Clomazone; Pesticide Tolerance
[Federal Register: February 14, 2001 (Volume 66, Number 31)]
[Rules and Regulations]
[Page 10196-10204]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14fe01-6]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301101; FRL-6764-2]
RIN 2070-AB78]
Clomazone; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
clomazone in or on tuberous and corm vegetable (except potato) subgroup
crop and cucurbit vegetable crop group. Interregional Research Project
Number 4 (IR--4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996.
DATES: This regulation is effective February 14, 2001. Objections and
requests for hearings, identified by docket control number OPP-301101,
must be received by EPA on or before April 16, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301101 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection
[[Page 10197]]
Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone
number: (703) 308-3194; and e-mail address: brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
.............................. 112 Animal production
311 Food manufacturing
.............................. 32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'', ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the `` Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301101. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 6, 2000 (65 FR 76249) (FRL-
6755-4), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of pesticide petitions (PP 9E6063 and 7E4865) for
tolerance by IR-4, 681 U.S. Highway #1 South, North Brunswick, New
Jersey 08902-3390. This notice included a summary of the petitions
prepared by FMC Corporation, the registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR 180.425 be amended by
establishing tolerances for residues of the herbicide clomazone, [2-(2-
chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone], in or on tanier,
cassava, yams, arracacha, and cucurbit vegetables at 0.05 and 0.1 parts
per million (ppm). The petition was subsequently amended to tuberous
and corm vegetable (except potato) crop subgroup and cucurbit vegetable
crop group at 0.05 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of clomazone on the tuberous
and corm vegetable (except potato) crop subgroup and cucurbit vegetable
crop group at 0.05 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by clomazone are
discussed in the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
[[Page 10198]]
Table 1. -- Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
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870.3100 90-Day oral NOAEL = 135.2/160.9
toxicity rat mg/kg/day, males/
females LOAEL =
273/319.3 mg/kg/
day, males/
females, based on
decreased body
weight, body
weight gains, food
consumption and
increased absolute
and relative liver
weights in females
and increased
absolute liver
weights in males
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL ³
toxicity mouse 1,200 mg/kg/day
(limit dose) LOAEL
> 1,200 mg/kg/day
------------------------------------------------------------------------
870.3700a Prenatal Maternal NOAEL =
developmental rat 100 mg/kg/day
LOAEL = 300 mg/kg/
day based on
chromorhinorrhea
and/or
abdominogenital
staining
Developmental
NOAEL = 100 mg/kg/
day LOAEL = 300 mg/
kg/day based on
indications of
delayed
ossification in
the form of either
partial
ossification or
the absence of
manubrium,
sternebrae 3-4,
xiphoid, caudal,
and metacarpals
------------------------------------------------------------------------
870.3700b Prenatal Maternal NOAEL =
developmental 240 mg/kg/day
rabbits LOAEL = 700 mg/kg/
day based on
effects seen at
1,000 mg/kg/day,
which included
mortality,
abortions,
decreased body
weight gain, and
decreased
defecation or no
feces
Developmental
NOAEL ³
700 mg/kg/day
highest dose
tested (HDT) LOAEL
> 700 mg/kg/day
------------------------------------------------------------------------
870.3800 2-Generation Parental NOAEL = 50
reproduction and mg/kg/day LOAEL =
fertility effects 100 mg/kg/day
based on
statistically
significantly
decreased body
weight and body
weight gain during
pre-mating, and
decreased body
weight during
gestation &
lactation male &
female. In
addition decreased
food consumption
in females and
hydro-nephritic
kidneys in males.
Offspring NOAEL =
50 mg/kg/day LOAEL
= 100 mg/kg/day
based on decreased
body weight in F2a
and F2b litters
------------------------------------------------------------------------
870.4100b Chronic toxicity NOAEL ³
dogs 1,038/1,012 mg/kg/
day, males/females
(HDT) LOAEL >
1,038/1,012 mg/kg/
day
------------------------------------------------------------------------
870.4300 Chronic toxicity/ NOAEL = 84.4/112.9
Carcinogenicity mg/kg/day, males/
rats females (HDT)
LOAEL ³
84.4/112.9 mg/kg/
day, males/females
Classified as a
``not likely human
carcinogen''
------------------------------------------------------------------------
870.4300 Carcinogenicity NOAEL = 300 mg/kg/
mice day (HDT) LOAEL =
> 300 mg/kg/day
Classified as a
``not likely human
carcinogen''
------------------------------------------------------------------------
870.5100 Gene mutation The test article
Salmonella was assayed up to
typhimurium and cytotoxic
Escherichia coli concentrations
reverse gene (5,000 mg/
mutation assay) plate), but in no
instance were
appreciably
increased number
of revertants to
histidine
prototrophy (his+)
found in any of
the tester
strains, either in
the presence or
absence of
metabolic
activation.
------------------------------------------------------------------------
870.5395 Cytogenetics In Negative. The
vivo rat incidence of
aberrations and
the aberrations/
cell were not
significantly
increased.
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870.5550 Other effects In Clomazone was
vitro UDS assay tested up to
in primary rat cytotoxicity
hepatocytes (relative toxicity
at 0.10 mL/
mL was 88.6%), but
in no cultures
treated with test
article was a
significant
increase in mean
net nuclear counts
indicative of UDS
recorded.
------------------------------------------------------------------------
870.7485 Metabolism and Clomazone is
pharmacokinetics extensively
metabolized by the
liver and excreted
in the urine and
feces within 24
hours. Sixteen
metabolites,
including the
parent, were
identified; and
the predominant
route of excretion
was in urine.
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic
[[Page 10199]]
Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to
accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q1*) is the primary
method currently used by the Agency to quantify carcinogenic risk. The
Q1* approach assumes that any amount of exposure will lead
to some degree of cancer risk. A Q1* is calculated and used
to estimate risk which represents a probability of occurrence of
additional cancer cases (e.g., risk is expressed as 1 x
10-\6\ or one in a million). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a `` point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOE cancer = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for clomazone used for human
risk assessment is shown in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints For Clomazone Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of NOAEL = 100 mg/kg/day FQPA SF = 1X Developmental rat
age
UF = 100 aPAD = acute RfD LOAEL = 300 mg/kg/day
¸FQPA SF = 1.0 based on delayed
mg/kg/day ossification.
Acute RfD = 1.0 mg/kg/
day
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population None None A risk assessment is
including infants and children not required for this
population subgroup.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL= 84.4 mg/kg/day FQPA SF = 1X 2--year rat feeding
study
UF = 100 cPAD = chronic RfD LOAEL > 84.4 mg/kg/day
¸ FQPA SF = (HDT)
0.84 mg/kg/day
Chronic RfD = 0.84 mg/ 90--day oral rat
kg/day
LOAEL = 319.3 mg/kg/day
based on based on
decreased body weight,
body weight gains,
food consumption and
increased absolute and
relative liver weights
in females and
increased absolute
liver weights in
males.
2--Generation
Reproduction
LOAEL = 100 mg/kg/day
based on statistically
significantly
decreased body weight
& body weight gain
during pre-mating, and
decreased body weight
during gestation &
lactation male &
female. In addition
decreased food
consumption in females
and hydro-nephritic
kidneys in males.
----------------------------------------------------------------------------------------------------------------
Oral, Short-Term (1 to 7 days) None None No residential uses. An
(Residential) endpoint was not
selected.
----------------------------------------------------------------------------------------------------------------
Oral, Intermediate-Term (1 week to None None No residential uses. An
several months) (Residential) endpoint was not
selected.
----------------------------------------------------------------------------------------------------------------
Dermal and Inhalation Short-Term (1 Maternal LOC for MOE = 100 Developmental rat study
to 7 days) (Residential)
NOAEL= 100 mg/kg/day Maternal
Dermal absorption = LOAEL = 300 mg/kg/day,
100% based on
chromorhinorrhea and
abdominogenital
staining
Inhalation absorption =
100%
----------------------------------------------------------------------------------------------------------------
Dermal and Inhalation, Intermediate- Oral LOC for MOE = 100 2-year rat feeding
term (1 week - several months) and study
Long-Term (several months -
lifetime) (Residential)
NOAEL= 84.4 mg/kg/day LOAEL > 84.4 mg/kg/day
(HDT)
90-day oral rat
[[Page 10200]]
LOAEL = 319.3 mg/kg/day
based on based on
decreased body weight,
body weight gains,
food consumption and
increased absolute and
relative liver weights
in females and
increased absolute
liver weights in males
2-Generation
Reproduction
LOAEL = 100 mg/kg/day
based on statistically
significantly
decreased body weight
and body weight gain
during pre-mating, and
decreased body weight
during gestation &
lactation male &
female. In addition
decreased food
consumption in females
and hydro-nephritic
kidneys in males.
Dermal Absorption =
100%
Inhalation absorption =
100%
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.425) for the residues of clomazone, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from clomazone 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)
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: A Tier 1 acute analysis was performed for females
13-50 years old using existing and recommended tolerance level
residues, 100% crop treated.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food consumption
as reported by respondents in the USDA (1989-1992) nationwide CSFII and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: A Tier 1
chronic analysis was performed for the general U.S. population and all
population subgroups using existing and recommended tolerance level
residues, 100% crop treated.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for clomazone 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 clomazone. Clomazone's major environmental
degradate, FMC 65317 (N-[2- chlorophenol)methyl] -3-hydroxy-2,2-
dimethyl propanamide) was also included in the drinking water
assessment.
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
screening concentration in ground water (SCI-GROW), which predicts
pesticide concentrations in ground water. In general, EPA will use
GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a
screening-level assessment for surface water. The GENEEC model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address
[[Page 10201]]
total aggregate exposure to clomazone they are further discussed in the
aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the EECs of clomazone and
FMC 65317 for acute exposures are estimated to be 95 parts per billion
(ppb) for surface water and 2.4 ppb for ground water. The EECs for
chronic exposures are estimated to be 23 ppb for surface water and 2.4
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, flea and tick control on pets).
Clomazone 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 clomazone 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,
clomazone 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 clomazone has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Safety Factor for Infants and Children
1. Safety factor for infants and children--i. 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
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 margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans.
ii. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology data base for clomazone is complete with respect to FQPA
considerations. There is no quantitative or qualitative evidence of
increased susceptibility of rats or rabbit fetuses to in utero exposure
in developmental studies. Although there was a suggestion of
susceptibility in the rat developmental study based on the presence of
delayed ossification in the fetuses, the EPA concluded that the fetal
effects were no more severe than the maternal effects because: There is
no dose response relationship for delayed ossification (i.e., absence
of increased incidence with increase in dose); low fetal/litter
incidences; delayed ossifications were not considered to be severe; and
no visceral or skeletal malformations were seen.
iii. Conclusion. There is a complete toxicity data base for
clomazone and exposure data are complete or are estimated based on data
that reasonably accounts for potential exposures. The FQPA factor was
reduced to 1X because of the following reasons: There is no indication
of quantitative or qualitative increased susceptibility of rats or
rabbits to in utero and/or postnatal exposure; a developmental
neurotoxicity study is not required; and the dietary (food and drinking
water) exposure assessments will not under estimate the potential
exposures for infants and children (there are currently no registered
residential uses).
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)). This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the US EPA Office of Water are used to calculate
DWLOCs: 2Liters (L)/70kilograms (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 ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. A Tier 1 acute dietary exposure analysis for
clomazone was performed using existing and proposed tolerance level
residues, 100 CT for all commodities, and DEEM default processing
factors. The acute analysis was performed for females 13-50 years old.
Using the exposure assumptions discussed in this unit for acute
exposure, the acute dietary exposure from food to clomazone will occupy
1% of aPAD for females 13-50 years and older at the 95th percentile. In
addition, there is potential for acute dietary exposure to clomazone in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in the following Table 3:
[[Page 10202]]
Table 3.--Aggregate Risk Assessment for Acute Exposure to Clomazone
----------------------------------------------------------------------------------------------------------------
aPAD, mg/kg/ Surface Water, Ground
Scenario/Population Subgroup day % aPAD (Food) ppb Water, ppb DWLOC ppb
----------------------------------------------------------------------------------------------------------------
Females 13-50 yrs old 1 1% 95 2.4 30,000
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. A Tier 1 chronic dietary exposure analysis for
clomazone was performed using existing and proposed tolerance level
residues, 100% CT for all commodities, and DEEM default processing
factors. The chronic analysis applied to the U.S. population and all
population subgroups. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to clomazone
from food will utilize 1% of the cPAD for the U.S. population and all
population subgroups. There are no residential uses for clomazone that
result in chronic residential exposure to clomazone. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in the following Table 4:
Table 4. -- Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clomazone
----------------------------------------------------------------------------------------------------------------
cPAD, mg/kg/ Surface Water, Ground
Scenario/Population Subgroup day % cPAD (Food) ppb Water, ppb DWLOC, ppb
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.84 1 23 2.4 29,000
----------------------------------------------------------------------------------------------------------------
All infants ( 1 year old) 0.84 1 23 2.4 8,400
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.84 1 23 2.4 8,400
----------------------------------------------------------------------------------------------------------------
Children (7-12 years old) 0.84 1 23 2.4 8,400
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.84 1 23 2.4 25,000
----------------------------------------------------------------------------------------------------------------
3. Short- and intermediate- term risk. Short-and intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Clomazone is not registered for use on any sites that would result
in residential exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. 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 clomazone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available for the determination of
the residues of clomazone in plants. Briefly, samples are acid
hydrolyzed, hexane extracted, Na2CO3 washed, and
cleaned-up with a FlorisilR column. The resulting samples are analyzed
by gas chromatography (GC) using a nitrogen phosphorus detector (NPD)
or mass spectrometer (MS). The limit of quantitation (LOQ) for this
method is 0.05 ppm. A confirmatory procedure (GC/MS-SIM) is available
(Method I, PAM II).
B. International Residue Limits
There is neither a Codex proposal, nor Canadian or Mexican limits
for residues of clomazone in/on the subject crops. Therefore, a
compatibility issue is not relevant to the proposed tolerance.
V. Conclusion
Therefore, tolerances are established for residues of clomazone,
[2-(2-chlorophenyl)methyl-4,4-dimethyl-3-isoxazolidinone], in or on the
tuberous and corm vegetable (except potato) crop subgroup and cucurbit
vegetable crop group at 0.05 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301101 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 April 16,
2001.
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
[[Page 10203]]
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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301101, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require OMB review or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides
[[Page 10204]]
and pests, Reporting and recordkeeping requirements.
Dated: January 18, 2001.
James Jones,
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 180.425 is amended by alphabetically adding commodities
to the table in paragraph (a) to read as follows:
Sec. 180.425 Clomazone; tolerances for residues.
(a) General.* * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Vegetable, cucurbit, group................................. 0.05
Vegetable, tuberous and corm, except potato, subgroup...... 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-3619 Filed 2-13-01; 8:45 am]
BILLING CODE 6560-50-S
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