[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Rules and Regulations]
[Pages 11420-11422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05284]



40 CFR Part 180

[EPA-HQ-OPP-2016-0365; FRL-9973-20]

Trinexapac-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes a tolerance for residues of 
trinexapac-ethyl in or on poppy, seed. Syngenta Crop Protection, LLC 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA) in order to cover residues of trinexapac-ethyl in imported 
poppy seed commodities.

DATES: This regulation is effective March 15, 2018. Objections and 
requests for hearings must be received on or before May 14, 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-2016-0365, 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.

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: 


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-2016-0365 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 14, 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-2016-0365, 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 
     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 November 30, 2016 (81 FR 86312) (FRL-
9954-06), 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 
6E8462) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for residues of the herbicide trinexapac-
ethyl, ethyl 4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylate expressed as its primary metabolite 
trinexpac, 4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylic acid, in or on poppy, seed at 8 parts per 
million (ppm). That document referenced a summary of the petition 
prepared by Syngenta Crop Protection, LLC, 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

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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 trinexapac-ethyl including 
exposure resulting from the tolerances established by this action.
    In the Federal Register of May 20, 2015 (80 FR 28843) (FRL-9926-
62), EPA amended tolerances for herbicide trinexapac-ethyl, ethyl 4-
(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylate expressed 
as its primary metabolite trinexpac, 4-(cyclopropylhydroxymethylene)-
3,5-dioxocyclohexanecarboxylic acid in or on several commodities. 
Because the majority of the Agency's conclusions remain the same, EPA 
is incorporating the discussions from the May 20, 2015, Federal 
Register document into this document and relying on the same supporting 
documents. The only difference is the potential to impact dietary 
exposure; because the use on poppy seeds is not approved in the United 
States, there is no impact on drinking water exposures or residential 
    The Agency has determined that a new dietary exposure assessment is 
not needed because poppy seed is not a significant part of the diet, 
and residues of trinexapac-ethyl do not concentrate in poppy seed oil. 
Therefore, residues in poppy seed oil are not expected to have an 
impact on the EPA's previous findings. Therefore, EPA relies upon the 
findings made in the May 20, 2015, Federal Register document, as well 
as the review of the poppy seed data in support of this rule. 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 trinexapac-ethyl residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances please refer to the May 
20, 2015, Federal Register document and its supporting documents, 
available at http://www.regulations.gov in document ``Trinexapac-ethyl; 
Pesticide Tolerances'' (80 FR 28843, May 20, 2015) in docket ID number 
EPA-HQ-OPP-2014-0340; FRL-9926-62. Further information about EPA's 
determination that an updated risk assessment was not necessary may be 
found in the document ``Trinexapac-ethyl. Section 3 Registration 
Request for New Uses on Imported Poppy Seeds. Summary of Analytical 
Chemistry and Residue Data'' in docket ID number EPA-HQ-OPP-2016-0365.

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 trinexapac-ethyl.

IV. Conclusion

    Therefore, tolerances are established for residues of trinexapac-
ethyl, ethyl 4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylate expressed as its primary metabolite 
trinexpac, 4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylic acid, in or on poppy, seed at 8 ppm.

V. 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

[[Page 11422]]

Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

VI. 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: March 7, 2018.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.662 adding alphabetically the entry for ``Poppy, seed 
imported'' and footnote 1 to the table in paragraph (a) to read as 

Sec.  180.662  Trinexapac-ethyl; tolerances for residues.

    (a) * * *

    \1\ There are no U.S. registrations for Poppy, seed as of March 
15, 2018.

                                                             Parts per
                        Commodity                             million
                                * * * * *
Poppy, seed imported \1\................................               8
                                * * * * *

* * * * *
[FR Doc. 2018-05284 Filed 3-14-18; 8:45 am]