Approval Tests and Standards for Closed-Circuit Escape Respirators; Notice of Proposed Rulemaking, 75027-75045 [E8-29235]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 238 (Wednesday, December 10, 2008)]
[Proposed Rules]
[Pages 75027-75045]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29235]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

RIN 0920-AA10


Approval Tests and Standards for Closed-Circuit Escape 
Respirators; Notice of Proposed Rulemaking

AGENCY: Centers for Disease Control and Prevention (CDC).

ACTION: Notice of proposed rulemaking.

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

SUMMARY: This notice proposes updated requirements that the Department 
of Health and Human Service's (HHS), Centers for Disease Control and 
Prevention's (CDC) National Institute for Occupational Safety and 
Health (NIOSH) would 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 
mines. NIOSH and MSHA jointly review and approve this type of 
respirator used for mine emergencies under 42 CFR pt. 84, Approval of 
Respiratory Protective Devices. NIOSH also approves these respirators 
used in other work environments where escape equipment may be provided 
to workers, such as vessels operated by U.S. Navy and Coast Guard 
personnel. The proposed rule would replace only those technical 
requirements in 42 CFR Part 84--Subpart H that are uniquely applicable 
to closed-circuit escape respirators (CCERs), a subset of the variety 
of escape respirators presently covered by Subpart H. All other 
applicable requirements of 42 CFR Part 84 would remain unchanged. The 
purpose of these updated requirements is to enable NIOSH and MSHA to 
more effectively ensure the performance, reliability, and safety of 
CCERs.

DATES: CDC invites comments on this proposed rule from interested 
parties. Comments must be received by February 9, 2009.

ADDRESSES: You may submit comments, identified by RIN: 0920-AA10, by 
any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: niocindocket@cdc.gov. Include ``RIN: 0920-AA10'' 
and ``42 CFR pt. 84'' in the subject line of the message.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking, RIN: 0920-AA10. All comments received will be posted 
without change at the NIOSH docket Web page: https://www.cdc.gov/niosh/
docket, including any personal information provided. For detailed 
instructions on submitting comments and additional information on the 
rulemaking process, see the ``Public Participation'' heading of the 
SUPPLEMENTARY INFORMATION section of this document. Background 
information on this rulemaking is available at the NIOSH Web page: 
https://www.cdc.gov/niosh/npptl.

FOR FURTHER INFORMATION CONTACT: Tim Rehak, NIOSH National Personal 
Protective Technology Laboratory (NPPTL), Pittsburgh, PA, (412) 386-
6866 (this is not a toll-free number). Information requests can also be 
submitted by e-mail to niocindocket@cdc.gov.

SUPPLEMENTARY INFORMATION: 

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this proposal.
    Comments submitted by e-mail or mail should be titled ``Docket 
005 Public Comments'', addressed to the ``NIOSH Docket 
Officer'', and identify the author(s), return address, and a phone 
number, in case clarification is needed. Comments can be submitted by 
e-mail to niocindocket@cdc.gov as e-mail text or as a Word or Word 
Perfect file attachment. Printed comments can be sent to the NIOSH 
Docket Office at the address above. All communications received on or 
before the closing date for comments will be fully considered by CDC.
    All comments submitted will be available for examination in the 
rule docket (a publicly available repository of the documents 
associated with the rulemaking) both before and after the closing date 
for comments. A complete electronic docket containing all comments 
submitted will be available after the closing date at https://
www.cdc.gov/niosh/docket. Comments will also be made available in 
writing upon request. NIOSH includes all comments received without 
change in the docket, including any personal information provided.

II. Background

A. Introduction

    A closed-circuit escape respirator (CCER) technically defined as a 
closed-circuit, self-contained breathing apparatus (SCBA) 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 (SCSR), is primarily used by 
miners to escape dangerous atmospheres in mines. It is also used by 
certain Navy personnel, such as crews working below decks on vessels, 
to escape dangerous atmospheres. To a lesser extent, it is also used by 
other industries involved in working

[[Page 75028]]

underground or in confined spaces, such as tunneling operations in the 
construction industry and in the maritime 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, that employ either 
compressed oxygen or a chemical source of oxygen, plus a chemical 
system for removing exhaled carbon dioxide from the breathing circuit. 
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 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. Certification of CCERs

    NIOSH certifies CCERs under 42 CFR pt. 84, Approval of Respiratory 
Protective Devices. NIOSH and MSHA jointly review and approve such 
respirators for use by miners to escape hazardous atmospheres generated 
during emergencies in underground coal mines.\1\ In those regulations, 
Subpart H, Self-Contained Breathing Apparatus, specifies testing and 
certification requirements for these respirators, identified in the 
regulations as closed-circuit apparatus for ``escape only.'' The 
subpart 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.
---------------------------------------------------------------------------

    \1\ See 42 CFR 84.3.
---------------------------------------------------------------------------

C. Need for Rulemaking

    Storage of CCERs in harsh environmental conditions, such as extreme 
heat, cold, and humidity, and the daily wearing of the respirators 
during physical work and on and around vibration-generating equipment 
and tools, can result in damage that degrades the respirators' 
performance, despite their protective cases. NIOSH field evaluations of 
certified 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 certified.\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 are not governed by current regulations 
and do not exist in some of the respirators currently available.
---------------------------------------------------------------------------

    \2\ Kyriazi N, Shubilla JP [2002]. Self-contained self-rescuer 
field evaluation: seventh-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, DHHS (NIOSH) Publication No. 2002-
127, RI 9656.
---------------------------------------------------------------------------

    Furthermore, current performance testing requirements for CCERs 
rely on a non-uniform testing regime, which does not control for 
differences between human subjects involved in the testing. This can 
produce variation in test results. The proposed improvements would 
establish a consistent testing regimen for evaluating the life support 
capability of CCERs.
    Finally, the current certification requirements might be 
contributing to a risk communication and risk management problem. NIOSH 
is currently required to approve these respirators as providing 
protection for a specific duration \3\ 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 
and less physically fit 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.
---------------------------------------------------------------------------

    \3\ These certifications are defined in four discrete durations 
ranging from 15 minutes to one hour.
---------------------------------------------------------------------------

    Since 1982, NIOSH has received reports of incidents in which users 
purportedly have not received the duration of protection implied by the 
certification. While such incidents could have resulted from the 
respirator failing to perform as certified, they might also reflect 
limitations of understanding about the testing criteria regarding 
duration.
    This rulemaking proposes to eliminate the duration-specific 
approval, replacing it with a capacity rating system based on the 
quantity of usable oxygen supplied by the model. NIOSH would also 
assist MSHA and other agencies to foster the use of effective practices 
by which employers can select the model of certified respirator best 
suited to the physical sizes of their employees and the particular 
escape contingencies their employees might encounter. Effective 
practices would include selecting a maximum capacity model of CCER or 
empirically testing different models in simulated escapes to determine 
which models provide an adequate breathing supply and are suitable in 
terms of other practical concerns.
    In addition, over the last several decades, the mining community 
has encountered various problems with particular CCER designs, some of 
which could be prevented through additional certification requirements. 
These issues are identified and addressed in the discussion of the new 
provisions for testing the safety features and the ``wearability'' of 
CCERs.
    Persons interested in a detailed examination of issues concerning 
the current use, limitations of, and opportunities for improving CCERs 
may wish to review the report of an interagency task force led by the 
Department of Labor, which included representatives from the mining 
industry, labor, and respirator manufacturers. The report, entitled 
``Joint Government, Labor, Industry Task Group on Person Wearable, 
Self-Contained, Self-Rescuers,'' is available from the NIOSH Web page: 
https://www.cdc.gov/niosh/npptl or upon request to NIOSH.

D. Scope of the Rulemaking

    This rulemaking is intended to apply only to CCERs. It would 
establish new testing and certification requirements for these 
respirators, replacing all testing and certification requirements of 42 
CFR pt. 84, Subpart H, that are uniquely applicable to closed-circuit 
SCBAs used only for escape. This rulemaking would not alter the testing 
and certification requirements applicable to the other types of 
respirators included under Subpart H.

E. Impact on Rulemaking and Other Activities of MSHA

    The proposed rule might require MSHA to promulgate limited, non-

[[Page 75029]]

substantive changes to incorporate the terminology of this rule, i.e., 
``CCER'' versus ``SCSR,'' and to reflect the new capacity rating system 
being proposed. As discussed and documented in the summary of the new 
rating system presented in Section 84.304, the proposed capacity rating 
of ``Cap 3'' is equivalent to the ``60-minute'' duration rating 
currently certified by NIOSH and referenced as a requirement in MSHA 
regulations.\4\
---------------------------------------------------------------------------

    \4\ See 30 CFR 75.1714(a).
---------------------------------------------------------------------------

    In addition, MSHA would modify relevant MSHA training programs to 
incorporate the use of respirators approved under the proposed new 
rating system and the proposed phasing-in of these respirators, 
discussed under Sec.  84.301.

F. Public Meetings for Discussion and Comment

    NIOSH held public meetings to discuss technical issues addressed in 
this proposed rule in Arlington, Virginia on April 10, 2003, and 
Golden, Colorado, on April 24, 2003. NIOSH held a second set of public 
meetings at these two locations on September 19th and September 28th of 
2006 respectively, to provide the public with an opportunity to address 
any new perspectives resulting from Sago and other recent mine 
disasters.\5\ Official transcripts of the meetings are available from 
the NIOSH Docket Office at the address provided above in the Summary.
---------------------------------------------------------------------------

    \5\ Notice of these meetings was published in the Federal 
Register on March 20, 2003 (68 FR 13712) and August 31, 2006 (71 FR 
51829). NIOSH also sent a letter announcing the meeting to known 
stakeholders and posted it on the NIOSH Web page: https://
www.cdc.gov/niosh/nppt1).
---------------------------------------------------------------------------

    NIOSH will convene public meetings to provide stakeholders with an 
opportunity to provide oral comment on this rulemaking during the 
comment period. The meetings will be in the vicinities of Washington DC 
and Denver, CO and are announced in a separate notice in this issue of 
the Federal Register.

III. Summary of Proposed Rule

    This proposed rule would establish new requirements for testing and 
certification of CCERs under a new Subpart O of 42 CFR pt. 84--Approval 
of Respiratory Protective Devices. The new subpart would replace all 
current requirements for testing and certification of CCERs found under 
Subpart H. The following is a section-by-section summary which 
describes and explains the provisions of the rule. The public is 
invited to provide comment on any aspect of the proposed rule. The 
complete, proposed regulatory text for the proposed rule is provided in 
the last section of this notice.

Subpart O

Section 84.300
    This section provides a general description of CCERs 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 certification program.
Section 84.301
    This section would establish a schedule for phasing-in the 
implementation of the testing and certification requirements of the 
proposed rule. A phase-in process would allow 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 will also ensure that during 
the interim, there is a constant supply of CCERs approved under the 
current regulations. Upon promulgation, the new requirements would be 
immediately applied to all new CCER designs that are submitted for 
approval. Manufacturers and distributors could continue to sell CCERs 
with current approvals for up to three years after promulgation of the 
new requirements. CCERs with current approvals could remain in use or 
be available for use as approved devices for up to six years after 
promulgation of the new requirements. The only exception would be for 
individual units that exceed their manufacturer-designated service life 
within this time period.
    The phase-in period would also substantially reduce the potential 
economic costs \6\ to employers of replacing or retrofitting any 
respirators that remain in use at their worksite, but do not pass the 
new certification tests. Designations of service life for currently 
approved CCERs range from 10 to 15 years.\7\ However, 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 less than 
designated, due to wear and tear and damaging environmental 
conditions.\8\
---------------------------------------------------------------------------

    \6\ See Section IV.A of this preamble for a discussion of these 
potential economic costs.
    \7\ 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.
    \8\ 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 NIOSH 
internal reports, and actionable findings provide the basis for 
remedies addressed by NIOSH and the applicant.
---------------------------------------------------------------------------

    NIOSH is seeking public comment on the proposed phase-in schedule. 
NIOSH believes this schedule allows sufficient time for the continued 
use of currently approved devices to ensure a constant, adequate supply 
while providing substantial incentives to manufacturers for bringing 
improved technology to market as quickly as possible. The phase-in 
would also require employers to replace deployed devices, including 
those with remaining service life, that cannot pass the proposed new 
requirements within a reasonable transition period. NIOSH expects that 
newly approved devices would become available soon after the final rule 
becomes effective since current technology, with relatively minor 
design improvements, can meet the proposed new requirements. 
Manufacturers have substantial incentive to bring to market as quickly 
as possible devices that meet the new requirements since employers are 
likely to prefer to purchase such devices for their improved 
performance and to minimize the potential economic costs of the six-
year approval limitation in the proposed rule.
    NIOSH also seeks public comment on an alternative to the proposed 
phase-in, which would be to retain the proposed three-year limit on 
sales of devices approved under the current standard, but eliminate the 
six-year limit on the approval status of devices purchased after the 
effective date of the final rule. The argument for this alternative is 
that employers would be able to use the full service life of devices 
purchased (which were approved under the current requirements). This 
would minimize any economic impact of the proposed rule on employers. 
However, under this alternative, it is conceivable that a substantial 
number of devices approved under the current requirements could remain 
deployed in workplaces for as long as 13 to 18 years following the 
effective date of the final standard, given the current service life 
range of 10 to 15 years.
    NIOSH invites public comment on reasons that it might be unlikely 
that large numbers of older devices would in fact remain deployed for 
such an extensive period, particularly in mining. For example, one 
reason may be that the deployment conditions in mining are

[[Page 75030]]

especially damaging, as discussed above, making it unlikely that a unit 
would remained deployed for 13 to 18 years. Second, it is in the 
interest of employers to provide their employees with the best 
available protective equipment; this is especially important in the 
mining industry, where concerns about the performance of CCERs are 
particularly salient. Finally, MSHA and OSHA have authority to require 
employers to provide employees with devices approved under the proposed 
new requirements, should the agencies determine such a regulatory 
measure were necessary to assure safe and healthful working conditions. 
NIOSH believes that none of these reasons provide assurance of a rapid 
replacement of devices that are not approved under the proposed new 
requirements. NIOSH lacks adequate information to predict how quickly 
devices that cannot pass the proposed new requirements would be fully 
replaced.
    Another alternative is establishment of a time-limit different from 
the proposed six years for the continued use of the CCERs certified 
under the current requirements. NIOSH seeks public comment on whether 
to establish a different balance between providing the best possible 
protective equipment to employees and controlling the potential 
economic impact on employers of replacing deployed equipment, 
recognizing that in any case manufacturers will require time to develop 
and bring new products to market. NIOSH judges that six years 
represents a reasonable balance between public health and economic 
concerns, allowing more than half of the service life \9\ of devices 
purchased up to the effective date of the final rule to pass before 
requiring their replacement (even if they're still operational).
---------------------------------------------------------------------------

    \9\ See note 7.
---------------------------------------------------------------------------

    NIOSH also invites comment on an alternative to the proposed phase-
in that would allow a specific exception for the Department of Defense 
(DoD). Under this alternative, for all uses other than for the DoD, the 
proposed three year limit on sales of devices approved under the 
current standard would be retained, and would also set the six-year 
limit on the approval status of devices after the effective date of the 
final rule. However, this alternative would permit the DoD to use the 
full service life of devices, which were approved under the current 
requirements, based on the DoD deployment plan where CCERs are retained 
in conditions of storage.
    NIOSH also seeks public comment specifying and characterizing the 
particular burden (financial or otherwise), if any, that would be 
imposed on specific affected parties by the proposed phase-in periods; 
whether there is an unsupportable or serious burden that would be 
imposed on any affected parties; and whether there are other interests 
that NIOSH should consider in deciding this matter.
    In seeking public input on the concepts underlying the proposed 
rule, NIOSH received comments from two respirator manufacturers and a 
representative of the Navy opposing the six-year limit on the 
deployment of devices approved under the current requirements. The 
commenters objected to the imposition of costs that would be incurred 
by employers who would have to replace deployed devices with remaining 
service life at the end of the six-year limit. No comment was received 
objecting to the three-year limit for the sale of devices approved 
under the current requirements.
Section 84.302
    This section specifies the components, attributes, and instructions 
that would be required to be included with 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 (b)).
    Paragraph (a)(2) would require the manufacturer to 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) would require the manufacturer to 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.\10\ Two manufacturers currently design 
their CCERs with a means of detecting such damage.
---------------------------------------------------------------------------

    \10\ Same as footnote 2.
---------------------------------------------------------------------------

    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 
pt. 107: ``Hazardous Materials Program Procedures,'' unless exempted 
under Subpart B of the DOT regulation.
    Paragraph (a)(5) would require the manufacturer to 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.\11\
---------------------------------------------------------------------------

    \11\ 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, DHHS (NIOSH) Publication No. 2000-
128, RI 9451.
---------------------------------------------------------------------------

    Paragraph (a)(6) would require the manufacturer to include a means 
to detect the ingress of any water or water vapor that could degrade 
the performance of the unit, unless the CCER were designed for its 
casing to be opened for frequent inspection. Because the chemical 
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 (c) would require manufacturers to 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 available from the NIOSH Web page https://
www.cdc.gov/niosh/npptl. The test will be conducted on a single CCER 
unit.

[[Page 75031]]

    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 would not be new. It is 
included under Subpart H of this part (Sec.  84.85) for all SCBAs 
currently approved by NIOSH.
    Paragraphs (d) and (e) would require that the design, construction, 
and materials of CCERs not introduce combustion or other unspecified 
safety or health hazards.
    Paragraph (f) would require manufacturers to provide users with 
instructions and a service life plan to accompany each unit. These 
requirements generally reflect current practice. It is important that 
users receive comprehensive guidance concerning the use and service 
life of CCERs.
Section 84.303
    This section would establish the general testing conditions and 
requirements for the certification of CCERs.
    Paragraph (a) specifies that NIOSH would use the breathing and 
metabolic simulator tests specified in this subpart for all 
quantitative evaluations of the performance of a CCER. NIOSH would 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.\12\ 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.\13\ These studies, which include side-by-side comparisons of 
respirator testing using three-person panels of human subjects on 
treadmills against testing using a breathing and metabolic simulator, 
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. The advantage of the 
simulators, as discussed in II.C. of the preamble, is that their 
performance for all metabolic parameters can be calibrated and 
replicated, whereas each human test subject performs uniquely, making 
the testing less repeatable.
---------------------------------------------------------------------------

    \12\ Kyriazi N (1986). Development of an automated breathing and 
metabolic simulator. Pittsburgh, PA: U.S. Department of the 
Interior, Bureau of Mines, IC 9110.
    \13\ Kyriazi N, Kovac JG, Shubilla JP, Duerr WH, Kravitz J 
[1986]. Self-Contained Self-Rescuer Field Evaluation: First-Year 
Results of 5-year Study. Pittsburgh, PA: U.S. Department of the 
Interior, Bureau of Mines, RI 9051.
    Kyriazi N, Shubilla JP [1992]. Self-Contained Self-Rescuer Field 
Evaluation: Results from 1982-1990. Pittsburgh, PA: U.S. Department 
of the Interior, Bureau of Mines, RI 9401.
    Kyriazi N, Shubilla JP [1994]. Self-Contained Self-Rescuer Field 
Evaluation: Fourth-Phase Results. Pittsburgh, PA: U.S. Department of 
the Interior, Bureau of Mines, RI 9499.
    Kyriazi N, Shubilla JP [1996]. Self-Contained Self-Rescuer Field 
Evaluation: Fifth-Phase Results. Pittsburgh, PA: U.S. Department of 
Energy, RI 9635.
    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, DHHS (NIOSH) Publication No. 2000-128, IC 9451.
    Kyriazi N, Shubilla JP [2002]. Self-Contained Self-Rescuer Field 
Evaluation: Seventh-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, DHHS (NIOSH) Publication No. 2002-127, IC 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 page: https://www.cdc.gov/niosh/npptl.
    Paragraph (b) specifies that four stressors would 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 sensed by the CCER user's trachea). Paragraph (d) 
establishes that CCERs must perform within the acceptable ranges of 
measurement specified in the table below.

                            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 \14\..............  <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.\15\ Decision-making was slightly 
impaired in some subjects after breathing 4 percent carbon dioxide for 
one 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 would require the CCER to 
maintain the inhaled levels of carbon dioxide below 4 percent (as a 
one-minute average) during all testing and below an average of 1.5 
percent over the full duration of the test.
---------------------------------------------------------------------------

    \14\ 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.
    \15\ Kamon E, Deno S, Vercruyyen M [1984a]. 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, p. 13.
---------------------------------------------------------------------------

    The normal, sea-level oxygen content of air is approximately 21 
percent. The minimum acceptable operating average of 19.5% for inhaled 
oxygen that NIOSH would require 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

[[Page 75032]]

level of oxygen for protecting the health and safety of workers. 
However, the technology used in CCERs requires NIOSH to permit brief 
excursions on the oxygen supply to above 15% for up to one minute. 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.\16\ Therefore, NIOSH would require the CCER to provide levels 
of oxygen above 15 percent (as a one-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.
---------------------------------------------------------------------------

    \16\ Fowler, B., Paul, M., Porlier, G., Elcombe, D.D., Taylor, 
M. 1985. A reevaluation of the minimum altitude at which hypoxic 
performance decrements can be detected. Ergonomics, 28(5): 781-791.
---------------------------------------------------------------------------

    The acceptable ranges for wet-bulb \17\ temperature are based on 
physiological research at Pennsylvania State University. Researchers 
found the highest tolerable wet-bulb temperature of inhaled air was 
approximately 50 [deg]C.\18\ Based on such research and NIOSH findings 
from testing escape respirators, NIOSH proposes 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 one-
hour certification tests.
---------------------------------------------------------------------------

    \17\ 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 et al., 1984b).
    \18\ Kamon E, Deno S, Vercruyyen M [1984b]. 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, p. 117, 119.
---------------------------------------------------------------------------

    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 millimeters 
of H2O for only a short period of time.\19\ Based on NIOSH 
findings from testing escape respirators, the 200 millimeter 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.
---------------------------------------------------------------------------

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

    In addition to establishing these stressor limits for testing, this 
section would provide 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 
relinquish 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 would 
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 would threaten the successful use of the CCER for 
an escape.
Section 84.304
    This section specifies the testing regime that would 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 would ensure the 
CCER provides the certified quantity as a constantly adequate supply of 
breathing gas, in terms of the stressors addressed in Section 84.303 of 
this Part. The capacity would be evaluated in terms of the volume of 
oxygen, in liters, that the CCER effectively delivers for consumption 
by the user. All volumes are given at standard temperature (0 [deg]C) 
and pressure (760 mm Hg), dry, unless otherwise noted. This capacity 
can differ from the volume of oxygen physically or chemically 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 one hundred and ninety 
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.\20\
---------------------------------------------------------------------------

    \20\ Kamon E, Bernard T, Stein R [1975]. Steady state 
respiratory responses to tasks used in Federal testing of self-
contained breathing apparatus. AIHA J 36:886-896.
---------------------------------------------------------------------------

    A three capacity ratings system would be established: ``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 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.
    The Cap 3 rating is equivalent to the current NIOSH-certified 60-
minute rating for CCERs. 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.\21\ 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. It would help prevent misunderstandings that 
could lead employers to select a CCER model that is inadequate for a 
particular set of escape contingencies and that could mislead an 
employee regarding the amount of breathing supply remaining during an 
escape. Using the hypothetical example of the one hundred and ninety 
pound man in the previous paragraph, 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

[[Page 75033]]

durations achieved by users in actual or simulated escapes.
---------------------------------------------------------------------------

    \21\ See 42 CFR 84.100, Table 4 for the specific requirements of 
Man test 4.

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

    NIOSH is seeking information on the capacity versus work activity 
information provided in the table to determine if the provided 
information is useful to users for developing escape respirator 
deployment plans. NIOSH is also seeking opinions on whether a table, 
such as described above, should be required to be provided by the CCER 
manufacturer in the CCER user instructions.
    In addition to having a capacity rating system to categorize 
products, manufacturers would be able to use the actual tested capacity 
of approved respirator models, which NIOSH would report to the 
manufacturer in increments of 5 liters, to specify more precisely the 
capacity of each product. This would 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 would evaluate seven CCER units using the 
breathing and metabolic simulator. Three would be tested in the 
condition received from the applicant (i.e., ``new'' condition), two 
would receive environmental treatments prior to capacity testing, and 
the remaining two units would be tested at the cold-temperature limit 
specified by the manufacturer, after being stored at the specified 
temperature.
    Each unit would be tested at the work rate identified in the table 
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 .\22\ As the table 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. To further evaluate these proposed test parameters, NIOSH 
invites the public to submit comparable data on physiological 
monitoring of worker populations at varied levels and durations of 
exertion.
---------------------------------------------------------------------------

    \22\ Kamon E, Bernard T, Stein R [1975]. Steady state 
respiratory responses to tasks used in Federal testing of self-
contained breathing apparatus. AIHA J 36:886-896.
---------------------------------------------------------------------------

    In December 2006, NIOSH received comments from a respirator 
manufacturer regarding the use of different work rates to test CCERs of 
different capacities. The manufacturer recommended that NIOSH apply the 
same work rate irrespective of the capacity of the device being 
evaluated.
    The Navy, which is the principal consumer of low capacity CCERs, 
has specifically requested that NIOSH test at a high work rate the 
CCERs used by Navy personnel. This is consistent with the premise that 
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 has specified such an approach in 
this proposed rule. NIOSH welcomes further comment and information 
regarding this matter.
    One of the units submitted would 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.

                                           Capacity Test Requirements
----------------------------------------------------------------------------------------------------------------
                                 Capacity (L of
        Capacity rating                O2)          VO2 (L/min)    VCO2 (L/min)     Ve (L/min)          RF
----------------------------------------------------------------------------------------------------------------
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/min; VCO2 = volume of carbon dioxide produced/min.
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 approved for use in coal mines 
under the Cap 3 rating, NIOSH would also continue to conduct the one-
hour Man test 4 discussed above, as required under the current 42 CFR 
Part 84 regulations. Although the proposed capacity system and tests 
using the breathing and metabolic simulator represent a substantial 
improvement over the existing Man test 4, the Federal Mine Safety and 
Health Act requires that ``no mandatory health or safety standard

[[Page 75034]]

* * * shall reduce the protection afforded miners by an existing 
mandatory health or safety standard.'' 30 U.S.C. 811(a)(9). Since NIOSH 
would no longer approve CCERs as one-hour devices under this proposed 
rule, NIOSH must be able to demonstrate that the use of the Cap 3 
rating and associated tests to approve equipment for use in underground 
mines would not constitute a reduction in protection or a reduction in 
the duration of breathing supply regulated under the current MSHA one-
hour requirement for SCSRs. NIOSH believes that the continued use of 
the Man test 4, as a supplement to the proposed new testing 
requirements and capacity rating system, would be the most practical 
method of accomplishing such a demonstration. NIOSH invites public 
comments on this or any alternative approaches that might effectively 
address this legal requirement.
    In addition, NIOSH invites public comment on the oxygen consumption 
rate associated with breathing and metabolic simulator testing for the 
Cap 3 rating. As discussed above, the oxygen consumption rate 
associated with this rating would be the average rate demonstrated 
through NIOSH testing of the 50th percentile miner by weight (191 
pounds) performing the 1-hour Man test 4. NIOSH could require a more 
stringent testing parameter, such as the oxygen consumption rate 
associated with the 95th percentile miner by weight (220 pounds). The 
effect of a more stringent standard would be to increase the minimum 
quantity of adequate breathing gas supplied under a Cap 3 rating. This 
increased minimum supply would be accompanied, however, by a 
commensurate increase in the minimum sizes of CCERs that could be 
designed under the Cap 3 rating. This is of concern because the larger 
that a CCER is designed to be (to supply a greater minimum capacity of 
breathing gas), the less practical the CCER becomes to be worn on a 
belt (for availability in case of an emergency) during routine work 
activities. Limiting the size of CCERs has been a consistent concern of 
miners. NIOSH is proposing an oxygen consumption rate based on the 50th 
percentile miner as a reasonable balance between establishing an 
adequate minimum breathing gas supply for demanding escape scenarios 
and ensuring that available devices can be worn safely, practically, 
and without excessive discomfort for the duration of a work shift.
Section 84.305
    This section specifies the performance testing regimen that would 
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 
would 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) 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.
    In December 2006, NIOSH received comments from a respirator 
manufacturer recommending that NIOSH test devices in compliance with 
the manufacturer's user instructions. This recommendation would mean 
that NIOSH would not evaluate the potential for hypoxia when testing a 
CCER that uses compressed rather than chemical oxygen, since users are 
not instructed to exhale into such respirators upon donning them.
    NIOSH performance testing assumes that some CCER users will not 
comply with manufacturer's instructions. 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. 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 has proposed a generic 
performance testing protocol, irrespective of CCER design, that 
includes the hypoxia testing procedure. NIOSH welcomes further comments 
and information from the public concerning this matter.
    The performance testing would evaluate five CCER units using the 
breathing and metabolic simulator. Of these, three units would be 
tested in new condition, and two would receive environmental treatments 
prior to performance testing. The testing regimen would 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 the table 
below.

                                          Performance Test Requirements
----------------------------------------------------------------------------------------------------------------
                                   Duration per                                                    RF (breaths/
     Work-rate test sequence       cycle (min.)     VO2 (L/min)    VCO2 (L/min)     Ve (L/min)         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/min; VCO2 = volume of carbon dioxide produced/min.
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.\23\
---------------------------------------------------------------------------

    \23\ ``Evaluation of Proposed Methods to Update Human Testing of 
SCBA,'' Turner, Beeckman, and Hodous, AIHA Journal, Volume 56, 
December 1995, pp 1195-1200. ``Cardiorespiratory strain in jobs that 
require respiratory protection,'' Louhevaara, V., T. Tuomi, J. 
Smolander, O. Korhonen, et al., Int. Arch. Occup. Environ. Health. 
55:195-206, 1985. ``The human energy cost of fire fighting,'' Lemon, 
P.W. and T.T. Hermiston, J. Occup. Med. 19:558-562, 1977.
---------------------------------------------------------------------------

    The test would be started by the exhalation of two large breaths 
into the unit before donning it. This would

[[Page 75035]]

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 would 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 
would repeat the cycle until the oxygen supply is exhausted, as 
indicated in the graph below.
    One unit would 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] TP10DE08.003

Section 84.306
    This section specifies the testing regimen that would 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 would not physically harm or significantly hinder the user and 
would provide an adequate and uninterrupted supply of breathing gas. 
Testing would be conducted using three human subjects of differing 
heights and weights,\24\ as specified, to provide reasonable assurance 
that the results would be representative of most potential CCER users.
---------------------------------------------------------------------------

    \24\ The size range is intended to be representative of 
respirator users. See: Zhuang Z and Bradtmiller B [2005]. Head-and-
face anthropometric survey of U.S. respirator users. Journal of 
Occupational and Environmental Hygiene 2: 567-576.
---------------------------------------------------------------------------

    Subsection (b) would require 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,\25\ is reasonably protective in the 
case of emergency scenarios involving an explosion or sudden detection 
of a hazardous breathing environment. This subsection would allow 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.
---------------------------------------------------------------------------

    \25\ Vaught C, Brnich MJ, and Kellner HJ (1988). 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, RI 9208.
---------------------------------------------------------------------------

    Subsection (c) and the table below specify the activities that 
would 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 would 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.

                      Wearability Test Requirements
------------------------------------------------------------------------
           Activity                         Minimum duration
------------------------------------------------------------------------
Sitting......................  1 min.
Stooped walking..............  1 min.
Crawling.....................  1 min.
Lying on left side...........  1 min.
Lying on right side..........  1 min.
Lying on back................  1 min.
Bending over to touch toes...  1 min.
Turning hea