[Federal Register Volume 68, Number 188 (Monday, September 29, 2003)]
[Rules and Regulations]
[Pages 55826-55833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24564]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0303; FRL-7327-3]


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 brassica, leafy greens, subgroup 5B; taro, corm; 
taro, leaves; and vegetable, fruiting, group 8. EPA is also deleting 
certain dimethomorph tolerances that are no longer needed as a result 
of this action. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA).

DATES: This regulation is effective September 29, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0303, 
must be received on or before November 28, 2003.

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

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division

[[Page 55827]]

(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-3194; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you an are 
agricultural producer, food manufacturer, and pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0303. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of August 20, 2003 (68 FR 50138) (FRL-7321-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP 2E6483 and 3E6558) by IR-4, 681 US Highway 
1 South, New Brunswick, NJ 08902-3390. That notice included a 
summary of the petitions prepared by BASF Corporation, the registrant.
    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 commodities: Brassica, 
leafy greens, subgroup 5B at 20.0 part per million (ppm); taro, corm at 
0.5 ppm; taro, leaves at 6.0 ppm; and vegetable, fruiting, group 8 at 
2.0 ppm. The tolerance petition for vegetable, fruiting, group 8 was 
subsequently amended to propose the tolerance at 1.5 ppm. EPA is also 
deleting tolerances for tomato, fruit at 0.5 ppm, and tomato, paste at 
1.0 ppm established under section 180.493 (a). These commodities will 
be covered by the tolerance for vegetable, fruiting, group 8 at 1.5 
ppm. There were no comments received on these petitions.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a rasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for residues of dimethomorph on 
brassica, leafy greens, subgroup 5B at 20.0 ppm; taro, corm at 0.5 ppm; 
taro, leaves at 6.0 ppm; and vegetable, fruiting, group 8 at 1.5 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the tolerances follow.

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 Federal Register of September 27, 2002 (67 FR 60916) 
(FRL-7199-2).

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

[[Page 55828]]

used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors 
(SF) is retained due to concerns unique to the FQPA, this additional 
factor is applied to the RfD by dividing the RfD by such additional 
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is 
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer= point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for dimethomorph used for human risk assessment is shown is 
shown in Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for Dimethomorph for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF* and
          Exposure Scenario               Dose Used in Risk        Endpoint for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   Not applicable           Not applicable           No endpoint
 age                                                                                      attributable to a
                                                                                          single dose was
                                                                                          identified.
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Acute dietary general population       Not applicable           Not applicable           No endpoint
 including infants and children                                                           attributable to a
                                                                                          single dose was
                                                                                          identified
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Chronic dietary all populations        NOAEL= 11 mg/kg/day      Special FQPA SF = 1      Carcinogenicity study
                                       UF = 100...............  cPAD = chronic RfD/       in the rat
                                       Chronic RfD = 0.1 mg/kg/  Special FQPA SF = 0.1   LOAEL = 46.3 mg/kg/day
                                        day.                     mg/kg/day.               based on decreased
                                                                                          body weight and
                                                                                          statistically
                                                                                          significant increases
                                                                                          in liver lesions in
                                                                                          female rats
-----------------------------------------------------------------------------------------
Short-term dermal (1 to 7 days)        Oral study NOAEL= 60 mg/ LOC for MOE = 100        Developmental toxicity
                                        kg/day                                            study in the rat
                                       (dermal absorption                                LOAEL = 160 mg/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 NOAEL= 15 mg/ LOC for MOE = 100        Subchronic feeding
 several months)                        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 current use pattern
 lifetime)                                                                                does not indicate a
                                                                                          concern for long-term
                                                                                          exposure/risk
-----------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days)    Oral study NOAEL= 60 mg/ LOC for MOE = 100        Developmental toxicity
                                        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 nhalation (1 week    Oral study NOAEL= 15 mg/ LOC for MOE = 100        Subchronic feeding
 to several months)                     kg/day                                            study in dogs
                                       (inhalation absorption                            LOAEL = 43 mg/kg/day
                                        rate = 100%).                                     based on decreased
                                                                                          absolute and relative
                                                                                          prostate weight and
                                                                                          possible threshold
                                                                                          liver effects
-----------------------------------------------------------------------------------------
Long-term inhalation (several months   Not applicable           Not applicable           The current use pattern
 to lifetime)                                                                             does not indicate a
                                                                                          concern for long-term
                                                                                          exposure/risk
-----------------------------------------------------------------------------------------

[[Page 55829]]

 
Cancer (oral, dermal, inhalation)      Not applicable           Not applicable           This chemical is
                                                                                          classified as ``not
                                                                                          likely'' to be a human
                                                                                          carcinogen
----------------------------------------------------------------------------------------------------------------

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; grape, raisin; hop, dried cones; lettuce, head; lettuce, leaf; 
potato, wet peel; tomato; tomato, paste; vegetable, bulb, group 3; and 
vegetable, cucurbit, group 9. Time-limited tolerances are also 
established for residues of dimethomorph in connection with use of the 
pesticide under emergency exemptions pursuant to the Federal 
Insecticide, Fungicide, and Rodenticide Act for cantaloupe, cucumber, 
squash, and watermelon at 1.0 ppm set to expire on December 31, 2003. 
Additionally, time-limited tolerances are established for inadvertent 
or indirect residues of dimethomorph in or on the following raw 
agricultural commodities when present therein as a result of the 
application of dimethomorph to growing crops: grain, cereal group, 
fodder; grain, cereal group, forage; grain, cereal group, grain; grain, 
cereal group, hay; and grain, cereal group, straw at 0.15 ppm, set to 
expire on May 12, 2004. Risk assessments were conducted by EPA to 
assess dietary exposures from dimethomorph in food as follows:
    i. Acute exposure. A quantitative acute dietary exposure and risk 
assessment was not conducted for dimethomorph since an acute oral 
endpoint attributed to a single-dose exposure could not be identified 
in any of the toxicology studies, including developmental and maternal 
toxicity in the developmental toxicity studies. No acute risk is 
expected from exposure to dimethomorph.
    ii. Chronic exposure. In conducting this acute dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEMTM/FCID) which 
incorporates food consumption data as reported by respondents in the 
United States Department of Agriculture (USDA) 1994-1996 and 1998 
nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions was made for the chronic exposure assessment: The chronic 
dietary risk assessment for dimethomorph assumed tolerance level 
residues and 100% crop treated (Tier 1) for all registered and proposed 
crops.
    iii. Cancer. EPA has classified dimethomorph as a ``not likely'' 
human carcinogen. Therefore, a quantitative cancer dietary exposure and 
risk assessment was not performed.
    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 the physical 
characteristics of dimethomorph.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and Screening Concentrations in Ground Water (SCI-GROW), which 
predicts pesticide concentrations in groundwater. In general, EPA will 
use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. ince DWLOCs 
address total aggregate exposure to dimethomorph they are further 
discussed in the aggregate risk sections in Unit E.
    Based on the GENEEC and SCI-GROW models the EECs of dimethomorph 
for acute exposures are estimated to be 79.8 parts per billion (ppb) 
for surface water and 0.30 ppb for ground water. The EECs for chronic 
exposures are estimated to be 28.5 ppb for surface water and 0.30 ppb 
for ground water.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use 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

[[Page 55830]]

dimethomorph they are further discussed in the aggregate risk Unit E.
    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 effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider available information concerning the cumulative effects 
of a particular pesticide's residues and other substances that have a 
common mechanism of toxicity.
    EPA does not have, at this time, available data to determine 
whether dimethomorph has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to dimethomorph 
and any other substances and 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 policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. The 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 data base for 
dimethomorph and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X SF to protect infants and children should be reduced to 
1X. The FQPA SF is removed because: Acceptable developmental toxicity 
studies in the rat and the rabbit are available, as is an acceptable 2-
generation reproduction study in the rat and there is no indication of 
qualitative or quantitative increased susceptibility of rats and 
rabbits to in utero or postnatal exposure. A developmental 
neurotoxicity study is not required for dimethomorph. The dietary (food 
and water) exposure assessments are not expected to underestimate the 
potential exposures for infants and children from the use of 
dimethomorph. Residential exposure to dimethomorph is not expected 
since there are no registered residential uses for the pesticide.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water [e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)]. This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
dimethomorph from food will utilize 7% of the cPAD for the U.S. 
population, 0.8% of the cPAD for all infants < 1 year old, 16% of the 
cPAD for children 1-2 years old (the most highly exposed population 
subgroup), and 6% of the cPAD for females 13-49 years old. Based on the 
lack of residential uses, chronic residential exposure to residues of 
dimethomorph is not expected. 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 Table 2 of this unit:

[[Page 55831]]



              Table 2.--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            7        28.50         0.30        3,253
----------------------------------------------------------------------------------------
All infants (<1 year old)                               0.10          0.8        28.50         0.30          960
----------------------------------------------------------------------------------------
Children (1-2 years old)                                0.10           16        28.50         0.30          842
----------------------------------------------------------------------------------------
Females (13-49 years old)                               0.10            6        28.50         0.30        2,812
----------------------------------------------------------------------------------------------------------------

    2. Short- and intermediate-term risk. Short- 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.
    3. Aggregate cancer risk for U.S. population. Dimethomorph is no 
carcinogenic. This classification was based upon lack of evidence of 
carcinogenicity in rats and mice. The Agency concludes that the 
pesticidal uses of dimethomorph are not likely to pose a cancer risk to 
humans.
    4. 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

    A reliable method for the determination of dimethomorph residues in 
fruiting vegetables crop group 8, leafy brassica greens subgroup 5B, 
taro leaves and roots exists; this method is the FDA Multi-Residue 
Method, Protocol D, as published in the Pesticide Analytical Manual I.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no established or proposed Codex, Canadian or Mexican 
maximum residue limits or tolerances for dimethomorph in or on taro, 
corm; taro, leaves; brassica, leafy greens, subgroup 5B; or vegetable, 
fruiting, group 8.

V. Conclusion

    Therefore, the tolerances are established for residues of 
dimethomorph, in or on brassica, leafy greens, subgroup 5B; taro, corm; 
taro, leaves; and vegetable, fruiting, group 8.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons o ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0303 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 
28, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The 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

[[Page 55832]]

Ave., NW., Washington, DC 20460-0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0303, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


[[Page 55833]]


    Dated:September 22, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.493 is amended by removing the entries ``tomato'' and 
``tomato, paste'' and by alphabetically adding the following 
commodities to the table in paragraph (a) to read follows:


Sec.  180.493  Dimethomorph; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Brassica, leafy greens, subgroup 5B........................         20.0
                                * * * * *
Taro, corm.................................................          0.5
Taro, leaves...............................................          6.0
                                * * * * *
Vegetable, fruiting, group 8...............................          1.5
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-24564 Filed 9-26-03; 8:45 am]
BILLING CODE 6560-50-S