Dimethomorph; Pesticide Tolerances

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 27, 2002 (Volume 67, Number 188)]
[Rules and Regulations]
[Page 60916-60923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se02-19]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0221; FRL-7199-2]

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:
jamerson.hoyt@epa.gov.

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
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Guideline No. Study Type Results
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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.
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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.
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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 (MOE_cancer = 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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. 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 (59 FR 22951, 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

Dimethomorph; Pesticide Tolerances

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