[Federal Register Volume 75, Number 149 (Wednesday, August 4, 2010)]
[Rules and Regulations]
[Pages 46847-46854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19053]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0797; FRL-8835-8]
Halosulfuron-methyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
halosulfuron-methyl in or on multiple commodities which are identified
and discussed later in this document. Additionally, this regulation
removes the existing tolerance on bean, snap, succulent at 0.05 parts
per million (ppm) in that it is superseded by this action establishing
a tolerance at 0.05 ppm on pea and bean, succulent shelled, subgroup
6B. The Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 4, 2010. Objections and
requests for hearings must be received on or before October 4, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0797. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are
[[Page 46848]]
not limited to those engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.
C. How Can I File an Objection or Hearing Request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0797 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 4, 2010. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0797, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Summary of Petitioned-For Tolerance
In the Federal Register of Wednesday, January 6, 2010 (75 FR 864)
(FRL-8801-5), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 9E7577) by IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08549. The petition requested that 40
CFR 180.479 be amended by establishing tolerances for residues of the
herbicide halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1 H-pyrazole-4-
carboxylate, and its metabolites and degradates (compliance with the
tolerance level specified is to be determined by measuring only those
halosulfuron-methyl residues convertible to 3-chloro-1-methyl-5-
sulfamoylpyrazole-4-carboxylic acid, expressed as the stoichiometric
equivalent of halosulfuron-methyl) in or on pea and bean, succulent
shelled, subgroup 6B; pea and bean, dried shelled, except soybean,
subgroup 6C; vegetables, tuberous and corm, subgroup 1C; bushberry,
subgroup 13-07B; apple; rhubarb; and okra at 0.05 ppm That notice
referenced a summary of the petition prepared by Gowan Company, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA is not
taking action at this time on the petitioned-for tolerance for pea and
bean, dried shelled, except soybean, subgroup 6C due to insufficient
field trial data to support this use. Additionally, the Agency is
revoking the existing tolerance on bean, snap, succulent at 0.05 ppm in
order to eliminate redundancy with the 0.05 ppm tolerance on pea and
bean, succulent shelled, subgroup 6B established by this action. EPA is
also revising the tolerance expressions for halosurfuron-methyl for new
uses in this regulation and for existing plant and livestock
commodities to clarify the chemical moieties that are covered by the
tolerances and specify how compliance with the tolerances is to be
measured. The reasons for these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information''. This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for halosulfuron-methyl
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
halosulfuron-methyl follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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.
[[Page 46849]]
Halosulfuron-methyl has low acute toxicity by oral, dermal, and
inhalation routes of exposure. It is not a dermal sensitizer nor is it
an eye or skin irritant. The toxicity mode of action in mammals is
undetermined. However, available data show that the dog is the most
sensitive animal species. In the dog, decreased body weight was seen in
the chronic oral toxicity study and decreased body weight gain was
observed in females in the subchronic oral toxicity study. In the rat
and mouse, there was a decrease in body weight gains at high dose
levels in short-term and long-term oral and dermal studies. Both acute
and subchronic neurotoxicity studies showed no neurotoxic effects.
There was no quantitative evidence for increased susceptibility
following pre- and/or post-natal exposure. However, there was
qualitative evidence for increased susceptibility. In the rat
developmental toxicity study, increases in resorptions, soft tissue
(dilation of the lateral ventricles) and skeletal variations, and
decreases in body weights were seen in the fetuses compared to clinical
signs and decreases in body weights and food consumption in the
maternal animals. In the rabbit study, increases in resorptions and
post-implantation losses and a decrease in mean litter size were seen
in the presence of decreases in body weight and food consumption in
maternal animals. Thus, in both species, the developmental effect was
considered to be qualitatively more severe than maternal effects.
Halosulfuron-methyl is classified as ``not likely to be
carcinogenic to humans'' based on a lack of evidence for
carcinogenicity in mice and rats following long-term dietary
administration. Halosulfuron-methyl is negative for mutagenicity in a
battery of genotoxicity studies. There is no evidence of immunotoxicity
in the available studies for halosulfuron-methyl. Acute and subchronic
neurotoxicity studies showed no evidence of neurotoxicity.
Specific information on the studies received and the nature of the
adverse effects caused by halosulfuron-methyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: ``Halosulfuron-Methyl: Human Health
Risk Assessment for IR-4 Proposed Uses on Crop Group 6B Succulent
Shelled Pea and Bean Subgroup, Crop Group 1C Tuberous and Corm
Vegetables Subgroup, Crop Group 6C Dried Shelled Pea and Bean (Except
Soybean), Subgroup 13-07B Bushberry, Okra, Apples, and Rhubarb, dated
April 5, 2010,'' p. 13 in docket ID number EPA-HQ-OPP-2009-0797-0005.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level - generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for halosulfuron-methyl
used for human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for for Use in Human Health Risk Assessment
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Point of Departure and
Exposure/Scenario Uncertainty/FQPA Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
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Acute dietary NOAEL = 50 milligrams/ Acute RfD = 0.5 mg/kg/ Developmental Toxicity
(Females 13-49 years of age)........ kilograms/day (mg/kg/ day Rabbit
day) aPAD = 0.5 mg/kg/day... LOAEL = 150 mg/kg/day
UFA = 10x.............. based on decreased
UFH = 10x.............. mean litter size,
FQPA SF = 1x........... increased number of
resorptions and
increased post-
implantations loss.
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Acute dietary N/A N/A No adverse effect
(General population including infants attributable to a
and children). single dose was
identified and no dose/
endpoint was selected.
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Chronic dietary NOAEL= 10 mg/kg/day UFA Chronic RfD = 0.1 mg/kg/ Chronic Toxicity - Dog
(All populations).................... = 10x day LOAEL = 40 mg/kg/day
UFH = 10x.............. cPAD = 0.1 mg/kg/day... based on decreased
FQPA SF = 1x........... body weight gains in
females.
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Incidental oral short-term NOAEL= 50 mg/kg/day UFA Residential LOC for MOE Developmental Toxicity
(1 to 30 days)....................... = 10x = 100. Rabbit
UFH = 10x.............. LOAEL = 150 mg/kg/day
FQPA SF = 1x........... based on decreased
body weight gain, food
consumption, and food
efficiency (maternal
toxicity).
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Incidental oral intermediate-term NOAEL= 10 mg/kg/day Residential LOC for MOE 13 week Subchronic
(1 to 6 months)...................... UFA= 10x = 100 toxicity - Dog
UFH= 10x............... LOAEL = 40 mg/kg/day
FQPA SF = 1x........... based on on decreased
body weight gains and
food efficiency along
with hematological and
clinical chemistry
changes.
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[[Page 46850]]
Dermal short-term Dermal study NOAEL = Residential LOC for MOE 21-Day Dermal Toxicity
(1 to 30 days)....................... 100mg/kg/day = 100 Study - Rat
UFA = 10x.............. LOAEL = 1,000 mg/kg/day
UFH = 10x.............. based on decreased
FQPA SF = 1x........... body weight gain in
males.
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Dermal intermediate-term Dermal study NOAEL= 10 Residential LOC for MOE 13 Week Subchronic
(1 to 6 months)...................... mg/kg/day (dermal = 100 Toxicity - Dog
absorption rate = 75%) LOAEL = 40 mg/kg/day
UFA = 10x.............. based on decreased
UFH = 10x.............. body weight gains and
FQPA SF = 1x........... food efficiency along
with hematological and
clinical chemistry
changes.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term Inhalation study NOAEL Residential LOC for MOE Developmental Toxicity
(1 to 30 days)....................... = 50 mg/kg/day = 100 Rabbit
(inhalation absorption LOAEL = 150 mg/kg/day
rate = 100%) based on decreased
UFA = 10x.............. body weight gain, food
UFH = 10x.............. consumption, and food
FQPA SF = 1x........... efficiency (maternal
toxicity).
----------------------------------------------------------------------------------------------------------------
Inhalation Intermediate-term Inhalation (or oral) Residential LOC for MOE 13 week Subchronic
(1 to 6 months)...................... study NOAEL = 10 mg/kg/ = 100 Toxicity - Dog
day (inhalation LOAEL = 40 mg/kg/day
absorption rate = based on based on
100%) decreased body weight
UFA = 10x.............. gains and food
UFH = 10x.............. efficiency along with
FQPA SF = 1x........... hematological and
clinical chemistry
changes.
----------------------------------------------------------------------------------------------------------------
Cancer Classification: not likely to be carcinogenic to humans by the oral route, based on no evidence of carcinogenicity from
studies in rats and mice.
----------------------------------------------------------------------------------------------------------------
A 75% dermal absorption factor should be used in route-to-route extrapolation for the intermediate term dermal
exposure risk. Absorption via the inhalation route is presumed to be equivalent to oral absorption.NOAEL = no
observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA =
extrapolation from animal to human (inter-species). UFH = potential variation in sensitivity among members of
the human population (intra-species). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute,
c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to halosulfuron-methyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing halosulfuron-methyl
tolerances in 40 CFR 180.479. EPA assessed dietary exposures from
halosulfuron-methyl in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure.
Such effects were identified for halosulfuron-methyl including
decreased mean litter size, increased number of resorptions (total and
per dam) and increased post-implantation loss (developmental toxicity)
were identified for the population subgroup females 13 to 49 years old
(the only population subgroup with a toxicological endpoint
attributable to a single dose of halosulfuron-methyl). In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture (USDA) 1994-1996 and 1998
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As
to residue levels in food, EPA assumed tolerance-level residues and 100
percent crop treated (PCT) for all existing and recommended new uses of
halosulfuron-methyl.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues and 100 PCT for all existing and recommended new uses of
halosulfuron-methyl
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that halosulfuron-methyl does not pose a cancer risk to
humans. Therefore, a dietary exposure assessment for the purpose of
assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for halosulfuron-methyl. Tolerance level residues and 100 PCT were
assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for halosulfuron-methyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of halosulfuron-methyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST),
Pesticide Root Zone Model /Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models,
the estimated drinking water concentrations
[[Page 46851]]
(EDWCs) of halosulfuron-methyl are Tier I EDWCs based on a maximum
annual application rate of 0.125 lb active ingredient (ai)/acre(A) for
rice.
Acute exposures and chronic exposures for non-cancer assessments
are estimated to be 59.2 parts per billion (ppb) based on FIRST model
for surface water and 0.065 ppb bases on SCI-GROW model results for
ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
For acute and chronic dietary risk assessment, the water
concentration value of 59.2 ppb was used to assess the contribution to
drinking 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).
Halosulfuron-methyl is currently registered for the following uses
that could result in residential exposures: Ornamentals, and commercial
and residential turfgrass. EPA assessed residential exposure using the
following assumptions: Residential handlers may receive short-term
dermal and inhalation exposures to halosulfuron-methyl when mixing,
loading and applying halosulfuron-methyl products. Adults and children
may be exposed to halosulfuron-methyl residues through dermal contact
with turf during postapplication activities. In addition, toddlers may
receive short- and intermediate-term oral exposure from incidental
ingestion during postapplication activities.
Halosulfuron-methyl exposure data for handler activities were not
submitted to EPA in support of registered lawn uses. EPA's Draft
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments, and Recommended Revisions were used as the basis for the
residential handler exposure calculations. The handler exposure data
used in this assessment are from the Outdoor Residential Exposure Task
Force (ORETF).
For residential exposure from lawn use, the Agency evaluated the
combined exposure and risk estimates to adults from halsulfuron-methyl
under scenarios including:
i. Mix/load and broadcast application of liquid formulation (garden
hose-end sprayer) for both dermal and inhalation routes, and
ii. Post-application exposure by dermal route.
For residential postapplication exposure, the following scenarios
resulting from lawn treatment were assessed:
a. Adult and children 3 to <6 years old post-application dermal
exposure,
b. Child 3 to <6 years old incidental ingestion of pesticide
residues on lawns from hand-to-mouth transfer,
c. Toddlers' object-to-mouth transfer from mouthing of pesticide-
treated turf grass, and
d. Children 3 to <6 years old incidental ingestion of soil from
pesticide-treated residential areas. Post-application exposures from
various activities following lawn treatment are considered to be the
most common and significant in residential settings.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found halosulfuron-methyl to share a common mechanism
of toxicity with any other substances, and halosulfuron-methyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
halosulfuron-methyl does not have 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 EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for halosulfuron-methyl includes rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. As discussed in Unit III.A., there was no quantitative
evidence for increased susceptibility following pre-natal and/or post-
natal exposure. However, there was qualitative evidence for increased
susceptibility of fetuses in the rat and rabbit developmental studies.
In the rat study, increases in resorptions, soft tissue (dilation of
the lateral ventricles) and skeletal variations, and decreases in body
weights were seen in the fetuses compared to clinical signs and
decreases in body weights and food consumption in the maternal animals.
In the rabbit study, increases in resorptions and post-implantation
losses and decrease in mean litter size was seen in the presence of
decreases in body weight and food consumption in maternal animals.
Thus, in both species, the developmental effect was considered to be
qualitatively more severe than maternal effects (i.e., qualitative
evidence for susceptibility). In both studies, there are clear NOAELs/
LOAELs for developmental and maternal toxicities, developmental effects
were seen in the presence of maternal toxicity, and the effects were
only seen at the high dose. Additionally, in rats, developmental
effects were seen at a dose which is approaching the limit-dose. The
degree of concern is low and there are no residual uncertainties for
prenatal toxicity in both rats and rabbits.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for halosulfuron-methyl is complete except
for an immunotoxicity study as required by the latest amendment to 40
CFR part 158. After analysis of the database, an additional factor
(UFDB) for database uncertainty is not needed to account for
the lack of this study because the available data do not suggest that
this chemical affects the immune system.
ii. There is no indication that halosulfuron-methyl is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. Although there is qualitative evidence of increased
susceptibility in the prenatal developmental studies in
[[Page 46852]]
rats and rabbits, as discussed in this unit, there are no residual
uncertainties after establishing toxicity endpoints and the degree of
concern for pre-and/or post-natal toxicity is low.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues, and conservative (protective)
assumptions in the ground water and surface water modeling were used to
assess exposure to halosulfuron-methyl in drinking water. Similarly
conservative assumptions were also used to assess post-application
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by halosulfuron-methyl.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to halosulfuron-methyl will occupy less than 1% of the aPAD for the
population subgroup of concern, females 13-49 years old, the only
population group where there are acute toxicology concerns.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
halosulfuron-methyl from food and water will utilize 5% of the cPAD for
all infants less than 1 year old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
halosulfuron-methyl is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Halosulfuron-
methyl is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to halosulfuron-methyl.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in short-term aggregate MOEs ranging
from 2,800 to 4,800. The MOE for the U.S. population is 4,700. The most
highly exposed subgroup is all infants (< 1 year old), with a MOE of
2,800. Because these estimates of short-term aggregate risk for
halosulfuron-methyl are above a MOE of 100, these MOEs are not of
concern to EPA.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Halosulfuron-methyl is currently registered for uses that could
result in intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with intermediate-term residential exposures to
halosulfuron-methyl.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs ranging from 500 to 680. The MOE for the U.S. population
is 500. The most highly exposed children's subgroup was all infants (<
1 year old), with a MOE of 680. These estimates of aggregate risk do
not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, halosulfuron-methyl is not expected to pose a cancer risk to
humans.
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, or to infants and children from aggregate
exposure to halosulfuron-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate analytical method is available for the enforcement of
tolerances for residues of halosulfuron-methyl in plants. Monsanto
Analytical Method RES-109-97-4 (gas chromatography, using thermionic-
specific detection, TSD, nitrogen specific) has been validated by EPA.
The method's limit of quantitation (LOQ) determined across a variety of
tested crops is 0.05 ppm. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: [email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
There are no Codex, Canadian or Mexican maximum residue limits
(MRLs) established for residues of halosulfuron-methyl in crop or
livestock commodities.
C. Revisions to Petitioned-For Tolerances
EPA is not taking action on the petitioned-for tolerance for pea
and bean, dried shelled (except soybean) due to inadequate data
available to support these uses. Generally, EPA recommends that five
field trials be submitted for peas but none have been submitted with
this petition.
EPA is revising the tolerance expressions for halosurfuron-methyl
for new uses in this regulation and for existing plant and livestock
commodities to clarify the chemical moieties that are covered by the
tolerances and specify how compliance with the tolerances is to be
measured.
The revised tolerance expression for livestock commodities makes
clear that the tolerances cover residues of halosulfuron-methyl and its
metabolites and degradates and that compliance with the tolerance
levels will be determined by measuring only those halosulfuron-methyl
residues containing the 3-chlorosulfonamide (3CSA) moiety, expressed as
the stoichiometric equivalent of halosulfuron-methyl.
[[Page 46853]]
EPA believes that it is reasonable to make these changes in the
tolerance expressions final without prior proposal and opportunity for
comment, because public comment is not necessary, in that the changes
have no substantive effect on the tolerance, but rather are merely
intended to clarify the tolerance expression compliance component(s)
measurement.
V. Conclusion
Therefore, tolerances are established for residues of the herbicide
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, including its metabolites and degradates, in or on pea
and bean, succulent shelled, subgroup 6B; vegetable, tuberous and corm,
subgroup 1C; bushberry, subgroup 13-07B; apple; rhubarb; and okra at
0.05 ppm. Compliance with the tolerance level specified below is to be
determined by measuring only halosulfuron-methyl.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 26, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.479 is amended as follows:
0
i. Revise the introductory text in paragraphs (a)(1) and (a)(2);
0
ii. In paragraph (a)(2), in the table, revise the commodity Bean, snap,
succulent to read Pea and bean, succulent shelled, subgroup 6; and
0
iii. Alphabetically add the following commodities to the table in
paragraph (a)(2) to read as follows:
Sec. 180.479 Halosulfuron-methyl; tolerances for residues.
(a) * * * (1) Tolerances are established for residues of the
herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino] carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only those halosulfuron-methyl residues containing the 3-
chlorosulfonamide (3-CSA) moiety, expressed as the stoichiometric
equivalent of halosulfuron-methyl, in or on the commodity.
* * * * *
(2) Tolerances are established for residues of the herbicide
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidiny)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified in the following table is to be determined by
measuring only halosulfuron-methyl.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Apple................................................ 0.05
* * * * *
Bushberry, subgroup 13-07B........................... 0.05
* * * * *
Okra................................................. 0.05
[[Page 46854]]
* * * * *
Pea and bean, succulent shelled, subgroup 6B......... 0.05
* * * * *
Rhubarb.............................................. 0.05
* * * * *
Vegetable, tuberous and corm, subgroup 1C............ 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-19053 Filed 8-3-10; 8:45 am]
BILLING CODE 6560-50-S