Document ID: EPA-HQ-OPP-2012-0384-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Imazapic
Posted Date: 2013-08-16T04:00Z

[Federal Register Volume 78, Number 159 (Friday, August 16, 2013)]
[Rules and Regulations]
[Pages 49927-49932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19867]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0384; FRL-9394-8]

Imazapic; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
imazapic in or on sugarcane, cane. BASF Corporation requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 16, 2013. Objections and

[[Page 49928]]

requests for hearings must be received on or before October 15, 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-2012-0384, 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: 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-2012-0384 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 15, 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-2012-0384, 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.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 July 25, 2012 (77 FR 43562) (FRL-9353-
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 
2E8021) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.490 be amended by 
establishing tolerances for residues of the herbicide imazapic 2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methyl-3-
pyridinecarboxylic acid in or on sugarcane at 0.01 parts per million 
(ppm). That document referenced a summary of the petition prepared by 
BASF Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance level and the commodity definition. EPA 
is also revising the tolerance expression to clarify the chemical 
moieties that are covered by the tolerances and specify how compliance 
will be measured. The reasons for these changes are explained in Unit 
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with 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 imazapic including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with imazapic follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as

[[Page 49929]]

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.
    Imazapic is categorized as having low acute toxicity by the oral, 
inhalation, and dermal routes of exposure. It is minimally irritating 
to the eye, non-irritating to the skin, and not a skin sensitizer.
    No evidence of subchronic toxicity was observed to rodents via the 
oral or dermal routes. In the chronic oral toxicity study in dogs, 
minimal degeneration and/or necrosis of the skeletal muscle of the 
thigh and/or abdomen was seen at the lowest dose tested. At higher 
doses, additional effects were seen in the liver (increased absolute 
weights and changes in clinical chemical parameters), kidney (decreased 
urinary pH in females), and erythropoietic system (changes in 
hematological parameters, and microscopic changes in the bone marrow 
and spleen). At the high dose, there was also inflammation in the 
esophagus similar to that in skeletal muscle as well as discoloration 
of the lung in both sexes.
    In the developmental toxicity study with rats, no maternal or 
developmental toxicity was seen at the limit dose. In the developmental 
toxicity study in rabbits, maternal effects of decreased body-weight 
gain and food consumption were observed at the dose level that did not 
result in developmental effects. In the 2-generation reproduction study 
in rats, no parental or reproductive toxicity was seen at the limit 
dose. In the battery of mutagenicity studies, no evidence of 
mutagenicity was observed.
    Imazapic is classified as a ``Group E'' chemical (not likely to be 
a human carcinogen) by any relevant route of administration based on 
the absence of carcinogenicity seen in rodents.
    Since the last risk assessment in 2001, acute neurotoxicity, 
subchronic neurotoxicity, and immunotoxicity studies were submitted in 
response to the 40 CFR part 158 data requirements. There was no 
evidence of immunotoxicity or neurotoxicity observed in the submitted 
studies.
    In the 2001 risk assessment and in the Federal Register of December 
26, 2001 (66 FR 66325) (FRL-6816-2), a 28-day inhalation toxicity study 
was required due to the potential for repeated handler inhalation 
exposure anticipated from use on pastures and rangeland. However, EPA 
concluded in the April 17, 2012 document ``Imazapic: Summary of Hazard 
and Science Policy Council (HASPOC) Meeting of March 15, 2012: 
Recommendations on the Requirement of a 28-day Inhalation Study'' that 
based on a weight-of-evidence approach, this study is not required at 
this time.
    Specific information on the studies received and the nature of the 
adverse effects caused by imazapic as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Imazapic. Human-Health Risk 
Assessment. Petition for Tolerances for Use on Soybeans and Sugarcane 
Without U.S. Registration,'' pp. 14-17 in docket ID number EPA-HQ-OPP-
2012-0384.

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 imazapic used for 
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Imazapic for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk         Study and
                                               factors                 assessment         toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population      None...................  None...................  No acute dietary
 including infants and children; and                                                      endpoint selected
 Females 13-50 years of age).                                                             based on the absence
                                                                                          of an appropriate
                                                                                          endpoint attributed to
                                                                                          a single dose.
Chronic dietary (All populations)....  LOAEL = 137 mg/kg/day..  Chronic RfD = 0.137 mg/  One-Year Dog Feeding
                                       UFA = 10X..............   kg/day.                  Study LOAEL = 137 mg/
                                       UFH = 10X..............  cPAD = 0.137 mg/kg/day.   kg/day based on
                                       FQPA SF/UFL = 10X......                            increased incidence of
                                                                                          minimal degeneration
                                                                                          and/or necrosis of
                                                                                          skeletal muscle.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. 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). UFL = use of a LOAEL to extrapolate a NOAEL.

[[Page 49930]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to imazapic, EPA considered exposure under the petitioned-for 
tolerances as well as all existing imazapic tolerances in 40 CFR 
180.490. EPA assessed dietary exposures from imazapic 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. No such effects were 
identified in the toxicological studies for imazapic; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated 
tolerance-level residues and 100 percent crop treated (PCT) for all 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that imazapic 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 imazapic. 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 imazapic in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of imazapic. 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 FQPA Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of imazapic for chronic 
exposures for non-cancer assessments are estimated to be 1.46 ppb for 
surface water and 13.73 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 13.73 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). Imazapic is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 imazapic to share a common mechanism of toxicity 
with any other substances, and imazapic does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that imazapic 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 is no evidence of 
increased pre- or postnatal susceptibility based on the results of the 
rat and rabbit prenatal developmental toxicity studies and the 2-
generation reproductive toxicity study.
    3. Conclusion. EPA is retaining the default 10X FQPA safety factor 
for all exposure scenarios due to the use of a LOAEL to extrapolate a 
NOAEL for the POD for the chronic dietary endpoint. That decision is 
based on the following findings:
    i. Although all required toxicity studies have been submitted for 
imazapic, the chronic study used for chronic dietary risk assessment 
did not demonstrate a NOAEL, and a LOAEL was used as an endpoint. 
Therefore, EPA is retaining the 10X FQPA safety factor for use of a 
LOAEL to extrapolate a NOAEL.
    ii. There is no indication that imazapic is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that imazapic results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic 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 imazapic in drinking water. These assessments 
will not underestimate the exposure and risks posed by imazapic.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
imazapic is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
imazapic from

[[Page 49931]]

food and water will utilize 4% of the cPAD for children 1-2 years old, 
the population group receiving the greatest exposure. There are no 
residential uses for imazapic.
    3. Short- and intermediate-term risks. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Because there are no 
currently registered residential uses, no short- or intermediate-term 
aggregate risk assessments were conducted for imazapic.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, imazapic 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 imazapic residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method SOP-PA.0288, a liquid 
chromatography with tandem mass spectroscopy (LC-MS/MS)) 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 imazapic on sugarcane.

C. Revisions to Petitioned-For Tolerances

    EPA revised the proposed commodity definition of ``sugarcane'' to 
reflect the correct terminology of ``sugarcane, cane'' and revised the 
proposed tolerance of 0.01 ppm to 0.03 ppm. All residues (parent plus 
metabolites) were below the limit of quantification (LOQ). The revised 
tolerance level is based upon the sum of the LOQs (0.01 + 0.01 + 0.01 = 
0.03 ppm) for each of the three compounds in the tolerance expression. 
In accordance with Agency guidance on tolerance expressions, the 
tolerance expressions for imazapic are revised by clarifying that the 
tolerances cover ``residues of imazapic, including its metabolites and 
degradates''.

 V. Conclusion

    Therefore, tolerances are established for residues of imazapic, 2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
methyl-3-pyridinecarboxylic acid and its metabolites in or on 
sugarcane, cane at 0.03 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 7, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

[[Page 49932]]

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. Amend Sec.  180.490 as follows:
0
a. Revise the section heading;
0
b. Revise the introductory text in paragraph (a)(1) and add 
alphabetically the following commodity to the table;
0
c. Revise the introductory text in paragraph (a)(2); and
0
d. Revise the heading in paragraph (c).
    The amendments read as follows:

Sec.  180.490  Imazapic; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
herbicide imazapic, including its metabolites and degradates, in or on 
the commodities listed in the following table. Compliance with the 
tolerance levels specified is to be determined by measuring the sum of 
imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-5-methyl-3-pyridinecarboxylic acid) and its metabolites ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-hydroxymethyl-3-pyridinecarboxylic acid and ()-2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
([beta]-D-glucopyranosyloxy)methyl-3-pyridinecarboxylic acid, 
calculated as the stoichiometric equivalent of imazapic.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane.........................................            0.03
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the herbicide 
imazapic, including its metabolites and degradates, in or on the 
commodities listed in the following table. Compliance with the 
tolerance levels specified is to be determined by measuring the sum of 
imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-5-methyl-3-pyridinecarboxylic acid) and its metabolite ()-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-
yl]-5-hydroxymethyl-3-pyridinecarboxylic acid, calculated as the 
stoichiometric equivalent of imazapic.
* * * * *
    (c) Tolerances with regional registrations. [Reserved]
* * * * *
[FR Doc. 2013-19867 Filed 8-15-13; 8:45 am]
BILLING CODE 6560-50-P