[Federal Register Volume 67, Number 132 (Wednesday, July 10, 2002)]
[Rules and Regulations]
[Pages 45650-45656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17265]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0117; FRL-7184-2]
Mesotrione; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-
cyclohexanedione, in or on sweet corn and sweet corn forage and stover.
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 corn. This
regulation establishes maximum permissible levels for residues of
mesotrione in these food commodities. The tolerances will expire and
are revoked on June 30, 2004.
DATES: This regulation is effective July 10, 2002. Objections and
requests for hearings, identified by docket control number OPP-2002-
0117, must be received on or before September 9, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0117 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9366; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register''--Environmental
Documents. You can also go directly to theFederal 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.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0117. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
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 tolerances for residues of the herbicide
mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione,
in or on sweet corn, sweet corn forage, and sweet corn stover at 0.01,
0.50, and 2.0 part per million (ppm), respectively. These tolerances
will expire and are revoked on June 30, 2004. EPA will publish a
document in the Federal Register to remove the revoked tolerances 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 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.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide
[[Page 45651]]
chemical residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
Section 18 of 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 (FQPA). EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Mesotrione on Sweet Corn and FFDCA
Tolerances
Due to an unusually warm winter, a non-routine and urgent situation
has occurred in Wisconsin due to volunteer potatoes. EPA has authorized
under FIFRA section 18 the use of mesotrione on sweet corn for control
of volunteer potatoes in Wisconsin. After having reviewed the
submission, EPA concurs that emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of mesotrione in or on sweet
corn. In doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerance under FFDCA
section 408(l)(6) 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 these tolerances without notice and opportunity for public
comment as provided in section 408(l)(6). Although these tolerances
will expire and are revoked on June 30, 2004, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerances remaining in or on sweet corn, sweet corn
forage, and sweet corn fodder 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
these tolerances at the time of that application. EPA will take action
to revoke these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether mesotrione
meets EPA's registration requirements for use on sweet corn or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of mesotrione by a State for special local needs
under FIFRA section 24(c). Nor do these tolerances serve as the basis
for any State other than Wisconsin to use this pesticide on this crop
under section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
mesotrione on sweet corn, 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 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).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
mesotrione and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of mesotrione, 2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-
cyclohexanedione, in or on sweet corn, sweet corn forage, and sweet
corn stover at 0.01, 0.50, and 2.0 ppm, respectively. EPA's assessment
of the dietary exposures and risks associated with establishing these
tolerances 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 Safety Factor.
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 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 mesotrione used for human
risk assessment is shown in the following Table 1:
[[Page 45652]]
Table 1.--Summary of Toxicological Dose and Endpoints for Mesotrione for Use in Human Risk Assessment\1\
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Dose Used in Risk FQPA SF and LOC for Study and Toxicological
Exposure Scenario Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary all populations Not applicable Not applicable No appropriate study
available.
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Chronic dietary all populations LOAEL= 2.1 mg/kg/day FQPA SF = 10X Reproduction Study -
UF = 300............... cPAD = chronic RfD..... mouse
Chronic RfD = 0.007 mg/ FQPA SF = 0.0007 mg/kg/ Offspring LOAEL = 2.1
kg/day. day. mg/kg/day based upon
tyrosinemia in F1 and
F2a offspring and
ocular discharge in F1
pups.
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Short-Term\1\ Incidental Oral (1-7 NOAEL = 100 mg/kg/day LOC for MOE = 1000 Developmental Toxicity
days) (Residential) Study - rat
(Residential)........................ Maternal LOAEL = 300 mg/
kg/day based upon
decreased body weight
gains during treatment
and decreased food
consumption.
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Intermediate-Term\1\ Incidental Oral LOAEL = 2.1 mg/kg/day LOC for MOE = 3000 Reproduction Study -
(7 days - several months) (Residential) mouse
(Residential) Offspring LOAEL = 2.1
mg/kg/day based upon
tyrosinemia in F1 and
F2a offspring and
ocular discharge in F1
pups.
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Short-Term\1\ dermal (1-7 days) Oral study LOC for MOE = 300 Developmental toxicity
(Occupational/Residential) LOAEL = 100 mg/kg/day (Occupational) study - rat
(dermal-absorption LOC for MOE = 3,000 Developmental LOAEL =
rate = 25%). (Residential). 100 mg/kg/day based
upon delays in
skeletal ossification
and changes in manus/
pes ossification
assessments.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term\1\ Dermal (1 week - Oral study LOC for MOE = 300 Reproduction Study -
several months) (Occupational/ LOAEL = 2.1 mg/kg/day (Occupational) mouse
Residential) (dermal- absorption LOC for MOE = 3,000 Offspring LOAEL = 2.1
rate = 25%). (Residential). mg/kg/day based upon
tyrosinemia in F1 and
F2a offspring and
ocular discharge in F1
pups.
----------------------------------------------------------------------------------------------------------------
Long-Term\1\ Dermal (several months - Oral study LOC for MOE = 300 Reproduction Study -
lifetime)(Occupational/Residential) LOAEL = 2.1 mg/kg/day (Occupational) mouse
(dermal- absorption LOC for MOE = 3,000 Offspring LOAEL = 2.1
rate = 25%). (Residential). mg/kg/day based upon
tyrosinemia in F1 and
F2a offspring and
ocular discharge in F1
pups.
----------------------------------------------------------------------------------------------------------------
Short-Term 1 Inhalation (1-7 days) Oral study LOAEL = 100 LOC for MOE = 300 Developmental Toxicity
(Occupational/Residential) mg/kg/day (inhalation- (Occupational) Study - rat
absorption rate = LOC for MOE = 3,000 Developmental LOAEL =
100%) (Residential). 100 mg/kg/day based
upon delays in
skeletal ossification
and changes in manus/
pes ossification
assessments.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term 1 Inhalation (1 Oral study LOAEL = 2.1 LOC for MOE = 300 Reproduction Study -
week - several months)(Occupational/ mg/kg/day (inhalation- (Occupational) mouse
Residential) absorption rate = LOC for MOE = 3,000 Offspring LOAEL = 2.1
100%) (Residential). mg/kg/day based upon
tyrosinemia in F1 and
F2a offspring and
ocular discharge in F1
pups.
----------------------------------------------------------------------------------------------------------------
Long-Term 1 Inhalation (several Oral study LOAEL = 2.1 LOC for MOE = 300 Reproduction Study -
months - lifetime) (Occupational/ mg/kg/day (inhalation- (Occupational) mouse
Residential) absorption rate = LOC for MOE = 3,000 Offspring LOAEL = 2.1
100%) (Residential). mg/kg/day based upon
tyrosinemia in F1 and
F2a offspring and
ocular discharge in F1
pups.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``not likely'' Not Applicable Acceptable oral rat and
mouse carcinogenicity
studies; no evidence
of carcinogenic or
mutagenic potential.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose,
MOE = margin of exposure, LOC = level of concern.
[[Page 45653]]
\1\ HED has revised the definitions used in its human health risk assessments to describe occupational and
residential exposure durations (Memo, M. Stasikowski, 04-JUN-2001, ``Changes in the Definition of Exposure
Durations for Occupational/Residential Risk Assessments Performed in the Health Effects Division''). The new
exposure durations are as follows: 1. short-term, defined as lasting from 1 day to 1 month; 2. intermediate-
term, defined as lasting from 1 to 6 months; 3. long-term, defined as lasting longer than 6 months. The
toxicity endpoints originally selected for the short- (1-7 days) and intermediate-term (1 week to several
months) incidental oral and the short- (1-7 days), intermediate- (1 week - several months) and long-term
(several months - lifetime) dermal and inhalation endpoints are also applicable for the new exposure duration
definitions for these routes of exposure.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
recently established (40 CFR 180.571) for the residues of mesotrione,
in or on field corn forage, grain, and stover. Risk assessments were
conducted by EPA to assess dietary exposures from mesotrione 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. No appropriate study available show any acute
dietary effects of concern.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM[reg]) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992- nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity. The following assumptions were made for the chronic exposure
assessments: Residue levels are at the recommended tolerances for field
and sweet corn, and 100% of the crop is treated with mesotrione. The
%cPAD for the general U.S. population is 2.1% and for the most
sensitive population subgroups, Children (1-6 years old), is 5%.
iii. Cancer. Acceptable oral rat and mouse carcinogenicity studies
showed no evidence of carcinogenic or mutagenic potential.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for mesotrione 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 mesotrione.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
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 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 mesotrione they are
further discussed in the aggregate risk sections below.
Based on the GENEEC (Version 1.2) and SCI-GROW models the EECs of
mesotrione for acute exposures are estimated to be 20 parts per billion
(ppb) for surface water and 0.15 ppb for ground water. The EECs for
chronic exposures are estimated to be 13 ppb for surface water and 0.15
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). Mesotrione is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether mesotrione 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,
mesotrione 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 mesotrione 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. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is quantitative
evidence of increased susceptibility demonstrated in the oral prenatal
developmental toxicity studies in rats, mice, and rabbits.
[[Page 45654]]
Delayed ossification was seen in the fetuses at doses below those at
which maternal toxic effects were noted. Maternal toxic effects in the
rat were decreased body weight gain during treatment and decreased food
consumption and in the rabbit, abortions and GI effects.
5. Conclusion. The FQPA safety factor (10X) is retained in
assessing the risk posed because there is quantitative evidence of
increased susceptibility of the young exposed to mesotrione in the
prenatal developmental toxicity studies in mice, rats, and rabbits and
in the multi-generation reproduction study in mice, there is
qualitative evidence of increased susceptibility of the young exposed
to mesotrione in the multi-generation reproduction study in rats; and a
Developmental Neurotoxicity Study is required to assess the effects of
tyrosinemia on the developing nervous system exposed to mesotrione.
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. 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 USEPA's Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to mesotrione in drinking water (when considered along with
other sources of exposure for which EPA has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because EPA considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, EPA will reassess the potential impacts of
mesotrione on drinking water as a part of the aggregate risk assessment
process.
1. Acute risk. Acute doses and endpoints were not selected for the
general U.S. population (including infants and children) or the females
(13-50 years old) population subgroup for mesotrione; therefore, an
acute dietary exposure analysis was not performed.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
mesotrione from food will utilize 2.1% of the cPAD for the U.S.
population, 4.4% of the cPAD for all infants < 1 year old and 5% of the
cPAD for children (1-6 years old). There are no residential uses for
mesotrione that result in chronic residential exposure to mesotrione.
In addition, despite the potential for chronic dietary exposure to
mesotrione in drinking water, after calculating DWLOCs and comparing
them to conservative model EECs of mesotrione in surface and ground
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Mesotrione
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................ 0.0007 2.1 4.3 0.15 24
All infants.................................... 0.0007 4.4 4.3 0.15 6.7
Children (1-6) years old)...................... 0.0007 5.0 4.3 0.15 6.6
Females (13-50 years old)...................... 0.0007 1.5 4.3 0.15 21
----------------------------------------------------------------------------------------------------------------
3. Aggregate cancer risk for U.S. population. Based on the lack of
carcinogenic response in rats and mice and the lack of mutagenic
effects, and that there are no data in the literature or SAR
information to indicate carcinogenic potential, no cancer risk is
posed.
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 mesotrione residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high pressure liquid
chromatography) is available to enforce the tolerance expression. The
method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703)
305-5229; e-mail address: [email protected].
B. International Residue Limits
There are no CODEX, Canadian, or Mexican tolerances/Maximum Residue
Levels for mesotrione residues; thus, harmonization is not an issue at
this time.
VI. Conclusion
Therefore, tolerances are established for residues of mesotrione,
2-[4-(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in or on
sweet corn, sweet corn forage, and sweet corn fodder at 0.01, 0.50, and
2.0 ppm, respectively.
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
[[Page 45655]]
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to the FFDCA by the
FQPA of 1996, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) provides essentially the same process for
persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d), as
was provided in the old FFDCA sections 408 and 409. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-2002-0117 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 September
9, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in 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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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 (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit 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.2. Mail your
copies, identified by the docket ID number OPP--2002-0117, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: [email protected]. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes time limited tolerances under FFDCA
section 408. 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 FFDCA section 408, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
[[Page 45656]]
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
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
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: June 24, 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 374.
2. Section 180.571 is amended by revising paragraph (b) to read as
follows:
Sec. 180.571 Mesotrione; tolerances for residues.
* * * * *
(b)Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the herbicide mesotrione, 2-[4-
(methylsulfonyl)-2-nitrobenzoyl]-1,3-cyclohexanedione, in connection
with use of the herbicide under section 18 emergency exemptions granted
by EPA. The tolerances are specified in the following table. The
tolerances will expire on the dates specified in the table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------- -------------
Corn, sweet, kernel plus cob with 0.01 06/30/04
husks removed.....................
Corn, sweet, forage................ 0.50 06/30/04
Corn, sweet, stover................ 2.0 06/30/04
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-17265 Filed 7-9-02; 8:45 am]
BILLING CODE 6560-50-S