FR Doc 04-21694

[Federal Register: September 29, 2004 (Volume 69, Number 188)]
[Rules and Regulations]
[Page 58058-58066]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se04-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0255; FRL-7681-3]

Fenamidone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-
phenyl-3-(phenylamino), (S)-) in or on garlic, bulb; garlic, great
headed; grape (imported); leek; onion, dry bulb; onion, green; onion,
welsh; shallot, bulb; shallot, fresh leaves; tomato; tomato, paste;
tomato, puree; vegetable, cucurbit, group 09; vegetable, tuberous and
corm, subgroup 01C and establishes tolerances for combined residues of
fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-
phenyl-3-(phenylamino), (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl) in or on fat (beef, goat, and
sheep); meat (beef, goat, and sheep); meat byproducts (beef, goat, and
sheep); milk; wheat, grain; wheat forage; wheat, hay; and wheat, straw.
Wheat tolerances are being established for inadvertent residues in/on a
rotated crop. Bayer CropScience 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 September 29, 2004. Objections and
requests for hearings must be received on or before November 29, 2004.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0255. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket/.

Although listed in the index, some information is not publicly
available, i.e., 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 either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Dennis McNeilly, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone
number: (703) 305-6742; e-mail address: mcneilly.dennis@epa.gov.

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 and Other
Related Information?

In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180

is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/
.

II. Background and Statutory Findings

In the Federal Register of January 28, 2004 (69 FR 4138-4143) (FRL-
7337-3), 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
1F6300) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle
Park, NC 27709. This amended the petition previously

[[Page 58059]]

announced in the Federal Register of January 4, 2002 (67 FR 592-597)
(FRL-6812-2) by including raw agricultural commodity subgroup 01C. The
petition requested that 40 CFR 180.579 be amended by establishing
tolerances for combined residues of the fungicide fenamidone, and its
metabolites in or on the raw agricultural commodities: Potato, 0.05
parts per million (ppm), tomato, 1.0 ppm; tomato paste, 3.5 ppm, tomato
puree, 3.5 ppm, bulb vegetable crop group, 1.5 ppm; cucurbit crop
group, 0.1 ppm; head lettuce, 15.0 ppm; leaf lettuce, 20.0 ppm; wheat
grain, 0.05 ppm, wheat straw, 0.5 ppm; wheat forage, 0.5 ppm, and wheat
hay, 0.5 ppm. Tolerances were also proposed for fenamidone and its
metabolite RPA 410193 on imported wine grapes at 0.5 ppm. Agency review
of the residue data indicates that the following tolerance levels are
appropriate: Fenamidone, 4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-
(methylthio)-5-phenyl-3-(phenylamino), (S)-, in or on garlic, bulb at
0.20 ppm; garlic, great headed at 0.20 ppm; grape (imported) at 1.0
ppm, leek at 1.5 ppm, onion, dry bulb at 0.20 ppm; onion, green at 1.5
ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20 ppm; shallot, fresh
leaves at 1.5 ppm; tomato at 1.0 ppm; tomato, paste at 2.2 ppm; tomato,
puree at 2.0 ppm; vegetable, cucurbit, group 09 at 0.15 ppm and
vegetable, tuberous and corm, subgroup 01C at 0.02 ppm and also for the
combined residues of fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-
methyl-2-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)) and its
metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl) in or
on fat (beef, goat, and sheep) at 0.10 ppm; meat (beef, goat, and
sheep) at 0,10 ppm, meat byproducts (beef, goat, and sheep) at 0.10
ppm; milk at 0.02 ppm; wheat forage at 0.15 ppm; wheat, grain at 0.10
ppm; wheat, hay at 0.50 ppm; wheat, straw at 0.35 ppm. The Agency is
establishing tolerances for animal tolerances based on review of the
residue data and evaluation of food animal diets, which could include
wheat forage and hay. That notice included a summary of the petition
prepared by Bayer CropScience, the registrant. There were no comments
received in response to the notice of filing.
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 FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

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 fenamidone, in or
on garlic, bulb at 0.20 ppm; garlic, great headed at 0.20 ppm; grape
(imported) at 1.0 ppm, leek at 1.5 ppm, onion, dry bulb at 0.20 ppm;
onion, green at 1.5 ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20
ppm; shallot, fresh leaves at 1.5 ppm; tomato at 1.0 ppm; tomato, paste
at 2.2 ppm; tomato, puree at 2.0 ppm; vegetable, cucurbit, group 09 at
0.15 ppm and vegetable, tuberous and corm, subgroup 01C at 0.02 ppm and
also for the combined residues of fenamidone (4H-imidazol-4-one, 3,5-
dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino), (S)-) and its
metabolite RPA 717879 (2,4-imidazolidinedione, 5-methyl-5-phenyl) in or
on fat (beef, goat, and sheep) at 0.10 ppm; meat (beef, goat, and
sheep) at 0,10 ppm, meat byproducts (beef, goat, and sheep) at 0.10
ppm; milk at 0.02 ppm; wheat forage at 0.15 ppm; wheat, grain at 0.10
ppm; wheat, hay at 0.50 ppm; wheat, straw at 0.35 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. The nature of the toxic effects caused by fenamidone are
discussed in the Federal Register of September 27, 2002 (67 FR 7196-
7198). There have been no changes in the toxicological profile since
that Federal Register notice and therefore, the Agency will not repeat
the entire table in this final rule but refers to the original
document.

B. Toxicological Endpoints

The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are
identified (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. A UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided

[[Page 58060]]

by an UF of 100 to account for interspecies and intraspecies
differences and any traditional uncertainty factors deemed appropriate
(RfD = NOAEL/UF). Where a special FQPA safety factor or the default
FQPA safety factor is used, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10^-\5\), one in a million (1 X 10^-\6\), or one in
ten million (1 X 10^-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for fenamidone used for
human risk assessment is shown in Table 1 of this unit:

Table 1.--Summary of Toxicological Dose and Endpoints for Fenamidone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
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Acute Dietary NOAEL = 125 milligram/ Special FQPA SF = 1X Acute Neurotoxicity
(General population including infants kilogram/day (mg/kg/ aPAD = acute RfD Study in Rats
and children). day) UF = 1,000 Acute (0.13)/Special FQPA SF LOAEL = 500 mg/kg/day
RfD = 0.13 mg/kg/day 1X = 0.13 mg/kg/day based on urination,
staining/soiling of
the anogenital region,
mucous in the feces,
and unsteady gait in
the females.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary NOAEL= 2.83 male/femal Special FQPA SF = 1X 2-Year Chronic Toxicity/
(All populations).................... (M/F) mg/kg/day UF = cPAD = chronic RfD Carcinogenicity Study
1,000 Chronic RfD = (0.003)/Special FQPA in Rats
0.003 mg/kg/day SF 1X = 0.003 mg/kg/ LOAEL = 7.07/9.24 mg/
day kg/day based on
increase in severity
of diffuse thyroid C-
cell hyperplasia in
both sexes.
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Short-Term Dermal Dermal (or oral) study LOC for MOE = 1,000 90-Day Feeding Study in
(1 to 7 days)........................ NOAEL= 10.4 mg/kg/day (Residential).......... Rats
(Residential)........................ LOAEL = 68.27 mg/kg/day
based on increased
liver weights and
incidences of ground
glass appearance of
the hepatocytes in
males.
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Intermediate-Term Dermal Dermal (or oral) study LOC for MOE = 1,000 2-Generation
(1 week to several months)........... NOAEL = 5.45 mg/kg/day (Residential).......... Reproduction Study in
(Residential)........................ Rats
LOAEL = 89.2 mg/kg/day
based on decreased
absolute brain weight
in female F1 adults
and females F2
offspring.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal Dermal (or oral) study LOC for MOE = 1,000 2-Year Chronic Toxicity/
(Several months to lifetime)......... NOAEL= 2.83 mg/kg/day (Residential).......... Carcinogenicity Study
(Residential)........................ in Rats
LOAEL = 7.07/9.24 mg/kg/
day M/F based on
increase in severity
of diffuse thyroid C-
cell hyperplasia in
both sexes.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation Inhalation (or oral) LOC for MOE = 1,000 90-Day Feeding Study in
(1 to 7 days)........................ study NOAEL= 10.4 mg/ (Residential).......... Rats
(Residential)........................ kg/day (inhalation LOAEL = 68.27 mg/kg/day
absorption rate = based on increased
100%) liver weights and
incidences of ground
glass appearance of
the hepatocytes in
males.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation Inhalation (or oral) LOC for MOE = 1,000 2-Generation
(1 week to several months)........... study NOAEL = 5.45 mg/ (Residential).......... Reproduction Study in
(Residential)........................ kg/day (inhalation Rats
absorption rate = LOAEL = 89.2 mg/kg/day
100%) based on decreased
absolute brain weight
in female F1 adults
and female F2
offspring.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation Inhalation (or oral) LOC for MOE = 1,000 2-Year Chronic Toxicity/
(Several months to lifetime)......... study NOAEL= 2.83 mg/ (Residential).......... Carcinogenicity Study
(Residential)........................ kg/day (inhalation in Rats
absorption rate = LOAEL = 7.07/9.24 mg/
100%) kg/day M/F based on
increase in severity
of diffuse thyroid C-
cell hyperplasia in
both sexes.
----------------------------------------------------------------------------------------------------------------
Cancer Classification: ``Not
(Oral, dermal, inhalation)........... likely''
----------------------------------------------------------------------------------------------------------------

[[Page 58061]]

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.579) for residues of fenamidone, in or on head
and leaf lettuce. Risk assessments were conducted by EPA to assess
dietary exposures from fenamidone in food as follows:
i. Acute exposure. Acute dietary 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 conducting the acute dietary risk 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 U.S. Department of Agriculture
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the acute exposure
assessments: The acute analysis assumed 100% crop treated and field
trial residue data treated at maximum labeled rate, minimum preharvest
interval. Therefore, the acute analysis is considered conservative. The
results, reported in Unit III.E. are for the general U.S. population,
all infants (< 1 year old), children 1-2, children 3-5, children 6-12,
youth 13-19, females, 13-49, adults 20-49, and adults 50+ years. The
acute dietary exposure estimates were < = 24% aPAD (95\th\ percentile;
children 1-2 years old were the most highly exposed population).
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
DEEM-FCID\TM\, which incorporates food consumption data as reported by
respondents in the USDA 1994-1996 and 1998 CSFII, and accumulated
exposure to the chemical for each commodity. The following assumptions
were made for the chronic exposure assessments: The chronic analysis
was refined through the use of projected percent crop treated (PCT)
estimates and average field trial residues. Since the chronic analysis
assumed that all meat/milk commodities will contain fenamidone residues
(i.e., no adjustment for feed PCT) and since the analysis made use of
field trial residues (treated at maximum labeled rate, minimum
preharvest interval), the Agency concludes that the chronic exposure
estimates are conservative.
iii. Cancer. Fenamidone is classified as ``not likely to be
carcinogenic to humans'' by all relevant routes of exposure based on
adequate studies in two animal species.
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 chemicals that have been
measured in food. If EPA relies on such information, EPA must 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. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E) of FFDCA, EPA
will issue a data call-in for information relating to anticipated
residues to be submitted no later than 5 years from the date of
issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid
basis to show what percentage of the food derived from such crop is
likely to contain such pesticide residue.
Condition 2, that the exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require
registrants to submit data on PCT.
The Agency used PCT information in Table 2 of this unit as follows:

Table 2.--Percent Crop Treated Estimates for Fenamidone
------------------------------------------------------------------------
Acute % Crop Chronic % Crop
Commodity Treated Treated
------------------------------------------------------------------------
Tomato 100% 31%
------------------------------------------------------------------------
Potato 100% 20%
------------------------------------------------------------------------
Lettuce 100% 24%
------------------------------------------------------------------------
Cucurbits 100% 9%
------------------------------------------------------------------------
Bulb crops 100% 19%
------------------------------------------------------------------------

For each crop, EPA projected a PCT estimate for fenamidone by
assuming that fenamidone would duplicate the PCT of the fenamidone
alternative that had the highest PCT and, like fenamidone, is a
relatively new pesticide, targets the same pests as fenamidone, and
tends to replace the same older pesticides (e.g., chlorothalonil and
EBDCs). Further, fenamidone had to be price competitive with the
alternative on which the projection was based.
The Agency believes that the three conditions listed in Unit
III.C.1.iv. have been met. With respect to Condition 1, PCT estimates
are derived from Federal and private market survey data on fenamidone
alternatives, which are reliable and have a valid basis. EPA uses a
weighted average PCT for chronic dietary exposure estimates. This
weighted average PCT figure is derived by averaging State-level data
for a period of up to 10 years, and weighting for the more robust and
recent data. A weighted average of the PCT reasonably represents a
person's dietary exposure over a lifetime, and is unlikely to
underestimate exposure to an individual because of the fact that
pesticide use patterns (both regionally and nationally) tend to change
continuously over time, such that an individual is unlikely to be
exposed to more than the average PCT over a lifetime. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an underestimation. As to Conditions 2 and 3, regional
consumption information and consumption information for significant
subpopulations is taken into account through EPA's computer-based model
for evaluating the exposure of significant subpopulations including
several regional groups. Use of this consumption information in EPA's
risk assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available information on the

[[Page 58062]]

regional consumption of food to which fenamidone may be applied in a
particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure 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 physical
characteristics of fenamidone.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and Screening Concentration in Ground Water (SCI-GROW), which
predicts pesticide concentrations in ground water. In general, EPA will
use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model)
for a screening-level assessment for surface water. The GENEEC model is
a subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to fenamidone they are
further discussed in the aggregate risk sections in Unit III.E.2.
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of fenamidone
for acute exposures are estimated to be 10.47 parts per billion (ppb)
for surface water and 8.19 ppb for ground water. The EECs for chronic
exposures are estimated to be 2.58 ppb for surface water and 8.19 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). 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 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
the policy statements released by EPA's OPP concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's web site 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
MOE 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 Agency concluded that
there is not a concern for pre- and/or postnatal toxicity resulting
from exposure to fenamidone. 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 highest
dose tested (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 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).
3. Conclusion. Exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. The toxicity
database is not complete because EPA has required that a developmental
neurotoxicity (DNT)

[[Page 58063]]

study be conducted due to evidence from fenamidone studies of clinical
signs of neurotoxicity and decreased brain weight. EPA has retained the
FQPA additional 10X safety factor for the protection of infants and
children because of the absence of the DNT study. This FQPA safety
factor is in the form of a database uncertainty factor. A 1,000-fold
uncertainty factor (10x UFDB for lack of a (DNT) study; 10X
for interspecies extrapolation; and 10x for intraspecies variation)
were incorporated into the acute and chronic RfD . The reference dose
(RfD) for acute and chronic risks from fenamidone is equal to the
applicable NOAEL divided by the 1000x uncertainty factor.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water [e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
fenamidone the highest exposed population subgroup was children 1-2
years old which accounted for 24% of the aPAD. The acute aggregate risk
associated with the proposed use of fenamidone does not exceed the
Agency's level of concern for the general U.S. population or any
population subgroups.. In addition, there is potential for acute
dietary exposure to fenamidone in drinking water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the aPAD, as
shown in Table 3 of this unit:

Table 3.--Aggregate Risk Assessment for Acute Exposure to Fenamidone
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC
Population Subgroup aPAD (mg/kg) % aPAD (Food DEEM) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
General U.S. population 0.13 16% 10.47 8.19 3800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 1-2 yearsold 0.13 24% 10.47 8.19 990
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 yearsold 0.13 15% 10.47 8.19 330
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 yearsold 0.13 17% 10.47 8.19 3800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.13 17% 10.47 8.19 3200
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Maximum water exposure (mg/kg/day) = aPAD (mg/kg/day) - food exposure (mg/kg/day).
2. The crop producing the highest level was used.
3. DWLOC calculated as follows:
DWLOC = (maximum water exposure (mg/kg/day)) x (body weight (kg)) x (1,000 [mu]g (gram)/mg) / water consumption (L/day)

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that the chronic dietary
exposure analysis was partially refined through the use of projected
PCT estimates and average field trial residues. Since the chronic
analysis assumed that all meat/milk commodities will contain fenamidone
residues (i.e. no adjustment for feed PCT) and since the analysis made
use of field trial residues (treated at maximum labeled rate, minimum
preharvest interval, samples frozen upon collection and remained frozen
until analysis), EPA concludes that the chronic exposure estimates are
conservative. The highest exposed population subgroup was children 1-2
years old which occupies 69% of the cPAD. There are no residential uses
for fenamidone that result in chronic residential exposure to
fenamidon. EPA does not expect the aggregate exposure to exceed 100% of
the cPAD, as shown in Table 4 of this unit:

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fenamidone
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC
Population Subgroup cPAD mg/kg/day %cPAD (Food) (ppb) (ppb) Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.003 29% 2.58 8.19 74
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 58064]]

Children 1-2 years old 0.003 69% 2.58 8.19 9.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth 13-19 years old 0.003 26% 2.58 8.19 67
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adults 20-49 years old 0.003 26% 2.58 8.19 78
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.003 26% 2.58 8.19 67
--------------------------------------------------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term risk assessment was not performed
because there are no existing or proposed residential uses for
fenamidone.
Fenamidone is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. Intermediate-term risk. Intermediate-term risk assessment was
not performed because there are no existing or proposed residential
uses for fenamidone.
Intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Fenamidone is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
5. Aggregate cancer risk for U.S. population. A cancer aggregate
risk assessment was not performed because fenamidone is not considered
to be carcinogenic.
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 fenamidone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The registrant has proposed a liquid chromatograph/mass
spectroscopy (LC/MS) method for the enforcement of the plant tolerances
(the method does not distinguish the S- and R-enantiomers). Adequate
method validation, radiovalidation, and independent method validation
(ILV) of the proposed enforcement method have been submitted.
The Agency concludes that livestock tolerances are necessary. The
petitioner has proposed a livestock enforcement method and submitted an
ILV for this method. The Agency notes that methods AR 200-99 (milk) and
AR 178-98 (tissue) have been adequately radiovalidated for the
determination of fenamidone, RPA 717879, and RPA 408056. An ILV study
has been submitted for the livestock enforcement method and it
indicates that the method is satisfactory for enforcement purposes.
Adequate enforcement methodology 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: (410) 305-2905; e-mail
address: residuemethods@epa.gov.

B. International Residue Limits

There are currently no established Codex, Canadian, or Mexican
maximum residue limits (MRLs) for fenamidone in/on requested crops;
therefore, harmonization is not an issue for this petition.

C. Conditions

1. Toxicity data requirements. A DNT study in rats is required. The
Agency concluded that the DNT was required based on the following:
i. Clinical signs of neurotoxicity were seen in the mutagenicity
studies with parent and plant metabolites, particularly RPA 412636 and
RPA 412708.
ii. In the acute neurotoxicity study in rats, decreased brain
weight in male rats was observed.
iii. In the 2-generation reproduction study in rats, decreased
absolute brain weight was observed in the female F1 adults and the
female F2 offspring.
The Agency reassessed the requirement for a DNT study in rats for
fenamidoene in response to the waiver request by Bayer CropSciences.
2. Residue chemistry data requirements--i. The Agency is requesting
that the petitioner hydrolyze the extractable and non extractable
residues from the N-phenyl studies to determine if conjugated
aniline(s) are present (data validating the storage interval are also
required).
ii. The Agency is also requiring additional identification/
characterization on the N-phenyl livestock samples to determine the
metabolic fate of the N-phenyl ring in livestock (data validating the
storage interval are also required).
iii. Submission of storage stability data for confined accumulation
in rotational crop study.

V. Conclusion

Therefore, the tolerance is established for residues of fenamidone,
4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino), (S)-, in or on garlic, bulb at 0.20 ppm; garlic, great
headed at 0.20 ppm; grape (imported) at 1.0 ppm, leek at 1.5 ppm,
onion, dry bulb at 0.20 ppm; onion, green at 1.5 ppm; onion, welsh at
1.5 ppm; shallot, bulb at 0.20 ppm; shallot, fresh leaves at 1.5 ppm;
tomato at 1.0 ppm; tomato, paste at 2.2 ppm; tomato, puree at 2.0 ppm;
vegetable, cucurbit, group 09 at 0.15 ppm and vegetable, tuberous and
corm, subgroup 01C at 0.02 ppm and also for the combined residues of
fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-
phenyl-3-(phenylamino), (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl) in or on fat (beef, goat, and
sheep) at 0.10 ppm; meat (beef, goat, and sheep) at 0,10 ppm., meat
byproducts (beef, goat, and sheep) at 0.10 ppm; milk at 0.02 ppm; wheat
forage at 0.15 ppm; wheat, grain at 0.10 ppm; wheat, hay at 0.50 ppm;
wheat, straw at 0.35 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate

[[Page 58065]]

adjustments, until the necessary modifications can be made. The new
section 408(g) of FFDCA provides essentially the same process for
persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d) of
FFDCA, as was provided in the old sections 408 and 409 of FFDCA.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0255 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 November
29, 2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0255, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. 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,
entitled 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

[[Page 58066]]

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.

VIII. 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: September 21, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.579 is amended by designating the text of paragraph
(a) as paragraph (a)(1) and alphabetically adding new commodities to
the table in paragraph (a)(1) and by adding new paragraph (a)(2) and
text to paragraph (d) to read as follows:

Sec. 180.579 Fenamidone; tolerances for residues.

(a) * * *
(1) Tolerances are established for residues of fenamidone (4H-
imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino), (S)-) from the application of the fumgicide fenamidone
in or on the following raw agricultural commodities:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
garlic, bulb............................................... 0.20
garlic, great headed....................................... 0.20
Grape (imported)........................................... 1.0
Leek....................................................... 1.5
* * * * *
Onion, dry bulb............................................ 0.20
Onion, green............................................... 1.5
Onion, welsh............................................... 1.5
Shallot, bulb.............................................. 0.20
Shallot, fresh leaves...................................... 1.5
Tomato.................................................... 1.0
Tomato, paste.............................................. 2.2
Tomato, puree.............................................. 2.0
Vegetable, cucurbit, group 09.............................. 0.15
Vegetable, tuberous and corm, subgroup 01C................. 0.02
------------------------------------------------------------------------

(2) Tolerances are established for the combined residues of
fenamidone (4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-
phenyl-3-(phenylamino), (S)-) and its metabolite RPA 717879 (2,4-
imidazolidinedione, 5-methyl-5-phenyl), expressed as parent compound,
in or on the following commodities:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
beef, fat.................................................. 0.10
beef, meat................................................. 0.10
beef, meat byproducts...................................... 0.10
goat, fat.................................................. 0.10
goat, meat................................................. 0.10
goat, meat byproducts...................................... 0.10
milk....................................................... 0.02
sheep, fat................................................. 0.10
sheep, meat................................................ 0.10
sheep, meat byproduct...................................... 0.10
------------------------------------------------------------------------

* * * * *
(d) Indirect or inadvertent residues. Tolerances are established
for 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 the following agricultural commodities when present therein as a
result of application of fenamidone to the crops in paragraph (a)(1).

[FR Doc. 04-21694 Filed 9-28-04; 8:45 am]

BILLING CODE 6560-50-S