[Federal Register: August 15, 2007 (Volume 72, Number 157)]
[Rules and Regulations]
[Page 45656-45663]
[DOCID:fr15au07-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0545; FRL-8143-1]

Lambda-Cyhalothrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the combined
residues of lambda-cyhalothrin, 1:1 mixture of (S)-[alpha]-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and its epimer expressed as epimer of
lambda-cyhalothrin, a 1:1 mixture of (S)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate in or on cucurbit vegetables (Group 9),
tuberous and corm vegetables (Subgroup 1C), grass (forage, fodder, and
hay) (Group 17), barley, buckwheat, oat, rye, wild rice, and
pistachios. Syngenta Crop Protection, Inc. and the Interregional
Project No. 4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 15, 2007. Objections and
requests for hearings must be received on or before October 15, 2007,
and must be filed in accordance with the

instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0545. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Bonaventure Akinlosotu, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2005-0545 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before October 15, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2005-0545, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 14, 2006 (71 FR 19509) (FRL-7771-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F6994) by Syngenta Crop Protection, Inc., 410 Swing Rd., Greensboro,
NC 27409 and IR-4, 681 U.S. Highway 1 South, North Brunswick,
NJ 08902-3390. The petition requested that 40 CFR 180.438 be amended by
establishing a tolerance for combined residues of the insecticide
lambda-cyhalothrin, (S)-[alpha]-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-
chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate
and (R)-[alpha]-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and the
epimer of lambda-cyhalothrin, (S)-[alpha]-cyano-3-phenoxybenzyl-(Z)-
(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate in or on food commodity crop groupings:
Cucurbit vegetables (Crop Group 9) at 0.05 parts per million (ppm);
grass, forage, fodder, hay (Crop Group 17) at 9.0 ppm; tuberous and
corm vegetables (Crop Subgroup 1-C) at 0.01 ppm; barley, buckwheat,
oat, rye, grain at 0.05 ppm; barley, bran at 0.2 ppm; oat, rye, forage
at 2.0 ppm; barley, oat, hay at 2.0 ppm; barley, oat, rye, straw at
2.0ppm; and wild rice, grain at 1.0 ppm. That notice referenced a
summary of the petition prepared by Syngenta Crop Protection, Inc., the
registrant, which is available to the public in the docket, http://www.regulations.gov.
 No

comments were received on the notice of filing.
    The April 14, 2006 notice announcing the pesticide petition from
Syngenta Crop Protection, Inc. and IR-4 inadvertently left out the PP
number for the IR-4 petition though the commodities IR-4 requested were
proposed. There are actually two petitions (PP 3E6593 and PP 5F6994).
PP 3E6593 submitted by IR-4 requested that 40 CFR 180.438 be amended by
establishing a tolerance for combined residues of the insecticide
lambda-cyhalothrin and its epimer in or on food commodities: Barley,
buckwheat, oat, rye, grain at 0.05 ppm; barley, bran at 0.2 ppm; oat,
rye, forage at 2.0 ppm; barley, oat, hay at 2.0 ppm; barley, oat, rye,
straw at 2.0 ppm; and wild rice, grain at 1.0 ppm. PP 5F6994 submitted
by Syngenta Crop Protection, Inc., requested that 40 CFR 180.438 be
amended by establishing a tolerance for combined residues of the
insecticide lambda-cyhalothrin and its epimer in or on food commodity
crop groupings: Cucurbit vegetables (Crop Group 9) at 0.05 ppm; grass,
forage, fodder, hay (Crop Group 17) at 9.0 ppm; tuberous and corm
vegetables (Crop Subgroup 1-C) at 0.01 ppm.
    In the Federal Register of October 11, 2006 (71 FR 59780) (FRL-
8097-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E7077) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.438 be amended by
establishing a tolerance for the combined residues of the insecticide
lambda-cyhalothrin in or on pistachio at 0.05 ppm. That notice
referenced a summary of the petition prepared by Syngenta Crop
Protection, Inc., the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received

in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for the combined residues of lambda-cyhalothrin in or on cucurbit
vegetables (Crop Group 9) at 0.05 ppm; grass, forage, fodder and hay
(Crop Group 17) at 7.0 ppm; tuberous and corm vegetables (Crop Subgroup
1C) at 0.02 ppm; barley, grain at 0.05 ppm; buckwheat, grain at 0.05
ppm; oat, grain at 0.05 ppm; rye, grain at 0.05 ppm; barley, bran at
0.2 ppm; rye, bran at 0.2 ppm; oat, forage at 2.0 ppm; rye, forage at
2.0 ppm; barley, hay at 2.0 ppm; oat, hay at 2.0 ppm; barley, straw at
2.0 ppm; oat, straw at 2.0 ppm; rye, straw at 2.0 ppm; rice, wild,
grain at 1.0 ppm; pistachio at 0.05 ppm; hog, fat at 0.2 ppm; hog, meat
at 0.01 ppm; hog, meat-byproducts at 0.02 ppm; and milk, fat at 10.0
ppm (reflecting 0.4 ppm in whole milk). EPA's assessment of exposures
and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by lambda-cyhalothrin as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the
final rule published in the Federal Register of April 8, 2004 (69 FR
18480) (FRL-7353-4).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UF) are
used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for lambda-cyhalothrin
used for human risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of April 8, 2004 (69 FR 18480)
(FRL-7353-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to lambda-cyhalothrin, EPA considered exposure under the
petitioned-for tolerances as well as all existing lambda-cyhalothrin
tolerances in (40 CFR 180.438). EPA assessed dietary exposures from
lambda-cyhalothrin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. In estimating acute dietary
exposure, EPA used the Dietary

Exposure Evaluation Model (DEEM-FCID\(TM)\, Version 2.03) which uses
food consumption information from the United States Department of
Agriculture's (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII). A refined acute probabilistic
dietary exposure assessment was performed for lambda-cyhalothrin which
included all existing and proposed food uses and drinking water. The
acute dietary exposure assessment incorporated processing factors and
percent crop treated (PCT) estimates. Acute anticipated residues were
derived from USDA's Pesticide Data Program (PDP) monitoring data, field
trial studies, and a market basket survey for beef-fat.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used DEEM-FCID\(TM)\, Version 2.03 which uses food
consumption information from the USDA's 1994-1996 and 1998 CSFII. As to
residue levels in food, EPA conducted a refined chronic dietary
exposure assessment for lambda-cyhalothrin to support all existing and
proposed food uses, utilizing a single-point estimate of anticipated
residues for food and drinking water. The chronic dietary exposure
assessment incorporated processing factors and PCT estimates. Chronic
anticipated residues were derived from PDP monitoring data, field trial
studies, and a market basket survey for beef-fat.
    iii.Cancer. Lambda-cyhalothrin is classified as ``not likely to be
carcinogenic to humans.'' Therefore, there is no cancer risk associated
with existing or proposed uses.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must pursuant
to FFDCA section 408(f)(1) require that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
    a. The data used are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide residue.
    b. The exposure estimate does not underestimate exposure for any
significant subpopulation group.
    c. Data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by section 408(b)(2)(F)
of FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    PCT estimates of agricultural uses for lambda-cyhalothrin were
obtained in the form of a screening-level usage assessment (SLUA),
based on data years 1999-2004. Average and maximum values for percent
crop treated data were used in the chronic and acute analyses,
respectively, for the following commodities with established
tolerances: Almonds (5 chronic, 5 acute), Apples (5 chronic, 10 acute),
Beans, Green (10 chronic, 20 acute), Broccoli (10 chronic, 20 acute),
Cabbage (30 chronic, 45 acute), Canola/Rapeseed (1 chronic, 2.5 acute),
Cauliflower (20 chronic, 30 acute), Cherries (5 chronic, 15 acute),
Corn (1 chronic, 2.5 acute), Cotton (10 chronic, 10 acute), Dry Beans/
Peas (1 chronic, 2.5 acute), Garlic (10 chronic, 30 acute), Lettuce (30
chronic, 45 acute), Onions (50 chronic, 55 acute), Peaches (5 chronic,
10 acute), Peanuts (5 chronic, 10 acute), Pears (15 chronic, 30 acute),
Peas, Green (1 chronic, 2.5 acute), Pecans (1 chronic, 5 acute),
Peppers (5 chronic, 15 acute), Prunes and Plums (5 chronic, 5 acute),
Rice (15 chronic, 30 acute), Sorghum (1 chronic, 2.5 acute), Soybeans
(5 chronic, 10 acute), Sugarcane (5 chronic, 10 acute), Sunflowers (10
chronic, 20 acute), Sweet Corn (45 chronic, 60 acute), Tomatoes (20
chronic, 20 acute), and Wheat (1 chronic, 2.5 acute). For all other
commodities and for new uses, 100% PCT was assumed. Tolerance level
values were used for the following commodities: Okra, eggplant,
poultry, tree nuts group (crop group 14) except almonds and pecans, and
tuberous and corm vegetables subgroup (crop subgroup 1C) except
potatoes.
    EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, State, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of 5% except for those situations in which the average
PCT is less than one. In those cases < 1% is used as the average and
< 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the single maximum value
reported overall from available Federal, State, and private market
survey data on the existing use, across all years, and rounded up to
the nearest multiple of 5%. In most cases, EPA uses available data from
United States Department of Agriculture/National Agricultural
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the
National Center for Food and Agriculture Policy (NCFAP) for the most
recent 6 years.
    The Agency believes that the three conditions listed in Unit
III.C.1.iv. have been met. With respect to Condition 1, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions 2 and 3, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which lambda-cyhalothrin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for lambda-cyhalothrin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of lambda-cyhalothrin. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at

http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentrations in Groundwater (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of lambda-cyhalothrin
for acute exposures are estimated to be 5.35 parts per billion (ppb)
for surface water and 0.00336 ppb for ground water. The EECs for
chronic exposures are estimated to be 0.130 ppb for surface water and
0.00336 ppb for ground water. The EDWCs for lambda-cyhalothrin were
calculated based on a maximum application rate of 0.5 pounds active
ingredient per acre per season (lb a.i./A/season) for orchards (ground
application) for surface and groundwater concentrations. A default
percent crop area (PCA) factor of 0.87 (87%) was applied to the
orchards scenario. The orchards scenario using the FIRST model produced
the highest concentrations.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 5.35 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.130 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Lambda-cyhalothrin is currently registered for the following
residential non-dietary sites: Ornamental gardens, lawns, landscapes,
turf, golf courses, and general insect control (spot treatments, and
crack and crevice treatments) in, around, and on buildings, structures,
and immediate surroundings. All registered products, except for one
aerosol can product, are limited to use only by certified applicators.
As such, this assessment ADDRESSES the single-residential handler
scenario for aerosol can users, and post-application scenarios
associated with any use in a residential environment. Both short-term
and intermediate-term exposures are possible.
    For the residential assessment, existing uses on turf, in gardens,
on golf courses, and for structural pest control were considered, but a
quantitative calculation was only completed for post-application
exposure on treated turf. The Agency used a conservative screening-
level approach to address the risks associated with the use of the
aerosol can product of lambda-cyhalothrin that can be purchased and
used by homeowners.
    A screening-level quantitative calculation was completed for post-
application exposure on treated turf only because this scenario is
expected to have the highest associated exposures of all residential
exposures. EPA believes that the selected post-application assessment
on lawns for children is protective for all residential exposures (even
the aerosol can handler scenario) because the dose levels for children
playing on treated lawns are thought to exceed those expected for all
other scenarios (lawn exposures for children represents the worst-case
scenario). This approach is based on the following conservative
considerations:
    i. EPA assumed that children contacted lawns immediately after
application of lawn product and thus there was no dissipation of
residues from the treated lawn.
    ii. EPA estimated dermal exposure based on a high duration of
exposure on the lawn and an intensity of activity that results in a
high degree of contact with the treated lawn.
    iii. EPA assumed that the pesticide was applied at the maximum
application rate.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    Lambda-cyhalothrin is a member of the pyrethroid class of
pesticides. Although all pyrethroids alter nerve function by modifying
the normal biochemistry and physiology of nerve membrane sodium
channels, EPA is not currently following a cumulative risk approach
(based on a common mechanism of toxicity) for the pyrethroids. Although
pyrethroids interact with sodium channels, there are multiple types of
sodium channels, and it is currently unknown whether pyrethroids have
similar effects on all channels. Nor is there a clear understanding of
effects on key downstream neuronal function (nerve excitability), nor
do we understand how these key events interact to produce their
compound specific patterns of neurotoxicity. There is ongoing research
by the EPA's Office of Research and Development (and pyrethroid
registrants) to evaluate the differential biochemical and physiological
actions of pyrethroids in mammals. When available, the Agency will
consider this research, and make a determination of common mechanism as
a basis for assessing cumulative risk. For information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. The completeness of the database. The toxicology database is
considered complete for the purposes of an FQPA risk assessment. Based
on the developmental studies in rats and rabbits, and the 3-generation
and neurodevelopmental studies in rats, there is no evidence of
increased susceptibility. The neurotoxicity observed in adult animal
studies raised a concern for potential neurodevelopmental effects. A
rat developmental neurotoxicity (DNT) study is available. In this
study, the lowest dose showing neurotoxicity in the offspring (effects
on mortality, body weights, body weight gains, learning, learning and
memory, and brain morphometry) is 10 milligram/kilogram body weight/day
(mg/kg bw/day), with a NOAEL of 4 mg/kg bw/day. Effects in offspring
and adult animals are found at a similar dose based on body weight
decreases. It should be noted that some of the parameters evaluated in
this DNT study were regarded as acceptable but several others were not,
leading to a study classification of ``unacceptable.'' The study
deficiencies which, taken together, led to the unacceptable
classification include:
    i. Statistical analyses that adjusted for body weights after
treatment had begun.

    ii. An inadequate assessment of motor activity.
    iii. An inadequate assessment of auditory startle in postnal day
(PND) 61 females.
    iv. Missing low- and mid-dose morphometry data.
However, it is not likely that these limitations will impact the risk
assessment for the following reasons. The slight changes in brain
morphometry were seen at the highest dose tested. Because these changes
were slight, it is uncertain whether toxicologically significant
differences would be seen at the mid dose, and it is unlikely that
significant changes would be seen at the lowest dose tested. The
auditory startle response is considered adequate for assessment in PND
23 males/females and PND 61 males where no treatment-related effects
were seen in auditory startle response. Only the auditory response data
for PND 61 females is inadequate. Motor activity was examined and there
did not appear to be any differences between treated and control
animals other than decreases for multiple subsessions in PND 18 males/
females at the high dose only, but due to the high variability and the
lack of habituation, these data are considered equivocal. There was no
published literature found that would indicate a neurodevelopmental
concern for lambda-cyhalothrin.
    The exposure assessments are based on reliable data and reasonable
worst-case assumptions, and are not likely to underestimate exposure.
Reliable data on anticipated dietary residues was relied upon including
crop field trial studies and monitoring data. Conservative ground and
surface water modeling estimates were used. Similarly, conservative
Residential Standard Operating Procedures were used to assess post-
application exposure to children as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by lambda-cyhalothrin.
    3. Prenatal and postnatal sensitivity. No quantitative or
qualitative evidence of increased susceptibility of rat or rabbit
fetuses to in utero exposure in the developmental studies was observed.
No developmental toxicity was observed in either of these studies. No
quantitative or qualitative evidence of increased susceptibility was
observed in the 3-generation reproduction study in rats. Offspring
toxicity (decreased pup weight and pup weight gain) was observed in the
reproduction study at the same dose level as parental toxicity
(decreased body weight and body weight gain). These effects are not
considered to be more severe than the effects in the parents.
    EPA has received a DNT for lambda-cyhalothrin (Master Record
Identification Number 46449102), which was classified as unacceptable/
guideline due to inadequacies in some of the developmental parameters
tested. Nonetheless, for the reasons noted in Unit VII.D.2., EPA does
not believe that correction of the deficiencies in this study would
meaningfully change its evaluation of the risk posed by lambda-
cyhalothrin and is not requiring that the study be repeated. In any
event, if a 10-fold factor is applied to this study's NOAEL, (i.e., 4
mg/kg bw/day) to account for the scientific limitations of the study,
the resulting value is 0.4 mg/kg bw/day. This estimate of 0.4 mg/kg/day
is similar to the doses from the chronic dog study used for risk
assessment (i.e., 0.5 mg/kg/day for acute dietary exposure scenarios
and 0.1 mg/kg/day for chronic dietary exposure scenarios). Therefore,
EPA concludes that using the NOAELs from the dog study would not
underestimate risks to infants and children from exposure to lambda-
cyhalothrin, and consequently, a repeat rat DNT study is not required.
    4. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for lambda-cyhalothrin is considered
complete for the purpose of an FQPA assessment.
    ii. All doses and endpoints for risk assessment are based on
neurotoxic effects seen in the dog, widely known as the most sensitive
test species for pyrethroids.
    iii. There is no evidence that lambda-cyhalothrin results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. The acceptable parameters of the developmental neurotoxicity
study in rats do not indicate increased susceptibility to pups exposed
in utero.
    iv. The exposure assessments are based on reliable data and
reasonable worst-case assumptions, and are not likely to underestimate
exposure.
    Based on all of the considerations in Unit III.D.3., there is not a
need to retain the additional 10X safety factor for children.
Application of the 10X intraspecies uncertainty factor (which accounts
for the possibility that a subpopulation may be 10 times more sensitive
than the average individual) and a 10X interspecies factor (which
accounts for the possibility that humans may be 10 times more sensitive
than animals) to the dog NOAEL (i.e., the most sensitive species)
should assure protection of human health including children. Therefore,
EPA has determined that reliable data show that it would be safe for
infants and children to reduce the FQPA safety factor to 1X.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to lambda-cyhalothrin will occupy 46% of the aPAD for the general U.S.
population, and 61% of the aPAD for all infants (< 1 year old), the most
highly exposed population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to lambda-
cyhalothrin from food and water will utilize 17% of the cPAD for the
general U.S. population, and 50% of the cPAD for children (1-2 years
old), the most highly exposed population subgroup. Based on the use
pattern, chronic residential exposure to residues of lambda-cyhalothrin
is not expected.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Lambda-cyhalothrin is currently registered for use that could
result in short-term and intermediate-term residential exposure and the
Agency has determined that it is appropriate to aggregate chronic food
and water and short-term exposures for lambda-cyhalothrin.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food,
water, and residential exposures aggregated result in aggregate MOEs of
140 to 490. The residential MOEs were aggregated together because,
regardless of the exposure route (dermal, inhalation, or

oral), lambda-cyhalothrin has similar adverse effects (neurotoxicity).
This aggregate risk assessment incorporates lawn post-application
exposure (the scenario with the highest potential for exposure), and is
a day-0 screening-level assessment. The resulting aggregate MOEs were
greater than the Agency target MOE of 100 (ranging from 140 to 490),
and there were thus no concerns for aggregate exposure.
    4. Aggregate cancer risk for U.S. population. Lambda-cyhalothrin is
classified as ``not likely to be carcinogenic to humans.'' Therefore,
there is no aggregate cancer risk associated with the existing or
proposed uses.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to lambda-cyhalothrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/electron
capture detector (GC/ECD) methods are available for enforcing
tolerances for lambda-cyhalothrin residues in plant and animal
commodities. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    The Codex Alimentarius Commission, Mexico, and Canada have all
established maximum residue limits (MRLs) for residues of lambda-
cyhalothrin in or on a variety of raw agricultural commodities. These
regulatory bodies express residues in terms of only cyhalothrin (Codex)
or of lambda-cyhalothrin (Canada, Mexico); none of these tolerances
include the epimer R157836 found in the U.S. tolerance expression. EPA
includes the epimer due to it being considered as toxic as the active
ingredient and its presence at quantifiable levels in many crops. For
the crop uses currently under consideration, only potatoes have
existing international tolerances. Although the recommended 0.02 ppm
U.S. tolerance agrees numerically with the Codex and Mexican MRLs,
strictly speaking they are not in harmony due to the different residue
definitions.

C. Response to Comments

    Several comments were received from a private citizen objecting to
IR-4 petitioning for tolerances, pesticide residues on food and the
establishment of these tolerances. The Agency has received similar
comments from this commenter on numerous previous occasions. Refer to
the Federal Registers of June 30, 2005 (70 FR 37686) (FRL-7718-3),
January 7, 2005 (70 FR 1354) (FRL-7691-4), and October 29, 2004 (69 FR
63096-63098) (FRL-7681-9) for the Agency's response to these
objections. In addition, the commenter noted several adverse effects
seen in animal toxicology studies with lambda-cyhalothrin and claims
because of these effects no tolerance should be approved. EPA has
found, however, that there is a reasonable certainty of no harm to
humans after considering these toxicological studies and the exposure
levels of humans to lambda-cyhalothrin. The commenter also identified
potential effects on the environment. This comment is considered
irrelevant because the safety standard for approving tolerances under
section 408 of FFDCA focuses on potential harms to human health and
does not permit consideration of effects on the environment. Effects on
the environment were considered by EPA in the registration process for
lambda-cyhalothrin under the Federal Insecticide, Fungicide, and
Rodenticide Act, 7 U.S.C. 136 et seq.

V. Conclusion

    Modifications to the pesticide petitions included in this final
rule include: Grass, (forage, fodder, hay) from 9.0 ppm to 7.0 ppm
because a crop group tolerance is appropriate--grass forage, fodder,
and hay (Group 17); rye, bran at 0.2 ppm based on the existing residue
data and tolerances in similar wheat commodities; hog, fat from 3.0 ppm
to 0.2 ppm, hog, meat from 0.2 ppm to 0.01 ppm, hog, and meat-
byproducts from 0.2 ppm to 0.02 ppm based on a Theoretical Dietary
Burden (TDB) of 0.9 ppm for swine, the maximum expected residues are
0.16 ppm in hog fat, 0.006 ppm in hog meat, and 0.011 ppm in hog meat-
byproducts; and milk, fat from 5.0 ppm to 10.0 ppm based on a TDB of
10.4 ppm for dairy cattle, the maximum expected residues in milk are
0.35 ppm, equivalent to 8.8 ppm in milk fat.
    Therefore, the tolerances are established for the combined residues
of lambda-cyhalothrin, 1:1 mixture of (S)-[alpha]-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and its epimer expressed as epimer of
lambda-cyhalothrin, a 1:1 mixture of (S)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate, in or on cucurbit vegetables (Crop
Group 9) at 0.05 ppm; grass, forage, fodder and hay (Crop Group 17) at
7.0 ppm; tuberous and corm vegetables (Crop Subgroup 1C) at 0.02 ppm;
barley, grain at 0.05 ppm; buckwheat, grain at 0.05 ppm; oat, grain at
0.05 ppm; rye, grain at 0.05 ppm; barley, bran at 0.2 ppm; rye, bran at
0.2 ppm; oat, forage at 2.0 ppm; rye, forage at 2.0 ppm; barley, hay at
2.0 ppm; oat, hay at 2.0 ppm; barley, straw at 2.0 ppm; oat, straw at
2.0 ppm; rye, straw at 2.0 ppm; rice, wild, grain at 1.0 ppm; pistachio
at 0.05 ppm; hog, fat at 0.2 ppm; hog, meat at 0.01 ppm; hog, meat-
byproducts at 0.02 ppm; and milk, fat at 10.0 ppm (reflecting 0.4 ppm
in whole milk).

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.

    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, this
rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 3, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.438 is amended by:
     i. Revising the entries ``hog, fat;'' ``hog, meat;'' ``hog, meat
byproducts;'' and ``milk, fat (reflecting 0.4 ppm in whole milk)'' in
the table in paragraph (a) (1).
     ii. Adding alphabetically the following commodities to the table
in paragraph (a)(1) to read as follows:

Sec. 180.438  Lambda-cyhalothrin and an isomer gamma-cyhalothrin;
tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Barley, bran...............................................          0.2
Barley, grain..............................................         0.05
Barley, hay................................................          2.0
Barley, straw..............................................          2.0
                                * * * * *
Buckwheat, grain...........................................         0.05
                                * * * * *
Grass, forage, fodder and hay, group 17....................          7.0
 Hog, fat..................................................          0.2
Hog, meat..................................................         0.01
Hog, meat byproducts.......................................         0.02
                                * * * * *
Milk, fat (reflecting 0.4 ppm in whole milk)...............         10.0
                                * * * * *
Oat, grain.................................................         0.05
Oat, forage................................................          2.0
Oat, hay...................................................          2.0
Oat, straw.................................................          2.0
                                * * * * *
Pistachio..................................................         0.05
                                * * * * *
Rice, wild, grain..........................................          1.0
Rye, bran..................................................          0.2
Rye, grain.................................................         0.05
Rye, forage................................................          2.0
Rye, straw.................................................          2.0
                                * * * * *
Vegetable, cucurbit, group 9...............................         0.05
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C..................         0.02
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-16050 Filed 8-14-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Proposed Rules]
[Pages 46303-46306]
[FR Doc No: 2013-18389]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0630; Directorate Identifier 2012-NM-213-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This
proposed AD was prompted by a design review, which revealed that, under
certain failure conditions, wiring in the main fuel tank could develop
a short circuit that might cause a hot spot on the wiring conduit or
puncture the wiring conduit wall. This proposed AD would require
installing fuses in the power supply wiring and/or return wiring for
various components in the fuel system; and revising the airplane
maintenance program by incorporating critical design configuration
control limitations. We are proposing this AD to prevent an ignition
source in the main fuel tank vapor space, which could result in a fuel
tank explosion and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by September 16,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL
Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the MCAI, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone (800)
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-
1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2013-0630;
Directorate Identifier 2012-NM-213-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://

www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2012-0241, dated November 12, 2012 (referred to
after this the Mandatory Continuing Airworthiness Information, or ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Prompted by an accident * * *, the FAA published Special Federal
Aviation Regulation (SFAR) 88, and the Joint Aviation Authorities
(JAA) published Interim Policy INT/POL/25/12.
    The design review conducted by Fokker Services on the Fokker 70
and Fokker 100 in response to these regulations revealed that under
certain failure conditions of the wiring of the Overflow Valve Reed
Switch, or the solenoid of the Level Control Pilot Valve (LCPV), or
the solenoid of the Re/De-fueling Shut-Off Valve, or the Collector-
Tank Low Level Float-Switch, a short circuit may develop that causes
a hot spot on the wiring conduit, or puncturing of the wiring
conduit wall in the main fuel tank.
    This condition, if not corrected, could create an ignition
source in the main fuel tank vapour space, possibly resulting in a
fuel tank explosion and consequent loss of the aeroplane.
    For the reasons described above, this [EASA] AD requires the
installation of fuses in the power supply wiring and/or return
wiring for the main tank overflow valve reed-switches, the LCPV
solenoid, the Re/De-fuel shut-off valve solenoid and the collector-
tank Low Level float switch and subsequently, the implementation of
the associated Critical Design Configuration Control Limitations
(CDCCL[s]) [and revising the maintenance program to incorporate the
CDCCLs].

You may obtain further information by examining the MCAI in the AD
docket.
    The FAA has examined the underlying safety issues involved in fuel
tank explosions on several large transport airplanes, including the
adequacy of existing regulations, the service history of airplanes
subject to those regulations, and existing maintenance practices for
fuel tank systems. As a result of those findings, we issued a
regulation titled ``Transport Airplane Fuel Tank System Design Review,
Flammability Reduction and Maintenance and Inspection Requirements''
(66 FR 23086, May 7, 2001). In addition to new airworthiness standards
for transport airplanes and new maintenance requirements, this rule
included Special Federal Aviation Regulation No. 88 (``SFAR 88,''
Amendment 21-78, and subsequent Amendments 21-82 and 21-83).
    Among other actions, SFAR 88 (66 FR 23086, May 7, 2001) requires
certain type design (i.e., type certificate (TC) and supplemental type
certificate (STC)) holders to substantiate that their fuel tank systems
can prevent ignition sources in the fuel tanks. This requirement
applies to type design holders for large turbine-powered transport
airplanes and for subsequent modifications to those airplanes. It
requires them to perform design reviews and to develop design changes
and maintenance procedures if their designs do not meet the new fuel
tank safety standards. As explained in the preamble to the rule, we
intended to adopt airworthiness directives to mandate any changes found
necessary to address unsafe conditions identified as a result of these
reviews.
    In evaluating these design reviews, we have established four
criteria intended to define the unsafe conditions associated with fuel
tank systems that require corrective actions. The percentage of
operating time during which fuel tanks are exposed to flammable
conditions is one of these criteria. The other three criteria address
the failure types under evaluation: Single failures, single failures in
combination with a latent condition(s), and in-service failure
experience. For all four criteria, the evaluations included
consideration of previous actions taken that may mitigate the need for
further action.
    The Joint Aviation Authorities (JAA) has issued a regulation that
is similar to SFAR 88 (66 FR 23086, May 7, 2001). (The JAA is an
associated body of the European Civil Aviation Conference (ECAC)
representing the civil aviation regulatory authorities of a number of
European States who have agreed to co-operate in developing and
implementing common safety regulatory standards and procedures.) Under
this regulation, the JAA stated that all members of the ECAC that hold
type certificates for transport category airplanes are required to
conduct a design review against explosion risks.
    We have determined that the actions identified in this AD are
necessary to reduce the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could result
in fuel tank explosions and consequent loss of the airplane.

Relevant Service Information

    Fokker Services B.V. has issued Fokker Service Bulletin SBF100-28-
068, dated August 10, 2012, including the following attachments (* the
issue date is not specified on the drawing):
     Fokker Drawing W41192, Sheet 051, Issue AS*;
     Fokker Drawing W41208, Sheet 002, Issue B*;
     Fokker Drawing W59520, Sheet 002, Issue E, dated March 18,
2011; and
     Fokker Manual Change Notification MCNM F100-143, dated
August 10, 2012.

    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This AD requires revisions to certain operator maintenance
documents to include Critical Design Configuration Control Limitations
(CDCCLs). Compliance with these CDCCLs is required by 14 CFR 91.403(c).
For airplanes that have been previously modified, altered, or repaired
in the areas addressed by this AD, the operator may not be able to
accomplish the actions described in the revisions. In this situation,
to comply with 14 CFR 91.403(c), the operator must request approval for
an alternative method of compliance according to paragraph (j) of this
AD. The request should include a description of changes to the required
actions that will ensure the continued operational safety of the
airplane.
    Where EASA Airworthiness Directive 2012-0241, dated November 12,
2012, specifies to install a fuse in the wiring of the level control
pilot valve, that action is not required by this AD. That action is
already required by AD 2011-21-01, Amendment 39-16824 (76 FR 63156,
October 12, 2011).

Costs of Compliance

    We estimate that this proposed AD affects 10 products of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Installation and revision of            29 work-hours x $85 per           $4,600          $7,065         $70,650
 maintenance program.                    hour = $2,465.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Fokker Services B.V.: Docket No. FAA-2013-0630; Directorate
Identifier 2012-NM-213-AD.

(a) Comments Due Date

    We must receive comments by September 16, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model F.28 Mark 0070 and
0100 airplanes, certificated in any category, all serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel.

(e) Reason

    This AD was prompted by a design review, which revealed that,
under certain failure conditions, wiring in the main fuel tank could
develop a short circuit that might cause a hot spot on the wiring
conduit or puncture the wiring conduit wall. We are issuing this AD
to prevent an ignition source in the main fuel tank vapor space,
which could result in a fuel tank explosion and consequent loss of
the airplane.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Installation of Fuses

    Within 24 months after the effective date of this AD: Install
fuses in the power supply wiring and return wiring, as applicable,
for the reed-switches in the main fuel tank overflow valve, level
control pilot valve solenoid, re/de-fuel shut off valve solenoid,
and the collector-tank low level float switch, in accordance with
the Accomplishment Instructions of Fokker Service Bulletin SBF100-
28-068, dated August 10, 2012, which includes the attachments
identified in paragraphs (g)(1) through (g)(4) of this AD (* the
issue date is not specified on the drawing).
    (1) Fokker Drawing W41192, Sheet 051, Issue AS*.
    (2) Fokker Drawing W41208, Sheet 002, Issue B*.
    (3) Fokker Drawing W59520, Sheet 002, Issue E, dated March 18,
2011.
    (4) Fokker Manual Change Notification MCNM F100-143, dated
August 10, 2012.

(h) Revision of Maintenance or Inspection Program

    After installing the fuses as required by paragraph (g) of this
AD, before further flight, revise the maintenance or inspection
program, as applicable, by incorporating the CDCCLs specified in
paragraph 1.L.(1)(c) of Fokker Service Bulletin SBF100-28-068, dated
August 10, 2012, which includes the attachments identified in
paragraphs (h)(1) through (h)(4) of this AD (* the issue date is not
specified on the drawing).
    (1) Fokker Drawing W41192, Sheet 051, Issue AS*.
    (2) Fokker Drawing W41208, Sheet 002, Issue B*.
    (3) Fokker Drawing W59520, Sheet 002, Issue E, dated March 18,
2011.
    (4) Fokker Manual Change Notification MCNM F100-143, dated
August 10, 2012.

(i) No Alternative CDCCLs

    After the CDCCLs have been incorporated, as required by
paragraph (h) of this AD, no alternative CDCCLs may be used unless
the CDCCLs are approved as an alternative method of compliance
(AMOC) in accordance with the procedures specified in paragraph (j)
of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch; ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal

inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency Airworthiness Directive 2012-
0241, dated November 12, 2012, for related information. The MCAI can
be found in the AD docket on the Internet at
http:[sol][sol]www.regulations.gov.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130
EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet
http:[sol][sol]www.myfokkerfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on July 21, 2013.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-18389 Filed 7-30-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 2 (Tuesday, January 4, 2011)]
[Notices]
[Page 353]
[FR Doc No: 2010-33157]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

December 20, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP11-1625-000.
    Applicants: Pine Prairie Energy Center, LLC.
    Description: Pine Prairie Energy Center, LLC submits tariff filing
per 154.204: Tariff Modifications to Implement PPEC NYMEX Pooling and
Imbalance Service to be effective 1/16/2011.
    Filed Date: 12/17/2010.
    Accession Number: 20101217-5120.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 29, 2010.

    Docket Numbers: RP11-1626-000.
    Applicants: Kinder Morgan Illinois Pipeline LLC.
    Description: Kinder Morgan Illinois Pipeline LLC submits fifteen
paper copies of a required cost and revenue study in compliance with
requirements of the July Order.
    Filed Date: 12/17/2010.
    Accession Number: 20101217-0202.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 29, 2010.

    Docket Numbers: RP11-1627-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Gulf Crossing Pipeline Company LLC submits tariff
filing per 154.204: Correct Title IDs to be effective 2/1/2011.
    Filed Date: 12/20/2010.
    Accession Number: 20101220-5012.
    Comment Date: 5 p.m. Eastern Time on Monday, January 3, 2011.

    Docket Numbers: RP11-1628-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: Correct Tariff IDs to be effective 2/1/2011.
    Filed Date: 12/20/2010.
    Accession Number: 20101220-5024.
    Comment Date: 5 p.m. Eastern Time on Monday, January 3, 2011.

    Docket Numbers: RP11-1629-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits tariff filing per
154.204: Correct Tariff IDs to be effective 2/1/2011.
    Filed Date: 12/20/2010.
    Accession Number: 20101220-5041.
    Comment Date: 5 p.m. Eastern Time on Monday, January 3, 2011.

    Docket Numbers: RP11-1630-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Texas Eastern Transmission, LP submits tariff filing
per 154.204: Chesapeake Utilities Service Agreements to be effective 1/
1/2011.
    Filed Date: 12/20/2010.
    Accession Number: 20101220-5044.
    Comment Date: 5 p.m. Eastern Time on Monday, January 03, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-33157 Filed 1-3-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Notices]
[Page 8721]
[DOCID:fr27fe07-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-200-019]

Rockies Express Pipeline LLC; Notice of Compliance Filing

February 21, 2007.
    Take notice that on February 16, 2007 Rockies Express Pipeline LLC
(REX) tendered for filing as part of its FERC Gas Tariff, First Revised
Volume No. 1, Fifteenth Revised Sheet No. 22, to be effective February
17, 2007.
    REX stated that a copy of this filing has been served upon all
parties to this proceeding, REX's customers, the Colorado Public
Utilities Commission and the Wyoming Public Service Commission.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E7-3351 Filed 2-26-07; 8:45 am]

BILLING CODE 6717-01-P