all testing and approval 
requirements of 42 CFR Part 84, Subpart H, that are uniquely applicable 
to closed-circuit escape respirators used only for escape. This 
rulemaking will not alter the testing and approval requirements 
applicable to the other types of respirators included under Subpart H.

E. Effects of Rulemaking on Federal Agencies

    Federal agencies may wish to harmonize their policies and/or 
regulations to be consistent with NIOSH's change from the duration-
based to capacity-based rating system. Federal agencies that require 
training as a component of their respirator use regulations may also 
need to assess and perhaps modify that training in concert with this 
rule.

II. Summary of Public Comments

    On December 10, 2008, HHS published a notice of proposed rulemaking 
(73 FR 75027) proposing to update the requirements employed by NIOSH to 
test and approve closed-circuit respirators used for escaping 
atmospheres considered to be immediately dangerous to life and health. 
This class of respirators also includes such respirators required by 
MSHA for use in underground coal mines. HHS initially solicited public 
comments from December 10, 2008 to February 9, 2009. On March 4, 2009, 
HHS reopened the public comment period from March 4, 2009 to April 10, 
2009 and announced it would hold two public meetings on the proposed 
rule on March 16, 2009 and March 23, 2009 (74 FR 9380). HHS again 
reopened the comment period from May 21, 2009 to June 19, 2009 (74 FR 
23814).
    HHS received comments from 14 organizations, including one labor 
union representing coal miners, four respirator manufacturers, one 
railroad, four trade associations, two federal agencies, one state 
agency, and one government technology consulting organization. One 
comment was received after the public comment period was closed and was 
not considered. In developing this final rule, HHS considered the 
comments and presentations at the public meetings. Summaries of these 
comments submitted to the docket and/or made at the public hearings and 
the corresponding responses from HHS are provided below. The 
description of the public comments and HHS's responses are followed by 
Section III, a description of the rule and the changes made in response 
to the comment received.

A. Need

    Comment: HHS received several comments regarding the need for this 
rulemaking. One commenter suggested that the proposed rule does not 
sufficiently address the range of problems associated with closed-
circuit escape respirators. The commenter's concerns related to matters 
outside the scope of this rulemaking, such as compliance enforcement.
    Response: HHS believes that while the final rule may not resolve 
every issue involving CCERs, it, along with enhanced training on the 
proper inspection and use of deployed units, will improve the 
protection provided by CCERs to the workers who rely on these devices 
to escape from environments immediately dangerous to life or health. As 
indicated in the notice of proposed rulemaking preamble, HHS has relied 
extensively on its investigations of units taken from the field to 
identify problems that could be addressed through improvements to the 
current performance standards.
    For example, a common problem among units deployed in various 
industries, including maritime, is that the handling of individual 
units tends to physically degrade or displace the chemicals necessary 
for oxygen production and carbon dioxide removal.
    This final rule addresses the issue of degradation by establishing 
improved performance measures to ensure the units are reasonably rugged 
and the user is able to inspect the unit and readily identify units 
which fail the manufacturers' inspection criteria.
    Comment: Another commenter stated that HHS presents no documentary 
evidence from device users to support the need for the rulemaking.

[[Page 14170]]

    Response: HHS has taken this regulatory action in response to 
decades of reports from the field, from underground coal miners in 
particular, which have demonstrated that expectations training cannot 
always prepare a user for the reality of how a CCER will function in an 
actual escape. It is widely acknowledged that over the course of many 
coal mine disasters, users have repeatedly reported that (a) units 
failed to work, (b) units appeared to work but stopped far short of the 
expected 1-hour duration, or (c) the decision to don a unit was delayed 
because fresh air was more than 1 hour away.
    In NIOSH's judgment, the current certification requirements might 
be contributing to a risk communication and risk management problem 
resulting in the situations indicated above. NIOSH is currently 
required to approve these respirators as providing protection for a 
specific duration \1\ applicable to the particular class of respirator. 
Durations may be misleading to employers and users, however, because 
the duration for which a respirator will provide effective protection 
in the workplace, versus in laboratory testing, will depend on the body 
weight and physical condition of the user and on the amount of exertion 
required by the escape. The heavier the user and the greater the 
exertion, the more rapidly the user will consume the limited oxygen 
supply and exhale carbon dioxide into the unit; the faster this is 
done, the greater the likelihood that the exhaled carbon dioxide will 
accumulate excessively within the user's breathing zone, making 
breathing intolerable.
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    \1\ 42 CFR 84.53.
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    Since 1982, NIOSH has received reports of incidents in which users 
purportedly have not received the duration of protection implied by the 
approval. While such incidents could have resulted from the respirator 
failing to perform as approved, they might also reflect limitations of 
understanding about the testing criteria regarding duration. 
Accordingly, this rulemaking eliminates the duration-specific approval, 
replacing it with a capacity rating system based on the quantity of 
usable oxygen supplied by the model. (See below for a more thorough 
discussion of the change to a volume-based standard).
    In addition to what NIOSH considers a risk communication/management 
problem, NIOSH field evaluations of approved CCERs conducted 
systematically and in response to the concerns of users have identified 
damaged respirators that failed to meet the performance criteria under 
which they were approved.\2\ In some instances, the designs of these 
respirators did not allow the user or employer to evaluate the 
condition of a particular respirator prior to its use in either an 
evacuation drill or an actual emergency. In response to the problems 
identified, respirator manufacturers have made design improvements to 
allow persons to check for certain types of damage. However, such 
checks or indicators are not governed by current regulations and do not 
exist in some of the respirators currently available. The final rule 
addresses these indicators which will simplify the inspection of units 
by employers and users and result in the removal from service of those 
which show evidence of exposure to conditions that may cause 
performance problems.
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    \2\ See, e.g., Kyriazi N, Shubilla JP. Self-contained self-
rescuer field evaluation: seventh-phase results. Pittsburgh, PA: 
U.S. Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Institute for Occupational Safety 
and Health; March 2002. DHHS (NIOSH) Publication No. 2002-127, RI 
9656.
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    This rulemaking also upgrades testing standards by more stringently 
verifying the quantity and quality of breathing gas supplied by 
approved CCERs. In certain circumstances, particularly during a 
prolonged or highly energetic escape, this type of respirator may 
provide the user with a constrained supply of oxygen and permit levels 
of carbon dioxide that can feel uncomfortable. The upgraded testing 
standards provide improved assurance that the levels of oxygen and 
carbon dioxide will be maintained consistently within tolerable limits 
throughout their use during an escape. Together with effective training 
to ensure that users are familiar with the particular breathing 
experience to be expected of this type of respirator, these 
improvements should help to ensure that workers can make full use of 
the respirators during an escape.
    HHS is also improving on the existing standard by avoiding human 
test subject variability in defining capacity and limiting its use in 
testing performance characteristics. Use of the breathing and metabolic 
simulator will ensure that neither the capacity nor the performance 
test criteria are wholly dependent on human subjects, which will 
establish a consistent and hence more reliable testing regimen.
    Comment: Finally, a commenter from the maritime sector expressed 
concern that the rulemaking and expenses associated with the 
replacement of currently-deployed units were unwarranted because HHS 
has not demonstrated that CCERs used on ships are problematic.
    Response: HHS does not expect the promulgation of this final rule 
to be a hardship on the maritime sector. The 6-year grandfather clause 
in the proposed rule has been omitted from this final rule, allowing 
units currently deployed on ships to remain in service until the end of 
their service life. To ensure no disruption in the supply of CCERS, 
currently-approved devices may not be manufactured and labeled as 
NIOSH-approved and sold after April 9, 2015.

B. Size

    Comment: Seven commenters expressed concern that the improved 
standards might result in the production of larger, heavier CCERs.
    Response: HHS does not expect that a manufacturer would increase 
the size or weight of a CCER design in response to the new standards. 
It is possible that manufacturers could enlarge certain individual 
respirator designs or increase their weight in order to meet the new 
capacity rating standards and the more effective eye protection 
requirements. However, because most current CCER designs include eye 
protection, HHS does not expect an increase in either size or weight 
solely for this reason. Further, NIOSH bench testing on currently-
approved units demonstrates that they can provide the same amount of 
oxygen as required by the capacity standards in this final rule. For 
example, current 1-hour units provide 80 liters (L) of oxygen, 
comparable to a Cap 3 device; 10-minute units provide approximately 25 
liters of oxygen, comparable to a Cap 1. The new standards afford 
greater latitude regarding potential variety in the capacity of 
individual respirator designs, given that each capacity rating 
encompasses a range of oxygen volumes (e.g. Cap 1 units can contain 
from 20 L to 59 L of oxygen). This latitude should promote designs that 
more closely meet the varied capacity, size, weight, and other 
requirements of different users, occupational settings, and emergency 
provisions and contingencies.

C. Scope

    Comment: HHS received three comments indicating that the scope of 
the rulemaking should be expanded to also include technical standards 
for open-circuit escape respirators. Another commenter concurred with 
the Agency's approach, stating that limiting this rulemaking to CCERs 
is warranted because of the clear distinctions between the two types of 
technology.
    HHS also received a comment demanding that the scope of the

[[Page 14171]]

proposed rule address all aspects of development, purchase, deployment, 
tracking, and use of CCERs in coal mines.
    Response: NIOSH is updating all of its standards under 42 CFR Part 
84 using an incremental or modular approach. The updating of CCER 
standards was a high priority to the Agency and to users and employers 
because of the extensive concerns raised regarding this technology. 
Open-circuit escape respirators employ distinct technology that is 
likely to require different changes to the current standards. HHS 
intends to address open-circuit escape respirators in a future 
rulemaking.
    Under 42 CFR Part 84, HHS establishes applicable construction, 
performance and respiratory protection requirements for respirators. 
Section 84.3 describes MSHA's authority to co-approve respirators 
determined to be suitable for use in mines. HHS does not have authority 
to regulate the deployment and use of CCERs in coal mining or other 
industries.

D. Feasibility

    Comment: HHS received one comment stating that HHS has not provided 
data indicating that it would be feasible for CCER manufacturers to 
produce designs capable of meeting the new certification standards 
before the 3-year cut-off date for sales of currently approved models.
    Response: CCER manufacturers have provided extensive comments 
during the development of this rule and have not indicated this 
concern. As discussed below, this final rule omits the proposed 6-year 
grandfather clause limiting the duration over which currently approved 
CCERs may continue to be used within their prescribed service lives; as 
discussed below under Sec.  84.301, the final rule does not discontinue 
the approvals of CCERs currently deployed or sold within 3 years of the 
effective date of this rule. Moreover, while the rule provides 
incentive for innovation, it does not specify new performance 
parameters that cannot be met by existing technology.

E. State Stakeholders

    Comment: One commenter indicated that the Department's efforts to 
reach out to state mine safety agencies on the development of this rule 
were inadequate.
    Response: HHS reached out to all stakeholders by providing numerous 
opportunities to comment throughout this rulemaking process. HHS 
announced all public meetings and opportunities to provide written 
comment in the Federal Register during both the concept and rulemaking 
stages. During the concept development work carried out by the Agency 
preceding this rulemaking, public meetings were held to solicit input 
from all stakeholders. These meetings included participation from 
representatives of labor and industry, other federal and state 
agencies, as well as manufacturers and academia. Subsequently, during 
this rulemaking, the docket and public comment meetings were open to 
all interested parties and included participation by a consultant to 
the mine safety agency of West Virginia.

F. Railroads

    Comment: Two commenters advised HHS to consider the use of CCER by 
railroads.
    Response: HHS acknowledges the use of escape respirators by the 
railroad industry, and specifically recognizes the respirator 
requirements codified by the Rail Safety Improvement Act (RSIA) of 2008 
(49 U.S.C. 20166; Pub. L. 110-432, sec. 413). While no final rule 
concerning escape respirators have yet been promulgated under the RSIA, 
HHS has considered the RSIA requirements in drafting this final rule. 
This final rule does not conflict with the RSIA respirator 
requirements, which address the supply of CCERs on railways but do not 
include design or performance specifications. The omission from the 
final rule of the proposed 6-year grandfather provision regarding the 
continued use of already deployed CCER units should eliminate any 
feasibility concern of the railroads.

G. Training

    Comment: HHS received two comments questioning whether the new rule 
will affect the training given to coal miners.
    Response: Such training is governed by MSHA, Department of Labor, 
pursuant to its authority under the Federal Mine Safety and Health Act 
(30 U.S.C. 952, 811), and codified under 30 CFR 75.1504. The Agency has 
worked with MSHA throughout the course of this rulemaking to ensure 
that MSHA policies will be consistent with the amendments to Part 84.

H. Section 84.300 Closed-Circuit Escape Respirator; Description

    Comment: HHS received three comments objecting to the use of the 
term ``closed-circuit escape respirator'' to identify the subject of 
this rulemaking. These commenters would prefer to classify these 
devices as ``self-contained self-rescuer,'' the term commonly used by 
the mining industry. One of these commenters suggested that the use of 
a terminology not recognized by the mining industry resulted in that 
community not understanding the rule's potential impact.
    Response: While the mining industry categorizes these devices under 
one term, they are referred to as ``emergency escape breathing 
apparatus'' on railroads, and as ``emergency escape breathing devices'' 
onboard ships. CCER is the classification of this type of respirator 
under any of these designations. HHS will retain the classification 
``closed-circuit escape respirator'' because it is the technically 
correct name of the devices to be considered for approval and because 
HHS does not intend to impose one industry's designation on other 
industries that have their own. The use of the term ``closed-circuit 
escape respirator'' in this rulemaking does not in any way proscribe 
the use of the term ``self-contained self-rescuer'' by manufacturers or 
the mining industry, or other terms used by other industries. This is 
consistent with the current standard (42 CFR Part 84, Subpart H), which 
does not refer to the devices as ``self-contained self-rescuers,'' but 
rather ``closed-circuit self-contained breathing apparatus.''

I. Section 84.301 Applicability to New and Previously Approved CCERs

    Comment: HHS received various comments on the proposed 3-year 
certification phase-in period for new devices and the proposed 6-year 
grandfather clause for units purchased prior to the effective date of 
the final rule. One commenter supported both the 3-year phase-in and 
the grandfather clause, and opposed the option discussed in the notice 
of proposed rulemaking of omitting the grandfather clause, which could 
result in currently approved CCER units remaining in the field for 13-
18 years (their potential service life) following promulgation of this 
final rule. One commenter requested that HHS include no phase-in 
period, and that instead manufacturers should be prepared to supply new 
units, approved under the final rule, immediately upon promulgation. 
The same commenter suggested that HHS would otherwise exceed its 
authority under the Mine Improvement and New Emergency Response (MINER) 
Act of 2006 (29 U.S.C. 671(h), Pub. L. 109-236, sec. 6) by delaying the 
deployment of new technologies. Two other commenters concurred with HHS 
regarding the exemption of the Department of Defense (DOD) from the 6-
year grandfather provision of the proposed rule, as proposed therein. 
Finally, four commenters opposed the 6-

[[Page 14172]]

year grandfather clause for units approved under the current standards. 
They argued that the discarding of CCERs with remaining service life 
would be financially costly and potentially infeasible, considering the 
difficulties experienced by manufacturers in producing sufficient CCER 
supplies for the mining industry under the expanded deployment 
requirements promulgated by MSHA under the MINER Act (30 U.S.C. 876 
(E)(iii)).\3\
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    \3\ U.S. Government Accountability Office. Additional guidance 
and oversight of mines' emergency response plans would improve the 
safety of underground coal miners. April 2008; GAO-08-424 at 24. 
http://www.gao.gov/new.items/d08424.pdf. Accessed October 7, 2010.
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    Response: HHS recognizes that recent amendments to the statutory 
schemes governing two of the three main users of CCERs--mining and 
railroads--require the deployment of substantially increased numbers of 
units of escape respirators. For example, the Rail Safety Improvement 
Act of 2008 requires that the Federal Railroad Administration in the 
Department of Transportation enact regulations mandating respirators on 
certain locomotives for all crewmembers (49 U.S.C. 20166; Pub. L. 110-
432, sec. 413). Similarly, the MINER Act requires mine operators to 
make additional caches of respirators available to workers, a provision 
which has been implemented by MSHA and mine operators. HHS also 
recognizes that the relevant, industry-specific regulatory agencies and 
DOD are authorized to govern respirator use within their specific 
industry domains and that their authorizations differ.
    Within 3 years of the effective date of this final rule, NIOSH will 
continue to recognize respirators manufactured and labeled as NIOSH-
approved devices and sold by manufacturers under the current approvals 
as long as they continue to be maintained and used in accordance with 
the conditions of approval. It is not appropriate for HHS, which is not 
authorized to govern respirator use in particular industries, to 
consider requirements or limitations on the continued use of approved 
CCERs that are deployed currently or may be deployed within the 3-year 
manufacturing/labeling and selling limitation of this final rule. Such 
consideration would involve matters outside of HHS's purview, including 
the varying service life ranges of different CCER designs currently 
approved by NIOSH; the different storage, maintenance, and use 
conditions; differing feasibility concerns regarding maintenance of an 
adequate supply of CCERs; and the agencies' different statutory and 
regulatory requirements.
    Eliminating the 6-year grandfather period in the final rule removes 
potential economic costs \4\ to employers that could result from 
replacing or retrofitting any respirator designs that remain in use at 
their worksite but are not submitted to NIOSH for retesting under the 
new approval tests. This change also fully addresses the feasibility 
concerns raised in the public comments. On the other hand, it allows 
that some currently-approved CCERs may remain in service for their 
entire service life, unless the relevant regulatory or purchasing 
agencies determine otherwise. Designations of service life for 
currently-approved CCERs range from 10 to 15 years.\5\ As noted in the 
notice of proposed rulemaking, these designations do not account for 
the highly varied conditions of storage and handling of CCERs across 
different work environments. Through extensive field studies evaluating 
the condition of CCERs deployed in coal mines, NIOSH and MSHA have 
found that the actual deployment duration of current CCERs in coal 
mines tends to be substantially less than designated, due to wear and 
tear and damaging environmental conditions.\6\ In other industries 
involving less physically degrading conditions, CCERs may be more 
likely to remain available for deployment for their full service life.
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    \4\ See Section IV.A of this preamble for a discussion of 
potential economic costs.
    \5\ One product has a service life of 15 years, but to achieve 
this service life, it must be reconditioned by the manufacturer at 
10 years if stored and at 5 years if carried.
    \6\ NIOSH evaluations of the physical condition and performance 
of deployed CCERs are conducted routinely as a quality assurance 
measure and in response to complaints, concerns, and emergency 
incidents. The findings of these evaluations are documented in 
published Long-Term Field Evaluations and NIOSH internal reports; 
actionable findings provide the basis for remedies addressed by 
NIOSH and the applicant.
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    With respect to the 3-year phase in period, HHS recognizes the 
difficulty experienced by some manufacturers in meeting the current 
demand for respirators and the potential need for design development 
and related production line changes. The Department finds that it would 
not be feasible to require manufacturers to redesign products and 
change their production processes immediately upon promulgation of the 
final rule. Therefore, HHS has retained in the final rule the proposed 
allowance for CCER manufacturers to continue the sale of manufactured 
and NIOSH-labeled currently-approved CCERs for 3 years, upon this 
rule's effective date. The final rule has been changed slightly from 
the language that was originally proposed, to indicate that respirators 
must be manufactured and labeled NIOSH-approved within the 3-year 
deadline, as well as sold by manufacturers within that deadline, to 
ensure that respirators approved under the new standard are integrated 
into the field as quickly as possible.
    As of the effective date of this rule, NIOSH will only accept 
applications for approval of CCERs under these new standards. NIOSH 
believes there are manufacturers who will be ready to submit 
applications to meet the new standards at that time and will do so to 
enhance the marketability of their products. In addition, the new rule 
permits the introduction of new technology, such as the dockable unit.

J. Section 84.302 Required Components, Attributes, and Instructions

    Comment: HHS received various comments regarding components 
required to indicate specific types of damage that might reduce the 
effectiveness of the CCER unit. Two commenters supported the provision 
in its entirety; one supported the objective but proposed that the 
indicators be designed to minimize false positives (when the indicator 
falsely indicates there is a problem) and false negatives (when the 
indicator falsely indicates there is not a problem). One commenter 
requested that all indicators be failsafe (100 percent accurate in 
indicating problems) and that indicators should become permanently 
altered to indicate material or functional degradation. Another 
commenter suggested that the rule should require an additional 
indicator, specific to CCERs that use compressed oxygen or chlorate 
candles, which would allow the user to verify that the oxygen starter 
will activate. Another commenter requested that oxygen starters 
employed in CCERs be required to include a pressure gauge.
    Response: HHS has retained requirements for indicators in certain 
circumstances. These requirements are intended to codify what has 
become standard equipment on currently-approved respirators. Some types 
of damage are obvious, but the purpose of the indicators is to reveal 
critical damage or unacceptable environmental exposures that would not 
be otherwise evident to users. Such indicators are required only to 
address susceptibilities of the particular CCER design and are required 
only for those components or attributes critical to the life-preserving 
functions of the respirator. While it may not be possible to build a 
device that

[[Page 14173]]

cannot be broken, it is possible to build a device that clearly 
indicates when it should no longer be relied upon to protect the 
wearer. HHS will require manufacturers to include indicators that 
unambiguously alert users to the detection of damage or degradation. 
These indicators will permit employers and users to inspect units, and 
remove from service those units that demonstrate exposure to conditions 
that may cause performance problems.
    NIOSH will examine the accuracy and reliability of indicators on a 
case-by-case basis, as this is an important element of ensuring that 
they are effective. A substantial potential for false negatives would 
be of particular concern since it might mislead employers and users 
regarding CCER units that should be removed from service. A high 
potential for false positives would also be problematic because the 
employer might remove undamaged units from service based on the false 
indications, which has cost implications but also could impact the 
credibility of the indicators, potentially discouraging compliance. 
However, in NIOSH's experience--which includes Long-Term Field 
Evaluations, manufacturer audits, and investigated field complaints--
true false positives are rare, as indicators are designed to minimize 
their occurrence. CCER units are known to experience performance 
degradation after exposure to extreme (as defined by the manufacturer) 
heat and moisture; temperature and heat indicators on currently-
approved units reliably alert users to exposures that have the 
potential to cause a unit to be unable to supply oxygen or scrub carbon 
dioxide at sufficient levels to effect an escape. The standard, as 
written, does not require that an indicator alert the user that the 
unit has sustained damage, but that the unit has been subjected to 
environmental conditions that could cause damage to the unit. NIOSH 
will validate indicators during the certification process and through 
post-approval testing under its Long Term Field Evaluation program 
discussed in the notice of proposed rulemaking (73 FR 75027 at 75037, 
December 10, 2008) and its Certified Product Investigation Program. HHS 
agrees that manufacturers should attempt to design indicators to 
minimize false positives and negatives, but will not require that 
standard in the final rule. To enable NIOSH to effectively evaluate the 
indicators, the final rule text requires manufacturers to provide NIOSH 
with information about each indicator, including an explanation of how 
the indicator works, any relevant data that will enable the evaluation, 
and any tools used by the manufacturer to evaluate indicator function.
    In this final rule, HHS has added a provision requiring an oxygen 
starter indicator or other component to detect certain damage or 
deficiencies to the starter if it is a critical component to the 
effective use of the CCER. For compressed air starters, this may mean a 
pressure gauge; for a chemical starter, it could mean a color change 
chemical indicator observable through a port/window; for any unit, it 
could mean instructions to observe conditions that may prevent intended 
activation and release of the starter oxygen (i.e., denting or damage 
or a pulled or broken starter pin) or an indicator of the starter 
assembly's exposure to moisture, excessive temperature, g-force, or 
other physical damage.
1. Chemical Bed Physical Integrity Indicator
    Comment: Two commenters addressed the issue of chemical bed 
physical integrity indicators for carbon dioxide scrubbers: One 
believed such an indicator is unwarranted since quality control during 
manufacturing will ensure that the scrubber will work when required, 
and post-approval testing will verify continuing effectiveness after 
deployment; the other commenter requested specific requirements for 
these indicators.
    Response: The chemical bed physical integrity indicator will not be 
required if the chemical oxygen supply or chemical carbon dioxide 
scrubber cannot be altered by impact, vibration, or any other 
environmental factor. This indicator would only be required when the 
design of the CCER would allow for the degradation of chemical oxygen 
supply or the carbon dioxide scrubber. The text of this provision has 
been revised to indicate that units in which the chemical oxygen 
storage or chemical carbon dioxide scrubber can be altered by impact or 
any other effect must include the chemical bed integrity indicator.
    HHS has not added any specific requirements for the design of such 
an indicator. An indicator, when required, must accurately and reliably 
indicate when the capacity or performance attributes of the CCER have 
been degraded such that the unit does not meet the capacity and 
performance testing requirements of this final rule. NIOSH will examine 
and/or test the accuracy and reliability of the indicator appropriate 
to the indicator's design attributes and their potential 
susceptibilities to failure. The manufacturer is not limited with 
respect to the possible indicator designs permissible to achieve this 
performance standard.
2. Instructions and Service Life Plan
    Comment: The proposed rule would have required manufacturers to 
include instructions and a service life plan with each new CCER unit. 
One commenter found the requirement unwarranted while another asserted 
in support of the proposal that the service life plan is an essential 
requirement.
    Response: Manufacturers include instructions with currently 
approved units in a variety of manners and this information is often 
lost or damaged because of the way in which units are handled in the 
field. Users are required to be trained in the donning and use of CCERs 
such that users should be thoroughly familiar with the devices in the 
event of an emergency. Accordingly, HHS agrees with the commenter noted 
above that manufacturers should not be required to provide instructions 
or a service life plan with each individual unit. The final rule has 
been modified accordingly.
3. Labeling
    Comment: HHS received one comment recommending that the capacity 
rating be identified on the device.
    Response: The Department does intend to require manufacturers to 
indicate the capacity rating (e.g. Cap 3) as well as the number of 
liters of oxygen as determined by the capacity test on the label of 
each CCER unit. This intent was implicit in the proposed rule's 
provisions for capacity ratings and NIOSH reporting of achieved 
capacity values under Sec.  84.304. This comment is adopted in the 
final rule and the language in the rule text has been clarified.

K. Section 84.303 General Testing Conditions and Requirements

1. Breathing & Metabolic Simulator
    Comment: HHS received several comments on the conduct of capacity 
and performance testing using the breathing and metabolic simulator for 
quantitative evaluation, and the use of human subjects for qualitative 
evaluation of units.
    One commenter supported the retention of some human subject testing 
to assess the human factors associated with CCERs; several commenters 
supported the use of simulators to conduct quantitative analysis on 
CCER units, however one of those commenters would have preferred that 
the use of human subjects represent the broader mining community and 
not be limited

[[Page 14174]]

to a single subject. Finally, one commenter requested that capacity 
and/or performance testing include a simulation of multiple realistic 
demand models, which should not terminate until the breach of specific 
performance thresholds.
    Response: HHS continues to find it appropriate to shift from human-
based testing to the breathing and metabolic simulator model to assess 
the quantitative aspects of CCER capacity and performance and has 
retained the breathing and metabolic simulator testing in the final 
rule. Breathing and metabolic simulator testing will provide a uniform, 
consistent basis for evaluating the functional characteristics of CCERs 
and allows NIOSH to evaluate CCER performance to the point at which the 
CCER gas supply is completely depleted, ensuring that the CCER's 
capacity and performance is fully evaluated. HHS has also retained 
limited human subject testing in the final rule, as specified in the 
proposed rule, to make ergonomic assessments and to ensure consistency 
with statutory requirements applicable to mining.\7\
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    \7\ The Federal Mine Safety and Health Act which governs the 
mandatory health and safety standards issued by the Secretary of 
Labor requires that ``no mandatory health or safety standard * * * 
shall reduce the protection afforded miners by an existing mandatory 
health or safety standard.'' 30 U.S.C. 811(a)(9). The continued use 
of man test 4, as a supplement to the new testing requirements and 
capacity rating system, will be the most practical method of 
ensuring that the use of these respirators, as approved under this 
final rule, is consistent with the standard set by the Act.
---------------------------------------------------------------------------

    In the Agency's judgment, it is not feasible for NIOSH to conduct 
scenario testing. The capacity testing protocol cannot fully predict a 
range of escape scenarios to address all situations in which CCERs 
might be deployed. Man test 4, required for capacity testing units 
intended for use in coal mines, is not designed to represent a mine 
escape; it is included as an ergonomic assessment of the physical 
orientations that may be required during a mine escape. This ergonomic 
assessment is sufficiently realistic; in NIOSH's judgment, a more 
realistic demand model is unwarranted.
    Comment: Two commenters said the proposed rule lacks test protocols 
to determine which respirators will pass or fail.
    Response: HHS has clearly specified in the proposed rule and in 
this final rule the performance standards by which respirators will be 
evaluated using the breathing and metabolic simulator and through human 
testing, addressing respirator capacity and performance. Upon request, 
NIOSH will make available to manufacturers its specific protocols and 
breathing and metabolic simulator performance specifications so that 
manufacturers can duplicate NIOSH testing methods. Standard test 
procedures will be posted on the NIOSH Web site at http://www.cdc.gov/niosh/npptl.
    Comment: One commenter has requested that HHS provide verification 
of the performance and accuracy of each breathing and metabolic 
simulator used by NIOSH for capacity and performance testing.
    Response: NIOSH is willing to share fully its experience over many 
years with its breathing and metabolic simulator, as well as its design 
specifications, as noted above. The technology used in the breathing 
and metabolic simulator used by NIOSH is readily calibrated and when 
calibrated, is not subject to significant variability in relation to 
the simulation and measurement performance required for testing 
specified under this final rule.
    To ensure the accuracy of the breathing and metabolic simulator, 
the analyzers are calibrated before each test along with transport and 
response time of the gas measurement system. All of these will be 
documented in the standard test procedures developed for the 
certification tests.
    Comment: HHS received one comment suggesting that the 
manufacturer's respirator donning and use instructions be applied 
during capacity and performance testing. The commenter offered text 
changes to provide that capacity and performance tests would be 
conducted in accordance with the manufacturer's instructions. While 
earmarked for Sec.  84.303(a), it appears this comment is meant to 
refer specifically to the hypoxia testing component of Sec.  84.305.
    Response: HHS believes the hypoxia test procedure is well-conceived 
and essential for determining whether a unit will expose a user to low 
inhaled oxygen concentrations. Many CCER users are trained to exhale 
into a CCER upon donning it because this is the recommended practice 
for CCERs supplied with chemical oxygen if the oxygen starter fails. In 
an emergency, it is likely that some users will exhale into the CCER 
regardless of its design, in which case NIOSH needs to ensure that the 
respirator will perform adequately. The final rule's requirements 
assume that a reasonably likely donning procedure will be applied by 
the user irrespective of the specific type of CCER available to the 
user. Therefore, performance tests will begin with two exhalations into 
the unit and then the manufacturer's instructions will be followed in 
order to determine the design's susceptibility to hypoxia.
    HHS also received many comments concerning the values included in 
Table 1--Monitored Stressors and Their Acceptable Ranges, including all 
four criteria (average inhaled carbon dioxide, average inhaled oxygen, 
peak breathing pressures, and wet-bulb temperature). Capacity, 
performance, and wearability tests will continuously monitor the 
stressors listed in this table. Those comments and HHS's responses 
follow below.
2. Carbon Dioxide
    Comment: Three commenters addressed acceptable operating average 
and acceptable range excursion values for carbon dioxide in Table 1. 
One commenter objected to the 1.5 percent average carbon dioxide 
concentration, and requested that HHS justify the change in this value 
for closed-circuit devices when the value for open-circuit devices 
(currently 2.5 percent) remains unchanged. The other two commenters 
objected to the proposed 4 percent carbon dioxide ``parameter,'' given 
the potential for slightly impaired decision-making in some subjects 
when exposed to this amount of carbon dioxide.
    Response: HHS has retained the average and acceptable range 
excursion values in the final rule. The 1.5 percent average limit for 
carbon dioxide is feasible using current technology (based on NIOSH 
testing of existing designs) and it is an important improvement for 
assuring the protection of users. As carbon dioxide levels rise users 
are increasingly likely to interpret the breathing experience as faulty 
and possibly indicative of a malfunctioning CCER. This could lead the 
user to abandon the CCER when its use is critical for survival.
    An excursion limit of 4 percent is physiologically tolerable for 
brief periods \8\ and its application to all CCER

[[Page 14175]]

designs would improve the quality of breathing gas in these 
respirators, as discussed above with respect to the average limit. With 
respect to the concern that the 4-percent level might be too high, HHS 
notes that 4 percent is allowed only as an excursion level. Excursions 
are recorded during testing in 1-minute increments, with the average 
level determined over the entire expended breathing gas supply of the 
unit. CCER designs that allow carbon dioxide levels to approach the 
excursion limit repeatedly or for significant time would not achieve 
the specified limit on the average carbon dioxide level. Accordingly, 
NIOSH will not approve units that would allow a carbon dioxide 
excursion for a duration that would impair the user during an escape.
---------------------------------------------------------------------------

    \8\ Glatte HA, Motsay GJ, Welch BE. Carbon dioxide tolerance 
studies. Brooks AFB, TX. U.S. Air Force, Aerospace Medicine 
Division, USAF School of Aerospace Medicine. Report SAM-TR-
67-77; 1967:1-22.
     Henning RA, Sauter SL, Reddan W, Lanphier EH. Behavioral 
impairment with altered ventilatory response to CO2. 
Federation of American Societies for Experimental Biology, Abstracts 
of 67th Annual Meeting, Chicago, IL, 10-15 April 1983. Federation 
Proceedings: 1983;42(4):1013.
     Kamon E, Deno S, Vercruyyen M. Physiological responses of 
miners to emergency. Vol. 1--Self-contained breathing apparatus 
stressors. University Park, PA: The Pennsylvania State University. 
U.S. Bureau of Mines contract No. J0100092; 1984:13.
     Sheehy JB, Kamon E, Kiser D. Effects of carbon dioxide 
inhalation on psychomotor and mental performance during exercise and 
recovery. Human Factors. 1982;24(5), 581-588.
     Storm WF, and Giannetta CL. Effects of hypercapnia and bed rest 
on psychomotor performance. Aviation, Space, and Environmental 
Medicine. 1974;45:431-33.
     Vercruyssen M, Kamon E. Behavioral effects of breathing 3% and 
4% carbon dioxide during and following physical work. Toronto, 
Ontario, Canada, 7-9 May, 1984. Proceedings of the 1984 
International Conference on Occupational Ergonomics.
---------------------------------------------------------------------------

    Finally, capacity and performance standards for open-circuit 
designs will be addressed in a future rulemaking.
3. Oxygen
    Comment: Two commenters discussed the proposed acceptable range 
excursion value for oxygen: One commenter found the excursion range 
unwarranted, and expressed concern that manufacturers would attempt 
only to meet this ``minimum threshold.'' The other commenter opposed 
the excursion limit and recommended further study.
    Response: HHS disagrees with the commenters and has retained the 
proposed acceptable excursion value for oxygen in Table 1. The 15 
percent range excursion limit for oxygen is not an operating parameter. 
As discussed above with respect to the carbon dioxide excursion limit, 
it allows only for brief variation to a low oxygen level, within 
physiologically established tolerance.\9\ To raise this excursion limit 
would require CCERs that would be ``overbuilt,'' resulting in 
unnecessarily large and/or heavy designs. The average limit of 19.5 
percent, which is the level of oxygen available at approximately 2,000 
feet above sea level, will ensure that users receive a fully adequate 
oxygen supply to execute their escapes. The brief excursions that would 
be allowed by this average level limit do not pose any impairment risk 
to the user.
---------------------------------------------------------------------------

    \9\ Ainslie PN, Barach A, Cummings KJ, Murrell C, Hamlin M and 
Hellemans J. Cardiorespiratory and cerebrovascular responses to 
acute poikilocapnic hypoxia following intermittent and continuous 
exposure to hypoxia in humans. Journal of Applied Physiology. 
2007;102:1953-1961.
     Fowler B, Paul M, Porlier G, Elcombe DD, Taylor M. A re-
evaluation of the minimum altitude at which hypoxic performance 
decrements can be detected. Ergonomics. 1985;28(5): 781-791.
     Malkin VB. Barometric pressure and gas composition. In 
Foundations of Space Biology and Medicine. Vol II, Book 1 
(Ecological and physiological bases of space biology and medicine). 
1975;25-31.
     Paul MA, Fraser WD. Performance during mild acute hypoxia. 
Aviation, Space, and Environmental Medicine. 1994;65(10):891-899.
     West JB, et al. Maximal exercise at extreme altitudes on Mt. 
Everest. Journal of Applied Physiology. 1983;55:688-698.
     Zoll J, et al. Exercise training in normobaric hypoxia in 
endurance runners. Journal of Applied Physiology. 2006;100:1238-
1248.
---------------------------------------------------------------------------

    During testing, readings are taken in 1-minute intervals, with the 
average level determined over the entire expended breathing gas supply 
of the unit; oxygen concentrations from 20 to 100 percent are recorded 
as 20 percent. Concentrations between 19.5 percent and the lowest 
allowable level, 15 percent, are recorded as the actual value. The 
average of these values must remain at or above 20 percent over the 
entire test. In a worst case scenario, this method of averaging allows 
for approximately 10 percent of the sample intervals to be at the 
excursion limit of 15 percent. For example, during a test composed of 
60, 1-minute sample intervals, five samples could indicate an oxygen 
level of 15 percent. If an additional 1-minute interval were to exhibit 
an oxygen level of less than 19.5 percent, the unit would not pass the 
test.
    Comment: One commenter requested that HHS consider CCER designs 
equipped with hoods, which effectively store unused oxygen for use 
after the oxygen source has been expended. This commenter believes that 
Sec.  84.303(c) restricts manufacturers' design options.
    Response: Section 84.303(c) would not restrict CCER designs. 
Section 84.303(c) specifies that tests will conclude when the oxygen 
supply has been fully expended. This would include oxygen that remains 
stored in a hood if a hood is part of the CCER design.
4. Peak Breathing Pressures
    Comment: HHS received two comments pertaining to peak breathing 
pressures. One commenter suggested that that the proposed values should 
be more conservative. Specifically, the commenter has proposed the 
value 100 millimeters of water (mm H2O) for the 
acceptable range operating average, and 200 mm 
H2O for the acceptable range excursion, on the grounds that 
the operating and excursion ranges offered in the proposed rule are 
unacceptable and may result in the user discarding the unit 
prematurely. Similarly, another commenter objected to the assertion 
that ``Users who cannot generate these [peak breathing] pressures may 
be forced at some point to slow the pace of their escape.'' \10\
---------------------------------------------------------------------------

    \10\ 73 FR 75,027 at 75,032 (December 10, 2008).
---------------------------------------------------------------------------

    Response: The values proposed by HHS are based on human 
physiological capability \11\ and are retained in the final rule. The 
lower pressure range suggested by the commenter would result in a 
bulkier, heavier device than is practical. The assertion that some 
users may be forced to slow their escape is based on the mechanical and 
chemical limitations of this type of respirator; certain users, 
especially very large individuals, would be able to exceed the supply 
capability required for an unlimited level of exertion. This inherent 
limitation of the technology is appropriately addressed through the 
training provided to users.
---------------------------------------------------------------------------

    \11\ Hodgson JL. Physiological costs and consequences of mine 
escape and rescue. University Park, PA: The Pennsylvania State 
University. U.S. Bureau of Mines contract No. J0345327; 1993:19.
---------------------------------------------------------------------------

5. Wet-Bulb Temperature
    Comment: HHS received four comments regarding wet-bulb temperature, 
included in the table of monitored stressors to represent the 
temperature of the inhaled breathing gas in the CCER user's trachea. 
One commenter warned against adopting the highest threshold number for 
evaluating wet-bulb temperatures. Another suggested that the proposed 
standard should rely on dry-bulb instead of wet-bulb temperature 
because dry-bulb temperature is technically easier to measure in the 
laboratory. This commenter further suggested that the comparison of 
wet-bulb temperature to a user's trachea is not accurate, as the 
trachea is not always a wet surface. Another commenter expressed 
concern that standardizing humidity responses between different 
simulators will be difficult, as the temperature reading is not a 
fundamental property and is specific to each breathing and metabolic 
simulator. For example, the commenter asserted that wet-bulb response 
will ``vary with different flow rates, different amounts of water on 
the thermocouple, or different size thermocouples,'' and suggested that 
HHS consider using a fast-response sensor. Finally, one commenter 
asserted that the inhaled gas temperature (piston and the mouth port is divided 
into three pipes covered both with heat tape and metal fins. This 
simulates the volume and surface area of the trachea, enabling heat 
transfer to and from the air stream, respectively, again emulating 
human response to the temperature of inhalation gases. NIOSH can set 
and specify the exhalation temperature of the airway gas while 
breathing room air, but cannot specify the breathing and metabolic 
simulator exhalation temperature for every combination of inhalation 
wet- and dry-bulb temperature. Because it is designed to physically 
simulate the human lung and airway, the simulator responds in a human-
like manner to rising inhalation temperatures.
    The wet-bulb thermocouple, designed and built in-house at NIOSH, is 
the only such instrument known which has a response time of 2 liters/minute), not at the 
high work rate tested in the University of Maryland study. The study 
does not provide any indication of size or weight changes to CCERs that 
might be produced in response to this final rule. It does validate the 
basis indicated by HHS for changing from a duration-based rating system 
to one that is capacity-based by demonstrating that test subjects of 
differing sizes and walking at variable speeds will not receive the 
same duration of breathable oxygen. The study reinforces the point that 
the only reliable metric for rating a respirator's capacity is the 
quantity of oxygen supplied by the respirator.
---------------------------------------------------------------------------

    \23\ 73 FR 75,027 at 75,042 (December 10, 2008).
---------------------------------------------------------------------------

    HHS has retained in this final rule the 3-tier rating system 
proposed. Since the actual liters of oxygen capacity achieved during 
testing by NIOSH will be specified on the label of the respirator, more 
capacity rating categories would be unnecessary. Nor would finer 
categorical distinctions be meaningful with respect to the differing 
escape contingencies or the need for further testing differences 
contingent on such distinctions. The three broad categories 
sufficiently delineate low, medium, and high capacity devices as 
general reference points for purchasers to identify devices potentially 
suited to the emergency needs of their employees. Similarly, they 
sufficiently delineate capacity for the assignment of appropriate 
testing regimens.
    The current ventilation rate for testing open-circuit escape 
respirators is not a

[[Page 14179]]

consideration for determining the rate to be applied to testing Cap 1 
devices under this final rule for CCERs. As discussed above, the rates 
for CCERs are based on physiological capacity. The current rate for 
open-circuit escape respirators is a matter that will be considered in 
future rulemaking addressing that different technology.
4. Achieved Capacity
    Comment: HHS received one comment regarding how the capacity rating 
is assigned. The commenter suggested that the rating be based on the 
average of the seven units tested, rather than on the least value 
achieved by the seven units tested using the breathing and metabolic 
simulator as proposed, and that all of the values should be within the 
capacity rating requested by the applicant. The commenter recommended 
corresponding text edits to Sec.  84.304(e).
    Response: HHS has retained in the final rule the approach presented 
in the proposed rule to use the least value achieved by the seven units 
tested. The use of the breathing and metabolic simulator to conduct 
these tests will indicate variability attributable to the CCER. HHS is 
using the lowest capacity demonstrated by testing to err on the side of 
safety. This conservatism is particularly important considering the 
small number of units being tested.

M. Section 84.305 Performance Test Requirements

1. Performance Testing
    Comment: HHS received one comment requesting the rate of speed and 
incline of the treadmill test (Sec.  84.305(a)(3)). Another commenter 
offered that the rule should require evaluation of the quality of the 
breathing gas at the first inhalation by the user.
    Response: Manufacturers must calibrate the treadmill to the 
specific physiology of each test subject. This standard is work rate, 
not exercise driven. So, for example, a smaller subject will require a 
steeper grade and faster speed than a larger subject to achieve the 
same work rate.
    HHS agrees that a performance standard might be appropriate for 
governing the quality of the breathing gas supplied by a CCER at the 
first inhalation. Such performance parameters and related testing have 
yet to be developed but the possibility will be evaluated for future 
rulemaking.
2. Work Rates
    Comment: HHS received a number of comments addressing the proposed 
performance test work rates; two suggested that the work rates are not 
supported by data. One of these commenters questioned why NIOSH has not 
conducted empirical testing of realistic mine escapes. Another 
commenter suggested modifying the proposed work rate test sequence to 
repeat only the high and low work rates, rather than cycling through 
the peak (highest) work rate as well. This commenter also recommended 
that units that are exhausted before the completion of the full test 
sequence only be permitted to continue with testing if the entire 
initial peak flow test was successfully completed. One commenter 
expressed concern that the 30-minute performance test will not provide 
accurate performance data for ``shorter duration'' units, and offered 
the example that some carbon dioxide scrubbers absorb less in the first 
minute of operation; if multiple units were required for completion of 
the test sequence, higher concentrations of carbon dioxide would result 
each time a new unit replaced a spent unit, thus skewing the test 
results. This commenter suggested that HHS design a test for the 
capacity of the unit being tested, rather than requiring the testing of 
multiple units. Finally, one commenter asserted that the work rates for 
Cap 1 and 2 devices can only be met by large increases in the sizes of 
units.
    Response: The performance tests are applicable to all uses of 
CCERs, representing realistically achievable and varying work rates for 
each category of devices (Cap 1 through Cap 3). Lower work rates would 
result in smaller, lighter devices more suitable for carrying, but if 
using such a device stresses the wearer beyond the human tolerance 
level, it may very well fail to meet their need for a successful 
escape.
    The performance test is a composite test including both high and 
low work rates intended to draw into use all the components of the 
apparatus, including the demand and relief valves. According to 
physiological research \24\ as well as common experience, the higher 
the work rate, the less time one can sustain that work rate. 
Accordingly, NIOSH is applying a high work rate for 5 minutes and then 
a lower work rate for 15 minutes. This protocol tests the ability of 
the carbon dioxide absorbent canister to absorb high rates of exhaled 
carbon dioxide and the accompanying breathing pressures at a high 
ventilation rate, due to both the canister and the demand valve. 
Reducing the work rate after 5 minutes reflects human physiological 
limits while examining the performance of the carbon dioxide absorbent 
in a low demand mode.
---------------------------------------------------------------------------

    \24\ Bink B. The physical working capacity in relation to 
working time and age. Ergonomics. January 1962;5:25-28.
---------------------------------------------------------------------------

    The work rates in the standard were not intended to simulate an 
escape. There are an infinite number of escape scenarios, ranging from 
walking at a very slow pace, feeling one's way out of the mine while 
impeded by heavy smoke and debris to running at speed or carrying an 
impaired victim. Given the impossibility of conducting representative 
simulations, NIOSH selected reasonable, scientifically-evaluated limits 
of likely human performance \25\ which are consistent with NIOSH's own 
laboratory experience.\26\ A well-established model developed by 
physiologists (the Bink-Bonjer curve) predicts that 95th percentile 
miners can maintain 3.0 liters/minute VO2 for 30 minutes and 
2.0 liters/minute VO2 for 160 minutes. Accordingly, the peak 
work rate value is set at 3.00 VO2, which reflects a very 
high work rate attainable by an average adult. The high work rate is 
set at 2.00 VO2, which represents a reasonably hard work 
rate. Longstanding laboratory testing of respirator users by NIOSH 
supports this work rate, which is expected to exceed the work rate 
experienced by users during escape under oxygen.\27\ The low work rate 
is set at 0.50 VO2, which represents a sedentary rate. NIOSH 
laboratory testing experience also supports this work rate, which is 
expected during escape under oxygen when the wearer is sedentary, as if 
awaiting rescue. With regard to the conduct of empirical studies, NIOSH 
has not conducted further research as suggested.
---------------------------------------------------------------------------

    \25\ See U.S. Air Force School of Aerospace Medicine. Physical 
fitness status of USAF firefighters. Final Report ESL-TR-86-05; 
1986. U.S. Bureau of Mines. Biomechanical and work physiology study 
in underground mining excluding low coal. Final Contract Report 
J0308058; July 1984.
    \26\ Kyriazi N. Proposal for certification tests and standards 
for closed-circuit breathing apparatus. Pittsburgh, PA: U.S. 
Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health; 1999. DHHS (NIOSH) Publication No. 
99-144, IC 9449.
    \27\ Kyriazi N. Proposal for certification tests and standards 
for closed-circuit breathing apparatus. Pittsburgh, PA: U.S. 
Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health; 1999. DHHS (NIOSH) Publication No. 
99-144, IC 9449.
---------------------------------------------------------------------------

    The performance test requirements are suitable for Cap 1 units and 
do not require a specialized test sequence. As discussed above, the 
purpose of the performance test is to ensure that an apparatus is able 
to provide life support to a user at high work rates for

[[Page 14180]]

reasonable lengths of time, and to draw into use all the components of 
the apparatus that could be activated by a user, in order to ensure 
that stressor levels do not exceed human tolerances. If an apparatus 
contains 
minute VO2) in order to evaluate the characteristics of the 
relief valve.
    The 1-minute average carbon dioxide measurement will not be tested 
cumulatively over the duration of multiple units; carbon dioxide cannot 
accumulate during testing and skew the test results, as suggested by 
one commenter. If the first unit tested fails to scrub carbon dioxide 
within the first minute at a 3-liter per minute demand, it will not 
pass the test; testing will conclude at that point, eliminating the 
need for multiple units.
    With respect to the comment that Cap 1 and Cap 2 devices would have 
to be larger than currently available devices to perform adequately 
under the proposed work rates for capacity testing, HHS does not 
believe this is accurate. At least one currently approved device meets 
the capacity requirements specified for a Cap 1 rating. This also 
suggests that higher capacity devices intended for the Cap 2 and Cap 3 
ratings would also not need to be larger than currently approved 
devices and certainly manufacturers have market incentive to minimize 
size and weight at any given capacity.
3. Hypoxia
    Comment: One commenter supported the proposed hypoxia testing, but 
requested that HHS address the problem posed by the utilization of 
units of different designs on user proficiency. Another stated that the 
hypoxia test could not be conducted on designs that include an initial 
oxygen starter, and suggested that the rule follow the hypoxia test 
with activation of the starter. Finally, a commenter opposed the 
hypoxia test on the grounds that the expectation by NIOSH that some 
users would exhale into a unit in opposition to manufacturer 
instructions, is an ``arbitrary assumption.'' This commenter also 
stated the performance test should be conducted in accordance with 
approved donning procedures for chemical oxygen units, including cold 
start procedures without the use of oxygen starters.
    Response: HHS does not have authority to govern whether CCERs from 
multiple manufacturers or otherwise of different designs can be used in 
a single locale or workplace, although the Department does recognize 
that problems can arise from this situation. The assumption that some 
users will inappropriately exhale into a CCER upon donning it or in an 
attempt to improve its performance is not arbitrary, and is supported 
by evidence from actual practice during emergencies. For example, in 
the MSHA investigation report on the Greenwich Collieries Number 1 mine 
explosion of 16 February 1984, the miners were asked the general 
question, ``Did you have any problems breathing after you put on the 
self-rescuer?'' Their testimony provides evidence that (1) some users 
do fill up the breathing bag apparatus with exhaled air, and (2) some 
users attempt to escape at an oxygen consumption rate higher than the 
apparatus' constant flow rate, which together cause the hypoxia 
scenario evaluated in the performance test. In the Department's 
judgment, it is important to evaluate the potential for the user to 
experience hypoxia. HHS is retaining the requirement that the 
performance test will begin with two exhalations and then follow the 
manufacturer's instructions, and has clarified in the rule text that 
the hypoxia test will be conducted upon initial donning.
    NIOSH does agree with the commenter that the performance test 
should evaluate the ability of chemical oxygen units to function using 
a cold (manual) start procedure. Accordingly, NIOSH will begin the 
hypoxia test with sufficient breaths to start chemical units without 
the benefit of their oxygen starters. Since not all CCER designs employ 
oxygen starters and this is a very specific testing protocol detail, it 
is not specified in the rule text.

N. Section 84.306 Wearability Test Requirements

    Comment: HHS received three comments addressing wearability 
testing: One suggested that test subjects should receive instruction in 
the use of the CCER prior to testing their ability to don it within the 
30-second limit. The other two comments requested that HHS address the 
potential need to ``cold-start'' a second unit when transitioning 
between units while in a toxic environment. Cold starting means 
exhaling sufficiently into a unit to stimulate the oxygen supply when 
the oxygen starter has malfunctioned.
    Response: The intent of the provision of concern is to ensure that 
the CCER can be donned and fully functional (under oxygen) within 30 
seconds. Test subjects will be provided with the manufacturer's 
instructions for donning and will be trained in their use, but an 
integral part of this test will be to observe the effectiveness of the 
supplied instructions; therefore, NIOSH will not supplement the 
manufacturer's instructions with any further information.
    A cold start is an aberrant situation but may not be a critical 
failure; depending on the system design, the CCER may still provide 
protection even if the user has to take additional steps to stimulate 
an increase in the level of oxygen supply. Nevertheless, this 
wearability test will require that CCERs that make use of oxygen 
starters can be donned and operational within the 30-second limit, 
irrespective of whether the oxygen starter functions.

O. Section 84.307 Environmental Treatments

    Comment: HHS received one general comment suggesting that evidence 
to support the proposed environmental treatments is lacking. The same 
commenter noted that the proposed rule does not address the 
environmental conditions in other industrial applications aside from 
mining.
    Response: The environmental treatments are not intended to be 
accelerated aging tests or to replicate the most severe field 
conditions in which units might be deployed. The purpose of these 
treatments is to expose CCERs to realistically harsh conditions 
representative of many industrial applications in order to assess that 
they are reasonably robust for their intended uses. HHS believes that 
these treatments are adequate for this purpose.
1. Humidity
    Comment: Two comments recommended adding a test of humidity 
resistance.
    Response: NIOSH will conduct a review to examine potential impact 
of humidity on CCER capacity or performance. If the review indicates 
that humidity degrades certain CCER designs within their expected 
service life, then HHS would consider further rulemaking to add such a 
requirement. Until such time, purchasers could use their acquisition 
processes to require humidity testing by manufacturers of designs they 
purchase, or conduct such testing through an independent testing 
laboratory, should they be concerned

[[Page 14181]]

about the potential impact of humidity in the environments where their 
CCERs are stored and worn.
2. Temperature
    Comment: HHS received one comment asking for clarification on 
whether the extreme temperature storage test is designed to evaluate 
the effect of temperature shock by changing the test temperature 
applied to the CCER from one extreme temperature immediately to the 
other (hot to cold or cold to hot). This commenter suggested allowing 
the units to return to room temperature between testing steps.
    Response: HHS agrees with the suggestion and has adopted it in the 
final rule. NIOSH did not intend to simulate temperature shock, which 
is not an expected environmental condition.
3. Shock
    Comment: HHS received two comments regarding shock testing of CCER 
units. One commenter sought clarification regarding which six 
orientations are to be tested, and recommended that a diagram be 
included in the final rule. The second commenter requested 
clarification regarding whether the shock testing should be conducted 
with units packed in their stowage containers, or whether the testing 
is meant to simulate the unit being dropped while being removed from 
its packaging.
    Response: The intent of the requirement is to test the CCER along 
its three principal axes: Top to bottom, left to right, and front to 
back. HHS has revised the text in the final rule to clarify the 
definition of these axes.
    NIOSH intends for testing to be conducted in the packaging 
condition designed by the applicant for individual use while deployed. 
If the CCER is provided within a container intended for storage, versus 
the state in which it is worn on a belt, carried, or transported by the 
user, the unit would be removed from the storage container. The text of 
the final rule reflects this intent.
4. Vibration
    Comment: HHS received one comment suggesting that vibration testing 
to high frequencies is not relevant if CCERs are properly stored or 
worn.
    Response: HHS has retained the vibration testing in the final rule 
because CCERs deployed in the mining environment experience such 
vibration when set on or near certain mining equipment (e.g. continuous 
miners, mantrips). Exposure to vibration would also be expected in 
association with engines and other machinery on ships and in tunneling 
and other underground construction and maintenance operations as well 
as during the transportation of CCERs.

P. Section 84.308 Additional Testing

    Comment: Three comments were received regarding issues not 
addressed in the proposed rule: Fire hazard attributable to the use of 
potassium superoxide and chlorate candles in chemical oxygen units.
    Response: With regard to the potassium superoxide and chlorate 
candles used in some chemical oxygen units, while NIOSH is aware of the 
potential for this chemical to create a hazard, experience with CCERs 
has shown that such hazards are generally created by misuse or 
mishandling of a device. Potassium superoxide is not known to pose a 
hazard to the individual when the unit is properly worn on a belt, but 
has been known, for example, to ignite upon being crushed by mining 
machinery. Use of CCER designs that employ potassium superoxide and 
chlorate candles is not within the purview of HHS; HHS is not 
authorized to address safety issues related to the proper transport and 
storage of these respirators.
    Comment: HHS received five comments regarding the provisions for 
eye protection. Two supported the proposed standards; two suggested 
that impact-resistant eye protection is not supported by end users and 
would increase the size of CCER units. A final commenter requested that 
goggles meet the high impact and flammability requirements of ANSI 
Z87.1-2003 Occupational and Educational Personal Eye and Face 
Protection Devices for maritime applications.
    Response: All manufacturers provide eye protection with currently 
certified 1-hour CCERs. The requirement for reasonable durability 
according to the cited consensus standard (Sub-clause 3.1 of ISO 
4855:1981, Personal Eye Protectors--Non-Optical Test Methods) is 
appropriate for the potentially physically challenging conditions while 
CCERs are belt-worn and during their use for an escape. NIOSH does not 
expect that compliance with this consensus standard would result in an 
increase in the size of the eye protection or, consequently, the CCER 
units in which they are stored.
    HHS does not find that the high impact and flammability 
requirements of ANSI Z87.1-2003 are relevant to most escape scenarios. 
Under particular use conditions, more stringent performance 
requirements could be specified in the acquisition process if deemed 
necessary by the purchaser.
    HHS has made clarifications to the text of Sec.  84.308(c)(3) and 
(4) which indicate the intent of the durability and fogging tests. It 
is imperative for the users' vision to be unimpeded by the eye 
protection when attempting to use the respirator for an escape.

Q. Section 84.309 Additional Testing and Requirements for Dockable 
CCERs

    Comment: One comment submitted to HHS supported the intent behind 
the dockable CCER provisions but was concerned that the provisions were 
not extensive enough. In particular, the commenter recommended HHS 
``force'' the introduction of this new technology for use in the mining 
industry.
    Response: The proposed provisions for dockable CCERs have been 
retained in the final rule. These provisions cover the apparent 
potential technical concerns associated with such technology that HHS 
has been able to identify. The use of this technology in mining is not 
regulated by HHS. Accordingly, this final rule includes provisions that 
will allow the approval of such devices, but does not include 
provisions to force the development of this technology and its 
introduction into the mining industry.

R. Section 84.310 Post-Approval Testing

    Comment: HHS received various comments on post-certification 
testing of deployed CCERs. One commenter encouraged HHS to expand the 
program. Another supported the program but suggested that the 
government should not be obligated to replace units that it tests. In 
relation to the replacement of CCERs obtained by NIOSH for post-
approval testing, another commenter questioned the ramifications of a 
manufacturer's decision to discontinue production of a certain unit, 
and whether manufacturers would be required to produce more of the 
discontinued units to replace those tested. Another commenter suggested 
that field evaluations do not accurately demonstrate the extent of 
problems associated with respirators in field, and suggested that at 
least 3 percent of all deployed units be tested at random. A final 
commenter suggested that the text of the rule specify that only units 
passing user inspection criteria should be examined in the post-
certification testing.
    Response: HHS has specified in the final rule under Sec.  84.310(f) 
that manufacturers who discontinue a particular line of respirators 
selected for field evaluation can replace those units

[[Page 14182]]

with similar, NIOSH-approved CCERs. HHS does not intend for the 
replacement requirement to create any barriers to the market exit of a 
discontinued product. Furthermore, NIOSH would continue to purchase 
replacement units, as currently practiced and proposed. The cost of 
these field evaluations, which are carried out as part of the research 
and assurance function of the NIOSH respirator certification program, 
would not be appropriate to impose on CCER owners. NIOSH believes this 
life-cycle evaluation (inspection and testing) program, as enhanced by 
the provisions of this final rule, will continue to be an effective 
method for the early identification of possible problems in these 
respirators after deployment.
    NIOSH randomly selects deployed CCER units for testing. The 
availability of resources has determined and will continue to determine 
the sample size. The evaluations select units from the field that are 
identified by the employer as having passed user inspection criteria; 
furthermore, the NIOSH evaluation itself begins with application of 
these same inspection criteria.

III. Summary of the Rule

    This rule establishes new requirements for testing and approval of 
CCERs under a new Subpart O of 42 CFR Part 84--Approval of Respiratory 
Protective Devices. The new subpart replaces all current requirements 
for testing and approval of CCERs found under Subpart H. The following 
is a section-by-section summary which describes and explains the 
provisions of the rule. The complete, final regulatory text is provided 
in the last section of this notice.
    In the summary below, HHS indicates the changes made in provisions 
of this rule since the notice of proposed rulemaking. These occur under 
Sec. Sec.  84.300, 84.301, 84.302, 84.304, 84.307, 84.308, and 84.310.

A. Subpart O--Closed-Circuit Escape Respirators

1. Section 84.300 Closed-Circuit Escape Respirator, Description
    This section provides a general description of the CCER as a class 
of respirator. It is intended to inform the public and to serve as a 
legal and practical definition for the purposes of the NIOSH and MSHA 
respirator approval program. In response to public comments, the 
definition of CCER now includes a brief description of respirator uses 
in the maritime and railroad industries, in addition to underground 
coal mining.
2. Section 84.301 Applicability to New and Previously Approved CCERs
    This section establishes a 3-year period for continued manufacture 
and labeling of CCERs approved under the current regulations and sold 
by manufacturers in order to phase-in the implementation of the testing 
and approval requirements of this final rule. This provision, which is 
changed slightly from the proposed rule, allows respirator 
manufacturers a reasonable period of time to modify existing CCER 
designs, if necessary, or to develop entirely new designs that respond 
to the new testing and certification requirements. It also ensures that 
during the interim, a constant supply of approved CCERs will remain 
available for purchase. The new requirements will be applied to all new 
CCER designs that are submitted for approval after the effective date 
of this rule. Manufacturers may continue to manufacture and label as 
NIOSH-approved and sell CCERs with current approvals for up to 3 years 
after the effective date.
    As discussed in the public comment section of the preamble above, 
HHS has eliminated from the final rule the proposal that currently 
approved CCERs be re-approved under the new requirements of this final 
rule to retain their approval beyond a 6-year grandfather period. CCERs 
with current approvals that are already deployed or are manufactured 
and labeled NIOSH-approved within the 3-year phase-in period will 
remain as NIOSH-approved devices until the conclusion of their service 
life.
3. Section 84.302 Required Components, Attributes, and Instructions
    This section specifies the components, attributes, and instructions 
required for each CCER. Some of these requirements simply continue the 
current Subpart H requirements, including the requirements for eye 
protection (paragraph (a)(1)); oxygen storage vessel (paragraph 
(a)(4)); and general construction (paragraph (c)).
    Paragraph (a)(2) requires that manufacturers include thermal 
exposure indicators to allow a person to determine whether the unit has 
been exposed to temperatures that exceed any temperature storage limits 
specified by the manufacturer. Currently, one manufacturer includes 
such indicators in response to NIOSH evaluations finding that 
exceptionally low and high storage temperatures degrade the 
functionality and performance of certain CCER designs. Adverse effects 
of low temperature storage on current products are reversible, but high 
storage temperatures can damage critical internal CCER components, as 
documented in the manufacturers' service life plans. There must be a 
means to detect and replace units exposed to such storage conditions.
    Paragraph (a)(3) requires that manufacturers include a means by 
which a person can detect any damage or alteration of the chemical 
oxygen storage or chemical carbon dioxide scrubber that could diminish 
the NIOSH-certified performance of the unit or pose a hazard to the 
user. These chemical components of CCERs, as presently designed, are 
susceptible to such degradation.\28\ Two manufacturers currently design 
their CCERs with a means of detecting such damage.
---------------------------------------------------------------------------

    \28\ Kyriazi N, Shubilla JP. Self-contained self-rescuer field 
evaluation: seventh-phase results. Pittsburgh, PA: U.S. Department 
of Health and Human Services, Centers for Disease Control and 
Prevention, National Institute for Occupational Safety and Health; 
March 2002. DHHS (NIOSH) Publication No. 2002-127, RI 9656.
---------------------------------------------------------------------------

    Paragraph (a)(4) maintains an existing requirement under Subpart H 
that if a CCER includes an oxygen storage vessel, the vessel must be 
approved by the U.S. Department of Transportation (DOT) under 49 CFR 
Part 107: ``Hazardous Materials Program Procedures,'' unless exempted 
under Subpart B of the DOT regulation.
    Paragraph (a)(5) requires that manufacturers design and construct 
the protective casing of the CCER to prevent the user from accidentally 
opening it and to prevent or clearly indicate its prior opening, unless 
the CCER casing were designed for such openings, for inspection or 
purposes other than use in an actual escape. These protections are 
needed because the opening and re-closing of a unit not designed for 
such operations, and the replacement of parts not intended for 
replacement, can damage the unit and degrade its performance. NIOSH has 
investigated circumstances in which units were opened and modified by 
unauthorized persons, effectually altering the design from the version 
that received NIOSH testing and certification.\29\
---------------------------------------------------------------------------

    \29\ Kyriazi N, Shubilla JP (2000). Self-contained self-rescuer 
field evaluation: sixth-phase results. Pittsburgh, PA: U.S. 
Department of Health and Human Services, Public Health Service, 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health; July 2000. DHHS (NIOSH) Publication 
No. 2000-128, RI 9451.
---------------------------------------------------------------------------

    Paragraph (a)(6) requires that manufacturers include a means to 
detect the ingress of any water or water vapor that could degrade the 
performance of the unit, unless the CCER was designed for its casing to 
be opened for frequent inspection. Because the chemical

[[Page 14183]]

components of CCERs are especially susceptible to damage or degradation 
from moisture, the user must be able to readily and reliably check a 
unit for potential water damage before each work shift.
    Paragraph (a)(7) is new (as discussed above), and requires that 
manufacturers provide a means to detect damage or deficiencies to units 
with oxygen starters if they are a component critical to the 
satisfactory performance of the CCER.
    Paragraph (b) requires that an indicator must clearly and 
unambiguously indicate the occurrence of the monitored condition.
    Paragraph (c) requires that manufacturers provide NIOSH with 
information about indicators, where they are required, to enable 
thorough evaluation by NIOSH. Such information should include an 
explanation of the operation and function of the indicator, data 
generated by the manufacturer, and any equipment or special devices 
used by the manufacturer to develop or test the indicators.
    Paragraph (d) mandates that CCER components must meet the general 
construction requirements in Sec.  84.61.
    Paragraph (e) requires that manufacturers construct the CCER to 
protect the user from inhaling most toxic gases that might occur in a 
work environment during an escape. To ensure such gases cannot readily 
penetrate the breathing circuit of the CCER during its use, NIOSH will 
test the integrity of the CCER breathing circuit by following the 
gasoline vapor test procedure for breathing bags available from the 
NIOSH Web site http://www.cdc.gov/niosh/npptl. The test will be 
conducted on a single CCER unit.
    The specified gasoline vapor test provides reasonable assurance 
that the breathing gas supply of the user will be protected from 
atmospheres that include hazardous vapors possibly associated with 
escapes from mines and most other enclosed or confined spaces. The 
proposed requirement for this testing is not new. It is included under 
Subpart H of this part (Sec.  84.85) for all self-contained breathing 
apparatus (the class of respirators to which CCERs belong) currently 
approved by NIOSH.
    Paragraphs (f) and (g) require that the design, construction, and 
materials of CCERs not introduce combustion or other unspecified safety 
or health hazards.
    In response to public comments, paragraph (h) requires that 
manufacturers provide purchasers with instructions, rather than 
requiring instructions to accompany each individual unit, as was 
proposed in the notice of proposed rulemaking. A service life plan must 
accompany each application to NIOSH for CCER approval. These 
requirements generally reflect current practice.
    In response to the public comment regarding labeling, paragraph (i) 
requires manufacturers to identify on each CCER approval label the 
capacity rating and number of liters of oxygen as determined by NIOSH 
through capacity testing.
4. Section 84.303 General Testing Conditions and Requirements
    This section establishes the general testing conditions and 
requirements for the approval of CCERs.
    Paragraph (a) specifies that NIOSH will use the breathing and 
metabolic simulator tests specified in this subpart for all 
quantitative evaluations of the performance of a CCER. NIOSH will use 
human subject tests for qualitative evaluations, which include 
evaluations of the ``wearability'' of the CCER design (e.g., ergonomic 
considerations concerning its practical impact on the user's escape).
    Breathing and metabolic simulators are mechanical devices that 
simulate human respiratory functions.\30\ They allow for precisely 
controlled and monitored tests, whereas comparable testing conducted 
using human subjects on a treadmill involves substantial variability 
with respect to one or more metabolic parameters. The use of these 
simulators to evaluate respirator performance has been validated by 
NIOSH through a series of MSHA peer-reviewed studies over the past 20 
years.\31\ These studies, which include side-by-side comparisons using 
three-person panels of human subjects on treadmills against testing 
using an ABMS, demonstrate that the simulator replicates the 
performance of human subjects with respect to all important metabolic 
variables, including oxygen consumption rate, average rates of carbon 
dioxide production, ventilation rates, respiratory frequencies, 
respiratory temperatures (dry- and wet-bulb), and breathing pressures. 
An advantage of the simulators is that their performance for all 
metabolic parameters can be calibrated and replicated, whereas each 
human test subject performs uniquely, making the testing more difficult 
to replicate.
---------------------------------------------------------------------------

    \30\ Kyriazi N. Development of an automated breathing and 
metabolic simulator. Pittsburgh, PA: U.S. Department of the 
Interior, Bureau of Mines; 1986. IC 9110.
    \31\ Kyriazi N, Kovac JG, Shubilla JP, Duerr WH, Kravitz J. 
Self-contained self-rescuer field evaluation: first-year results of 
5-year study. Pittsburgh, PA: U.S. Department of the Interior, 
Bureau of Mines; January 1986. RI 9051.
    Kyriazi N, Shubilla JP. Self-contained self-rescuer field 
evaluation: results from 1982-1990. Pittsburgh, PA: U.S. Department 
of the Interior, Bureau of Mines; January 1992. RI 9401.
    Kyriazi N, Shubilla JP. Self-contained self-rescuer field 
evaluation: fourth-phase results. Pittsburgh, PA: U.S. Department of 
the Interior, Bureau of Mines; January 1994. RI 9499.
    Kyriazi N, Shubilla JP. Self-contained self-rescuer field 
evaluation: fifth-phase results. Pittsburgh, PA: U.S. Department of 
Energy; December 1996. RI 9635.
    Kyriazi N, Shubilla JP. Self-contained self-rescuer field 
evaluation: sixth-phase results. Pittsburgh, PA: U.S. Department of 
Health and Human Services, Public Health Service, Centers for 
Disease Control and Prevention, National Institute for Occupational 
Safety and Health; July 2000. DHHS (NIOSH) Publication No. 2000-128, 
IC 9451.
    Kyriazi N, Shubilla JP. Self-contained self-rescuer field 
evaluation: seventh-phase results. Pittsburgh, PA: U.S. Department 
of Health and Human Services, Centers for Disease Control and 
Prevention, National Institute for Occupational Safety and Health; 
March 2002. DHHS (NIOSH) Publication No. 2002-127, RI 9656.
---------------------------------------------------------------------------

    Manufacturers and others who would wish to duplicate NIOSH 
breathing and metabolic simulators in their own testing facilities can 
obtain technical specifications from NIOSH. General, non-proprietary 
information on the design and operation of the simulators is also 
available from the NIOSH Web site: http://www.cdc.gov/niosh/npptl.
    Paragraph (b) specifies that 4 stressors will be monitored 
constantly throughout testing: The average concentrations of inhaled 
carbon dioxide and oxygen, peak breathing pressures at inhalation and 
exhalation, and the wet-bulb temperature (the temperature of inhaled 
breathing gas as would be? sensed by the CCER user's trachea). 
Paragraph (d) establishes that CCERs must perform within the acceptable 
ranges of measurement specified in Table 1 below.
---------------------------------------------------------------------------

    \32\ Wet-bulb temperature is a measurement of the temperature of 
a wet surface. It represents the temperature of the inhaled 
breathing gas in the CCER user's trachea.

[[Page 14184]]

                            Table 1--Monitored Stressors and Their Acceptable Ranges
----------------------------------------------------------------------------------------------------------------
             Stressor                Acceptable range operating  average         Acceptable range excursion
----------------------------------------------------------------------------------------------------------------
Average inhaled CO2..............  19.5%................................  >=15%.
Peak Breathing...................  [Delta]P 2O for only a short period of time.\38\ Based on NIOSH 
findings from testing escape respirators, the 200 mm average operating 
requirement provides a tolerable limit for the duration of an escape. 
Use of these values as limits will allow most CCER users to escape 
without any constraint on their level of exertion. Users who cannot 
generate these pressures may be forced at some point to slow the pace 
of their escape.
---------------------------------------------------------------------------

    \38\ Hodgson JL. Physiological costs and consequences of mine 
escape and rescue. University Park, PA: The Pennsylvania State 
University. U.S. Bureau of Mines contract No. J0345327; 1993:19.
---------------------------------------------------------------------------

    In addition to establishing these stressor limits for testing, this 
section provides under paragraph (c) that capacity and performance 
tests conclude when the stored breathing gas supply has been fully 
expended. This is important because the adequacy of the performance of 
a CCER depends upon the user clearly recognizing when the breathing gas 
supply is expended. High carbon dioxide levels can deceive the user 
into believing the respirator is not working and hence to prematurely 
abandon use of the CCER during an escape. Designing CCERs so that 
carbon dioxide levels are controlled until the oxygen supply is fully 
expended will help ensure that a user can make use of all of the 
available oxygen.
    This section also provides under paragraph (d)(2) that a CCER will 
fail a wearability test if a human subject cannot complete the test for 
any reason related to the CCER. Any design, construction, or 
performance attribute of a CCER that prevents a user from completing 
the wearability test will threaten the successful use of the CCER for 
an escape.
5. Section 84.304 Capacity Test Requirements
    This section specifies the testing regime that will be used to rate 
and quantify the capacity of the CCER, in terms of the volume of oxygen 
that the respirator provides to the user. It ensures the CCER will 
provide the quantity as measured in the NIOSH testing as a constantly 
adequate supply of breathing gas, in terms of the stressors addressed 
in Sec.  84.303 of this part. The capacity will be evaluated in terms 
of

[[Page 14185]]

the volume of oxygen, in liters, that the CCER effectively delivers for 
consumption by the user. All volumes are given at standard temperature 
(0 [ordm]C) and pressure (760 mm Hg), dry, unless otherwise noted. This 
capacity can differ from the volume of oxygen stored by the CCER, some 
of which may be wasted rather than inhaled by the user, depending on 
the particular design of the CCER and the work rate of the user. A CCER 
will operate for a shorter duration when the oxygen consumption rate is 
high. Hypothetically, a 190-pound man, at rest, is estimated to consume 
a volume of oxygen of .5 liters per minute. If he were walking in an 
upright position at 3 miles per hour, it is estimated that he could 
consume 1.18 liters per minute. The same man running in an upright 
position at 5 miles per hour is estimated to consume 2.72 liters per 
minute.\39\
---------------------------------------------------------------------------

    \39\ Kamon E, Bernard T, Stein R. Steady state respiratory 
responses to tasks used in Federal testing of self-contained 
breathing apparatus. AIHAJ. 1975;36:886-896.
---------------------------------------------------------------------------

    A 3-capacity ratings system is established in this section: ``Cap 
1--Cap 3.'' Cap 1 provides 20 to 59 liters of oxygen for short escapes 
that could be accomplished quickly; Cap 2 provides 60 to 79 liters for 
escapes of moderate distance; and Cap 3 provides 80 or more liters for 
the lengthiest escapes. The 3 capacity ratings correspond to the liter 
quantities of breathing gas supplies that are expended during the NIOSH 
capacity testing within approximately 10, 30, and 60 minutes, 
respectively.
    The Cap 3 rating is comparable to the current NIOSH-certified 60-
minute rating for CCERs; 10-minute units provide approximately 25 
liters of oxygen, comparable to a Cap 1. The oxygen consumption rate 
associated with this rating is the average rate demonstrated through 
NIOSH testing of the 50th percentile miner by weight (191 pounds) 
performing the 1-hour ``man test 4.'' \40\ The test is a series of 
laboratory-based physical activities similar to those involved in coal 
mine rescues and escapes, including vertical treadmill climbs, walks, 
runs, and carries and pulls of substantial weights. As discussed under 
II(C), however, the duration of adequate breathing gas supply actually 
provided to a user by a respirator of a given capacity rating will 
depend on the degree of exertion involved in the particular escape and 
the size of the respirator user. For this reason, as discussed under 
II(C), NIOSH believes the change from a certification based on duration 
to one based on capacity is important. Using the hypothetical example 
of the 190-pound man above, the following table provides a set of 
possible use durations for illustrative purposes. These are calculated 
based on a consideration of limited factors and ideal use conditions 
and would be unlikely to match actual durations achieved by users in 
actual or simulated escapes.
---------------------------------------------------------------------------

    \40\ See 42 CFR 84.100, Table 4 for the specific requirements of 
man test 4.

                                                              Capacity Versus Work Activity
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Capacity 1  (20 liters)                Capacity 2  (60 liters)               Capacity 3  (80 liters)
--------------------------------------------------------------------------------------------------------------------------------------------------------
At Rest..............................  40 minutes...........................  120 minutes.........................  160 minutes.
(.5 L/minute)........................
Run at 3 mph.........................  17 minutes...........................  51 minutes..........................  68 minutes.
(1.18 L/minute)......................
Run at 5 mph.........................  7 minutes............................  21 minutes..........................  28 minutes.
(2.72 L/minute)......................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In addition to having a capacity rating system to categorize 
products, manufacturers will use the actual tested capacity of approved 
respirator models, which NIOSH will report to the manufacturer in 
increments of 5 liters, to specify more precisely the capacity of each 
product. This will enable employers to readily compare differences in 
respirator capacity within a given rating, more closely match a 
respirator model to their particular needs, and choose the respirator 
model that best serves their employees. For example, an employer might 
determine through simulation of escapes that employees will need a Cap 
3 CCER model that provides 95 liters to allow for the worst 
contingencies. Alternatively, an employer might determine that a Cap 3 
model that provides 80 liters is sufficient and better designed, in 
terms of physical dimensions or operational characteristics, to 
accommodate the routine work tasks and escape contingencies of the 
employees.
    The capacity testing will evaluate seven CCER units using the 
breathing and metabolic simulator. Three will be tested in the 
condition received from the applicant (i.e., ``new'' condition), two 
will receive environmental treatments prior to capacity testing, and 
the remaining two units will be tested at the cold-temperature limit 
specified by the manufacturer, after being stored at the specified 
temperature.
    Each unit will be tested at the work rate identified in Table 2 
below, according to the capacity level designated by the applicant. In 
terms of the rate of oxygen usage, carbon dioxide production, 
ventilation rate, and respiratory frequency, the work rates are 
representative of the average work rate that the typical CCER user 
might sustain during an escape, based on laboratory physiological 
testing involving miners.\41\ As Table 2 shows, the greater the 
capacity of the CCER, the lower the work rate that would be used to 
test the CCER, reflecting the lower average rate of exertion that the 
typical user would be capable of sustaining for escapes of longer 
duration. Low capacity devices are likely to be used for short, very 
challenging escapes that would induce exceptionally high work rates. 
NIOSH finds it is appropriate to apply a work rate that represents the 
level of exertion sustainable by a typical user while using a device of 
a particular capacity. Hence, NIOSH specifies such an approach in this 
rule.
---------------------------------------------------------------------------

    \41\ Kamon E, Bernard T, Stein R. Steady state respiratory 
responses to tasks used in Federal testing of self-contained 
breathing apparatus. AIHAJ. 1975;36:886-896.
---------------------------------------------------------------------------

    One of the units submitted will be tested by a human subject on a 
treadmill. The purpose of this human test is to provide assurance that 
the simulator is reasonably measuring the capacity of the respirator as 
it would be expended in actual use.

[[Page 14186]]

                                       Table 2--Capacity Test Requirements
----------------------------------------------------------------------------------------------------------------
                                                                VO2  (L/    VCO2  (L/                RF (Breaths/
           Capacity rating              Capacity  (L of O2)       min)         min)     Ve  (L/min)      min)
----------------------------------------------------------------------------------------------------------------
Cap 1...............................  20 = 80...............         1.35         1.15           30           18
----------------------------------------------------------------------------------------------------------------
VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute.
Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

    In addition to this standard testing regime to be used for all 
CCERs, when testing CCER models to be co-approved with MSHA for use in 
coal mines, NIOSH will also continue to conduct the appropriate man 
test 4 protocol discussed above for determination of the suitability of 
these CCERs to be used in U.S. underground coal mines. This testing is 
the same as is required under the current 42 CFR Part 84 regulations. 
The Federal Mine Safety and Health Act requires that ``no mandatory 
health or safety standard * * * shall reduce the protection afforded 
miners by an existing mandatory health or safety standard.'' \42\ The 
use of the capacity rating system and associated tests to approve 
equipment for use in underground coal mines will not constitute a 
reduction in protection or a reduction in the duration of breathing 
supply regulated under the current MSHA duration requirements for self-
contained self-rescuers. Nevertheless, NIOSH and MSHA agree that the 
continued use of man test 4, as a supplement to the final new testing 
requirements and capacity rating system, will be the most practical 
method demonstrating such compliance with the cited provision of the 
Federal Mine Safety and Health Act. The Cap 3 unit approved for use in 
mining also meets the 1-hour requirement and the Cap 1 and Cap 2 units 
approved for use in mining also meet no less than the 10-minute 
requirement under MSHA's existing standards.
---------------------------------------------------------------------------

    \42\ 30 U.S.C. 811(a)(9).
---------------------------------------------------------------------------

6. Section 84.305 Performance Test Requirements
    This section specifies the performance testing regimen that will be 
used to certify the ability of the CCER to provide a constantly 
adequate breathing supply for the user immediately upon donning and 
under varied work rates, including a level representative of peak 
demand and minimal demand. The high work rates used during the test 
will activate the demand valve, if present in the CCER model, and 
stress the carbon dioxide absorbent. The low work rate would activate 
the relief valve, if present. The test includes a procedure (immediate 
exhalation into the unit upon donning) to evaluate the potential for 
the user to experience hypoxia (a deficient oxygen concentration) upon 
donning the CCER. Hypoxia could occur with a CCER using compressed 
oxygen and a demand valve if the user forces enough nitrogen into the 
breathing circuit to prevent the activation of the demand valve and the 
user had consumed more oxygen than the constant quantity supplied by 
the CCER. Such a situation is more likely to arise if a CCER user is 
not adequately trained in its use.
    Many CCER users are trained to exhale into a CCER upon donning it 
because this is the recommended practice for CCERs supplied with 
chemical oxygen if the oxygen starter fails. In an emergency, it is 
likely that some users will exhale into the CCER regardless of its 
design, in which case NIOSH needs to ensure that the respirator will 
perform adequately. For this reason, NIOSH is establishing a generic 
performance testing protocol, irrespective of CCER design, that 
includes the hypoxia testing procedure in which the test will begin 
with two exhalations into the unit at the specified ventilation rate 
and then follow the manufacturer's instructions to determine the 
design's susceptibility to hypoxia upon initial donning.
    The performance testing will evaluate CCER units using the 
breathing and metabolic simulator. Of these, three units will be tested 
in new condition, and two will receive environmental treatments prior 
to performance testing. The testing regimen will employ the following 
oxygen use-rate cycle: 3.0 liters per minute for 5 minutes, 2.0 liters 
per minute for 15 minutes, and 0.5 liters per minute for 10 minutes. 
Other parameters of the testing are specified in Table 3 below.

                                     Table 3--Performance Test Requirements
----------------------------------------------------------------------------------------------------------------
                                                   Duration
                                                  per cycle     VO2  (L/    VCO2  (L/                     RF
            Work-rate test sequence                  (in          min)         min)     Ve  (L/min)   (breaths/
                                                   minutes)                                              min)
----------------------------------------------------------------------------------------------------------------
1. Peak........................................            5         3.00         3.20         65.0           25
2. High........................................           15         2.00         1.80         44.0           20
3. Low.........................................           10         0.50         0.40         20.0           12
----------------------------------------------------------------------------------------------------------------
VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute.
Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

    The 3.0 liters per minute oxygen use-rate represents peak exertion. 
The 2.0 liters per minute oxygen use-rate is high, representing 
substantial exertion. The 0.5 liters per minute oxygen use-rate is very 
low, representing a sedentary person, such as a worker who might be 
trapped and awaiting rescue.\43\
---------------------------------------------------------------------------

    \43\ Turner N, Beeckman D, Hodous T. Evaluation of proposed 
methods to update human testing of self-contained breathing 
apparatus. AIHAJ. Dec. 1995;56:1195-1200.
     Louhevaara V, Tuomi T, Smolander J, et al. Cardiorespiratory 
strain in jobs that require respiratory protection. Int. Arch. 
Occup. Environ. Health. 1985;55:195-206.
    Lemon PW, Hermiston RT. The human energy cost of fire fighting. 
J. Occup. Med. Aug. 1977;19:558-562.

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

[[Page 14187]]

    The test will be started by the exhalation of two large breaths 
into the unit before donning it. This will determine the susceptibility 
of the CCER to hypoxia.
    Since the testing cycle requires 50 liters of oxygen, CCERs that 
have less than a 50 liter capacity will exhaust their capacity prior to 
completing a full cycle as specified. To accommodate this limitation, 
if a unit contains less than 50 liters of useable oxygen (as determined 
by the capacity test under Sec.  84.304), NIOSH will require the 
submission of additional units so that the test can be completed 
through the testing of a sequence of two or three units, as necessary. 
Such a requirement ensures that the CCER is tested at each work rate in 
its entirety. CCERs with greater than a 50 liter capacity will repeat 
the cycle until the oxygen supply is exhausted, as indicated in the 
graph below.
    One unit will be tested by a human subject on a treadmill. The 
purpose of the human subject test is to provide assurance that the 
respirator will perform effectively when responding to the more 
variable loading produced by a human subject.
[GRAPHIC] [TIFF OMITTED] TR08MR12.020

7. Section 84.306 Wearability Test Requirements
    This section specifies the testing regimen that will be used to 
ensure that the CCER can be easily and quickly donned. The testing 
procedures also ensure that during any reasonably anticipated activity, 
the CCER will not physically harm or significantly hinder the user and 
would provide an adequate and uninterrupted supply of breathing gas. 
Testing will be conducted using three human subjects of differing 
heights and weights,\44\ as specified, to provide reasonable assurance 
that the results would be representative of most potential CCER users.
---------------------------------------------------------------------------

    \44\ The size range is intended to be representative of 
respirator users. See: Zhuang Z and Bradtmiller B. Head-and-face 
anthropometric survey of U.S. respirator users. J. Occup. Environ 
Hyg. 2005;2:567-576.
---------------------------------------------------------------------------

    Subsection (b) requires that trained users be able to successfully 
don the CCER, initiating breathing through the device within 30 
seconds. This criterion, derived from current training requirements for 
the use of CCERs used in mining,\45\ is reasonably protective in the 
case of emergency scenarios involving an explosion or sudden detection 
of a hazardous breathing environment. This subsection allows NIOSH to 
determine whether any particular design, construction, or material 
characteristic of the CCER could hinder the user in the correct and 
timely donning of the CCER. These determinations may be made based on 
either the demonstrated ability of a human subject to don the CCER as 
required or the identification of plausible circumstances that would 
prevent the required timely donning.
---------------------------------------------------------------------------

    \45\ Vaught C, Brnich MJ, and Kellner HJ. Instructional mode and 
its effect on initial self-contained self-rescuer donning attempts 
during training. Pittsburgh, PA: U.S. Department of the Interior, 
Bureau of Mines; 1988. RI 9208.
---------------------------------------------------------------------------

    Subsection (c) and the table below specify the activities that will 
be performed by the human subjects to test the CCER. These activities 
are derived from the present regulations and represent the types of 
activities and physical orientations that may occur during escapes. The 
test will continuously monitor the CCER to ensure these activities and 
orientations do not adversely affect the adequacy of the CCER's supply 
of breathing gas and to identify any potential for the CCER to harm or 
hinder the user during an escape.

                 Table 4--Wearability Test Requirements
------------------------------------------------------------------------
                 Activity                         Minimum duration
------------------------------------------------------------------------
Sitting...................................  1 minute.
Stooped walking...........................  1 minute.
Crawling..................................  1 minute.
Lying on left side........................  1 minute.
Lying on right side.......................  1 minute.
Lying on back.............................  1 minute.
Bending over to touch toes................  1 minute.
Turning head from side to side............  1 minute (at least 10
                                             times).
Nodding head up and down..................  1 minute (at least 10
                                             times).
Climbing steps or a laddermill............  1 minute (1 step/second).
Carrying 50-lb bag on treadmill at 5 kph..  1 minute.
Lifting 20-lb weight from floor to an       1 minute (at least 10
 upright position.                           times).
Running on treadmill at 10 kph............  1 minute.
------------------------------------------------------------------------

8. Section 84.307 Environmental Treatments
    This section specifies the environmental treatments that will be 
administered to the CCER to ensure that it is reasonably durable and 
resistant to the potentially performance-degrading environmental 
factors of extreme storage temperatures, shock, and vibration.
    The extreme storage temperature test specified in subsection (b) is 
based on worst-case scenarios. For example, the high temperature (71 
[deg]C) test is based on

[[Page 14188]]

the temperature associated with storage in the trunks of vehicles. In 
response to public comments, units will be allowed to return to room 
temperature between steps.
    The shock test specified in subsection (c), which is a series of 1-
meter drops onto a concrete surface, is based on the height at which 
the respirator would be handled and attached to the user's belt. In 
response to public comments, the provision specifies that the shock 
test will be conducted on units in the casing in which they are 
deployed for individual use.
    The vibration test specified in subsection (d) is a composite test 
based on the vibration levels measured on the frames of underground 
longwall and continuous mining machines and on underground and surface 
haulage vehicles.\46\
---------------------------------------------------------------------------

    \46\ Dayton T. Brown, Inc. Environmental test criteria for the 
acceptability of mine instrumentation. Phase 1, Final Report 
DTB2GR80-0643. U.S. Bureau of Mines contract No. J0100040; June 
1980;72.
---------------------------------------------------------------------------

9. Section 84.308 Additional Testing
    This section specifies several other tests that NIOSH will conduct, 
as appropriate. Each unit tested must meet the conditions specified in 
the test to receive approval.
    Under subsection (b), NIOSH will perform safety hazard tests on any 
CCER that stores more than 200 liters of oxygen or that stores 
compressed oxygen at pressures exceeding 3,000 psi. None of the current 
1-hour CCER designs has such storage capacities. However, if such a 
design were submitted for approval, the applicant would have to provide 
an additional 15 units of the CCER for these additional tests. The 
specifications for the tests are provided in a series of Bureau of 
Mines reports referenced in the regulatory text.
    Under subsection (c), NIOSH will perform a series of tests on one 
or more units of every CCER submitted for approval to evaluate the 
effectiveness of the required eye protection (goggles or an escape hood 
lens) against dust, gas, and fogging that could impair the user's 
vision, as well as for durability. The tests proposed for dust and gas 
and durability were established by the International Organization for 
Standardization (ISO), a globally recognized consensus standard setting 
organization.\47\ The test for fogging was established by the European 
Committee for Standardization, a consensus standard-setting 
organization within the European Union.\48\ These specified tests, 
which are widely accepted by the safety and manufacturing communities, 
are incorporated by reference into this rule.
---------------------------------------------------------------------------

    \47\ ISO 4855:1981, Personal eye-protectors--Non-optical test 
methods. International Organization for Standardization. Clauses 13, 
14; Sub-Clause 3.1. Copies are available for inspection at NIOSH 
(see rule text for details) and for purchase from the ISO Web site 
at: http://www.iso.org/iso/catalogue_detail.htm?csnumber=10838. 
Accessed October 7, 2010.
    \48\ European Standard BS EN 168:2002, Personal eye-protection, 
Non-optical test methods. European Committee for Standardization. 
January 2002. Copies are available for inspection at NIOSH (see rule 
text for details) and for purchase from the BSI British Standards 
Web site at: http://shop.bsigroup.com/en/ProductDetail/?pid=000000000030036280. Accessed October 7, 2010.
---------------------------------------------------------------------------

10. Section 84.309 Additional Testing and Requirements for Dockable 
CCERs
    This section will provide for NIOSH to test and approve dockable 
CCERs, which are CCERs that would allow the user to resupply the 
breathing gas source included in the CCER through the attachment 
(docking) of breathing gas resupply sources that would be cached at 
locations along escape routes. Such dockable CCERs do not presently 
exist in the U.S. respirator market, but substantial interest in such 
technology has been expressed in the mining community, most recently in 
response to the Sago Mine disaster in 2006.\49\
---------------------------------------------------------------------------

    \49\ McAteer JD, et al. The Sago Mine disaster: a preliminary 
report to Governor Joe Manchin III. Buckhannon, West Virginia; July 
2006;14. http://www.wvgov.org/SagoMineDisasterJuly2006FINAL.pdf. 
Accessed October 7, 2010.
---------------------------------------------------------------------------

    Paragraph (a) specifies that NIOSH will conduct testing to ensure 
that the CCER user will be able to perform the docking process safely, 
reliably, and quickly under escape conditions. Precise testing 
protocols are not specified because they will depend on the technology, 
which has yet to be developed; test protocols will be posted on the 
NIOSH Web site once they are created. However, the provisions clearly 
specify the qualitative performance characteristics required for 
approval.
    Paragraph (b) provides that NIOSH will designate CCERs that meet 
the testing requirements of this section as ``Dockable.''
    Paragraph (c) provides that NIOSH will assign the capacity rating 
to the dockable CCER using only the breathing gas supply included for 
the initial use of the wearable apparatus. In other words, the capacity 
of the breathing gas resupply units will not be taken into account in 
rating the capacity of the CCER.
    Paragraph (d) provides that NIOSH test the breathing gas resupply 
units produced for the dockable unit and specify their capacities using 
capacity testing procedures consistent with those applied to testing 
the dockable CCER. This testing is necessary so that users have NIOSH 
verification of the capacity of the resupply units. The provision also 
provides for appropriate labeling to specify the capacity of the 
resupply unit and its compatibility with the CCER.
    Paragraph (e) provides that NIOSH will be able to require the 
applicant to provide additional units of the CCER for the additional 
testing associated with dockable units. NIOSH cannot determine at this 
time whether additional units will be needed.
    Paragraph (f) provides that NIOSH will not approve a CCER with 
docking components, even without the NIOSH ``Dockable'' designation, 
unless it satisfies the testing and other requirements proposed for 
approving dockable units. This provision is intended to avoid the 
plausible circumstance of users mistaking certified CCERs with docking 
components as having been approved by NIOSH as dockable.
11. Section 84.310 Post-Approval Testing
    This section provides for NIOSH to conduct periodic testing of 
deployed units of approved CCERs. The purpose of such post-approval 
testing is to evaluate the capacity and performance of the approved 
CCER after it has been subject to actual field conditions including 
operations, storage, and handling at worksites. NIOSH will obtain such 
units from employers in exchange for new units, substituted at no cost 
to the employer. NIOSH will require, as a condition of continued 
approval, that the applicant make available for purchase by NIOSH a 
sufficient number of new units (not to exceed 100 units annually) to 
support the post-approval testing program. On several occasions, NIOSH 
has been hampered by the lack of an available supply of a CCER model, 
either because the manufacturer produces the products intermittently or 
has ceased production permanently. In response to public comments, the 
rule allows manufacturers that discontinue a particular line of 
respirators selected for field evaluation to replace those units with 
similar, NIOSH-approved CCERs.
    If testing indicates that deployed units of a CCER are not 
consistently meeting the capacity and performance standards under which 
the CCER was approved, NIOSH will request remedial actions by the 
applicant. NIOSH will be authorized to revoke the approval of a CCER if 
the applicant does not remediate the cause(s) of the problem(s). In 
such a case, NIOSH will work with the relevant regulatory agencies and 
industry and

[[Page 14189]]

labor organizations to notify users of the revocation.
    A program of post-approval testing is important for assuring users 
of the effectiveness of their equipment. Simulations of environmental 
conditions conducted in a laboratory during the approval process cannot 
perfectly and comprehensively replicate all conditions that might be 
associated with the actual storage and wearing of CCERs in mines and 
other work environments. The post-approval testing also serves to 
identify potential problems of quality control in the manufacturing 
process. The regulatory requirements of this section ensure the 
feasibility of a post-approval testing program and establish specific 
authorities and obligations in connection with the results of such 
testing.
12. Section 84.311 Registration of CCER Units Upon Purchase
    This section requires that manufacturers provide each purchaser of 
a CCER unit with copies of procedures for registering purchased units 
with NIOSH. NIOSH will also work with relevant agencies and industry 
and labor associations to publicize the registration program. It is 
particularly important to reach purchasers and users of CCERs who 
obtain their devices from secondary markets and through equipment 
transfers from other work sites. This registration will enable NIOSH to 
notify purchasers when: (1) A problem associated with a model of CCER 
is identified; (2) such a problem requires a remedial action; or (3) 
NIOSH revokes the certification of a CCER. Presently, NIOSH has limited 
ability to locate users of particular CCER models. Manufacturers do not 
consistently retain records of purchasers and may sell product through 
distributors. Also, there is a secondary market for re-selling 
purchased CCERs as purchasers go out of business, reduce their 
employment, or select an alternate CCER model.

B. Subpart G--General Construction and Performance Requirements

1. Sections 84.60, 84.63-84.65
    These sections of Subpart G, which provide general construction and 
performance requirements for respirators approved under 42 CFR Part 84, 
are presently limited to covering respirator types specified under 
Subparts H through L. Since this rule removes CCER provisions from 
under Subpart H and places them under a newly created Subpart O, 
Subpart G is revised to cover Subpart O as well as Subparts H through 
L. Furthermore, by technical error, existing Subparts N and KK have 
been inadvertently omitted from coverage under Subpart G, even though 
this provision was intended to apply to all respirators types. In this 
final rule, HHS extends the coverage of Subpart G to all respirators 
certified under this Part (i.e., Subparts H through KK) to clearly 
specify the comprehensive coverage of Subpart G to all respirator types 
presently approved. This change also provides coverage under Subpart G 
for respirator types that might be distinguished under newly created 
sections in the future.

C. Subpart H--Self-Contained Breathing Apparatus

1. Section 84.70 Self-Contained Breathing Apparatus; Description
    This section excludes CCERs from coverage under any provisions of 
Subpart H, except as provided for under Sec.  84.304(a)(5). The 
provisions of Subpart H concerning respirators used for escape only 
from hazardous environments apply solely to those with an open-circuit 
design.

IV. 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 rule is being treated as a ``significant regulatory action'' 
within the meaning of E.O. 12866 because it raises novel legal or 
policy issues. Current MSHA regulations (30 CFR 75.1714-1) require that 
underground coal mine operators provide miners with CCERs (referred to 
in the mining community as a self-contained self-rescuer or SCSR) which 
have been approved by MSHA and NIOSH under 42 CFR Part 84, as follows:
    (a) 1-hour SCSR;
    (b) A SCSR of not less than 10 minutes and a 1-hour canister; or
    (c) Any other self-contained breathing apparatus which provides 
protection for a period of 1 hour or longer and which is approved for 
use by MSHA as a self-rescue device when used and maintained as 
prescribed by MSHA.
    By changing the nomenclature used to identify different size CCER 
models, the new rule will change the criteria by which NIOSH and MSHA 
approve CCERs intended for use in mines. MSHA, as a co-approver, will 
determine whether they meet the requirements of paragraphs (a) and (b) 
of the MSHA regulation, consistent with the NIOSH approval process. As 
discussed above in Section I.C. of the preamble, there is evidence that 
the duration rating system causes the user to believe that the 
apparatus will last for a specific length of time, regardless of the 
user's weight, physical condition, or activity. This is not an accurate 
interpretation. Relying on a 1-hour unit to supply 1 hour of oxygen to 
all users under all circumstances can lead to inappropriate deployment 
and misuse in emergencies. NIOSH believes that transition to the 
capacity rating will alleviate these misinterpretations.
    The rule is not considered economically significant, as defined in 
sec. 3(f)(1) of E.O. 12866. HHS anticipates that respirator 
manufacturers will need to modify some existing CCER designs and make 
related changes to their manufacturing processes to meet the new 
capacity and performance testing requirements. However, these changes 
are not expected to require manufacturers to use fundamentally 
different or substantially more costly technology. Similarly, NIOSH 
does not expect the new requirements for indicators of excessive 
thermal exposure, moisture damage, or chemical bed integrity to have a 
substantial impact on the manufacturing cost of CCERs. Such indicators 
have already been incorporated into CCER designs by some manufacturers 
without substantially increasing product prices. Hence, NIOSH does not 
expect that manufacturers will have to engage in new manufacturing 
processes that would substantially increase manufacturing costs or 
product prices.
    Moreover, even a substantial cost increase in CCERs would not be 
economically significant. The scope of the market for CCERs is 
presently very limited. According to MSHA, there are approximately 
47,000 coal miners, the principal users of CCERS in the private sector, 
working underground in such positions as mining machine operators, 
excavating machine operators, roof bolters, earth drillers, 
electricians, helpers, and first line supervisors.\50\ The

[[Page 14190]]

service lives of current CCER models range from 10 to 15 years, 
although some units may be damaged or used for an escape or escape 
simulation and consequently would be taken out of service sooner. 
Assuming conservatively that each CCER unit is replaced every 10 years 
on average and given that approximately 180,000 units \51\ are 
currently deployed, the mining industry would purchase an average of 
18,000 units annually. Given an average cost of $675 per unit,\52\ 
these data suggest that this principal component of the current CCER 
market represents approximately $12.2 million in annual sales. Other 
major components of the CCER market include sales to the Navy and Coast 
Guard and possibly the maritime industry. Among these, the Navy is the 
largest consumer, with over 400,000 units in current use; assuming 
conservatively that each of the Navy's CCER units is replaced every 10 
years, the Navy purchases an estimated 40,000 units annually; 
therefore, the annual CCER market for the Navy represents approximately 
$27 million.\53\ In sum, the CCER market is estimated to be 
approximately $39.2 million per year. Although HHS does not expect the 
cost of individual CCER units to rise significantly in response to the 
new testing and approval standards, a hypothetical increase of 50 
percent in the price per unit would result in an average annual market 
of $58.8 million. The estimated impact of the final rule on respirator 
sales (the difference between estimated current annual sales and 
estimated annual sales under the new standards calculated using a 50 
percent per unit increase) is $19.6 million per year, or less than 20 
percent of the $100 million threshold for a significant regulatory 
action having an annual effect on the economy. Further, the rule will 
not adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities. No respirator manufacturer or underground coal mine 
operator offered comment on this analysis.
---------------------------------------------------------------------------

    \50\ U.S. Department of Labor, Mine Safety and Health 
Administration. Mining Industry Accident, Injuries, Employment, and 
Production Data--Address & Employment Self-Extracting Files. http://www.msha.gov/stats/part50/p50y2k/aetable.htm. Accessed July 7, 2011.
    \51\ This figure was supplied by MSHA, which maintains a 
registry of all CCER units deployed to U.S. coal mines.
    \52\ NIOSH calculated this average price based on the products 
supplied by the three CCER manufacturers that supply U.S. coal 
mines, unit prices to NIOSH for its recent purchases of these 
products, and the approximate deployment distribution of these 
products among U.S. coal mines as indicated by the MSHA CCER 
registry for coal mines.
    \53\ Estimated from information provided by the Naval Surface 
Warfare Center, Panama City, Florida, December 20, 2004.
---------------------------------------------------------------------------

    The new requirements will likely produce economic benefits. First, 
they will provide more product performance information to purchasers, 
which will result in a more efficient market. Respirators will be 
tested for their specific capacity, in addition to being rated by 
general categories of capacity. As discussed under Section III--84.304 
of the preamble, this specificity will allow purchasers to match 
respirators more closely to their particular needs. As a result, 
manufacturers will have incentive to innovate and address the diverse 
needs of users. Further, having specific NIOSH-approved capacity levels 
will provide manufacturers with more incentive to differentiate the 
performance of their products from those of their competitors. This 
competition should result in a market of products that more closely 
meet the design and performance needs of different work sites, thereby 
improving the protection of miners and other workers who rely on CCERs 
in emergencies. While NIOSH is unable to quantify the benefits of a 
more efficient market, it is reasonable to assume that the development 
of products more specifically tailored to the needs of purchasers will 
eliminate wasteful spending by employers and improve worker protection.
    Second, the new requirements for safety features (which provide for 
the detection of units that have undergone excessive environmental 
stresses or mishandling) have the potential to increase the ability of 
purchasers, users, inspectors, and others to contribute to assuring the 
reliability of deployed CCER units. This should make operator safety 
programs and regulatory compliance investments by the government more 
efficient by making it less likely that bad product will make its way 
to a worker's hands. While HHS cannot quantify this benefit, it is 
logical and reasonable to expect that a positive economic impact will 
derive from improved safety features.
    Third, the new requirements for safety features and for capacity 
and performance testing are designed to better protect workers relying 
on CCERs for their survival. Although NIOSH lacks information on the 
number of workers annually who rely on a CCER for their survival and 
the quantifiable benefit they will derive from the improvements in this 
rule, the improved standards are likely to result in fewer negative 
outcomes and lower associated costs. In addition, substantial costs 
associated with rescue operations could be averted if workers escape 
independently.
    The rule will not interfere with State, local, or tribal 
governments in the exercise of their governmental functions.
    OMB has reviewed this proposed rule for consistency with the 
President's priorities and the principles set forth in E.O. 12866.

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 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.
    CCERs currently sold in the United States are manufactured by only 
two U.S. companies: CSE Corporation of Monroeville, Pennsylvania, and 
Ocenco Incorporated of Pleasant Prairie, Wisconsin. (A third company, 
Draeger, is based in Germany.) These manufacturing companies are small 
businesses as defined under the Small Business Act for this industry 
sector (NAICS 339113--Surgical Appliance and Supplies Manufacturing), 
employing fewer than 500 employees. Accordingly, HHS has given 
consideration to the potential impact of this rule on these two 
companies.
    HHS did not receive any comments on the economic analysis published 
in the Federal Register (73 FR 75027, December 10, 2008).
    Manufacturers will likely have to design new products and make 
related changes to their manufacturing processes for these products. 
However, in NIOSH's judgment, such new designs and production changes 
would not require substantial technological innovation in order to meet 
the improved performance standards. Similarly, NIOSH does not expect 
the new requirements for indicators of excessive thermal exposure, 
moisture damage, or chemical bed integrity to have a substantial impact 
on the manufacturing cost of CCERs. Such indicators have already been 
incorporated into CCER designs by some manufacturers without 
substantially increasing product prices. Most importantly, any 
associated costs incurred by the manufacturers for compliance with this 
rule could be

[[Page 14191]]

passed on to consumers entirely since the demand for these products is 
essentially inelastic.\54\ HHS is unable to quantify the impact on the 
two small manufacturers; however, the Department believes that 
manufacturers did not offer comment on this analysis because the cost 
of compliance is not expected by any stakeholder to exceed the benefits 
derived from this final rule. Accordingly, HHS finds there would not be 
a significant economic impact on the two U.S. respirator manufacturers 
which produce the CCERs covered by this rule. The table below 
identifies the two domestic CCER manufacturers and the non-U.S. 
company, the products each make that are used in underground coal 
mining, the cost to NIOSH of purchasing an individual unit, and the 
market share of each type of respirator.\55\
---------------------------------------------------------------------------

    \54\ The MINER Act requires underground coal mine operators to 
supply each underground worker with at least 4 hours of breathable 
air; the International Convention for the Safety of Life at Sea 
similarly requires ships to carry breathable air in designated 
locations.
    \55\ Kyriazi N, Shubilla JP. Self-contained self-rescuer field 
evaluation: seventh-phase results. Pittsburgh, PA: U.S. Department 
of Health and Human Services, Centers for Disease Control and 
Prevention, National Institute for Occupational Safety and Health; 
March 2002. DHHS (NIOSH) Publication No. 2002-127, RI 9656.

                            Closed-Circuit Escape Respirator Manufacturers and Costs
----------------------------------------------------------------------------------------------------------------
                                                                                                  Market share
                Manufacturer                           Respirator                  Cost            (percent)
----------------------------------------------------------------------------------------------------------------
CSE........................................  SR-100.......................               $689                 46
Ocenco.....................................  EBA 6.5......................                670                 39
Ocenco.....................................  M-20.........................                412                  2
Draeger....................................  OKY-X Plus...................                537                  5
MSA *......................................  Life-Saver 60................  .................  .................
----------------------------------------------------------------------------------------------------------------
* MSA supplied CCERs to 7% of the market in 2002; they have since stopped U.S. sales.

    Further, because the Mine Act (30 U.S.C. 842(h)) and MSHA 
regulations (30 CFR 75.1714-1) require coal mine operators to supply 
CCERs approved by NIOSH and MSHA for the protection of coal miners 
working in underground coal mines, HHS has also considered the 
secondary or ``downstream'' economic impact of this rule on coal mine 
operators that would be considered small businesses, which the Small 
Business Administration defines as those mines employing fewer than 500 
employees. CCERs are purchased by bituminous coal mining companies 
(NAICS 212112) and anthracite coal mining companies (NAICS 212113). 
According to MSHA, 488 underground coal mines can currently be 
considered small.\56\ According to the 2007 Economic Census, the value 
of coal shipments made in these two industries is approximately $15.5 
billion annually; \57\ because nearly all bituminous and anthracite 
coal mining companies are considered small, it is reasonable to assume 
that this value approximates revenues for those small manufacturers.
---------------------------------------------------------------------------

    \56\ U.S. Department of Labor, Mine Safety and Health 
Administration. Mining Industry Accident, Injuries, Employment, and 
Production Data--Address & Employment Self-Extracting Files. http://www.msha.gov/stats/part50/p50y2k/aetable.htm. Accessed July 7, 2011.
    \57\ U.S. Census Bureau. 2007 Economic Census. http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0721I1&-_lang=en. Accessed August 24, 2011.
---------------------------------------------------------------------------

    NIOSH does not expect that the prices of CCERs will be 
substantially affected by the new approval testing requirements. 
Respirator manufacturers may need to modify existing CCER designs to 
meet the new capacity or performance testing requirements. However, 
these requirements should not cause the manufacturers to use 
fundamentally different or substantially more costly technology, as 
discussed above. Hence, NIOSH does not expect that manufacturers would 
have to engage in markedly different manufacturing processes that might 
substantially increase product prices. The manufacturers would incur 
one-time costs for redesign of products or product components and 
associated production operations, as well as one-time costs for 
obtaining certification testing and approval from NIOSH and MSHA. 
Attempting to calculate price increases that would cover such costs 
would require more data than are available to NIOSH. Instead, HHS has 
evaluated the relative magnitude of possible costs under the extremely 
conservative assumption that CCER prices would be increased permanently 
by 50 percent to amortize the one-time product and production redesign 
and NIOSH approval application costs. Currently, the weighted average 
price of a CCER is $675 \58\ and MSHA's CCER registry indicates there 
are approximately 180,000 CCERs deployed in underground coal mines. 
There were approximately 47,000 coal miners working underground in 
large and small U.S. coal mines in the first quarter of 2011.\59\ 
Assuming very conservatively that each unit requires replacement every 
5 years,\60\ assuming that all CCERs deployed in mines would be 
replaced in the first year of this final rule, and assuming that the 
prices of all CCERs were to increase by 50 percent as a result of this 
rule, the annualized additional costs would amount to between 
approximately $282 and $315 per underground coal miner.\61\ This 
increase in labor-associated costs would not be significant in the 
context of the total per capita labor costs of underground coal mine 
operators. The total earnings of non-union coal miners (wages and 
benefits), which generally represents employment for small coal mine 
operators, is approximately

[[Page 14192]]

$72,000.\62\ HHS finds that an average of $282 to $315 in additional 
annual costs per coal miner (less than 0.39 to 0.44 percent of per 
capita labor costs), or $13.3 to $14.8 million in estimated annual 
costs to the 488 small underground coal mines were this rule to 
increase CCER prices by 50 percent, does not represent a significant 
economic impact on small mine operators (.09 to .1 percent of annual 
revenue); nor would a 100 percent increase in CCER prices, which HHS 
does not find to be plausible considering the facts discussed here, 
impose a significant economic impact on small mine operators.\63\
---------------------------------------------------------------------------

    \58\ NIOSH calculated this weighted average price using the 
products of the three CCER manufacturers that supply U.S. coal 
mines, unit prices to NIOSH for its recent purchases of these 
products, and the approximate deployment distribution of these 
products among U.S. coal mines as indicated by the MSHA CCER 
registry for coal mines. The use of this weighted average price 
simplifies the analysis and is adequate considering the equivalency 
of these prices for the major share holders (Ocenco and CSE) as 
indicated in Table 1.
    \59\ U.S. Department of Labor, Mine Safety and Health 
Administration. Mining Industry Accident, Injuries, Employment, and 
Production Data--Address & Employment Self-Extracting Files. http://www.msha.gov/stats/part50/p50y2k/aetable.htm.Accessed July 7, 2011.
    \60\ This replacement rate is an exceptionally conservative 
estimate. A more realistic estimate is 10 percent annually (i.e., 
the replacement of a CCER unit every 10 years), based on the known 
service-life of CCERS of 10-15 years, the MSHA CCER registry, and 
NIOSH long-term field evaluation data. These latter two sources 
indicate the current replacement rate is well under 10 percent.
    \61\ The lower value was obtained using a cost of capital rate 
of 3 percent: $675/unit x 0.5 cost increase x 180,000 units x 0.2184 
annualization factor/47,000 underground miners = annual costs per 
underground miner. The higher value was obtained using a cost of 
capital rate of 7 percent: $675/unit x 0.5 cost increase x 180,000 
units x 0.2439 annualization factor/47,000 underground miners = 
annual costs per underground miner.
    \62\ According to the National Mining Association, coal miners 
have average annual earnings of $72,200. See National Mining 
Association. Profile of the U.S. coal miner 2008. August 2009. 
http://www.nma.org/pdf/c_profile.pdf. Accessed October 23, 2009. 
This figure is consistent with the pay rate reported for non-union 
underground coal miners at $35.56 per hour. See InfoMine USA, Inc. 
U.S. coal mines salaries, wages, and benefits, 2009. February 2010. 
This non-union pay rate applied to a 2,000 hour work year represents 
total wages and benefits paid by small coal mine operators.
    \63\ HHS guidance defines ``significant economic impact'' as a 
3-5 percent or more average annual impact on the total costs or 
revenues of small entities. See: U.S. Department of Health and Human 
Services. Guidance on proper consideration of small entities in 
rulemakings of the U.S. Department of Health and Human Services. May 
2003.
---------------------------------------------------------------------------

    HHS consulted with and received approval from the Small Business 
Administration on this analysis of the final rule's impact on small 
entities.
    For the reasons provided, a regulatory flexibility analysis, as 
provided for under RFA, is not required.

C. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), 
a Federal agency shall not conduct or sponsor a collection of 
information from 10 or more persons other than Federal employees unless 
the agency has submitted a Standard Form 83, Clearance Request, and 
Notice of Action, to the Director of the Office of Management and 
Budget (OMB), and the Director has approved the proposed collection of 
information. A person is not required to respond to a collection of 
information unless it displays a currently valid OMB control number.
    HHS has determined that this final rule contains information 
collections that are subject to review by OMB. OMB has approved NIOSH's 
collection of information from applicants under OMB Control No. 0920-
109, ``Respiratory Protective Devices,'' which covers all information 
collected under 42 CFR Part 84. Current OMB approval for this data 
collection expires August 31, 2014. The requirements of this final rule 
will not pose an additional burden on applicants because the 
application will not change from current practices.

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 must 
report to Congress the promulgation of a final rule, once it is 
developed, prior to its taking effect. The report will state that HHS 
has concluded that the 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 testing and 
certification requirements it will apply 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)

    HHS 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 will 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 because it 
applies to the underground mining sector. The rule would not result in 
any costs to mines. Hence this rule does not constitute a ``significant 
energy action.'' Accordingly, E.O. 13211, Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use, requires no further Agency action or analysis.

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.

V. Final Rule

List of Subjects in 42 CFR Part 84

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

    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 continues to read as follows:

    Authority:  29 U.S.C. 651 et seq., and 657(g); 30 U.S.C. 3, 5, 
7, 811, 842(h), 844.

Subpart G--General Construction and Performance Requirements

Sec.  84.60  [Amended]

0
2. Amend Sec.  84.60(a) to remove the phrase ``in subparts H through 
L'' and add in its place the phrase ``in subparts H through KK.''

Sec.  84.63  [Amended]

0
3. Amend Sec.  84.63(a), (b), and (c) to remove the phrase ``in 
subparts H through L'' and add in its place the phrase ``in subparts H 
through KK.''

[[Page 14193]]

Sec.  84.64  [Amended]

0
4. Amend Sec.  84.64(b) to remove the phrase ``of subparts H through 
L'' and add in its place the phrase ``of subparts H through KK.''

Sec.  84.65  [Amended]

0
5. Amend Sec.  84.65(a) to remove the phrase ``to subparts H through 
L'' and add in its place the phrase ``to Subparts H through KK.''

Subpart H--Self-Contained Breathing Apparatus

0
6. Amend Sec.  84.70 to:
0
a. Redesignate paragraphs (a) through (d) as (b) through (e), 
respectively; and
0
b. Add a new paragraph (a) to read as follows:

Sec.  84.70  Self-contained breathing apparatus; description.

    (a) Limitation on scope. None of the provisions of Subpart H apply 
to closed-circuit escape respirators to be approved specifically for 
escape only from hazardous atmospheres, except as provided for under 
Sec.  84.304(a)(5). Such respirators are covered under the provisions 
of subpart O of this part.
* * * * *

0
7. Add subpart O to part 84 to read as follows:
Subpart O--Closed-Circuit Escape Respirators
Sec.
84.300 Closed-circuit escape respirator; description.
84.301 Applicability to new and previously approved CCERs.
84.302 Required components, attributes, and instructions.
84.303 General testing conditions and requirements.
84.304 Capacity test requirements.
84.305 Performance test requirements.
84.306 Wearability test requirements.
84.307 Environmental treatments.
84.308 Additional testing.
84.309 Additional testing and requirements for dockable CCERs.
84.310 Post-approval testing.
84.311 Registration of CCER units upon purchase.

Subpart O--Closed-Circuit Escape Respirators

Sec.  84.300  Closed-circuit escape respirator; description.

    The closed-circuit escape respirator (CCER), technically a subset 
of self-contained breathing apparatus (SCBAs) which are otherwise 
covered under subpart H of this part, is used in certain industrial and 
other work settings in emergencies to enable users to escape from 
atmospheres that can be immediately dangerous to life and health. Known 
in the mining community as self-contained self-rescuers (SCSRs), and in 
other industries as emergency escape breathing devices (EEBDs) or 
apparatus (EEBAs), CCERs are relied upon primarily by underground coal 
miners, sailors in federal service, and railroad workers to escape 
dangerous atmospheres after a fire, explosion, or chemical release. 
CCERs are commonly worn on workers' belts or stored in close proximity 
to be accessible in an emergency. They are relatively small 
respirators, typically the size of a water canteen, that employ either 
compressed oxygen with a chemical system for removing exhaled carbon 
dioxide from the breathing circuit, or a chemical that both provides a 
source of oxygen and removes exhaled carbon dioxide. Users re-breathe 
their exhalations after the oxygen and carbon dioxide levels have been 
restored to suitable levels, which distinguishes these ``closed-
circuit'' self-contained respirators from ``open-circuit'' self-
contained respirators, which vent each exhalation.

Sec.  84.301  Applicability to new and previously approved CCERs.

    This subpart applies to the following CCERs:
    (a) All CCERs submitted to NIOSH for a certificate of approval 
after April 9, 2012; and
    (b) All CCERs manufactured and labeled NIOSH-approved and sold by 
manufacturers after April 9, 2015.

Sec.  84.302  Required components, attributes, and instructions.

    (a) Each CCER must include components and/or attributes appropriate 
to its design, as follows:
    (1) Eye protection: Each CCER must include safety goggles or an 
escape hood lens that protects against impact, fogging, and permeation 
by gas, vapor, and smoke, as specified under Sec.  84.308(c);
    (2) Thermal exposure indicators: If the manufacturer specifies a 
maximum and/or minimum environmental temperature limit for storage of 
the CCER, then the CCER must include a component, an attribute, or 
other means by which a person can determine whether the CCER has been 
exposed to temperatures that exceed the limit(s);
    (3) Chemical bed physical integrity indicators: If the CCER 
includes a chemical oxygen storage or chemical carbon dioxide scrubber 
that can be functionally damaged by impact, vibration, or any other 
environmental factor to which the CCER might be exposed, then the CCER 
must include a component, an attribute, or other means by which a 
person can detect any damage or alteration of the chemical oxygen 
storage or chemical carbon dioxide scrubber that could diminish the 
NIOSH-certified performance of the CCER, as tested under this subpart;
    (4) Oxygen storage vessel: If the CCER includes an oxygen storage 
vessel, the vessel must be approved by the U.S. Department of 
Transportation (DOT) under 49 CFR part 107, ``Hazardous Materials 
Program Procedures,'' unless exempted under subpart B of 49 CFR part 
107;
    (5) Tamper-resistant/tamper-evident casing: If the CCER is not 
designed for its casing to be opened prior to use for an actual escape 
(e.g., for maintenance, escape drills, or inspection of the 
components), the casing must include a component, an attribute, or 
other means to prevent a person from accidentally opening the casing 
and, upon such opening, to either prevent the casing from being closed 
or to clearly indicate to a potential user that the casing has been 
previously opened; and
    (6) Moisture damage indicators: If the CCER is not designed for its 
casing to be opened for inspection of its internal components, the 
casing must include a component, an attribute, or other means by which 
a person can detect any ingress of water or water vapor that could 
diminish the NIOSH-certified performance, as tested under this subpart.
    (7) Oxygen starter indicators: If the oxygen starter is a critical 
component of the CCER design, then the CCER must include a component, 
an attribute, or other means by which a person can detect observable 
damage, premature activation, or recognized potential defect of the 
starter.
    (b) Where an indicator is required, the indication of the 
occurrence of the monitored condition must be clear and unambiguous: It 
must not depend on a subjective interpretation of subtle, graduated, or 
other non-discrete changes to the indicator.
    (c) Where an indicator is required, the manufacturer shall provide 
NIOSH with an explanation of its function and operation, and shall 
provide relevant data and equipment to allow NIOSH to conduct a 
thorough evaluation of its accuracy and reliability.
    (d) The components of each CCER must meet the general construction 
requirements specified in Sec.  84.61.
    (e) The CCER must be resistant to the permeation of the breathing 
circuit by gasoline vapors. To verify such resistance, NIOSH will test 
one unit by applying the gasoline vapor permeation test specified on 
the NIOSH Web site at http://www.cdc.gov/niosh/npptl, using a

[[Page 14194]]

breathing machine applying a ventilation rate of 40 liters per minute, 
performing the test for the longest duration achieved by any of the 
units that underwent the capacity testing specified under Sec.  84.304.
    (f) Exposed parts of the CCER must not be composed of metals or 
other materials that could, upon impact, create frictional sparks or 
that could store or generate static electrical charges of sufficient 
energy to ignite flammable gaseous mixtures.
    (g) The design, construction, or materials of the CCER must not 
constitute a hazard to the user as a result of the wearing, inspection, 
or use of the CCER.
    (h) CCER instructions and a service life plan must be provided to 
purchasers. This document must be clearly written.
    (1) Instructions must address the following topics and elements:
    (i) An explanation of how the CCER works;
    (ii) A schematic diagram of the CCER;
    (iii) Procedures for donning and use;
    (iv) Procedures for inspecting the operating condition of the CCER;
    (v) Procedures and conditions for storage, including but not 
limited to any recommended minimum and maximum temperatures for 
storage;
    (vi) Limitations on use, including but not limited to any 
recommended minimum and maximum temperatures for use;
    (vii) Procedures for disposal; and
    (viii) Procedures for registration of the unit with NIOSH, pursuant 
to Sec.  84.311.
    (2) The service life must be addressed covering at least the 
following topics:
    (i) The maximum number of years, from the date of manufacture, that 
the unit may remain available for use; this limit is intended to 
prevent the continued use of a unit that the applicant cannot assure 
would continue to perform as approved by NIOSH, due to reasonably 
foreseeable degradation of materials used in its construction;
    (ii) Any other conditions, other than that specified under 
paragraph (h)(2)(i) of this section, that should govern the removal 
from service of the CCER (including an indication given by the 
activation or operation of any required indicator showing the monitored 
condition has occurred); and
    (iii) Any procedures by which a user or others should inspect the 
CCER, perform any maintenance possible and necessary, and determine 
when the CCER should be removed from service.
    (i) Each individual CCER unit approval label shall identify the 
capacity rating and number of liters of oxygen as determined by the 
capacity testing, pursuant to Sec.  84.304.

Sec.  84.303  General testing conditions and requirements.

    (a) NIOSH will conduct capacity and performance tests on the CCER 
using a breathing and metabolic simulator to provide quantitative 
evaluations and human subjects on a treadmill to provide qualitative 
evaluations. Information on the design and operation of the simulator 
is available from the NIOSH Web site at http://www.cdc.gov/niosh/npptl. 
Technical specifications can be obtained from NIOSH by contacting the 
National Personal Protective Technology Laboratory (NPPTL) by mail: 
P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236. 
Telephone: 412-386-4000 (this is not a toll-free number). Email: 
npptl@cdc.gov.
    (b) Capacity, performance, and wearability tests will continuously 
monitor the stressors listed in Table 1. The stressors and their 
respective acceptable ranges will be measured at the interface between 
the CCER and the mouth by instruments capable of breath-by-breath 
measurement. Stressor measurements will be evaluated as 1-minute 
averages. The operating averages of each stressor will be calculated 
upon the completion of each test as the average of the 1-minute 
measurements of the stressor recorded during the test. The level of any 
excursion for a stressor occurring during a test will be defined by the 
1-minute average value(s) of the excursion(s).

                            Table 1--Monitored Stressors and Their Acceptable Ranges
----------------------------------------------------------------------------------------------------------------
                                         Acceptable range operating
                Stressor                           average                    Acceptable range excursion
----------------------------------------------------------------------------------------------------------------
Average inhaled CO2....................  19.5%....................  >=15%.
Peak Breathing Pressures...............  [Delta]P  3 [deg]C; and
    (2) Atmospheric pressures of 735 mm Hg  15 mm Hg.

Sec.  84.304  Capacity test requirements.

    (a) NIOSH will conduct the capacity test on a total of 8 to 10 of 
the units submitted for approval, as follows:
    (1) Three units will be tested on a breathing and metabolic 
simulator in the condition in which they are received from the 
applicant;
    (2) Two units will be tested on a breathing and metabolic simulator 
after being subjected to the environmental treatments specified in 
Sec.  84.307 of this subpart;
    (3) Two units will be tested on a breathing and metabolic simulator 
at the cold-temperature limit recommended by the manufacturer under 
Sec.  84.302(h)(1), after the unit has been stored for a minimum of 24 
hours at this limit; and
    (4) One unit, in the condition in which it is received from the 
applicant, will be tested by a human subject on a treadmill.
    (5) To approve a CCER for use in coal mines, two units will also be 
tested by a human subject under the specifications of Sec. Sec.  84.99 
and 84.100 that are applicable to man test 4.

[[Page 14195]]

    (b) The capacity test will begin upon the first inhalation from or 
exhalation into the unit.
    (c) Each unit will be tested at a constant work rate, depending on 
the capacity value specified by the manufacturer, according to the 
requirements specified in Table 2. All volumes are given at standard 
temperature (0 [ordm]C) and pressure (760 mm Hg), dry, unless otherwise 
noted.
    (d) NIOSH will rate an approved CCER using the appropriate capacity 
rating, as specified in Table 2.

                                       Table 2--Capacity Test Requirements
----------------------------------------------------------------------------------------------------------------
                                                                VO2  (L/    VCO2  (L/                RF (Breaths/
           Capacity rating              Capacity  (L of O2)       min)         min)     Ve  (L/min)      min)
----------------------------------------------------------------------------------------------------------------
Cap 1...............................  20 = 80...............         1.35         1.15           30           18
----------------------------------------------------------------------------------------------------------------
VO2 = volume of oxygen consumed per minute; VCO 2 = volume of carbon dioxide produced per minute.
Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

    (e) NIOSH will document the least value achieved by the seven units 
tested using the breathing and metabolic simulator. NIOSH will quantify 
this value of achieved capacity within an increment of 5 liters, 
rounding intermediate values to the nearest lower 5-liter increment.

Sec.  84.305  Performance test requirements.

    (a) NIOSH will conduct the performance test on a total of six of 
the units submitted for approval, as follows:
    (1) Three units will be tested on a breathing and metabolic 
simulator in the condition in which they were received from the 
applicant; and
    (2) Two units will be tested on a breathing and metabolic simulator 
after being subjected to the environmental treatments specified in 
Sec.  84.307; and
    (3) One unit will be tested, in the condition in which it was 
received from the applicant, by a human subject on a treadmill.
    (b) Except as provided under paragraph (c) of this section, the 
performance test will apply a repeating cycle of work rates, according 
to the sequence and requirements specified in Table 3, until the oxygen 
supply of the unit is exhausted.
    (c) Testing of CCERs with less than 50 liters of capacity, as 
determined by the capacity testing under Sec.  84.304, will require the 
submission of additional test units to fully apply the work-rate test 
sequence and requirements specified in Table 3. The testing of each 
individual unit will complete the cycle specified in Table 3 until the 
breathing supply of the initial test unit is exhausted. This initial 
test unit will then be replaced by a second unit, which will continue 
the test cycle, beginning at the work rate in the cycle at which the 
initial unit was exhausted, and completing the full period specified in 
Table 3 for that work rate before proceeding to the subsequent work 
rate, if any, specified in Table 3. Each initial testing unit will be 
replaced as many times as necessary to complete the cycle, not to 
exceed two replacement units per initial test unit.
    (d) The performance test will begin with two exhalations into the 
unit at the specified ventilation rate and then follow the 
manufacturer's instructions to determine the design's susceptibility to 
hypoxia upon initial donning.

                                     Table 3--Performance Test Requirements
----------------------------------------------------------------------------------------------------------------
                                                   Duration
                                                  per cycle                  VCO2 (L/                RF (breaths/
            Work-rate  test sequence                 (in      VO2 (L/min)      min)      Ve (L/min)      min)
                                                   minutes)
----------------------------------------------------------------------------------------------------------------
1. Peak........................................            5         3.00         3.20         65.0           25
2. High........................................           15         2.00         1.80         44.0           20
3. Low.........................................           10         0.50         0.40         20.0           12
----------------------------------------------------------------------------------------------------------------
VO2 = volume of oxygen consumed per minute; VCO2 = volume of carbon dioxide produced per minute.
Ve = ventilation rate in liters of air per minute; RF = respiratory frequency.

Sec.  84.306  Wearability test requirements.

    (a) NIOSH will conduct the wearability test on a total of three of 
the units submitted for approval. Three human subjects (two males and 
one female), one subject per unit, will conduct the test. The three 
subjects will range in height and weight as follows: One subject of 
height >=174 cm and weight >=90 kg; one subject of either 163 cm = weight second).
Carrying 50-lb bag on treadmill at 5 kph........  1 minute.
Lifting 20-lb weight from floor to an upright     1 minute (at least 10 times).
 position.
Running on treadmill at 10 kph..................  1 minute.
----------------------------------------------------------------------------------------------------------------

Sec.  84.307  Environmental treatments.

    (a) Four units submitted for approval will be tested for capacity 
and performance, pursuant to the requirements of Sec. Sec.  84.303 
through 84.305, after exposure to environmental treatments simulating 
extreme storage temperatures, shock, and vibration.
    (b) The units will be stored for 16 hours at a temperature of -45 
[deg]C and for 48 hours at a temperature of 71 [deg]C. Units will be 
returned to room temperature between high and low temperature 
treatments. The maximum rate of change for thermal loading shall not 
exceed 3 [deg]C per minute and constant temperatures shall be 
maintained within 2 [deg]C.
    (c) The units, in the casing in which they are deployed for 
individual use, will be subjected to physical shock according to the 
following procedure:
    (1) The unit will be dropped six times from a height of 1 meter 
onto a concrete surface; and
    (2) Each drop will test a different orientation of the unit, with 
two drops along each of its three major axes (top to bottom, left to 
right, and front to back).
    (d) The units will be subjected to vibration according to the 
following procedure:
    (1) The unit will be firmly secured to a shaker table, which will 
be vibrated with motion applied along a single axis for 180 minutes;
    (2) The unit will be vibrated one axis at a time along each of 
three axes for a total of 9 hours; and
    (3) The vibration frequency regimen applied to each axis will be 
cyclical, repeating the sequence and specifications provided in Table 5 
every 20 minutes.

                    Table 5--Vibration Test Sequence
------------------------------------------------------------------------
                                                            Acceleration
                   Sequence                     Frequency     g ( peak)
------------------------------------------------------------------------
1............................................         5-92           2.5
2............................................       92-500           3.5
3............................................     500-2000           1.5
------------------------------------------------------------------------

Sec.  84.308  Additional testing.

    (a) NIOSH will conduct additional tests, as indicated below, on one 
or more of the units submitted for approval. Each unit tested must meet 
the conditions specified in these tests for the CCER to receive 
approval.
    (b) NIOSH will perform safety hazard tests on any CCER that stores 
more than 200 liters of oxygen or that stores compressed oxygen at 
pressures exceeding 3,000 psi. The applicant must submit 15 units in 
addition to the 21-23 units required for testing under Sec. Sec.  
84.304 through 84.307. These units will be evaluated for fire and 
explosion hazards using the tests specified in RI 9333, pages 4-18; RI 
8890, pages 6-62; and PRC Report No. 4294, pages 18-62.
    (c) NIOSH will perform the following tests on the eye protection 
(gas-tight goggles or escape hood lens) of one or more units of every 
CCER submitted for approval:
    (1) NIOSH will test the effectiveness of the eye protection against 
dust using the method specified in ISO 4855-1981(E) Clause 13, Test for 
protection against dust. The result will be satisfactory if the 
reflectance after the test is equal to or greater than 80 percent of 
its value before testing.
    (2) NIOSH will test the effectiveness of the eye protection against 
gas using the method specified in ISO 4855-1981(E), Clause 14, Test for 
protection against gas. The test must not result in staining of the 
area enclosed by the eye protection.
    (3) NIOSH will test the durability of the eye protection using the 
method specified in International Standard ISO 4855-1981(E), Sub-clause 
3.1, Unmounted oculars. The lens shall not crack or fracture as a 
result of the test.
    (4) NIOSH will test the eye protection's resistance to fogging in 
accordance with the method specified in BS EN 168:2002, Clause 16, Test 
for resistance to fogging of oculars. The lens shall remain free from 
fogging for a minimum of 8 seconds, pursuant to Clause 16.
    (d) The standards required in this section are incorporated by 
reference into this section with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR Part 51. All approved 
material is available for inspection at NIOSH, National Personal 
Protection Technology Laboratory (NPPTL), Bruceton Research Center, 626 
Cochrans Mill Road, Pittsburgh, PA 15236. To arrange for an inspection 
at NIOSH, call 412-386-6111. Copies are also available for inspection 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (1) British Standards Institute, 389 Chiswick High Road, London W4 
4AL, UK, http://www.bsigroup.com/en/Standards-and-Publications:
    (i) BS EN 168:2002, Personal Eye Protectors--Non-Optical Test 
Methods, November 2001.
    (ii) [Reserved]
    (2) International Organization for Standardization, 1, ch. de la 
Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org/iso/store.htm:

[[Page 14197]]

    (i) ISO 4855-1981(E), Personal Eye Protectors--Non-Optical Test 
Methods, First edition April 1, 1981.
    (ii) [Reserved]
    (3) U.S. Department of the Interior, Bureau of Mines, 2401 E 
Street, NW., MS 9800, Washington, DC 20241-0001. These reports 
are also available from NIOSH upon request 1-800-CDC-INFO (232-4636).
    (i) Pittsburgh Research Center (PRC) Report No. 4294, Evaluation of 
the Safety of One-Hour Chemical Self Rescuers, July 1980;
    (ii) Report of Investigations (RI) 8890, Evaluation of the Safety 
of One-Hour Compressed Oxygen Self-Rescuers--Results of Destructive 
Testing, 1984;
    (iii) RI 9333 Evaluation of the Safety of the CSE SR-100 Self-
Contained Self-Rescuer, 1991.

Sec.  84.309  Additional testing and requirements for dockable CCERs.

    (a) NIOSH will conduct additional testing of the CCERs that are 
designed to allow the user to resupply the oxygen source and the carbon 
dioxide scrubber while using the respirator during an escape.
    (1) NIOSH will test the docking mechanism and procedure to ensure 
that they maintain the integrity of the breathing circuit (against the 
intake of hazardous fumes or gases) and the continuity of the breathing 
gas supply throughout the docking process.
    (2) NIOSH will test the docking mechanism and procedure to ensure 
that users can employ the docking process reliably, safely, and quickly 
under escape conditions.
    (b) NIOSH will designate CCERs that pass the tests specified in 
this section as ``Dockable.''
    (c) NIOSH will assign the capacity rating to the dockable CCER, as 
specified under Sec.  84.304(d), by conducting the capacity testing 
using only the breathing gas supply included for the initial use of the 
wearable apparatus.
    (d) NIOSH will test the supplemental capacities of all breathing 
gas resupply units produced by the manufacturer for use with the 
dockable CCER. Such tests will follow procedures consistent with those 
specified under Sec.  84.304, including the rating requirements in 
Sec.  84.304(d). The manufacturer must label the breathing gas resupply 
unit to indicate its capacity as tested by NIOSH and its compatibility 
with the CCER for which it is designed.
    (e) NIOSH may require the applicant to provide additional units of 
the CCER and breathing gas resupply units to conduct the testing 
specified in this section.
    (f) NIOSH will not approve a CCER with docking components, with or 
without the ``Dockable'' NIOSH designation, unless it satisfies the 
testing and other requirements of this section.

Sec.  84.310  Post-approval testing.

    (a) NIOSH will periodically test the capacity and performance of 
units of approved CCERs.
    (b) NIOSH may test units that are new and/or units that have been 
deployed in the field and have remaining service life.
    (c) NIOSH will conduct such testing pursuant to the methods 
specified in Sec. Sec.  84.303 through 84.305, except as provided under 
paragraph (d) of this section.
    (d) The numbers of units of an approved CCER to be tested under 
this section may exceed the numbers of units specified for testing in 
Sec. Sec.  84.304 and 84.305.
    (e) Failure of a unit to meet the capacity and performance 
requirements of this section may result in revocation of the approval 
for the CCER or in requirements for specific remedial actions to 
address the cause or causes of the failure.
    (f) NIOSH will replace deployed units obtained for testing with new 
NIOSH-approved units of the same or similar design, at no cost to the 
employer.
    (g) To maintain the approved status of a CCER, an applicant must 
make available for purchase by NIOSH, within 3 months of a NIOSH 
purchase request, the number of units requested by the Institute. 
Within any 12-month period, NIOSH will not request to purchase more 
than 100 units for post-approval testing.

Sec.  84.311  Registration of CCER units upon purchase.

    (a) The user instructions will include a copy of procedures for 
registering the units with NIOSH. The applicant can obtain a copy of 
these procedures from the NIOSH web page: http://www.cdc.gov/niosh/npptl.
    (b) The applicant shall notify in writing each purchaser of the 
purpose of registering a unit with NIOSH, as specified under paragraph 
(c) of this section. If the purchaser is a distributor of the CCER, the 
applicant must request in writing that the distributor voluntarily 
notify in writing each of its purchasers of the purpose of registering 
a unit with NIOSH, as specified under paragraph (c) of this section.
    (c) ``The National Institute for Occupational Safety and Health 
(NIOSH) requests, but does not require, that purchasers of this 
respirator register each unit with NIOSH. Registration will enable 
NIOSH, which approved this model of respirator, to attempt to notify 
you if a problem is discovered that might affect the safety or 
performance of this respirator. Registration will also assist NIOSH in 
locating deployed units to periodically evaluate whether this 
respirator model is remaining effective under field conditions of 
storage and use.''

    Dated: October 11, 2011.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-4691 Filed 3-7-12; 8:45 am]
BILLING CODE 4163-18-P
```