[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]
[Page 60266-60272]
[DOCID:fr24oc07-16]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0848; FRL-8152-9]

Fenamidone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fenamidone in or on carrot; sunflower; Brassica, head and stem,
subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable, fruiting,
group 8, except nonbell pepper; pepper, nonbell; vegetable, leafy,
except Brassica, group 4; cotton, gin byproducts; cotton, undelinted
seed; and combined residues of fenamidone and its metabolite RPA 717879
in or on strawberry. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective October 24, 2007. Objections and
requests for hearings must be received on or before December 24, 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-2006-0848. 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: Shaja R. Brothers, 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:
brothers.shaja@epa.gov@epa.govbrothers.shaja<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 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.

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-2006-0848 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 December 24, 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-2006-0848, 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 November 8, 2006 (71 FR 65506-65507)
(FRL-8099-9), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide
petitions by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540, and Bayer Crop Science, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709. The petitions requested that 40 CFR 180.579 be
amended by establishing tolerances for residues of the fungicide
fenamidone, (4H-Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-
phenyl-3-(phenylamino)-,(S)-), in or on carrot at 0.15 parts per
million (ppm) (PP 6E7109); sunflower at 0.08 ppm (PP 5E6924); brassica,
head and stem, subgroup 5A at 4.0 ppm (PP 5E6925); brassica,
leafy greens, subgroup 5B at 35 ppm (PP 5E6925); vegetables, fruiting,
group 8, except nonbell peppers at 2.0 ppm (PP 5E6925); vegetable,
leafy, except brassica, group 4 at 35 ppm (PP 5E6925); cotton,
undelinted seed at 0.02 ppm (PP 5F6898); and cotton, gin byproducts at
0.02 ppm (PP 5F6898), and residues of the fungicide fenamidone (4-H-
imidazol-4-one, 3,5-dihydro-5-methyl-2-(methlthio)-5-phenyl-3-
(phenylamino)-, (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl), in or on strawberry at 0.02 ppm
(PP 5F6898).
    This notice referenced a summary of the petition prepared by Bayer
Crop Science, the registrant, which is available to the public in the
docket, at http://www.regulations.gov. There were no comments received

in response to the notice of filing.
    Based upon review of the data supporting the petitions, EPA has
revised the tolerance levels for some of the proposed petitions. The
reason for these changes is explained in Unit IV.C.

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 residues of fenamidone on carrot at 0.15 ppm; sunflower at 0.02
ppm; Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica, leafy
greens, subgroup 5B at 55 ppm; vegetable, fruiting, group 8, except
nonbell pepper at 1.0 ppm; pepper, nonbell at 3.5 ppm; vegetable,
leafy, except Brassica, group 4 at 60 ppm; cotton, gin byproducts at
0.02 ppm; cotton, undelinted seed at 0.02 ppm; and strawberry at 0.02
ppm. EPA's assessment of exposures and risks associated with
establishing the 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. Specific information on the studies received and the nature
of the adverse effects caused by fenamidone 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 Human Health
Risk Assessment for Fenamidone on pages 31-34. The referenced document
is available in the docket established by this action, which is
described under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0848.
The docket is electronically available at http://www.regulations.gov.

    The existing toxicological database for fenamidone supports the
establishment of permanent tolerances for residues of fenamidone in or
on the commodities proposed in this action. Fenamidone has low acute
toxicity via the oral, dermal, and inhalation routes with all studies
being in toxicity category III or IV. It is a moderate eye irritant,
but is not a dermal irritant or a dermal sensitizer. The acute oral
assay tests indicated that female rats were more sensitive to the
parent than male rats.
    The target organs in chronic studies in the mouse and dog were the
liver, and in the rat were the liver and thyroid. In the chronic
toxicity rat study, the systemic NOAEL was based on diffuse C-cell
hyperplasia of the thyroid in both sexes as the most sensitive
indicator of toxicity. At higher doses, follicular cells and the liver
were affected. The similarity in the systemic NOAELs and the type of
toxicity observed (primarily liver) for the 90-day rat studies with the
parent and plant metabolites (RPA 412636, RPA 412708, and RPA 410193)
demonstrated that, on a subchronic basis, the plant metabolites were
not more toxic than the parent. The carcinogenic potential was negative
for mice dosed up to the limit dose with liver effects seen as the
systemic toxicity. In rats, fenamidone did produce a statistically
significant increase (p<  0.01 for both trend and pair-wise comparison)
in benign, endometrial stromal polyps at 5,000 ppm, the highest dose
tested (HDT). Consultation with an EPA consulting pathologist resulted
in these findings being characterized as benign proliferate lesions
that do not progress to malignant carcinomas or sarcomas. Based on
these findings, EPA classified fenamidone as ``not likely'' to be a
human carcinogen. All mutagenicity studies were negative for both the
parent and plant metabolites (RPA 412636, RPA 412708, and RPA 410193).
    Fenamidone did not demonstrate any qualitative or quantitative
increased susceptibility in the rat and rabbit developmental toxicity
studies or the 2-generation rat reproduction study. In rabbits, there
were no developmental effects up to the HDT and in the presence of
maternal toxicity. In rats, developmental findings and maternal
findings both occurred at the limit dose. In the reproduction study
(Sprague Dawley rat), decreased absolute brain weight and pup body
weight occurred at the same dose levels as decreased absolute brain
weight and parental body weight, food consumption, and increased liver
and spleen weight. There were no effects on fertility and other
measured reproductive parameters. In the acute neurotoxicity study in
rats, the most commonly observed clinical sign was staining/soiling of
the anogenital region at 500 and 2,000 milligrams/kilogram (mg/kg).
These findings were observed at low incidences and were consistent with
those observed on day 1 of the functional observational battery (FOB).
Other day-1 FOB findings included mucous in the feces of the 500 and
2,000 mg/kg males and females; hunched posture when walking or sitting
in the 2,000 mg/kg females; and unsteady gait in the 500 and 2,000 mg/
kg females. In the subchronic neurotoxicity study (Sprague Dawley rat),
marginal decrease in brain weights was observed only in high dose
males. Additionally, fenamidone displayed decreased brain weight in
F1 female adults and F2 female offspring in the
rat reproduction study. Other evidence of neurotoxicity (clinical signs
such as lethargy, prostration, tremors, eye closure, unsteady gait) was
observed in a mouse bone marrow micronucleus assay with plant
metabolites (RPA 412636 and RPA 412708).
    Based on the evidence of neurotoxicity summarized above, EPA
requested a developmental neurotoxicity (DNT) study conducted with
Sprague Dawley rats. The petitioner submitted a DNT study conducted
with Wistar rats. In this study, no maternal toxicity was observed at
doses up to 4,700 ppm (429 mg/kg/day). The offspring systemic toxicity
manifested as decreased body weight (9 to 11%) and body weight gain (8
to 20%) during pre-weaning and decreased body weight (4 to 6%) during
post-weaning. The offspring NOAEL was 1,000 ppm (92.3 mg/kg/day). The
results of this DNT study suggest increased susceptibility of offspring
to fenamidone; however, the concern for increased susceptibility is low
since there is a well established NOAEL protecting the offspring and
the NOAEL used for establishing the chronic reference dose (cRfD) is
approximately 45X below the NOAEL observed for the offspring toxicity
in the DNT study. EPA reviewed these data and determined that the 10X
database uncertainty factor due to lack of DNT should be removed.
However, since this study was conducted using Wistar rats rather than
Sprague Dawley rat as requested, EPA requested a modified DNT in the
Sprague Dawley rat with measurement of the following endpoint: brain
weights (samples should be retained for possible morphometric
measurements); this study is necessary to confirm the lack of brain
weight changes in the Wistar rat DNT.

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 (UFs)
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 fenamidone used for
human risk assessment can be found at http://www.regulations.gov in the

document entitled ``Fenamidone Human Health Risk Assessment'' on page
12 in Docket ID EPA-HQ-OPP-2006-0848.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenamidone, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenamidone tolerances in 40 CFR
180.579. The Agency generated dietary exposure estimates for exposure
to fenamidone and its residues of concern. The following paragraphs are
summaries of these analyses. EPA assessed dietary exposures from
fenamidone 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 one-day or single exposure.
    In estimating acute dietary exposure to fenamidone, EPA used food
consumption information from the USDA 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed maximum field trial residues for the
residues of concern for risk assessment and 100% crop treated. The
Dietary Exposure Evaluation Model (DEEMTM) (ver. 7.81)
default processing factors were maintained for all commodities
excluding grape juice, dried potato, tomato paste, and tomato puree;
for these commodities; the DEEMTM (ver. 7.81) default
processing factors were reduced to 1 based on processing data (grape),
or empirical processing factors were applied to the RAC residue (tomato
paste, tomato puree, and dried potato).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment for fenamidone, EPA used the food consumption data from the
USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA
assumed maximum field trial residues for the residues of concern for
risk assessment and 100% crop treated. DEEMTM (ver. 7.81)
default processing factors were maintained for all commodities
excluding grape juice, dried potato, tomato paste, and tomato puree;
for these commodities, the DEEMTM (ver. 7.81) default
processing factors were reduced to 1 based on processing data (grape),
or empirical processing factors were applied to the RAC residue (tomato
paste, tomato puree, and dried potato).
    iii. Cancer. EPA has classified fenamidone as a ``not likely''
human carcinogen. Therefore, a cancer dietary exposure analysis was not
performed.
    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.
    2. Dietary exposure from drinking water. Biotransformation
(metabolism) under aerobic conditions and direct photolysis in water
are the major routes of transformation of fenamidone in the
environment. Fenamidone half-lives were 5 to 8 days in aerobic soils,
67 to 128 days in aerobic water-sediments, and 5 to 8 days in water
exposed to summer sunlight (direct photolysis). Fenamidone is highly
persistent in anaerobic water-sediment systems (half-life longer than
1,000 days). Adsorption of fenamidone onto soils is moderate (mean
Koc less than 388). Therefore, fenamidone is not persistent
in soil or in shallow water under aerobic conditions. Under field
conditions, the half-lives of fenamidone ranged from 9 to 82 days.
Given that biotransformation is the major route of degradation and
considering the widespread, potential use areas of different soils,
microbial population and activity, water bodies, climates/meteorology,
and agricultural practices, high variability in persistence in soil and
water-sediment systems is to be expected. Likewise, variability in type
and relative amount of products would also be expected. EPA reviewed
the environmental fate data for fenamidone and concluded that the
residues of concern in water are RPA 412636, RPA 412708, RPA 411639,
RPA 413255, and RPA 409446, RPA 410995RPA-412636.
    The Agency lacks sufficient monitoring data to complete a
comprehensive dietary exposure analysis and risk assessment for
fenamidone 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 fenamidone. 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 Groundwater
(SCI-GROW) models, the estimated environmental concentrations (EECs) of
fenamidone for acute exposures are estimated to be 41.66 parts per
billion (ppb) for surface water and 178 ppb for ground water. The EECs
for chronic exposures are estimated to be 11.88 ppb for surface water
and 178 ppb for ground water. Estimates were performed for combined
residues of parent fenamidone and the residues of concern previously
mentioned.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute and chronic
dietary risk assessment, the water concentration value of 178 ppb
(highest estimate; based on three applications at 0.267 pounds of
active ingredient per acre) was used to access 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).
    Fenamidone 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 fenamidone and any other
substances and fenamidone 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 fenamidone 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 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. Prenatal and postnatal sensitivity. No quantitative or
qualitative evidence of increased susceptibility of rat or rabbit
fetuses to in utero exposure in the developmental toxicity studies was
observed. There was no developmental toxicity in rabbit fetuses up to
100 mg/kg/day (HDT), which resulted in an increased absolute liver
weight in the does. Since the liver was identified as one of the
principal target organs in rodents and dogs, the occurrence of this
finding in rabbits at 30 and 100 mg/kg/day was considered strong
evidence of maternal toxicity. In the rat developmental study,
developmental toxicity manifested as decreased fetal body weight and
incomplete fetal ossification in the presence of maternal toxicity in
the form of decreased body weight and food consumption at the limit
dose (1,000 mg/kg/day). The effects at the limit dose were comparable
between fetuses and dams. No quantitative or qualitative evidence of
increased susceptibility was observed in the 2-generation reproduction
study in rats. In that study, both the parental and offspring LOAELs
were based on decreased absolute brain weight in female F1
adults and female F2 offspring at 89.2 mg/kg/day. At 438.3
mg/kg/day, parental effects consisted of decreased body weight and food
consumption, and increased liver and spleen weight. Decreased pup body
weight was also observed at the same dose level of 438.3 mg/kg/day.
There were no effects on reproductive performance up to 438.3 mg/kg/day
(HDT). The DNT study conducted with Wistar rats showed no maternal
toxicity up to 429 mg/kg/day. The offspring systemic toxicity
manifested as decreased body weight (9 to 11%) and body weight gain (8
to 20%) during pre-weaning and decreased body weight (4 to 6%) during
post-weaning with a NOAEL of 92.3 mg/kg/day. The results of this DNT
study suggest increased susceptibility of offspring to fenamidone;
however, the concern for increased susceptibility is low since there is
a well established NOAEL protecting the offspring and the NOAEL used
for establishing the chronic reference dose (cRfD; see below) is
approximately 45x below the NOAEL observed for the offspring toxicity
in the DNT study.
    There is confidence that the sensitivity of any developmental
neurological effects have been identified. EPA required a DNT based on
a marginal decrease in brain weight in high dose males in the
subchronic neurotoxicity study in rats, decreased brain weight in
female adults and female offspring in the 2-generation reproduction
study, and clinical signs that may be indicative of neurotoxic effects
at relatively high doses in several studies. A DNT was conducted and
showed no neurotoxic effects. Because, however, the DNT was conducted
in a different strain of rat (Wistar) than the studies that showed
brain effects (Sprague-Dawley), EPA has required that an abbreviated
DNT be conducted in the Sprague-Dawley rat that focuses on brain
effects. Due to the clear NOAEL from the existing DNT as well as the
clear NOAELs in the studies evidencing brain effects, EPA regards the
abbreviated DNT as confirmatory in nature and unlikely to change the
characterization or magnitude of the risk for fenamidone.
    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 toxicology database is complete other than the confirmatory
DNT study.
    ii. No qualitative or quantitative increased susceptibility in the
developmental toxicity studies (rat and rabbit).
    iii. No qualitative or quantitative increased susceptibility in the
2-generation reproduction study (rat).
    iv. Low concern for residual uncertainties in the DNT study (rat)
since there is a well established offspring NOAEL which is 45X greater
than the NOAEL used to establish the chronic dietary endpoint.
    v. 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 or maximum
levels from crop field trials. Conservative ground and surface water
modeling estimates were used. These assessments will not underestimate
the exposure and risks posed by fenamidone.

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 fenamidone will occupy 5% of the aPAD for the population group
children 1 to 2 years old, the highest estimated acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fenamidone from food and water will utilize 82% of the cPAD for the
population group children 1 to 2 years old, the highest estimated
chronic risk. There are no residential uses for fenamidone that result
in chronic residential exposure to fenamidone.
    3. Aggregate cancer risk for U.S. population. EPA has classified
fenamidone as a ``not likely'' human carcinogen. EPA does not expect
fenamidone 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 fenamidone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (a liquid chromatograph/mass
spectrometer/mass spectrometer (LC/MS/MS) is available to enforce the
tolerance expression. 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 currently no established Codex maximum residue limits for
the proposed tolerances.

C. Explanation of Tolerance Revisions

    1. Sunflower. The geographical representation of the sunflower
field trial data fulfill the data requirements suggested in OPPTS
860.1500 for sunflower. Based on the sunflower seed field trial data,
EPA concludes that a sunflower seed tolerance for residues of
fenamidone per se of 0.02 ppm is appropriate.
    2. Brassica, head and stem, subgroup 5-A. The geographical
representation of the broccoli, cabbage, and mustard green field trial
data fulfill the data requirements suggested in OPPTS 860.1500 for a
Brassica (cole) leafy vegetables crop group registration or crop
subgroup 5a and 5b tolerances. EPA notes that these field trials
employed 1.0x the proposed single application rate but 1.4x the
proposed seasonal rate. Based on the residue decline data which
indicated that combined residues of fenamidone, RPA 717879, RPA 408056,
and RPA 405862 reduced 52% (broccoli), 43% (cabbage), and 87% (mustard
green) as the pre-harvest (PHI) increased from 0 to 7 days, EPA
concludes that the final application, which was conducted at 1x the
proposed rate, will drive the magnitude of the residue in or on the
Brassica (cole) leafy vegetables. Based on the broccoli, cabbage, and
mustard green field trial data and the tolerance spreadsheet
calculator, tolerances for residues of fenamidone per se of 5.0 ppm,
1.3 ppm, and 55 ppm were recommended. Since the maximum residues and
recommended tolerances are not within 5x, EPA concludes that a crop
group tolerance is not appropriate but that crop subgroup tolerances
are appropriate. EPA concludes that a head and stem Brassica crop
subgroup 5a tolerance of 5.0 ppm and a leafy Brassica greens crop
subgroup 5b tolerance of 55 ppm for residues of fenamidone per se are
appropriate.
    3. Vegetable, fruiting, group 8. The geographical representation of
the tomato and pepper field trial data fulfill the data requirements
suggested in OPPTS 860.1500 for a fruiting vegetable crop group
registration. EPA notes that these field trials employed 1.0x the
proposed single application rate but 1.4x the proposed seasonal rate.
Based on the residue decline data which indicated that combined
residues of fenamidone, RPA 717879, RPA 408056, and RPA 405862 reduced
65% (bell pepper) and 34 to 73% (tomato) as the PHI increased from 0 to
21 (bell pepper) and 7 to 35 days (tomato; nonbell pepper decline data
were not submitted), EPA concludes that the final application, which
were conducted at 0.7 to 1.0x the proposed rate, will drive the
magnitude of the residue in or on fruiting vegetables.
    4. Pepper, nonbell. Based on the tomato, bell pepper, and nonbell
pepper field trial data and the tolerance spreadsheet calculator,
tolerances for the residues of fenamidone per se of 1.0 ppm, 0.40 ppm,
and 3.5 ppm were recommended. Since the pepper and nonbell pepper
maximum residues and recommended tolerances are not within 5X, EPA
concludes that a fruiting vegetable crop group tolerance is not
appropriate. Based on the residue data and since tomato is the major
food commodity in the fruiting vegetable crop group, EPA concludes that
it is appropriate to set nonbell pepper and fruiting vegetable (except
nonbell pepper) tolerances. Therefore, EPA concludes that the following
tolerances for residues of fenamidone per se are appropriate: fruiting
vegetable (except nonbell pepper) - 1.0 ppm and nonbell peppers - 3.5
ppm (the currently established tomato tolerance should be deleted).
    5. Vegetable, leafy, except Brassica, group 4. The geographical
representation of the lettuce (head and leaf), celery, and spinach
field trial data fulfill the data requirements suggested in OPPTS
860.1500 for leafy vegetables (except Brassica) crop group
registration. EPA notes that these field trials employed 1.0x the
proposed single application rate but 1.3 to 1.4x the proposed seasonal
rate. Based on the residue decline data which indicated that combined
residues of fenamidone, RPA 717879, RPA 408056, and RPA 405862 reduced
36% (celery), 70% (spinach), and 99% (leaf lettuce) as the PHI
increased from 0 to 7 days, EPA concludes that the final application,
which was conducted at 1x the proposed rate, will drive the magnitude
of the residue in or on leafy vegetables (except Brassica). Based on
the head lettuce, leaf lettuce, celery, and spinach field trial data
and the tolerance spreadsheet calculator, tolerances for the residues
of fenamidone per se of 18 ppm, 45 ppm, 45 ppm, and 60 ppm were
recommended. EPA concludes that a leafy vegetables (except Brassica)
crop group tolerance of 60 ppm for residues of fenamidone per se is
appropriate (the currently established lettuce, leaf and lettuce, head
tolerances should be deleted).

V. Conclusion

    Therefore, the tolerances are established for residues of
fenamidone, (4H-Imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-
phenyl-3-(phenylamino)-(S)-), in or on carrot at 0.15 ppm; sunflower at
0.02 ppm; Brassica, head and stem, subgroup 5A at 5.0 ppm; Brassica,
leafy greens, subgroup 5B at 55 ppm; vegetable, fruiting, group 8,
except nonbell pepper at 1.0 ppm; pepper, nonbell at 3.5 ppm;
vegetable, leafy, except Brassica, group 4 at 60 ppm; cotton, gin
byproducts at 0.02 ppm; and cotton, undelinted seed at 0.02 ppm.
    The tolerance is also established for combined residues of
fenamidone, (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methlthio)-5-
phenyl-3-(phenylamino, (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl) in or on strawberry at 0.02 ppm.
    Tolerances should be deleted for lettuce, leaf; lettuce; head; and
tomato as these commodities are included in the newly established
``vegetable, fruiting, group 8, except nonbell peppers,'' group, and
vegetable, leafy, except Brassica, group 4.

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: October 5, 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 180.579 is amended by alphabetically adding the
commoditiesBrassica, head and stem, subgroup 5A; Brassica, leafy
greens, subgroup 5B;carrot; cotton, gin byproducts; cotton, undelinted
seed, pepper, nonbell; sunflower; vegetable, fruiting, group 8, except
nonbell pepper; vegetable, leafy, except Brassica, group 4; and by
removing lettuce, head; lettuce, leaf; and tomato from the table in
paragraph (a)(1) and by alphabetically adding strawberry to the table
in paragraph (d) to read as follows:

Sec.  180.579  Fenamidone; tolerances for residues.

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

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A.......................          5.0
Brassica, leafy greens, subgroup 5B........................           55
Carrot.....................................................         0.15
Cotton, gin byproducts.....................................         0.02
Cotton, undelinted seed....................................         0.02
                                * * * * *
Pepper, nonbell............................................          3.5
                                * * * * *
Sunflower..................................................         0.02
                                * * * * *
Vegetable, fruiting, group 8, except nonbell pepper........          1.0
Vegetable, leafy, except Brassica, group 4.................           60
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Strawberry.................................................         0.15
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-20670 Filed 10-23-07; 8:45 am]

BILLING CODE 6560-50-S