[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per million (ppm) in that it is superseded by this action establishing 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
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario            Uncertainty/FQPA Safety   RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

[[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.
----------------------------------------------------------------------------------------------------------------
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