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[Federal Register: January 3, 2003 (Volume 68, Number 2)]
[Rules and Regulations]
[Page 274-283]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja03-12]
[[Page 274]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0331; FRL-7283-2]
S-metolachlor; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for the
combined residues (free and bound) of the herbicide s-metolachlor [(S)-
2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], its R-enantiomer and its metabolites,
determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound in or on sweet
potatoes. This action is in response to EPA's granting of an emergency
exemption under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on sweet
potatoes. This regulation establishes a maximum permissible level for
residues of s-metolachlor in this food commodity. The tolerance will
expire and is revoked on December 31, 2004. Although the exemption was
granted for the active ingredient s-metolachlor and the time-limited
tolerance is being set for s-metolachlor, the Agency has determined
that residues of concern for s-metolachlor are the same as those for
metolachlor, and therefore, the tolerance is being included under 40
CFR 180.368 but under its own section in paragraph (b). Metabolites of
metolachlor are assumed to be toxicologically equivalent to parent
metolachlor. The Agency has determined that the residues of concern for
plant and animal commodities are metolachlor and its metabolites,
determined as the derivatives CGA-37913 and CGA-49751.
DATES: This regulation is effective January 3, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2002-0331,
must be received on or before March 4, 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 VII. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Andrew Ertman,Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:(703)308-9367; e-mail address: sec-18-mailbox@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are a federal
or state government agency involved in administration of environmental
quality programs (i.e., Departments of Agriculture, Environment, etc).
Potentially affected entities may include, but are not limited to:
[sbull] Federal or State Government Entity, (NAICS 9241),
Departments of Agriculture, Environment, etc.
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-2002-0331. 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
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for the combined residues
(free and bound) of the herbicide s-metolachlor [(S)-2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its R-
enantiomer and its metabolites, determined as the derivatives, 2-[(2-
ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-
2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent
compound, in or on sweet potatoes at 0.2 parts per million (ppm). This
tolerance will expire and is revoked on December 31, 2004. EPA will
publish a document in the Federal Register to remove the revoked
tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
[[Page 275]]
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 reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for S-metolachlor on Sweet Potatoes and FFDCA
Tolerances
The States of Louisiana and Mississippi requested the use of s-
metolachlor on sweet potatoes to control sedges due to an increased
pressure from these weed species and a lack of effective registered
alternatives. EPA has authorized under FIFRA section 18 the use of s-
metolachlor on sweet potatoes for control of sedges in Louisiana and
Mississippi. After having reviewed the submission, EPA concurs that
emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of s-metolachlor in or on
sweet potatoes. In doing so, EPA considered the safety standard in
section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing this tolerance without notice and
opportunity for public comment as provided in section 408(l)(6) of the
FFDCA. Although this tolerance will expire and is revoked on December
31, 2004, under section 408(l)(5) of the FFDCA, residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on sweet potatoes after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
this tolerance at the time of that application. EPA will take action to
revoke this tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether s-metolachlor
meets EPA's registration requirements for use on sweet potatoes or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this tolerance serves as
a basis for registration of s-metolachlor by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Louisiana and Mississippi to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of EPA's regulations implementing FIFRA section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for s-metolachlor, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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) .
The Agency has determined that the residues of concern for plant
and animal commodities are metolachlor and its metabolites, determined
as the derivatives CGA-37913 and CGA-49751. Metabolites of metolachlor
are assumed to be toxicologically equivalent to parent metolachlor. The
residues of concern for s-metolachlor are the same as those for
metolachlor.
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 s-
metolachlor and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for a time-limited
tolerance for the combined residues (free and bound) of the herbicide
s-metolachlor [(S)-2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], its R-enantiomer and its metabolites,
determined as the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-
propanol and 4-(2-ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-
morpholinone, each expressed as the parent compound in or on sweet
potatoes at 0.2 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
A. 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 endpoint. 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 intra species 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 SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (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
[[Page 276]]
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 x10-\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.
S-metolachlor, [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], is a member of the chloroacetanilide class of
herbicides. In this risk assessment the term s-metolachlor will refer
to a metolachlor product which is enriched in the S-isomer. The term
metolachlor will refer to a racemic mixture of the R and S isomers.
Toxicological endpoints have been selected for metolachlor and s-
metolachlor for use in human health risk assessments. The Agency has
determined that metolachlor and s-metolachlor are of comparable
toxicity, and therefore, studies with both chemicals were used
interchangeably for toxicology endpoint selection.
A summary of the toxicological endpoints for s-metolachlor used for
human risk assessment is shown in the following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for S-Metolachlor for Use in Human Risk Assessment
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FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years of NOAEL = 300 mg/kg/day FQPA SF = 1x Prenatal developmental
age) UF = 100............... aPAD = acute RfD/FQPA toxicity study in rats
Acute RfD = 3.0 mg/kg/ SF. LOAEL = 1,000 mg/kg/day
day. = 3.0 mg/kg/day........ based on death,
clinical signs of
toxicity (clonic and/
or tonic convulsions,
excessive salivation,
urine-stained
abdominal fur and/or
excessive salivation)
and decreased body
weight gain
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Acute Dietary (General population NOAEL = 300 mg/kg/day FQPA SF = 1x Prenatal developmental
including infants and children) UF = 100............... aPAD = acute RfD/FQPA toxicity study in rats
Acute RfD = 3.0 mg/kg/ SF. LOAEL = 1,000 mg/kg/day
day. = 3.0 mg/kg/day........ based on death,
clinical signs of
toxicity (clonic and/
or tonic convulsions,
excessive salivation,
urine-stained
abdominal fur and/or
excessive salivation)
and decreased body
weight gain
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Chronic Dietary (All populations) NOAEL = 9.7 mg/kg/day FQPA SF = 1x Chronic study in dogs
UF = 100............... cPAD = chronic RfD/FQPA LOAEL = 33.0 mg/kg/day
Chronic RfD = 0.1 mg/kg/ SF. based on decreased
day. = 0.1 mg/kg/day........ body weight gain in
females
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Short-Term Dermal (1 to 7 days) Hazard was not identified for quantification of risk. No systemic
(Residential) toxicity was seen at the limit dose (1,000 mg/kg/day) following dermal
applications and there is no concern for developmental toxicity in rats
or rabbits.
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Intermediate-Term Dermal (1 week to Hazard was not identified for quantification of risk. No systemic
several months) (Residential) toxicity was seen at the limit dose (1000 mg/kg/day) following dermal
applications and there is no concern for developmental toxicity in rats
or rabbits.
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Long-Term Dermal (several months to dermal (or oral) study LOC for MOE = 100 Chronic toxicity study
lifetime) (Residential) NOAEL= 9.7 mg/kg/day... (Residential) in dogs
(dermal absorption rate LOAEL = 33.0 mg/kg/day
= 58% when based on decreased
appropriate). body weight gain in
females
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Short-Term Inhalation (1 to 7 days) Inhalation (or oral) LOC for MOE = Prenatal developmental
(Residential) study 100 (Residential)...... toxicity study in rats
NOAEL= 50 mg/kg/day.... LOAEL = 500 mg/kg/day
(inhalation absorption based on increased
rate = 100%). incidence of clinical
signs, decreased body
weight/body weight
gain, food
consumption, and food
efficiency
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Intermediate-Term Inhalation (1 week Inhalation (or oral) LOC for MOE = Subchronic (6 month)
to several months) (Residential) study 100 (Residential)...... toxicity study in dogs
NOAEL = 8.8 mg/kg/day.. LOAEL based on
(inhalation absorption decreased body weight
rate = 100%). gain
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[[Page 277]]
Long-Term Inhalation (several months Inhalation (or oral) LOC for MOE = Chronic toxicity study
to lifetime) (Residential) study 100 (Residential)...... in dogs
NOAEL= 9.7 mg/kg/day... LOAEL = 33.0 mg/kg/day
(inhalation absorption based on decreased
rate = 100%). body weight gain in
females
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Metolachlor has been classified as a Group C, possible human carcinogen.
This classification was based on the occurrence of liver tumors in rats
at the highest dose level tested (150 mg/kg/day). The carcinogenic risks
for metolachlor have been quantitated using a non-linear approach, with
a NOAEL of 15 mg/kg/day. However, the NOAEL of 15 mg/kg/day that was
established based on liver tumors in rats is comparable to the NOAEL of
9.7 mg/kg/day selected for establishing the chronic reference dose for
metolachlor. It is assumed that the chronic dietary endpoint is
protective for cancer dietary exposure. Therefore, a separate cancer
aggregate risk assessment was not conducted, and cancer DWLOC values
were not calculated.
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* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. S-metolachlor, [2-
chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide], is a member of the chloroacetanilide class of
herbicides. In this risk assessment the term s-metolachlor will refer
to a metolachlor product which is enriched in the S-isomer. The term
metolachlor will refer to a racemic mixture of the R and S isomers.
Currently, there are permanent tolerances for metolachlor (40 CFR
180.368) on a variety of crops and animal commodities. These tolerances
range from 0.02 ppm to 30 ppm. There are also time-limited tolerances
(in conjunction with section 18 uses) on grass, spinach, and tomatoes.
Risk assessments were conducted by EPA to assess dietary exposures from
metolachlor and s-metolachlor 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. The Dietary Exposure Evaluation Model (DEEM\TM\)
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 following assumptions were made for the acute
exposure assessments: The analyses assumed tolerance-level residues
(with the exception of those with DEEM default processing factors) and
100% crop treated for all commodities.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: The analyses assumed tolerance-level residues (with the
exception of those with DEEM default processing factors) and 100% crop
treated for all commodities.
iii. Cancer. Metolachlor has been classified as a Group C, possible
human carcinogen. This classification was based on the occurrence of
liver tumors in rats at the highest dose level tested (150 mg/kg/day).
The carcinogenic risks for metolachlor have been quantitated using a
non-linear approach, with a NOAEL of 15 mg/kg/day. However, the NOAEL
of 15 mg/kg/day that was established based on liver tumors in rats is
comparable to the NOAEL of 9.7 mg/kg/day selected for establishing the
chronic reference dose for metolachlor. It is assumed that the chronic
dietary endpoint is protective for cancer dietary exposure. Therefore,
a separate cancer aggregate risk assessment was not conducted, and
cancer DWLOC values were not calculated.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for s-metolachlor in drinking
water. Because the Agency does not have comprehensive monitoring data
for both parent and the degradates of concern in drinking water,
exposure from drinking water is being addressed through modeled
estimated environmental concentrations (EECs) and the use of drinking
water levels of comparison (DWLOCs). This assessment includes
concentrations of parent metolachlor and the degradates metolachlor
ethanesulfonic acid (ESA) and metolachlor oxanilic acid (OA). Although
it was determined by the Agency that the ESA and OA metabolites appear
to be less toxic than parent metolachlor, they are included in this
risk assessment because they were found in greater abundance than the
parent in water monitoring studies.
The surface water EECs were derived from the National Water Quality
Assessment Database (parent) and the FIRST Model (ESA and OA
metabolites). The SCI-GROW Model was used to generate all ground-water
EECs For a screening-level assessment for surface water EPA will
generally 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 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
[[Page 278]]
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 metolachlor and s-metolachlor they are further discussed in
the aggregate risk sections below.
Based on the National Water Quality Assessment Database (parent)
and the FIRST Model (ESA and OA metabolites) and SCI-GROW models the
estimated environmental concentrations (EECs) of parent metolachlor and
its degradates for acute exposures are estimated to be 201 parts per
billion (ppb) (parent: 77.6 ppb, ESA: 31.9 ppb, and OA: 91.4 ppb) for
surface water and 103 ppb (parent: 5.5 ppb, ESA: 65.8 ppb, and OA: 31.7
ppb) for ground water. The EECs for chronic exposures are estimated to
be 92 ppb (parent: 4.3 ppb, ESA: 22.8 ppb, and OA: 65.1 ppb) for
surface water and 103 ppb (parent: 5.5 ppb, ESA: 65.8 ppb, and OA: 31.7
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).
i. Handlers. Metolachlor and s-metolachlor are registered (as an
emulsifiable concentrate formulation) for use on lawn, turf (including
sod farms), golf courses, sports fields, and ornamental gardens.
Although metolachlor is not labeled as a restricted-use pesticide, it
is not intended for homeowner purchase or use. On this basis, a
residential handler is not expected to be exposed to residues of
metolachlor and s-metolachlor. Therefore, a residential handler
assessment was not conducted.
ii. Postapplication. There is potential for postapplication
exposure to adults and children resulting from the use of metolachlor/
s-metolachlor on residential lawns. Although the use sites for
metolachlor and s-metolachlor vary from golf courses to ornamental
gardens, the residential lawn scenario represents what the Agency
considers to be the likely upper-end of possible exposure.
Postapplication exposures from various activities following lawn
treatment are considered to be the most common and significant in
residential settings.
Postapplication exposure is considered to be short-term (one to 30
days of exposure) only, based on a label specification of a six week
interval before the re-application of metolachlor/s-metolachlor. The
registrant has also indicated a label revision to limit application to
one time per season.
A short-term dermal endpoint was not selected because no systemic
toxicity was seen at the limit dose of 1,000 mg/kg/day. As a result, a
dermal risk assessment was not conducted and dermal risks are assumed
to be minimal. Postapplication inhalation exposure is expected to be
minimal since metolachlor and s-metolachlor are only applied in an
outdoor setting, the vapor pressure is low (2.8 x 10-\5\ mm
Hg at 25[]C), and the label specifies that
residents should not re-enter treated areas until after sprays have
dried.
The following postapplication incidental oral scenarios which
result from application to lawns and turf have been identified:
a. Short-term oral exposure to toddlers and children following
hand-to-mouth exposure;
b. Short-term oral exposure to toddlers and children following
object-to-mouth exposure; and
c. Short-term oral exposure to toddlers and children following soil
ingestion. The term ``incidental'' is used to distinguish the
inadvertent oral exposure of small children from exposure that may be
expected from treated foods or residues in drinking water.
As the FQPA safety factor for the protection of children and
infants was reduced to 1x, a target MOE value of 100 has been
identified for residential assessments. MOE values greater than 100 are
not considered to be of concern to the Agency. MOE estimates are based
on the dose level of 50 mg/kg/day established for short-term oral risk
assessment.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether s-metolachlor 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, s-
metolachlor 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 s-metolachlor 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).
C. 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. Developmental toxicity studies--i. Prenatal developmental
toxicity study--Metolachlor--Rat. The maternal toxicity LOAEL was 1,000
mg/kg/day based on an increased incidence of death, clinical signs of
toxicity (clonic and/or toxic convulsions, excessive salivation, urine-
stained abdominal fur and/or excessive lacrimation) and decreased body
weight gain. The NOAEL was 300 mg/kg/day.
The developmental toxicity LOAEL was conservatively established at
1,000 mg/kg/day based on slightly decreased number of implantations per
dam, decreased number of live fetuses/dam, increased number of
resorptions/dam and significant decrease in mean fetal body weight. The
NOAEL was 300 mg/kg/day.
ii. Prenatal developmental toxicity study--S-metolachlor--Rat. The
maternal toxicity NOAEL was 50 mg/kg/day with a LOAEL of 500 mg/kg/day
based on increased clinical signs of toxicity, decreased body weights
and body weight gains and reduced food consumption and reduced food
efficiency.
No significant treatment related developmental toxicity was noted
at the dose levels tested. The developmental toxicity NOAEL was equal
to or greater
[[Page 279]]
than 1,000 mg/kg/day, the highest dose tested (HDT); a LOAEL was not
reached.
iii. Prenatal developmental toxicity study--Metolachlor--Rabbit.
The maternal toxicity LOAEL was 360 mg/kg/day based on an increased
incidence of clinical observations (persistent anorexia) and decreased
body weight gain. The NOAEL was 120 mg/kg/day. The developmental
toxicity LOAEL was not established. The NOAEL was 360 mg/kg/day.
iv. Prenatal developmental toxicity study--S-metolachlor--Rabbit.
The maternal toxicity NOAEL was 20 mg/kg/day with a LOAEL of 100 mg/kg/
day based on clinical signs of toxicity.
No significant treatment related developmental toxicity was noted
at the dose levels tested. The developmental toxicity NOAEL was equal
to or greater than 500 mg/kg/day, HDT; a LOAEL was not reached.
3. Reproductive toxicity study. No reproduction studies with s-
metolachlor are available, however, in the two-generation reproduction
study with metolachlor in rats, there was no evidence of parental or
reproductive toxicity at approximately 80 mg/kg/day, HDT. At this dose,
there was a minor decrease in fetal body weight beginning at lactation
day 4; the NOAEL was approximately 25 mg/kg/day. Since a similar body
weight decrease was not seen on lactation day 0, the cause of the
effect on later lactation days was most likely due to exposure of the
pups to metolachlor in the diet and/or milk and therefore is not
evidence of an increased quantitative susceptibility in post-natal
animals.
The parental toxicity LOAEL was not established. The NOAEL was 1000
ppm (F0 males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/84.5
mg/kg/day).
The reproductive toxicity LOAEL was not established. The NOAEL was
1000 ppm (F0 males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/
84.5 mg/kg/day).
The offspring LOAEL was conservatively established at 1000 ppm (F0
males/females: 75.8/85.7 mg/kg/day; F1males/females: 76.6/84.5 mg/kg/
day) based on decreased body weight in F1 and F2 litters. The NOAEL is
300 ppm (F0 males/females: 23.5/ 26.0 mg/kg/day; F1males/females: 23.7/
25.7 mg/kg/day).
4. Prenatal and postnatal sensitivity. The data bases for prenatal
developmental toxicity for metolachlor and s-metolachlor are considered
complete. The prenatal developmental studies in the rat and rabbit with
both metolachlor and s-metolachlor revealed no evidence of a
qualitative or quantitative susceptibility in fetal animals. No
significant developmental toxicity was observed in most studies even at
the HDT.
The data base for reproductive toxicity of metolachlor is
considered complete. No reproduction studies with s-metolachlor are
available. In the two-generation reproduction study with metolachlor in
rats, there was no evidence of parental or reproductive toxicity at
approximately 80 mg/kg/day, HDT. At this dose, there was a minor
decrease in fetal body weight beginning at lactation day 4; the NOAEL
was approximately 25 mg/kg/day. Since a similar body weight decrease
was not seen on lactation day 0, the cause of the effect on later
lactation days was most likely due to exposure of the pups to
metolachlor in the diet and/or milk and therefore is not evidence of an
increased quantitative susceptibility in post-natal animals.
5. Conclusion. There is a complete toxicity data base for s-
metolachlor when bridged with the database for metolachlor 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 removed. The FQPA
factor is removed because:
i. The toxicological database is complete for FQPA assessment;
ii. There is no indication of quantitative or qualitative increased
susceptibility of rats or rabbits to in utero and/or postnatal
exposure;
iii. A developmental neurotoxicity study is not required; and
iv. The dietary (food and drinking water) and residential exposure
assessments will not underestimate the potential exposures for infants
and children.
D. 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 + chronic non-dietary, non-occupational 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 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 s-metolachlor 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 s-metolachlor on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to s-
metolachlor will occupy <1 % of the aPAD for the U.S. population, <1 %
of the aPAD for females 13 years and older, <1 % of the aPAD for all
infant and children subpopulations. In addition, despite the potential
for acute dietary exposure to s-metolachlor in drinking water, after
calculating DWLOCs and comparing them to conservative model estimated
environmental concentrations of s-metolachlor in surface and ground
water, EPA does not expect the aggregate exposure to exceed 100% of the
aPAD, as shown in Table 2 of this unit:
[[Page 280]]
Table 2.-- Aggregate Risk Assessment for Acute Exposure to S-Metolachlor
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb)* (ppb)* (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 3.0 < 1 201 103 1.0 x 105
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old) 3.0 <1 201 103 3.0 x 104
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 3.0 <1 201 103 3.0 x 104
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old) 3.0 <1 201 103 3.0 x 104
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 3.0 <1 201 103 9.0 x 104
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old) 3.0 <1 201 103 1.0 x 105
----------------------------------------------------------------------------------------------------------------
Males (20+ years old) 3.0 <1 201 103 1.0 x 105
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old) 3.0 <1 201 103 1.0 x 105
----------------------------------------------------------------------------------------------------------------
* Represents the combined value of parent plus the ESA and OA degradates.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to s-
metolachlor from food will utilize 2 % of the cPAD for the U.S.
population, 2 % of the cPAD for all infants < 1 year old and 3 % of the
cPAD for children 1-6 years old. Based the use pattern, chronic
residential exposure to residues of s-metolachlor is not expected. In
addition, despite the potential for chronic dietary exposure to s-
metolachlor in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of s-
metolachlor in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of
this unit:
Table 3.-- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to S-Metolachlor
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.1 2 92 103 3400
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old) 0.1 2 92 103 980
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.1 3 92 103 970
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old) 0.1 2 92 103 980
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.1 1 92 103 3000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old) 0.1 2 92 103 3400
----------------------------------------------------------------------------------------------------------------
Males (20+ years old) 0.1 1 92 103 3500
----------------------------------------------------------------------------------------------------------------
Seniors (55+ years old) 0.1 1 92 103 3500
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
For metolachlor and s-metolachlor, potential short-term, non-
occupational risk scenarios include oral exposure of children to
treated lawns. In this aggregate short-term risk assessment, exposure
from food, drinking water, and residential lawns has been considered.
Since only children have the potential for non-occupational, short-term
risk, they are the only population subgroup included below. Short-term
DWLOC values have been calculated for both metolachlor and s-
metolachlor, with the only difference in the calculations being
different oral exposure values for metolachlor vs. s-metolachlor (based
on different application rates).
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 640 for metolachlor and 1000 for
s-metolachlor for children 1-6 years old (the only population sub-group
of concern. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food and residential uses. In
addition, short-term DWLOCs were calculated and compared to the EECs
for chronic exposure of s-metolachlor in ground water and surface
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect short-term aggregate
exposure to exceed the Agency's level of concern, as shown in Table 4
of this unit:
[[Page 281]]
Table 4.-- Aggregate Risk Assessment for Short-Term Exposure to Metolachlor and S-Metolachlor
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Children (1-6); Metolachlor 640 100 92 103 4,200
----------------------------------------------------------------------------------------------------------------
Children (1-6); S-Metolachlor 1,100 100 92 103 4,500
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. An intermediate-term aggregate risk
assessment considers potential exposure from food, drinking water, and
non-occupational (residential) pathways of exposure. However, for
metolachlor, no intermediate-term non-occupational exposure scenarios
(greater than 30 days exposure) are expected to occur. Therefore,
intermediate-term DWLOC values were not calculated, and an
intermediate-term aggregate risk assessment is not required.
5. Aggregate cancer risk for U.S. population. An aggregate cancer
risk assessment considers potential carcinogenic exposure from food,
drinking water, and non-occupational (residential) pathways of
exposure. Metolachlor has been classified as a Group C, possible human
carcinogen. This classification was based on the occurrence of liver
tumors in rats at the highest dose level tested (150 mg/kg/day). The
HED Cancer Assessment Review Committee has recommended that
carcinogenic risks for metolachlor be quantitated using a non-linear
approach, with a NOAEL of 15 mg/kg/day. However, the NOAEL of 15 mg/kg/
day that was established based on liver tumors in rats is comparable to
the NOAEL of 9.7 mg/kg/day selected for establishing the chronic
reference dose for metolachlor. It is assumed that the chronic dietary
endpoint is protective for cancer dietary exposure. Therefore, a
separate cancer aggregate risk assessment was not conducted, and cancer
DWLOC values were not calculated.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to s-metolachlor residues.
V. Other Considerations
A. Analytical Enforcement Methodology
The Pesticide Analytical Manual (PAM) Vol. II, lists a GC/NPD
method (Method I) for determining residues in/on plants and a GC/MSD
method (Method II) for determining residues in livestock commodities.
These methods determine residues of metolachlor and its metabolites as
either CGA-37913 or CGA-49751 following acid hydrolysis.
B. International Residue Limits
No maximum residue limits (MRLs) for either metolachlor or S-
metolachlor have been established or proposed by Codex, Canada, or
Mexico for any agricultural commodity; therefore, no compatibility
questions exist with respect to U.S. tolerances.
VI. Conclusion
Therefore, the tolerance is established for the combined residues
(free and bound) of the herbicide s-metolachlor [(S)-2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide, its R-
enantiomer and its metabolites, determined as the derivatives, 2-[(2-
ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-
2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent
compound, in or on sweet potatoes at 0.2 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the 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-2002-0331 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 March 4,
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
[[Page 282]]
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 20460-0001.
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 VII.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 the docket ID number OPP-2002-0331, 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).
VIII. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under section
408 of the FFDCA. 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 FIFRA
section 18 exemption under section 408 of the FFDCA, such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
IX. 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
[[Page 283]]
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: December 20, 2002.
Debra Edwards,
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 180.368 is amended by designating the existing paragraph
(b) as paragraph (b)(1) and adding a new paragraph (b)(2) to read as
follows:
Sec. 180.368 Metolachlor; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions.
(1) * * *
(2) Time-limited tolerances are established for the combined
residues (free and bound) of the herbicide s-metolachlor [(S)-2-chloro-
N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], its
R-enantiomer and its metabolites, determined as the derivatives, 2-[(2-
ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-
2-hydroxy-5-methyl-3-morpholinone, each expressed as the parent
compound in connection with the use of the pesticide under section 18
emergency exemptions granted by EPA. The tolerance is specified in the
following table. The tolerances will expire and are revoked on the
dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Sweet potato 0.2 12/31/04
------------------------------------------------------------------------
* * * * *
[FR Doc. 03-5 Filed 1-2-03; 8:45 am]
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