Document ID: EPA-HQ-OPP-2013-0644-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Zoxamide
Posted Date: 2014-07-18T04:00Z

[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Rules and Regulations]
[Pages 41911-41915]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16807]

[[Page 41911]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0644; FRL-9913-35]

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 onion, bulb, subgroup 3-07A. Gowan Company requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective July 18, 2014. Objections and 
requests for hearings must be received on or before September 16, 2014, 
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-2013-0644, 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

 Crop production (NAICS code 111).
 Animal production (NAICS code 112).
 Food manufacturing (NAICS code 311).
 Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2013-0644 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 
September 16, 2014. 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-2013-0644, 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 May 23, 2014 (79 FR 29731) (FRL-9910-
29), 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 
3F8164) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition 
requested that 40 CFR 180.567 be amended by establishing tolerances for 
residues of the fungicide 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 onion, bulb, 
subgroup 3-07A at 0.7 parts per million (ppm). That document referenced 
a summary of the petition prepared by Gowan Company, the registrant, 
which is available in the docket, http://www.regulations.gov. Comments 
were received on the notice of filing. EPA's response to these comments 
is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing the tolerance as requested but revising the tolerance 
expressions for zoxamide. The reason for these changes are explained in 
Unit IV.D.

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

[[Page 41912]]

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.
    The toxicity data of zoxamide indicate that the primary target 
organ is the liver. Liver and thyroid weights increased along with 
liver histopathological change and increases in alkaline phosphatase. 
Systemic toxicity was not observed in the 28-day rat dermal toxicity 
study up to the limit dose (1,000 milligram/kilogram/day (mg/kg/day)). 
There are no concerns for neurotoxicity, immunotoxicity, developmental 
toxicity, or reproductive toxicity. There was no evidence of increased 
susceptibility (quantitative or qualitative) for the offspring in the 
reproduction studies or for fetuses following in utero exposure in the 
developmental studies. Zoxamide is classified as ``not likely to be 
carcinogenic to humans'' based on the lack of treatment-related tumors 
in acceptable/guideline carcinogenicity studies in rats and mice.
    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 document Zoxamide. Health Risk Assessment for 
the Proposed New Use on Bulb Onions (Crop Subgroup 3-07A) in docket ID 
number EPA-HQ-OPP-2013-0644.

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

    Table--Summary of Toxicological Doses and Endpoints for Zoxamide 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 (all populations)..  There is no indication of an adverse effect attributable to a single dose.
                                    Additionally, developmental, neurotoxicity, and reproductive effects were
                                    not observed in the database. An aRfD was not established.
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Chronic dietary (all populations)  NOAEL= 48 mg/kg/day.  Chronic RfD = 0.48   Chronic Toxicity--Dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 255 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.48 mg/kg/    body weight changes, increases in
                                   FQPA SF = 1x........   day.                 liver and thyroid weights, and
                                                                               increases in alkaline
                                                                               phosphatase.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days).  There were no systemic or dermal toxicity findings in a 28-day dermal
                                    toxicity study in the rat up to the limit dose (1000 mg/kg/day) and there
                                    were no developmental, reproductive, or neurotoxicity concerns observed in
                                    the database.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  LOC for MOE = 100..  Chronic Toxicity--Dog.
 days) and Inhalation               study NOAEL= 48 mg/                       LOAEL = 255 mg/kg/day based on
 Intermediate-term (1 to 6          kg/day.                                    body weight changes, increases in
 months).                          UFA = 10x...........                        liver and thyroid weights, and
                                   UFH = 10x...........                        increases in alkaline
                                   FQPA SF = 1x........                        phosphatase.
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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). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

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:

[[Page 41913]]

    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 USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). As to residue levels in food, EPA assumed 
tolerance-level residues, 100% crop treated (CT), and default 
processing factors from the Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEM-FCID) Version 7.81 
(except for grape, raisin and potato granules/flakes).
    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.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for zoxamide in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of zoxamide. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of zoxamide 
for chronic exposures (non-cancer) are estimated to be 0.81 parts per 
billion (ppb) for surface water and 65.8 ppb for ground water, 
respectively.
    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://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. The prenatal and postnatal 
toxicity studies include rat and rabbit prenatal developmental studies 
in addition to a reproduction and fertility effects study in rats; and 
the highest doses used in these studies are at or above the limit dose. 
In the developmental studies, maternal and fetal toxicity was not 
observed up to the limit dose (1,000 mg/kg/day). In the rat 
reproduction and fertility effects study, decreased body weights and 
body weight gains was observed in only the parental females at the 
highest dose tested. Therefore, EPA has concluded that there was no 
evidence of increased susceptibility (quantitative or qualitative) for 
the offspring in the reproduction studies or for fetuses following in 
utero exposure in the developmental studies.
    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% CT 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 4.8% of the cPAD for children 
1 to 2 years old, the population group receiving the greatest

[[Page 41914]]

exposure. There are no residential uses for zoxamide.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate risk takes into account short-term and 
intermediate-term residential exposure, respectively, plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Zoxamide is currently not registered for any use patterns that 
could result in short-term or intermediate-term residential exposure. 
Because short- or intermediate-term residential exposure and chronic 
dietary exposure have already been assessed under the appropriately 
protective cPAD (which is at least as protective as the POD used to 
assess short-term risk), further assessment of short- and intermediate-
term risk is not necessary. 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.
    Neither Codex, Canada, nor Mexico has not established a MRL for 
zoxamide in/on bulb onions, so there will be no need to harmonize the 
international standards.

C. Response to Comments

    One comment was received in response to the notice of filing of 
Gowan Company's application. The commenter objected to the increase of 
chemical residues generally and expressed concerns about the 
carcinogenic effects of chemicals in general on humans. The Agency 
understands the commenter's concerns regarding toxic chemicals and 
their potential effects on humans. Pursuant to its authority under the 
FFDCA, and as discussed further in this preamble, EPA conducted a 
comprehensive assessment of zoxamide, which included an assessment on 
the carcinogenic potential of zoxamide. Based on its assessment of the 
available data, the Agency has concluded that zoxamide is not likely to 
be a carcinogen and that there is a reasonable certainty that no harm 
will result from aggregate exposure to residues of zoxamide.

D. Revisions to Petitioned-For Tolerances

    EPA is revising the tolerance expressions to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of Zoxamide not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

 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 stoichiometric equivalent of zoxamide, 
in or on onion, bulb, subgroup 3-07A at 0.7 ppm.
    In addition, EPA is revising the tolerance expressions for zoxamide 
contained in paragraphs (a)(1) and (a)(2), and in paragraph (b), 
removing the commodity ginseng, and reserving paragraph (b).

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

[[Page 41915]]

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: July 10, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.567 is amended as follows:
0
a. Revise the introductory text of paragraph (a)(1);
0
b. Revise the introductory text of paragraph (a)(2);
0
c. Alphabetically add ``Onion, bulb, subgroup 3-07A'' to the table in 
paragraph (a)(2); and
0
d. Remove and reserve paragraph (b) to read as follows:

Sec.  180.567  Zoxamide; tolerance for residues.

    (a) General. (1) Tolerances are established for residues of 
zoxamide including metabolites and degradates, in or on the commodities 
in the table below. Compliance with the tolerance levels specified 
below is to be determined by measuring only zoxamide (3,5-dichloro-N-
(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide).
* * * * *
    (2) Tolerances are established for residues of zoxamide including 
metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only 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.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Onion, bulb, subgroup 3-07A................................          0.7
 
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2014-16807 Filed 7-17-14; 8:45 am]
BILLING CODE 6560-50-P