[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Rules and Regulations]
[Pages 58035-58045]
[FR Doc No: 2012-23138]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2011-0111; FRL-9729-5]
RIN-2060-AQ84

Protection of Stratospheric Ozone: Listing of Substitutes for
Ozone-Depleting Substances--Fire Suppression and Explosion Protection

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to list substitutes for
ozone-depleting substances (ODSs) in the fire suppression and explosion
protection sector as acceptable subject to use restrictions under the
EPA's Significant New Alternatives Policy program. This program
implements Section 612 of the Clean Air Act, as amended in 1990, which
requires EPA to evaluate substitutes for ozone-depleting substances and
find them acceptable where they pose comparable or lower overall risk
to human health and the environment than other available substitutes.

DATES: This rule is effective on December 18, 2012 without further
notice, unless EPA receives adverse comment or receives a request for a
public hearing on or before October 19, 2012. If EPA receives adverse
comment or receives a request for a public hearing, we will publish a
timely withdrawal in the Federal Register informing the public that all
or part of this rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2011-0111, by one of the following methods:
     Email<EMAIL_ADDRESS>     Mail: OAR Docket and Information Center, U.S.
Environmental Protection Agency, Mailcode 6102T, 1200 Pennsylvania Ave.
NW., Washington, DC 20460. To expedite review, a second copy of the
comments should be sent to Bella Maranion at the address listed below
under FOR FURTHER INFORMATION CONTACT.
     Hand Delivery: Air and Radiation Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC 20004. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2011-0111. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information

claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise protected through
www.regulations.gov or email. The www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
through www.regulations.gov or in hard copy at the Air and Radiation
Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Air and Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Bella Maranion, Stratospheric
Protection Division, Office of Atmospheric Programs (6205J),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 343-2363; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA is publishing this rule without a prior
proposed rule because we view this as a non-controversial action and
anticipate no adverse comment. However, in the ``Proposed Rules''
section of today's Federal Register, we are publishing a separate
document that will serve as the proposed rule if adverse comments are
received or a public hearing is requested on this direct final rule. We
will not institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document. If EPA receives adverse comment or a request for a
public hearing, we will publish a timely withdrawal in the Federal
Register informing the public that this direct final rule will not take
effect. If a public hearing is requested, EPA will provide notice in
the Federal Register as to the location, date, and time. We would
address all public comments in a subsequent final rule based on the
proposed rule.
    The regulations implementing the Significant New Alternatives
Policy (SNAP) program are codified at 40 CFR part 82, subpart G. The
appendices to subpart G list substitutes for ozone-depleting substances
(ODSs) for specific end uses as unacceptable or acceptable with certain
restrictions imposed on their use. In addition, a list of acceptable
substitutes without restrictions is available at http://www.epa.gov/ozone/snap/lists/index.html. The action in this direct final rule will
add a total of three fire suppression agents to the SNAP list of
acceptable substitutes in the appendices to subpart G: two fire
suppression agents are added to the list of substitutes for halon 1301
that are acceptable subject to use conditions and one fire suppression
agent is added to the list of substitutes for halon 1211 that are
acceptable subject to narrowed use limits. This action does not place
any significant burden on the regulated community but lists as
acceptable, subject to use restrictions, three new halon substitutes.
The restrictions will ensure that these substitutes will not pose a
greater risk to human health or the environment than other potentially
available substitutes in the fire suppression end use.
    This direct final rule regulates the use of Powdered Aerosol F
(KSA[supreg]) and Powdered Aerosol G (Dry Sprinkler Powdered Aerosol
(DSPA) Fixed Generators) by finding them acceptable subject to use
conditions as substitutes for halon 1301 for use in total flooding fire
suppression systems in normally unoccupied spaces. This action also
finds C7 Fluoroketone acceptable subject to narrowed use limits as a
substitute for halon 1211 for use as a streaming agent in portable fire
extinguishers in nonresidential applications. Halons are chemicals that
were once widely used in the fire protection sector but have been
banned from production in the U.S. since 1994 because their emissions
into the atmosphere are highly destructive to the stratospheric ozone
layer. This action will provide users that need specialized fire
protection applications with more alternatives to the use of halons.
Businesses that may be regulated, either through manufacturing,
distribution, installation and servicing, or use of the fire
suppression equipment containing the substitutes are listed in the
table below:

  Table 1--Potentially Regulated Entities, by North American Industrial
                   Classification System (NAICS) Code
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                                                      Description of
            Category               NAICS code       regulated entities
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Construction...................          238210  Alarm system (e.g.,
                                                  fire, burglar),
                                                  electric, installation
                                                  only.
Manufacturing..................          325998  Fire extinguisher
                                                  chemical preparations
                                                  manufacturing.
Manufacturing..................          332919  Nozzles, fire fighting,
                                                  manufacturing.
Manufacturing..................          334290  Fire detection and
                                                  alarm systems
                                                  manufacturing.
Manufacturing..................          336611  Shipbuilding and
                                                  repairing.
Manufacturing..................          339999  Fire extinguishers,
                                                  portable,
                                                  manufacturing.
Manufacturing..................          336411  Aircraft manufacturing.
Manufacturing..................          336413  Other aircraft parts
                                                  and auxiliary
                                                  equipment
                                                  manufacturing.
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This table is not intended to be exhaustive, but rather a guide
regarding entities likely to be regulated by this action. If you have
any questions about whether this action applies to a particular entity,
consult the person listed in the FOR FURTHER INFORMATION CONTACT
section.

Table of Contents

I. Section 612 Program
    A. Statutory Requirements
    B. Regulatory History
II. Listing Decision: Fire Suppression and Explosion Protection
    A. Total Flooding: Powdered Aerosol F (KSA[supreg])--Acceptable
Subject to Use Conditions
    B. Total Flooding: Powdered Aerosol G (Dry Sprinkler Powdered
Aerosol (DSPA) Fixed Generators)--Acceptable Subject to Use
Conditions
    C. Streaming: C7 Fluoroketone--Acceptable Subject to Narrowed
Use Limits
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act

I. Section 612 Program

A. Statutory Requirements

    Section 612 of the Clean Air Act (CAA) requires EPA to develop a
program for evaluating alternatives to ozone-depleting substances. EPA
refers to this program as the Significant New Alternatives Policy
(SNAP) program. The major provisions of Section 612 are:
     Rulemaking--Section 612(c) requires EPA to promulgate
rules making it unlawful to replace any class I (chlorofluorocarbon,
halon, carbon tetrachloride, methyl chloroform, and
hydrobromofluorocarbon) or class II (hydrochlorofluorocarbon) substance
with any substitute that the Administrator determines may present
adverse effects to human health or the environment where the
Administrator has identified an alternative that (1) reduces the
overall risk to human health and the environment, and (2) is currently
or potentially available.
     Listing of Unacceptable/Acceptable Substitutes--Section
612(c) also requires EPA to publish a list of the substitutes
unacceptable for specific uses and to publish a corresponding list of
acceptable alternatives for specific uses. The list of acceptable
substitutes is found at http://www.epa.gov/ozone/snap/lists/index.html,
and the lists of ``unacceptable,'' ``acceptable subject to use
conditions,'' and ``acceptable subject to narrowed use limits''
substitutes are found in the appendices to subpart G of 40 CFR part 82.
     Petition Process--Section 612(d) grant the right to any
person to petition EPA to add a substitute to, or delete a substitute
from, the lists published in accordance with Section 612(c). The Agency
has 90 days to grant or deny a petition. Where the Agency grants the
petition, EPA must publish the revised lists within an additional six
months.
     90-Day Notification--Section 612(e) directs EPA to require
any person who produces a chemical substitute for a class I substance
to notify the Agency not less than 90 days before new or existing
chemicals are introduced into interstate commerce for significant new
uses as substitutes for a class I substance. The producer must also
provide the Agency with the producer's unpublished health and safety
studies on such substitutes.
     Outreach--Section 612(b)(1) states that the Administrator
shall seek to maximize the use of federal research facilities and
resources to assist users of class I and II substances in identifying
and developing alternatives to the use of such substances in key
commercial applications.
     Clearinghouse--Section 612(b)(4) requires the Agency to
set up a public clearinghouse of alternative chemicals, product
substitutes, and alternative manufacturing processes that are available
for products and manufacturing processes which use class I and II
substances.

B. Regulatory History

    On March 18, 1994, EPA published the original rulemaking (59 FR
13044) which established the process for administering the SNAP program
and issued EPA's first lists identifying acceptable and unacceptable
substitutes in the major industrial use sectors (subpart G of 40 CFR
part 82). These sectors include: refrigeration and air-conditioning;
foam blowing; solvents cleaning; fire suppression and explosion
protection; sterilants; aerosols; adhesives, coatings and inks; and
tobacco expansion. These sectors comprise the principal industrial
sectors that historically consumed the largest volumes of ODS.
    Section 612 of the CAA requires EPA to list as acceptable those
substitutes that do not present a significantly greater risk to human
health and the environment as compared with other substitutes that are
currently or potentially available.
    Under the SNAP regulations, anyone who plans to market or produce a
substitute to replace a class I substance or class II substance in one
of the eight major industrial use sectors must provide notice to the
Agency, including health and safety information on the substitute at
least 90 days before introducing it into interstate commerce for
significant new use as an alternative. 40 CFR 82.176(a). This
requirement applies to the persons planning to introduce the substitute
into interstate commerce,\1\ which typically are chemical manufacturers
but may include importers, formulators, or end-users when they are
responsible for introducing a substitute into commerce.\2\ The 90-day
SNAP review process begins once EPA receives the submission and
determines that the submission includes complete and adequate data (40
CFR 82.180(a)). As required by the CAA, the SNAP regulations, 40 CFR
82.174(a), prohibit the introduction of a substitute into interstate
commerce earlier than 90 days after notice has been provided to the
Agency.
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    \1\ As defined at 40 CFR 82.104, ``interstate commerce'' means
the distribution or transportation of any product between one state,
territory, possession or the District of Columbia, and another
state, territory, possession or the District of Columbia, or the
sale, use or manufacture of any product in more than one state,
territory, possession or District of Columbia. The entry points for
which a product is introduced into interstate commerce are the
release of a product from the facility in which the product was
manufactured, the entry into a warehouse from which the domestic
manufacturer releases the product for sale or distribution, and at
the site of United States Customs clearance.
    \2\ As defined at 40 CFR 82.172, ``end-use'' means processes or
classes of specific applications within major industrial sectors
where a substitute is used to replace an ODS.
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    The Agency has identified four possible decision categories for
substitutes that are submitted for evaluation: acceptable; acceptable
subject to use conditions; acceptable subject to narrowed use limits;
and unacceptable \3\ (40 CFR 82.180(b)). Use conditions and narrowed
use limits are both considered ``use restrictions'' and are explained
below. Substitutes that are deemed acceptable with no use

restrictions (no use conditions or narrowed use limits) can be used for
all applications within the relevant end-uses within the sector.
Substitutes that are acceptable subject to use restrictions may be used
only in accordance with those restrictions.
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    \3\ The SNAP regulations also include ``pending,'' referring to
submissions for which EPA has not reached a determination, under
this provision.
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    After reviewing a substitute, the Agency may determine that a
substitute is acceptable only if certain conditions in the way that the
substitute is used are met to minimize risks to human health and the
environment. EPA describes such substitutes as ``acceptable subject to
use conditions.'' Entities that use these substitutes without meeting
the associated use conditions are in violation of EPA's SNAP
regulations. 40 CFR 82.174(c).
    For some substitutes, the Agency may permit a narrow range of use
within an end-use or sector. For example, the Agency may limit the use
of a substitute to certain end-uses or specific applications within an
industry sector. EPA describes these substitutes as ``acceptable
subject to narrowed use limits.'' A person using a substitute that is
acceptable subject to narrowed use limits in applications and end-uses
that are not consistent with the narrowed use limit is using the
substitute in an unacceptable manner and is in violation of section 612
of the CAA and EPA's SNAP regulations. 40 CFR 82.174(c).
    The Agency publishes its SNAP program decisions in the Federal
Register (FR). EPA first publishes decisions concerning substitutes
that are deemed acceptable subject to use restrictions (use conditions
and/or narrowed use limits), or substitutes deemed unacceptable, as
proposed rulemakings to allow the public opportunity to comment, before
publishing final decisions.
    In contrast, EPA publishes decisions concerning substitutes that
are deemed acceptable with no restrictions in ``notices of
acceptability,'' rather than as proposed and final rules. As described
in the preamble to the rule initially implementing the SNAP program (59
FR 13044; March 18, 1994), EPA does not believe that rulemaking
procedures are necessary to list alternatives that are acceptable
without restrictions because such listings neither impose any sanction
nor prevent anyone from using a substitute.
    Many SNAP listings include ``Comments'' or ``Further Information''
to provide additional information on substitutes. Since this additional
information is not part of the regulatory decision, these statements
are not binding for use of the substitute under the SNAP program.
However, regulatory requirements so listed are binding under other
regulatory programs (e.g., worker protection regulations promulgated by
the U.S. Occupational Safety and Health Administration (OSHA)). The
``Further Information'' classification does not necessarily include all
other legal obligations pertaining to the use of the substitute. While
the items listed are not legally binding under the SNAP program, EPA
encourages users of substitutes to apply all statements in the
``Further Information'' column in their use of the substitute. In many
instances, the information simply refers to sound operating practices
that have already been identified in existing industry and/or building
codes and standards. Thus, many of the comments, if adopted, would not
require the affected user to make significant changes in existing
operating practices.
    For copies of the comprehensive SNAP lists of substitutes or
additional information on SNAP, refer to EPA's Ozone Layer Protection
Web site at www.epa.gov/ozone/snap/index.html. For more information on
the Agency's process for administering the SNAP program or criteria for
evaluation of substitutes, refer to the March 18, 1994, SNAP final
rulemaking (59 FR 13044), codified at 40 CFR part 82, subpart G. A
complete chronology of SNAP decisions and the appropriate citations are
found at http://www.epa.gov/ozone/snap/chron.html.

II. Listing Decision: Fire Suppression and Explosion Protection

A. Total Flooding: Powdered Aerosol F (KSA[supreg])--Acceptable Subject
to Use Conditions

EPA's Decision: EPA Finds Powdered Aerosol F Acceptable Subject to Use
Conditions as a Substitute for Halon 1301 for Use in Total Flooding
Fire Suppression Systems in Normally Unoccupied Spaces
    Powdered Aerosol F is acceptable, subject to use conditions, as a
halon 1301 substitute for total flooding uses. As requested by the
submitter, the use condition requires that Powdered Aerosol F be used
only in areas that are not normally occupied. Powdered Aerosol F is
used as a fire suppression agent in an aerosol fire-extinguishing
system. It may be marketed under the name KSA[supreg].
    The submitter has claimed the composition of Powdered Aerosol F as
confidential business information (CBI). You may find the submission
under docket EPA-HQ-OAR-2011-0111 at http://www.regulations.gov.
    Environmental information: EPA has reviewed the potential
environmental impacts of this substitute. The active ingredients for
this technology are solids before and fine solid particulates after
use; therefore, the ozone depletion potential (ODP), global warming
potential (GWP), and atmospheric lifetime (ALT) are zero. Thus,
Powdered Aerosol F is not expected to pose any significant adverse
impacts on the ozone layer or climate.
    All manufacturing occurs in a facility with strict controls on all
raw materials and processes, so minimal release to the ambient air is
expected during the manufacturing process. Because installation and
servicing occur at very large sites, releases in such locations are
expected to be well below the acceptable exposure limits. In the event
of a fire, Powdered Aerosol F is dispersed as fine solid particulates,
reacting to the heat to suppress the fire. The constituents of Powdered
Aerosol F are not volatile organic compounds (VOCs). If all spilled and
settled material in the manufacturing facility and all on-site
(installation, servicing, and system discharge) releases are cleaned up
and disposed of according to federal, state, and local requirements,
consistent with the material safety data sheet (MSDS), no release to
the environment is expected.
    Toxicity and exposure data: EPA evaluated occupational and general
population exposure at manufacture and at end use to ensure that the
use of Powdered Aerosol F will not pose unacceptable risks to workers
or the general public. This risk screen is available in docket EPA-HQ-
OAR-2011-0111 under the name, ``Risk Screen on Substitute for Halon
1301 Total Flooding Systems in Unoccupied Spaces Substitute: Powdered
Aerosol F (KSA[supreg]).'' In particular, the risk screen considered
the highly respirable nature of the substitute as well as the potential
effect of increased blood pH from inhalation of the substitute. As
discussed below, the use of proper personal protective equipment (PPE)
during manufacturing, at installation, maintenance, and clean-up
minimizes personnel exposure from inhalation of the substitute. Blood
pH modeling also indicates that the levels of the constituent in
Powdered Aerosol F affecting blood pH are not expected to pose a health
risk. Based on this evaluation, EPA recommends the following
specifications for filling containers or installing total flooding fire
suppression systems with this agent:

--Appropriate protective clothing (e.g., goggles, particulate removing
respirators, and gloves) should be worn during the manufacture, clean
up, and disposal of this agent.

--Appropriate protective clothing (e.g., goggles, particulate removing
respirators, and gloves) should be worn during the installation and
maintenance of the extinguishing units filled with the agent.
--Training for safe handling procedures should be provided to all
employees that would be likely to handle the containers of the agent or
extinguishing units filled with the agent. Use of this agent should be
in accordance with the safety guidelines in the latest edition of the
National Fire Protection Association (NFPA) 2010 Standard for Aerosol
Extinguishing Systems.

    The post activation product of Powdered Aerosol F is entirely
particulates, and as indicated by the submitter, of a fine size which
makes it highly respirable. A constituent of Powdered Aerosol F,
despite having low toxicity, can pose a human health risk because it
can raise blood pH level if inhaled in sufficient quantities. The
potential to increase blood pH is not considered a significant adverse
health effect because the body can restore the pH to normal range.
Using information provided by the submitter, we modeled a reasonable
worst-case accidental release (without a fire), exposing maintenance
personnel to the maximum design concentration provided by the
submitter. Blood pH modeling indicates that Powdered Aerosol F is not
expected to pose a significant health risk. This calculation and the
assumptions for respirable amounts and releases of Powdered Aerosol F
are included in the risk screen conducted for this substitute and are
available in the docket for this rule. While the levels of soluble
particles of Powdered Aerosol F are not expected to pose a significant
health risk, EPA recommends the following:

--Releases in all settings should be limited to an appropriate design
concentration for the protected space so that increased pH level would
not adversely affect exposed individuals; exposed individuals should be
given an electrolyte solution to drink afterwards to restore the pH
within the appropriate range;
--Users should provide special training to individuals required to be
in environments protected by Powdered Aerosol F extinguishing systems;
each container of the Powdered Aerosol F should be clearly labeled with
the potential hazards from use and safe handling procedures; and
--In the case of an accidental spill, the area should be well-
ventilated, and workers should wear protective equipment while
following good industrial hygiene practices for clean-up and disposal.

The MSDS contains similar requirements with regard to safe handling,
protection from, and clean-up of Powdered Aerosol F.

    Use of Powdered Aerosol F should conform to relevant Occupational
Safety and Health Administration (OSHA) requirements, including 29 CFR
Part 1910, Subpart L, Sections 1910.160 and 1910.162. Per OSHA
requirements, protective gear (self-contained breathing apparatus)
should be available in the event that personnel re-enter the area after
Powdered Aerosol F has been discharged.
    Comparison to other fire suppressants: According to the submitter,
the active ingredients for Powdered Aerosol F are solids before and
fine solid particulates after use. The post-activation products of
Powdered Aerosol F have an ODP and a GWP of zero, which is comparable
to or less than that for other non-ozone depleting substitutes for
halon 1301, such as Inert Gas 100, HFC-227ea or HFC-125, with GWPs of
zero, 3220, and 3500, respectively.\4\ Toxicity risks are low as
discussed above. We find that Powdered Aerosol F is acceptable for use
in normally unoccupied spaces because it poses comparable or lower
overall risk to public health and the environment than the other
available substitutes for the same end use.
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    \4\ IPCC, 2007: Climate Change 2007: The Physical Science Basis.
Contribution of Working Group I to the Fourth Assessment Report of
the Intergovernmental Panel on Climate Change [Solomon, S., D. Qin,
M. Manning, Z. Chen, M. Marquis, K.B. Averyt, M. Tignor and H.L.
Miller (eds.)]. Cambridge University Press, Cambridge, United
Kingdom and New York, NY, USA. This document is accessible at http://www.ipcc.ch/publications_and_data/ar4/wg1/en/contents.html.
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B. Total Flooding: Powdered Aerosol G (Dry Sprinkler Powdered Aerosol
(DSPA) Fixed Generators)--Acceptable Subject to Use Conditions

EPA's Decision: EPA Finds Powdered Aerosol G (DSPA Fixed Generators)
Acceptable as a Substitute for Halon 1301 for Total Flooding Uses in
Normally Unoccupied Spaces
    Powdered Aerosol G is acceptable, subject to use conditions, as a
halon 1301 substitute for total flooding uses. As requested by the
submitter, the use condition requires that Powdered Aerosol G be used
only in areas that are normally unoccupied. Powdered Aerosol G is a
solid material in pellet form, which aerosolizes upon activation, and
housed in various-sized generator units. Depending on the fire
suppression requirement, a single generator or several generators may
be used in the protected space. When electrically or thermally
activated, Powdered Aerosol G produces combustion by-products (micron-
sized particles and a gaseous mixture of primarily nitrogen
(N2, CAS Reg. No. 7727-37-9)) that mix together into a
uniform fire extinguishing aerosol before being released into the
protected area. The released inert gases extinguish a fire in the space
by displacing the oxygen available for combustion and reducing the heat
of the combustion source. The submitter has claimed the composition of
Powdered Aerosol G as CBI. You may find the submission under docket
EPA-HQ-OAR-2011-0111 at http://www.regulations.gov.
    Environmental information: The pre-activation constituents of
Powdered Aerosol G are solids before use and therefore have zero ODP
and zero GWP. Further, the ODP of each of the post-activation
constituents of Powdered Aerosol G is zero, and the GWPs of post-
activation constituents are 1 or less.
    Of the organic constituents of Powdered Aerosol G, only hydrogen
cyanide (a post-activation product) has not been exempted as a VOC as
defined under CAA regulations (40 CFR 51.100(s)); however, it
constitutes approximately 5x10-3 percent of the post-
activation products by weight which is a very small amount. VOC
emissions from the production of the generators containing Powdered
Aerosol G are controlled through standard industry practices, and as
such, VOC emissions from manufacture are expected to be minimal.
Potential emissions of VOCs from the use of Powdered Aerosol G in the
fire extinguishing and explosion prevention sector are likely to be
insignificant relative to VOCs from all other sources (i.e., other
industries, mobile sources, and biogenic sources). An assessment was
performed to compare the annual VOC emissions from use of Powdered
Aerosol G in total flooding systems produced in one year to other
anthropogenic sources of VOC emissions. This assessment is available in
docket EPA-HQ-OAR-2011-0111 under the name, ``Risk Screen on Substitute
for Halon 1301 Total Flooding Systems in Unoccupied Spaces, Substitute:
Powdered Aerosol G (Dry Sprinkler Powdered Aerosol (DSPA) Fixed
Generators).'' Assuming that 100 percent of Powdered Aerosol G produced
in one year\5\ were to be used

in fire occurrences and thus released to the atmosphere (extremely
unlikely), only 0.04 metric tonnes of VOCs would be emitted, which is
approximately equal to 8.6x10-6 percent of the annual VOC
emissions caused by fires,\6\ or only about 1.5x10-6 percent
of annual VOC emissions caused by highway vehicles.\7\ This assessment
finds that even at an unlikely release rate of 100 percent, the VOC
emissions from use of Powdered Aerosol G are several orders of
magnitude lower than other anthropogenic emissions; therefore, the
environmental impacts of these VOCs are not considered a significant
risk to local air quality.
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    \5\ Maximum total production per year at market saturation
figure is based on DSPA SNAP submission.
    \6\ Based on 2010 projections calculated using 2008 EPA annual
VOC emissions data for residential wood burning and agricultural
field burning (EPA 2008 and EPA 2011) and ICF assumptions.
    \7\ Based on 2010 projections calculated using 2008 EPA annual
VOC emissions data (EPA 2009) and ICF assumptions.
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    Toxicity and exposure data: EPA evaluated occupational and general
population exposure at manufacture and at end use to ensure that the
use of Powdered Aerosol G will not pose unacceptable risks to workers
or the general public. This risk screen is available in docket EPA-HQ-
OAR-2011-0111 under the name, ``Risk Screen on Substitute for Halon
1301 Total Flooding Systems in Unoccupied Spaces, Substitute: Powdered
Aerosol G (Dry Sprinkler Powdered Aerosol (DSPA) Fixed Generators).''
    Exposure to the DSPA generator upon activation may result in
irritation if inhalation, ingestion, skin contact, or eye contact
occurs. Exposure to an aerosol suppression agent may cause temporary,
mild irritation of mucous membranes if inhaled and may cause slight
irritation of the skin. In the event of an accidental discharge, the
room should be immediately evacuated and the instructions listed in the
MSDS for Powdered Aerosol G should be followed. Workers should not
enter the space following discharge until all particles have settled
and/or been ventilated and the gases released by the system have
dissipated.
    EPA finds that the use of the exposure controls discussed in the
following sections and adherence with the appropriate occupational
safety guidelines and requirements in the manufacturer's MSDS are
sufficient to ensure that the manufacture, installation, maintenance,
and cleanup of Powdered Aerosol G do not pose a risk to human health.
Likewise, no consumer exposure is expected because Powdered Aerosol G
systems are designed for use in commercial and industrial applications
only in normally unoccupied spaces.
    Powdered Aerosol G is not expected to pose a risk to workers during
manufacture due to an automated production process. The only place
where workers may be exposed to the constituents is during the loading
of the processing vessel/mixer, which accounts for less than 10 minutes
of the production time. According to the submitter, these workers wear
PPE including protective suits, safety glasses, and respirators. The
entire manufacturing space is ventilated with a local exhaust system to
reduce airborne exposure of the Powdered Aerosol G constituents. The
submitter reported to EPA that manufacture of Powdered Aerosol G
pellets and generators does not take place in the United States. Only
the final product, the Powdered Aerosol G generator unit, consisting of
the rigid steel case containing solid blocks of the Powdered Aerosol G
extinguishing compound is sold in the United States. In the ``Further
Information'' columns of the tables summarizing today's listing
decisions, EPA recommends the following for establishments filling,
installing, or servicing generator units or systems to be used in total
flooding applications:

--Appropriate protective clothing (e.g., goggles, particulate removing
respirators, and gloves) should be worn during the manufacture, clean
up, and disposal of this agent as well as during the installation and
maintenance of the generator units filled with the agent;
--Training for safe handling procedures should be provided to all
employees that would be likely to handle the agent or the generator
units containing the agent; and
--Use of this agent should be in accordance with the safety guidelines
in the latest edition of the National Fire Protection Association
(NFPA) 2010 Standard for Aerosol Extinguishing Systems.

    Powdered Aerosol G generators are not expected to pose a risk to
workers during installation, maintenance, and cleanup. In accordance
with Department of Health and Human Services regulations (42 CFR part
84), safety glasses and a NIOSH/CDC-approved N99 respirator are
required for individuals installing Powdered Aerosol G fixed systems.
In the event of an accidental discharge, the manufacturer's MSDS should
be followed, including the use of a NIOSH N99 respirator and goggles.
For cleanup operations, workers should not enter the space after
discharge until all particles have settled and/or been ventilated and
the gases released by the system have dissipated. Workers entering the
space before it has been ventilated should wear protective clothing,
goggles, and a self-contained breathing apparatus (SCBA). In accordance
with the MSDS, EPA recommends the following:

--The post-activation products of Powdered Aerosol G should be
collected by hand (e.g., with a dustpan and duster or a vacuum
cleaner);
--Waste should be collected in suitable drums for disposal and the area
should be washed clean with sufficient quantities of water;
--Employers should provide special training to workers required to
clean up after discharge or required to work near spaces protected by
Powdered Aerosol G fixed generator total flooding systems;
--Each Powdered Aerosol G generator unit should be clearly labeled with
the potential hazards of use and with safe handling procedures; and
--In the case of an accidental discharge, the area should be well-
ventilated, and workers should wear protective equipment while
following good industrial hygiene practices for clean-up and disposal.

    Use of Powdered Aerosol G generators should conform to relevant
OSHA requirements, including 29 CFR part 1910, subpart L, sections
1910.160 and 1910.162. Per OSHA requirements, protective gear (self-
contained breathing apparatus) should be available in the event that
personnel re-enter the area before the particles have settled
(approximately 30-40 minutes after discharge) or before the space has
been ventilated.
    Comparison to other fire suppressants: The post-activation products
of Powdered Aerosol G have ODPs of zero and GWPs of 1 or less,
comparable to or less than that for other non-ozone depleting
substitutes for halon 1301, such as Inert Gas 100, HFC-227ea or HFC-
125, with GWPs of zero, 3220, and 3500, respectively.\8\ Toxicity risks
are low when used in normally unoccupied areas for commercial and
industrial specialty fire protection applications. We find that
Powdered Aerosol G is acceptable for use in normally unoccupied areas
because it poses comparable or lower overall risk to public health and
the environment than the other substitutes acceptable in

the end use listed above when used in accordance with the use
condition.
---------------------------------------------------------------------------

    \8\ IPCC, 2007.
---------------------------------------------------------------------------

C. Streaming: C7 Fluoroketone--Acceptable Subject to Narrowed Use
Limits

EPA's decision: EPA Finds C7 Fluoroketone Is Acceptable Subject to
Narrowed Use Limits as a Substitute for Halon 1211 for Use as a
Streaming Agent. The Narrowed Use Limits Require That C7 Fluoroketone
Be Used Only in Nonresidential Applications
    C7 Fluoroketone is also known as C7 FK or FK-6-1-14. This
substitute is a blend of two isomers, 3-pentanone,1,1,1,2,4,5,5,5-
octafluoro-2,4-bis(trifluoromethyl) (Chemical Abstracts Service
Registry Number [CAS Reg. No.] 813-44-5) and 3-
hexanone,1,1,1,2,4,4,5,5,6,6,6-undecafluoro-2-(trifluoromethyl) (CAS
Reg. No. 813-45-6). You may find the submission under docket EPA-HQ-
OAR-2011-0111 at http://www.regulations.gov.
    Environmental information: C7 Fluoroketone has zero ODP and a GWP
of approximately 1. Therefore, C7 Fluoroketone is not expected to pose
any significant adverse impact on the ozone layer or climate.
    The physicochemical properties of the majority of halon substitutes
make it unlikely that the substitutes would be released to surface
water as a result of use. In the case of C7 Fluoroketone, the proposed
substitute is insoluble in water and readily volatilizes. Thus, EPA
expects that all of the constituents would rapidly vaporize during
expulsion from the container, would not be likely to settle, and
therefore would be unlikely to lead to surface water contamination or
generation of solid waste.
    C7 Fluoroketone has not been exempted as a VOC under the CAA (40
CFR 51.100(s)). VOC emissions from the production of portable
extinguishers charged with C7 Fluoroketone are controlled through
standard industry practices, and as such, emissions from manufacture of
units are likely to be minimal. An assessment was performed to compare
the annual VOC emissions from use of C7 Fluoroketone in portable
extinguishers in one year to other anthropogenic sources of VOC
emissions. This assessment is available in docket EPA-HQ-OAR-2011-0111
under the name, ``Risk Screen on Substitute for Halon 1211 as a
Streaming Agent in Portable Fire Extinguishers Substitute: C7
Fluoroketone.'' This assessment finds that even if the entire portion
for streaming agent applications of the allowable quantity of C7 FK
produced by the submitter in one year was all released to the
atmosphere (extremely unlikely), the resulting VOC emissions would be
approximately equal to 3.0 x 10-2 percent of annual VOC
emissions caused by fires,\9\ or only about 1.1 x 10-3
percent of all annual anthropogenic VOC emissions.\10\ As these
emissions are several orders of magnitude less than other anthropogenic
emissions, the environmental impacts of these VOCs are not considered a
significant risk to local air quality.
---------------------------------------------------------------------------

    \9\ Based on 2010 projections calculated using 2008 EPA annual
VOC emissions data for residential wood burning and agricultural
field burning (EPA 2008 and EPA 2011) and ICF assumptions.
    \10\ Based on 2010 projections calculated using 2008 EPA annual
VOC emissions data (EPA 2009) and ICF assumptions.
---------------------------------------------------------------------------

    Toxicity and exposure data: Inhalation of C7 Fluoroketone could
cause respiratory tract irritation and symptoms may include cough,
sneezing, nasal discharge, headache, hoarseness, and nose and throat
pain. Contact with the eyes and/or skin during product use is not
expected to result in significant irritation. Ingestion of C7
Fluoroketone is not expected to cause health effects, and there is no
anticipated need for first aid if C7 Fluoroketone is ingested. The
potential health effects of C7 Fluoroketone can be minimized by
following the exposure guidelines and recommendations for ventilation
and PPE outlined in the MSDS and discussed further below.
    EPA evaluated occupational and general population exposure at
manufacture and at end use to ensure that the use of C7 Fluoroketone
will not pose unacceptable risks to workers or the general public. This
risk screen is available in docket EPA-HQ-OAR-2011-0111 under the name,
``Risk Screen on Substitute for Halon 1211 as a Streaming Agent in
Portable Fire Extinguishers Substitute: C7 Fluoroketone.''
    EPA is providing the following additional information regarding use
of C7 Fluoroketone as a streaming agent in nonresidential applications.
Appropriate protective measures should be taken and proper training
administered for the manufacture, clean-up and disposal of this
product. For this new chemical, the manufacturer developed an
acceptable exposure limit (AEL) for the workplace set at a level
believed to protect from chronic adverse health effects those workers
who are regularly exposed, such as in the manufacturing or filling
processes. EPA reviewed the submitter's supporting data and accepts the
manufacturer's AEL for C7 Fluoroketone of 225 ppm over an 8-hour time-
weighted average.\11\ EPA recommends the following for establishments
filling canisters to be used in streaming applications:
---------------------------------------------------------------------------

    \11\ ``Determination of an AEL for C7 Fluoroketone (C7 FK),''
Appendix A to Risk Screen on Substitute for Halon 1211 as a
Streaming Agent in Portable Fire Extinguishers Substitute: C7
Fluoroketone. Available in docket EPA-HQ-OAR-2011-0111.
---------------------------------------------------------------------------

--Adequate ventilation should be in place;
--All spills should be cleaned up immediately in accordance with good
industrial hygiene practices; and
--Training for safe handling procedures should be provided to all
employees that would be likely to handle the containers of the agent or
extinguishing units filled with the agent.

EPA anticipates that C7 Fluoroketone will be used consistent with the
recommendations specified in the manufacturer's MSDS.

    EPA recommends use of C7 Fluoroketone as a streaming agent in
accordance with the latest edition of NFPA Standard 10 for Portable
Fire Extinguishers. We expect that users will be able to meet the
recommended workplace exposure limit and address potential health risks
by following the above recommendations, using the substitute in
accordance with the manufacturer's MSDS, and following other safety
precautions common to the fire protection industry.
    Comparison to other fire suppressants: C7 Fluoroketone is not
ozone-depleting with a GWP of 1 in contrast to halon 1211 (with an ODP
of 7.1 and a GWP of 1890), the ODS which it replaces. Compared to other
substitutes for halon 1211, such as HCFC Blend B (with ODP of roughly
0.01 and GWP of roughly 80), HFC-227ea (with ODP of 0 and GWP of 3220),
and HFC-236fa (with an ODP of 0 and GWP of 9810), C7 Fluoroketone has a
similar or less significant impact on the ozone layer and climate. Risk
to the general population is expected to be negligible provided that
the substitute is not used in residential applications as requested by
the submitter and as established under the narrowed use limits.
Occupational exposure should not pose a problem if use is in accordance
with the manufacturer's MSDS and other precautions normally used in the
fire protection industry. Thus, we find that C7 Fluoroketone is
acceptable subject to narrowed use limits because the overall
environmental and human health risk posed by C7 Fluoroketone is lower
than or comparable to the risks posed by

other available substitutes in the same end use.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    OMB notified EPA on May 5, 2011, that it considers this action not
a ``significant regulatory action'' under the terms of Executive Order
12866 (58 FR 51735, October 4, 1993) and it is therefore not subject to
review under Executive Orders 12866 and 13563 (76 FR 3821, January 21,
2011).

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
This final rule is an Agency determination. It contains no new
requirements for reporting. However, the Office of Management and
Budget (OMB) has previously approved the information collection
requirements contained in the existing regulations in subpart G of 40
CFR part 82 under the provisions of the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. and has assigned OMB control numbers 2060-0226 (EPA
ICR No. 1596.08). The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statutes unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impact of today's rule on small
entities, small entities are defined as (1) a small business that
produces or uses fire suppressants as total flooding and/or streaming
agents with 500 or fewer employees or total annual receipts of $5
million or less; (2) a small governmental jurisdiction that is a
government of a city, county, town, school district or special district
with a population of less than 50,000; and (3) a small organization
that is any not-for-profit enterprise which is independently owned and
operated and is not dominant in its field.
    After considering the economic impacts of today's final rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This final
rule will not impose any requirements on small entities beyond current
industry practices. Today's action effectively supports the
introduction of three new alternatives to the market for fire
protection extinguishing systems, thus providing additional options for
users making the transition away from ozone-depleting halons.
    Use of halon 1301 total flooding systems and halon 1211 streaming
agents have historically been in specialty fire protection applications
including essential electronics, civil aviation, military mobile weapon
systems, oil and gas and other process industries, and merchant
shipping with smaller segments of use including libraries, museums, and
laboratories. The majority of halon system and equipment owners
continue to maintain and refurbish existing systems since halon
supplies continue to be available in the U.S. Owners of new facilities
make up the market for the new alternative agent systems and may also
consider employing other available fire protection options including
new, improved technology for early warning and smoke detection. Thus,
EPA is providing more options to any entity, including small entities,
by finding substitutes acceptable for use. The use restrictions imposed
on the substitutes in today's rule are consistent with the applications
suggested by the submitters and with current industry practices.
Therefore, we conclude that the rule does not impose any new cost on
businesses.
    Although this final rule will not have a significant economic
impact on a substantial number of small entities, EPA nonetheless has
tried to reduce the impact of this rule on small entities. By
introducing three new substitutes, today's rule gives additional
flexibility to small entities that are concerned with fire suppression.
EPA also has worked closely together with the NFPA, which conducts
regular outreach with small entities and involves small state, local,
and tribal governments in developing and implementing relevant fire
protection standards and codes.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandate Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. This action imposes no enforceable duty on any State, local, or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 or 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This direct final
rule will provide additional options for fire protection subject to
safety guidelines in industry standards. These standards are typically
already required by state or local fire codes, so this action will not
affect small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will 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, as
specified in Executive Order 13132. This regulation applies directly to
facilities that use these substances and not to governmental entities.
Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. It will not have substantial direct effects on
tribal governments, on the relationship between the Federal government
and Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. It does not significantly or uniquely affect the
communities of Indian tribal governments, because this regulation
applies directly to facilities that use these substances and not to
governmental entities. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to E.O. 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in E.O.
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children. This action's health and risk assessments are
discussed in section II.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This rulemaking does not involve setting technical standards. EPA
defers to existing NFPA voluntary consensus standards and Occupational
Safety and Health Administration (OSHA) regulations that relate to the
safe use of halon substitutes reviewed under SNAP. EPA refers users to
the latest edition of NFPA 2010 Standard on Aerosol Extinguishing
Systems which provides for safe use of aerosol extinguishing agents and
technologies and NFPA 10 Standard for Portable Fire Extinguishers.
Copies of these standards may be obtained by calling the NFPA's
telephone number for ordering publications at 1-800-344-3555. The NFPA
2010 standards meet the objectives of the rule by setting
scientifically-based guidelines for safe exposure to halocarbon and
inert gas agents and aerosol extinguishing agents, respectively. In
addition, EPA has worked in consultation with OSHA to encourage
development of technical standards to be adopted by voluntary consensus
standards bodies.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. This direct final rule would provide fire
suppression substitutes that have no ODP and low or no GWP. The avoided
ODS and GWP emissions would assist in restoring the stratospheric ozone
layer, avoiding adverse climate impacts, and result in human health and
environmental benefits.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective December 18, 2012.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements,
Stratospheric ozone layer.

    Dated: September 11, 2012.
Lisa P. Jackson,
Administrator.
    For the reasons set out in the preamble, 40 CFR part 82 is amended
as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

Subpart G--Significant New Alternatives Policy Program

0
2. Subpart G of part 82 is amended by adding Appendix S to read as
follows: Appendix S to Subpart G of Part 82--Substitutes Listed in the
September 19, 2012 Final Rule, Effective December 18, 2012.

             Fire Suppression and Explosion Protection Sector--Acceptable Subject To Use Conditions
----------------------------------------------------------------------------------------------------------------
           End-Use                Substitute        Decision        Conditions          Further information
----------------------------------------------------------------------------------------------------------------
Total Flooding...............  Powdered         Acceptable       For use only in  Use of this agent should be in
                                Aerosol F        subject to use   normally         accordance with the safety
                                (KSA[supreg])    conditions.      unoccupied       guidelines in the latest
                                as a                              areas.           edition of the NFPA 2010
                                substitute for                                     standard for Aerosol
                                Halon 1301.                                        Extinguishing Systems.
                                                                                For establishments filling,
                                                                                installing, servicing, using,
                                                                                or disposing of containers or
                                                                                systems to be used in total
                                                                                flooding applications, EPA
                                                                                recommends the following:
                                                                                --appropriate protective
                                                                                clothing (e.g., goggles,
                                                                                particulate removing
                                                                                respirators, and gloves)
                                                                                should be worn during the
                                                                                installation and maintenance
                                                                                of the extinguishing units
                                                                                filled with the agent or
                                                                                during clean up and disposal
                                                                                of this agent;
                                                                                --training should be provided
                                                                                to all employees that would
                                                                                be likely to handle
                                                                                containers of the agent or
                                                                                extinguishing units filled
                                                                                with the agent, required to
                                                                                clean up after discharge or
                                                                                required to work near spaces
                                                                                protected by Powdered Aerosol
                                                                                F.
                                                                                Releases in all settings
                                                                                should be limited to an
                                                                                appropriate design
                                                                                concentration for the
                                                                                protected space so that
                                                                                increased blood pH level
                                                                                would not adversely affect
                                                                                exposed individuals.
                                                                                Exposed individuals should be
                                                                                given an electrolyte solution
                                                                                to drink afterwards to
                                                                                restore the pH within the
                                                                                appropriate range.
                                                                                Each extinguisher should be
                                                                                clearly labeled with the
                                                                                potential hazards from use
                                                                                and safe handling procedures.
                                                                                In the case of an accidental
                                                                                spill, the area should be
                                                                                well-ventilated, and workers
                                                                                should wear protective
                                                                                equipment while following
                                                                                good industrial hygiene
                                                                                practices for clean-up and
                                                                                disposal.
                                                                                See additional comments 1, 2,
                                                                                3, 4.
Total Flooding...............  Powdered         Acceptable       For use only in  Use of this agent should be in
                                Aerosol G (Dry   subject to use   normally         accordance with the safety
                                Sprinkler        conditions.      unoccupied       guidelines in the latest
                                Powdered                          areas.           edition of the NFPA 2010
                                Aerosol (DSPA)                                     standard for Aerosol
                                Fixed                                              Extinguishing Systems.
                                Generators) as                                    For establishments filling,
                                a substitute                                       installing, servicing, using
                                for Halon 1301.                                    or disposing of generator
                                                                                units or systems in total
                                                                                flooding applications, EPA
                                                                                recommends the appropriate
                                                                                protective clothing (e.g.,
                                                                                goggles, particulate removing
                                                                                respirators, and gloves)
                                                                                should be worn during the
                                                                                installation and maintenance
                                                                                of the extinguishing units
                                                                                filled with the agent or
                                                                                during clean up and disposal
                                                                                of this agent.
                                                                                Powdered Aerosol G should be
                                                                                collected by hand (e.g., with
                                                                                a dustpan and duster or a
                                                                                vacuum cleaner); waste should
                                                                                be collected in suitable
                                                                                drums for disposal and the
                                                                                area should be washed clean
                                                                                with sufficient quantities of
                                                                                water; and training should be
                                                                                provided to all employees
                                                                                that would be likely to
                                                                                handle the agent or generator
                                                                                units filled containing the
                                                                                agent, required to clean up
                                                                                after discharge or required
                                                                                to work near spaces protected
                                                                                by Powdered Aerosol G fixed
                                                                                generator total flooding
                                                                                systems.
                                                                                In accordance with Department
                                                                                of Health and Human Services
                                                                                regulations (42 CFR Part 84),
                                                                                safety glasses and a NIOSH/
                                                                                CDC-approved N99 respirator
                                                                                are required for individuals
                                                                                installing Powdered Aerosol G
                                                                                fixed systems.
                                                                                Each generator unit should be
                                                                                clearly labeled with the
                                                                                potential hazards from use
                                                                                and safe handling procedures.
                                                                                In the case of an accidental
                                                                                discharge, the area should be
                                                                                well-ventilated, and workers
                                                                                should wear protective
                                                                                equipment while following
                                                                                good industrial hygiene
                                                                                practices for clean-up and
                                                                                disposal.
                                                                                See additional comments 1, 2,
                                                                                3, 4.
----------------------------------------------------------------------------------------------------------------
Additional comments:
1--Should conform to relevant OSHA requirements, including 29 CFR 1910, Subpart L, Sections 1910.160 and
  1910.162.
2--Per OSHA requirements, protective gear (SCBA) should be available in the event personnel should reenter the
  area.
3--The agent should be recovered from the fire protection system in conjunction with testing or servicing, and
  recycled for later use or destroyed.
4--EPA has no intention of duplicating or displacing OSHA coverage related to the use of personal protective
  equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other
  occupational safety and health standard with respect to halon substitutes.

           Fire Suppression and Explosion Protection Sector--Acceptable Subject to Narrowed Use Limits
----------------------------------------------------------------------------------------------------------------
           End-Use                Substitute        Decision        Conditions          Further information
----------------------------------------------------------------------------------------------------------------
Streaming....................  C7 Fluoroketone  Acceptable       For use only in  Use of this agent should be in
                                as a             subject to       non-             accordance with the latest
                                substitute for   narrowed use     residential      edition of NFPA Standard 10
                                Halon 1211.      limits.          applications.    for Portable Fire
                                                                                Extinguishers.
                                                                                For operations that fill
                                                                                canisters to be used in
                                                                                streaming applications, EPA
                                                                                recommends the following:
                                                                                --Adequate ventilation should
                                                                                be in place;
                                                                                --All spills should be cleaned
                                                                                up immediately in accordance
                                                                                with good industrial hygiene
                                                                                practices; and
                                                                                --Training for safe handling
                                                                                procedures should be provided
                                                                                to all employees that would
                                                                                be likely to handle
                                                                                containers of the agent or
                                                                                extinguishing units filled
                                                                                with the agent.
                                                                                See additional comments 1, 2,
                                                                                3, 4.
----------------------------------------------------------------------------------------------------------------
Additional comments:
1--Should conform to relevant OSHA requirements, including 29 CFR 1910, Subpart L, Sections 1910.160 and
  1910.162.
2--Per OSHA requirements, protective gear (SCBA) should be available in the event personnel should reenter the
  area.
3--The agent should be recovered from the fire protection system in conjunction with testing or servicing, and
  recycled for later use or destroyed.
4--EPA has no intention of duplicating or displacing OSHA coverage related to the use of personal protective
  equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other
  occupational safety and health standard with respect to halon substitutes.

[FR Doc. 2012-23138 Filed 9-18-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 20, 2009 (Volume 74, Number 74)]
[Notices]
[Page 17962-17964]
[DOCID:fr20ap09-49]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0163]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Draft Guidance, Emergency Use Authorization of Medical
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the proposed extension of the
collection of information related to emergency use authorizations
(EUAs) by the agency.

DATES: Submit written or electronic comments on the collection of
information by June 19, 2009.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Reporting and Recordkeeping for Emergency Use Authorization of Medical
Products (OMB Control Number 0910-0595--Extension)

    The draft guidance describes the agency's general recommendations
and procedures for issuance of EUAs under section 564 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360bbb-3), which was
amended by the Project BioShield Act of 2004 (Public Law 108-276). The
act permits the FDA Commissioner (the Commissioner) to authorize the
use of unapproved medical products or unapproved uses of approved
medical products during an emergency declared under section 564 of the
act. The data to support issuance of an EUA must demonstrate that,
based on the totality of the scientific evidence available to the
Commissioner, including data from adequate and well-controlled clinical
trials (if available), it is reasonable to believe that the product may
be effective in diagnosing, treating, or preventing a serious or life-
threatening disease or condition (21 U.S.C. 360bbb-3(c)). Although the
exact type and amount of data needed to support an EUA may vary
depending on the nature of the declared emergency and the nature of the
candidate product, FDA recommends that a request for consideration for
an EUA include scientific evidence evaluating the product's safety and
effectiveness, including the adverse event profile for diagnosis,
treatment, or prevention of the serious or life-threatening disease or
condition, as well as data and other information on safety,
effectiveness, risks and benefits, and (to the extent available)
alternatives.
    Under section 564 of the act, the Commissioner may establish
conditions on the approval of an EUA. Section 564(e) of the act
requires the Commissioner (to the extent practicable given the
circumstances of the emergency) to establish certain conditions on an
authorization that the Commissioner finds necessary or appropriate to
protect the public health and permits the Commissioner to establish
other conditions that he finds necessary or appropriate to protect the
public health. Conditions authorized by section 564(e) of the act
include, for example: (1) Requirements for information dissemination to
health care providers or authorized dispensers and product recipients;
(2) adverse event monitoring and reporting; (3) data collection and
analysis; (4) recordkeeping and records access; (5) restrictions on
product advertising, distribution, and administration; and (6)
limitations on good manufacturing practices requirements. Some
conditions, the statute specifies, are mandatory to the extent
practicable for authorizations of unapproved products and discretionary
for authorizations of unapproved uses of approved products. Moreover,
some conditions may apply to manufacturers of an EUA product, while
other conditions may apply to any person who carries out any activity
for which the authorization is issued. Section 564 of the act also
gives the Commissioner authority to establish other conditions on an
authorization that he finds to be necessary or appropriate to protect
the public health.
    For purposes of estimating the burden of reporting, FDA has
established six categories of respondents: (1) Those who file a Request
for Consideration for an EUA after a determination of actual or
potential emergency and, in lieu of submitting the data, provide
reference to a pending or approved application; (2) those who file a
Request for Consideration for an EUA and the data after a determination
of actual or potential emergency, without reference to a pending or
approved application; (3) those who submit data to FDA on a candidate
EUA product, which is subject to a pending or approved application,
prior to a determination of actual or potential emergency; (4) those
who submit data to FDA prior to a determination of actual or potential
emergency about a candidate EUA product for which there is no pending
or approved application; (5) manufacturers of an unapproved EUA product
who must report to FDA regarding such activity; and (6) state and local
public health officials who carry out an activity related to an
unapproved EUA product (e.g., administering the product to civilians)
and who must report to FDA regarding such activity.
    For purposes of estimating the burden of recordkeeping, FDA has
calculated the anticipated burden on manufacturers of unapproved
products authorized for emergency use. The Agency anticipates that the
federal government will perform some of the additional recordkeeping
necessary for unapproved products (e.g., related to the administration
of unapproved EUA products to military personnel). FDA also anticipates
that some state and local public health officials may be required to
perform additional recordkeeping (e.g., related to the administration
of unapproved EUA products to civilians) and calculated a recordkeeping
burden for those activities.
    No burden was attributed to reporting or recordkeeping for
unapproved uses of approved products, since those products already are
subject to approved collections of information (Adverse Experience
Reporting for biological products is approved under OMB Control No.
0910-0308 through September 30, 2011; Adverse Drug

Experience Reporting is approved under OMB Control No. 0910-0230
through April 30, 2009; and IND regulations are approved under OMB
Control No. 0910-0014 through May 31, 2009) and any additional burden
imposed by this proposed collection would be minimal. Thus, FDA
estimates the burden of this collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
                      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                 15                 15
 Consideration;
 Pending
 Application on
 File
----------------------------------------------------------------------------------------------------------------
Request for                        1                  1                  1                 50                 50
 Consideration;
 No Application
 Pending
----------------------------------------------------------------------------------------------------------------
Pre-Emergency                     10                  1                 10                 20                200
 Submissions;
 Pending
 Application on
 File
----------------------------------------------------------------------------------------------------------------
Pre-Emergency                      3                  1                  3                 75                225
 Submissions; No
 Application
 Pending
----------------------------------------------------------------------------------------------------------------
Manufacturers of                   3                  4                 12                  2                 24
 an Unapproved
 EUA Product
----------------------------------------------------------------------------------------------------------------
State and Local                   30                  4                120                  2                240
 Public Health
 Officials;
 Unapproved EUA
 Product
----------------------------------------------------------------------------------------------------------------
Total                                                                                754
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2.--Estimated Recordkeeping Annual Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual
                     Recordkeepers    per Recordkeeping       Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
Manufacturers of                   3                  4                 12                 25                300
 an Unapproved
 EUA Product
----------------------------------------------------------------------------------------------------------------
State and Local                   30                  4                120                  3                360
 Public Health
 Officials;
 Unapproved EUA
 Product
----------------------------------------------------------------------------------------------------------------
Total                                                                                660
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The annual burden estimate for this information collection is 1,414
hours. The estimated reporting burden for this collection is 754 hours
and the estimated recordkeeping burden is 660 hours.

    Dated: April 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8922 Filed 4-17-09; 8:45 am]

BILLING CODE 4160-01-S