[Federal Register Volume 67, Number 188 (Friday, September 27, 2002)]
[Rules and Regulations]
[Pages 60916-60923]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24485]



[[Page 60916]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0221; FRL-7199-2]


Dimethomorph; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
dimethomorph in or on hop, dried cones at 60 parts per million (ppm); 
lettuce, leaf and lettuce, head at 10 ppm; vegetable, cucurbit, group 
at 0.5 ppm; and vegetable, bulb, group at 2.0 ppm. The Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996.

DATES: This regulation is effective September 27, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0221, 
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 ID number OPP-2002-0221 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 308-9368; 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 Potentially
             Categories                 NAICS       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 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 ID number OPP-2002-0221. 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 August 21, 2002 (67 FR 54192) (FRL-7191-
1), 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 pesticide petitions (PP 0E6178, 2E6386, 2E6410, 2E6432) 
by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390. This 
notice included a summary of the petitions prepared by BASF 
Corporation, Research Triangle Park, NC., the registrant. There were no 
comments received in response to the notice of filing.
    The petitions requested that 40 CFR 180.493 be amended by 
establishing tolerances for residues of the fungicide dimethomorph, 
[[(E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-
propenyl]morpholine]], in or on the following food commodities:
    1. PP 0E6178 proposed a tolerance for hop, dried cones at 60 ppm. 
This tolerance replaces the existing tolerance for hops, cones, dried 
at 60 ppm. There were no U.S. registrations for use of dimethomorph on 
hops when the existing tolerance was established. IR-4 provided 
magnitude of residue studies and has requested a new tolerance for hop, 
dried cones at 60 ppm in support of U.S. registration for hops.
    2. PP 2E6386 proposed a tolerance for lettuce, leaf and lettuce, 
head at 10 ppm.
    3. PP 2E6410 proposed a tolerance for vegetable, cucurbit, group at 
0.5 ppm.
    4. PP 2E6432 proposed a tolerance for vegetable, bulb, group at 2.0 
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) 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

[[Page 60917]]

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 dimethomorph on hop, dried 
cones at 60 ppm; lettuce, leaf and lettuce, head at 10 ppm; vegetable, 
cucurbit, group at 0.5 ppm; and vegetable, bulb, group at 2.0 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by dimethomorph 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 toxicity        NOAEL = 73 milligrams/kilogram/day (mg/kg/
                                          rodents                     day) for males, and 82 mg/kg/day for
                                                                      females. A LOAEL was not established,
                                                                      because the highest dose tested produced
                                                                      no biologically significant effect.
----------------------------------------------------------------------------------------------------------------
870.3150                                 90-Day oral toxicity in     NOAEL = 15 mg/kg/day
                                          nonrodents                 LOAEL = 43 mg/kg/day based on a decrease in
                                                                      the absolute and relative weights of the
                                                                      prostate and possible threshold liver
                                                                      effects (increased alkaline phosphatase
                                                                      activity at weeks 6 and 13).
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 60 mg/kg/dayLOAEL = 160 mg/
                                          rodents                     kg/day based on based on decreased mean
                                                                      body weight on gestation days 10-15;
                                                                      decreased body weight gain on gestation
                                                                      days 10-15, decreased food consumption
                                                                      days 6-15 .Developmental NOAEL = 60 mg/kg/
                                                                      dayLOAEL = 160 mg/kg/day based on
                                                                      increased resorptions.
----------------------------------------------------------------------------------------------------------------
870.3700                                 Prenatal developmental in   Maternal NOAEL = 300 mg/kg/day
                                          nonrodents                 LOAEL = 650 mg/kg/day based on decreased
                                                                      body weights and body weight gain.
                                                                     Developmental NOAEL = 650 mg/kg/day. No
                                                                      developmental toxicity was observed in
                                                                      this study.
----------------------------------------------------------------------------------------------------------------
870.3800                                 Reproduction and fertility  Parental/Systemic NOAEL = 20.8 mg/kg/day in
                                          effects                     males and 24 mg/kg/day in females.
                                                                     LOAEL = 69 mg/kg/day for males and 79.3 mg/
                                                                      kg/day for females based on decreased body
                                                                      weights and body weight gain.
                                                                     Reproductive NOAEL = 69 mg/kg/day for males
                                                                      and 79.3 mg/kg/day for females (highest
                                                                      dose tested).
                                                                     Offspring NOAEL = 20.8 mg/kg/day for males
                                                                      and 24 mg/kg/day for females.
                                                                     LOAEL = 69 mg/kg/day for males and 79.3 mg/
                                                                      kg/day for females based on delayed
                                                                      incisor eruption at day 10 postpartum.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity rodents    NOAEL = 11.9 mg/kg/day for females and 36.2
                                                                      mg/kg/day for males.LOAEL = 57.7 mg/kg/day
                                                                      for female rats based on decreased body
                                                                      weight and a significant increase in the
                                                                      incidence of ground glass foci in the
                                                                      liver, and 99.9 mg/kg/day for male rats
                                                                      based on decreased body weight and
                                                                      increased incidence of arteritis.
----------------------------------------------------------------------------------------------------------------
870.4100                                 Chronic toxicity dogs       NOAEL = 14.7 mg/kg/day for males and 15.7
                                                                      mg/kg/day for females. LOAEL = 44 mg/kg/
                                                                      day for males and 47 mg/kg/day for females
                                                                      based on based on decreased prostate
                                                                      weight in males.
----------------------------------------------------------------------------------------------------------------
870.4200                                 Carcinogenicity rats        NOAEL = 33.9 mg/kg/day for males and 11.4
                                                                      mg/kg/day for females.
                                                                     LOAEL = 94.6 mg/kg/day for males and 46.3
                                                                      mg/kg/day for females based on decreased
                                                                      body weight gain.The test material had no
                                                                      significant effect on the development of
                                                                      neoplasms in male or female rats at the
                                                                      doses tested. Dimethomorph was tested at
                                                                      adequate doses based on significant
                                                                      decreases in body weight (17% and 13%) and
                                                                      body weight gains (27% and 14%) in females
                                                                      and males, respectively, in the high dose
                                                                      groups.
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        There were no treatment-related increases
                                                                      in the incidence of any neoplastic
                                                                      lesions. The chemical was adequately
                                                                      tested based on decreased body weight gain
                                                                      at 1,000 mg/kg/day. The NOAEL for systemic
                                                                      toxicity is 100 mg/kg/day.

[[Page 60918]]

 
                                         Gene Mutation/Cytogenetics/ Dimethomorph did not cause gene mutations
                                          Other Effects               in Salmonella or E. coli bacterial
                                                                      strains, as well as in mammalian gene
                                                                      mutation studies. It was negative for
                                                                      structural chromosomal aberrations in the
                                                                      mouse micronucleus assay at up to 5,000 mg/
                                                                      kg after oral treatment, and up to 200 mg/
                                                                      kg when administered intraperitoneally.
                                                                      However, dimethomorph gave positive
                                                                      responses when tested in Chinese hamster
                                                                      lung at high doses. Dimethomorph was
                                                                      weakly positive when tested in human
                                                                      lymphocytes when treated up to the highly
                                                                      toxic dose of 422 micrograms/milliliter,
                                                                      but was negative in the absence of
                                                                      activation at all doses. Dimethomorph was
                                                                      negative in the cell transformation assay
                                                                      in Syrian hamster embryo cells with and
                                                                      without activation at up to cytotoxic
                                                                      levels.
----------------------------------------------------------------------------------------------------------------
870.7485                                 Metabolism and              Oral administration of dimethomorph results
                                          pharmacokinetics            in rapid excretion into the urine and
                                                                      feces of rats. For all treatment
                                                                      protocols, most (80-90%) of the radiolabel
                                                                      administered was excreted in the feces. A
                                                                      considerably smaller amount (6-16%) was
                                                                      excreted in the urine and only minimal
                                                                      levels (0.1-0.4%) were detected in the
                                                                      organs and tissues. Rapid absorption may
                                                                      be inferred by the rapid excretion of
                                                                      metabolites in the urine and bile.
                                                                      Retention of dimethomorph or \14\ C-
                                                                      dimethomorph-derived radioactivity was
                                                                      generally <=1% for most tissues although
                                                                      the liver exhibited slightly higher levels
                                                                      (1.4%). Urinary metabolites resulted from
                                                                      demethylation of the dimethoxyphenyl ring
                                                                      and oxidation of the morpholine ring.
                                                                      Biliary excretion exhibited first-order
                                                                      kinetics with a low-dose (10 mg/kg) half-
                                                                      life of approximately 3 hours and a high-
                                                                      dose (500 mg/kg) half-life of 11 hours for
                                                                      males and about 6 hours for females.
                                                                      Biliary metabolites accounted for most of
                                                                      the fecal excretion following low-dose
                                                                      treatment. The major biliary metabolites
                                                                      were glucuronides of one and possibly two
                                                                      of the compounds produced by demethylation
                                                                      of the dimethoxyphenyl ring.
----------------------------------------------------------------------------------------------------------------
870.7600                                 Dermal penetration          In a dermal penetration study, radio-
                                                                      labeled \14\ C-dimethomorph in water was
                                                                      administered dermally to 4 male SD rats/
                                                                      group for 8 hours at doses of 7.73 (2.5% w/
                                                                      v aqueous suspension) or 79.62 mg/kg (25%
                                                                      w/v aqueous suspension). Dermal absorption
                                                                      was 0.05%, 0.07% and 0.27% of the
                                                                      administered dose from rats 4, 8, and 24
                                                                      hours after dermal treatment at 7.73 mg/
                                                                      kg, and 0.02%, 0.16% and 0.12% of the dose
                                                                      at 79.62 mg/kg. Six days after treatment
                                                                      the percent total absorption of the dose
                                                                      in the 7.73 and 79.62 mg/kg was 4.76 and
                                                                      1.20 percent respectively.
----------------------------------------------------------------------------------------------------------------

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 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 dimethomorph used for human risk assessment is shown in 
the following Table 2:

[[Page 60919]]



     Table 2.--Summary of Toxicological Dose and Endpoints for Dimethomorph 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 effects attributable
                                                                                          to a single exposure
                                                                                          (dose) were observed
                                                                                          from oral toxicity
                                                                                          studies including
                                                                                          developmental toxicity
                                                                                          studies.
----------------------------------------------------------------------------------------------------------------
Chronic Dietaryall populations         NOAEL= 11 mg/kg/day      FQPA SF = 1X             Rat carcinogenicity
                                       UF = 100...............  cPAD = chronic RfD/FQPA   study
                                       Chronic RfD = 0.1 mg/kg/  SF = 0.1 mg/kg/day.     LOAEL = 46.3 mg/kg/day
                                        day.                                              based on decreased
                                                                                          body weight and
                                                                                          statistically
                                                                                          significant increases
                                                                                          in liver lesions in
                                                                                          female rats.
----------------------------------------------------------------------------------------------------------------
Short-term Dermal (1 to 7              oral study               LOC for MOE = 100        Developmental Toxicity
 days)(Residential)                    NOAEL = 60 mg/kg/day                               Study in the rat
                                        (dermal absorption                               LOAEL = 160 mk/kg/day
                                        factor = 5%)..                                    based on decreased
                                                                                          body weight, decreased
                                                                                          body weight gain, and
                                                                                          decreased food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate -Term Dermal (1 week to   Oral study               Not applicable.          Subchronic Feeding
 several months)(Residential)          NOAEL = 15 mg/kg/day                               Study in Dogs
                                        (dermal absorption                               LOAEL = 43 mg/kg/day
                                        factor = 5%.                                      based on decreased
                                                                                          absolute and relative
                                                                                          prostate weight and
                                                                                          possible threshold
                                                                                          liver effects.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    Not applicable.          Not applicable.          The use pattern does
 lifetime)                                                                                not indicate a concern
                                                                                          for long-term exposure/
                                                                                          risk.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)    Oral study               LOC for MOE = 100        Developmental Toxicity
                                       NOAEL = 60 mg/kg/day                               Study in the Rat
                                        (inhalation absorption                           LOAEL = 160 mg/kg/day
                                        factor = 100%).                                   based on decreased
                                                                                          body weight, decreased
                                                                                          body weight gain, and
                                                                                          decreased food
                                                                                          consumption.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week   Oral study               LOC for MOE = 100        Subchronic Feeding
 to several months)                    NOAEL = 15 mg/kg/day                               Study in Dogs
                                        (inhalation absorption                           LOAEL = 43 mg/kg/day
                                        rate = 100%).                                     based on decreased
                                                                                          absolute and relative
                                                                                          prostrate weight and
                                                                                          possible threshold
                                                                                          liver effects.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   Not applicable.          Not applicable.          The use patterns do not
 to lifetime)                                                                             indicate a concern for
                                                                                          long-term exposure/
                                                                                          risk.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Not applicable.          Not applicable.          Dimethomorph was
                                                                                          classified as Not
                                                                                          Likelyto be a human
                                                                                          carcinogen. This
                                                                                          classification is
                                                                                          based on the lack of
                                                                                          evidence of
                                                                                          carcinogenicity in
                                                                                          mice and rats when
                                                                                          tested at doses that
                                                                                          were judged to be
                                                                                          adequate to assess
                                                                                          carcinogenicity.
----------------------------------------------------------------------------------------------------------------
* 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. Tolerances have been 
established (40 CFR 180.493) for the residues of dimethomorph, in or on 
grape at 3.5 ppm; hops, cones, dried at 60 ppm; raisins at 6.0 ppm; 
potato at 0.05 ppm; potato, wet peel at 0.15 ppm; tomato at 0.5 ppm and 
tomato, paste at 1.0 ppm. There were no U.S. registrations for grape, 
hop, or raisins at the time the tolerances were established for these 
food commodities. Time-limited tolerances are established for residues 
of dimethomorph in or on cantaloupe, cucumber, squash, and watermelon 
at 1.0 ppm in connection with the use of the pesticide under section 18 
emergency exemptions. Risk assessments were conducted by EPA to assess 
dietary exposures from dimethomorph 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. An acute exposure assessment was not performed 
since no effects attributable to a single exposure (dose) were observed 
from oral toxicity studies.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) 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 chronic exposure assessment is based on very 
conservative assumptions that all commodities that have tolerances for 
dimethomorph and the commodities included in this action will contain 
residues (100 percent crop treated) at the tolerance level.
    iii. Cancer. A cancer exposure assessment was not performed since 
dimethomorph is classified as Not Likely to be a human carcinogen.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for dimethomorph in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on

[[Page 60920]]

the physical characteristics of dimethomorph.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow groundwater. For a screening-level assessment 
for surface water EPA will use FIRST (a tier 1 model) before using 
PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for 
pesticides. While both FIRST and PRZM/EXAMS incorporate an index 
reservoir environment, the PRZM/EXAMS model includes a percent crop 
area factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
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 dimethomorph they are 
further discussed in the aggregate risk sections in Unit III.E of this 
preamble.
    Based on the FIRST and SCI-GROW models the EECs of dimethomorph for 
chronic exposures are estimated to be 28.5 ppb parts per billion (ppb) 
for surface water and 0.30 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). Dimethomorph 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 dimethomorph 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, 
dimethomorph 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 dimethomorph 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 database 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 margin of exposure 
(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 developmental and 
reproductive toxicity data did not indicate increased susceptibility of 
rats or rabbits to in utero and/or postnatal exposure.
    3. Conclusion. There is a complete toxicity database for 
dimethomorph and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
reduced to 1X. The FQPA factor was reduced because:
    i. The toxicology database is complete; the developmental and 
reproductive toxicity data did not indicate increased quantitative or 
qualitative susceptibility of rats or rabbits to in utero and/or 
postnatal exposure.
    ii. A developmental neurotoxicity study is not required by the 
Agency. There is no evidence of neurotoxicity in the current toxicity 
database.
    iii. The dietary (food and water) exposure assessment did not 
indicate a concern for potential risk to infants and children when 
tolerance level residues were used. The use of tolerance level residues 
results in an overestimate of dietary exposure.
    iv. Residential exposure is not expected since dimethomorph is not 
registered for residential use.

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 U.S. EPA 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, EPA concludes with reasonable certainty that 
exposures to

[[Page 60921]]

the pesticide in drinking water (when considered along with other 
sources of exposure for which EPA has reliable data) would not result 
in unacceptable levels of aggregate human health risk at this time. 
Because EPA 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, EPA 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. An appropriate endpoint attributable to a single 
exposure for the general U.S. population (including infants and 
children) was not identified. An acute risk assessment was not 
performed, since no acute risk from dietary exposure is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
dimethomorph from food will utilize 5% of the cPAD for the U.S. 
population, 6% of the cPAD for infants less than 1 year old and 10% of 
the cPAD for children 1 to 6 years old, the subpopulation at greatest 
exposure. There are no residential uses that result in chronic 
residential exposure to dimethomorph. In addition, there is potential 
for chronic dietary exposure to dimethomorph 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 3:

              Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Dimethomorph
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.10            5         28.5         0.30        3,300
----------------------------------------------------------------------------------------------------------------
Infants, less than 1 year old                           0.10            6         28.5         0.30          940
----------------------------------------------------------------------------------------------------------------
Children, 1 to 6 years old                              0.10           10         28.5         0.30          900
----------------------------------------------------------------------------------------------------------------
Females 13 to 50 years old                              0.10            5         28.5         0.30        2,900
----------------------------------------------------------------------------------------------------------------

    3. Short- and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Dimethomorph 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. Aggregate cancer risk for U.S. population. The Agency concludes 
that pesticidal uses of dimethomorph are not likely to pose a 
carcinogenic hazard to humans.
    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 dimethomorph residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate method is available for enforcement of the tolerances. 
FAMS 002-02 is a high pressure liquid chromatography analytical method 
with ultraviolet detection and is adequate for determining residues of 
dimethomorph per se. The method has been successfully validated by the 
Agency's Analytical Laboratory. The method may be requested from: Paul 
Golden, U.S. EPA/OPP/BEAD/ACB, Environmental Science Center, 701 Mapes 
Road, Fort Meade, MD 20755-5350; telephone number: 410-305-2960; FAX 
410-305-3091; e-mail address: RAM Mailbox.

B. International Residue Limits

    There are no established or proposed maximum residue limits or 
tolerances for dimethomorph in or on hop, dried cones; lettuce, leaf; 
lettuce, head; vegetable, cucurbit, group; or vegetable, bulb, group.

V. Conclusion

    Therefore, the tolerance is established for residues of 
dimethomorph, [(E,Z)4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-
oxo-2-propenyl]morpholine]], in or on hop, dried cones at 60 ppm; 
lettuce, leaf and lettuce, head at 10 ppm; vegetable, cucurbit, group 
at 0.5 ppm; and vegetable, bulb, group at 2.0 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 ID number OPP-2002-0221 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

[[Page 60922]]

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., 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 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 ID number OPP-2002-0221, 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 
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

[[Page 60923]]

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 23, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.493 is amended by removing the entry for ``Hops, 
cones, dried \1\'', and by alphabetically adding the following 
commodities to the table in paragraph (a)(1) to read as follows:


Sec.  180.493  Dimethomorph; tolerances for residues.

    (a) General. * * *

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Hop, dried cones......................................                                                        60
                                                    * * * * *
Lettuce, head.........................................                                                        10
Lettuce, leaf.........................................                                                        10
                                                    * * * * *
Vegetable, bulb, group................................                                                       2.0
Vegetable, cucurbit, group............................                                                       0.5
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 02-24485 Filed 9-26-02; 8:45 am]
BILLING CODE 6560-50-S