Document ID: EPA-HQ-OPP-2014-0922-0005
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Zoxamide
Posted Date: 2016-03-08T05:00Z

[Federal Register Volume 81, Number 45 (Tuesday, March 8, 2016)]
[Rules and Regulations]
[Pages 12011-12015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04740]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0922; FRL-9942-18]

Zoxamide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
zoxamide in or on the tomato subgroup 8-10A, the small, vine climbing 
fruit, except fuzzy kiwifruit, subgroup 13-07F, the tuberous and corm 
vegetable subgroup 1C and ginseng. Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 8, 2016. Objections and 
requests for hearings must be received on or before May 9, 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-2014-0922, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs,

[[Page 12012]]

Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0922 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 
May 9, 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-2014-0922, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-
00), 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 
4E8335) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 
08540. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of residues of the sum of zoxamide 
(3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide) and its metabolites 3,5-dichloro-1,4-
benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-
hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the 
stoichiometric equivalent of zoxamide in or on the raw agricultural 
commodity ginseng at 0.30 parts per million (ppm) and vegetable, 
tuberous and corm, subgroup 1C at 0.060 ppm. In addition, IR-4 
requested to establish tolerances for residues, determined by measuring 
only zoxamide (3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxypropyl)-
4- methylbenzamide, in or on the raw agricultural commodity tomato 
subgroup 8-10A at 2.0 ppm and fruit, small, vine climbing, except fuzzy 
kiwifruit, subgroup 13-07F at 5.0 ppm. IR-4 also proposed, upon the 
approval of the aforementioned tolerances, to remove established 
tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 
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 zoxamide including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with zoxamide follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    In repeat dose oral and dermal toxicity studies in rats, there were 
no indications of systemic toxicity up to the highest dose tested 
(HDT); most of the highest doses were at or above the limit dose (1,000 
milligrams/kilogram/day (mg/kg/day)). In the repeat dose oral toxicity 
studies in dogs, effects included increased liver and thyroid weights, 
liver histopathology (i.e., hepatocellular hypertrophy), and increased 
alkaline phosphatase.

[[Page 12013]]

    In the rat and rabbit prenatal developmental toxicity studies, 
there were no indications of susceptibility, as there was neither 
maternal nor developmental toxicity up to the HDT. In the rat 
reproduction study, there were no indications of susceptibility, since 
parental effects (i.e., decreased maternal body weight) occurred in the 
absence of reproductive or offspring toxicity.
    Zoxamide has been classified as ``not likely to be carcinogenic in 
humans'' based on the results of carcinogenicity studies in rats and 
mice. In the acute and subchronic neurotoxicity studies, there were no 
indications of neurotoxicity up to the HDT.
    Specific information on the studies received and the nature of the 
adverse effects caused by zoxamide 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 titled ``Zoxamide. Human Health 
Aggregate Risk Assessment for the Proposed New Uses on Ginseng, Tomato 
Subgroup 8-10A; Small Fruit, Vine Climbing, Except Fuzzy Kiwifruit, 
Subgroup 13-07F; and Tuberous and Corm Vegetable Subgroup 1C'' on page 
25 in docket ID number EPA-HQ-OPP-2014-0922.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for zoxamide used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of July 18, 2014 (79 FR 41911) (FRL-
9913-35).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to zoxamide, EPA considered exposure under the petitioned-for 
tolerances as well as all existing zoxamide tolerances in 40 CFR 
180.567. EPA assessed dietary exposures from zoxamide 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 
zoxamide; 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 United States 
Department of Agriculture's (USDA's) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) 
database. As to residue levels in food, EPA assumed tolerance-level 
residues and 100 percent crop treated (PCT) for all established and 
proposed commodities. The assessment also utilized default processing 
factors from the Dietary Exposure Evaluation Model--Food Commodity 
Intake Database (DEEM-FCID) version 7.81 except for raisin and potato 
granules/flakes, where the processing factor was set at 1.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that zoxamide 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 
zoxamide. Tolerance level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for zoxamide and its major metabolites in drinking water. 
These simulation models take into account data on the physical, 
chemical, and fate/transport characteristics of zoxamide and its 
metabolites. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW) model, the estimated drinking water concentrations (EDWCs) of 
zoxamide and its major metabolites for chronic exposures are estimated 
to be 22.84 parts per billion (ppb) for surface water and 65.8 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 65.8 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). Zoxamide 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 zoxamide to share a common mechanism of toxicity 
with any other substances, and zoxamide does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that zoxamide 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

[[Page 12014]]

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 Safety Factor (FQPA 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 for 
increased susceptibility following prenatal exposure in prenatal 
developmental toxicity studies in rats and rabbits. Additionally, there 
was no evidence for increased susceptibility following pre- or 
postnatal exposure in the reproduction and fertility effects study in 
rats.
    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 zoxamide is complete.
    ii. There is no indication that zoxamide 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 zoxamide 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 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to zoxamide in drinking water. These assessments 
will not underestimate the exposure and risks posed by zoxamide.

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, 
zoxamide 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 
zoxamide from food and water will utilize 6.3% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for zoxamide.
    3. Short- and intermediate-term risk. 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).
    A short- and intermediate-term adverse effect was identified; 
however, zoxamide is not registered for any use patterns that would 
result in either short- or intermediate-term residential exposure. 
Short- and intermediate-term risk is assessed based on short- and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because there is no short- or intermediate-term residential exposure 
and chronic dietary exposure has already been assessed under the 
appropriately protective cPAD (which is at least as protective as the 
POD used to assess short- or intermediate-term risk), no further 
assessment of short- or intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risk for zoxamide.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, zoxamide 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 zoxamide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Gas chromatography with electron 
capture detection (GC/ECD) and GC with mass selective detection (GC/
MSD)) 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 tolerances being established for the tomato subgroup 8-10A and 
the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13-07F 
are harmonized with established Codex MRLs on tomato and grape, 
respectively. The tolerance being established for the tuberous and corm 
vegetable subgroup 1C at 0.06 ppm is not harmonized with a Codex MRL on 
potato at 0.02 ppm. The underlying residue data and residue definition 
used to support the Subgroup 1C tolerance supports a tolerance 
recommendation that is higher than the established Codex MRL on potato 
at 0.02 ppm. There is not a Codex MRL for ginseng.

V. Conclusion

    Therefore, tolerances are established for residues of zoxamide 
(3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide) and its metabolites 3,5-dichloro-1,4-
benzenedicarboxylic acid (RH-1455 and RH-141455) and 3,5-dichloro-4-
hydroxymethylbenzoic acid (RH-1452 and RH-141452) calculated as the

[[Page 12015]]

stoichiometric equivalent of zoxamide in or on the raw agricultural 
commodity ginseng at 0.30 ppm and vegetable, tuberous and corm, 
subgroup 1C at 0.06 ppm. In addition, tolerances are established for 
residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-
chloro-1-ethyl-1-methyl-2-oxypropyl)-4-methylbenzamide, in or on raw 
agricultural commodity tomato subgroup 8-10A at 2.0 ppm and fruit, 
small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 
ppm. Lastly, upon the establishment of the aforementioned tolerances, 
the established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and 
potato at 0.060 ppm are removed as unnecessary.

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: February 25, 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.  180.567:
0
a. In the table in paragraph (a)(1):
0
i. Add alphabetically entries for ``Fruit, small vine climbing'' and 
``Tomato subgroup 8-10A''; and
0
ii. Remove the entries for ``Grape'' and ``Tomato''; and
0
b. In the table in paragraph (a)(2):
0
i. Add alphabetically entries for ``Ginseng'' and ``Vegetable, tuberous 
and corm''; and
0
ii. Remove the entry ``Potato''.
    The additions read as follows:

Sec.  180.567  Zoxamide; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup         5.0
 13-07F.....................................................
 
                                * * * * *
Tomato subgroup 8-10A.......................................         2.0
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Ginseng.....................................................        0.30
 
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C...................        0.06
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-04740 Filed 3-7-16; 8:45 am]
 BILLING CODE 6560-50-P