[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Rules and Regulations]
[Pages 53047-53051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20906]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0586; FRL-9393-8]


Halosulfuron-methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
halosulfuron-methyl in or on artichoke and caneberry subgroup 13-07A. 
The Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 28, 2013. Objections and 
requests for hearings must be received on or before October 28, 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-2012-0586, 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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-2012-0586 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 28, 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-2012-0586, 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.

[[Page 53048]]

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), 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 
2E8050) by IR-4, IR-4 Project Headquarters, 500 College Rd. East, Suite 
201 W., 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-pyrimidinyl)amino] 
carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, 
including its metabolites and degradates, in or on artichoke and 
caneberry subgroup 13-07A at 0.05 parts per million (ppm). That 
document referenced a summary of the petition prepared by Gowan 
Company, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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 their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. With repeated dosing, halosulfuron-methyl produces non-
specific effects, which are frequently characterized by reduced body 
weight/body weight gain in the test animals. 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 decrease in mean litter size were 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.'' It is negative for mutagenicity in a battery 
of genotoxicity studies.
    Although there is no immunotoxicity study for halosulfuron-methyl, 
the available data indicate that halosulfuron-methyl is unlikely to be 
an immuno toxicant. EPA is currently reviewing a waiver request for 
these data.
    Specific information on the studies received and the nature of the 
adverse effects caused by halosulfuron-methyl as well as the NOAEL and 
Lowest Observed-Adversed-Effective-Level (LOAEL) from the toxicity 
studies can be found at http://www.regulations.gov in document: 
``Halosulfuron-Methyl: Human Health Risk Assessment for Proposed New 
Uses on Artichoke and Caneberry (Crop subgroup 13-07A),'' dated March 
25, 2013, pp. 30-34, docket ID number EPA-HQ-OPP-2012-0586-0004.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for halosulfuron-methyl 
used for human risk assessment is discussed in Unit III. of the final 
rule published in the Federal Register of December 3, 2012 (77 FR 
71555) (FRL-9370-6).

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. There was no indication of 
an adverse effect attributable to a single dose for the general U.S. 
population including infants and children. Therefore, an acute dietary 
assessment was not conducted for the U.S. general population. However, 
such effects were identified for females 13-49 years old

[[Page 53049]]

for halosulfuron-methyl. In estimating acute dietary exposure, EPA used 
the Dietary Exposure Evaluation Model--Food Consumption Intake Database 
(DEEM-FCID, ver. 3.16), which incorporates consumption information from 
the United States Department of Agriculture (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA); 
2003-2008). As to residue levels in food, EPA conducted an unrefined 
assessment that assumed 100 percent crop treated (PCT), dietary 
exposure evaluation model (DEEM) 7.81 default processing factors, and 
tolerance-level residues for all existing and proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, ver. 3.16 which incorporates 
consumption information from the USDA NHANES/WWEIA; 2003-2008. As to 
residue levels in food, EPA conducted an unrefined assessment that 
assumed 100 PCT, DEEM 7.81 default processing factors, and tolerance-
level residues for all existing and proposed uses.
    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 and100 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 Tier 1 Rice Model v.1.0 and Screening Concentration in 
Ground Water (SCI-GROW) models, respectively, 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.
    For chronic exposures for non-cancer assessments EDWC's 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 both the 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 use. EPA 
assessed residential exposure using the following assumptions: 
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 Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity database for halosulfuron-methyl includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. As discussed in Unit III.A., there was no quantitative 
evidence for increased susceptibility following prenatal and/or 
postnatal exposure. However, there was qualitative evidence for 
increased susceptibility of fetuses in the rat and rabbit developmental 
studies. In the rat study, increases in resorptions, soft tissue 
(dilation of the lateral ventricles) and skeletal variations, and 
decreases in body weights were seen in the fetuses compared to clinical 
signs and decreases in body weights and food consumption in the 
maternal animals. In the rabbit study, increases in resorptions and 
post-implantation losses and decrease in mean litter size was seen in 
the presence of decreases in body weight and food consumption in 
maternal animals. Thus, in both species, the developmental effect was 
considered to be qualitatively more severe than maternal effects (i.e., 
qualitative evidence for susceptibility). Nevertheless, the degree of 
concern for these effects is low, and there are no residual 
uncertainties for prenatal toxicity in both rats and rabbits for the 
following reasons:
    i. In both studies, there are clear NOAELs/LOAELs for developmental 
and maternal toxicities.
    ii. Developmental effects were seen in the presence of maternal 
toxicity.
    iii. The effects were only seen at the high dose.
    iv. In rats, developmental effects were seen at a dose which 
approached the limit-dose.
    3. Conclusion. EPA has determined that reliable data show the 
safety of

[[Page 53050]]

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 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 or 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 uncertainty factors to account for neurotoxicity.
    iii. Although there is qualitative evidence of increased 
susceptibility in the prenatal developmental studies in rats and 
rabbits, as discussed in Unit III.D.2., there are no residual 
uncertainties after establishing toxicity endpoints and the degree of 
concern for pre- and/or postnatal toxicity is low.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. 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 postapplication 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 population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer 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 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, 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 5.5% of the cPAD 
for all children 1-2 years old, the population group receiving the 
greatest exposure. Chronic residential exposure to residues of 
halosulfuron-methyl is not expected. Therefore, the chronic aggregate 
risk would be equivalent to the chronic dietary exposure estimate.
    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. Residential exposure for use in the aggregate 
assessment of adults and children 1 to <2 years old reflects the 
combined post-application dermal plus hand-to-mouth exposures from turf 
treated with liquid applications of halosulfuron-methyl. Because EPA's 
level of concern for halosulfuron-methyl is a MOE of 100 or below, 
these estimates of aggregate risk do not exceed the Agency's level 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 pathway. Because there 
is no intermediate-term residential exposure, the intermediate-term 
aggregate risk would be equivalent to the chronic dietary exposure 
estimate. Chronic dietary exposure has already been assessed under the 
appropriately protective cPAD (which is at least as protective as the 
equivalent POD value used to assess intermediate-term risk), no further 
assessment of intermediate-term risk is necessary.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, halosulfuron-methyl is not expected to pose a cancer risk to 
humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to halosulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available for enforcement of 
tolerances for halosulfuron-methyl residues in plants. The gas 
chromatography (GC) method quantifies halosulfuron-methyl as its 
rearrangement ester (RRE; 1-H-pyrazole-4-carboxylic acid, 3-chloro-5-
[(4,6-dimethoxy-2-pyrimidinyl)amino]-1-methyl, methyl ester) using 
thermionic-specific detection (TSD, nitrogen specific). For 
confirmation, the RRE can be determined by gas chromatography mass 
spectroscopic detection (GC/MS).
    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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint 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

[[Page 53051]]

which the United States is a party. EPA may establish a tolerance that 
is different from a Codex MRL; however, FFDCA section 408(b)(4) 
requires that EPA explain the reasons for departing from the Codex 
level. There are no Codex MRLs established for residues of 
halosulfuron-methyl in/on any commodity.

 V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidiny)amino] 
carbonylaminosulfonyl]-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, 
including its metabolites and degradates, in or on the commodities 
artichoke at 0.05 ppm and caneberry subgroup 13-07A at 0.05 ppm.

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: August 14, 2013.
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, add alphabetically the following commodities to 
the table in paragraph (a)(2) to read as follows:


Sec.  180.479  Halosulfuron-methyl; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Artichoke...................................................        0.05
 
                                * * * * *
Caneberry subgroup 13-07A...................................        0.05
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-20906 Filed 8-27-13; 8:45 am]
BILLING CODE 6560-50-P