[Federal Register Volume 74, Number 183 (Wednesday, September 23, 2009)]
[Rules and Regulations]
[Pages 48396-48402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22915]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0003; FRL-8436-7]


Halosulfuron-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
halosulfuron-methyl and its metabolites and degradates, in or on 
soybean, seed. Canyon Group, LLC requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 23, 2009. Objections and 
requests for hearings must be received on or before November 23, 2009, 
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-2009-0003. 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: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.

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 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet

[[Page 48397]]

under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr. 
You may also access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS Harmonized Guidelines referenced in this document, go 
directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2009-0003 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before November 23, 2009.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0003, 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. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), 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 
8F7424) by Canyon Group, LLC, c/o Gowan Company, 370 South Main St., 
Yuma, AZ 85364. The petition requested that 40 CFR 180.479 be amended 
by establishing a tolerance for residues of the herbicide halosulfuron-
methyl, methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-
ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylic acid, in or on 
soybean at 0.05 parts per million (ppm). That notice referenced a 
summary of the petition prepared by Canyon Group, LLC, the registrant, 
which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    EPA has revised the proposed commodity term from ``soybean'' to 
``soybean, seed'' to agree with the Agency's Food and Feed Commodity 
Vocabulary. EPA has also revised the tolerance expressions for the 
existing plant and livestock commodity tolerances and the new tolerance 
on soybean, seed. The reasons for these changes are explained in Unit 
IV.C.

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 the petitioned-for 
tolerance for residues of halosulfuron-methyl and its metabolites and 
degradates on soybean, seed at 0.05 ppm. EPA's assessment of exposures 
and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Halosulfuron-methyl has low acute toxicity via the oral, dermal, 
and inhalation routes of exposure. It is non-irritating to the skin and 
eyes and is not a dermal sensitizer. With repeated dosing, the 
available data show that the dog is the most sensitive mammalian 
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 non-specific decrease in body weight gain at high dose levels in 
short-term and long-term oral and dermal studies. 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 mutagenicity studies. There is no evidence 
of immunotoxicity or neurotoxicity in the available studies for 
halosulfuron-methyl.
    There was no quantitative evidence for increased susceptibility of 
fetuses or offspring following prenatal and/or postnatal exposure to 
halosulfuron-methyl in the developmental and reproductive toxicity 
studies. However, there was qualitative evidence for increased 
susceptibility. In the rat developmental toxicity study, increased 
fetal and litter incidences of soft tissue (dilation of the lateral 
ventricles) and skeletal variations, and decreased mean fetal body 
weight and mean litter size were seen at a dose resulting in less 
severe maternal effects (increased incidence of clinical observations, 
reduced body weight gains, reduced food consumption and food 
efficiency). 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,

[[Page 48398]]

the developmental effect was considered to be qualitatively more severe 
than maternal effects. In the reproduction study in rats, parental 
effects (decreased body weights, body weight gains, and reduced food 
consumption during the premating period in both sexes) were comparable 
in severity to offspring effects (decreased body weight in the F1 pups 
and marginal decreased body weight in F2 pups).
    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 the document, Halosulfuron-methyl: Human Health 
Risk Assessment for Proposed Uses on Soybean, page 36 in docket ID 
number EPA-HQ-OPP-2009-0003.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the level of 
concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in the document, Halosulfuron-methyl: Human Health 
Risk Assessment for Proposed Uses on Soybean, page 13 in docket ID 
number EPA-HQ-OPP-2009-0003.

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 tolerance 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 (decreased mean 
litter size, increased number of resorptions and increased 
postimplantation loss, assumed to occur after a single exposure) were 
identified for the population subgroup females 13 to 49 years old. No 
such effects were identified for the general population, including 
infants and children.
    In estimating acute dietary exposure of females 13 to 49 years old, 
EPA used food consumption information from the U.S. Department of 
Agriculture (USDA) 1994-1996 Nationwide Continuing Surveys of Food 
Intakes by Individuals (CSFII). As to residue levels in food, EPA 
assumed tolerance-level residues and 100 percent crop treated (PCT) for 
all existing and 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 new uses of 
halosulfuron-methyl.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA classified halosulfuron-methyl as ``not likely to be 
carcinogenic to humans.'' Therefore, an exposure assessment to evaluate 
cancer risk is unnecessary for this chemical.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue 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) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of halosulfuron-methyl 
for acute exposures are estimated to be 8.3 parts per billion (ppb) for 
surface water and 0.065 ppb for ground water. The EDWCs for chronic 
exposures for non-cancer assessments are estimated to be 1.7 ppb for 
surface water and 0.065 ppb 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 from drinking water. This value is 
substantially higher than the modeled EDWCs for acute and chronic 
exposures (8.3 ppb and 1.7 ppb, respectively) and was derived from 
preliminary modeling using a different model (a Tier one rice model). 
This model overestimates levels that would occur in drinking water, 
because it does not consider the degradation of the pesticide or the 
dilution of the pesticide as it is transported away from the rice field 
into the drinking water source. The Agency has concluded that the EDWCs 
derived using the FIRST model and based on the crop scenarios corn and 
sugarcane provide a more reasonable high end estimate of expected 
levels in surface water used for drinking water. However, since acute 
and chronic exposure estimates using the higher value are below EPA's 
LOC, EPA did not revise the dietary exposure assessment to incorporate 
the lower EDWCs.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in

[[Page 48399]]

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: Residential turfgrass and 
ornamentals. EPA assessed residential exposure using the following 
assumptions: Residential handlers may receive short-term dermal and 
inhalation exposure 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 post-application activities. In addition, toddlers may 
receive short-term and intermediate-term oral exposure from incidental 
ingestion during post-application activities. EPA assessed short-term 
dermal and inhalation exposure of residential handlers and the 
following post-application exposure scenarios:
    i. Adult and toddler post-application dermal exposure
    ii. Toddlers' incidental ingestion of pesticide residues on lawns 
from hand-to-mouth transfer.
     iii. Toddlers' object-to-mouth transfer from mouthing of 
pesticide-treated turfgrass.
    iv. Toddlers' incidental ingestion of soil from pesticide-treated 
residential areas.
    v. 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 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 qualitative 
evidence of increased susceptibility of fetuses in the rat and rabbit 
developmental studies. Fetal effects (increased incidences of soft 
tissue and skeletal variations, decreased mean fetal body weight and 
mean litter size in the rat study; increases in resorptions and post-
implantation losses and a decrease in mean litter size in the rabbit 
study) occurred at doses resulting in less severe maternal toxicity 
(increased incidence of clinical observations, reduced body weight 
gains, reduced food consumption and food efficiency in the rat study; 
decreases in body weight and food consumption in the rabbit study). The 
degree of concern for these effects is low, and there are no residual 
uncertainties for prenatal toxicity in rats and rabbits for the 
following reasons. In both studies, there are clear NOAELs/LOAELs for 
developmental and maternal toxicities; developmental effects were seen 
in the presence of maternal toxicity; and effects were seen only at the 
high dose. Additionally, in rats, developmental effects were seen at a 
dose which is approaching the limit-dose.
    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 adequate to 
assess prenatal and postnatal toxicity. In accordance with 40 CFR part 
158 Toxicology Data requirements, an immunotoxicity study (870.7800) is 
required for halosulfuron-methyl. In the absence of specific 
immunotoxicity studies, EPA has evaluated the available halosulfuron-
methyl toxicity data to determine whether an additional uncertainty 
factor is needed to account for potential immunotoxicity. The 
toxicology database for halosulfuron-methyl does not show any evidence 
of biologically relevant effects on the immune system following 
exposure to this chemical. The overall weight-of-evidence suggests that 
this chemical does not directly target the immune system. Based on 
these considerations, EPA does not believe that conducting 
immunotoxicity testing will result in a point of departure lower than 
those already selected for halosulfuron-methyl risk assessment, and an 
additional database uncertainty factor is not needed to account for the 
lack of this study.
    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 evidence of increased qualitative 
susceptibility in in utero rats and rabbits in the prenatal 
developmental studies, the degree of concern for developmental effects 
is low, and EPA did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment of halosulfuron-methyl.
    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. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to halosulfuron-methyl in drinking water. EPA 
used similarly conservative assumptions 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of

[[Page 48400]]

additional cancer cases given the estimated aggregate exposure. Short-
term, intermediate-term, and chronic-term risks are evaluated by 
comparing the estimated aggregate food, water, and residential exposure 
to the POD to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    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 <1% of the aPAD for females 13 to 49 
years old, the only population group for which acute exposure is of 
toxicological concern.
    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 1.6% of the cPAD 
for the general U.S. population and 4.6% of the cPAD for 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 aggregate MOEs ranging from 2,800 
(infants less than 1 year old) to 4,800 (females, 13 to 49 years old). 
The aggregate MOEs for adults include short-term dermal and inhalation 
exposures for residential handlers and post-application dermal 
exposures from activities on turfgrass previously treated with 
halosulfuron-methyl. The aggregate MOEs for children's subgroups 
include short-term post-application dermal and incidental oral 
exposures from activities on halosulfuron-methyl-treated turfgrass.
    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 to 
halosulfuron-methyl through food and water with intermediate-term 
exposures for 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 (U.S. population, females 13 to 49 
years old, and adults 50 years and older) to 700 (infants less than 1 
year old). The aggregate MOEs for adults include intermediate-term 
dermal and inhalation exposures for residential handlers and post-
application dermal exposures from activities on turfgrass previously 
treated with halosulfuron-methyl. The inclusion of intermediate-term 
residential handler exposures in the aggregate MOE is conservative 
(protective), since intermediate-term exposure of handlers is unlikely. 
The aggregate MOEs for children's subgroups, including infants, include 
intermediate-term post-application dermal and incidental oral exposures 
from activities on halosulfuron-methyl-treated turfgrass.
    5. Aggregate cancer risk for U.S. population. Based on a lack of 
evidence for carcinogenicity in mice and rats following long-term 
dietary administration, halosulfuron-methyl is not expected to pose a 
cancer risk.
    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

    Adequate enforcement methodology (gas chromatography, Monsanto 
Analytical Method RES-109-97-4) is available to enforce the tolerance. 
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: 
residuemethods@epa.gov.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residues limits (MRLs) for halosulfuron-methyl.

C. Revisions to Petitioned-For Tolerance

    EPA has revised the proposed commodity term from ``soybean'' to 
``soybean, seed'' to agree with the Agency's Food and Feed Commodity 
Vocabulary. EPA is also revising the tolerance expression for soybean, 
seed and the 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 plants 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 halosulfuron-methyl. 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 convertible to 3-chloro-1-
methyl-5-sulfamoylpyrazole-4-carboxylic acid, expressed as the 
stoichiometric equivalent of halosulfuron-methyl. EPA is also revising 
the chemical name for halosulfuron-methyl to conform to the 
nomenclature recommendations of the Chemical Abstracts Service (CAS): 
methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl] 
amino] sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate.
    EPA has determined that it is reasonable to make these changes in 
the tolerance expression 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 existing tolerance expression.

V. Conclusion

    Therefore, a tolerance is established for residues of halosulfuron-
methyl and its metabolites and degradates on soybean, seed at 0.05 ppm. 
Compliance with the tolerance level will be determined by measuring 
only halosulfuron-methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino] carbonyl] amino] sulfonyl]-1-methyl-1H-pyrazole-4-
carboxylate, in or on the commodity.

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

[[Page 48401]]

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: September 15, 2009.
Rachel C. Holloman,
Acting 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 by revising the introductory text of 
paragraphs (a)(1) and (a)(2) and alphabetically adding an entry for 
``soybean, seed'' 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 3-chloro-5-[[[[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonyl] amino] sulfonyl]-1-methyl-1H-pyrazole-4-
carboxylate, and its metabolites and degradates in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below 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 the commodity.
* * * * *
    (2) Tolerances are established for residues of the herbicide 
halosulfuron-methyl and its metabolites and degradates in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only halosulfuron-
methyl, methyl 3-chloro-5-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] 
carbonyl] amino] sulfonyl]-1-methyl-1H-pyrazole-4-carboxylate, in or on 
the commodity.

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Soybean, seed.........................................                                                      0.05
                                                    * * * * *
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[FR Doc. E9-22915 Filed 9-22-09; 8:45 am]
BILLING CODE 6560-50-S