[Federal Register Volume 73, Number 238 (Wednesday, December 10, 2008)]
[Proposed Rules]
[Pages 75027-75045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-29235]
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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.
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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: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected]. 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: http://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:
http://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 [email protected].
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 [email protected] 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 http://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.
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\1\ See 42 CFR 84.3.
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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.
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\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.
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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.
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\3\ These certifications are defined in four discrete durations
ranging from 15 minutes to one hour.
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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
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:
http://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\
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\4\ See 30 CFR 75.1714(a).
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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.
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\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: http://www.cdc.gov/niosh/nppt1).
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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\
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\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.
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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).
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\9\ See note 7.
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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.
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\10\ Same as footnote 2.
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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\
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\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.
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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 http://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.
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\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.
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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: http://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
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Acceptable range operating
Stressor average Acceptable range excursion
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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.
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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.
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\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 head from side to 1 min. (at least 10 times).
side.
Nodding head up and down..... 1 min. (at least 10 times).
Climbing steps or a 1 min. (1 step/sec).
laddermill.
[[Page 75036]]
Carrying 50-lb bag on 1 min.
treadmill at 5 kph.
Lifting 20-lb weight from 1 min. (at least 10 times).
floor to an upright position.
Running on treadmill at 10 1 min.
kph.
------------------------------------------------------------------------
Section 84.307
This section specifies the environmental treatments that would 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 the temperature associated with storage in the trunks
of vehicles. The shock test specified in subsection (c), which is a
series of one 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. The vibration test specified in subsection (d) is a
composite test based on the reported vibration levels measured on the
frames of underground longwall and continuous mining machines and on
underground and surface haulage vehicles.\26\
---------------------------------------------------------------------------
\26\ Dayton T. Brown, Inc. Environmental Test Criteria for the
Acceptability of Mine Instrumentation. USBM contract J0100040, Phase
1, Final Report DTB2GR80-0643, June 1980, 131 pp., Table 2, p. 72.
---------------------------------------------------------------------------
Section 84.308
This section specifies several other tests that NIOSH would
conduct, as appropriate. Each unit tested must meet the conditions
specified in the test to receive approval.
Under subsection (b), NIOSH would 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
one-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 would 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. The tests proposed for dust and gas were established by the
International Organization for Standardization (ISO), a globally
recognized consensus standard setting organization.\27\ The test for
fogging was established by the European Committee for Standardization
(CEN), a consensus standard-setting organization within the European
Union.\28\ NIOSH has also proposed an ISO test for the robustness of
the construction of the eye protection.\29 \These specified tests,
which are widely accepted by the safety and manufacturing communities,
would be incorporated by reference into this rule.
---------------------------------------------------------------------------
\27\ See clauses 13 and 14 of ISO 4855, (1981-04-01). 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/store.htm.
\28\ See European Standard EN 168:2002, (28 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://www.bsigroup.com/en/Standards-and-Publications.
\29\ Sub-clause 3.1 of ISO 4885, (1981-04-01). Copies are
available from NIOSH. 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/store.htm.
---------------------------------------------------------------------------
NIOSH received comments from one respirator manufacturer indicating
that these standards for the safety and durability of eye protection
might not be appropriate for eye protection included with CCERs.
It is reasonable to question whether eye protection that is stored
within the protective cover of a CCER and used only during a one-time
escape requires the same durability as eye protection worn daily. At
this time, NIOSH lacks other alternative standards, but considers it
important that eye protection provided with a CCER be able to endure
the rough handling of CCERs in mines and be adequate for various escape
scenarios. This would include all of the potentially degrading
conditions addressed by the consensus standards that NIOSH has proposed
to include by reference. NIOSH welcomes public comments and information
concerning this matter.
Section 84.309
This section would 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.\30\
---------------------------------------------------------------------------
\30\ ``The Sago Mine Disaster: A preliminary report to Governor
Joe Manchin III'', McAteer, J. Davitt et al., July 2006, p. 14,
Buckhannon, West Virginia, http://www.wvgov.org.
---------------------------------------------------------------------------
Paragraph (a) specifies that NIOSH would conduct testing to ensure
that the CCER user would be able to perform the docking process safely,
reliably, and quickly under escape conditions. Precise testing
protocols are not specified because they would depend on the
technology, which has yet to be developed. However, the provisions
clearly specify the qualitative performance characteristics required
for approval.
Paragraph (b) provides that NIOSH would designate CCERs that meet
the testing requirements of this section as ``Dockable.''
Paragraph (c) provides that NIOSH would 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 would not be taken into account in
rating the capacity of the CCER.
Paragraph (d) provides that NIOSH would 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 would also provide for appropriate labeling to specify
the capacity of the resupply unit and its compatibility with the CCER.
Paragraph (e) provides that NIOSH would 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.
[[Page 75037]]
Paragraph (f) provides that NIOSH would 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 certified by NIOSH as dockable.
Section 84.310
This section would provide for NIOSH to conduct periodic testing of
deployed units of approved CCERs. The purpose of such post-
certification 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 would
obtain such units from employers in exchange for new units, substituted
at no cost to the employer. NIOSH would 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-certification testing program. 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 would request remedial actions by the applicant. NIOSH
would 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 would work with the relevant regulatory agencies and industry and
labor organizations to notify users of the revocation.
A program of post-certification testing is important for assuring
users of the effectiveness of their equipment. Simulations of
environmental conditions conducted in a laboratory during the
certification 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-
certification testing also can serve to identify potential problems of
quality control in the manufacturing process.
For such testing to occur, NIOSH must be able to purchase a
sufficient number of units of a CCER to replace deployed units selected
for testing. 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. The regulatory requirements of this section would ensure
the feasibility of a post-certification testing program and would
establish specific legal authorities and obligations in connection with
the results of such testing.
Section 84.311
This section would require manufacturers to provide each purchaser
of a CCER unit with copies of procedures for registering purchased
units with NIOSH. NIOSH would also work with relevant agencies and
industry and labor associations to publicize the registration program.
It would be 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 would
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.
Subpart G
Sections 84.60, 84.63-84.65
These sections of Subpart G, which provide general construction and
performance requirements for respirators certified under 42 CFR pt. 84,
are presently limited to covering respirator types specified under
Subparts H through L. Since this rule would remove CCERs provisions
from under Subpart H and would place them under a newly created Subpart
O, Subpart G needs to be 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.
NIOSH would extend 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 certified. This change will also provide coverage under
Subpart G for respirator types that might be distinguished under newly
created sections in the future.
Subpart H
Section 84.70
This section would exclude CCERs from coverage under any provisions
of Subpart H. The provisions of Subpart H concerning respirators used
for escape from hazardous environments would be applicable solely to
those with an open-circuit design.
IV. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993),
the Agency must determine whether a regulatory action is
``significant'' and therefore subject to review by the Office of
Management and Budget (OMB) and the requirements of the executive
order. Under Section 3(f), E.O. 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a rule (1)
having an annual effect on the economy of $100 million or more, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities (also
referred to as ``economically significant''); (2) creating serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in E.O. 12866.
This proposed rule is being treated as a ``significant regulatory
action'' within the meaning of E.O. 12866. In particular, the proposed
rule would limit the applicability of current MSHA requirements under
30 CFR 75.1714-1 that mine operators provide miners in underground coal
mines with CCERs (referred to in the mining community as ``SCSRs'')
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 canisters; 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.''
The proposal would eliminate the practice by NIOSH and MSHA of
approving CCERs on the basis of the duration of breathing supply
provided
[[Page 75038]]
by the CCER. Hence, paragraphs (a) and (b) of the MSHA regulation would
no longer have effect.
As discussed above, categorization of a CCER's capacity according
to the duration of its breathing gas supply during testing can be
misleading to purchasers and users because testing results may not
reflect actual performance for varied users under actual escape
conditions. The most reliable practice to ensure that miners are
adequately provisioned for escapes would be to empirically test
``worst-case'' escape scenarios for a particular mine site using
respirators likely to have sufficient capacity and then to make
selections accordingly. The MSHA rule would have to be modified to
either replace the current duration denominations with capacity ratings
pursuant to the rating system in this proposed rule or require mine
operators to conduct empirical tests to select appropriate CCERs.
The proposed rule is not considered economically significant, as
defined in Sec. 3(f)(1) of the E.O. 12866. Respirator manufacturers
will probably have to modify existing CCER designs to meet the proposed
new capacity and performance testing requirements. However, these
changes are not expected to require manufacturers to use fundamentally
different or substantially more costly technology. Benchmark testing of
currently approved technology using the capacity and performance
requirements of the proposed rule shows that at least one current CCER
product is likely to pass these new tests without any change in design.
Similarly, NIOSH does not expect the proposed 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 would have to engage in
new manufacturing processes (to meet the requirements under this
proposed rule) that would substantially increase manufacturing costs or
product prices.
Moreover, the scope of the market for CCERs is presently very
limited. According to data from the Bureau of Labor Statistics, in 2003
there were fewer than 45,000 U.S. miners and other workers in
underground extractive occupations (such as mining machine operators;
excavating machine operators; and loaders, roof bolters, and their
helpers) who might use CCERs. According to MSHA, there are
approximately 37,000 underground coal miners, the principal users of
CCERS in the private sector. The service life of current CCER models
ranges from 10 to 15 years, although some units may be damaged or used
for an escape or escape simulation and used sooner. Assuming that each
CCER unit is replaced, on average, every ten years and taking into
account that approximately 203,000 units will be deployed under the
current MSHA emergency standard,\31\ the mining industry would purchase
an average of 20,300 units annually. Since the average cost of CCERs is
$665 \32\ and is not expected to increase substantially as a result of
the proposed rule, these data suggest that this principal component of
the current CCER market represents less than $14.0 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 and anticipated average annual purchases of approximately $20
million.\33\
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\31\ MSHA estimates there were approximately 45,000 CCERs
deployed for coal mining prior to the MSHA emergency temporary
standard for emergency mine evacuation, one unit for each
underground miner or mine contractor, and MSHA estimates an
additional 168,000 units would be deployed in compliance with the
Final Emergency Mine Evacuation standard.
\32\ MSHA Regulatory Economic Analysis, Emergency Mine
Evacuation, Final Rule, December 2006 (RIN: 1219-AB46), p. 57.
\33\ Estimated from information provided by the Naval Surface
Warfare Center, Panama City, Florida, December 20, 2004.
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Mine operators and other employers would be most significantly
impacted by the one-time costs associated with potentially having to
replace CCERs approved under the existing standard with CCERs approved
under the final rule, upon promulgation and expiration of the phase-in
period. As proposed, these purchasers would have to replace any
currently deployed CCERs that are not re-approved under the proposed
rule within six years after the final rule is promulgated. Assuming
that 40 percent, or 81,200 units, would have to be replaced by mine
operators prior to the end of their service life \34\ at the assumed 10
percent annual replacement rate,\35\ the proposed rule would cost all
mine operators combined a maximum of $8 million. This estimate
represents the present value of the remaining service life of deployed
units that would have to be replaced at the end of the six-year
grandfather period. The replacement cost for the Navy would be
approximately $12 million in terms of the present value of deployed
units that would have to be replaced.\36\
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\34\ This assumption is conservative. It supposes that CCERs
deployed in mines would last for a service life of 10 years. It is
the experience of NIOSH researchers that CCERs do not typically
remain in approved condition this long, due to the harsh physical
conditions to which they are subjected in and outside of the mine
while donned, worn, stored, and transported on mine vehicles. It
also assumes that mine operators will purchase newly approved
devices once the NIOSH final rule is promulgated and becomes
effective, despite the three year grandfather period during which
respirator manufacturers could continue to sell devices that would
not be approved under the final rule.
\35\ MSHA estimates that approximately 45,000 CCERs were
deployed in mines prior to promulgation of the MSHA final standard
and that approximately 168,000 units will be deployed as a result of
the final standard. The 81,200 units would have an average of 2.5
years of remaining service life at the end of the 6-year grandfather
period, if NIOSH promulgates a final rule in 2008. The present value
of the remaining service life years of deployed units was calculated
by using a 7 percent discount rate and an average cost of a CCER of
$665.
\36\ The Navy has approximately 400,000 units in service and is
replacing them at a rate of approximately 40,000 per year and a cost
of approximately $500 per unit. This means 160,000 units would have
to be replaced at the end of the 6-year grandfather period, being
replaced an average of 2.5 years prior to their planned replacement.
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The cost of replacing deployed units whose service life has not
expired would be incurred only once since this rule includes no
provisions that would force respirator manufacturers to design CCERs
with shorter service lives than are achieved by currently certified
models of these respirators.
The new requirements would likely produce economic benefits. First,
they would provide more product performance information to purchasers,
which would serve to produce a more efficient market. Respirators would
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 would allow purchasers to match
respirators more closely to their particular needs. As a result, the
new requirements would provide an incentive for manufacturers to
innovate and possibly produce more diverse products. Having specific
NIOSH-certified capacity levels would 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.
Second, the new requirements for safety features (which provide for
the detection of units that have undergone
[[Page 75039]]
excessive environmental stresses or mishandling) has potential for
increasing the ability of purchasers, users, inspectors, and others to
contribute to assuring the reliability of deployed CCER units.
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 would derive from the improvements in
this rule, costs associated with death and disability could be avoided.
In addition, costs associated with rescue operations could be averted
if workers escape independently.
The proposed rule would not interfere with State, local, and 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
proposed rule would not have a significant economic impact on a
substantial number of small entities within the meaning of the RFA.
The proposed rule establishes new testing and certification
requirements for the particular type of respirator, the CCER, used by
workers in mines and other settings to escape hazardous atmospheres.
MSHA and Occupational Safety and Health Administration (OSHA)
regulations require that when employers provide respirators to their
employees, the respirators must be NIOSH/MSHA-certified or NIOSH-
certified respirators. Hence, the proposed rule would impose new
requirements on the manufacturers of CCERs, who may have to design new
products and make related changes to their manufacturing process for
such products. However, such new designs would not require substantial
technological innovation and any additional costs incurred by the
manufacturers would be passed on to consumers since there is
essentially no demand elasticity for these products, which are required
by Federal safety and health regulations.
Furthermore, CCERs are presently manufactured by only two U.S.
companies: CSE Corporation of Monroeville, Pennsylvania, and Ocenco
Incorporated of Pleasant Prairie, Wisconsin. While these manufacturing
companies are small businesses as defined under the Small Business Act
(Pub. L. 85-536) for this industry sector (NAICS 339112--Surgical and
Medical Instrument Manufacturers), employing fewer than 500 employees,
HHS proposes that two companies do not represent a substantial number
of entities under the RFA.
The proposed rule will have an economic impact on the operators of
the 580 underground coal mines in the United States in 2003 \37\, the
majority of which are defined as small businesses by the Small Business
Administration. Underground coal mine operators are required to supply
each underground coal miner with NIOSH/MSHA-certified CCERs. These mine
operators might have to replace some of their stock of CCERs that have
remaining service life if the CCERs have not been re-approved by NIOSH
under the new requirements of the final rule. This economic impact
would not be significant, however. The present value of respirators
that might have to be replaced as a result of this rule would not
exceed $8 million, as discussed above. This represents less than 0.1
percent of the estimated annual revenues for underground coal mine
operators.\38\
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\37\ Table 2: Coal Production and Number of Mines by State,
County, and Mine Type, 2003. Annual Coal Report 2003. Energy
Information Administration.
\38\ MSHA estimates revenues of underground coal mine operators
at $9,488,466,936. See Can this be put in quotes? Previous footnote
documents are not underlined. MSHA Regulatory Economic Analysis,
Emergency Mine Evacuation, Final Rule, December 2006 (RIN: 1219-
AB46), p. 106.
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In addition to costs for replacing any respirators with remaining
service life that are not re-approved by NIOSH, any change in the cost
of respirators would also be borne by mine operators.
Although NIOSH is not able to forecast whether the prices of CCERs
would indeed be affected by the new certification testing requirements,
it is unlikely that any increase in costs would prove substantial.
Respirator manufacturers would probably have 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 new manufacturing processes that would substantially
increase product prices.
Moreover, even if product prices were to increase substantially, it
would not produce a substantial economic impact on mine operators.
Currently, the average price of a CCER is $665.\39\ Assuming that each
unit requires replacement every 10 years and that the prices of CCERs
were to increase by 50 percent as a result of this rule, the annualized
additional costs of $26 per underground coal miner \40\ would not be
significant in the context of the total per capita labor costs of
underground coal mine operators.\41\
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\39\ MSHA Regulatory Economic Analysis, Emergency Mine
Evacuation, Final Rule, December 2006 (RIN: 1219-AB46), p. 57.
\40\ $665/unit x 0.5 cost increase x 203,000 units x 0.1 annual
replacement rate x 0.1424 annualization factor / 37,000 underground
miners = annual costs per underground miner.
\41\ According to the National Mining Association, coal miners
have average annual earnings of $50,000. Profile of the U.S. Coal
Miner 2003; http://www.nma.org/pdf/c_profile.pdf; updated October
2004.
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For the reasons provided, a regulatory flexibility analysis, as
provided for under RFA, is not required.
C. What Are the Paperwork and Other Information Collection Requirements
(Subject to the Paperwork Reduction Act) Imposed Under This Rule?
The Paperwork Reduction Act is applicable to the data collection
aspects of this rule. Under the Paperwork Reduction Act of 1995, a
Federal agency shall not conduct or sponsor a collection of information
from ten 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.
OMB has approved NIOSH's collection of information from applicants
under this rule (OMB Control 0920-109, ``Respiratory
Protective Devices,'' which covers all information collection under 42
CFR pt. 84). The information NIOSH would collect pursuant to this
rulemaking does not differ substantially from the information presently
collected by NIOSH from applicants who presently hold NIOSH approvals
of their CCER products. Furthermore, NIOSH is aware of only three
manufacturers (two that are U.S. companies) intending to continue
manufacturing CCERs.
[[Page 75040]]
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 would 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 proposed 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 proposed 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 would apply uniformly to all applications
from manufacturers of CCERs. This proposed rule has been reviewed
carefully to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
HHS has reviewed this proposed rule in accordance with Executive
Order 13132 regarding federalism, and has determined that it does not
have ``federalism implications.'' The proposed 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 proposed rule on
children. HHS has determined that the proposed rule would have no
effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this proposed rule on energy supply, distribution, or use
because it applies to the underground mining sector. The proposed rule
would not result in any yearly costs to mines and could result in one-
time costs of $8 million associated with the replacement of deployed
CCERs that do not pass the tests in this proposed rule and have not
reached the end of their service life. Relative to the annual revenues
of the underground coal mining industry, which were $11.1 billion in
2004, these one time costs are not ``likely to have a significant
adverse effect on the supply, distribution, or use of energy'' and
hence this proposed 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.
List of Subjects in 42 CFR Part 84
Incorporation by reference, Mine safety and health, Occupational
safety and health, Personal protective equipment, Respirators.
Text of the Rule
For the reasons discussed in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR Part 84 as follows:
PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
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]
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]
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''.
Sec. 84.64 [Amended]
4. Amend Sec. 84.64(b) to remove the phrase ``in Subparts H
through L'' and add in its place the phrase ``in Subparts H through
KK''.
Sec. 84.65 [Amended]
5. Amend Sec. 84.65(a) to remove the phrase ``in Subparts H
through L'' and add in its place the phrase ``in Subparts H through
KK''.
Subpart H--Self-Contained Breathing Apparatus
6. Amend Sec. 84.70 to:
a. Redesignate paragraphs (a) through (d) as (b) through (e),
respectively; and
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 from hazardous atmospheres. Such respirators are covered under
the provisions of Subpart O--Closed-Circuit Escape Respirators.
* * * * *
7. Amend Part 84 to add Subpart O 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-certification testing.
84.311 Registration of CCER units upon purchase.
Subpart O--Closed-Circuit Escape Respirators
Sec. 84.300 Closed-circuit escape respirator; description.
A closed-circuit escape respirator (CCER), technically a subset of
self-contained breathing apparatuses (SCBA) 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-rescuer (SCSR)s, CCERs are
relied upon by miners to escape dangerous atmospheres in underground
coal mines after a mine fire or explosion. CCERs are commonly worn on
workers' belts or stored in close proximity to be
[[Page 75041]]
accessible in an emergency. They are relatively small respirators that
employ either compressed oxygen or a chemical source of oxygen, plus a
chemical system for removing exhaled carbon dioxide from the user's
recirculated air. 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.
(a) This subpart applies to the following CCERs:
(1) All CCERs submitted to NIOSH for a certificate of approval
after [DATE RULE BECOMES EFFECTIVE]; and
(2) All CCERs sold after [DATE 3 YEARS AFTER DATE RULE BECOMES
EFFECTIVE].
(b) After [DATE 6 YEARS AFTER DATE RULE BECOMES EFFECTIVE], NIOSH
certificates of approval are rescinded, without further action or
notification by NIOSH, for all CCERs certified by NIOSH prior to [DATE
RULE BECOMES EFFECTIVE].
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) of this
subpart;
(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: 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.
(b) The components of each CCER must meet the general construction
requirements specified in Subpart G, Sec. 84.61.
(c) 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 page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html, using a 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.
(d) 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.
(e) 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.
(f) Each new CCER unit must be accompanied by instructions and a
service life plan. These documents 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 of this subpart.
(2) The service life plan must completely address 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 certified by NIOSH, due to reasonably
foreseeable degradation of materials used in its construction;
(ii) Any other conditions, other than that specified under
paragraph (f)(2)(i) of this section, that should govern the removal
from service of the CCER; 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.
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 page at http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.
(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 one-minute
averages. The operating averages of each stressor will be calculated
upon the completion of each test as the average of the one-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
one-minute average value(s) of the excursion(s).
[[Page 75042]]
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 one-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 23C 3C; 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 eight to ten
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(f)(1)(F) of this subpart, 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 under a Cap 3 rating 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 of this part that are
applicable to a one-hour Man test 4.
(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 specified by the manufacturer, according to the
requirements specified in Table 2. All volumes are given at standard
temperature (0 [deg]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
----------------------------------------------------------------------------------------------------------------
Capacity (L of VCO2 (L/min) RF (Breaths/
Capacity rating O2) VO2 (L/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 [gteqt] 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.
(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 of this subpart; 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 to determine the design's
susceptibility to hypoxia.
[[Page 75043]]
Table 3--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.VO2 = 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 (2) males
and one (1) female), one subject per unit, will conduct the test. The
three subjects will range in height and weight as follows: one subject
of height [gteqt] 174 cm and weight [gteqt] 90 kg; one subject of
either 163 cm <= height < 174 cm, regardless of weight, or 72 kg
[gteqt] 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 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) of
this subpart, 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 the user
during reasonably anticipated conditions and activities of an escape.
Table 4--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 head from side to 1 min. (at least 10 times).
side.
Nodding head up and down..... 1 min. (at least 10 times).
Climbing steps or a 1 min. (1 step/sec).
laddermill.
Carrying 50-lb bag on 1 min.
treadmill at 5 kph.
Lifting 20-lb weight from 1 min. (at least 10 times).
floor to an upright position.
Running on treadmill at 10 1 min.
kph.
------------------------------------------------------------------------
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-
84.305 of this subpart, after exposure to environmental treatments
simulating extreme storage temperatures, shock, and vibration.
(b) The units will be stored for sixteen hours at a temperature of
-45 [deg]C and for forty-eight hours at a temperature of 71 [deg]C. 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 will be subjected to physical shock according to the
following procedure:
(1) The unit will be dropped six times from a height of one meter
onto a concrete surface; and
(2) Each drop will test a different orientation of the unit, with
two drops along each major axis.
(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 nine hours; and
(3) The vibration frequency regimen applied to each axis will be
cyclical, repeating the sequence and specifications provided in Table 5
every twenty minutes.
Table 5--Vibration Test Sequence
------------------------------------------------------------------------
Acceleration g
Sequence Frequency (
(Hertz) peak)
------------------------------------------------------------------------
1....................................... 5-92 2.5
2....................................... 92-500 3.5
3....................................... 500-2000 1.5
------------------------------------------------------------------------
[[Page 75044]]
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.
84.304-84.307 of this part. These units will be evaluated for fire and
explosion hazards using the tests specified in the following reports
published by the Bureau of Mines: Reports of Investigations 9333
(1991), pages: 4-18; 8890 (1984), pages 6-62; and PRC Report No. 4294
(1980), pages: 18-62. These reports are available from NIOSH upon
request; to request a copy, call 1-800-CDC-INFO (232-4636).
(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 Clause 13 of International Standards
Organization (ISO) 4855 (First edition, 1981). The result will be
satisfactory if the reflectance after the test is equal to or greater
than 80% of its value before testing.
(2) NIOSH will test the effectiveness of the eye protection against
gas using the method specified in Clause 14 of ISO 4855. 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 Sub-clause 3.1 of ISO 4855 of ISO 4855.
(4) NIOSH will test the eye protection's resistance to fogging in
accordance with the method specified in European Standard EN 168: 2002.
(5) 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 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. A copy is also available for inspection at NIOSH,
National Personal Protection Technology Laboratory, Bruceton Research
Center, 626 Cochrans Mill Road, Pittsburgh, PA 15236. To arrange for an
inspection at NIOSH, call 412-386-6593. Copies of the ISO standard 4855
are also available for purchase from the International Organization for
Standardization (ISO) Web site at: http://www.iso.org/iso/store.htm.
Copies of the European Standard 168 are available for purchase from BSI
British Standards Web site at: http://www.bsigroup.com/en/Standards-and-Publications.
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) of this part, 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 of this part, 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-certification 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. 84.303-84.305 of this subpart, 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. 84.304-84.305 of this subpart.
(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
units 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 three 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-certification testing.
Sec. 84.311 Registration of CCER units upon purchase.
(a) Each CCER unit sold will include, within the user instructions,
a copy of procedures for registering the unit with NIOSH. The applicant
can obtain a copy of these procedures from from the NIOSH Web page:
http://www.cdc.gov/niosh/npptl/resources/certpgmspt/default.html.
(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 each purchaser of this
respirator register all units purchased with NIOSH. Registration will
enable NIOSH, which certified this model of respirator, to attempt to
notify you if a problem is discovered that might affect the safety or
performance of this respirator.
[[Page 75045]]
Registration will also assist NIOSH in locating deployed units to
periodically evaluate whether this respirator is remaining effective
under field conditions of storage and use.''
Editorial Note: This document was received at the Office of the
Federal Register on December 5, 2008.
Dated: July 23, 2008.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.
[FR Doc. E8-29235 Filed 12-9-08; 8:45 am]
BILLING CODE 4163-18-P