[Federal Register: September 29, 2003 (Volume 68, Number 188)]
[Rules and Regulations]
[Page 55826-55833]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se03-19]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0303; FRL-7327-3]
Dimethomorph; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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: brothers.shaja@epa.gov.
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/http://.
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.
-----------------------------------------------------------------------------------------
Acute dietary general population Not applicable Not applicable No endpoint
including infants and children attributable to a
single dose was
identified
-----------------------------------------------------------------------------------------
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: residuemethods@epa.gov.
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 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
[[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: 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. 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