[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Rules and Regulations]
[Pages 14167-14197]
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.
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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
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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\
---------------------------------------------------------------------------
\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.
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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\
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\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 (<43 [deg]C acceptable range
operating average) is arbitrary, and suggested adopting International
Organization for Standardization (ISO) 23269-1:2008, Ships and marine
[[Page 14176]]
technology--Breathing apparatus for ships--Part 1: Emergency escape
breathing devices (EEBD) for shipboard use, which sets the maximum
inhaled gas temperature at 50 [deg]C.
Response: HHS has retained in the final rule the use of wet-bulb
temperature and the average and excursion ranges specified (<43 and
<=50 [deg]C, respectively) because the trachea is always wet and
because monitoring wet-bulb temperature provides a more accurate
measure of the heat content of the inhaled gas and human thermal
sensitivity is related to the wet-bulb temperature.\12\ As with other
testing protocols, manufacturers may copy the technology and technique
to be applied by NIOSH for certification testing.
---------------------------------------------------------------------------
\12\ 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; 1984:117, 119.
---------------------------------------------------------------------------
The ISO 23269-1:2008 performance requirements establish that ``the
temperature of inhalation gas shall not exceed 50 [deg]C'' for
respirators deployed for shipboard use. In accordance with the ISO
standard, this final rule also establishes that the acceptable range
excursion for CCERs is 50 [deg]C, while the average operating
temperature must be less than 43 [deg]C.
From running many treadmill tests on both compressed- and chemical-
oxygen breathing apparatus, NIOSH knows that the exhalation temperature
of human subjects rises as inhalation temperature rises. The exhalation
temperature of human subjects breathing room air varies from 30 to 33
[deg]C. As inhalation temperature rises, NIOSH has observed the
exhalation temperature rise to as high as 45 [deg]C. The ventilatory
components of our breathing and metabolic simulator were designed to
simulate human subjects based on shape, size, and orientation. There is
a water reservoir which heats the water and pumps it into a plenum
above the lung where it spreads out and rains down onto the piston. The
water in the lung is a moderate quantity, unlike most other simulators
which have a larger quantity. This enables our simulator to be
overwhelmed by higher inhalation temperatures, emulating human beings.
The air pathway between the lung/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 <1 second.
Since the human respiratory tract is essentially a wet-bulb
thermometer, human beings are sensitive to wet-bulb temperature, not
dry-bulb temperature. For this reason, the inhalation temperature
limits are specified in terms of wet-bulb temperature. Large wet-bulb
thermometers have long response times due to their large size and,
thus, large thermal inertias. They need high flows and long times to
achieve the full wet-bulb depression. The NIOSH wet-bulb thermocouple,
due to its small size, requires neither high flow rates nor long
response times to achieve the full wet-bulb depression. Also, the
miniscule quantity of water on the wet-bulb thermocouple will have a
commensurately miniscule effect on the apparatus bed reaction.
L. Section 84.304 Capacity Test Requirements
Section 84.304(a)(5) is changed from the proposed rule to require
that CCER designs of any capacity submitted to NIOSH for deployment in
U.S. coal mines pass man test 4 which is set forth in the present
regulation at Sec. 84.99 and Sec. 84.100. The test provides assurance
that the CCER certification testing for devices used in mine escape
remains at least as rigorous as testing under the current standards.
Section 84.304(d) establishes a new rating system for CCERs, shifting
the classification scheme from duration to oxygen capacity.
1. Man Test 4
Comment: HHS received several comments regarding the proposed use
of man test 4: One commenter objected to the use of the 50th percentile
weight test subject, and suggested that the rule should be expanded to
include a wider range of workers. Another commenter requested
clarification regarding use of the 50th percentile worker and whether
that standard is consistent with established certification test
practices (which, according to the commenter, represents the 95th and
at times the 99th percentile miner). Another questioned whether it is
possible that the device could pass the duration test on the breathing
and metabolic simulator but fail man test 4, and recommended that the
breathing and metabolic simulator be used to determine duration and the
man test for wearability. Finally, one commenter suggested that the
inclusion of man test 4 does not address the legal duty under the
Federal Mine Safety and Health Act requiring that ``no mandatory health
or safety standard promulgated under this title shall reduce the
protection afforded miners by an existing mandatory health or safety
standard.''\13\
---------------------------------------------------------------------------
\13\ 30 U.S.C. 811(a)(9).
---------------------------------------------------------------------------
Response: HHS has retained the provision in the final rule that
requires those units used in coal mines pass man test 4. HHS, however,
has amended the provision slightly to indicate that any size unit
submitted to NIOSH for approval for use in coal mining will be subject
to man test 4. Man test 4 is an exceptionally challenging test with the
average miner in mind, and translates to demanding performance
requirements. Neither the present regulation nor this final regulation
specifies the weight range of the test subject for man test 4.
With regard to the established approval testing, this improved
standard is changing the metrics used to approve CCERs. The work rate
for the 50th percentile miner is already used to assess deployed units
during the long-term field evaluations conducted by NIOSH. Using that
standard here is consistent with current NIOSH practices.
Finally, as of the effective date of this rule, NIOSH will no
longer approve CCERs according to the duration of breathing gas supply.
The breathing and metabolic simulator will be used to evaluate the
oxygen capacity of a given CCER design; man test 4 is included here to
establish that approval of devices intended for use in a specific
application--underground coal mines--is at least as effective as the
current standard, and that the devices will perform as required by the
Federal Mine Safety and Health Act. However, with regard to the comment
that a unit might fail the simulator testing but pass man test 4, a
unit that fails on the simulator at the capacity rating indicated by
the manufacturer will not proceed to man test 4.
With respect to Federal Mine Safety and Health Act sec. 811(a)(9),
HHS is promulgating these CCER approval standards because they are an
improvement over the current standards. The main developments are that
the new standards shift to a more instructional and informative rating
[[Page 14177]]
system that addresses the documented shortcomings with the traditional,
duration-based system; the new standards avoid human test subject
variability in defining capacity by relying on the breathing and
metabolic simulator; the quality of breathing gas is more closely
monitored; and requirements for durability and functionality checks are
codified.
2. Duration Versus Capacity
Comment: HHS received ten comments on the proposal to rate these
respirators by capacity rather than by duration, as has been done
historically. Several of these commenters acknowledged that rating
CCERs according to their duration of breathing air poses problems for
users in the field, because, for example, 1-hour rated units often do
not provide 1 hour of air. One commenter in particular noted a concern
that ``miners have historically complained about units that stop
working prematurely,'' and that ``the criterion, `good for one hour,'
is misleading, at best.'' Two commenters said the change from duration
to capacity ratings will aid in the selection of CCERs for specific
industrial applications and will benefit physiologists and other
knowledgeable professionals. However, many commenters claimed the
change would be confusing to users and one commenter noted this would
be especially true where other self-contained breathing apparatus used
in the same workplace were still rated by duration. Some asserted that
no evidence exists to justify the need for such a change. Two of these
commenters opposing the change were among those who also acknowledged
that certifying CCERs according to duration is problematic and
potentially dangerous, as discussed above. One commenter asserted that
the proposed change is inconsistent with the rating system for every
open- and closed-circuit escape respirator in the world. Several
commenters requested that the final rule prescribe ``common sense''
instructions intended for use by the end-user, to provide a ``rule of
thumb'' example of the relationship between capacity and duration. One
commenter was particularly concerned that the change to a capacity
rating system will undermine the current 1-hour duration standard for
respirators used in underground coal mines, and sees no benefit to
miners of having information about capacity rather than duration. This
commenter suggested that the formula for assessing duration is not
rigid enough to ensure a full 1-hour duration and referred to
complaints by miners that, at times, units have appeared to stop
working prematurely or failed to function during escapes. The commenter
requested that HHS establish in the rule that units of less than 1-hour
duration cannot be used as a substitute for 1-hour units. Finally, one
respondent further commented that capacity-based certification could
result in conflicts under the Rail Safety Improvement Act (RSIA) of
2008; another expressed concern that capacity-based certification could
result in conflicts with ISO 23269-1:2008 Ships and marine technology--
Breathing apparatus for ships--Part 1: Emergency escape breathing
devices (EEBD) for shipboard use.
Response: HHS has considered these comments carefully, and has
decided to retain the provision that approved devices will be
classified according to capacity in the final rule. Because the
duration of adequate breathing gas supply actually provided to a user
by a CCER will depend on the degree of exertion involved in the
particular escape and the size of the respirator user, HHS believes the
change from an approval based on duration to one based on capacity is
important. The present duration rating is misleading and potentially
dangerous to users. The capacity rating system in the final rule
provides important information to those selecting CCERs that will
permit them to decide which respirator meets their needs.
The final rule establishes a 3-capacity ratings system: ``Cap 1,''
``Cap 2,'' and ``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 three 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.
As several commenters recognized, there is evidence that the
present duration system causes the user to believe that the apparatus
will last for a specific time, regardless of the user's weight,
physical condition, or activity.\14\ 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.
---------------------------------------------------------------------------
\14\ See, e.g., U.S. Mine Safety and Health Administration.
Report of Investigation: Fatal underground coal mine explosion;
January 2, 2006; Sago Mine, Wolf Run Mining Co.; Tallmansville,
Upshur County, WV. ID No. 46-08791.
---------------------------------------------------------------------------
It is important to remember that a CCER contains a fixed quantity
of oxygen; the duration of the oxygen it ultimately supplies will be
inversely proportional to its rate of use. 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.\15\
---------------------------------------------------------------------------
\15\ 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.
---------------------------------------------------------------------------
Under the final rule, NIOSH will measure the capacity of a CCER in
terms of the volume of oxygen, in liters, that the CCER effectively
delivers for consumption by the user. The final rule will require the
manufacturer to list on its label the liters of oxygen actually
delivered to the user as measured during the NIOSH capacity testing
(see Sec. 84.304(e)).
This information 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. An employer might
determine through simulation or analysis of possible escape scenarios
that its 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 of its workplace, to accommodate the routine work tasks
and escape contingencies of the employees. HHS believes that providing
the employers and the other professionals doing this analysis with
information as to the general capacity of the unit (low (Cap 1),
moderate (Cap 2) and high (Cap 3)) and the actual least achieved
quantity of oxygen the specified CCER will supply will greatly aid in
their ability to select the proper respirator.
This change to capacity rating will not result in a rating system
that is inconsistent with how other countries classify or are
considering classifying similar types of self contained breathing
apparatus. The European Norms (EN standards) currently categorize open-
and closed-circuit self-contained breathing apparatus (a type of
respirator similar to the CCER but used for entry
[[Page 14178]]
as well as escape) by volume and pressure of breathing gas; \16\ users
decide what size unit best meets their application. Moreover, while
CCERs are currently certified in Europe according to the duration of
oxygen provided by a unit, the International Standards Organization,
whose standards are intended to replace this current system, is also
considering a change to capacity ratings. HHS plans, in future
rulemakings, to move toward this capacity rating system for other self-
contained breathing apparatus that it regulates.
---------------------------------------------------------------------------
\16\ See European Standard BS EN 137:2006. Respiratory
protective devices--Self-contained open-circuit compressed air
breathing apparatus with full face mask--Requirements, testing,
marketing. British Standards Institute.
---------------------------------------------------------------------------
HHS will not require manufacturers to provide users with capacity
versus work activity information, although manufacturers are not
prohibited from providing such information. However, HHS does not
encourage or support the provision of such information, as it may
misinform CCER users about the actual amount of oxygen available to
them in any given escape, as discussed in the notice of proposed
rulemaking.\17\ Employers and their employees should test CCERs in
realistic scenarios and engage in appropriate training to identify CCER
models that meet their needs and to establish a clear understanding of
related performance factors. In particular, training is essential for
the employees to understand that the duration of time that they receive
protection from the device varies according to the actual amount of
oxygen in the unit and the rate of oxygen use which depends on the
escape conditions and the employee's body size and the employee's
physical condition.
---------------------------------------------------------------------------
\17\ 73 FR 75,027 at 75,032 (December 10, 2008).
---------------------------------------------------------------------------
With regard to the use of CCERs in coal mines, the record of
perceived and actual failures in coal mining played a substantial role
in instigating these improvements in respirator certification
standards. CCERs intended for use in mines will be so identified in the
NIOSH application for approval and subject to man test 4 as a condition
of MSHA co-approval. In addition to Cap 3 devices, Cap 1 and Cap 2
devices may be very appropriate for certain deployment conditions. This
deployment issue is not subject to HHS regulation or oversight.
With regard to the RSIA, the regulations required under that
statute concerning the use of emergency escape breathing apparatus
(nomenclature used by the railroad industry) have not yet been
promulgated. There is no reason to believe, however, that the capacity
rating to be implemented under this final rule would be problematic
with respect to such regulations. Similarly, with regard to the
maritime consensus standard, ISO 23269-1:2008, HHS does not find any
element of this final rule to conflict with the standard, which is more
restrictive than this rule. The maritime industry would not be
prevented from identifying CCERs as having a service duration of at
least 10 minutes, as specified under its consensus standard.
3. Capacity Ratings
Comment: HHS received several comments concerned with the capacity
ratings themselves, and the values proposed to achieve them. Two
comments questioned the proposed work rates for Cap 1 and 2 capacity
testing; in particular, the comments claimed that no evidence supports
the Cap 1 and 2 work rates. One comment disputed the use of the 1975
Kamon study \18\ to justify the proposed work rates, and also argued
that a 2005 University of Maryland study,\19\ which found that
exceptionally high work rates can exhaust current 60-minute CCERs in
far less than 60 minutes, provides evidence that the proposed capacity
work rates for Cap 1 and Cap 2 CCERs would require that these CCERs
increase in size and weight. Another comment proposed adding two
capacity ratings, and modifying Cap 3 oxygen capacity to range from 80
<= L <= 89. Finally, one comment suggested that the ventilation rate
for Cap 1 devices is contrary to experience with open-circuit escape
respirators that function with lower ventilation rates.
---------------------------------------------------------------------------
\18\ 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.
\19\ Johnson, AT. A review of self-contained self-rescuer
research. University of Maryland, Biological Resources Engineering,
Human Performance Laboratory; 2005.
---------------------------------------------------------------------------
Response: With regard to the Cap 1 and 2 work rates, higher
sustained work rates over shorter durations are fully supported by
human physiology research as cited in the proposed rule \20\ and by the
Kamon study. While the commenter notes the discrepancy between the
values determined by Kamon and the values applied in this rule, Kamon
cautioned that his data presented ``do not include the effects of a
breathing apparatus,'' and thus ``represents a minimum of the oxygen
requirements.'' \21\ HHS has taken into account the increased work rate
demands associated with the use of a breathing apparatus and with the
physiological limits defined by research. The work rates in this final
rule, including the higher rates specified for lower capacity devices,
were supported by the Navy in their comments during the concept
development stage of this rulemaking.\22\ The Navy makes extensive use
of these lower capacity CCERs and expects them to be designed to
support the high exertion levels expected for sailors escaping during
below-deck emergencies.
---------------------------------------------------------------------------
\20\ Louhevaara V, et al. Cardiorespiratory strain in jobs that
require respiratory protection. Int. Arch. Occup. Environ. Health.
1985;55:195-206. Lemon PW and Hermiston TT. The human energy cost of
fire fighting. J. Occup. Med. 1977;19:558-562.
\21\ 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 [emphasis in original].
\22\ 73 FR 75,027 at 75,033 (December 10, 2008).
---------------------------------------------------------------------------
With regard to the University of Maryland study, NIOSH notes that
CCER capacity testing will be determined ``depending on the capacity
specified by the manufacturer.'' \23\ Thus, for example, a device
identified as an 80 liter unit by the manufacturer will be tested at
the Cap 3 work rate (1.35 VO2 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 <45 L of oxygen, more than one unit must be tested in order to
be able to evaluate the relief valve which may not yet have been used.
For example, testing a CCER which has approximately 24 L of oxygen
would theoretically result in that unit running out of oxygen 4.5
minutes into period 2. This will sufficiently test the demand valve and
carbon dioxide absorbent canister; however, the pressure required to
operate the relief valve will still be unknown. Therefore, a second
unit would have to be tested at the sedentary work rate (0.5 liters/
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.............. <1.5%................................. <=4%.
Average inhaled O2............... >19.5%................................ >=15%.
Peak Breathing................... [Delta]P <= 200 mm H2O................ -300 <= [Delta]P <= 200 mm H2O.
Pressures........................
Wet-bulb temperature.\32\........ <43 [deg]C............................ <=50 [deg]C.
----------------------------------------------------------------------------------------------------------------
The acceptable ranges for inhaled carbon dioxide were determined by
physiological testing performed at the Noll Lab for Human Performance
Research at Pennsylvania State University. This research showed no
disabling physical effects in active men breathing 5 percent carbon
dioxide for long periods of time.\33\ Decision-making was slightly
impaired in some subjects after breathing 4 percent carbon dioxide for
1 hour. NIOSH has found in the testing of escape respirators that
carbon dioxide levels of 1.5 percent can be tolerated for the limited
periods for which these devices are designed without any deleterious
effect on the test subjects. Therefore, NIOSH requires the CCER to
maintain the inhaled levels of carbon dioxide below 4 percent (as a 1-
minute average) during all testing and below an average of 1.5 percent
over the full duration of the test.
---------------------------------------------------------------------------
\33\ 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.
---------------------------------------------------------------------------
The normal, sea-level oxygen content of air is approximately 21
percent. The minimum acceptable operating average of 19.5 percent for
inhaled oxygen that NIOSH requires the CCER to provide over the full
duration of the certification tests was determined based on OSHA's
respiratory protection standard 29 CFR 1910.134, which establishes a
minimum level of oxygen for protecting the health and safety of
workers. However, permitting oxygen levels to go as low as 15 percent
enables size and weight reductions of CCERs with little user
impact.\34\ The acceptable range for these excursions was determined
based on testing of pilots at various altitudes. This research
indicates that judgment, reaction time, spatial orientation, and other
cognitive processes begin to become impaired from chronic exposure at
oxygen levels below 15 percent.\35\ Therefore, NIOSH requires the CCER
to provide levels of oxygen above 15 percent (as a 1-minute average)
during all testing and above an average of 19.5 percent over the full
duration of the test. These limits would provide assurance that the
CCER user would never be prevented from escaping due to an insufficient
concentration of oxygen in the breathing gas supplied by the CCER.
---------------------------------------------------------------------------
\34\ Paul MA, Fraser WD. Performance during mild acute hypoxia.
Aviation, Space, and Environmental Medicine. 1994;65(10):891-899;
Malkin VB. Barometric pressure and gas composition. Foundations of
Space Biology and Medicine, Vol. II, Book 1: Ecological and
Physiological Bases of Space Biology and Medicine. 1975 at 25-31;
and Fowler B, Paul M, Porlier G, Elcombe DD, and Taylor M. A re-
evaluation of the minimum altitude at which hypoxic performance
decrements can be detected. Ergonomics. 1985;28(5):781-791.
\35\ Fowler B, Paul M, Porlier G, Elcombe DD, Taylor M. A
reevaluation of the minimum altitude at which hypoxic performance
decrements can be detected. Ergonomics. 1985;28(5):781-791.
---------------------------------------------------------------------------
The acceptable ranges for wet-bulb \36\ temperature are based on
physiological research conducted at Pennsylvania State University.
Researchers found the highest tolerable wet-bulb temperature of inhaled
air was approximately 50 [deg]C.\37\ Based on such research and NIOSH
findings from testing escape respirators, NIOSH establishes 50 [deg]C
as an excursion limit and 43 [deg]C as an average operating
requirement. Test subjects have found this temperature to be tolerable
during the 1-hour certification tests.
---------------------------------------------------------------------------
\36\ For the same inhaled air temperature, the thermal load of
humid air is higher than that of dry air. The maximum thermal load
tolerated by a human being can be specified by many combinations of
dry-bulb temperature and relative humidity, or by one wet-bulb
temperature, for which the temperature is measured using a wet
thermometer surface. Researchers have demonstrated that the wet-bulb
temperature of the inspired air most accurately measures heat stress
to the tissues of the mouth, as compared to temperature readings
from an ordinary, dry thermometer, even when combined with the
control of relative humidity. 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.
\37\ 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.
---------------------------------------------------------------------------
The ranges for peak breathing pressures were determined based on
physiological research indicating that most individuals can generate
peak breathing pressures equaling or exceeding -300 to 200 mm of
H2O 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 <= L <= 59......... 2.50 2.50 55 22
Cap 2............................... 60 <= L <= 79......... 2.00 1.80 44 20
Cap 3............................... L >= 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\
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\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.
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[[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.
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\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.
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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.
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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\
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\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.
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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.................... <1.5%..................... <=4%.
Average inhaled O2..................... >19.5%.................... >=15%.
Peak Breathing Pressures............... [Delta]P <= 200 mm H2O.... -300 <= [Delta]P <= 200 mm H2O.
Wet-bulb temperature\1\................ <43[deg]C................. <=50[deg]C.
----------------------------------------------------------------------------------------------------------------
\1\ 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.
(c) Capacity and performance tests will conclude when the stored
breathing gas supply has been fully expended.
(d) NIOSH will determine a CCER to have failed a capacity,
performance, or wearability test if any of the following occurs:
(1) A 1-minute average measurement of any stressor listed in Table
1 occurs outside the acceptable excursion range specified in Table 1;
or an average stressor measurement calculated at the completion of a
performance or capacity test exceeds the acceptable operating average
range specified in Table 1; or
(2) A human subject cannot complete the test for any reason related
to the CCER, as determined by NIOSH.
(e) Unless otherwise stated, tests required under this subpart will
be conducted at the following ambient conditions:
(1) Ambient temperatures of 23 [deg]C 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 <= L <= 59......... 2.50 2.50 55 22
Cap 2............................... 60 <= L <= 79......... 2.00 1.80 44 20
Cap 3............................... L >= 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 <=
height <174 cm, regardless of weight, or 72 kg >= weight <90 kg,
regardless of height; and one subject of height <163 cm and weight <72
kg. All units tested must meet all conditions specified in this section
to receive approval.
(b) NIOSH will evaluate the ease and speed with which users can don
the CCER, as follows:
(1) Each test subject will be provided with manufacturer
instructions, and must be able to don the CCER correctly, isolating the
lungs within 30 seconds; \1\ and
---------------------------------------------------------------------------
\1\ This time limit does not apply to any additional steps that
might be required after the lungs are protected to adjust the unit
for wear.
---------------------------------------------------------------------------
(2) A CCER must not include any design, construction, or material
characteristic that can be anticipated or demonstrated, under plausible
conditions, to hinder the user in the correct and timely donning of the
CCER.
(c) NIOSH will continuously monitor CCER use by each test subject
during the activities specified in Table 4 to evaluate the ability of
the CCER to provide an adequate and uninterrupted breathing supply,
including but not limited to the requirements of Sec. 84.303(b),
without harming or hindering a user. NIOSH will not approve a CCER if
the use of any unit during these activities indicates any potential for
the CCER to harm or hinder the user or to fail to provide an adequate
and uninterrupted breathing supply to
[[Page 14196]]
the user during reasonably anticipated conditions and activities of 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 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