[Federal Register Volume 69, Number 188 (Wednesday, September 29, 2004)]
[Rules and Regulations]
[Pages 58058-58066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21694]


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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 <greek-i>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: <a href="/cdn-cgi/l/email-protection#8be6e8e5eee2e7e7f2a5efeee5e5e2f8cbeefbeaa5ece4fd"><span class="__cf_email__" data-cfemail="c9a4aaa7aca0a5a5b0e7adaca7a7a0ba89acb9a8e7aea6bf">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> 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<SUP>-</SUP>\5\), one in a million (1 X 10<SUP>-</SUP>\6\), or one in 
ten million (1 X 10<SUP>-</SUP>\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 (MOE<INF>cancer</INF> = 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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 UF<INF>DB</INF> 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: <a href="/cdn-cgi/l/email-protection#b4c6d1c7ddd0c1d1d9d1c0dcdbd0c7f4d1c4d59ad3dbc2"><span class="__cf_email__" data-cfemail="720017011b1607171f17061a1d1601321702135c151d04">[email protected]</span></a>.

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: <a href="/cdn-cgi/l/email-protection#94fbe4e4b9f0fbf7fff1e0d4f1e4f5baf3fbe2"><span class="__cf_email__" data-cfemail="f29d8282df969d91999786b2978293dc959d84">[email protected]</span></a>. 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).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Wheat, grain...............................................         0.10
Wheat, hay.................................................         0.50
Wheat, forage..............................................         0.15
Wheat, straw...............................................         0.35
------------------------------------------------------------------------


[FR Doc. 04-21694 Filed 9-28-04; 8:45 am]
BILLING CODE 6560-50-S


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