[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ 42 CFR 84.71(a)(6).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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