[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Rules and Regulations]
[Page 47057-47063]
[DOCID:fr13au08-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0099; FRL-8360-2]

Flubendiamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide,
in or on certain food and raw agricultural commodities. Bayer
CropScience, LP in c/o Nichino America, Inc. (U.S. subsidiary of Nihon
Nohyaku Co., Ltd.) requested these tolerances under the Federal Food,
Drug and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 13, 2008. Objections and
requests for hearings must be received on or before October 14, 2008,
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-2007-0099. 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
Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA 22202-4501. 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: Carmen Rodia, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Avenue, 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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

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-2007-0099 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 14, 2008.
    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-2007-0099, 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
Avenue, NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Room S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA 22202-4501. 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 February 28, 2007 (72 FR 9000) (FRL-
8115-2), 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
6F7065) by Bayer CropScience, LP in c/o Nichino America, Inc. (U.S.
subsidiary of Nihon Nohyaku Co., Ltd.), P.O. Box 12014, Research
Triangle Park, NC 27709-2014. The petition requested that 40 CFR part
180 be amended by establishing permanent tolerances in primary crops
for residues of the insecticide flubendiamide, N2-[1,1-
Dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-
[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-
benzenedicarboxamide, in or on the following raw agricultural and
processed commodities: Almond, hulls at 9.0 parts per million (ppm);
brassica, head and stem subgroup at 0.60 ppm; brassica, leafy greens
subgroup at 6.0 ppm; corn, field, forage at 8.0 ppm; corn, corn, field,
grain at 0.02 ppm; field, stover at 15.0 ppm; corn, pop, grain at 0.02
ppm; corn, pop, stover at 15.0 ppm; corn, sweet, forage at 9.0 ppm;
corn, sweet, kernel plus cob with husks removed at 0.02 ppm; corn,
sweet, stover at 25.0 ppm; cottonseed at 2.0 ppm; cotton, gin byproduct
at 60.0 ppm; fruit, pome group at 0.7 ppm; fruit, stone group at 1.6
ppm; grape at 1.4 ppm; nut, tree group at 0.06 ppm; okra at 0.30 ppm;
vegetable, cucurbit group at 0.20 ppm; vegetable, fruiting group at
0.30 ppm and vegetable, leafy, except brassica at 11.0 ppm; in or on
the following rotational crop commodities: Alfalfa, forage at 0.15 ppm;
alfalfa, hay at 0.04 ppm; barley, hay at 0.04 ppm; barley, straw at
0.07 ppm; buckwheat at 0.07 ppm; clover, forage at 0.15 ppm; clover,
hay at 0.04 ppm; grass, forage at 0.15 ppm; grass, hay at 0.04 ppm;
grass, silage at 0.27 ppm; millet, pearl, forage at 0.15 ppm; millet,
pearl hay at 0.04 ppm; millet, proso, forage at 0.15 ppm; millet,
proso, hay at 0.04 ppm; millet, proso, straw at 0.07 ppm; oats, forage
at 0.15 ppm; oats, hay at 0.04 ppm; oats, straw at 0.07 ppm; rye,
forage at 0.15 ppm; rye, straw at 0.07 ppm; sorghum, grain, forage at
0.03 ppm; sorghum, grain, stover at 0.06 ppm; soybean, forage at 0.02
ppm; soybean, hay at 0.04 ppm; teosinte, forage at 0.15 ppm; teosinte,
hay at 0.04 ppm; teosinte, straw at 0.07 ppm; triticale, forage at 0.15
ppm; triticale, hay at 0.04 ppm; triticale, straw at 0.07 ppm; wheat,
forage at 0.15 ppm; wheat, hay at 0.03 ppm and wheat, straw at 0.03
ppm; and in the following livestock commodities: Cattle, fat at 0.80
ppm; cattle, kidney at 0.60 ppm; cattle, liver at 0.60 ppm; cattle,
muscle at 0.10 ppm; eggs at 0.03 ppm; goat, fat at 0.80 ppm; goat,
kidney at 0.60 ppm; goat, liver at 0.60 ppm; goat, muscle at 0.10 ppm;
hog, fat at 0.80 ppm; hog, kidney at 0.60 ppm; hog, liver at 0.60 ppm;
hog, muscle at 0.10 ppm; horse, fat at 0.80 ppm; horse, kidney at 0.60
ppm; horse, liver at 0.60 ppm; horse, muscle at 0.10 ppm; milk at 0.20
ppm; poultry, fat at 0.08 ppm; poultry, liver at 0.03 ppm; poultry,
muscle at 0.01 ppm; sheep, fat at 0.80 ppm; sheep, kidney at 0.60 ppm;
sheep, liver at 0.60 ppm; and sheep, muscle at 0.10 ppm. That notice
referenced a summary of the petition prepared by Bayer CropScience, LP
in c/o Nichino America, Inc. (U.S. subsidiary of Nihon Nohyaku Co.,
Ltd.), 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.
    Based upon review of the data supporting this petition and EPA
policy, the Agency has revised commodity definitions and/or some of the
proposed tolerances and concludes that the establishment of the
following tolerance is appropriate for the insecticide flubendiamide
per se in or on the following food commodities: Almond, hulls at 9.0
ppm; apple, wet pomace at 2.0 ppm; brassica, head and stem, subgroup 5A
at 0.60 ppm; brassica, leafy greens, subgroup 5B at 5.0 ppm; cattle,
fat at 0.30 ppm; cattle, kidney at 0.30 ppm; cattle, liver at 0.30 ppm;
cattle, muscle at 0.05 ppm; corn, field, forage at 8.0 ppm; corn,
field, grain at 0.02 ppm; corn, field, stover at 15 ppm; corn, pop,
grain at 0.02 ppm; corn, pop, stover at 15 ppm; corn, sweet, forage at
9.0 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm;
corn, sweet, stover at 25 ppm; cotton gin byproducts at 60 ppm; cotton,
undelinted seed at 0.90 ppm; egg at 0.01 ppm; fruit, pome, group 11 at
0.70 ppm; fruit, stone, group 12 at 1.6 ppm; goat, fat at 0.30 ppm;
goat, kidney at 0.30 ppm; goat, liver at 0.30 ppm; goat, muscle at 0.05
ppm; grain, aspirated fractions at 5.0 ppm; grape at 1.4 ppm; horse,
fat at 0.30 ppm; horse, kidney at 0.30 ppm; horse, liver at 0.30 ppm;
horse, muscle at 0.05 ppm; milk at 0.04 ppm; milk, fat at 0.30 ppm;
nut, tree, group 14 at 0.06 ppm; okra at 0.30 ppm; poultry, fat at 0.02
ppm; poultry, liver at 0.01 ppm; poultry, muscle at 0.01 ppm; sheep,
fat at 0.30 ppm; sheep, kidney at 0.30 ppm; sheep, liver at 0.30 ppm;
sheep, muscle at 0.05 ppm; vegetable, cucurbit, group 9 at 0.20 ppm;
vegetable, fruiting, group 8 at 0.60 ppm and vegetable, leafy, except
brassica, group 4 at 11 ppm; and in or on the following raw
agricultural commodities: Alfalfa, forage at 0.15 ppm; alfalfa, hay at
0.04 ppm; barley, hay at 0.04 ppm; barley, straw at 0.07 ppm; buckwheat
at 0.07 ppm; clover, forage at 0.15 ppm; clover, hay at 0.04 ppm;
grass, forage at 0.15 ppm; grass, hay at 0.04 ppm; millet, pearl,
forage at 0.15 ppm; millet, pearl, hay at 0.04 ppm; millet, proso,
forage at 0.15 ppm; millet, proso, hay at 0.04 ppm; millet, proso,
straw at 0.07 ppm; oats, forage at 0.15 ppm; oats, hay at 0.04 ppm;
oats, straw at 0.07 ppm; rye, forage at 0.15 ppm; rye, straw at 0.07
ppm; sorghum, grain, forage at 0.03 ppm; sorghum, grain, stover at 0.06
ppm; soybean, forage at 0.02 ppm; soybean, hay at 0.04 ppm; teosinte,
forage at 0.15 ppm; teosinte, hay at 0.04 ppm; teosinte, straw at 0.07
ppm; triticale, forage at 0.15 ppm; triticale, hay at 0.04 ppm;
triticale, straw at 0.07 ppm; wheat, forage at 0.15 ppm; wheat, hay at
0.03 ppm and wheat, straw at 0.03 ppm.

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....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information submitted 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 tolerances for residues of the insecticide
flubendiamide. EPA's assessment of exposures and risks associated with
establishing tolerances 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.
    Flubendiamide has low acute toxicity via the oral and dermal
routes, is only a slight eye irritant, is non-irritating to the dermis
and tests negative for skin sensitization. In the longer-term studies
in the flubendiamide mammalian toxicology database, the primary target
organs identified were the liver, thyroid, kidney and eyes. Liver
effects reported in rats, mice and/or dogs include organ weight
increase, periportal fatty change, hypertrophy and minimal foci of
cellular alteration. Thyroid effects include organ weight increase,
follicular cell hypertrophy and slight perturbations of
triiodothyronine (TC) and thyroid stimulating hormone (TSH) in the rat
and mouse. Kidney effects include increases in absolute and/or relative
to body kidney weights and chronic nephropathy in the rat. Eye effects
include eye enlargement, opacity and exophthalmus with hemorrhage and
appear only in rat pups. Other changes include mild microcytic anemia,
decreased serum triglycerides and cholesterol in female rat, increased
gamma glutamyl peptidase, alkaline phosphatase and shortened activated
prothrombin time in dogs, and adrenal weight increase and an increase
in adrenal cortical cell hypertrophy in dogs.
    The hazard assessment indicated potential toxicity resulting from
exposure to flubendiamide via different routes over different
durations. The observed eye effects were selected as a critical effect
for the acute dietary exposure scenario; whereas liver and thyroid
effects were determined critical for the chronic dietary exposure
scenario. Short-term and intermediate-term dermal risks were also based
on liver and thyroid effects as well as blood effects. Short-term and
intermediate-term inhalation risks are based on liver toxicity as well
as adrenal weight increase and an increase in adrenal cortical cell
hypertrophy.
    There was no evidence of carcinogenicity in rats and mice up to the
limit dose at 24- and 18-months, respectively. Flubendiamide was
determined to be non-mutagenic in bacteria, negative in an in vivo
mammalian cytogenetics assay and did not cause unscheduled DNA
synthesis (repair of DNA damage) in mammalian cells in vitro. Overall,
there was no clear evidence that flubendiamide was either mutagenic or
clastogenic in either in vivo or in vitro assays. The cancer
classification is ``Not Likely to be Carcinogenic to Humans.''
    More detailed information on the studies received and the nature of
the adverse effects caused by flubendiamide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the document
entitled, ``Flubendiamide: Human Health Risk Assessment for Proposed
Uses on Corn, Cotton, Tobacco, Tree fruit, Tree nuts, Vine crops and
Vegetable crops,'' dated April 3, 2008, by going to http://
www.regulations.gov. The referenced document is available in the docket
established by this action, which is described under ADDRESSES, and is
identified as EPA-HQ-OPP-2007-0099-0005 in that docket. Locate and
click on the hyperlink for docket ID number EPA-HQ-OPP-2007-0099.
Double-click on the document to view the referenced information on
pages 65-70 of 105.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD 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
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term,
intermediate-term and chronic-term risks are evaluated by comparing
food, water and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, refer to http://
www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flubendiamide used for
human risk assessment can be found in the document entitled,
``Flubendiamide: Human Health Risk Assessment for Proposed Uses on
Corn, Cotton, Tobacco, Tree fruit, Tree nuts, Vine crops and Vegetable
crops,'' dated April 3, 2008, by going to http://www.regulations.gov.
The referenced document is available in the docket established by this
action, which is described under ADDRESSES, and is identified as EPA-
HQ-OPP-2007-0099-0005 in that docket. Locate and click on the hyperlink
for docket ID number EPA-HQ-OPP-2007-0099. Double-click on the document
to view the referenced information on pages 37-38 of 105.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flubendiamide, EPA considered exposure under the

petitioned-for tolerances and assessed dietary exposures from
flubendiamide 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 food consumption information from the Dietary
Exposure Evaluation Model-Food Commodity Intake Database (DEEM-
FCID\TM\, Version 2.03), which incorporates food consumption data from
the U.S. Department of Agriculture's (USDA's) Nationwide Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.
The acute assessments assumed that 100% of crops with requested uses of
flubendiamide are treated and that all treated crops contain residues
at tolerance-level. In addition, tolerance-level residues for livestock
commodities were included in these analyses to account for the
potential transfer of plant residues to livestock tissues.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used DEEM-FCID\TM\, Version 2.03, which incorporates
food consumption data from the USDA's CSFII from 1994-1996 and 1998.
The chronic assessments assumed that 100% of crops with requested uses
of flubendiamide are treated and that all treated crops contain
residues at the average residue levels found in the crop field trials
and experimentally-determined processing factors where available. In
addition, average-level residues for livestock commodities were also
included in these analyses to account for the potential transfer of
plant residues to livestock tissues.
    iii. Cancer. As explained in Unit III.A., flubendiamide is
considered to be ``Not Likely to be Carcinogenic to Humans.'' As a
result, cancer exposure assessment is not needed for flubendiamide.
    iv. Anticipated residue 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 require pursuant to FFDCA section 408(f)(1)
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 these
tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flubendiamide in drinking water. These simulation models
take into account data on the physical, chemical and fate/transport
characteristics of flubendiamide.
    Flubendiamide is persistent and potentially mobile in terrestrial
and aquatic environments. These fate properties suggest that it has a
potential to move into surface and ground water. The Agency lacks
sufficient monitoring exposure data for use in risk assessments, as
flubendiamide is a new active ingredient. 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 physical and fate characteristics of flubendiamide.
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 Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and the Screening Concentration in Ground Water
(SCI-GROW) model, the estimated drinking water concerns (EDWCs) of
flubendiamide for acute exposures are estimated to be 12.93 parts per
billion (ppb) for surface water and 0.06 ppb for ground water. For
chronic exposures for non-cancer assessments, the EDWCs are estimated
to be 11.95 ppb for surface water and 0.06 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 12.93 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 11.95 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). Flubendiamide is not
registered for any specific use patterns that would result in
residential exposure. That is, no residential uses are being requested
for flubendiamide at this time; therefore, no residential risk
assessment has been conducted.
    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.''
    EPA has not found flubendiamide to share a common mechanism of
toxicity with any other substances, and flubendiamide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action; therefore, EPA has assumed that
flubendiamide does not have a common mechanism of toxicity with other
substances. 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(b)(2)(c) of FFDCA provides that EPA
shall apply an additional ten-fold (10x) margin of safety for infants
and children in the case of threshold effects to account for pre-natal
and/or post-natal 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 Food Quality Protection Act Safety Factor (FQPA SF). In applying
this provision, EPA either retains the default value of 10x or uses a
different additional SF when reliable data available to EPA support the
choice of a different factor.
    2. Pre-natal and post-natal sensitivity. While both the rat and
rabbit developmental studies did not identify teratogenic effects and
showed no evidence of increased pre-natal susceptibility, adverse eye
effects (eye enlargement) were noted in post-natal rat pups older than
14 days in multiple studies (the 2-generation reproduction and 1-
generation supplemental studies) and the developmental neurotoxicity
(DNT) study reported eye effects appearing in some offspring between
lactation days 14 and 42, even though exposure stopped at lactation day
21, indicating a possible delay (a latent response) from the time of
last exposure to onset of bupthalmos. These eye

effects did not occur in adult rats. Since the iris and chamber angle
are differentiating and specializing into definite structures during
post-natal days 5-20, neonatal rats appear to have an increased
susceptibility to flubendiamide exposure as compared to adults. The DNT
study also reported that pre-mating exposures are not required to
elicit the eye effect in pups. In addition to the reported eye effects
in the DNT study, there was also a balano-preputial separation
(separation of the prepuce (foreskin) from the glans penis (balanus))
delay. While these effects are considered adverse, they are not assumed
to be developmental effects from in utero exposure. Even though the
delay in balanopreputial separation may be a result of post-natal
exposure (sensitivity of the young), and the effect is adverse, it is
considered reversible and not an indication of perinatal sensitivity/
susceptibility.
    Human microsomes have been shown to be capable of approximately 4
times higher hydroxylation rates of flubendiamide as compared to female
mouse microsomes and may be able to efficiently metabolize and excrete
flubendiamide, preventing accumulation of the parent compound. It
remains unclear whether the ability to metabolize and clear the parent
compound is the only requirement to avoid ocular toxicity. Due to the
potential concern for increased susceptibility of the human neonate as
compared to adults, this perinatal ocular effect is considered in the
human health risk assessment for flubendiamide.
    3. Conclusion. EPA evaluated the quality of the toxicity and
exposure data and, based on these data, has determined that the safety
of infants and children would be adequately protected if the FQPA SF
were reduced to 1x. That decision is based on the following findings:
    i. The toxicology database for flubendiamide is complete for
purposes of this risk assessment and the characterization of potential
pre-natal and/or post-natal risks to infants and children. Although
susceptibility was identified in the toxicological database (eye
effects), the selected regulatory PODs (which are based on clear
NOAELs) are protective of these effects; therefore, the human health
risk assessment is protective.
    ii. There are no treatment-related neurotoxic findings in the acute
neurotoxicity and DNT studies in rats; although eye effects were
observed in the DNT study. As noted in the previous paragraph, the PODs
employed in the risk assessment are protective of this effect.
    iii. There are no residual uncertainties identified in the exposure
databases and the exposure assessment is protective. The acute dietary
food exposure assessment utilizes tolerance-level residues, the chronic
dietary food exposure assessment utilizes average residue levels found
in the crop field trials/livestock commodities and both assume 100% of
crops with requested uses of flubendiamide are treated. The drinking
water assessment generated EDWCs using models and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations. The highest
relevant EDWCs were used in the dietary (food and drinking water)
exposure assessment. By using these screening-level exposure
assessments in the acute and chronic dietary (food and drinking water)
assessments, risk is not underestimated for flubendiamide.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    For flubendiamide, there is potential exposure from food and
drinking water, but not from residential use sites (as there are no
proposed residential uses for flubendiamide). Since hazard was
identified via the oral route over both the acute and chronic duration,
the aggregate risk assessment considers exposures from food and
drinking water consumed over the acute and chronic durations.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to flubendiamide will occupy less than 8% of the aPAD for the mostly
highly exposed population subgroup, children aged 1-2 years old.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flubendiamide from food and water will utilize less than 15% of the
cPAD for the mostly highly exposed population subgroup, children aged
1-2 years old. There are no residential uses for flubendiamide.
    3. Aggregate cancer risk for U.S. population. Flubendiamide has
been classified as ``Not Likely to be Carcinogenic to Humans'' and is
not expected to pose a cancer risk.
    4. 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 flubendiamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (LC/MS/MS, Methods 00816/M002 and
00912) is available to enforce the tolerance expression. The method may
be requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no established CODEX, Canadian or Mexican
maximum residue limits (MRLs) for residues of flubendiamide in or on
various crop or livestock commodities.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data submitted in support of this
tolerance petition for flubendiamide and EPA policy, the Agency has
revised commodity definitions and/or some of the proposed tolerances.
No residue data were submitted to support the proposed uses on okra and
popcorn. The available field trial data for fruiting vegetables may be
translated to okra, and the submitted data for field corn may also be
translated to popcorn. The proposed uses on all types of corn (field,
pop and sweet) are identical.
    Parent residue levels vary based on crop (for edible commodities,
residues ranging from 0.018 ppm, corn, field, grain to 6.7 ppm,
spinach). Most crops indicated parent residues declined with successive
sampling dates and were determined to be available on the surface of
plants/RACs. The Agency will allow translation of residue data from
trials conducted on rotated barley, sorghum and wheat to support the
proposed rotational crop tolerances for the forages, hay and straw of
other types of cereal grains and grasses. The Agency

will also allow translation of residue data from trials conducted on
rotated soybean to support the proposed rotational crop tolerances for
the forages, fodder, hay and straw on alfalfa and clover to support the
rotational plant-back intervals. Based on the transfer coefficients for
livestock tissues and the relatively low dietary burden for swine of
0.02 ppm for flubendiamide, tolerances for hogs are not needed.

V. Conclusion

    Therefore, tolerances are established forresidues of the
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 tolerances 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 9,
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 1, 2008.
Debra Edwards,
Director, 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 180.639 is added to read as follows:

Sec.  180.639  Flubendiamide; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide,
in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................            9.0 ppm
Apple, wet pomace....................................            2.0 ppm
Brassica, head and stem, subgroup 5A.................           0.60 ppm
Brassica, leafy greens, subgroup 5B..................            5.0 ppm
Cattle, fat..........................................           0.30 ppm
Cattle, kidney.......................................           0.30 ppm
Cattle, liver........................................           0.30 ppm
Cattle, muscle.......................................           0.05 ppm
Corn, field, forage..................................            8.0 ppm
Corn, field, grain...................................           0.02 ppm
Corn, field, stover..................................             15 ppm
Corn, pop, grain.....................................           0.02 ppm
Corn, pop, stover....................................             15 ppm
Corn, sweet, forage..................................            9.0 ppm
Corn, sweet, kernel plus cob with husks removed......           0.01 ppm
Corn, sweet, stover..................................             25 ppm
Cotton, gin byproducts...............................             60 ppm
Cotton, undelinted seed..............................           0.90 ppm
Egg..................................................           0.01 ppm
Fruit, pome, group 11................................           0.70 ppm
Fruit, stone, group 12...............................            1.6 ppm
Goat, fat............................................           0.30 ppm
Goat, kidney.........................................           0.30 ppm
Goat, liver..........................................           0.30 ppm
Goat, muscle.........................................           0.05 ppm
Grain, aspirated fractions...........................            5.0 ppm
Grape................................................            1.4 ppm
Horse, fat...........................................           0.30 ppm
Horse, kidney........................................           0.30 ppm
Horse, liver.........................................           0.30 ppm
Horse, muscle........................................           0.05 ppm
Milk.................................................           0.04 ppm
Milk, fat............................................           0.30 ppm
Nut, tree, group 14..................................           0.06 ppm
Okra.................................................           0.30 ppm
Poultry, fat.........................................           0.02 ppm
Poultry, liver.......................................           0.01 ppm
Poultry, muscle......................................           0.01 ppm
Sheep, fat...........................................           0.30 ppm
Sheep, kidney........................................           0.30 ppm
Sheep, liver.........................................           0.30 ppm
Sheep, muscle........................................           0.05 ppm
Vegetable, cucurbit, group 9.........................           0.20 ppm
Vegetable, fruiting, group 8.........................           0.60 ppm
Vegetable, leafy, except Brassica, group 4...........             11 ppm
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established
for the indirect or inadvertent residues of the

insecticide flubendiamide per se, N2-[1,1-Dimethyl-2-
(methylsulfonyl)ethyl-3-iodo-N1-[2-methyl-4-[1,2,2,2-
tetrafluoro-1-(trifluoromethyl)ethyl]phenyl]-1,2-benzenedicarboxamide,
in or on the following raw agricultural commodities when present
therein as a result of the application of flubendiamide per se to the
growing crops listed in paragraph (a) of this section:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage......................................           0.15 ppm
Alfalfa, hay.........................................           0.04 ppm
Barley, hay..........................................           0.04 ppm
Barley, straw........................................           0.07 ppm
Buckwheat............................................           0.07 ppm
Clover, forage.......................................           0.15 ppm
Clover, hay..........................................           0.04 ppm
Grass, forage........................................           0.15 ppm
Grass, hay...........................................           0.04 ppm
Millet, pearl, forage................................           0.15 ppm
Millet, pearl, hay...................................           0.04 ppm
Millet, proso, forage................................           0.15 ppm
Millet, proso, hay...................................           0.04 ppm
Millet, proso, straw.................................           0.07 ppm
Oats, forage.........................................           0.15 ppm
Oats, hay............................................           0.04 ppm
Oats, straw..........................................           0.07 ppm
Rye, forage..........................................           0.15 ppm
Rye, straw...........................................           0.07 ppm
Sorghum, grain, forage...............................           0.03 ppm
Sorghum, grain, stover...............................           0.06 ppm
Soybean, forage......................................           0.02 ppm
Soybean, hay.........................................           0.04 ppm
Teosinte, forage.....................................           0.15 ppm
Teosinte, hay........................................           0.04 ppm
Teosinte, straw......................................           0.07 ppm
Triticale, forage....................................           0.15 ppm
Triticale, hay.......................................           0.04 ppm
Triticale, straw.....................................           0.07 ppm
Wheat, forage........................................           0.15 ppm
Wheat, hay...........................................           0.03 ppm
Wheat, straw.........................................           0.03 ppm
------------------------------------------------------------------------

[FR Doc. E8-18324 Filed 8-12-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Page 51134]
[FR Doc No: 2021-19742]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC21-128-000.
    Applicants: PSEG Fossil LLC, PSEG Fossil Sewaren Urban Renewal LLC,
PSEG Keys Energy Center LLC, PSEG Energy Resources & Trade LLC, Parkway
Generation, LLC, Parkway Generation Essex, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of PSEG Fossil LLC, et al.
    Filed Date: 9/2/21.
    Accession Number: 20210902-5163.
    Comment Date: 5 p.m. ET 11/1/21.

    Docket Numbers: EC21-129-000.
    Applicants: Bay Tree Solar, LLC, Bay Tree Lessee, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act of Bay Tree Solar, LLC, et al.
    Filed Date: 9/3/21.
    Accession Number: 20210903-5211.
    Comment Date: 5 p.m. ET 9/24/21.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER18-1587-001.
    Applicants: Tyr Energy, LLC.
    Description: Supplement to August 2, 2021 Notice of Change in
Status of Tyr Energy, LLC.
    Filed Date: 9/3/21.
    Accession Number: 20210903-5149.
    Comment Date: 5 p.m. ET 9/24/21.

    Docket Numbers: ER21-2535-000.
    Applicants: Dichotomy Power Maine, LLC.
    Description: Supplement to July 28, 2021 Market-based Rate
Application of Dichotomy Power Maine, LLC.
    Filed Date: 9/3/21.
    Accession Number: 20210903-5136.
    Comment Date: 5 p.m. ET 9/13/21.

    Docket Numbers: ER21-2698-000.
    Applicants: Portland General Electric Company.
    Description: Portland General Electric Company submits Average
System Cost Filing for Sales of Electric Power to the Bonneville Power
Administration, FY 2022-2023.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5137.
    Comment Date: 5 p.m. ET 9/28/21.

    Docket Numbers: ER21-2840-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Interim ISA, Service
Agreement No. 6166, Queue No. AF2-122 to be effective 8/8/2021.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5046.
    Comment Date: 5 p.m. ET 9/28/21.

    Docket Numbers: ER21-2841-000.
    Applicants: Ohio Power Company, American Electric Power Service
Corporation, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Ohio Power Company submits
tariff filing per 35.13(a)(2)(iii: AEP submits the Saint Marys FA re:
ILDSA SA No. 1672 to be effective 11/7/2021.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5088.
    Comment Date: 5 p.m. ET 9/28/21.

    Docket Numbers: ER21-2842-000.
    Applicants: PacifiCorp.
    Description: Tariff Amendment: Termination of Lehi City
Construction Agreement--Spring Creek to be effective 11/21/2021.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5099.
    Comment Date: 5 p.m. ET 9/28/21.

    Docket Numbers: ER21-2843-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-ETT (Clear Crossing)
Facilities Development Agreement to be effective 8/27/2021.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5119.
    Comment Date: 5 p.m. ET 9/28/21.

    Docket Numbers: ER21-2844-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA/CSA, Service
Agreement Nos. 6157/6158; Queue No. AB2-036 to be effective 8/8/2021.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5125.
    Comment Date: 5 p.m. ET 9/28/21.

    Docket Numbers: ER21-2845-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Interim ISA, SA No. 6156;
Queue No. AC1-194 to be effective 8/8/2021.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5140.
    Comment Date: 5 p.m. ET 9/28/21.

    Docket Numbers: ER21-2846-000.
    Applicants: System Energy Resources, Inc.
    Description: Sec.  205(d) Rate Filing: SERI UPSA Errata to be
effective 6/1/2018.
    Filed Date: 9/7/21.
    Accession Number: 20210907-5153.
    Comment Date: 5 p.m. ET 9/28/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 7, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-19742 Filed 9-13-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 20, 2006 (Volume 71, Number 244)]
[Rules and Regulations]
[Page 76173-76177]
[DOCID:fr20de06-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0532; FRL-8104-6]

Dimethomorph; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of the
fungicide, dimethomorph, (E,Z) 4-[3-(4-

chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl] morpholine in
or on brassica, head and stem, subgroup 5A. The Interregional Research
Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ
08540 requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA).

DATES: This regulation is effective December 20, 2006. Objections and
requests for hearings must be received on or before February 20, 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-2005-0532. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, 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:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 provides
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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2005-0532 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 on or
before February 20, 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 your copies, identified by docket ID
number EPA-HQ-OPP-2005-0532, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of March 10, 2006 (71 FR 12356) (FRL-7761-
6), 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
4E6848) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.493 be amended by
establishing a tolerance for residues of the fungicide, dimethomorph,
(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]
morpholine in or on Brassica head and stem (Subgroup 5A) at 2.0 parts
per million (ppm). That notice included a summary of the petition
prepared by BASF, the registrant. There were no comments received in
response to the notice of filing.
    Supporting documents including the Agency's Human Health Risk
Assessment of dimethomorph and other documents are available at
http://www.regulations.gov under the index of the docket for this action,

docket ID number EPA-HQ-OPP-2005-0537.
    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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of dimethomorph on
brassica, head and stem, subgroup 5A food commodities at 2.0 ppm. 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 toxic effects caused by dimethomorph as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov under docket ID number EPA-HQ-OPP-2005-0532;

entitled, ``Amended: Dimethomorph: Human Health Risk Assessment for
Proposed Uses on Brassica Stem and Head Subgroup 5A'', dated November
15, 2006.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the LOAEL is sometimes
used for risk assessment if no NOAEL was achieved in the toxicology
study selected. An uncertainty factor (UF) is applied to reflect
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.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

    A summary of the toxicological endpoints for dimethomorph used for
human risk assessment can be found at http://www.regulation.gov under docket

ID number EPA-HQ-OPP-2005-0532, entitled, ``Amended: Dimethomorph:
Human Health Risk Assessment for Proposed Uses on Brassica Stem and
Head Subgroup 5A'', dated November 15, 2006.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.493) for the residues of dimethomorph, in or on
a variety of raw agricultural commodities including: Brassica, leafy
greens, subgroup 5B; lettuce, head; lettuce, leaf; potato, wet peel;
taro, corm; taro, leaves; vegetable, bulb, group 3; vegetable,
cucurbit, group 9; and vegetable, fruiting, group 8. Risk assessments
were conducted by EPA to assess dietary exposures from dimethomorph 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.
     No such effects were identified in the toxicological studies for
dimethomorph. A quantitative acute dietary exposure and risk assessment
was therefore not conducted for dimethomorph. No acute risk is expected
from exposure to dimethomorph.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
In conducting a Tier 1 chronic dietary risk assessment, the Agency made
the following conservative assumptions:
     a. All commodities having dimethomorph tolerances contain residues
at the level of the tolerance, and
     b. Treatment of 100% of all registered and proposed crops.
    iii. Cancer. EPA has classified dimethomorph ``not likely'' to be
human carcinogen. Therefore, a quantitative cancer dietary exposure and
risk assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for dimethomorph 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 physical
characteristics of dimethomorph. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.

    Acute and chronic estimated drinking water concentrations (EDWCs)
of dimethomorph in surface water were calculated using Generic
Estimated Environmental Concentration (GENEEC) Model. Drinking water
residues were then incorporated into the DEEM-FCID(\TM\) into the food
categories ``water, direct, all sources'' and ``water, indirect, all
sources.''
    Based on the Tier 1 GENEEC and Surface Water and Screening
Concentrations in Ground Water (SCI-GROW) models, the EDWCs of
dimethomorph for chronic exposures are 28.5 parts per billion (ppb) for
surface water and 0.30 ppb for ground 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).
    Dimethomorph is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to dimethomorph and any other
substances and dimethomorph does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that dimethomorph has
a common mechanism of toxicity with other substances. 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 the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on 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 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
margin of exposure analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. 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 safety factor value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
    2. Prenatal and postnatal sensitivity. The toxicology data on
dimethomorph provide no indication of enhanced sensitivity of infants
and children based on the results from developmental studies conducted
with rats and rabbits as well as a 2-generation reproduction study
conducted with rats. There were no toxic effects observed in either the
rat developmental toxicity or the rat 2-generation reproductive
toxicity studies that were lower than doses which produced toxic
effects in the parents. No developmental toxicity was demonstrated in
the rabbit developmental toxicity study. The developmental and
reproductive toxicity data did not indicate increased susceptibility of
rats or rabbits to in utero and/or postnatal exposure.
    3. 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 dimethomorph is complete.
    ii. There is no evidence that dimethomorph 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.
    iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated (CT) and tolerance-level residues. Conservative
ground water and surface water modeling estimates were used.
    Residential exposure to dimethomorph is not expected since there
are no currently registered residential uses for the pesticide.

E. Aggregate Risks and Determination of Safety

    In examining aggregate risk, the Agency takes into account all
available reliable information concerning exposures from pesticide
residues in food and other exposures including drinking water and
potential residential exposure to pesticides from such uses as lawn
care applications (turf), golf course and others. Aggregate risk
assessment considerations must also include potential exposures from
oral, dermal and inhalation routes.
    1. Acute risk. No acute dietary toxicity endpoints were identified;
no acute risk is expected from exposure to dimethomorph.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
dimethomorph from food + water will utilize 8.6% of the chronic
population adjusted dose (cPAD) for the U.S. population, 7.0% of the
cPAD for all infants <  1 year, and 19.9% of the cPAD for children -2
years. There are no residential uses for dimethomorph that result in
chronic residential exposure. Risk estimates for all population
subgroups are below the Agency's LOC (do not exceed 100% of the cPAD).
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Dimethomorph is not registered for use on any sites that would
result in residential exposure. Therefore, a short-tern aggregate risk
assessment is not required. The aggregate risk is the sum of the risk
from food and water, which do not exceed the Agency's LOC.
    4. Intermediate-term risk Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Dimethomorph is not registered for use on any sites that would
result in residential exposure. Therefore, an intermediate-term risk
assessment is not required. The aggregate risk is the sum of the risk
from food and water, which do not exceed the Agency's LOC.
    5. Aggregate cancer risk for U.S. population. Dimethomorph has been
classified as a Group E carcinogen showing no evidence of human
carcinogenicity. This classification was based upon lack of evidence of
carcinogenicity in rat and mice studies. The Agency concludes that the
pesticidal uses of dimethomorph are not likely to pose a cancer risk to
humans.
    6. 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, and to infants and children from aggregate
exposure to dimethomorph residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A reliable method for the determination of dimethomorph residues in
brassica, head and stem subgroup 5A exist; this method is the Food and
Drug Administration (FDA) Multi-Residue Method, Protocol D, as
published in the Pesticide Analytical Manual I. In addition, 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

    There are no established or proposed Codex, Canadian or Mexican
maximum residue limits or tolerance for dimethomorph in or on brassica,
head and stem, subgroup 5A.

V. Conclusion

    Therefore, the tolerance is established for residues of
dimethomorph, (E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2-propenyl] morpholine in or on brassica, head and stem, subgroup
5A at 2.0 ppm.

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 due to its lack of
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of 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: December 8, 2006.
Donald R. Stubbs,
Acting 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 180.493 is amended by alphabetically adding a commodity to
the table in paragraph (a) to read as follows:

Sec.  180.493  Dimethomorph; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Brassica, head and stem, subgroup 5A.................                2.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-21499 Filed 12-19-06; 8:45 am]

BILLING CODE 6560-50-S