Cloquintocet-mexyl; Pesticide Tolerances, 50630-50635 [2016-17534]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 81, Number 148 (Tuesday, August 2, 2016)]
[Rules and Regulations]
[Pages 50630-50635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17534]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

EPA-HQ-OPP-2012-0843; FRL-9947-78]


Cloquintocet-mexyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
cloquintocet-mexyl and its acid metabolite in or on multiple 
commodities which are identified and discussed later in this document 
when cloquintocet-mexyl is used as an inert ingredient (herbicide 
safener) in pesticide formulations containing the new active ingredient 
halauxifen-methyl (XDE-729 methyl).

[[Page 50631]]

Dow AgroSciences, LLC requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 2, 2016. Objections and 
requests for hearings must be received on or before October 3, 2016, 
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-2012-0843, is available at https://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 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 https://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 https://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-2012-0843 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 3, 2016. 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-2012-0843, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 19, 2012 (77 FR 75082) (FRL-
9372-6), 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 
2F8085) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 
46268. The petition requested that 40 CFR 180.560 be amended by 
expanding the tolerances therein to cover residues of the inert 
ingredient (herbicide safener) cloquintocet-mexyl (acetic acid [(5-
chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-
2), and its acid metabolite (5-chloro-8-quinolinoxyacetic acid) when 
used in pesticide formulations containing the new active ingredient 
halauxifen-methyl (XDE-729 methyl), in or on barley grain, barley hay, 
barley straw, wheat forage, wheat grain, wheat hay, and wheat straw. No 
numerical change to the tolerances for the specific commodities was 
sought. That document referenced a summary of the petition prepared by 
Dow AgroSciences LLC, the registrant, which is available in the docket, 
https://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 cloquintocet-mexyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with cloquintocet-
mexyl follows.

[[Page 50632]]

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.
    Cloquintocet-mexyl has a low order of acute oral, dermal, and 
inhalation toxicity. It is slightly irritating to the eyes and non-
irritating to the skin. Cloquintocet-mexyl is a skin sensitizer. The 
chemical is not genotoxic and is not a reproductive and developmental 
toxicant. There is no evidence of neurotoxicity in the available 
studies. Cloquintocet-mexyl is classified as ``not likely to be a human 
carcinogen.'' The main metabolite for cloquintocet-mexyl is 5-chloro-8-
quin-linoxyacetic acid, and testing on the metabolite is part of the 
toxicology database for cloquintocet-mexyl.
    Specific information on the studies received and the nature of the 
adverse effects caused by cloquintocet-mexyl 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 https://www.regulations.gov in document Cloquintocet-Mexyl--Updated Human 
Health Risk Assessment from Uses of Halauxifen-methyl (PC Code 117501) 
in docket ID number EPA-HQ-OPP-2012-0843.

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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for cloquintocet-mexyl 
used for human risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Cloquintocet-Mexyl for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Developmental toxicity study in
 years of age).                     day.                  day.                 rats (MRID 44387429).
                                   UFA = 10............  aPAD = 1 mg/kg/day.  LOAEL = 400 mg/kg/day based on
                                   UFH = 10............                        higher incidence of skeletal
                                   FQPA SF = 1x........                        variants and decrease in fetal
                                                                               body weights in the high dose
                                                                               group.
Acute dietary (General population  N/A.................  N/A................  Based on available data, a
 including infants and children).                                              suitable endpoint was not
                                                                               identified for the general
                                                                               population because there were no
                                                                               effects observed in oral toxicity
                                                                               studies appropriate to this
                                                                               population that could be
                                                                               attributed to a single dose
                                                                               exposure.
Chronic dietary (All populations)  NOAEL = 4.3 mg/kg/    Chronic RfD = 0.04   Chronic/Oncogenicity Toxicity--Rat
                                    day.                  mg/kg/day.           (MRID 44387431).
                                   UFA = 10x...........  cPAD = 0.04 mg/kg/   LOAEL = 41.2 mg/kg/day based on
                                   UFH = 10x...........   day.                 thyroid hyperplasia in females.
                                   FQPA SF = 1x........
Cancer (Oral, dermal, inhalation)  Cloquintocet-mexyl is classified as ``not likely to be carcinogenic to
                                    humans''.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term
  risk assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cloquintocet-mexyl, EPA considered exposure under the 
petitioned-for tolerances as well as all existing cloquintocet-mexyl 
tolerances in 40 CFR 180.560. EPA assessed dietary exposures from 
cloquintocet-mexyl 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 cloquintocet-mexyl and are applicable only to females 13-49 years 
old in order to account for fetal effects (higher incidence of skeletal 
variants and decrease in fetal body weights) that were seen in the 
developmental toxicity study in rats. In estimating acute dietary 
exposure, EPA used food consumption information from the 2003-2008 
National Health and Nutrition Examination Surveys (NHANES). As to 
residue levels in food, EPA assumed tolerance-level residues of 
cloquintocet-mexyl and cloquintocet acid in all forms of barley, 
triticale, and wheat, and assumed that all of those crops are treated 
(i.e., 100% crop treated).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment

[[Page 50633]]

EPA used the food consumption data from the 2003-2008 National Health 
and Nutrition Examination Surveys (NHANES). As to residue levels in 
food, EPA assumed tolerance-level residues of cloquintocet-mexyl and 
cloquintocet acid in all forms of barley, triticale, and wheat, and 
assumed that all of those crops are treated (i.e., 100% crop treated).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cloquintocet-mexyl does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for cloquintocet-mexyl in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of cloquintocet-mexyl. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and the 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of cloquintocet-mexyl 
for acute exposures are estimated to be 0.186 parts per billion (ppb) 
for surface water and 0.000061 ppb for ground water, chronic exposures 
are estimated to be 0.005 ppb for surface water and 0.000061 ppb for 
ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. As a conservatism in the 
assessment, the acute drinking water estimate (0.186 ppb), rather than 
the chronic drinking water estimate (0.005 ppb) was used in chronic 
dietary assessment.
    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). Cloquintocet-mexyl 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 cloquintocet-mexyl to share a common mechanism of 
toxicity with any other substances, and cloquintocet-mexyl does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
cloquintocet-mexyl 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 https://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 evidence of 
increased susceptibility of in utero or post-natal exposure to rats or 
rabbits in the prenatal developmental studies or in rats in the 2-
generation reproduction study. NOAELs for maternal/parental toxicity 
were either less than or equal to the NOAELs for fetal or reproductive 
toxicity.
    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 cloquintocet-mexyl is sufficient for 
risk assessment.
    ii. There is no indication that cloquintocet-mexyl 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 cloquintocet-mexyl 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 dietary food exposure assessments were performed based 
on 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to cloquintocet-mexyl in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
cloquintocet-mexyl.

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 cloquintocet-mexyl will occupy <1% of the aPAD for females age 13-
49, 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 
cloquintocet-mexyl from food and water will utilize <1% of the cPAD for 
all subpopulations. There are no residential uses for cloquintocet-
mexyl.
    3. Short-term and intermediate-term risk. Because cloquintocet-
mexyl is not registered for use in pesticide formulations that will 
result in residential exposure, EPA concludes that cloquintocet-mexyl 
will not pose a short-term or intermediate-term risk.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cloquintocet-mexyl is not expected to pose a cancer risk to 
humans.
    5. 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 cloquintocet-mexyl residues.

[[Page 50634]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology 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 cloquintocet-mexyl.

V. Conclusion

    The residue data indicate that combined residues of cloquintocet-
mexyl and cloquintocet acid are unlikely to exceed the existing 
tolerances for residues in barley, triticale, and wheat commodities, 
therefore, the existing tolerance levels remain unchanged. However, the 
active ingredient, halauxifen-methyl, will be added to the list of 
active ingredients addressed in the tolerance expression for 
cloquintocet-mexyl as a result of this tolerance amendment for 
cloquintocet-mexyl.
    Therefore, 40 CFR 180.560 is amended by establishing a tolerance 
for the combined residues of cloquintocet-mexyl (acetic acid [(5-
chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-
2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid) when used 
as an inert ingredient (safener) in pesticide formulations containing 
the active ingredients clodinafop-propargyl (wheat only), dicamba 
(wheat only), flucarbazone-sodium (wheat only), halauxifen-methyl 
(wheat or barley), pinoxaden (wheat or barley), or pyroxsulam (wheat 
only) at 0.1 ppm in/on barley commodities (grain, hay, and straw), 
wheat grain, and wheat straw; at 0.2 ppm in/on wheat forage; and at 0.5 
ppm in/on wheat hay.

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 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: June 28, 2016.
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.  180.560, revise the introductory text of paragraph (a) to 
read as follows:


Sec.  180.560  Cloquintocet-mexyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the inert 
ingredient cloquintocet-mexyl, including its metabolites and 
degradates, in or on the commodities in the following table when used 
as a safener in pesticide formulations containing the active 
ingredients clodinafop-propargyl (wheat only), dicamba (wheat only), 
flucarbazone-sodium (wheat only), halauxifen-methyl (wheat or barley), 
pinoxaden (wheat or barley), or pyroxsulam (wheat only). Compliance 
with the tolerance levels specified is to be determined by measuring 
the combined residues of cloquintocet-mexyl, (acetic acid [(5-

[[Page 50635]]

chloro-8-quinolinyl)oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-
2) and its acid metabolite (5-chloro-8-quinolinoxyacetic acid), 
expressed as cloquintocet-mexyl, in or on the following commodities:
* * * * *
[FR Doc. 2016-17534 Filed 8-1-16; 8:45 am]
 BILLING CODE 6560-50-P