Document ID: EPA-HQ-OPP-2014-0574-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Halosulfuron-methyl
Posted Date: 2015-09-17T04:00Z

[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 55768-55773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23298]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0574; FRL-9933-00]

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 in or on the pome fruit group 11-10 and a tolerance 
with regional registration for residues of halosulfuron-methyl in or on 
the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 17, 2015. Objections and 
requests for hearings must be received on or before November 16, 2015, 
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-2014-0574, 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), West William

[[Page 55769]]

Jefferson Clinton 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2014-0574 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 
November 16, 2015. 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-2014-0574, 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 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.html. 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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 
4E8297) by IR-4, IR-4 Project Headquarters, Rutgers, The State 
University of New Jersey, Suite 201 W, 500 College Road East, 
Princeton, NJ 08540. 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-pyrimidiny)amino] 
carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, 
including its metabolites and degradates, in or on the raw agricultural 
commodities: Fruit, pome, group 11-10 at 0.05 parts per million (ppm), 
and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F 
at 0.05 ppm (associated with a regional registration). That document 
referenced a summary of the petition prepared by the Canyon Group, c/o 
Gowan Company, the registrant, which is available in the docket, http://www.regulations.gov. No comments were received on the notice of 
filing.
    Based upon available data, EPA is establishing tolerances as 
requested.

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 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.
    With repeated dosing, the available data on halosulfuron-methyl did 
not demonstrate a target organ or tissue in any of the test animals. 
Reduction in body weight was seen in the 90-day and 1-year oral 
toxicity studies in dogs. Reduced body weights were also seen in

[[Page 55770]]

rat studies at higher dose levels than those seen in dogs. An effect on 
the hematological parameters was detected in the dog studies, but the 
magnitude of changes was slight and the effect was considered to be 
marginal. Thus, the slight hematological changes were not considered to 
be adverse.
    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 a similar dose level. In 
the rabbit developmental toxicity study, increases in resorptions and 
post-implantation losses and decreases in mean litter size were 
observed in the presence of decreases in body weight and food 
consumption in maternal animals. The fetal effects seen in 
developmental toxicity studies in rats and rabbits represented a 
qualitative increase in susceptibility. However, a clear no-observed-
adverse-effect-level (NOAEL) for these effects was established in both 
rat and rabbit developmental toxicity studies. No quantitative 
susceptibility was found in studies following pre-and/or post-natal 
exposures. Halosulfuron-methyl did not produce any effects on 
reproductive parameters in the 2-generation reproduction study in rats. 
No neurotoxic effects were observed in the acute or subchronic 
neurotoxicity studies up to 2,000 mg/kg or 760 mg/kg/day, respectively. 
In addition, no adverse effect was found in a 21-day dermal toxicity 
study at doses up to the limit dose (1,000 mg/kg/day).
    Halosulfuron-methyl is negative for mutagenicity in a battery of 
genotoxicity studies and is classified as ``not likely to be 
carcinogenic to humans'' based on lack of evidence for carcinogenicity 
in mice and rats following long-term dietary administration.
    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 document 
``Halosulfuron-Methyl. Human Health Risk Assessment for a Proposed Use 
on Pome Fruit Crop Group 11-10 and Small Fruit Vine Climbing Subgroup, 
Except Fuzzy Kiwifruit, Subgroup 13-07F'' at page 28 in docket ID 
number EPA-HQ-OPP-2014-0574.

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 used for 
human risk assessment is discussed in Unit III. B. of the final rule 
published in the Federal Register of December 3, 2012 (77 FR 71555) 
(FRL-9370-6). However, there is one change to the prior toxicity 
endpoint and point of departure selections for halosulfuron-methyl 
discussed in the 2012 document. The previous toxicity endpoint for 
dermal exposure assessments was based on the results of a 21-day dermal 
toxicity study, where the no observed effect level (NOEL) and lowest 
observed effect level (LOEL) were established at 100 and 1,000 mg/kg/
day, respectively. The LOEL was based on ``total body weight gains in 
males.'' However, following a reevaluation of this study according to 
the current evaluation standard, there was only 4% reduction in 
absolute body weight in the affected 1,000 mg/kg/day males. This 
reduction was not considered to be adverse and no other adverse effect 
was reported in this study. No LOAEL could be established, and the 
NOAEL was 1,000 mg/kg/day. Based on this re-evaluation, halosulfuron-
methyl did not cause adverse effects at the limit dose (1,000 mg/kg/
day), and no toxicity endpoint could be established for the dermal 
exposure scenario. In addition, no quantitative susceptibility was 
found in studies following pre-and/or post-natal exposures. Hence, no 
dermal exposure assessment was necessary.

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. Exposure and 
risk assessments were conducted using the Dietary Exposure Evaluation 
Model software with the Food Commodity Intake Database (DEEM-FCID). 
This software uses 2003-2008 food consumption data from the United 
States Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, EPA assumed tolerance-level residues and 100 
percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA assumed tolerance-level 
residues and 100 PCT for all commodities.
    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 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

[[Page 55771]]

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 59.2 parts per billion (ppb) 
for surface water and 0.065 ppb for ground water and for chronic 
exposures are estimated to be 59.2 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 dietary risk 
assessment, the water concentration value of 59.2 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 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 use by residential 
handlers on residential turf. EPA re-assessed residential exposure for 
aggregate risk assessment reflecting the removal of the dermal POD. EPA 
assessed short-term (1-30 days) exposure to halosulfuron-methyl for 
residential handlers (inhalation exposure) and children 1 to < 2 years 
old (post-application incidental oral exposures).
    The residential exposure scenario used in the adult aggregate 
assessment reflects inhalation exposure from mixing/loading/applying 
halosulfuron-methyl via backpack sprayer or manually pressurized 
handwand to turf.
    The residential exposure scenario used in the children 1 to <2 
years old aggregate assessment reflects hand-to-mouth incidental oral 
exposures from post-application exposure to treated turf.
    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. There was no quantitative 
evidence of increased susceptibility following pre- and/or post-natal 
exposure to halosulfuron-methyl. Qualitative susceptibility was seen in 
the prenatal developmental toxicity study in rats and in rabbits; 
however, this qualitative susceptibility was of low concern because (1) 
in both studies, there were clear NOAELs/LOAELs for developmental and 
maternal toxicities; (2) the developmental effects were seen in the 
presence of maternal toxicity; and (3) the effects were only seen at 
the high dose levels. In rats, the developmental effects were seen at a 
dose (750 mg/kg/day) which was approaching the limit-dose (1,000 mg/kg/
day). Furthermore, the PODs for risk assessment are protective of the 
effects which occur at high doses.
    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 considered 
complete.
    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. There was no quantitative evidence of increased susceptibility 
following pre- and/or post-natal exposure and the qualitative 
susceptibility observed in the developmental toxicity studies in rats 
and rabbits was of low concern for the reasons outlined in section 
III.D.2.
    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 
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 only population group of 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

[[Page 55772]]

5.7% of the cPAD for children 1-2 years old, the population subgroup 
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 25,000 for adults 
and 1,800 for children 1 to < 2 years old. 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 methodology (gas chromatography (GC) 
thermionic-specific detection (TSD, nitrogen specific)) is available to 
enforce the tolerance expression.
    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; 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.
    The Codex has not established a MRL for halosulfuron-methyl for any 
of the crops covered by this Final Rule.

V. Conclusion

    Therefore, a tolerance is established for residues of 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 fruit, pome, 
group 11-10 at 0.05 ppm, and a tolerance with regional registration is 
established for fruit, small vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 0.05 ppm. In addition, the existing tolerance for 
the commodity ``Apple'' in paragraph (a)(2) of Sec.  180.479 is removed 
since it is covered by the newly established fruit, pome, group 11-10 
tolerance.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary

[[Page 55773]]

consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act (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: September 4, 2015.
Susan Lewis,
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:
0
a. Remove the entry for ``Apple'' from the table in paragraph (a)(2);
0
b. Add alphabetically the entry for ``Fruit, pome, group 11-10'' to the 
table in paragraph (a)(2), and
0
c. Revise paragraph (c).
    The additions and revision read as follows:

Sec.  180.479  Halosulfuron-methyl; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Fruit, pome, group 11-10...................................         0.05
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. Tolerances with 
regional registrations 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.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Fruit, small vine climbing, except fuzzy kiwifruit,                 0.05
 subgroup 13-07F...........................................
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-23298 Filed 9-16-15; 8:45 am]
BILLING CODE 6560-50-P