[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60966-60976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24652]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0229; FRL-7196-8]


Fenamidone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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 lettuce, head at 15 ppm and 
lettuce, leaf at 20 ppm. Aventis CropScience requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996. Subsequent to the filing of this 
petition, Bayer Corporation acquired Aventis CropScience to form Bayer 
CropScience. Therefore, the registrant is now Bayer CropScience.

DATES: This regulation is effective September 27, 2002. Objections and 
requests for hearings, identified by docket control number OPP-2002-
0229, must be received on or before November 26, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-2002-0229 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW.,Washington, DC 20460; telephone number: (703) 305-7740; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112...............  Animal production
                                  311...............  Food manufacturing
                                  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a

[[Page 60967]]

beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0229. The official 
record consists of the documents specifically referenced in this 
action, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of January 4, 2002 (67 FR 592) (FRL-6812-
2), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing 
the filing of a pesticide petition (PP 1F06300) by Aventis CropScience, 
2 Alexander Drive, Research Triangle Park, NC 27709. This notice 
included a summary of the petition prepared by, the registrant. 
Subsequent to the filing of this petition, Bayer Corporation acquired 
Aventis CropScience to form Bayer CropScience. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide [4H-Imidazol-4-
one, 3,5-dihydro-5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-
(phenylamino)-, (S)-], fenamidone and its metabolites RPA 412708, RPA 
412636 and RPA 410193, in or on letttuce, head at 15 ppm and lettuce, 
leaf at 20 part per million (ppm).
    Section 408(b)(2)(A)(i) of the 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) 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) 
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 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), 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), for tolerances for residues of fenamidone on lettuce, head 
at 15 ppm and lettuce, leaf at 20 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 following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

           Table 1.-- Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type            Results
------------------------------------------------------------------------
870.3100                          90-day oral         NOAEL = 29.68/
                                   toxicity rodents    35.39 mg/kg/day
                                   (rats)              in males and
                                  Parent compound      females,
                                   tested.             respectively.
                                                      LOAEL = 305.48/
                                                       337.19 mg/kg/day
                                                       in males and
                                                       females,
                                                       respectively,
                                                       based on
                                                       decreased body
                                                       weights, body
                                                       weight gains, and
                                                       food consumption
                                                       in males and
                                                       females,
                                                       enlargement and
                                                       prominent
                                                       germinal centers
                                                       in the spleen in
                                                       males, and
                                                       periportal
                                                       vaculation and
                                                       bile duct
                                                       hyperplasia in
                                                       the liver of
                                                       males.
------------------------------------------------------------------------
870.3100                          90-day oral         NOAEL = 10.41/
                                   toxicity rodents    12.00 mg/kg/day
                                   (rats)              in males and
                                  Parent compound      females,
                                   tested.             respectively.
                                                      LOAEL = 68.27/
                                                       83.33 mg/kg/day
                                                       based on
                                                       increased liver
                                                       weights and
                                                       incidence of
                                                       ground glass
                                                       appearance of the
                                                       hepatocytes
                                                       (mostly
                                                       centrilobular) in
                                                       the males.
------------------------------------------------------------------------

[[Page 60968]]

 
870.3100                          90-day oral         NOAEL = 6.419/
                                   toxicity rodents    7.725 mg/kg/day
                                   (rats)              in males and
                                  RPA 412636 plant     females,
                                   metabolite tested.  respectively.
                                                      LOAEL = 32.860/
                                                       39.111 mg/kg/day
                                                       in the males and
                                                       females,
                                                       respectively,
                                                       based on
                                                       increased liver
                                                       weights, liver
                                                       enlargement,
                                                       centrilobular
                                                       hepatocyte
                                                       hypertrophy and
                                                       vacuolation, and
                                                       follicular
                                                       epithelial height
                                                       of the thyroid in
                                                       males.
------------------------------------------------------------------------
870.3100                          90-day oral         NOAEL = 9.4/11.5
                                   toxicity in         mg/kg/day in
                                   rodents (rat)       males and
                                  RPA 410193 plant     females,
                                   metabolite tested.  respectively.
                                                       LOAEL = 93.3/
                                                       114.9 mg/kg/day
                                                       in males and
                                                       females
                                                       respectively.
                                                       based on liver
                                                       enlargement and
                                                       increased liver
                                                       weights and
                                                       chlolesterol in
                                                       the males and on
                                                       incidences of
                                                       centrilobular
                                                       hepatocellular
                                                       hypertrophy in
                                                       the males and
                                                       females.
------------------------------------------------------------------------
870.3100                          90-day oral         NOAEL = 44.49/
                                   toxicity in         54.13 mg/kg/day
                                   rodents (mice)      in males and
                                  Parent compound      females,
                                   tested.             respectively.
                                                      LOAEL = 220.17/
                                                       273.86 mg/kg/day
                                                       in males and
                                                       females
                                                       respectively
                                                       based on mild
                                                       hepatotoxicity as
                                                       evidenced by
                                                       increased liver
                                                       weights and
                                                       incidences of
                                                       pale liver and
                                                       hepatic
                                                       microvacuolation
                                                       in the males and
                                                       decreased
                                                       cholesterol and
                                                       increased
                                                       incidence of
                                                       prominent
                                                       lobulation of the
                                                       liver in the
                                                       females.
------------------------------------------------------------------------
870.3150                          90-day oral         NOAEL = 500 mg/kg/
                                   toxicity in         day for males and
                                   nonrodents (dogs)   females. Highest
                                  Parent compound      dose tested
                                   tested.             (HDT).
                                                       LOAEL = Not
                                                       determined.
------------------------------------------------------------------------
870.3200                          21/28-Day dermal    NOAEL = 1000 mg/kg/
                                   toxicity (rat)      day in females.
                                  Parent compound      Not established
                                   tested.             in males.
                                                      LOAEL = 1000 mg/kg/
                                                       day in males
                                                       based on
                                                       decreased body
                                                       weight, body
                                                       weight gain, and
                                                       food consumption.
                                                       The LOAEL was not
                                                       observed in
                                                       females.
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental in    150 mg/kg/day
                                   rodents (rats)     Maternal LOAEL =
                                  Parent compound      1000 mg/kg/day
                                   tested.             based on
                                                       decreased body
                                                       weight, body
                                                       weight gains, and
                                                       decreased food
                                                       consumption.
                                                       Developmental
                                                       NOAEL = 150 mg/kg/
                                                       day
                                                       Developmental
                                                       LOAEL = 1000 mg/
                                                       kg/day based on
                                                       decreased fetal
                                                       weights and
                                                       incomplete
                                                       ossification.
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental in    10 mg/kg/day
                                   nonrodents         Maternal LOAEL =
                                   (rabbits)           30 mg/kg/day
                                  Parent compound      based on
                                   tested.             increased liver
                                                       weights.
                                                      Developmental
                                                       NOAEL = 100 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = not
                                                       observed
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 4.04/5.45
                                   with acid (rat)     mg/kg/day in
                                  Parent compound      males and in
                                   tested.             females
                                                      Parental/Systemic
                                                       LOAEL = 68.6/89.2
                                                       mg/kg/day in
                                                       males and females
                                                       based on
                                                       decreased
                                                       absolute brain
                                                       weight in F1
                                                       females.
                                                       Reproductive/
                                                       Offspring NOAEL =
                                                       4.04/5.45 mg/kg/
                                                       day in males and
                                                       females.
                                                       Reproductive/
                                                       Offspring LOAEL =
                                                       68.6/89.2 mg/kg/
                                                       day based on
                                                       decreased
                                                       absolute brain
                                                       weight in F2
                                                       female pups.
------------------------------------------------------------------------
870.4100                          Chronic toxicity    NOAEL = 100 mg/kg/
                                   in dogs (1 year)    day in males and
                                  Parent compound      females
                                   tested.             respectively.
                                                       LOAEL = 1000 mg/
                                                       kg/day in males
                                                       and females based
                                                       on increased
                                                       liver weight,
                                                       triglycerides,
                                                       and biliary
                                                       proliferation in
                                                       males, and
                                                       alkaline
                                                       phosphatase
                                                       activity in both
                                                       sexes.
------------------------------------------------------------------------

[[Page 60969]]

 
870.4300                          Carcinogenicity in  NOAEL = 2.83/3.63
                                   rats                mg/kg/day in
                                  Parent compound      males and
                                   tested.             females,
                                                       respectively.
                                                       LOAEL = 7.07/9.24
                                                       mg/kg/day in
                                                       males and females
                                                       respectively
                                                       based on an
                                                       increase in
                                                       severity of
                                                       diffuse thyroid C-
                                                       cell hyperplasia
                                                       in both sexes.
                                                       No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.4200                          Carcinogenicity in  NOAEL = 47.5/63.8
                                   mice                mg/kg/day in
                                  Parent compound      males and
                                   tested.             females,
                                                       respectively.
                                                       LOAEL = 525.5/
                                                       690.5 mg/kg/day
                                                       in males and
                                                       females,
                                                       respectively
                                                       based on
                                                       decreased body
                                                       weight, weight
                                                       gain, food
                                                       efficiency,
                                                       increased food
                                                       consumption and
                                                       absolute and
                                                       relative (to
                                                       body) liver
                                                       weights and liver
                                                       nuclear
                                                       pleomophism in
                                                       both sexes.
------------------------------------------------------------------------
870.5265                          Gene Mutation with  Fenamidone was non-
                                   parent              mutagenic when
                                                       tested up to or
                                                       cytotoxic levels,
                                                       in presence and
                                                       absence of
                                                       activation, in S.
                                                       typhimurium
                                                       strains TA98,
                                                       TA100, TA102,
                                                       TA1535 and
                                                       TA1537.
------------------------------------------------------------------------
870.5265                          Gene Mutation with  RPA 410193 was non-
                                   RPA 410193          mutatagenic when
                                                       tested up to
                                                       5,000 [mu]g/plate
                                                       or cytotoxic
                                                       levels, in
                                                       presence and
                                                       absence of
                                                       activation, in S.
                                                       typhimurium
                                                       strains Ta98,
                                                       TA100, TA1535,
                                                       and TA1537 and E.
                                                       coli strain
                                                       WP2uvrA.
------------------------------------------------------------------------
870.5265                          Gene Mutation with  RPA 412708 was non-
                                   RPA 412708          mutagenic when
                                                       tested up to
                                                       5,000 [mu]g/plate
                                                       or cytotoxic
                                                       levels, in
                                                       presence and
                                                       absence of
                                                       activation, in S.
                                                       typhimurium
                                                       strains TA98,
                                                       TA100, TA1535,
                                                       and TA1537 and E.
                                                       coli strain
                                                       WP2uvrA.
------------------------------------------------------------------------
870.5265                          Gene Mutation with  RPA 412636 was non-
                                   RPA 412636          mutagenic when
                                                       tested up to
                                                       5,000 [mu]g/plate
                                                       or cytotoxic
                                                       levels, in
                                                       presence and
                                                       absence of
                                                       activation, in S.
                                                       typhimurium
                                                       strains TA98,
                                                       TA100, TA1535,
                                                       and TA1537 and E.
                                                       coli strain
                                                       WP2uvrA.
------------------------------------------------------------------------
870.5300                          Mouse lymphoma      Fenamidone was non-
                                   cell/mammalian      mutagenic at
                                   activation gene     doses up to the
                                   forward mutation    limit of
                                   assay (L5178Y       solubility (1600
                                   hgprt) with         [mu]g/mL) in both
                                   parent              the presence and
                                                       absence of S9
                                                       metabolic
                                                       activation.
------------------------------------------------------------------------
870.5300                          Mouse lymphoma      RPA 412636 was non-
                                   cell/mammalian      mutagenic at
                                   activation gene     doses up to the
                                   forward mutation    limit of
                                   assay (l5178Y       solubility (1600
                                   hgprt) with RPA     [mu]g/mL) in both
                                   412636.             the presence and
                                                       absence of S9
                                                       metabolic
                                                       activation.
------------------------------------------------------------------------
870.5300                          Mouse lymphoma      RPA 410193 was non-
                                   cell/mammalian      mutagenic at
                                   activation gene     doses up to the
                                   forward mutation    limit of
                                   assay (L5178Y       solubility (800
                                   hgprt) with RPA     [mu]g/mL) in both
                                   410193.             the presence and
                                                       absence of S9
                                                       metabolic
                                                       activation.
------------------------------------------------------------------------
870.5375                          In vitro mammalian  There was evidence
                                   cytogenetics        of chromosome
                                   (Chromosomal        aberrations
                                   aberration assay    induce over
                                   in human            background both
                                   peripheral blood)   in the presence
                                   with parent.        and absence of S-
                                                       9 activation.
------------------------------------------------------------------------
870.5395                          In vivo Mouse       Fenamidone was
                                   Micronucleus with   negative for
                                   parent.             chromosomal
                                                       aberrations in
                                                       the cytogenetic
                                                       assay when
                                                       administered
                                                       singly or for 2
                                                       days to CD-1 mice
                                                       up to 2,000 mg/kg/
                                                       day.
------------------------------------------------------------------------
870.5395                          In vivo mouse       RPA 412636 was not
                                   micronucleus with   clastogenic in
                                   RPA 412636          the mouse
                                                       micronucleus test
                                                       up to 350 mg/kg
                                                       (HDT).
------------------------------------------------------------------------
870.5395                          In vivo mouse       RPA 412708 was not
                                   micronucleus with   clastogenic in
                                   RPA 412708          the mouse
                                                       micronucleus
                                                       assay when tested
                                                       once daily for 2
                                                       days up to
                                                       cytotoxic levels
                                                       of 150 mg/kg.
------------------------------------------------------------------------
870.5395                          In vivo mouse       RPA 410193 was not
                                   micronucleus with   clastogenic in
                                   RPA 410193          the mouse
                                                       micronucleus
                                                       assay when tested
                                                       once daily for 2
                                                       days up to
                                                       cytotoxic levels
                                                       of 2,000 mg/kg.
------------------------------------------------------------------------

[[Page 60970]]

 
870.5550                          Unscheduled DNA     Fenamidone did not
                                   synthesis with      produce any
                                   parent              evidence of
                                                       unscheduled DNA
                                                       synthesis, as
                                                       determined by
                                                       radioactive
                                                       tracer procedures
                                                       (nuclear silver
                                                       grain counts), in
                                                       rat primary
                                                       hepatocyte
                                                       cultures exposed
                                                       up to cytotoxic
                                                       levels.
------------------------------------------------------------------------
870.5550                          Unscheduled DNA     Fenamidone did not
                                   synthesis with      produce any
                                   parent              evidence of
                                                       unscheduled DNA
                                                       synthesis, as
                                                       determined by
                                                       radioactive
                                                       tracer procedures
                                                       (nuclear silver
                                                       grain counts), in
                                                       rat primary
                                                       hepatocyte
                                                       cultures exposed
                                                       up to cytotoxic
                                                       levels.
------------------------------------------------------------------------
870.6200                          Acute               NOAEL = 125 mg/kg/
                                   Neurotoxicity-rat   day
                                  Parent compound      LOAEL = 500 mg/kg/
                                   tested.             day based on
                                                       urination,
                                                       staining/soiling
                                                       of the anogenital
                                                       region, mucous in
                                                       the feces, and
                                                       unsteady gait in
                                                       females.
------------------------------------------------------------------------
870.6200                          Subchronic          NOAEL = 73.5/83.4
                                   Neurotoxicity       mg/kg/day in
                                   Screening Battery-  males and
                                   rat                 females,
                                  Parent compound      respectively.
                                   tested.             LOAEL = 392.3/
                                                       414.2 mg/kg/day
                                                       in males and
                                                       females based on
                                                       decreased
                                                       absolute brain
                                                       weight in males,
                                                       and decreased
                                                       body weight,
                                                       weight gains, and
                                                       food consumption
                                                       in both sexes.
------------------------------------------------------------------------
870.7485                          Metabolism and      In a rat
                                   pharmacokinetics -  metabolism with
                                    rat                C14- labeled
                                  Parent compound      fenamidone,
                                   tested.             Sprague-Dawley
                                                       rats receive
                                                       doses of 3 mg/kg
                                                       (single, low
                                                       dose), 3 mg/kg x
                                                       14 days (repeated
                                                       low dose) and 300
                                                       mg/kg (high
                                                       dose). Fenamidone
                                                       was well absorbed
                                                       and rapidly
                                                       excreted,
                                                       primarily in the
                                                       urine and bile,
                                                       at the low dose
                                                       and repeated low
                                                       dose. At 300 mg/
                                                       kg, biliary
                                                       excretion was not
                                                       measured,
                                                       although fecal
                                                       excretion was 50-
                                                       68% of the dose.
                                                       Tissue levels of
                                                       radioactivity
                                                       were primarily
                                                       found in the
                                                       liver at the
                                                       single low dose
                                                       and in the
                                                       thyroid in the
                                                       repeated and high
                                                       dose studies.
                                                       Metabolite
                                                       identification
                                                       included RPA
                                                       408056 (racemic
                                                       form of RPA
                                                       412708) and RPA
                                                       717879 (racemic
                                                       mixture of RPA
                                                       412636)
------------------------------------------------------------------------
870.7600                          Dermal Penetration- Dermal penetration
                                   rat                 approximated 10%
                                  Parent compound      using the
                                   tested.             protocol for 10
                                                       hours of
                                                       exposure.
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for intra 
species variations.
    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 by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, 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 FQPA 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 is expressed as 1 x 10-\6\ or one in a million). 
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 the 
following Table 2:

[[Page 60971]]



      Table 2.--Summary of Toxicological Dose and Endpoints for Fenamidone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF* and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NOAEL = 125 mg/kg        FQPA SF = 1X             Acute Neurotoxicity in
 including infants and children        UF = 300...............  aPAD = acute RfD/FQPA     Rats
                                       Acute RfD = 0.43 mg/kg.   SF.                     LOAEL = 500 mg/kg based
                                                                = 0.43 mg/kg...........   on urination, staining/
                                                                                          soiling of the
                                                                                          anogenital region,
                                                                                          mucous in the feces,
                                                                                          and unsteady gait in
                                                                                          the females.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL= 2.83 mg/kg/day    FQPA SF = 1X             2-Year Chronic Toxicity/
                                       UF = 300...............  cPAD = chr RfD/FQPA SF.   Carcinogenicity in
                                       Chronic RfD = 0.01 mg/   = 0.01 mg/kg/day.......   Rats
                                        kg/day.                                          LOAEL = 7.07 mg/kg/day
                                                                                          based on increase in
                                                                                          severity of diffuse
                                                                                          thyroid C-cell
                                                                                          hyperplasia in both
                                                                                          sexes.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
  observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
  MOE = margin of exposure, LOC = level of concern.
* The reference to the FQPA safety factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. No tolerances have 
previously been established for the residues of fenamidone. 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 one day 
or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 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 Agency notes that there is a degree of 
uncertainty in extrapolating exposures for certain population subgroups 
which may not be sufficiently represented in the consumption surveys 
(i.e, nursing infants). Therefore, risks estimated for these 
subpopulations were included in representative populations having 
sufficient numbers of survey respondents (i.e., all infants or females 
13-50 years old). Thus, the population subgroups listed in Table 3 
include those subgroups having sufficient numbers of survey repondents 
in CSFII food consumption survey. The acute dietary exposure analysis 
assumed tolerance level residues and 100% crop treated (Tier 1 
analysis).
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\ \) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 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 chronic exposure 
assessments: The chronic dietary exposure analysis incorporated average 
residues from the field trial studies and assumed 100% crop treated. 
(Tier 2 analysis) The most highly exposed population subgroup for the 
chronic analysis was children 7-12 years old at 10% cPAD.

               Table 3.--Summary of Results from Acute and Chronic DEEM\TM\ Analyses of Fenamidone
----------------------------------------------------------------------------------------------------------------
                                                           Acute Dietary                  Chronic Dietary
                                                 ---------------------------------------------------------------
               Population Subgroup                 Dietary Exposure                Dietary Exposure
                                                     (mg/kg/day)        %aPAD        (mg/kg/day)        %cPAD
----------------------------------------------------------------------------------------------------------------
U.S. population - total                                    0.016993            4           0.000938            9
----------------------------------------------------------------------------------------------------------------
All Infants (<1 year old)                                       0.0           <1           0.000016           <1
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                   0.016289            4           0.000743            7
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                                  0.018555            4           0.001047           10
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                  0.019273            4           0.001044           10
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                    0.014797            3           0.000805            8
----------------------------------------------------------------------------------------------------------------
Males (20+ years old)                                      0.015994            4           0.000917            9
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old)                                    0.015981            4           0.000902            9
----------------------------------------------------------------------------------------------------------------

    iii. Cancer. Based on the negative carcinogenic potential of 
fenamidone in rats and mice, the Agency has classified fenamidone as 
not likely to be carcinogenic in humans by all relevant routes of 
exposure. Therefore, a cancer dietary analysis is not necessary and has 
not been conducted.
    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

[[Page 60972]]

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/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in groundwater. 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 coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever 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) from these models 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.
    Based on the PRZM/EXAM and SCI-GROW models the estimated 
environmental concentrations (EECs) of fenamidone and its metabolites 
of concern for acute exposures are estimated to be 49.7 parts per 
billion (ppb) for surface water and 45.4 ppb for ground water. The EECs 
for chronic exposures are estimated to be 8.92 ppb for surface water 
and 45.4 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 exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether fenamidone has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1.  In general. FFDCA section 408 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 data base on toxicity and exposure 
unless EPA determines 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.
    2. Prenatal and postnatal sensitivity. The Agency concluded that 
there is no 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 (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, maternal toxicity in the form of decreased 
body weight and food consumption occurred at 1,000 mg/kg/day (limit 
dose). Also at this same dose, developmental toxicity was observed as 
decreased fetal body weight and incomplete fetal ossification. The 
developmental and maternal NOAEL was 150 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 NOAEL was established at 60 ppm (5.45 mg/kg/day) based on 
decreased absolute brain weight in female F1 adults and female F2 
offspring at 1,000 ppm (89.2 mg/kg/day). At 5,000 ppm (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. Other than a developmental neurotoxicity study, 
there is a complete toxicity data base for fenamidone and exposure data 
are complete or are estimated based on data that reasonably accounts 
for potential exposures. The Agency has determined that an additional 
safety factor of 3X is necessary to protect the safety of infants and 
children in assessing fenamidone exposures and risks based on the 
following considerations.
    There is a concern for developmental neurotoxicity resulting from 
exposure to fenamidone due to the clinical signs of neurotoxicity in 
the mutagenicity studies, abnormal gait and other evidence in the acute 
neurotoxicity study in rats, the decreased absolute brain weight in the 
subchronic neurotoxicity study in male rats, and the decreased absolute 
brain weight in the female F1 adults and female F2 offspring in the 2-
generation rat reproduction study. The Agency has determined that an 
uncertainty factor of

[[Page 60973]]

3X (as opposed to a higher value) is sufficiently protective because 
available DNT data demonstrate that a 3-fold factor is generally 
sufficient to address the uncertainty that results from a missing DNT 
study when there are concerns for neurological development (A 
retrospective analysis of twelve development neurotoxicity studies 
submitted by the USEPA, Office of Prevention, Pesticides, and Toxic 
Substances, Presented to the Science Advisory Panel (SAP), December 8-
9, 1998). In addition, fenamidone is not a cholinesterase inhibitor 
and, therefore, the comments made at the June 26-27, 2002 Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) SAP meeting on the 
Determination of the Appropriate FQPA Safety Factor(s) in the 
Organophosphorous Pesticide Cumulative Risk Assessment: Susceptibility 
and Sensitivity to the Common Mechanism, Acetylcholinesterase 
Inhibition should not influence this uncertainty factor decision.
    No Special FQPA Safety Factor is necessary because:
    i. There is no evidence of increased susceptibility of rat or 
rabbit fetuses following in utero exposure in the developmental studies 
with fenamidone, and there is no evidence of increased susceptibility 
of young rats in the reproduction study with fenamidone;
    ii. There are no residual uncertainties identified in the exposure 
databases as the dietary food exposure assessment is conservative, 
since tolerance-level residues and 100% crop treated are assumed; and
    iii. The dietary drinking water exposure is based on conservative 
modeling estimates, and there are no registered or proposed residential 
uses at this time, so these assessments will not underestimate the 
exposure and risks posed by fenamidone.
    Any concern that the additional 3X factor is not sufficiently 
protective is more than offset by the conservative nature of the 
exposure estimate. For the following reasons, the exposure estimate, in 
all likelihood, has overstated potential residue levels by at least a 
factor of 10. Specifically, in regards to the Agency's dietary food 
exposure assessment, the Agency has assumed tolerance level residues 
and 100% crop treated in conducting its acute risk assessment. In 
conducting the chronic dietary food exposure assessment, the Agency has 
assumed average residues based on field trial data and 100% crop 
treated. In July 2001, the U.S. Department of Agriculture issued a 
report entitled ``Agricultural Chemical Usage, Vegetable Summary,'' in 
which the Department determined that no greater than 66 percent of the 
national lettuce crop is treated with any fungicide. Treatment with any 
one fungicide is lower than this figure and, in most cases, 
dramatically so. The assumption of 100% crop treated, therefore, is an 
overestimate and is, therefore, protective. Both the use of tolerance 
level residues and the use of average residues from field trial data 
for use in conducting a chronic dietary risk assessment will lead to 
substantial overstatement of exposure because:
    a. Residue levels decline sharply (by a factor of over 200X) within 
1 week of treatment at the minimum pre-harvest interval;
    b. The average residue calculations assumed consumption of leaf 
wrappers from head lettuce; data submitted in support of the use of 
fenamidone on head lettuce indicate that average residues without 
wrappers, which are typically discarded prior to consumption, are lower 
than the values used in this assessment by a factor of 6X; and
    c. The assessment does not take into account the residue reduction 
associated with washing of lettuce prior to consumption; fenamidone is 
not a systemic fungicide and, therefore, residues are likely to be 
surface residues only and would be reduced through washing.

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 the model estimates of 
a pesticide's concentration in water (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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/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 groundwater 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 will occupy 4% of the aPAD for the U.S. population, 4% of 
the aPAD for females and 13-50 and 4% of the aPAD for children 7-12 
years old. Children are the population with the greatest potential for 
exposure to fenamidone. 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 the following Table 4:

[[Page 60974]]



                      Table 4.--Aggregate Risk Assessment for Acute Exposure to Fenamidone
----------------------------------------------------------------------------------------------------------------
                                                                  Food       Surface       Ground
              Population Subgroup                aPAD (mg/kg/   Exposure    Water EEC    Water EEC   Acute DWLOC
                                                     day)      (mg/kg/day     (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.43        0.017         49.7         45.4       14,000
----------------------------------------------------------------------------------------------------------------
All infants less than 1 year old                        0.43        0.000         49.7         45.4        4,300
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                0.43        0.016         49.7         45.4        4,100
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old)                               0.43        0.019         49.7         45.4        4,100
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                               0.43        0.019         49.7         45.4       12,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenamidone from food will utilize 10 % of the cPAD for the U.S. 
population, <1 % of the cPAD for all infants <1 year old and 10 % of 
the cPAD for children 7-12 years old. There are no residential uses for 
fenamidone. In addition, there is potential for chronic 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 cPAD, as shown in 
the following Table 5:

              Table 5.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Fenamidone
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/      Food      Water EEC    Water EEC     Chronic
                                                     day        Exposure      (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.01       0.0009          8.9         45.4          320
----------------------------------------------------------------------------------------------------------------
All infants less than 1 year old                        0.01      0.00002          8.9         45.4          100
----------------------------------------------------------------------------------------------------------------
Children 7 to 12 years old                              0.01        0.001          8.9         45.4           90
----------------------------------------------------------------------------------------------------------------
Females, 13-50 years old                                0.01        0.001          8.9         45.4          270
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure take 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, short- and intermediate- term risk 
assessments were not performed.
    4. Aggregate cancer risk for U.S. population. Fenamidone is not 
likely to be carcinogenic.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fenamidone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Livestock tolerances for residue of fenamidone are not currently 
necessary; therefore, information pertaining to a livestock enforcement 
method is not relevant to the current petition.
    Fenamidone, RPA 408056, RPA 717979 and RPA 405862 were tested 
through FDA Multiresidue Method of Protocols. Residues of fenamidone 
and all three metabolites were completely recovered using Protocol D. 
Low recoveries of fenamidone were observed from Protocols E (31%) and F 
(54%). Metabolites RPA 408056, RPA 717879, and RPA 405862 were not 
recovered using Protocols E and F. Protocol B was not tested because 
fenamidone and its metabolites are not acids or phenols, and Protocol A 
was not fully tested because the compounds were not found to naturally 
fluoresce. These data have been forwarded to the FDA for further 
evaluation. Adequate method validation, radiovalidation, and 
independent laboratory validation of the petitioner proposed LC/MS/MS 
enforcement method have been received. The proposed enforcement method 
has been forwarded to the ACB for petition method validation. The 
registrant must make any modifications to the proposed enforcement 
methods that the Agency finds necessary during its validation of the 
methods. A successful PMV is necessary before this method can be 
employed as an enforcement method. Upon successful completion of the 
validation, the method will be forwarded to FDA for publication for 
future revision of the Pesticide Analytical Manual, Vol-II (Prior to 
publication and upon request, the method will be available from the 
Analytical Chemistry Branch (ACB), BEAD (75053). Contact Francis D. 
Griffith, telephone (410) 305-2905, e-mail:[email protected]. 
Analytical standards are also available from the EPA National 
Repository at the same location.
    Adequate enforcement methodology (example--gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    CODEX, Canada, and Mexico do not have maximum residue limits (MRLs) 
for residues of fenamidone, in/on head lettuce or leaf lettuce.

V. Conclusion

    Therefore, the tolerance is established for residues of [4H-
Imidazol-4-one, 3,5-

[[Page 60975]]

dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-, (S)-], 
fenamidone, in or on head lettuce at 15 ppm and leaf lettuce at 20 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-2002-0229 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 
26, 2002.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your written request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlinton, VA. 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 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. 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 Unit I.B.2. Mail your 
copies, identified by docket control number OPP-2002-0229, 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. 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. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section

[[Page 60976]]

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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    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 13, 2002.
James Jones,
Acting Director, 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), 346(a) and 374.

    2. Section 180.579 is added to read as follows:


Sec.  180.579  Fenamidone; tolerances for residues.

    (a) General. 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 fungicide fenamidone 
on the following raw agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Lettuce, head........................................             15 ppm
Lettuce, leaf........................................             20 ppm
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 02-24652 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S