83 FR 5717 - Zoxamide; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 28 (February 9, 2018)

This regulation establishes tolerances for residues of zoxamide in or on banana. Gowan Company, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Rules and Regulations]
[Pages 5717-5720]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02668]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0681; FRL-9972-69]


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 banana. Gowan Company, LLC requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 9, 2018. Objections and 
requests for hearings must be received on or before April 10, 2018, 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-2016-0681, 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: Michael L. Goodis, P.E., Director, 
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: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0681 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 
April 10, 2018. 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-2016-0681, 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

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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 June 8, 2017 (82 FR 26641) (FRL-9661-
14), 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 
6E8524) by Gowan Company, LLC, P.O. Box 556, Yuma, AZ 85366. The 
petition requested that 40 CFR 180.567 be amended by establishing a 
tolerance for residues of the fungicide zoxamide (3, 5-dichloro-N-(3-
chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide), in or on 
banana at 0.3 parts per million (ppm). That document referenced a 
summary of the petition prepared by Gowan Company, LLC, the registrant, 
which is available in the docket, http://www.regulations.gov. One 
comment was received on the notice of filing. EPA's response is 
discussed in Unit IV.C. Based upon review of the data supporting the 
petition, EPA has determined that a tolerance of 0.20 ppm on banana is 
appropriate rather than the petitioned-for 0.3 ppm tolerance. The 
reason for this change is 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 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 import tolerance established by this action.

A. Risk Assessment

    In the Federal Register of March 8, 2016 (81 FR 12011) (FRL-9942-
18), EPA established tolerances for residues of zoxamide in or on 
several commodities. Because much of the safety assessment of zoxamide 
for the current action remains the same, EPA is incorporating several 
aspects of that previous rule and relying in part upon the findings 
made in the March 8, 2016 final rule in support of this action.
    A summary of the toxicological profile and endpoints used for human 
risk assessment is discussed in Units III.A. and III.B of the March 8, 
2016 final rule. In evaluating dietary exposure for this action, EPA 
considered exposure under the petitioned-for tolerances as well as all 
existing zoxamide tolerances in 40 CFR 180.567. The residue data used 
for the acute and chronic dietary exposure assessments have not changed 
since the assessment supporting the March 8, 2016 final rule, except to 
incorporate the exposure associated with the tolerance on banana, for 
which the Agency assumed tolerance-level residues, default processing 
factors, and 100 percent crop treated. For a summary of how EPA 
assessed these dietary exposures, see Unit III.C.1 of the March 8, 2016 
final rule. In addition, because there is no U.S. registration 
associated with the use of zoxamide on banana, the estimated drinking 
water exposures reported in the 2016 final rule remain the same for 
this rule. A summary of EPA's assessment of drinking water exposure is 
discussed in Unit III.C.2. of the March 8, 2016 final rule. Similarly, 
the Agency's assessment of cumulative risks remains the same as in the 
March 8, 2016 final rule.
    Because there have been no changes to the potential for prenatal 
and postnatal toxicity or in the completeness of data with respect to 
toxicity and exposure, EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
additional tenfold (10X) margin of safety required under section 
408(b)(2)(C) (``FQPA safety factor'') were reduced to 1X. A summary of 
EPA's rationale for this determination is discussed in Unit III.D. of 
the March 8, 2016 final rule.

B. Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute population-adjusted dose (aPAD) and chronic population-adjusted 
dose (cPAD). Short-, intermediate-, and chronic-term risks are 
evaluated by comparing the estimated aggregate food, water, and 
residential exposure to the appropriate points of departure to ensure 
that an adequate margin of exposure exists.
    No acute effects were identified in the toxicological studies for 
zoxamide; therefore, a quantitative acute dietary exposure assessment 
is unnecessary. The chronic dietary risk is 1.8% of the chronic 
population adjusted dose (cPAD) for the general U.S. population and 
6.4% of the cPAD for children 1 to 2 years old, the population subgroup 
with the highest estimated chronic dietary exposure to zoxamide. The 
Agency level of concern are percentage numbers greater than 100% of the 
cPAD. Because there are no existing or proposed residential uses for 
zoxamide, there are no exposures expected via the residential exposure 
pathway. Therefore, all aggregate risk estimates are expected to be 
equivalent only to dietary (food and drinking water) risk estimates 
mentioned above.
    Therefore, 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.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer both to the 
March 8, 2016 final rule and its supporting documents, available at 
http://www.regulations.gov in docket ID number EPA-HQ-OPP-2014-0922, 
and to the risk assessment for this current action ``Zoxamide: Human 
Health Risk Assessment for the Petition for a Tolerance Without U.S. 
Registration for Residues in/on Banana.'' in docket ID number EPA-HQ-
OPP-2016-0681.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A gas chromatography/mass selective detection (GC/MSD) method, 
modified Rohm and Haas Method #34-99-85, was previously submitted and 
concurrently revalidated with the submission of the current petition 
for the determination of residues of zoxamide in/on samples of banana. 
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-

[[Page 5719]]

2905; email address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to 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 zoxamide.

C. Response to Comments

    One comment was received from an anonymous respondent. The comment 
is general to all pesticides and is against tolerances being approved 
for any chemical on any commodity. Although the Agency recognizes that 
some individuals believe that no residue of pesticides should be 
allowed in or on food, the existing legal framework provided by section 
408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes the 
establishment of pesticide tolerances or exemptions where the Agency 
determines that tolerance or exemption meets the safety standard 
imposed by the statute. EPA has sufficient data to support a safety 
determination for the tolerance for residues of zoxamide in or on 
banana. The commenter provided no additional information supporting a 
determination that the exemption is not safe.

D. Revisions to Petitioned-For Tolerances

    The Agency is establishing a tolerance for residues of zoxamide in 
or on banana at 0.20 ppm, which is lower than the 0.30 ppm tolerance 
requested. This is because there is a difference between how the 
petitioner calculated the proposed tolerance and how the Agency 
calculates the tolerance. The 0.20 ppm tolerance being set on banana 
was calculated using the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedures and available 
field-trial residue data. The field-trial data on unbagged, whole fruit 
banana residues with a 0-day pre-harvest interval (PHI) were used from 
each field trial to calculate the tolerance.

V. Conclusion

    Therefore, a tolerance is established for residues of zoxamide, (3, 
5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-
methylbenzamide), in or on banana at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). 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: January 23, 2018.
Michael Goodis,
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, add alphabetically the entry ``Banana'' to the 
table in paragraph (a) and add footnote 1 to the table to read as 
follows:


Sec.  180.567  Zoxamide; tolerances for residues.

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

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------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Banana 1....................................................        0.20
 
                                * * * * *
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1 There are no U.S. registrations allowing use of zoxamide on banana as
  of February 9, 2018.

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[FR Doc. 2018-02668 Filed 2-8-18; 8:45 am]
BILLING CODE 6560-50-P