[Federal Register Volume 68, Number 127 (Wednesday, July 2, 2003)]
[Rules and Regulations]
[Pages 39462-39471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16736]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0130; FRL-7310-9]


Famoxadone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
famoxadone (3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-
dione) in or on vegetables, fruiting, group 8 (except tomato) at 4.0 
parts per million (ppm), tomato at 1.0 ppm; vegetables cucurbit, group 
9 at 0.30 ppm; lettuce, head at 10.0 ppm; potato at 0.02 ppm; grape at 
2.50 ppm; grape, raisin at 4.0 ppm; fat of cattle, horses, goats, sheep 
at 0.02 ppm; liver of cattle, horses, goats, sheep at 0.05 ppm; and 
milk fat (reflecting negligible residues in whole milk) at 0.060 ppm. 
E.I. Dupont Nemours and Company (Dupont) requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA). These reflect the first 
food tolerances for this fungicide in the United States.

DATES: This regulation is effective July 2, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0130, 
must be received on or before September 2, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dennis M. McNeilly, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-6742; e-mail address: 
[email protected].

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:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0130. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., 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.
    2. Electronic access. 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 at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
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.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of January 10, 2001 (66 FR 1981) (FRL-6760-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide petition (PP 0F6070) for establishing tolerances for 
potatoes at 0.05 ppm, curcurbit vegetable crop group (cucumbers, melon, 
squash) at 0.7 ppm; fruiting vegetable crop group (tomatoes, and 
peppers) at 1.0 ppm; and head lettuce at 15 ppm by Dupont, P.O. Box 
80038, Wilmington, DE 19880-0038. That notice included a summary of the 
petition prepared by Dupont, the registrant. There were no comments 
received in response to the notice of filing.
    In a second Federal Register of August 1, 2001 (66 FR 39762) (FRL-
6789-2), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 7E4847) for establishing a tolerance 
for grapes at 2.0 parts per million by Dupont, P.O. Box 80038, 
Wilmington, DE 19880-0038. That notice included a summary of the 
petition prepared by Dupont, the registrant. The Agency received a 
written comment from the World Wildlife Fund (WWF) dated August 31, 
2001. The Agency's response to this comment can be found at Unit III.B.
    The initial petitions requested that 40 CFR 180.587 be amended by 
establishing tolerances for residues of the fungicide famoxadone (3-
anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione) in or 
on potatoes at 0.05 ppm; cucurbit vegetable crop group at 0.7 ppm; 
fruiting vegetable crop group at 1.0 ppm; head lettuce at 15 ppm; 
grapes at 2.0 ppm; and raisins at 4.0 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) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will

[[Page 39463]]

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 the FFDCA requires EPA 
to give special consideration to exposure of infants and children to 
the pesticide chemical residue in establishing a tolerance and to 
``ensure that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see 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 the 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 the FFDCA, for tolerances for residues of famoxadone on 
vegetables, fruiting, group 8 (except tomato) at 4.0 ppm; tomato at 1.0 
ppm; vegetables, cucurbit, group 9 at 0.30 ppm; lettuce, head at 10.0 
ppm; potato at 0.02 ppm; grape at 2.50 ppm; grape, raisin at 4.0 ppm; 
fat of cattle, horses, goats, sheep at 0.02 ppm; liver of cattle, 
horses, goats, sheep at 0.05 ppm and milk, fat (reflecting negligible 
residues in whole milk) at 0.060 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 famoxadone are 
discussed in Table 1 of this unit 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 toxicity in     NOAEL = Male (M): 3.3 milligrams/kilogram/
                                          rats                        day (mg/kg/day); Female (F): 4.2 mg/kg/
                                                                      day.
                                                                     LOAEL = M: 13.0 mg/kg/day based on mild
                                                                      hemolytic anemia and decreased glucose. F:
                                                                      16.6 mg/kg/day based on decreased body
                                                                      weight gain, food consumption, and food
                                                                      efficiency; mild hemolytic anemia and
                                                                      decreased globulin.
----------------------------------------
870.3100                                 90-Day oral toxicity in     NOAEL = M: 62.4 mg/kg/day; F: 79.7 mg/kg/
                                          mice                        day.
                                                                     LOAEL = M: 534 mg/kg/day based on mild
                                                                      hemolytic anemia with secondary responses
                                                                      in spleen and mild hepatotoxicity in the
                                                                      liver. F: 757 mg/kg/day based on mild
                                                                      hemolytic anemia with secondary responses
                                                                      in spleen and mild hepatotoxicity in the
                                                                      liver.
----------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = M: 1.3 mg/kg/day; F: 1.4 mg/kg/day
                                          nonrodents (dogs)          LOAEL = M: 10.0 mg/kg/day based on lens
                                                                      cataracts in eyes. At 23.8/21.2 mg/kg/day,
                                                                      also myotonic twitches (starting on day
                                                                      21); decreased body weight, body weight
                                                                      gain, food consumption, and food
                                                                      efficiency; slight anemia and
                                                                      hyperkalemia. F: 1.4 mg/kg/day based on
                                                                      lens cataracts in eyes. At 10.1 mg/kg/day,
                                                                      no additional effects. At 23.3/20.1 mg/kg/
                                                                      day, same effects as for males at 23.8/
                                                                      21.2 mg/kg/day.
----------------------------------------
870.3200                                 28-Day dermal toxicity in   NOAEL = M: 250 mg/kg/day; F: 1,000 mg/kg/
                                          rats                        day
                                                                     LOAEL = M: 500 mg/kg/day based on increased
                                                                      alkaline phosphatase, alanine
                                                                      aminotransferase and sorbitol
                                                                      dehydrogenase; and mild hepatotoxicity in
                                                                      the liver. F: none (>1,000 mg/kg/day). No
                                                                      dermal irritation in M or F.
----------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 250 mg/kg/day
                                          rats                       LOAEL = 500 mg/kg/day based on transient
                                                                      decreased body weight gain and food
                                                                      consumption.
                                                                     Developmental NOAEL = 1,000 mg/kg/day
                                                                     LOAEL = none (>1,000 mg/kg/day
----------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 350 mg/kg/day
                                          nonrodents (rabbits)       LOAEL = 1,000 mg/kg/day based on abortions;
                                                                      decreased body weight, body weight gain,
                                                                      and food consumption; and abnormal stools.
                                                                     Developmental NOAEL = 350 mg/kg/day
                                                                     LOAEL = 1,000 mg/kg/day based on abortions
                                                                      and equivocal increases in
                                                                      postimplantation loss and mean resorptions
                                                                      per dose.
----------------------------------------

[[Page 39464]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = M/F: 11.3/14.2 mg/
                                          effects (rats)              kg/day
                                                                     LOAEL = M/F: 44.7/53.3 mg/kg/day based on
                                                                      decreased body weight, body weight gain,
                                                                      and food consumption; and hepatotoxicity
                                                                      in the liver.
                                                                     Reproductive NOAEL = M/F: 44.7/53.3 mg/kg/
                                                                      day
                                                                     LOAEL = M/F: none (>44.7/53.3 mg/kg/day
                                                                     Offspring NOAEL = M/F: 11.3/14.2 mg/kg/day
                                                                     LOAEL = M/F: 44.7/53.3 mg/kg/day based on
                                                                      decreased body weights for F1 and F2 pups
                                                                      throughout lactation.
----------------------------------------
870.4100                                 Chronic toxicity in dogs    NOAEL = M: 1.2 mg/kg/day. F: 1.2 mg/kg/day.
                                                                     LOAEL = M: 8.8 mg/kg/day based on lens
                                                                      cataracts in eyes. F: 9.3 mg/kg/day based
                                                                      on lens cataracts in eyes. No other
                                                                      adverse effects were observed in M or F.
----------------------------------------
870.4100                                 Chronic toxicity in         NOAEL = M: 100 mg/kg/day. F: 100 mg/kg/day.
                                          Cynomolgus monkeys         LOAEL = M: 1,000 mg/kg/day based on mild
                                                                      hemolytic anemia with secondary responses
                                                                      in spleen, liver and kidney; and sinus
                                                                      dilatation in spleen. F: 1,000 mg/kg/day
                                                                      based on mild hemolytic anemia with
                                                                      secondary responses in spleen, liver and
                                                                      kidney; and sinus dilatation in spleen.No
                                                                      evidence of lens cataracts in eyes of M or
                                                                      F.
----------------------------------------
870.4200                                 Carcino-genicity in mice    NOAEL = M: 96 mg/kg/day. F: 130 mg/kg/day.
                                                                     LOAEL = M: 274 mg/kg/day based on slight
                                                                      hepatotoxicity in the liver; no anemia. F:
                                                                      392 mg/kg/day based on amyloidosis and
                                                                      slight hepatotoxicity in the liver; no
                                                                      anemia.
                                                                     No evidence of carcinogenicity in M or F.
----------------------------------------
870.4300                                 Combined chronic toxicity/  NOAEL = M: 8.4 mg/kg/day. F: 2.2 mg/kg/day
                                          carcinogenicity in rats    LOAEL = M: 16.8 mg/kg/day based on slight
                                                                      hemolytic anemia with compensatory
                                                                      erythropoiesis and secondary responses in
                                                                      spleen and bone marrow; and mild
                                                                      hepatotoxicity in the liver. F: 10.7 mg/kg/
                                                                      day based on decreased body weight gain
                                                                      and slight hemolytic anemia. At 23.0 mg/kg/
                                                                      day, also secondary responses to anemia in
                                                                      spleen, bone marrow and/or liver; and mild
                                                                      hepatotoxicity in the liver.
                                                                     No evidence of carcinogenicity M or F.
----------------------------------------
870.5100                                 Reverse gene mutation       Negative without and with S-9 activation up
                                                                      to limit dose of 5,000 [mu]gram(g)/plate.
----------------------------------------
870.5300                                 Forward gene mutation       Negative without and with S-9 activation up
                                         (In Vitro Mammalian Cell     to the limit of solubility (in DMSO) of 30
                                          Gene Mutation Test).        [mu]g/mL.
----------------------------------------
870.5300                                 Forward gene mutation       Negative without and with S-9 activation up
                                         (CHO/HGPRT locus).........   to cytotoxic concentrations (>= 200 [mu]g/
                                                                      mL without S-9 and >= 150 [mu]g/mL with S-
                                                                      9).
----------------------------------------
870.5375                                 Chromosome aberration       Positive (weak clastogenic effect) without
                                          (human lymphocytes)         S-9 activation. Statistically significant
                                                                      increases in percentage of aberrant cells
                                                                      at several dose levels ranging from 5-15
                                                                      [mu]g/mL. Cytotoxicity was observed at 10-
                                                                      18 [mu]g/mL. Negative with S-9 activation.
----------------------------------------
870.5375                                 Chromosome aberration       Positive (weak clastogenic effect) without
                                          (human lymphocytes)         S-9 activation. Statistically significant
                                                                      increases in percentage of aberrant cells
                                                                      at several dose levels ranging from 15-30
                                                                      [mu]g/mL. Cytotoxicity was observed at 20-
                                                                      30 [mu]g/mL. Negative with S-9 activation.
----------------------------------------
870.5395                                 Micronucleus assay          Negative at single-oral doses of up to
                                         (mouse bone marrow).......   limit dose of 5,000 mg/kg.
----------------------------------------
870.5550                                 Unscheduled DNA synthesis   Positive response (increased net nuclear
                                         (rat hepatocytes).........   grain counts) observed at several
                                                                      treatment levels ranging from 0.05-10
                                                                      [mu]g/mL. Cytotoxicity was observed at 10
                                                                      [mu]g/mL.
----------------------------------------
870.5550                                 Unscheduled DNA synthesis   Negative at treatment levels up to 10 [mu]g/
                                          (rat hepatocytes)           mL. Cytotoxicity was observed at 10 [mu]g/
                                                                      mL.
----------------------------------------
870.5550                                 Unscheduled DNA synthesis   Negative at treatment levels up to 5.0
                                          (prim. rat hepatocytes)     [mu]g/mL. Cytotoxicity was observed at 2.5
                                                                      and 5.0 [mu]g/mL.
----------------------------------------
870.5550                                 Unscheduled DNA synthesis   Negative at single-oral doses of up to
                                          (hepatocytes derived from   2,000 mg/kg. No marked increases in net
                                          male rats given             nuclear grain counts or percentage of
                                          Famoxadone)                 cells in repair in hepatocyte cultures.
----------------------------------------

[[Page 39465]]

 
870.6200                                 Acute neurotoxicity         NOAEL = M: 1,000 mg/kg F: 2,000 mg/kg.
                                          screening battery (rats)   LOAEL = M: 2,000 mg/kg based on decreased
                                                                      body weight gain and food consumption (on
                                                                      days 1-2); and palpebral (eyelid) closure
                                                                      (on day 1 only). F: none (>2,000 mg/kg).
----------------------------------------
870.6200                                 Subchronic neurotoxicity    NOAEL = M: 11.7 mg/kg/day F: 14.4 mg/kg/
                                          screening battery (rats)    day.
                                                                     LOAEL = M: 47 mg/kg/day based on decreased
                                                                      body weight, body weight gain, food
                                                                      consumption and food efficiency. F:59 mg/
                                                                      kg/day based on decreased body weight,
                                                                      body weight gain, food consumption and
                                                                      food efficiency. No evidence of
                                                                      neurotoxicity in M or F.
----------------------------------------
870.7800                                 Immunotoxicity study, rats  NOAEL = M: 14 mg/kg/day. F: 16 mg/kg/day.
                                          (28-days)                  LOAEL = M: 55 mg/kg/day based on decreased
                                                                      body weight, body weight gain, food
                                                                      consumption, and food efficiency; and
                                                                      increased spleen weights (probably due to
                                                                      increased pigment in spleen). F: 57 mg/kg/
                                                                      day based on decreased body weight, body
                                                                      weight gain, food consumption, and food
                                                                      efficiency; and increased spleen weights
                                                                      (probably due to increased pigment in
                                                                      spleen). No evidence of immunotoxicity in
                                                                      M or F.
----------------------------------------
870.7800                                 Immunotoxicity study,mice   NOAEL = M: 1186 mg/kg/day. F: 417 mg/kg/
                                          (28-days)                   day.
                                                                     LOAEL = M: none (>1,186 mg/kg/day). F:
                                                                      1,664 mg/kg/day based on increased spleen
                                                                      weights (probably due to increased pigment
                                                                      in spleen). No evidence of immunotoxicity
                                                                      in M or F.
----------------------------------------
870.7485                                 Metabolism and              Only about 40% of the administered dose was
                                          pharmacokinetics, rats      absorbed. Most of the administered dose
                                                                      (87-6%) was eliminated in the feces within
                                                                      24 hours; very little (3-12%) was
                                                                      eliminated in the urine. Unchanged parent
                                                                      (51-84% of administered dose) and 2
                                                                      hydroxylated metabolites (IN-KZ534 and IN-
                                                                      KZ007) were the major components recovered
                                                                      in the feces. No significant qualitative
                                                                      or quantitative differences were observed
                                                                      for sex, dose level, or repeated dosing.
----------------------------------------
870.7485                                 Metabolism and              Absorption was limited. Most of the
                                          pharmacokinetics, dogs      administered dose (62%) was eliminated in
                                          (males only)                the feces within 24 hours; very little
                                                                      (about 8%)was eliminated in the urine.
                                                                      Initially, unchanged parent (94-97% of
                                                                      radioactivity in feces) was recovered in
                                                                      the feces, but later (>24 hrs) unchanged
                                                                      parent (12-35% of radioactivity in feces),
                                                                      IN-KZ007 (21-3% of radioactivity in feces)
                                                                      and IN-ML815 (4-9% of radioactivity in
                                                                      feces) were recovered. Even later (>48
                                                                      hrs), trace amounts of the hydroxylated
                                                                      metabolites IN-KZ532 and IN-KZ534 were
                                                                      also identified in the feces.
----------------------------------------------------------------------------------------------------------------

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. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    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 factors 
(SF) 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 SF.
    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 famoxadone used for human risk assessment is shown in 
Table 2 of this unit:

[[Page 39466]]



      Table 2.--Summary of Toxicological Dose and Endpoints for Famoxadone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          Not applicable           Not applicable           No appropriate endpoint
(Females 13-50 years of age).........                                                     attributable to a
                                                                                          single-oral dose was
                                                                                          identified in the
                                                                                          available toxicology
                                                                                          studies on famoxadone.
--------------------------------------
Acute Dietary                          Not applicable           Not applicable           No appropriate endpoint
(General population including infants                                                     attributable to a
 and children).                                                                           single-oral dose was
                                                                                          identified in the
                                                                                          available toxicology
                                                                                          studies on famoxadone.
--------------------------------------
Chronic Dietary                        LOAEL= 1.4 mg/kg/day     FQPA SF = 1              13-Week feeding study
(All populations)....................  UF = 1,000\a\..........  cPAD = chronic RfD/FQPA   in dogs.\b\
                                       Chronic RfD = 0.0014 mg/  SF.                     LOAEL = 1.4 mg/kg/day
                                        kg/day.                 Chronic PAD = 0.0014 mg/  based on microscopic
                                                                 kg/day.                  lens lesions
                                                                                          (cataracts) in eyes of
                                                                                          female dogs.
--------------------------------------
Cancer                                 Not applicable           Not applicable           Classification: Not
(Oral, dermal, and inhalation).......                                                     Likely to be
                                                                                          carcinogenic to
                                                                                          humans.
----------------------------------------------------------------------------------------------------------------
 * The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
 \a\ The UF of 1,000 includes the conventional 100 and an additional 10 for the use of the LOAEL and dose from a
  subchronic (13-week) study for chronic risk assessment.
 \b\ Regarding the chronic RfD for famoxadone, a 1-year chronic feeding study in dogs is available, but was
  determined to not be an appropriate study for use in chronic risk assessment at this time. Although the
  testing laboratory reported a NOAEL of 1.2 mg/kg/day for treatment-related lens lesions (cataracts) in the
  eyes of the male and female dogs, a subsequent evaluation by a consulting pathologist of the microscopic
  sections of the eyes from all dogs in this study strongly suggested that a serious fixation artifact affected
  all the eye sections such that only prominent cataracts were detectable and as a consequence, a NOAEL could
  not be reliably determined with any degree of confidence. Considering this second evaluation, the Agency
  concluded that this fixation artifact may have had a profound effect on the interpretation of the
  histopathological findings in the eyes of all dogs in this study. In view of the considerable uncertainty
  relating to the microscopic findings in the eyes of all dogs in this study and the resulting uncertainty with
  regard to determining a NOAEL for eye effects, the Agency decided to not use the results from this 1-year
  study for the purpose of determining a chronic RfD for famoxadone at this time. Based on a consideration of
  findings in the eyes of dogs in both the 13-week and 1-year feeding studies, it was determined that the lowest
  dose at which evidence of cataracts was actually observed was in the female dogs in the 13-week study at the
  lowest dose tested of 1.4 mg/kg/day (the LOAEL). This 13-week study, rather than the 1-year study, was
  selected to be the most appropriate study for chronic risk assessment at this time. Since a LOAEL, rather than
  a NOAEL, and a subchronic study, rather than a chronic study, were used to determine the chronic RfD, an
  additional 10x UF was added to the conventional UF of 100x. The chronic RfD (LOAEL of 1.4 mg/kg/day/UF of
  1,000) for famoxadone was determined to be 0.0014 mg/kg/day.

    The comment received from WWF concerned a toxicity issue in 
particular: The potential for famoxadone to be an endocrine disruptor. 
WWF quoted the notice of filing which was written by Dupont. ``Chronic, 
lifespan and multi-generational bioassays in mammals and acute and 
subchronic studies on aquatic organisms and wildlife did not reveal 
endocrine effects. Any endocrine related effects would have to have 
been detected in this definitive array of required tests. The 
probability of any such effects due to agricultural uses of famoxadone 
is negligible.'' WWF stated that pursuant to FQPA, the Agency is 
establishing a new endocrine disruptor screening and testing program 
because existing toxicology protocols are not adequate to detect 
endocrine disruption. Therefore, Dupont's evaluation of the endocrine 
disruptor potential is incomplete and consequently misleading. WWF also 
urges the Agency to consider not only evidence of 
increasedsusceptibility, but also the significance of endocrine 
disruptor data gaps when determining the FQPA SF for famoxadone.
    In response to the WWF the Agency notes that FQPA requires EPA to 
develop a screening program to determine whether certain substances 
(including all pesticide active and other ingredients) may have an 
effect in humans that is similar to an effect produced by a naturally 
occurring estrogen, or such other endocrine effect... EPA has been 
working with interested stakeholders to develop a screening and testing 
program as well as a priority-setting scheme. In the available toxicity 
studies on famoxadone, no evidence of endocrine-related effects was 
observed. However, famoxadone may be subjected to further screening 
and/or testing to better characterize potential effects related to 
endocrine disruption when additional appropriate screening and/or 
testing protocols have been developed by the Agency's Endocrine 
Disruptor and Testing Advisory Committee (EDSTAC).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances are being 
established for (40 CFR 180.587) for the residues of famoxadone, in or 
on a variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from famoxadone 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. No toxicological endpoint attributable to a single-
oral dose was identified in the available toxicology studies on 
famoxadone that would be applicable to females (13-50 years) or to the 
general population (including infants and children). Therefore, 
famoxadone is not expected to pose an acute dietary risk.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1994-1996 and 1998-nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: Anticipated residues based upon average field 
trial values and assumptions that 100% of each crop is treated with 
famoxadone.
    iii. Cancer. The Agency has classified famoxadone as not likely to 
be

[[Page 39467]]

carcinogenic to humans. As such, famoxadone is not expected to pose a 
cancer dietary risk.
    iv. Anticipated residue and percent crop treated (PCT) information.
    Section 408(b)(2)(E) of the 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. No PCT information was used in the risk 
assessment. The Agency used 100% which would over estimate exposure.
    2. Dietary exposure from drinking water.
    The Agency lacks monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
famoxadone in drinking water because this is a new chemical. 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 famoxadone.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) 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 FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 
model) for a screening-level assessment for surface water. The FIRST 
model is a subset or meta-model of the PRZM/EXAMS model that uses 
specific high-end runoff scenario for pesticides. FIRST incorporates an 
index reservoir environment and a percent crop area (PCA), while PRZM/
EXAMS incorporate an index reservoir environment, PCA, all available 
information on the pesticide's fate and use pattern, and site-specific 
cropping information.
    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 
highly 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) 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 famoxadone they are further 
discussed in the aggregate risk sections in Unit E.
    Based on the PRZM/EXAMS and SCI-GROW models the EECs of famoxadone 
for chronic exposures are estimated to be 0.47 parts per billion (ppb) 
for surface water and 0.23 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).
    Famoxadone 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) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether famoxadone 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, 
famoxadone 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 famoxadone 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. Section 408 of the 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 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 not a concern for pre- and/or postnatal toxicity resulting 
from exposure to famoxadone.
    No quantitative or qualitative evidence of increased 
susceptibility, as compared to adults, of rat or rabbit fetuses to in 
utero exposure to famoxadone was observed in the developmental toxicity 
studies. No quantitative or qualitative evidence of increased 
susceptibility, as compared to adults, of rat fetuses or neonates was 
observed in the 2-generation reproduction study.
    In the rat developmental toxicity study, the NOAEL for maternal 
toxicity was 250 mg/kg/day and the LOAEL was 500 mg/kg/day, based on 
transient decreases in body weight gain and food consumption. At 1,000 
mg/kg/day, no additional treatment-related effects were observed in the 
dams. No developmental toxicity was observed in the rat study. The 
NOAEL for developmental toxicity was 1,000 mg/kg/day, the highest dose 
tested.
    In the rabbit developmental toxicity study, the maternal and 
developmental NOAELs and LOAELs were the same. The NOAEL for maternal 
toxicity and developmental toxicity was 350 mg/kg/day. The LOAEL for 
maternal toxicity was 1,000 mg/kg/day, based on abortions in 4 out of 
17 does; markedly decreased body weight, reduced body weight gain and 
reduced food consumption in the same 4 does, and increased number of 
does with abnormal or little or no stools. The LOAEL for developmental 
toxicity was 1,000 mg/kg/day; based on abortions in 4 out of 17 does; 
and equivocal increases in percent post implantation loss and mean 
number of resorptions

[[Page 39468]]

per doe. In the rabbit study, maternal toxicity (does) and 
developmental toxicity (fetuses) are considered to be equally sensitive 
to the test material. Therefore, based on the results in these two 
developmental toxicity studies in rats and rabbits, no increased 
susceptibility of the fetuses (as compared to adults) was demonstrated 
for famoxadone.
    In the 2-generation reproduction study in rats, the NOAEL for 
parental toxicity was 200 ppm (equal to 11.3/14.2 mg/kg/day, M/F) and 
the LOAEL was 800 ppm (44.7/53.3 mg/kg/day, M/F), based on decreased 
body weight, body weight gain, and food consumption; and heptotoxicity 
in the liver. Also, at 800 ppm, adaptive hepatocellular responses 
indicating enzyme induction were observed. No reproductive toxicity was 
observed in this study. The NOAEL for reproductive toxicity was 800 ppm 
(44.7/53.3 mg/kg/day, M/F), the highest dose tested. In this same 
study, the NOAEL for offspring toxicity was 200 ppm (equal to 11.3/14.2 
mg/kg/day, M/F) and the LOAEL was 800 ppm (44.7/53.3 mg/kg/day, based 
on decreased body weights for F1 and F2 pups 
throughout their respective lactation periods.
    3. Neurotoxicity. The Agency concluded that there is not a concern 
for developmental neurotoxicity resulting from exposure to famoxadone 
and that a developmental neurotoxicity study is not required.
    Although clinical signs of neurotoxicity were observed in dogs in 
the 13-week study at the highest dose tested (>20 mg/kg/day), this 
effect was not observed at lower doses of about 10 mg/kg/day in the 
same 13-week study or in a subsequently performed 1-year feeding study 
in dogs. Also, toxicologically significant signs of neurotoxicity were 
not observed in any of the other studies on famoxadone in any species 
(including rats, mice, or monkeys) at any time. In addition, pre- and 
postnatal studies in rats and rabbits demonstrated no increased 
susceptibility of fetuses or neonates to famoxadone as compared to 
adults. Toxicologically significant neurotoxic effects would not be 
expected to occur in an additional study in rats. The clinical signs of 
neurotoxicity (muscle twitches) observed only in dogs, only in males, 
and only at the highest dose tested, would not be anticipated to occur 
in a developmental neurotoxicity study in rats.
    4. Conclusion. The Agency concluded that the toxicology database 
was complete for FQPA purposes and that there are no residential 
uncertainties for pre-/postnatal toxicity. Based on the hazard data, 
the Agency recommended the special FQPA SF be reduced to 1x. The 
famoxadone risk assessment team evaluated the quality of the exposure 
data; and, based on these data, recommended that the special FQPA SF be 
reduced to 1x. The recommendation is based on the following:
    i. There is no quantitative or qualitative evidence of increased 
susceptibility of rat and rabbit fetuses to in utero exposure in 
developmental studies. There is no quantitative or qualitative evidence 
of increased susceptibility of rat offspring in the multi-generation 
reproduction study.
    ii. The chronic dietary food exposure assessment utilizes average 
field trial residue data and for all proposed uses, 100% crop treated 
is assumed. The chronic assessment is somewhat refined and based on 
reliable data derived from studies designed to produce worst-case 
residues and unlikely to underestimate exposure.

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. 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: 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 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. No appropriate endpoint attributable to a single-
oral dose was identified in the available toxicology studies on 
famoxadone. Therefore, no acute risk from famoxadone is not expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
famoxadone from food will utilize 36% of the cPAD for the U.S. 
population, 76% of the cPAD for Children ages 1-2 and 68% of the cPAD 
for Children ages 3-5. Children ages 1-2 are expected to be the most 
highly exposed subpopulation to famoxadone. There are no residential 
uses for famoxadone. In addition, there is potential for chronic 
dietary exposure to famoxadone 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 Table 3 of this unit:

                                   Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Famoxadone
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Surface Water EEC       Ground Water EEC
        Population Subgroup              cPAD mg/kg/day           % cPAD (Food)              (ppb)                  (ppb)           Chronic DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population                      0.0014                  36%                     0.47                   0.23                   31
------------------------------------

[[Page 39469]]

 
Children 1-2 years old               0.0014                  76%                     0.47                   0.23                   3.4
------------------------------------
Children 3-5 years old               0.0014                  68%                     0.47                   0.23                   4.5
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background-exposure level). Famoxadone 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 aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background-exposure level). Famoxadone 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. Famoxadone is 
classified as ``not likely to be carcinogenic to humans.'' As such, no 
cancer risk is expected.
    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, including infants and children, from 
aggregate exposure to famoxadone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Famoxadone was screened through multi-residue methods listed in the 
Pesticide Analytical Manual Volume I (PAM Vol. I), Third Edition 
(January 1994), using Protocols C to E. Protocols A and B were not used 
because famoxadone does not have an n-methyl carbamate structure 
(Protocol A), nor is it an acid or phenol (Protocol B). Protocol C 
showed good analytical response using the electron-capture detector 
(ECD) and nitrogen-phosphorus detector (NPD). Good recoveries were 
obtained for the analysis of wine, grapes, and tomatoes (92-138%) using 
Protocol D. Food commodities can be analyzed for famoxadone residues 
using the appropriate extraction method with the mixed ether elution 
system, resulting in recovery values of 92 to 108%.
    The multi-residue methods testing appears to be scientifically 
acceptable and has been sent to the FDA for further evaluation. 
Preliminary analysis suggests that Protocol D may be appropriate for 
analysis of famoxadone in plant matrices and has the potential to be 
the primary enforcement method.
    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: [email protected].

B. International Residue Limits

    No CODEX maximum residue limits currently exist for famoxadone: 
Maximum Residue Levels (MRLs) have been established for potatoes in the 
Netherlands at 0.02 ppm and for grapes in Germany at 2.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of famoxadone 
(3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione) in 
or on vegetables, fruiting, group 8 (except tomato) at 4.0 ppm; tomato 
at 1 ppm; vegetables cucurbit, group 9 at 0.30 ppm; lettuce, head at 
10.0 ppm; potato at 0.02 ppm grape at 2.50 ppm (import only); raisin at 
4.0 ppm (import only); fat of cattle, horses, goats, sheep at 0.02 ppm; 
liver of cattle, horses, goats, sheep at 0.05 ppm; and milk, fat 
(reflecting negligible residues in whole milk) at 0.060 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the 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 the 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-2003-0130 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 September 
2, 2003.
    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 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The

[[Page 39470]]

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-
0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by docket ID number OPP-2003-0130, 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 Unit I.B.1. 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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the 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 the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

[[Page 39471]]

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: June 20, 2003.
Jim Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Section 180.587 is added to read as follows:


Sec.  180.587  Famoxadone.

    (a) General. Tolerances are established for residues of the 
fungicide famoxadone (3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-
oxazolidine-2,4-dione) in or on the following commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat....................................                     0.02
Cattle, liver..................................                     0.05
Goat, fat......................................                     0.02
Goat, liver....................................                     0.05
Grape\1\.......................................                     2.50
Grape, raisin\1\...............................                      4.0
Horse, fat.....................................                     0.02
Horse, liver...................................                     0.05
Lettuce, head..................................                     10.0
Milk, fat (reflecting negligible residues in                        0.06
 whole milk)...................................
Potato.........................................                     0.02
Sheep, fat.....................................                     0.02
Sheep, liver...................................                     0.05
Tomato.........................................                      1.0
Vegetable, cucurbits, group 9..................                     0.30
Vegetable, fruiting, group 8 except tomato.....                      4.0
------------------------------------------------------------------------
 \1\ There are no U.S. registrations as of May 15, 2003.

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

[FR Doc. 03-16736 Filed 7-1-03; 8:45 am]
BILLING CODE 6560-50-S