[Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)]
[Rules and Regulations]
[Pages 52866-52873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20229]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0181; FRL-7192-9]
Chlorsulfuron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
chlorsulfuron; (2-chloro-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)aminocarbonyl]benzenesulfonamide) in or on grass, forage and grass,
hay. E.I. du Pont de Nemours and Company, Inc. 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 August 14, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0181,
must be received on or before October 15, 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 VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0181 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: 703-305-6224; e-mail address:
[email protected].
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 Potentially
Categories NAICS 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/. 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. 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 ID number OPP-2002-0181. 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 March 8, 2002 (67 FR pages 10722 -
10727) (FRL-6825-8), 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 a pesticide petition (PP 6F4752) by
E.I. du Pont de Nemours and Company, Inc., P.O. Box 30, Newark,
Delaware 19714-0030. This notice included a summary of the petition
prepared by E.I. du Pont de Nemours and Company, the registrant. There
were no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.405 be amended by
establishing tolerances for residues of the herbicide chlorsulfuron;
(2-chloro-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)aminocarbonyl]benzenesulfonamide), in or on grass, forage at 11.0
part per million (ppm) and grass, hay at 19.0 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical
[[Page 52867]]
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 tolerances for residues of chlorsulfuron in or on grass,
forage at 11.0 ppm and grass, hay at 19.0 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerances
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 chlorsulfuron are
discussed in the following Table 1 as well as the no observed adverse
effect level and the lowest observed adverse effect level from the
toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
------------------------------------------------------------------------
870.3150 6 Month oral NOAEL = 18.5 mg/kg/
toxicity in day
nonrodents LOAEL = 82.3 mg/kg/
day based on
decreased body
weight and body-
weight gain.
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL = 165
developmental in mg/kg/day
rodents LOAEL = 500 mg/kg/day
based on clinical
signs, vaginal
discharge with
associated alopecia.
Developmental NOAEL =
500 mg/kg/day
LOAEL = 1500 mg/kg/
day based on
decreased fetal body
weight.
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL = 75
developmental in mg/kg/day
nonrodents LOAEL = 200 mg/kg/day
based on decreased
body weight gain.
Developmental NOAEL =
200 mg/kg/day
LOAEL = 400 mg/kg/day
based on a slight
increase in visceral
malformations and
decreased fetal body
weight.
------------------------------------------------------------------------
870.3800 3-Generation Parental NOAEL = 125
Reproduction in mg/kg/day
rodents LOAEL is greater than
125 mg/kg/day, no
effects observed.
Reproductive NOAEL =
5 mg/kg/day
LOAEL = 25 mg/kg/day
based on decreased
female fertility
Offspring NOAEL = 125
mg/kg/day
LOAEL = 125 mg/kg/
day, no effects
observed.
------------------------------------------------------------------------
870.4100 Chronic toxicity NOAEL = 60.6 mg/kg/
dogs day
LOAEL = 215 mg/kg/day
based on decreased
body-weight gain,
erythrocyte counts
and hemoglobin
levels.
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870.4200 Carcino-genicity NOAEL = 108 mg/kg/day
mice LOAEL = 750 mg/kg/day
based on decreased
body weight and body-
weight gain.
(no) evidence of
carcinogenicity
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870.4300 Carcinogenicity NOAEL = 5 mg/kg/day
rats LOAEL = 25 mg/kg/day
based on decreased
body weight in
males.
(no) evidence of
carcinogenicity
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870.5385 Cytogenetics No evidence of
chromosomal
aberrations
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870.7485 Metabolism and Chlorsulfuron is
pharmacokinetics rapidly absorbed,
metabolized, and
excreted following
oral exposure. The
major routes of
elimination are the
urine (58% - 72%)
and feces (20% -
35%).
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[[Page 52868]]
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. The 3-
generation reproductive toxicity study is classified unacceptable, and
it is considered a datagap. Reproductive toxicity was observed but was
of questionable significance in both litters of the F3
generation, as evidenced by decreased female fertility. Offspring
toxicity was not observed. This study had numerous deficiencies
including but not limited to:
1. No assessment of estrous cyclicity, sperm parameters.
2. No assessment of male reproductive performance.
3. Parental animals not subjected to gross pathology or
histopathology examinations.
4. No assessment of developmental landmarks.
5. Pup histopathology evaluations conducted only for the
F3B generation.
Although this reproduction study on chlorsulfuron conformed to the
old guideline requirements, it is unacceptable under the current
guideline requirement in light of the fact that most of the parameters
used for FQPA assessment are not provided in the available study. The
Agency applied a FQPA database uncertainty factor of 3X to account for
the unacceptable reproduction study. Exposure estimates are upper bound
and will not underestimate exposure to chlorsulfuron. The 3X FQPA
database uncertainty factor applies to all dietary and non-dietary
residential exposure scenarios and no Special FQPA safety factor is
required.
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 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 chlorsulfuron used for human
risk assessment is shown in the following Table 2:
Table 2.--Summary of Toxicological Dose and Endpoints for Chlorsulfuron for 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 no appropriate endpoint for this exposure scenario was identified
age
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population no appropriate endpoint for this exposure scenario was identified
including infants and children
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations NOAEL = 5 mg/kg/day FQPA SF = 1 rat chronic toxicity/
UF = 300............... cPAD = chronic RfD carcinogenicity LOAEL
Chronic RfD = 0.02 mg/ FQPA SF = = 25 mg/kg/day based
kg/day. 0.02 mg/kg/day. on decreased body
weight in males
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Short-Term NOAEL = 75 mg/kg/day FQPA SF = 1 developmental toxicity
Residential Only UF=300................. LOC for MOE = 300...... study in rabbits
LOAEL=200 mg/kg/day
based on decreased
body-weight gain
----------------------------------------------------------------------------------------------------------------
Incidental Oral, Intermediate-Term NOAEL = 75 mg/kg/day FQPA SF = 1 developmental toxicity
Residential Only UF=300................. LOC for MOE = 300...... study in rabbits
LOAEL=200 mg/kg/day
based on decreased
body-weight gain
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days) NOAEL = 75 mg/kg/day FQPA SF = 1 developmental toxicity
(Residential) UF = 300............... LOC for MOE = 300 study in rabbits LOAEL
(Residential). = 200 mg/kg/day based
on decreased body-
weight gain
----------------------------------------------------------------------------------------------------------------
[[Page 52869]]
Intermediate-Term Dermal (1 week to NOAEL = 75 mg/kg/day FQPA SF = 1 developmental toxicity
several months) (Residential) UF = 300............... LOC for MOE = 300 study in rabbits LOAEL
(Residential). = 200 mg/kg/day based
on decreased body-
weight gain
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to NOAEL = 5 mg/kg/day FQPA SF = 1 chronic toxicity/
lifetime) (Residential) UF = 300 when LOC for MOE = 300 carcinogenicity study
appropriate). (Residential). in rats LOAEL = 25 mg/
kg/day based on
decreased body weight
in males
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days) NOAEL = 75 mg/kg/day FQPA SF = 1 developmental toxicity
(Residential) UF = 300............... LOC for MOE = 300 study in rabbits LOAEL
(Residential). = 200 mg/kg/day based
on decreased body-
weight gain
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week NOAEL = 75 mg/kg/day FQPA SF = 1 developmental toxicity
to several months) (Residential) UF = 300).............. LOC for MOE = 300 study in rabbits LOAEL
(Residential). = 200 mg/kg/day based
on decreased body
weight gain
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months NOAEL = 5 mg/kg/day FQPA SF = 1 chronic toxicity/
to lifetime) (Residential) UF = 300).............. LOC for MOE = 300 carcinogenicity study
(Residential). in rats LOAEL = 25 mg/
kg/day based on
decreased body weight
in males
----------------------------------------------------------------------------------------------------------------
* 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 180.405) for the residues of chlorsulfuron, in or
on a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from chlorsulfuron 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 toxicological endpoint attributable to a single
exposure was identified in the available toxicology studies. No
appropriate studies available show any acute dietary effects of
concern.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment 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 chronic
exposure assessments: Residue levels are at the recommended tolerances
and 100% crop treated with chlorsulfuron. Results of dietary analyses
showed exposure to chlorsulfuron consumed no more than 19.3% of the
cPAD.
iii. Cancer. Chlorsulfuron was classified as having ``no evidence
of carcinogenicity'' based upon lack of evidence of carcinogenicity in
rats and mice. Therefore, a cancer dietary exposure analysis was not
performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for chlorsulfuron 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 chlorsulfuron.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentration in Ground Water (SCI-GROW) model
is used to predict pesticide concentrations in shallow groundwater. For
a screening-level assessment for surface water EPA will 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 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 chlorsulfuron, they are
further discussed in the aggregate risk sections in Unit III. E. of
this preamble.
[[Page 52870]]
Based on the FIRST and SCI-GROW models the EECs of total
chlorsulfuron residues (both parent and degradation products) for acute
exposures are estimated to be 59.7 parts per billion (ppb) and for
chronic exposures are estimated to be 41.3 ppb in surface water. The
EECs for acute and chronic exposures of chlorsulfuron (parent only) are
estimated to be 3.5 ppb in 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).
Chlorsulfuron is currently registered for use on the following
residential non-dietary sites: Lawns. The risk assessment was conducted
using the following residential exposure assumptions: Adult handlers
and adult and toddler postapplication exposure to treated turf.
Residential exposure risk was assessed using the Residential Exposure
Assessment Standard Operating Procedures (ResSOPs) standard values and
assumptions. Adult handler exposure risk was not of concern with MOEs
ranging between 8,800 and 190,000. Postapplication exposure risks for
adults and toddlers also exceeded target MOEs, ranging between 770 and
400,000. Since the ResSOPs ranged between median and high end
assessments, and the use assessed was for spot treatment, not the
entire lawn, the residential postapplication exposure risk assessment
was conservative.
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 chlorsulfuron 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,
chlorsulfuron 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 chlorsulfuron 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. 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 MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The toxicology database for
chlorsulfuron contains acceptable guideline developmental studies which
show no quantitative or qualitative evidence of increased
susceptibility following in utero exposure. Susceptibility cannot be
assessed in the 3-generation reproduction study in rats. The Agency
determined that a 2-generation reproduction study is required for
chlorsulfuron.
3. Conclusion. The existing toxicological database for
chlorsulfuron, while not complete, supports the establishment of
permanent tolerances for chlorsulfuron per se and exposure data are
complete or are estimated based on data that reasonably accounts for
potential exposures. For dietary exposure estimates, a FQPA safety
factor of 3 was used. Due to data deficiencies in the toxicology
database, the Agency determined that an additional 3X database UF is
needed for the protection of infants and children. An UF of 3X (as
opposed to a 10X) is adequate because the chronic RfD is based on the
NOAEL of 5 mg/kg/day established in the Combined Chronic/
Carcinogenicity Study in Rats. This dose (5 mg/kg/day) is 25X lower
than the highest dose tested (125 mg/kg/day) in the existing 3-
generation Reproduction Study in which the effects noted were
considered of questionable toxicological significance.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure [(i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + residential exposure)]. This allowable exposure
through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA 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 the pesticide 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 residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. An appropriate endpoint attributable to a single
dose was not identified, therefore, no acute risk is expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
chlorsulfuron from food will utilize no more than 6.6% of the cPAD for
the U.S. population, 7.3% of the cPAD for all infants and 19.3% of the
cPAD for children 1-6 years old. Based on the use pattern, chronic
[[Page 52871]]
residential exposure to residues of chlorsulfuron is not expected.
Since no chronic residential scenarios have been identified, chronic
DWLOCs for chlorsulfuron were calculated based on residues in food
alone. 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 3:
Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Chlorsulfuron
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPADmg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.02 6.6 41.3 3.5 654
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old 0.02 4.3 41.3 3.5 574
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old 0.02 19.3 41.3 3.5 161
----------------------------------------------------------------------------------------------------------------
All Infants 0.02 7.3 41.3 3.5 185
----------------------------------------------------------------------------------------------------------------
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).
Chlorsulfuron is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for chlorsulfuron.
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 1,265 for adult males, 1,274 for
adult females and 722 for toddlers. 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 chlorsulfuron in ground
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
the following Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Chlorsulfuron
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adult Male 1,265 300 41.3 3.5 6,674
----------------------------------------------------------------------------------------------------------------
Adult Female 1,274 300 41.3 3.5 5,734
----------------------------------------------------------------------------------------------------------------
Toddler 722 300 41.3 3.5 1,461
----------------------------------------------------------------------------------------------------------------
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). The
intermediate-term aggregate risk is the same as the short-term
aggregate risk (Table 4) since the toxicity end points are the same for
both exposures.
5. Aggregate cancer risk for U.S. population. The carcinogenic
potential of chlorsulfuron was classified as no evidence of
carcinogenicity. Therefore, no cancer risk is expected.
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 chlorsulfuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Methods are available for the enforcement of tolerances for
chlorsulfuron residues in/on plant and animal commodities. PAM Vol. II
lists Methods I and II, High performance liguid chromotography methods
with photoconductivity detection, for the determination of
chlorsulfuron residues in plants and livestock commodities and milk.
B. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits,
therefore, issues of compatibility do not exist.
C. Conditions
The following data gaps must be fulfilled; a 21-day repeat dermal
toxicity study, a subchronic inhalation study, and a 2-generation
reproduction study.
V. Conclusion
Therefore, tolerances are established for residues of chlorsulfuron
in or on grass, forage at 11.0 ppm and grass, hay at 19.0 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.
[[Page 52872]]
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 ID number OPP-2002-0181 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 October
15, 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 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 ID number OPP-2002-0181, 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).
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). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under 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
[[Page 52873]]
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.
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 and pests, Reporting and
recordkeeping requirements.
Dated: July 30, 2002.
Donald R. Stubbs,
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 180.405 is revised to read as follows:
Sec. 180.405 Chlorsulfuron; tolerances for residues.
(a) General. (1) Tolerances are established for the combined
residues of chlorsulfuron (2-chloro-N-[(4-methoxy-6-methyl-1,3,5-
triazin-2-yl)aminocarbonyl]benzenesulfonamide) and its metabolite, 2-
chloro-5-hydroxy-N-[(4-methoxy-6-methyl-1,3,5-triazin-2-
yl)aminocarbonyl] benzenesulfonamide in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain.............................................. 0.1
Barley, straw.............................................. 0.5
Oat, forage................................................ 20.0
Oat, grain................................................. 0.1
Oat, straw................................................. 0.5
Wheat, forage.............................................. 20.0
Wheat, grain............................................... 0.1
Wheat, straw............................................... 0.5
------------------------------------------------------------------------
(2) Tolerances are established for residues of chlorsulfuron (2-
chloro-N-[(4-methoxy-6-methyl-1,3,5-triazin-2- yl)aminocarbonyl]
benzenesulfonamide) in or on the following raw agricultural
commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.3
Cattle, meat............................................... 0.3
Cattle, meat byproducts.................................... 0.3
Goat, fat.................................................. 0.3
Goat, meat................................................. 0.3
Goat, meat byproducts...................................... 0.3
Grass, forage............................................. 11.0
Grass, hay................................................. 19.0
Hog, fat................................................... 0.3
Hog, meat.................................................. 0.3
Hog, meat byproducts....................................... 0.3
Horse, fat................................................. 0.3
Horse, meat................................................ 0.3
Horse, meat byproducts..................................... 0.3
Milk....................................................... 0.1
Sheep, fat................................................. 0.3
Sheep, meat................................................ 0.3
Sheep, meat byproducts..................................... 0.3
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved].
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 02-20229 Filed 8-13-02; 8:45 am]
BILLING CODE 6560-50-S