[Federal Register Volume 79, Number 158 (Friday, August 15, 2014)]
[Proposed Rules]
[Pages 48098-48105]
[FR Doc No: 2014-18959]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 25, 121, and 129

[Docket No.: FAA-2014-0500; Notice No. 14-07]
RIN 2120-AK30

Fuel Tank Vent Fire Protection

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action would amend certain airworthiness regulations for
transport category airplanes to require fuel tank designs that prevent
a fuel tank explosion caused by flame propagation through the fuel tank
vents from external fires. This action would add a new requirement for
fuel tank vent fire protection and would increase the time available
for passenger evacuation and emergency response. This proposed
amendment would apply to applications for new type certificates and
certain applications for amended or supplemental type certificates. It
would also require certain airplanes produced in the future and
operated by air carriers to meet the new standards.

DATES: Send comments on or before November 13, 2014.

ADDRESSES: Send comments identified by docket number FAA-2014-0500
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Mike Dostert, Propulsion and Mechanical Systems
Branch, ANM-112, Transport Airplane Directorate, Aircraft Certification
Service, Federal Aviation Administration, 1601 Lind Ave. SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    For legal questions concerning this action, contact Sean Howe,
Office of the Regional Counsel, ANM-7, Federal Aviation Administration,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2591; facsimile<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for this Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
Requirements.'' Under that section, the FAA is charged with promoting
safe flight of civil aircraft in air commerce by prescribing
regulations and minimum standards for the design and performance of
aircraft that the Administrator finds necessary for safety in air
commerce. This regulation is within the scope of that authority. It
prescribes new safety standards for the design and operation of
transport category airplanes.

I. Overview of Proposed Rule

A. General

    This proposed rule would prevent fuel tank explosions caused by
ignition (from potential external ignition sources) of fuel vapor
present in or exiting through the fuel tank vent outlets. Ignition
sources may include, but are not limited to, ground handling equipment,
fuel fires that result from refueling spills, or ground fire that may
be present following a survivable crash landing in which the fuel tank
and the vent system remain intact. The FAA has determined that a means
to prevent propagation of flame \1\ from external sources into the tank
through the fuel tank vents, such as flame arrestors or a means of
inerting the fuel tanks, could be used to prevent or delay fuel tank
explosions following certain accidents. This prevention or delay would
provide time for the safe evacuation of passengers from the airplane.
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    \1\ Flame propagation is defined as the spread of a flame in a
combustible environment outward from the point at which the
combustion started.
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    This proposed rule would apply to applications for new type
certificates and applications for amended or supplemental type
certificates on significant product level change projects in which
Title 14, Code of Federal Regulations (14 CFR) 25.975, Fuel tank vents
and carburetor vapor vents, is applicable to a changed area. We are
also proposing a new operating requirement applicable to newly produced
airplanes that are issued an original airworthiness certificate after a
specified date, per 14 CFR part 121, Operating Requirements: Domestic,
Flag, and Supplemental Operations, and 14 CFR part 129, Operations:
Foreign Air Carriers and Foreign Operators of U.S.-Registered Aircraft
Engaged in Common Carriage. We do not propose to require retrofit of
the existing fleet.
    Currently, there is not an advisory circular (AC) that describes
compliance means for protection of fuel tank vents from external
ignition sources. We have provided compliance means information to
applicants for type certificates through project-specific issue papers.
These issue papers describe how to demonstrate that flame will not
progress through the fuel tank vents into the fuel tank.
    Concurrent with the publication of this proposal, we are also
publishing for

comment an associated draft AC 25.975-X that will provide applicants
with one acceptable means of compliance for preventing propagation of
flames through the fuel tank vents.

B. Total Costs and Benefits of This Proposed Rule

    The FAA finds the proposed rule to be cost-beneficial because the
costs of the rule are low enough that the expected benefits of
preventing just two fatalities would outweigh the expected costs ($4.9
million in present value benefits versus $4.4 million in present value
costs). If this action is not taken, a hazard would continue to exist
even though effective and low-cost means are available to minimize or
eliminate it.

II. Background

A. Statement of the Problem

    Fires outside of the airplane fuel tanks can be caused by events
such as fuel spilled during refueling, fuel and oil spillage following
survivable accidents from engines that separate from the airplane, or
leaking airplane fuel tanks. In some cases, external fires have ignited
fuel vapors that exit the fuel tank vents, resulting in flames
traveling through the vent lines into the fuel tank, causing fuel tank
explosions. These explosions have caused fatalities to passengers and
have prevented emergency personnel from assisting survivors.
    During an industry review of potential post-crash survivability,
the Special Aviation Fire and Explosion Reduction (SAFER) Advisory
Committee \2\ determined that four fuel tank explosions resulting from
post-crash fires could have been avoided if flame arrestors or surge
tank explosion suppression systems \3\ had been installed in the
airplane fuel tank vents \4\. The SAFER committee examined methods of
preventing fuel tank explosions following impact survivable accidents.
Options included controlling the fuel tank flammability using nitrogen
inerting systems, using fire suppression systems, and installation of
flame arrestors.
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    \2\ Special Aviation Fire and Explosion Reduction (SAFER)
Advisory Committee final report, volume 1, FAA/AFS-80-4 dated June
26, 1973, through June 26, 1980.
    \3\ Surge tank explosion suppression systems were installed on
some Boeing airplanes to prevent a lightning strike from igniting
fuel vapor in the fuel tank vent system. These systems used light
sensors that activated the discharge of fire suppression agent into
the fuel tank vent surge tank to prevent the fire from traveling
through the vents into the airplane fuel tanks.
    \4\ SAFER Report, page 49, Figure 3.
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    The SAFER committee determined the most practical means of
preventing post-crash fuel tank explosions was the use of flame
arrestors. Flame arrestors or suppression systems delay propagation of
ground fires into the fuel tank and the subsequent explosions,
providing additional time for the safe evacuation of passengers. Flame
arrestors stop the flame from traveling through the fuel tank vents by
quenching the flame. Flame arrestors are typically made of numerous
small stainless steel passages that remove heat from the flame so it
dies out before passing through the vent. Flame arrestors for a typical
transport airplane range in weight from 2 to 4 pounds each.
    The current airworthiness standards related to fuel system
explosion prevention in 14 CFR 25.981 include requirements to prevent
ignition inside the fuel tanks caused by system failures or external
heating of the fuel tank walls. The fuel tank venting standards also
include requirements to ensure fuel tank structural integrity following
failures of the refueling system that could result in overfilling of
the fuel tanks or clogging of the vents due to ice. Additionally, Sec.
25.954, Fuel system lightning protection, requires fuel tank vents be
designed and arranged to prevent the ignition of fuel vapor within the
system by lightning strikes.

B. History

    In 1995, based on the SAFER Committee report noted above, the FAA
issued the notice of proposed rulemaking (NPRM) entitled, ``Fuel System
Vent Fire Protection,'' (60 FR 6632), dated February 2, 1995. This
notice proposed a requirement for fuel tank vent fire protection in new
type design transport airplanes and retrofit of the existing fleet of
transport category airplanes through an amendment of operating rules.
Comments received in response to the notice questioned the accuracy of
the FAA's economic analysis related to the proposed retrofit
requirement. Comments also indicated that additional guidance, in the
form of an AC, should be developed to provide an acceptable means to
qualify flame arrestors to meet the proposed requirement.
    To address these issues, the FAA obtained additional cost
information from component suppliers and developed an AC that included
means of compliance. In 2001, the FAA tasked the Aviation Rulemaking
Advisory Committee (ARAC) to review the draft final rule, including the
FAA's proposed disposition of public comments, and to review the draft
AC. Due to the ARAC tasking, on August 23, 2002 the FAA published a
notice in the Federal Register of withdrawal of the ``Fuel System Vent
Protection'' NPRM published in 1995. As a result of industry resource
issues and FAA rulemaking prioritization activities, no work was done
on these ARAC taskings. The FAA published a withdrawal of the tasks on
June 21, 2004.
    As a result of limited ARAC resources, the FAA developed a strategy
for a number of rulemaking projects that had been tasked to ARAC and
issued a letter \5\ dated June 14, 2005, to the head of the Transport
Airplane and Engine Issues Group describing our intent to use the
existing 14 CFR 21.21 (finding an ``unsafe design feature'') to address
the need for flame arrestors in the fuel tank vents. Since 2005, this
has resulted in new type certificated airplanes having flame arrestors.
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    \5\ Hickey, John. Letter to Craig Bolt. 14 June 2005.
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    Prior to issuance of the letter in 2005, following industry
recommendations, many manufacturers voluntarily introduced flame
arrestors into their new type designs. Currently, most new type designs
and most newly produced transport category airplanes incorporate flame
arrestors in the fuel tank vents. Additionally, several applicants have
installed fuel tanks in the airplane fuselage that have vents located
in areas prone to lightning strikes (defined as zone 2), such that
flame arrestors were provided to prevent flame propagation into the
fuel tanks to comply with Sec.  25.954.
    However, some models of newly manufactured airplanes produced under
older type certificates, including business jets and smaller transport
category airplanes, do not incorporate a means to prevent flame
propagation through the fuel vent lines to the fuel tanks. Airplanes in
14 CFR part 121 operation that do not have such a means include older
models like the DC-9, MD-80, as well as all past and currently produced
DHC-8 turboprops, and Canadair Regional Jets.
    As a result of the review of several fuel tank explosions on older
designs, including a Philippine Airlines Boeing 737,\6\ the FAA issued
an airworthiness directive (AD) for Boeing Model 737 airplanes
mandating incorporation of flame arrestors.\7\ Early models of the 737
did not have means to prevent propagation of a flame from the fuel tank
vent outlet into the fuel tanks. The Philippine explosion occurred
while the airplane was parked at the gate. The ignition source that
caused the explosion could not be determined.

However, external ignition sources such as ground handling equipment or
hot surfaces on lighting located near the vent outlet were evaluated as
the possible source of the ignition.
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    \6\ On May 11, 1990, a Philippine Airlines 737-300 was destroyed
by a fuel tank explosion on the apron at Manila Ninoy Aquino
International Airport.
    \7\ AD 99-03-04 BOEING: Amendment 39-11018; Docket 98-NM-50-AD;
effective March 9, 1999.
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    In addition to the 737 AD, we have issued other ADs to either
require flame arrestors or verify their functionality on the Lockheed
Model 1649A piston airplane,\8\ Boeing Models 707 and 720,\9\ the Beech
Model 400A,\10\ and the Lockheed Model 382.\11\
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    \8\ AD 59-20-02 LOCKHEED: Effective October 15, 1959, for items
(1) and (2) and December 1, 1959, for item (3).
    \9\ AD 67-23-02 BOEING: Amendment 39-462. Effective September
10, 1967.
    \10\ AD 92-16-14 BEECH: Amendment 39-8323; Docket No. 92-NM-95-
AD; effective September 1, 1992.
    \11\ AD 2011-15-02 LOCKHEED: Amendment 39-16749; Docket No.,
FAA-2010-1305; effective August 19, 2011.
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    Since 2005, the FAA has also addressed the possibility of fuel tank
ignition resulting from post-crash fire propagation through fuel vent
lines with issue papers applied to specific certification projects.
    However, the lack of a specific part 25 regulation has resulted in
some manufacturers completing initial airplane designs and applying for
a U.S. type certificate without considering the need to mitigate the
risk of flame propagation through fuel vent lines. Some newly
manufactured airplanes introduced into the U.S. fleet do not have flame
arrestors in the fuel tank vents.\12\
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    \12\ Bombardier Q400 (Dash 8) and Canadair Regional Jets.
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III. Discussion of the Proposal

A. General

    This proposal would establish a minimum time period for preventing
a fuel tank explosion caused by flame propagation through the fuel tank
vents of 2 minutes and 30 seconds, measured from the time a flame first
impinges on any fuel tank vent. This capability would allow time to
evacuate passengers and crew to a safe distance from the airplane and
for emergency response to begin. The minimum performance standard in
this proposal is based on a balance between the available technology,
practicality considerations, and providing a satisfactory passenger
evacuation safety standard.
    The proposed regulatory text is intended to prevent, or at least
delay, fuel tank explosions or fires caused by external fires that
ignite fuel or vapor in the fuel tank. External fires may be caused by
sources such as post-crash ground fires, fires resulting from fuel
leakage during refueling, and ignition of fuel exiting the fuel vents.
The proposal requires consideration of flames in the fuel tank vent
outlets including propagation through the vent line, as well as
ignition sources created by damage to the vent system caused by the
external fire, such as burn-through of fuel tank vent system components
or heating of the vent system components.
    To limit propagation of external fires through the vent system, it
is necessary to design a flame arrestor, a flame suppression device, or
other system to prevent flame penetration and propagation through the
airplane fuel tank vents. The minimum time period should be no less
than the time required to evacuate the airplane. The FAA has previously
established a performance standard that, under specified conditions,
the airplane must be capable of being evacuated within 90 seconds
(Sec.  25.803, Emergency evacuation). The conditions under which the
airplane is evacuated assume availability of a minimum number of exits
and all passengers are uninjured and physically capable of departing
the airplane. This is not always the case.
    In addition to time for evacuation of passengers, we have also
established minimum standards for penetration of a fuel fire through
the airplane fuselage to allow emergency crews time to arrive at an
accident and to establish control of a fire (Sec.  25.856, Thermal/
Acoustic insulation materials). Analysis of past accidents showed the
greatest benefits when a minimum of 5 minutes is provided. This time
includes 1 minute for a fire to penetrate the fuselage skin and an
additional 4 minutes for the fire to burn through the insulation. The
time of 5 minutes for penetration of a post-crash ground fire into the
fuselage was based on research into studies of past accidents.\13\ \14\
As part of a project commissioned by the FAA, data have been gathered
on the relative proportion of accidents that involve ground pooled fuel
fires and statistical data on the following:
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    \13\ DOT/FAA/AR-99/57, Fuselage Burnthrough Protection for
Increased Postcrash Occupant Survivability: Safety Benefit Analysis
Based on Past Accidents, September 1999.
    \14\ DOT/FAA/AR-09/18, Determination of Evacuation and
Firefighting Times Based on an Analysis of Aircraft Accident Fire
Survivability Data, May 2009.
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     Time to initiate an evacuation;
     Time to complete an evacuation;
     Time to arrival of fire-fighters; and
     Time for fire-fighters to establish control in a ground
pool fire accident.
    The data were extracted from accident reports and other information
published by investigating and airworthiness authorities using the
Cabin Safety Research Technical Group aircraft accident database.
    Current technology flame arrestors installed in the transport fleet
have been designed to have a capability to prevent flame propagation
into the fuel tanks for up to 2 minutes and 30 seconds after flame
enters the fuel tank vent and contacts the face of the flame arrestor.
    The FAA is proposing a minimum standard of 2 minutes and 30
seconds. This time is greater than the 90 second evacuation time noted
above and allows additional time for passengers to exit from the crash
scene. No adverse service experience has occurred on airplanes equipped
with flame arrestors that provide this amount of time. While this time
is less than the 5 minute test standard required by Sec.  25.856 for a
ground fire to penetrate into the fuselage, the FAA has determined
providing fuel tank vent protection in excess of 2 minutes and 30
seconds would not be practical. Comments received to the notice issued
in 1995 indicated flame arrestors that meet a 5 minute standard would
need to be significantly larger, weigh more, and would introduce
significant pressure loss in the fuel system vent line, resulting in
the need to increase the size of the vent line to meet airplane
refueling performance requirements.

B. Potential for Blockage of Vents

    During the approval process for the existing compliance means that
use flame arrestors in the vent lines, several applicants expressed
concerns that requiring flame arrestors may reduce the level of safety
due to restrictions being introduced into the vents. The FAA
acknowledges that introducing flame arrestors in the fuel tank vents
may introduce the potential for clogging of the vent lines from ice and
debris. This could result in adverse consequences like more severe tank
pressures during fueling/over-fueling, greater differential pressures
on the tank skins during emergency descent or defueling, reduced fuel
jettison capability, and an increased risk of vent system blockage.
    To address these design considerations, applicants have included
positive and negative pressure relief provisions in their vent system
designs. This has afforded an excellent safety record. Service
experience of thousands of airplanes in the current fleet equipped with
flame arrestors indicates that each of these concerns (and other such
concerns not listed above) can be safely mitigated with proper design
and certification of the fuel tank vent fire protection. Proposed

AC 25.975-X would provide the guidance necessary to address these
issues.

C. Revise ``Fuel Tank Vents and Carburetor Vapor Vents'' (Sec.  25.975)

    Section 25.975 currently prescribes standards for fuel tank vents
but does not contain a standard for protecting the fuel tanks from
external flame propagating into the tank. We propose to add a new
paragraph, Sec.  25.975(a)(7), to establish a requirement for a means
to prevent the propagation of flames, for a limited time, from outside
the fuel tank through the fuel tank vents that could cause a fuel tank
explosion.
    Means of compliance available today include incorporation of flame
arrestors in the fuel system vent lines. Other means that might be
available in the future include full time fuel tank inerting systems
that prevent fuel tank explosions due to post-crash or other external
fires.
    We considered alternative technical solutions, such as mandating
nitrogen inerting systems that would prevent a fuel tank explosions
caused by external fires by eliminating fuel tank flammability. Current
fuel tank flammability limits in Sec.  25.981 have resulted in the use
of nitrogen inerting systems in some or all fuel tanks. However, the
fuel tanks become flammable during certain portions of airplane
operations such as during fuel tank refueling and times when the
inerting system cannot produce enough nitrogen to inert the fuel tanks.
During these times, the tanks continue to be vulnerable to explosion
from flame propagation through fuel system vent lines. The cost to
incorporate full-time nitrogen inerting systems in all fuel tanks would
be excessive.
    Another alternative we considered was to continue using
certification project-specific issue papers to address fuel tank vent
fire protection. However, this alternative does not allow public review
and comment and does not result in broad industry awareness of the need
to incorporate vent system protection into new designs early in the
airplane design process. In addition, this method is more costly and
time consuming for both the FAA and applicants due to the need to
process an issue paper identifying specific requirements for each
project. Some applicants have objected to this approach, and it has
proven more difficult to apply in a standardized manner.
    After considering these alternatives, we have concluded that the
most practical and cost effective method to address this safety issue
is the incorporation of flame arrestors in the fuel system vent lines
(as recommended in the SAFER committee report).

D. Newly Produced Airplanes

    Parts 121 and 129 prescribe operating requirements for air
carriers, including requirements for the airworthiness of each
airplane. Part 121 applies to domestic operators and, for airworthiness
requirements, part 129 applies to foreign operators operating U.S.-
registered airplanes. We propose to add a new operating requirement
that would apply to newly manufactured airplanes entering service 2
years after the effective date of this proposed regulation. This
compliance time is based on the estimated time needed to design and
develop a flame arrestor installation for existing airplanes. Flame
arrestor technology is currently available, and adaptation of this
technology to currently produced airplanes, certifying the design and
incorporation of the design in production, should be achievable within
the 2-year compliance time.
    While this proposal does not require manufacturers of existing type
designs to develop design features meeting the requirements, we
anticipate operators of the affected airplane models will enter into
business agreements with manufacturers to provide compliant designs
that meet the proposed operating regulations. Newly manufactured
airplanes that enter service typically have a minimum operating life of
20 years in passenger service. Therefore, the safety benefits of
incorporating flame arrestors would be greatest in newly produced
airplanes entering service.
    We are not proposing a requirement to retrofit airplanes in the
current fleet. This decision was based on the determination that many
of the older airplane models that do not have flame arrestors are being
retired. The cost to retrofit these airplanes for the safety
improvement is not in the public interest.

IV. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 and Executive Order 13563 direct
that each Federal agency shall propose or adopt a regulation only upon
a reasoned determination that the benefits of the intended regulation
justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub.
L. 96-354) requires agencies to analyze the economic impact of
regulatory changes on small entities. Third, the Trade Agreements Act
(Pub. L. 96-39) prohibits agencies from setting standards that create
unnecessary obstacles to the foreign commerce of the United States. In
developing U.S. standards, the Trade Act requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) requires agencies to prepare a written assessment of
the costs, benefits, and other effects of proposed or final rules that
include a Federal mandate likely to result in the expenditure by state,
local, or tribal governments, in the aggregate, or by the private
sector, of $100 million or more annually (adjusted for inflation with
base year of 1995). This portion of the preamble summarizes the FAA's
analysis of the economic impacts of the proposed rule. We suggest
readers seeking greater detail read the full regulatory evaluation, a
copy of which we have placed in the docket for this rulemaking.
    In conducting these analyses, FAA has determined that this proposed
rule: (1) Has benefits that justify its costs; (2) is not an
economically ``significant regulatory action'' as defined in section
3(f) of Executive Order 12866; (3) is not ``significant'' as defined in
DOT's Regulatory Policies and Procedures; (4) would not have a
significant economic impact on a substantial number of small entities;
(5) would not create unnecessary obstacles to the foreign commerce of
the United States; and (6) would not impose an unfunded mandate on
state, local, or tribal governments, or on the private sector by
exceeding the threshold identified above.
    These analyses are summarized below.
Total Costs and Benefits of This Proposed Rule
    The FAA finds the proposed rule to be cost-beneficial because the
costs of the rule are low enough that the expected benefits of
preventing just two fatalities would outweigh the expected costs ($4.9
million in present value benefits versus $4.4 million in present value
costs). If this action is not taken, a hazard would continue to exist
even though effective and low-cost means are available to minimize or
eliminate it.
Who is potentially affected by this rule?
    Manufacturers of newly certified part 25 airplanes and U.S.
operators of these airplanes are affected by the rule as a result of
its applicability to new certification part 25 airplanes. Manufacturers
and operators of

currently produced part 25 airplanes (production cut-in) are affected
by the rule as a result of its applicability to airplanes engaged in
part 121 or 129 operations produced two years or more after the
effective date of this rule.
Principal Assumptions and Sources of Information
     Discount rate is 7 percent (Office of Management & Budget,
Circular A-94, ``Guidelines and Discount Rates for Benefit-Cost
Analysis of Federal Programs,'' October 29, 1992, p. 8).
     Value of statistical life (VSL) begins at $9.1 million in
2012 and increases thereafter by an annual growth factor of 1.0107.
Memorandum: Guidance on Treatment of the Economic Value of a
Statistical Life in Department Analyses. [February 2013]. United
States, Office of the Secretary of Transportation.
     For small part 25 manufacturers: Two U.S. airplane
certifications in next 10-year period, twenty-one annual U.S.
deliveries per U.S. certification; three foreign airplane
certifications in next 10-year period, eleven annual U.S. deliveries
per foreign certification, 15-year airplane production run; 30-year
retirement age. Internal FAA study.
     Current airplane models that could be affected by
production cut-in requirement (Bombardier Dash 8, CJ-700, and CJ-900):
FAA 2013 Fleet Forecast, Fleet Forecast Sheet, ``FAA U.S. Airlines
2013-2013 1-18-2103,'' ``Totals & FAA Tables.''
     The period of analysis for new certifications is 45 years
to account for a complete product life cycle determined by a 15-year
production period and a 30-year service period.
     Certification cost estimates for part 25 airplanes--Survey
of small U.S. part 25 airplane manufacturers.
     Maintenance cost per airplane (every four years) for
Bombardier CJ-700/CJ-900 regional jets (subject to production cut-in)--
$240. This estimate is much lower than the U.S. estimate because it is
for passenger airplane models, while the U.S. estimate is for business
jet models. Since business jets are more prone to sit for extended
periods of time, their flame arrestors can more easily be clogged by
ice, mud daubers, or other debris, thus requiring more frequent and
longer maintenance.
     Minimal fuel costs as flame arrestors weigh between 2 and
4 pounds each.
Costs of This Proposed Rule
    The costs of the proposed rule are engineering, production, and
maintenance compliance costs for newly certificated part 25 airplanes
and for new production of currently-produced part 25 airplanes used in
part 121 operations (production cut-in). We first estimate compliances
costs for new certifications and then for the production cut-in.
Compliance Costs of New Certification Airplanes to Manufacturers and
Operators
    For newly certificated airplanes, compliance costs consist of
engineering and production costs of U.S. manufactured airplanes
delivered to U.S. operators and maintenance costs of both U.S. and
foreign airplanes delivered to U.S. operators. U.S. part 25
manufacturers directly incur the engineering and production costs while
U.S. operators directly incur the maintenance costs. Engineering and
production costs incurred by foreign manufacturers are not included in
the costs of compliance, as costs directly attributable to foreign
entities are not included in the cost and benefit analysis of proposed
U.S. regulations.
    To calculate the cost of new U.S. certifications, we assume that
all new certifications will be approved one year after the effective
date of the rule, with production beginning one year later. Using an
airplane life cycle model, we estimate the economic impact for two new
certificates, production of 21 airplanes/certificates/year, production
runs of 15 years, and an airplane retirement age of 30 years.
Compliance costs per year are calculated over an airplane life cycle of
45 years.
    Industry cost estimates were solicited from small part 25
manufacturers because large airplane manufacturers (Boeing and Airbus)
are already compliant with the proposed rule. These cost estimates are
shown in the table below.

  Industry Cost Estimates Using Flame Arrestors To Comply With Proposed
                                  Rule
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           Cost category                 Cost              Notes
------------------------------------------------------------------------
Nonrecurring Engineering Costs.....     $142,000  per model.
Production Costs (Hardware &               3,000  per airplane (two
 Installation).                                    flame arrestors
                                                   @$1,500 each).
Maintenance Costs (U.S.                      415  per airplane annually.
 manufacturers).
Maintenance Costs (Bombardier).....          240  per airplane every 4
                                                   years.
------------------------------------------------------------------------

    The industry cost estimates consist of nonrecurring (one-time)
engineering costs, production costs for two flame arrestors per
airplane (one per fuel tank), and maintenance costs per airplane per
year. (The Bombardier maintenance cost estimate is used for estimating
production cut-in costs of compliance.) Incorporating the industry cost
estimates into the airplane life cycle model, we find total costs for
new certification airplanes to be $16.2 million with present value of
$4.2 million. $2.2 million of these costs (present value $1.2 million)
are directly incurred by U.S. manufacturers and $14.0 million (present
value $2.1 million) are directly incurred by U.S. operators.\15\
---------------------------------------------------------------------------

    \15\ Details may not sum to totals due to rounding.
---------------------------------------------------------------------------

Compliance Costs of Production Cut-In
    In addition to the requirement applying to new certifications, the
proposed rule would also require a production cut-in for currently
produced part 25 airplanes used in part 121 operations.\16\ To
calculate this cost, we first note that the only currently produced and
U.S. operated airplane models not already in compliance are the
Bombardier Dash 8 turboprops and Bombardier CJ-700/CJ-900 regional
jets. The final rule would apply to these Bombardier models produced
beginning in 2018. Since the FAA forecasts no Dash 8 deliveries to U.S.
airline operators after 2017, we expect no Dash 8 compliance cost for
these operators.
---------------------------------------------------------------------------

    \16\ We do not estimate costs for the analogous part 129
requirement as these costs are directly incurred by foreign
operators.
---------------------------------------------------------------------------

    The FAA does forecast the delivery of 338 CRJ-700 and 161 CRJ-900
model airplanes to U.S. airline operators over the period 2018-2033.
The engineering and production compliance costs for these airplanes are
not included in our cost estimates because, as noted above, costs
directly incurred by foreign entities are not included in the cost and

benefit analysis of proposed U.S. regulations. Accordingly, for these
airplanes we assess the impact on U.S. operators only, using
Bombardier's maintenance cost estimate of $240 every four years.
Allocating this cost as $60 annually and assuming a production period
of 16 years, we calculate the maintenance costs for these airplanes
from the first year of service to the retirement year of the last
airplanes produced, using a procedure analogous to that used for new
certification airplanes. We find these costs to operators to be
$898,200 with present value $178,439.
    Production cut-in costs of $898,200 (present value $178,439) added
to new certification airplane costs of $16.2 million (present value
$4.2 million) yield total rule costs of $17.1 million (present value
$4.4 million).
Benefits of This Proposed Rule
    Notwithstanding the absence of post-crash fuel tank explosions in
recent years and lacking other sufficient bases upon which to estimate
future risks, the merits of the proposed rule can be assessed by
considering the number of fatalities that would need to be prevented to
offset the costs of the rule.
    We estimate the breakeven benefits of the rule by estimating the
number of averted fatalities necessary to offset the $4.4 million
present value costs of the rule. We find that just two averted
fatalities would offset these estimated costs.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation.'' To achieve this principle, agencies are
required to solicit and consider flexible regulatory proposals and to
explain the rationale for their actions to assure that such proposals
are given serious consideration.'' The RFA covers a wide range of small
entities, including small businesses, not-for-profit organizations, and
small governmental jurisdictions. Agencies must perform a review to
determine whether a rule will have a significant economic impact on a
substantial number of small entities. If the agency determines that it
will, the agency must prepare a regulatory flexibility analysis as
described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    All small U.S. manufacturers affected by this rule are wholly owned
subsidiaries of large companies, who have more than 1,500 employees
(the small business criterion for aircraft manufacturing) and,
therefore, are not classified as small entities by the Small Business
Administration. Part 121 operators would be directly affected by the
average $415 annual maintenance cost per airplane. These costs are
minimal, especially compared to the high cost of new part 25 airplanes.
    If an agency determines that a rulemaking will not result in a
significant economic impact on a substantial number of small entities,
the head of the agency may so certify under section 605(b) of the RFA.
Therefore, as provided in section 605(b), the head of the FAA certifies
that this rulemaking would not result in a significant economic impact
on a substantial number of small entities.
    The FAA solicits comments regarding this determination.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Public Law 96-39), as amended by
the Uruguay Round Agreements Act (Public Law 103-465), prohibits
Federal agencies from establishing standards or engaging in related
activities that create unnecessary obstacles to the foreign commerce of
the United States. Pursuant to these Acts, the establishment of
standards is not considered an unnecessary obstacle to the foreign
commerce of the United States, so long as the standard has a legitimate
domestic objective, such as the protection of safety, and does not
operate in a manner that excludes imports that meet this objective. The
statute also requires consideration of international standards and,
where appropriate, that they be the basis for U.S. standards.
    This proposed rule would not create an unnecessary obstacle to
foreign commerce as foreign and domestic manufacturers are equally
affected and its effect on part 121 operators would be domestic only.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law
104-4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $151.0 million in lieu of $100
million. This proposed rule does not contain such a mandate; therefore,
the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there would be no new requirement for information collection associated
with this proposed rule.

F. International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these proposed regulations.

G. Environmental

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f and involves no extraordinary
circumstances.

V. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this proposed rule under the principles and
criteria of Executive Order 13132, Federalism. The agency has
determined that this action would not have a substantial direct effect
on the States, or the relationship between the Federal Government and
the States, or on the distribution of power and responsibilities among
the various levels of government, and,

therefore, would not have Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
would not be a ``significant energy action'' under the executive order
and would not be likely to have a significant adverse effect on the
supply, distribution, or use of energy.

VI. Additional Information

A. Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. The agency
also invites comments relating to the economic, environmental, energy,
or federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit only one time.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or delay. The agency may change this proposal in
light of the comments it receives.
    Proprietary or Confidential Business Information: Commenters should
not file proprietary or confidential business information in the
docket. Such information must be sent or delivered directly to the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this document, and marked as proprietary or confidential. If submitting
information on a disk or CD ROM, mark the outside of the disk or CD
ROM, and identify electronically within the disk or CD ROM the specific
information that is proprietary or confidential.
    Under 14 CFR 11.35(b), if the FAA is aware of proprietary
information filed with a comment, the agency does not place it in the
docket. It is held in a separate file to which the public does not have
access, and the FAA places a note in the docket that it has received
it. If the FAA receives a request to examine or copy this information,
it treats it as any other request under the Freedom of Information Act
(5 U.S.C. 552). The FAA processes such a request under Department of
Transportation procedures found in 49 CFR part 7.

B. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
Internet by:
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or
    3. Accessing the Government Printing Office's Web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket or notice number of this
rulemaking.
    All documents the FAA considered in developing this proposed rule,
including economic analyses and technical reports, may be accessed from
the Internet through the Federal eRulemaking Portal referenced in item
1 above.

List of Subjects

14 CFR Part 25

    Aircraft, Aviation safety, Life-limited parts, Reporting and
recordkeeping requirements.

14 CFR Part 121

    Air carriers, Aircraft, Aviation safety, Reporting and
recordkeeping requirements, Safety, Transportation.

14 CFR Part 129

    Air carriers, Aircraft, Aviation safety, Reporting and
recordkeeping requirements.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend chapter I of Title 14, Code of Federal
Regulations as follows:

PART 25--AIRWORTHINESS STANDARDS: TRANSPORT CATEGORY AIRPLANES

0
1. The authority citation for part 25 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, and 44704.
0
2. Amend Sec.  25.975 by revising paragraphs (a)(5) and (a)(6), and
adding a new paragraph (a)(7) to read as follows:

Sec.  25.975  Fuel tank vents and carburetor vapor vents.

    (a) * * *
    (5) There may be no point in any vent line where moisture can
accumulate with the airplane in the ground attitude or the level flight
attitude, unless drainage is provided;
    (6) No vent or drainage provision may end at any point--
    (i) Where the discharge of fuel from the vent outlet would
constitute a fire hazard; or
    (ii) From which fumes could enter personnel compartments; and
    (7) Each fuel tank system must be designed to prevent explosions
caused by propagation of flames from outside the tank through the fuel
tank vents into fuel tank vapor spaces for a minimum of 2 minutes and
30 seconds of continuous exposure to flame impingement on any fuel tank
vent.
* * * * *

PART 121--OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND SUPPLEMENTAL
OPERATIONS

0
3. The authority citation for part 121 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 40119, 41706, 44101, 44701-
44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 46105.
0
4. Add Sec.  121.1119 to subpart AA to read as follows:

Sec.  121.1119  Fuel tank vent explosion protection.

    (a) Applicability. This section applies to transport category,
turbine-powered airplanes with a type certificate issued after January
1, 1958, that, as a result of original type certification or later
increase in capacity, have:
    (1) A maximum type-certificated passenger capacity of 30 or more,
or
    (2) A maximum payload capacity of 7,500 pounds or more.
    (b) New production airplanes. No certificate holder may operate an
airplane for which the State of Manufacture issued the original
certificate of airworthiness or export airworthiness approval after
[insert date 2 years after effective date of rule] unless fuel tank
vent system explosion prevention means meeting the requirements of
Sec.  25.975 of this chapter, are installed and operational.

PART 129--OPERATIONS: FOREIGN AIR CARRIERS AND FOREIGN OPERATORS OF
U.S.-REGISTERED AIRCRAFT ENGAGED IN COMMON CARRIAGE

0
5. The authority citation for part 129 continues to read as follows:

    Authority: 49 U.S.C. 40113, 40119, 41301, 44101, 44701-44702,
44705, 44709-44711, 44713, 44716-44717, 44722, 44901-44904, 44906,
44912, 46105, Public Law 107-71 sec. 104.
0
6. Add Sec.  129.119 to subpart B to read as follows:

Sec.  129.119  Fuel tank vent explosion protection.

    (a) Applicability. This section applies to transport category,
turbine-powered airplanes with a type certificate issued after January
1, 1958, that, as a result of original type certification or later
increase in capacity, have:
    (1) A maximum type-certificated passenger capacity of 30 or more,
or
    (2) A maximum payload capacity of 7,500 pounds or more.
    (b) New production airplanes. No certificate holder may operate an
airplane for which the State of Manufacture issued the original
certificate of airworthiness or export airworthiness approval after
[insert date 2 years after effective date of rule] unless fuel tank
vent system explosion prevention means meeting the requirements of
Sec.  25.975 of this chapter, are installed and operational.

    Issued under authority provided by 49 U.S.C. 106(f), 44701(a),
and 44703 in Washington, DC, on August 1, 2014.
Frank Paskiewicz,
Acting Director, Aircraft Certification Service.
[FR Doc. 2014-18959 Filed 8-14-14; 8:45 am]
BILLING CODE 4910-13-P


EPA Registration Division contact: Sidney Jackson,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

PP# 7E7172

	EPA has received a pesticide petition (PP) [7E7172] from the IR-4, 500
College Road East, Suite 201 W, Princeton, NJ 08540, proposing, pursuant
to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a(d), to amend 40 CFR part 180. 627 by establishing a
tolerance for residues of the fungicide, fluopicolide, 2,6-dichloro- N
-[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl] benzamide, in or on
the raw agricultural commodity vegetable, root and tuber, group 1 at 0.2
parts per million (ppm); Vegetable, leaves of root and tuber, group 2 at
12 ppm; Vegetable, bulb, group 3, at 5 ppm; Chive, fresh leaves at 5
ppm; Chive, Chinese, fresh leaves at 5 ppm; Daylily, bulb at 5 ppm;
Elegans hosta at 5 ppm; Fritillaria, bulb at 5 ppm; Fritillaria, leaves
at 5 ppm; Garlic, Serpent, bulb at 5 ppm; Kurrat at 5 ppm; Lady’s leek
at 5 ppm; Leek, wild at 5 ppm; Lily, bulb at 5 ppm; Onion, Beltsville
bunching at 5 ppm; Onion, Chinese, bulb at 5 ppm; Onion, fresh at 5 ppm;
Onion, macrostem at 5 ppm; Onion, pearl at 5 ppm; Onion, potato, bulb at
5 ppm; Onion, tree, tops at 5 ppm; Shallot, bulb at 5 ppm; Shallot,
fresh leaves at 5 ppm; Brassica, head and stem, subgroup 5A at 5 ppm.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408 (d)(2) of the FDDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the petition.
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The fate of fluopicolide in plants is clearly
understood.  Metabolism studies were conducted with grapes, potato, and
lettuce.  The metabolic profile of fluopicolide was similar in all three
crops and demonstrated that fluopicolide is degraded by oxidation and
hydrolysis.  The primary residue found in all crops, and the only
residue of concern, is the parent molecule fluopicolide.

	2. Analytical method. A practical analytical method utilizing liquid
chromatography and mass spectrometry detection is available and has been
validated for detecting and measuring levels of fluopicolide in and on
crops. The validated limit of quantitation is 0.01 ppm.

	3. Magnitude of residues. Residue data for the use of fluopicolide on
the commodities listed within this notice has been submitted.

B. Toxicological Profile

	1. Acute toxicity.  A battery of acute toxicity studies places
technical fluopicolide in toxicity category IV. No evidence of
sensitization was observed in guinea pigs.  In an acute neurotoxicity
study in rats, only statistically lower body temperature was observed 6
hours after dosing at the limit dose of 2000 mg/kg. No other
treatment-related changes were noted in the study, and the NOAEL was
considered to be 100 mg/kg.

	2. Genotoxicty. Fluopicolide has been evaluated for genotoxicity using
a battery of tests, including bacterial reverse mutation tests, a
mammalian cell gene mutation (HPRT) assay, an in vivo mouse micronucleus
assay, an in vitro chromosome aberration test, and an in vivo
unscheduled DNA synthesis test. The weight of evidence from all of these
assays shows that fluopicolide is not genotoxic.

	3. Reproductive and developmental toxicity.

i. In a developmental toxicity study in rats gavage dosed from gestation
days 7 to 20 at levels of 0, 5, 60 or 700 mg/kg/day, evidence of
maternal and fetal toxicity was observed at 700 mg/kg/day, the highest
dose tested. The maternal and fetal NOAEL was 60 mg/kg/day based on
statistically lower body weights in dams and fetuses, and skeletal
findings in fetuses that included delayed ossification of some bones and
slight increases in the incidence of various rib and thoracic vertebrae
anomalies.

ii. In a developmental toxicity study with rabbits, pregnant animals
were given oral doses of 0, 5, 20 or 60 mg/kg/day on gestation days 6 to
28. At the high dose, 15 animals were sacrificed following spontaneous
abortions and 3 animals were found dead. The few surviving animals in
this group had live fetuses at cesarean sectioning but other than lower
fetal weight and crown/rump length, no treatment-related findings were
observed upon external, visceral and skeletal examinations of these
fetuses. The NOAEL for maternal and fetal toxicity was 20 mg/kg/day.

iii. In a 2-generation reproductive toxicity study, fluopicolide was
administered to rats at dietary levels of 0, 100, 500, or 2000 ppm. The
NOAEL was 500 ppm (equivalent to 26 and 33 mg/kg/day for males and
females, respectively) for developing offspring and for
parental/systemic toxicity. The LOAEL was 2000 ppm based on decreased
body weight and organ weight changes in both F0 and F1 adults and F1 and
F2 pups. The reproductive NOAEL was 2000 ppm.

	4. Subchronic toxicity.

Ninety-day feeding studies were conducted in dogs, mice and rats.

i. No evidence of toxicity was observed in dogs up to the limit dose of
1000 mg/kg/day.  The NOAEL in dogs is 1000 mg/kg/day.

ii. In 90-day feeding studies in both CD-1 and C57BL/6 mice, liver was
the only target organ identified with hepatocellular hypertrophy seen at
dietary levels of 320 ppm and higher. The NOAEL in C57BL/6 mice was 200
ppm (equivalent to 37.8 and 52.8 mg/kg/day in males and females,
respectively).

iii. In a 90-day rat study with dietary levels of 100, 1400 and 20,000
ppm, the maximum tolerated dose (MTD) was exceeded at 20,000 ppm based
on body weight gain of 30 to 40% below control. The target organs
identified in rats were the liver (centrilobular hypertrophy) in both
sexes and the kidneys in males (accumulation of hyaline droplets, single
cell death at the proximal tubule epithelium, slight foci of basophilic
tubules and granular casts) at 1400 ppm and 20000 ppm. The NOAEL was 100
ppm, equivalent to 7.4 and 8.4 mg/kg/day, in males and females,
respectively.

iv. In a subchronic neurotoxicity study, rats were treated with 0, 200,
1400 or 10000 ppm in the diet for 13 weeks.  The NOAEL for systemic
toxicity is 1400 ppm (107 mg/kg/day in males and 125 mg/kg/day in
females) based on findings in the liver and kidney.  There were no
neurotoxicity findings.  The NOAEL for neurotoxicity is 10,000 ppm (781
mg/kg/day in males and 866 mg/kg/day in females).

v.  In a subchronic dermal toxicity study, male and female rats were
treated with fluopicolide at dose levels of 0, 100, 250, 500 and 1000
mg/kg/day.  There were no effects at any dose level.  The NOAEL of the
study is 1000 mg/kg/day.

	5. Chronic toxicity.

i. Lower body weight gain at the limit dose of 1000 mg/kg/day was the
only treatment-related effect noted in a 52-week dog study performed at
70, 300, and 1000 mg/kg/day by gavage. Thus, the NOAEL in dogs was
established at 300 mg/kg/day.

ii. Chronic toxicity/carcinogenicity was assessed in rats at dietary
levels of 50, 200, 750 and 2500 ppm. The NOAEL was 200 ppm (8.4
mg/kg/day in males and 10.8 mg/kg/day in females) based on microscopic
changes in the liver and kidneys similar to those observed in the 90-day
rat study.  No evidence of carcinogencity was observed in rats up to
2500 ppm.

iii. The oncogenic potential of fluopicolide was investigated in C57BL/6
mice at dietary levels of 0, 50, 400, or 3200 ppm. Significantly lower
body weight gain was seen at 3200 ppm in conjunction with a slight
decrease in food consumption. Increased liver weight and centrilobular
hepatocellular hypertrophy were observed at 400 and 3200 ppm in both
sexes. In addition at 3200 ppm, an increased incidence of hepatocellular
adenomas was noted in both sexes, but the incidence of hepatocellular
carcinomas was not affected. The NOAEL was 50 ppm (equivalent to 7.9 and
11.5 mg/kg/day in males and females, respectively). Subsequent
mechanistic work demonstrated a marked transient hepatocellular
proliferation, which returned to control levels after 28 days of
treatment.  This was accompanied by a clear induction of total
cytochrome P-450 and related enzymes.  These results parallel findings
with Phenobarbital, which has a well understood threshold-based
mechanism of rodent tumor formation commonly known to be of no relevance
to humans.

	6. Animal metabolism.

The animal metabolism of fluopicolide is well understood. Fluopicolide
is rapidly absorbed and excreted when administered to rats and the
resulting tissue residues are very low. The metabolic pathway for
fluopicolide is similar in rodents, goats and hens. Metabolism in
livestock proceeded primarily via hydroxylation and hydrolysis.

	7. Metabolite toxicology.

Four metabolites (AE C653711, AE C657188, AE C657378, and AE 1344122)
were identified as low-level plant and/or soil metabolites of
fluopicolide.  Several of the metabolites were identified at low levels
in the rat following fluopicolide or AE C653711 administration and were
therefore covered by the tox studies conducted with the parent molecule.
 All compounds were tested for acute, subchronic (28-day) and genetic
toxicity and AE C653711 and AE C657188 were additionally studied in in
vivo ADME studies.  All were found to be equally or less toxic than the
parent molecule itself.  These metabolites are therefore considered not
toxicologically relevant to the overall assessment of fluopicolide human
health.

	8. Endocrine disruption. The toxicology database for fluopicolide is
current and complete. No special studies to evaluate the potential
endocrine effects of fluopicolide have been conducted.  However, the
studies in this database include evaluation of the potential effects on
reproduction and development, and an evaluation of the pathology of the
endocrine organs following short- or long-term exposure.  These studies
revealed no endocrine-related effects.

C. Aggregate Exposure

	1. Dietary exposure.

An assessment was conducted to evaluate potential risks due to chronic
and acute dietary exposure of the U.S. population subgroups to residues
of fluopicolide.  This analysis covers all pending crop uses.

	i. Food.

Acute:  No appropriate toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies conducted
with fluopicolide.  Since no acute toxicological endpoints could be
established, the acute aggregate risk is considered to be negligible.

Chronic: Chronic assessments were conducted to evaluate potential risks
due to chronic dietary exposure to the U.S. population and selected
population subgroups to residues of fluopicolide.  This analysis was
conducted using the Cumulative and Aggregate Risk Evaluation System
(CARES) using actual field trial residue and estimated percent crop
treated.

	ii. Drinking Food. Acute: Since no acute toxicological endpoints could
be established, the acute aggregate risk is considered to be negligible.

	2. Non-dietary exposure.

There is a potential residential exposure to adults applying
fluopicolide, and adults and children entering residential turf areas
treated with fluopicolide. Based on the application of fluopicolide to
residential turf, conservative estimates of exposure were calculated for
both children and adults.  All estimates resulted in calculated margins
of exposure in excess of 100.

D. Cumulative Effects

Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity”.  EPA does not have, at this time,
available data to determine whether fluopicolide has a common mechanism
of toxicity with other substances or how to include this pesticide in a
cumulative risk assessment.  For the purposes of this tolerance action,
EPA has not assumed that fluopicolide has a common mechanism of toxicity
with other substances.

E. Safety Determination

	1. U.S. population.

Acute: No appropriate toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies conducted
with fluopicolide.  Since no acute toxicological endpoints could be
established, the acute aggregate risk is considered to be negligible.

	2. Infants and children.

Acute: No appropriate toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies conducted
with fluopicolide.  Since no acute toxicological endpoints could be
established, the acute aggregate risk is considered to be negligible.

Chronic: The results of the chronic dietary and drinking water exposure
and risk analysis demonstrate that there is a reasonable certainty that
no harm will result to the U.S. sub-populations of infants and children
from chronic dietary exposure resulting from the proposed uses of
fluopicolide.  The percentile of chronic dietary exposure (food) was
highest among children 1 to 5 years of age.  The percentile of chronic
drinking water exposure was highest among infants “0" years of age.
The percentile aggregate chronic exposure from food and water was
highest among infants “0" years of age.

The maximum chronic exposure from food and water for each population
sub-group was estimated to be less than 1 % of the c-PAD.

F. International Tolerances

	There are no CODEX tolerances for residues of fluopicolide.

{
}

{
}

{
}


[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Page 7576]
[FR Doc No: 2012-3296]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9630-2; EPA-HQ-ORD-2011-0390]

Draft Toxicological Review of 1,4-Dioxane: In Support of Summary
Information on the Integrated Risk Information System (IRIS)

AGENCY: Environmental Protection Agency .

ACTION: Notice of Peer Review Meeting.

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

SUMMARY: EPA is announcing that Versar, Inc., an EPA contractor for
external scientific peer review, will convene an independent panel of
experts and organize and conduct an external peer review meeting to
review the draft human health assessment titled, ``Toxicological Review
of 1,4-Dioxane: In Support of Summary Information on the Integrated
Risk Information System (IRIS)'' [EPA/635/R-11/003]. The draft
assessment was prepared by the National Center for Environmental
Assessment (NCEA) within the EPA Office of Research and Development.
EPA is releasing this draft assessment for the purposes of public
comment and peer review. This draft assessment is not final as
described in EPA's information quality guidelines, and it does not
represent and should not be construed to represent Agency policy or
views.
    Versar, Inc. invites the public to register to attend this meeting
as observers. In addition, Versar, Inc. invites the public to give
brief oral comments and/or provide written comments at the meeting
regarding the draft assessment under review. Space is limited, and
reservations will be accepted on a first-come, first-served basis. In
preparing a final report, EPA will consider Versar, Inc.'s report of
the comments and recommendations from the external peer review meeting
and any written public comments that EPA receives in accordance with
the announcements of the public comment period for the 1,4-dioxane
assessment in Federal Register Notices published August 31, 2011, (76
FR 54225) and September 16, 2011 (76 FR 57739).

DATES: The peer review panel meeting on the draft assessment for 1,4-
dioxane will be held on March 19, 2012, beginning at 9 a.m. and ending
at 5 p.m. Eastern Time.

ADDRESSES: The draft ``Toxicological Review of 1,4-Dioxane: In Support
of Summary Information on the Integrated Risk Information System
(IRIS)'' is available primarily via the Internet on the NCEA home page
under the Recent Additions and Publications menus at http://www.epa.gov/ncea. A limited number of paper copies are available from
the Information Management Team (Address: Information Management Team,
National Center for Environmental Assessment [Mail Code: 8601P], U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; telephone:<PHONE_NUMBER>; facsimile: 703-347-
8691). If you request a paper copy, please provide your name, mailing
address, and the draft assessment title.
    The peer review meeting on the draft 1,4-dioxane assessment will be
held at Hyatt Place, Raleigh-Durham Airport, 200 Airgate Drive,
Morrisville, NC 27560. To attend the meeting, register no later than
March 12, 2012, by contacting Versar, Inc., by email<EMAIL_ADDRESS>(subject line: 1,4-Dioxane Peer Review Meeting), by phone: (703) 642-
6727 (ask for Betzy Colon, the 1,4-Dioxane Peer Review Meeting
Coordinator), or by faxing a registration request to<PHONE_NUMBER>
(please reference the 1,4-Dioxane Peer Review Meeting and include your
name, title, affiliation, full address and contact information). Space
is limited, and reservations will be accepted on a first-come, first-
served basis. There will be limited time at the peer review meeting for
comments from the public. Please inform Betzy Colon if you wish to make
comments during the meeting.
    Information on Services for Individuals with Disabilities: EPA
welcomes public attendance at the ``1,4-Dioxane Peer Review Meeting''
and will make every effort to accommodate persons with disabilities.
For information on access or services for individuals with
disabilities, contact: Versar, Inc., at 6850 Versar Center,
Springfield, VA 22151; by email<EMAIL_ADDRESS>(subject line: 1,4-
Dioxane Peer Review Meeting), by phone:<PHONE_NUMBER> (ask for Betzy
Colon, the 1,4-Dioxane Peer Review Meeting Coordinator), or by faxing a
registration request to<PHONE_NUMBER> (please reference the 1,4-
Dioxane Peer Review Meeting and include your name, title, affiliation,
full address and contact information).
    Additional Information: For information on the draft assessment,
please contact Patricia Gillespie, National Center for Environmental
Assessment [Mail Code: B-243-01], U.S. Environmental Protection Agency,
National Center for Environmental Assessment, Office of Research and
Development, Research Triangle Park, NC 27711; telephone: (919) 541-
1964; facsimile:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About IRIS

    EPA's IRIS is a human health assessment program that evaluates
quantitative and qualitative risk information on effects that may
result from exposure to chemical substances found in the environment.
Through the IRIS Program, EPA provides the highest quality science-
based human health assessments to support the Agency's regulatory
activities. The IRIS database contains information for more than 550
chemical substances that can be used to support the first two steps
(hazard identification and dose-response evaluation) of the risk
assessment process. When supported by available data, IRIS provides
oral reference doses (RfDs) and inhalation reference concentrations
(RfCs) for chronic noncancer health effects and cancer assessments.
Combined with specific exposure information, government and private
entities use IRIS to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

    Dated: January 30, 2012.
Darrell A. Winner,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2012-3296 Filed 2-10-12; 8:45 am]
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