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[Federal Register Volume 77, Number 122 (Monday, June 25, 2012)]
[Proposed Rules]
[Pages 37862-37865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14764]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 84

RIN 0920-AA38
[Docket No. CDC-2012-0009; NIOSH-258]

Open-Circuit Self-Contained Breathing Apparatus Remaining 
Service-Life Indicator Performance Requirements

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: As a component of its ongoing update of respirator 
certification standards under Part 84 and in response to a petition to 
amend 42 CFR 84.83(F), HHS proposes a revision to the current 
requirement for open-circuit self-contained breathing apparatus (OC-
SCBA) remaining service-life indicators (indicators), which are devices 
built into a respirator to alert the user that the breathing air 
provided by the respirator is close to depletion. HHS intends to revise 
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 latitude 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 revision sets a default service life at 25 
percent of the rated service time and allows the indicator to be 
adjusted higher by the manufacturer, at the request of the purchaser.

DATES: Comments must be received by August 24, 2012.

ADDRESSES: You may submit comments, identified by HHS RIN 0920-AA38, by 
either of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments to Docket CDC-2012-
0009.
     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 Regulation Identifier Number (RIN) for this 
rulemaking. All relevant comments received will be posted without 
change to http://www.regulations.gov, 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.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov or http://www.cdc.gov/niosh/docket/review/docket258/default.html.

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 notice of proposed 
rulemaking is organized as follows:

I. Public Participation
II. Background
    A. Introduction
    B. Background and Significance
    C. Need for Rulemaking
    D. Public Meetings for Discussion and Comment
III. Summary of Proposed Rule
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. Proposed Rule

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. In addition, HHS invites comment specifically on the 
following question related to this rulemaking:
    1. HHS proposes that the remaining service-life indicator 
(indicator) be set at 25 percent of the rated service time of the 
respirator, as a default setting, with the option for the setting to be 
adjusted higher by the manufacturer, at the discretion of the 
purchaser. Is 25 percent of the rated service time of the respirator an 
appropriate default setting for the indicator?
    2. Should the rule 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? Are there possible emergency or rescue 
scenarios for which

[[Page 37863]]

one would want an indicator to alarm at 50 percent or more of the rated 
service time?
    Comments submitted should be titled ``Open-Circuit Self-Contained 
Breathing Apparatus Remaining Service-Life Indicator Performance 
Requirements, RIN 0920-AA38,'' and should identify the author(s), 
return address, and a phone number, in case clarification is needed. 
Electronic comments can be submitted to http://www.regulations.gov. 
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 HHS.
    All relevant comments submitted will be available for examination 
in the rule docket (a publicly available repository of the documents 
associated with the rulemaking). A complete electronic docket 
containing all comments submitted will be available at http://www.regulations.gov; comments will be available in writing by request. 
All comments received are included without change in the dockets, 
including any personal information provided.

II. Background

A. Introduction

    Under 42 CFR Part 84, ``Approval of Respiratory Protective 
Devices'' (Part 84), NIOSH approves respirators used by workers in 
mines and other workplaces for protection against hazardous 
atmospheres. The Mine Safety and Health Administration (MSHA) and the 
Occupational Safety and Health Administration (OSHA) require U.S. 
employers to supply NIOSH-approved respirators to their employees 
whenever the employer requires the use of a respirator.

B. Background and Significance

    Employers rely on NIOSH-approved respirators to protect their 
employees from airborne toxic contaminants and oxygen-deficient 
environments. More than 3.3 million private sector employees in the 
United States wear respirators for certain work tasks. The most 
effective and reliable means of protecting workers from oxygen-
deficient environments is to prevent their causes or entry into them by 
workers. However, it is not technologically or economically feasible in 
all workplaces and operations to reduce airborne concentrations of 
contaminants to safe levels and to prevent exposure to oxygen-deficient 
environments. In such cases, workers depend on respirators to protect 
them from asphyxiation or airborne contaminants that are known or 
suspected to cause acute and chronic health effects, such as heavy 
metal poisoning, acid burns, chronic obstructive pulmonary disease, 
silicosis, neurological disorders, and cancer.
    Open-circuit self-contained breathing apparatus are used primarily 
by firefighters and other rescue workers to provide breathable air in 
an environment that may be immediately dangerous to life and health 
(IDLH). These respirators are characterized by a cylinder of compressed 
breathing air, which is inhaled by the user and then exhaled out of the 
system. OC-SCBA are required by HHS regulations to have a ``remaining 
service life indicator or warning device,'' \1\ which is intended to 
alert users when the breathing air supply has been depleted to a 
certain percentage of breathing air available for use. The remaining 
service life indicator, referred to as a ``low-air alarm,'' or ``end-
of-service-time indicator'' by various industries, is relied upon by 
rescuers to warn when they have begun to utilize their reserve supply 
of breathing air. The current HHS regulation requires that the 
indicator alarms when the rated service time of the respirator is 
reduced to within 20 to 25 percent.
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    \1\ 42 CFR 84.71(a)(6).
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C. Need for Rulemaking

    In 2003, NIOSH received a petition from David Bernzweig of the 
Columbus (OH) Professional Firefighters International Association of 
Fire Fighters Local 67 requesting that the agency initiate rulemaking 
to change the provisions of paragraph Sec.  84.83(f).\2\ The current 
rule requires that the indicator alarm within the 20 to 25 percent 
range; stakeholders request 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 (see Section II.D. below). 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 propose 
amending NFPA 1981: Standard on Open-Circuit Self-Contained Breathing 
Apparatus (SCBA) for Emergency Services \3\ to require that the 
indicator alarm at 33 percent in its upcoming revision of the standard.
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    \2\ 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.
    \3\ NFPA 1981: Standard on open-circuit self-contained breathing 
apparatus (SCBA) for emergency services, Chapter 4. 2007 Edition.
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    Studies conducted by NFPA have demonstrated that, while the number 
of structure fires in the United States has declined more than 50 
percent between 1977 and 2002, the rate of traumatic firefighter deaths 
has increased in recent years.\4\ A majority of those deaths (over 63 
percent) are due to smoke inhalation or asphyxiation, and many are 
attributed to firefighters going deep into large structures, becoming 
caught, lost, or disoriented, and then subsequently running out of 
breathing air before being able to exit.\5\ NFPA 1404, Standard for 
Fire Service Respiratory Protection Training, requires that 
firefighters leave the IDLH atmosphere before the indicator alarms, 
that is, before the individual begins to consume the respirator's 
reserve breathing air supply. While modern practice is for firefighters 
to practice ``air management,'' or allocate enough breathing air for 
entry, work, and exit,\6\ many find maintaining situational awareness 
difficult.\7\ Many still rely on the indicator alarm to tell them to 
begin their exit, which is problematic because fire departments are 
finding that allotting 20-25 percent of the breathing air supply to 
exit does not allow enough time for escape from a large structure.\8\ 
If the firefighter becomes disoriented in the smoke, rescuers will have 
very little time to bring the individual out of the building unharmed.
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    \4\ 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.
    Fahy F. U.S. Fire Service fatalities in structure fires, 1977-
2009. National Fire Protection Association. June 2010.
    \5\ Fahy F. U.S. Fire Service fatalities in structure fires, 
1977-2009. National Fire Protection Association. June 2010.
    \6\ Bernocco S, Gagliano M, Phillips C, Jose P. Is your 
department complying with the NFPA 1404 air management policy? Fire 
Engineering 2008;161.
    \7\ E.g. see, City of Charleston, Post incident assessment and 
review team. Firefighter fatality investigative report: Sofa Super 
Store, 1807 Savannah Highway, Charleston, SC, June 18, 2007. Phase 
II Report. May 15, 2008.
    \8\ Marino D. Air management: Know your air-consumption rate. 
Fire Engineering. October 1, 2006.
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    OC-SCBA used in firefighting are certified by both NIOSH (under 42 
CFR Part 84) and NFPA, under NFPA 1981: Standard on Open-Circuit Self-
Contained Breathing Apparatus (SCBA)

[[Page 37864]]

for Emergency Services.\9\ NFPA is proposing to increase the indicator 
alarm time in the 2013 edition of NFPA 1981 in order to provide the 
user with more reserve breathing air for self- or assisted-escape from 
the IDLH environment. Current NFPA standards require that the indicator 
``meet the activation requirements of NIOSH certification,'' \10\ which 
may result in indicator notification at less than 25 percent of 
cylinder volume. As discussed above, this may not allow an early enough 
warning that the user has begun depleting the respirator's reserve 
breathing air. The NFPA has decided to amend its standard to increase 
the indicator setting to 33 percent (+5/-0).\11\
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    \9\ NFPA 1981: Standard on open-circuit self-contained breathing 
apparatus (SCBA) for emergency services, Chapter 4. 2007 Edition.
    \10\ NFPA 1981: 6.2.3 (2007).
    \11\ Fahy RF, Fire Analysis and Research Division, National Fire 
Protection Association. ``U.S. Fire Service fatalities in structure 
fires, 1977-2009.'' June 2010.
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    HHS finds that revising 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 OC-SCBA users. In 
fact, HHS believes that specifying a default setting of 25 percent and 
allowing respiratory protection program managers to request the 
indicator to be set at a certain value will result in a more meaningful 
alarm that will reduce firefighter fatalities and may offer greater 
protection for users in other industries.

D. Public Meetings for Discussion and Comment

    NIOSH held a public meeting to discuss underlying issues and 
technical matters addressed in this proposed rule on December 2, 2008, 
at the Pittsburgh Hyatt Regency, Pittsburgh International Airport (73 
FR 65860, November 5, 2008). 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). Most comments were generally supportive of the need to 
modify the indicator requirement. Those opposed to changing the 
requirement generally recommended that efforts to improve training in 
air management techniques should be pursued instead of changing this 
indicator requirement.

III. Summary of Proposed Rule

    This proposed change would establish a default setting of 25 
percent, and allow purchasers to request that the manufacturer set the 
remaining service-life indicator alarm at a value appropriate for the 
purchaser's occupational needs. Although it is not required, purchasers 
may also have the indicator setting modified for already fielded OC-
SCBA units by an authorized representative of the manufacturer. The 
amendment would also codify a long-standing NIOSH policy requiring the 
indicator to alarm continuously until the respirator's breathing air 
supply is depleted.
    HHS recognizes that not all OC-SCBA users find that the current 
standard places workers in jeopardy. Accordingly, HHS finds it prudent 
to retain the higher value (25 percent) established by the current 
regulation as a default setting, which would allow respiratory 
protection program managers who would prefer not to make any changes to 
the OC-SCBA used in their occupational setting to maintain their status 
quo. The proposed amendment to Sec.  84.83(f) would, however, allow 
managers who have determined that a higher set-point is warranted for 
their application the latitude to request a different value. Allowing 
managers to establish an earlier indicator alarm level would enable 
firefighters and incident commanders at structure fires involving 
substantial exit challenges to rely on the indicator alarm in emergency 
circumstances to warn that the reserve breathing air supply is being 
utilized. Allowing respiratory protection program managers to request 
that manufacturers set the indicator alarm at a certain value may also 
benefit workers in other industries that rely on OC-SCBA.
Alternatives Considered
    While developing the proposed rule, HHS did not identify any 
acceptable alternatives to lifting the restriction created by the 
current regulation. We did, however, consider the appropriate value for 
the alarm, and the necessity for a single value or a range in which the 
alarm should sound. As discussed above, many OC-SCBA are used in 
occupational settings for which the current remaining service-life 
indicator setting of 25 percent has been integrated into user protocols 
without concern or incident. Different emergency and rescue uses are 
likely to be best served by different indicator alarm settings. For 
this reason, we did not find it appropriate to adopt the proposed NFPA 
standard, 33 percent, as the minimum alarm setting for all uses.
    HHS also considered the possibility of allowing a ``user-
adjustable'' alarm setting, but rejected that option because of the 
complexity of the remaining service-life indicator. Allowing 
respiratory program managers to adjust the settings in the field would 
require extensive training and due to the technical difficulties of 
this task would introduce a reliability (and hence safety) concern.

IV. Regulatory Assessment Requirements

A. Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563 directs 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 proposed rule is not being treated as a ``significant'' action 
under E.O. 12866. It would modify the settings for an indicator 
required by current regulation, as well as codify a long-standing 
policy of requiring that the indicator alarm continuously once it has 
begun. The current rule requires that a remaining service-life 
indicator alarm when the breathing air provided by an OC-SCBA reaches 
between 20 and 25 percent of its limit. The proposed rule would replace 
the range with a default value of 25 percent, which would allow 
facility managers to be able to request that the manufacturer set the 
indicator value at a higher limit than 25 percent of remaining 
breathing air. There are no costs and only benefits associated with 
this change: All approved OC-SCBA models have a remaining service-life 
indicator for which alarm limits are set during manufacturing; allowing 
respiratory protection program managers to specify that value (to be 
set by the manufacturer) if they find it necessary to do so will save 
lives by improving the respiratory protection of emergency personnel 
and other users and indirectly by increasing the likelihood that 
victims will be successfully rescued in emergency response operations.
    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

[[Page 37865]]

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-SCBA 
models are equipped with a remaining service-life indicator that will 
not require any expenditure of resources to set at the proposed alarm 
limit. This proposed rule will allow small organizations such as local 
fire departments to specify their desired indicator limit 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 would 
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, adjusted annually for inflation. 
For 2011, the inflation-adjusted threshold is $136 million.

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. The proposed amendment to an existing 
respirator approval standard would apply uniformly to all applicants. 
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 
and has determined that the rule will not have a significant adverse 
effect.

J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
Government administers or enforces. HHS has attempted to use plain 
language in promulgating the proposed rule consistent with the Federal 
Plain Writing Act guidelines.

V. Proposed 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 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. 577a, 651 et seq., and 657(g); 30 U.S.C. 
3, 5, 7, 811, 842(h), 844.

Sec.  84.83  [Amended]

    2. Amend Sec.  84.83 as follows:
    a. 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 shall 
give an alarm when the reserve capacity of the apparatus is reached, 
and shall alarm continuously until depletion of the breathing air 
supply. The remaining service-life indicator shall be set by the 
manufacturer at 25 percent rated service time unless requested by 
purchasers to set the indicator to alarm at a higher value. For 
deployed units, the remaining service-life indicator may be set by an 
authorized representative of the manufacturer.

    Dated: June 11, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-14764 Filed 6-22-12; 8:45 am]
BILLING CODE 4163-18-P
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