[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Rules and Regulations]
[Pages 71555-71561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29105]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0781; FRL-9370-6]


Halosulfuron-Methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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[[Page 71556]]

SUMMARY: This regulation establishes tolerances for residues of 
halosulfuron-methyl in or on multiple commodities which are identified 
and discussed later in this document. Canyon Group L.L.C., c/o Gowan 
Company requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 3, 2012. Objections and 
requests for hearings must be received on or before February 1, 2013, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0781, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Maggie Rudick, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 347-0257; email address: rudick.maggie@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
OCSPP test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

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-2011-0781 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 
February 1, 2013. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2011-0781, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of December 8, 2011 (75 FR 76676) (FRL-
9328-8), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1F7916) by Canyon Group L.L.C., c/o Gowan Company, 370 South Main St., 
Yuma, AZ 85364. The petition requested that 40 CFR 180.479 be amended 
by establishing tolerances for residues of the herbicide halosulfuron-
methyl, methyl 5-[(4,6-dimethoxy-2-
pyrimidinyl)amino]carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-
4-carboxylate, in or on millet, proso, forage at 7.0 parts per million 
(ppm); millet, proso, hay at 0.02 ppm; millet, proso, grain at 0.01 
ppm; millet, proso, straw at 0.01 ppm; grass, forage, fodder, and hay, 
group 17, forage at 17 ppm; and grass, forage, fodder, and hay, group 
17, hay at 0.90 ppm. That document referenced a summary of the petition 
prepared by Canyon Group, L.L.C., the registrant, which is available in 
the docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance levels, determined that established 
tolerances for certain livestock commodities should be increased and 
multiple new livestock commodity tolerances should be established. 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

[[Page 71557]]

result to infants and children from aggregate exposure to the pesticide 
chemical residue * * *.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure 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 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 a low acute toxicity via the oral, dermal, 
and inhalation routes of exposure. Halosulfuron-methyl is a non-
irritant for skin and eyes and is not a dermal sensitizer.
    With repeated dosing, halosulfuron-methyl produces non-specific 
effects, which are frequently characterized by reduced body weight/body 
weight gain in the test animals. 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 decrease in body weight gains 
at high dose levels in short- and long-term oral and dermal studies.
    In the prenatal developmental toxicity study in rats, 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 at similar dose level.
    In the rabbit developmental toxicity 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 were observed. However, a clear no-
observed-adverse-effect-level (NOAEL) for these effects was established 
in both rat and rabbit developmental toxicity studies.
    Halosulfuron-methyl did not produce reproductive effects. No 
neurotoxic effects were observed in the acute or subchronic 
neurotoxicity studies. Halosulfuron-methyl is classified as ``not 
likely to be carcinogenic to humans'' because in both rat and mouse 
carcinogenicity studies halosulfuron-methyl does not cause; compound-
related increases in tumor incidence. It is negative for mutagenicity 
in a battery of genotoxicity studies. Specific information on the 
studies received and the nature of the adverse effects caused by 
halosulfuron-methyl as well as the 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 New Uses on Proso Millet and Crop 
Group 17 (Grass, Forage, Fodder, and Hay)'' at p. 19 in docket ID 
number EPA-HQ-OPP-2011-0781.

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 (LOC) 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 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 
following Table.

    Table--Summary of Toxicological Doses and Endpoints for Halosulfuron-Methyl for Use in Human Health Risk
                                                   Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 50 mg/kg/day  Acute RfD = 0.5 mg/  Developmental Toxicity--Rabbit.
 years of age).                    UFA = 10X...........   kg/day.             LOAEL = 150 mg/kg/day based on
                                   UFH = 10X...........  aPAD = 0.5 mg/kg/     decreased mean litter size,
                                   FQPA SF = 1X........   day.                 increased number of resorptions
                                                                               (total and per dam) and increased
                                                                               post-implantation loss
                                                                               (developmental toxicity).
Acute dietary (General population  N/A.................  N/A................  No adverse effect attributable to
 including infants and children).                                              a single dose was identified;
                                                                               therefore, no dose/endpoint was
                                                                               selected for this exposure
                                                                               scenario.
Chronic dietary (All populations)  NOAEL = 10 mg/kg/day  Chronic RfD = 0.1    Chronic Toxicity--Dog.
                                   UFA = 10X...........   mg/kg/day.          LOAEL = 40 mg/kg/day based on
                                   UFH = 10X...........  cPAD = 0.1 mg/kg/     decreased body weight gains in
                                   FQPA SF = 1X........   day.                 females.

[[Page 71558]]

 
Incidental oral short-term (1 to   NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Developmental Toxicity--Rabbit.
 30 days).                         UFA = 10X...........                       LOAEL = 150 mg/kg/day based on
                                   UFH = 10X...........                        decreased body weight gain, food
                                   FQPA SF = 1X........                        consumption, and food efficiency
                                                                               (maternal toxicity).
Incidental oral intermediate-term  NOAEL = 10 mg/kg/day  LOC for MOE = 100..  13 Week Subchronic Toxicity--Dog.
 (1 to 6 months).                  UFA= 10X............                       LOAEL = 40 mg/kg/day based on
                                   UFH= 10X............                        decreased body weight gains and
                                   FQPA SF = 1X........                        food efficiency along with
                                                                               hematological and clinical
                                                                               chemistry changes.
Dermal short-term (1 to 30 days).  NOAEL = 100 mg/kg/    LOC for MOE = 100..  21 Day Dermal Toxicity Study--
                                    day.                                       Rats.
                                   UFA = 10X...........                       LOAEL = 1,000 mg/kg/day based on
                                   UFH = 10X...........                        decreased body weight gains in
                                   FQPA SF = 1X........                        males.
Dermal intermediate-term (1 to 6   NOAEL = 10 mg/kg/day  LOC for MOE = 100..  13 Week Subchronic Toxicity--Dog.
 months).                          UFA = 10X...........                       LOAEL = 40 mg/kg/day based on
                                   UFH = 10X...........                        decreased body weight gains and
                                   FQPA SF = 1X........                        food efficiency along with
                                                                               hematological and clinical
                                                                               chemistry changes.
Inhalation short-term (1 to 30     NOAEL = 50 mg/kg/day  LOC for MOE = 100..  Developmental Toxicity--Rabbit.
 days).                            UFA = 10X...........                       LOAEL = 150 mg/kg/day based on
                                   UFH = 10X...........                        decreased body weight gain, food
                                   FQPA SF = 1X........                        consumption, and food efficiency
                                                                               (maternal toxicity).
Inhalation (1 to 6 months).......  NOAEL = 10 mg/kg/day  LOC for MOE = 100..  13 Week Subchronic Toxicity--Dog.
                                   UFA = 10X...........                       LOAEL = 40 mg/kg/day based on
                                   UFH = 10X...........                        decreased body weight gains and
                                   FQPA SF = 1X........                        food efficiency along with
                                                                               hematological and clinical
                                                                               chemistry changes.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  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.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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. In estimating acute dietary exposure, EPA used 
food consumption information from the U.S. Department of Agriculture 
(USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake 
by Individuals (CSFII). As to residue levels in food, EPA conducted an 
unrefined assessment that assumed 100 percent crop treated (PCT), 
dietary exposure evaluation model (DEEMTM) 7.81 default 
concentration factors, and tolerance-level residues for all existing 
and proposed uses. There was no indication of an adverse effect 
attributable to a single dose for the general U.S. population. 
Therefore, an acute dietary assessment was not conducted for the 
general U.S. population.
    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 conducted a chronic 
dietary assessment that utilized the same food residue assumptions as 
in the acute dietary exposure assessment discussed in Unit III.C.1.i.
    iii. Cancer. In both rat and mouse carcinogenicity studies, 
halosulfuron-methyl does not produce compound related increases in 
tumor incidence; 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/or 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

[[Page 71559]]

http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier 1 Rice Model and Screening Concentration in 
Ground Water (SCI-GROW) models, the estimated drinking water 
concentrations (EDWCs) of halosulfuron-methyl for acute and chronic 
exposures are estimated to be 59.2 parts per billion (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 both acute and chronic 
dietary risk assessments, 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: Residential turf. EPA assessed residential 
exposure using the default assumptions of the 2012 Residential Standard 
Operating Procedures (SOPs). Residential handler short-term (1-30 days) 
dermal and inhalation exposures, and residential post-application 
short-term dermal and incidental oral (hand-to-mouth, object-to-mouth, 
and soil ingestion) exposures are expected from activities associated 
with the existing uses. Intermediate-term exposures are not likely 
because of the intermittent nature of applications by homeowners. 
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 Web site 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 pre-natal 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 e.g., 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 
e.g., 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 complete except 
for an immunotoxicity study. In accordance with 40 CFR part 158, 
Toxicology Data Requirements, an immunotoxicity study 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 POD 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 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 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

[[Page 71560]]

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 <1% of the aPAD for females 13-49 
years old, the population group receiving the greatest exposure.
    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 6% of the cPAD for 
all infants, 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 of 1,800 for adults 
and 840 for children. For adults, potential pathways of exposure 
include oral (background) and dermal (post-application primary) routes, 
while for children, potential pathways of exposure include oral 
(background) and incidental oral and dermal (primary) routes. Because 
EPA's level of concern for halosulfuron-methyl is a MOE of 100 or 
below, these MOEs are not of concern.
    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). An intermediate-term adverse effect was identified; however, 
halosulfuron-methyl is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for halosulfuron-methyl.
    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

    Adequate enforcement methodologies are available to enforce the 
tolerance expression: A gas chromatography with nitrogen phosphorus 
detection; GC/NPD method for crop commodities and a gas chromotagraphy 
with electron capture detection (GC/ECD) method for livestock 
commodities. The methods may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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 United Nations 
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 Maximum 
Residue Limits (MRLs) established by Codex, Canada, or Mexico for any 
crop or livestock commodities for halosulfuron-methyl.

C. Response to Comments

    An anonymous citizen objected to the presence of any pesticide 
residues on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned completely. However, the existing legal framework provided by 
section 408 of the FFDCA contemplates that tolerances greater than zero 
may be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. This citizen's comment appears to be directed at the 
underlying statute and not EPA's implementation of it; the citizen has 
made no contention that EPA has acted in violation of the statutory 
framework.

D. Revisions to Petitioned-for Tolerances

    EPA has revised the requested tolerances by increasing the 
tolerance values for millet, proso, forage and grass, forage, fodder, 
and hay, group 17, forage and reducing the tolerance values for millet, 
proso, hay and grass, forage, fodder, and hay, group 17, hay. 
Differences in proposed and recommended tolerances may be attributed to 
the petitioner having used the North American Free Trade Agreement 
(NAFTA) tolerance calculation procedures for determining the tolerance 
and EPA's use of the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedures. Recently, EPA has 
adopted use of the OECD tolerance calculation procedures to increase 
international harmonization of tolerance levels. For grass hay, the 
petitioner used values below the level of quantitation (LOQ) in the 
tolerance calculation whereas EPA used LOQ values. In addition, already 
established tolerances for cattle, goat, horse, and sheep meat 
byproducts are being increased and multiple new livestock commodity 
tolerances are being established. Livestock tolerances are derived from 
reevaluation of the dairy/beef cattle diet with new feed items (millet 
and grass).

V. Conclusion

    Therefore, tolerances are established for residues of halosulfuron-
methyl, including its metabolites and degradates, as set forth in the 
regulatory text.

[[Page 71561]]

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this 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 FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: November 21, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.479 revise the table in paragraph (a)(1) and add 
alphabetically the following new entries to the table in paragraph 
(a)(2).
    The revised and added text read as follows:


Sec.  180.479  Halosulfuron-methyl; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat...............................................          0.05
Cattle, meat..............................................          0.05
Cattle, meat byproducts...................................          1.0
Goat, fat.................................................          0.05
Goat, meat................................................          0.05
Goat, meat byproducts.....................................          1.0
Hog, meat byproducts......................................          0.1
Horse, fat................................................          0.05
Horse, meat...............................................          0.05
Horse, meat byproducts....................................          1.0
Milk......................................................          0.05
Sheep, fat................................................          0.05
Sheep, meat...............................................          0.05
Sheep, meat byproducts....................................          1.0
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Grass, forage, fodder, and hay, group 17, forage..........         20
Grass, forage, fodder, and hay, group 17, hay.............          0.5
 
                                * * * * *
Millet, proso, forage.....................................         10
Millet, proso, grain......................................          0.01
Millet, proso, hay........................................          0.01
Millet, proso, straw......................................          0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-29105 Filed 11-30-12; 8:45 am]
BILLING CODE 6560-50-P