[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Rules and Regulations]
[Pages 2618-2622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00371]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 84
[Docket No. CDC-2012-0009; NIOSH-258]
RIN 0920-AA38
Self-Contained Breathing Apparatus Remaining Service-Life
Indicator Performance Requirements
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
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SUMMARY: On June 25, 2012, the Department of Health and Human Services
(HHS) published a notice of proposed rulemaking proposing to update
respirator approval standards in response to a petition to amend our
regulations, current requirements for self-contained breathing
apparatus (SCBA) remaining service-life indicators or warning devices.
These indicators are built into a respirator to alert the user that the
breathing air provided by the respirator is close to depletion. In this
final rule, HHS responds to public comment on the proposed rule and
revises the current standard, employed by the National Institute for
Occupational Safety and Health (NIOSH) located within the Centers for
Disease Control and Prevention (CDC), to allow greater flexibility in
the setting of the indicator alarm to ensure that the alarm more
effectively meets the different worker protection needs of different
work operations. This final rule sets a minimum alarm point at 25
percent of the rated service time and allows the manufacturer to offer
remaining service life set point at a higher value or values
appropriate to the purchaser's use scenario.
DATES: This final rule is effective February 13, 2013.
FOR FURTHER INFORMATION CONTACT: Jonathan Szalajda, NIOSH National
Personal Protective Technology Laboratory (NPPTL), P.O. Box 18070, 626
Cochrans Mill Road, Pittsburgh, PA 15236, (412) 386-5200 (this is not a
toll-free number).
SUPPLEMENTARY INFORMATION: The preamble to this final rule is organized
as follows:
I. Public Participation
II. Background
III. Summary of Final Rule and Response to Public Comments
IV. Regulatory Assessment Requirements
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of Children From
Environmental Health Risks and Safety Risks)
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
J. Plain Writing Act of 2010
V. Final Rule
I. Public Participation
Interested persons or organizations were invited to participate in
this rulemaking by submitting written views, arguments,
recommendations, and data. Comments were invited on any topic related
to this proposal, but comments were specifically solicited regarding
whether: (1) 25 percent of the rated service time of the respirator is
an appropriate default setting for the indicator to alarm; (2) the rule
should specify an upper limit that would require that the indicator be
set to alarm no earlier than a set amount, such as 50 percent of rated
service time; and (3) there are possible emergency or rescue scenarios
for which one would want an indicator to alarm at 50 percent or more of
the rated service time?
HHS received 8 submissions from the public in response to this
rulemaking. Commenters represented local fire departments,
manufacturers of self-contained breathing apparatus (SCBA) used in the
fire service, and a firefighters' union. A summary of comments and the
HHS response are found in Section III, below.
[[Page 2619]]
II. Background
In 2003, NIOSH received a petition from David Bernzweig of the
Columbus (OH) Professional Firefighters International Association of
Fire Fighters (IAFF) Local 67 requesting that the agency initiate
rulemaking to amend 42 CFR 84.83(f).\1\ The current rule requires that
the self-contained breathing apparatus (SCBA) service-life indicator
(also known in the firefighter community as an end-of-service-time
indicator (EOSTI), or a low-air alarm) give an alarm within the 20 to
25 percent range. Stakeholders in agreement with Mr. Bernzweig
requested that HHS eliminate the lower value (20 percent) and require
the indicator to alarm no later than at 25 percent of rated service
time. NIOSH considered the request and facilitated discussion among
stakeholders by holding a public meeting to discuss underlying issues
and technical matters on December 2, 2008, in Pittsburgh, Pennsylvania
(73 FR 65860, November 5, 2008).\2\
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\1\ National Institute for Occupational Safety and Health,
National Personal Protective Technology Laboratory, transcript of
public meeting held December 2, 2008. Available at http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-034-A/0034-A-120208-Transcript.pdf. Last accessed October 25, 2011.
\2\ The official transcript of this meeting as well as public
comments are available on NIOSH Docket 34-A (See http://www.cdc.gov/niosh/docket/archive/docket034A.html). NIOSH had previously
collected public comments on remaining service-life indicators in
2004 (See NIOSH Docket 34, http://www.cdc.gov/niosh/docket/archive/docket034.html).
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The National Fire Protection Association (NFPA), which sets
standards for personal protective equipment used in the fire service,
initiated an effort in 2008 to develop consensus on the matter and
recently decided to amend NFPA 1981: Standard on Open-Circuit Self-
Contained Breathing Apparatus (SCBA) for Emergency Services \3\ to
require that the indicator alarm at 33 percent.
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\3\ NFPA 1981: Standard on open-circuit self-contained breathing
apparatus (SCBA) for emergency services, Chapter 4. 2007 Edition.
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For reasons discussed in the notice of proposed rulemaking
published in the Federal Register on June 25, 2012 (77 FR 37862), HHS
finds that amending Sec. 84.83(f) to allow greater latitude with
regard to setting the indicator alarm would not reduce the amount of
protection afforded to firefighters and other SCBA users. In fact, HHS
has determined that specifying a minimum setting of 25 percent and
allowing manufacturers to offer different alarm settings more suited to
purchasers' use scenarios will result in a more meaningful alarm that
may offer greater protection for users.
III. Summary of Final Rule and Response to Public Comments
The amendment to 42 CFR 84.83(f) establishes that the low-air
indicator must activate at a minimum setting of 25 percent of the
SCBA's rated service time. If a purchaser has determined that an
earlier alarm will benefit the specific occupational purpose for which
the respirator is to be used, the purchaser may request that the
manufacturer offer a remaining service-life indicator alarm set-point
at a higher value (or values) appropriate to the purchaser's use
scenario. If the manufacturer chooses to offer a respirator with a
different set-point (at no less than 25 percent of the SCBA's rated
service time), the modified respirator must be approved by NIOSH.
Purchasers may also have the indicator setting modified for already
fielded SCBA units by an authorized representative of the manufacturer,
provided that the respirator model has received a new NIOSH approval
specifying the new alarm set-point.
The final rule also codifies a long-standing NIOSH policy requiring
the indicator for demand and pressure-demand open-circuit (OC)SCBA to
alarm continuously until the respirator's breathing air supply is
depleted.
Changes to the proposed rule text are made in response to public
comment, to clarify our overall intent; to specify that the requirement
for continuous alarming is intended for open-circuit, demand and
pressure demand units only; and to require that manufacturers identify
the indicator setting on each unit. Specific comments and responses are
discussed below. The rule text is also amended slightly to better
comply with Federal plain language requirements.
Comment: Two commenters were fully supportive of the rulemaking.
One commenter stated that requiring fire service respirators to alarm
when breathing air reaches 25 percent ``does not serve the needs or
interests of today's fire service.'' According to the commenter,
``[t]here is no safety purpose served by not allowing an earlier set
point for the EOSTI. An earlier set point would allow for a greater
margin of safety for the end user. Not having an earlier set point
would continue to place firefighters at risk by not having an adequate
air reserve when the EOSTI activates.'' The commenter further agreed
that the alarm should not be field-adjustable and that purchasers
should be able to specify the setting at the time of purchase or
service.
HHS response: We thank these commenters for their response.
Comment: We received two comments that appeared to confuse the
standard proposed by HHS (a default of 25 percent unless the purchaser
requests a different, higher, value) with the standard being developed
by NFPA (alarm activation at 33 percent). One commenter expressed
approval for giving purchasers the ability to set the remaining
service-life indicator alarm between 33 percent and 50 percent. The
other commenter expressed disapproval for changing the indicator to
activate at 33 percent rather than 25 percent.
HHS response: The amended standard is responsive to the various
concerns. Manufacturers are not required to modify existing approvals
to comply with this rule; they may continue to market and sell
respirators approved under the current standard, indefinitely. If, in
response to purchaser needs, the manufacturer chooses to market and
sell respirators that activate at the 25 percent minimum requirement or
earlier, the manufacturer must obtain a new or revised NIOSH approval.
Comment: One commenter supported the inclusion of a 50 percent
upper limit for the alarm set-point; other commenters neither supported
nor opposed the upper limit.
HHS response: We did not receive justification for applying a 50
percent upper limit. It is conceivable that some use scenarios might
warrant an earlier alarm point. Accordingly, we have not revised the
proposal in response to the comment.
Comment: One commenter suggested that allowing individual fire
departments to determine their own remaining service-life indicator
setting may cause ``incident related'' problems. The commenter further
stated that there was no discussion in the notice of proposed
rulemaking about the use of the heads-up-display for monitoring
breathing air depletion or the reliance on teamwork to maintain
situational awareness.
HHS response: This comment raises training issues regarding the
users' response to an alarm being activated. We understand that a
change in the mechanical alarm setting may necessitate a change in
training protocols. However, training for the proper use of these
respirators is outside the scope of this rulemaking.
Comment: One commenter agreed with the intent of the proposed rule
text but suggested a number of edits. The commenter stated that the
proposed rule text did not account for the distinction between
respirator models whose alarms are designed either to activate
electronically or activate using the device's compressed air. According
to
[[Page 2620]]
the commenter, ``[i]f the EOSTI is activated electrically then the
alarm can sound continuously until the depletion of the breathing air
supply. If the EOSTI is activated using the compressed air in the
system then at some point the alarm sound will decrease in decibels and
even cease to sound before the breathing air is depleted.'' The
commenter suggested adding the text ``if electrically controlled or to
a pressure of 10 bar (145 psi) if operated by the compressed air in the
system'' to the text in Sec. 84.83(f).
HHS response: The purpose of the alarm is to advise the user that
the system is depleting its air supply. While the rule text does not
specifically identify models that alarm either electronically or using
compressed air, we intend for the indicator to alarm until the air
supply runs out in order to warn the user of the situation so they can
take appropriate action for their setting. That the indicator may not
continue to alarm until the air supply is absolutely depleted is
understood and is evaluated in NIOSH testing (see NIOSH standard
testing procedure RCT-ASR-STP-0124, Determination of Remaining Service-
Life Indicator--Open-Circuit, Demand and Pressure-Demand, Self-
Contained Breathing Apparatus, at http://www.cdc.gov/niosh/npptl/stps/pdfs/RCT-ASR-0124.pdf, which will be updated to comport with this
rulemaking).
Comment: Another comment referred to long duration closed-circuit
breathing apparatus (CCBA), which are also regulated under Subpart H in
Part 84. The commenter stated that ``it can be interpreted that even
long duration CCBA would also need to meet the proposed new
requirements. For example, this would require that a CCBA with a rated
service time of 4 hours would need to have the EOSTI alarm continuously
for 1 hour and this would be annoying to the users and may affect their
activities in a negative manner.'' The commenter accordingly suggested
that the text in Sec. 84.83(f) should address only open-circuit
devices, and offers a new Sec. 84.83(g) which suggests that, for
closed-circuit devices, the indicator should alarm for a limited time
period when the reserve capacity of the apparatus is reached, and a
continuous alarm when a prescribed pressure is reached.
HHS response: HHS did not intend for the continuous alarm
requirement to pertain to long-duration closed-circuit devices.
However, the open-circuit demand and pressure-demand devices are
expected to alarm continuously once activated. Accordingly, we have
amended the final rule text to require that only open-circuit demand
and pressure-demand (as described in 42 CFR 84.70(a)(2)(i) and 42 CFR
84.70(a)(2)(ii)) respirators need to alarm continuously.
Comment: One commenter suggested that only purchasers who are
required by a third-party standard to request an alarm set-point other
than the default 25 percent be allowed to request a different alarm
setting.
HHS response: We do not agree that the 25 percent default value
should only be raised when prescribed by a third party standard. While
Sec. 84.83(f) is amended in response to a petition on behalf of the
U.S. fire service, we note that OC-SCBAs are used by industries and in
occupational settings other than firefighting. We intend to maintain
flexibility with regard to the alarm setting requirement to avoid
further limitations on the ability of purchasers to request an alarm
set-point appropriate to their use scenarios and the ability of
manufacturers to offer such respirators.
Comment: One commenter stated that the terms `default' and
`adjusted' used in the rule summary are vague and ``cause policy or
test requirement issues.'' The commenter recommended that the word
`default' be removed because it ``implies the product must meet the
minimum setting and shall be capable of fulfilling a higher setting. We
believe this is not the intent of the proposed changes and can lead to
unnecessarily design-restrictive interpretations.'' The commenter
requested that, in addition to adjustable designs, the rule should
``allow flexibility to permit others such as dedicated set point
designs.'' The commenter suggested that the rule text should be
modified to state: ``Each remaining service-life indicator or warning
device shall give an alarm when the remaining service life of the
apparatus is reduced to the manufacturers' specified range and shall
alarm continuously until the breathing air supply approaches depletion.
The manufacturer can specify either a set point of 25 or 33 percent of
its rated service time in response to the user's specific request.''
HHS response: The terms `default' and `adjusted' do not occur in
the rule text; however, HHS does intend for the product to be able to
meet the 25 percent value as the minimum setting and/or any higher
setting requested by the purchaser. During performance testing for
approval, NIOSH will test the alarm setting identified by the
manufacturer in its request for approval of the respirator system. If
the manufacturer does not identify an alarm setting, the indicator will
be tested to show that it activates at the value of 25 percent of its
rated service life.
The rule does not specify or restrict how manufacturers must comply
with its provisions; manufacturers who find it in their best interest
may offer specific set-points. Manufacturers are not required to
produce a device that is adjustable to different users' needs, and can
continue to market and sell SCBA models approved by NIOSH prior to the
effective date of this rule. However, should the manufacturer wish to
modify such a model for any reason, including a change to their
service-life indicator set point, the manufacturer is required to apply
to NIOSH for a new approval.
Additionally, in evaluating this comment, HHS determined that the
user should be able to readily identify a respirator's alarm setting to
distinguish models from one another. Models that meet the revised
performance requirements of this rule should have labels and/or
markings that identify the alarm setting for that particular model. At
the discretion of the manufacturer, these markings could be addressed
as part of the cautions and limitations associated with these devices,
or as an additional label. In accordance with this determination, the
final rule text is amended to address labels and/or markings.
Comment: One commenter recommended that 42 CFR 84.82 ``include an
additional section for a 33 percent'' remaining service-life indicator.
According to the commenter, ``[a]llowing manufacturers the ability to
utilize the same gauge for both alarm set points will reduce cost and
complexity within the market.''
HHS response: HHS has determined that the provisions in 42 CFR
84.82 are sufficiently flexible to allow manufacturers to produce
gauges that accurately indicate the amount of breathing air contained
in a unit.
Comment: HHS received one comment on the E.O. 12866 and E.O. 13563
analysis in Section IV.A., below. According to the commenter, ``[i]t is
important to realize that additional costs for multiple or adjustable
set points are inevitable. In addition to added design and
documentation costs, options introduced into production will increase
assembly and inspection times. Inventory costs increase with optional
material warehousing.* * *. While they may be independent, other
pressure gauges and electronic systems must be designed to correlate
with the RSLI and the system(s) must be thoroughly verified. Differing
RSLI settings may require differing gauge faces and electronics/
programming designs to
[[Page 2621]]
maintain correlation. For all these reasons, costs will increase.''
HHS response: The commenter misunderstands the requirement. HHS
does not require manufacturers to produce products with new features
allowing for adjustment of the service life indicator alarm set point,
or for various product models with different set points. Any
manufacturer can choose to meet product demand by either manufacturing
products with fixed set points or by manufacturing products with
manufacturer-adjustable set points. Alternatively, the manufacturer can
choose to take no action, and continue to sell respirators under
existing NIOSH approvals. HHS is reducing the longstanding constraint
on these product designs for a single alarm set point. Accordingly, we
continue to conclude that there are no costs associated with this
rulemaking, and solely benefits in terms of greater flexibility for
manufacturers to meet the diverse needs of their customers.
IV. Regulatory Assessment Requirements
A. Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity).
This final rule is not being treated as a ``significant'' action
under E.O. 12866. It modifies the settings for an indicator required by
current regulation, as well as codifies a long-standing policy of
requiring that the OC demand and pressure demand SCBA indicator alarm
continuously once it has begun. The current rule requires that a
remaining service-life indicator activate when the breathing air
provided by an OC demand and pressure demand SCBA reaches between 20
and 25 percent of its rated limit. The final rule replaces the range
with a default value of 25 percent, and allows manufacturers to offer
indicator set-point values at a higher limit than 25 percent of
remaining breathing air.
All approved OC demand and pressure demand SCBA models have a
remaining service-life indicator for which alarm limits are set during
manufacturing. Allowing respirator manufacturers to offer a respirator
with an earlier activation set-point value will ensure that the alarm
more effectively meets the varying worker protection needs of different
work operations.
Although HHS determined that there are no costs and only benefits
associated with this rulemaking, we received one comment on this
economic analysis, summarized above. As discussed above, HHS continues
to conclude that there are no costs associated with this rulemaking,
and solely benefits in terms of greater flexibility for manufacturers
to meet the diverse needs of their customers.
The rule does not interfere with State, local, or tribal
governments in the exercise of their governmental functions.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,
requires each agency to consider the potential impact of its
regulations on small entities, including small businesses, small
governmental units, and small not-for-profit organizations. As
discussed above, all OC demand and pressure-demand SCBA models are
equipped with a remaining service-life indicator that will not require
additional expenditure of resources to set at the activation limit.
This final rule allows small organizations such as local fire
departments to request an earlier indicator activation set-point when
purchasing new devices from the manufacturer. The Secretary of HHS has
certified to the Chief Counsel, Office of Advocacy of the Small
Business Administration, that this rule does not have a significant
impact on a substantial number of small entities. Accordingly, no
regulatory impact analysis is required.
C. Paperwork Reduction Act of 1995
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires
an agency to invite public comment on and to obtain OMB approval of any
regulation that requires 10 or more people to report information to the
agency or to keep certain records. This rule does not contain any
information collection requirements; thus HHS has determined that the
PRA does not apply to this rule.
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 will
report to Congress the promulgation of a final rule, once it is
developed, prior to its taking effect. The report will state that HHS
has concluded that the rule is not a ``major rule'' because it is not
likely to result in an annual effect on the economy of $100 million or
more.
E. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
et seq.) directs agencies to assess the effects of Federal regulatory
actions on State, local, and tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this final 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, adjusted annually for inflation.
For 2012, the inflation-adjusted threshold is $139 million.
F. Executive Order 12988 (Civil Justice)
This final rule has been drafted and reviewed in accordance with
Executive Order 12988, Civil Justice Reform, and will not unduly burden
the Federal court system. The amendment to an existing respirator
approval standard will apply uniformly to all applicants. This final
rule has been reviewed carefully to eliminate drafting errors and
ambiguities.
G. Executive Order 13132 (Federalism)
HHS has reviewed this final rule in accordance with Executive Order
13132 regarding federalism, and has determined that it does not have
``federalism implications.'' The final 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 final rule on children.
HHS has determined that the final rule will have no effect on children.
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
In accordance with Executive Order 13211, HHS has evaluated the
effects of this final rule on energy supply, distribution, or use and
has determined that the rule will not have a significant adverse
effect.
[[Page 2622]]
J. Plain Writing Act of 2010
Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
Government administers or enforces. HHS has attempted to use plain
language in promulgating the final rule consistent with the Federal
Plain Writing Act guidelines. HHS did not receive any public comments
on this matter.
V. Final Rule
List of Subjects in 42 CFR Part 84
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 amends 42 CFR part 84 as follows:
PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
0
1. The authority citation for part 84 continues to read as follows:
Authority: 29 U.S.C. 577a, 651 et seq., and 657(g); 30 U.S.C.
3, 5, 7, 811, 842(h), 844.
0
2. In Sec. 84.83, revise paragraph (f) to read as follows:
Sec. 84.83 Timers; elapsed time indicators; remaining service life
indicators; minimum requirements.
* * * * *
(f) Each remaining service-life indicator or warning device must
give an alarm when the remaining service life is reduced to a minimum
of 25 percent of its rated service time or any higher minimum percent
value or values as specified in the approval. Open-circuit demand and
pressure-demand respirators must alarm continuously until depletion of
the breathing air supply. The percent value set for indicator
activation must be identified by labels and/or markings on each
respirator unit.
Dated: December 28, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-00371 Filed 1-11-13; 8:45 am]
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