[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Rules and Regulations]
[Pages 2618-2622]
From the Federal Register Online via the Government Printing 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]
BILLING CODE 4163-18-P