[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Rules and Regulations]
[Pages 70062-70064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23040]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0046; FRL-10012-51]


Trinexapac-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
trinexapac-ethyl in or on sugarcane, cane and sugarcane, molasses. 
Syngenta Crop Protection, LLC requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 4, 2020. Objections and 
requests for hearings must be received on or before January 4, 2021, 
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-2020-0046, 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. Due to public health concerns related to 
COVID-19, the EPA Docket Center and Public Reading Room are closed for 
the time being, although EPA staff are continuing to provide remote 
assistance. Please review additional information about the docket 
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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 
Publishing 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-2020-0046 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 
January 4, 2021. 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-2020-0046, 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 March 3, 2020 (85 FR 12454) (FRL-10005-
58), 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 
9F8761) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR part 180.662 be amended by 
establishing tolerances for residues of the herbicide trinexapac-ethyl, 
(4-(cyclopropyl-a-hydroxy-methylene)-3,5-dioxo-cyclohexanecarboxylic 
acid ethyl ester), and its primary metabolite CGA-179500 in or on 
sugarcane, cane at 1.5 parts per million (ppm) and sugarcane, molasses 
at 5.0 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. 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 
modifying the tolerance expression and the tolerance for sugarcane, 
molasses at a different level than petitioned-for. The reasons for 
these 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

[[Page 70063]]

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 Trinexapac-ethyl including 
exposure resulting from the tolerances established by this action.
    EPA published a final rule in the Federal Register on May 20, 2015 
(80 FR 28843) (FRL-9926-62) establishing tolerances for residues of 
trinexapac-ethyl in or on rice and rye commodities based on the 
Agency's conclusion that there is a reasonable certainty that no harm 
will result from aggregate exposure to trinexapac-ethyl to the general 
population, including infants and children. That document contains a 
summary of the toxicological profile, a reference to toxicological 
endpoints, a description of EPA's position on the potential for 
cumulative risk, as well as the rationale for the Agency's 
determination regarding the children's safety factor. As those sections 
continue to reflect the Agency's current position on those topics, 
those sections are incorporated here by reference.
    EPA's exposure assessments have been updated to include the 
additional exposure from the increased tolerance of trinexapac-ethyl 
from use in or on sugarcane, cane and sugarcane, molasses. Those 
assessments rely on tolerance-level residues, 2019 default processing 
factors, and an assumption of 100% crop treated (PCT). EPA's aggregate 
exposure assessment incorporated this additional dietary exposure, as 
well as exposure in drinking water and from residential sources, 
although those latter exposures are not impacted by the modified use on 
sugarcane and thus have not changed since the last assessment.
    Acute dietary risks are below the Agency's level of concern: 2.5% 
of the acute population adjusted dose (aPAD) for females 13 to 49 years 
old, the population group of concern. Chronic dietary risks are below 
the Agency's level of concern: 6.6% of the chronic population adjusted 
dose (cPAD) for children 1 to 2 years old, the population group 
receiving the greatest exposure. Aggregating chronic (or background) 
dietary exposure with short- and intermediate-term exposures, EPA has 
concluded that the combined food, water, and short- and intermediate-
term residential exposures result in aggregate margins of exposures 
above the level of concern for all scenarios assessed and are not of 
concern. Finally, EPA has concluded that trinexapac-ethyl is not 
expected to pose a cancer risk, given the lack of evidence of 
carcinogenicity in the database.
    Therefore, based on the risk assessments and information described 
above, EPA concludes 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. Further information 
about EPA's risk assessment and determination of safety can be found at 
http://www.regulations.gov in the document titled ``Trinexapac-ethyl. 
Human Health Risk Assessment for the Petition to Amend the Pre-Harvest 
Intervals on Sugarcane.'' dated July 13, 2020 in the docket ID number 
EPA-HQ-OPP-2020-0046.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method GRM020.01A), which 
utilizes high performance liquid chromatography with triple-quadrupole 
mass spectrometry (LC-MS/MS) 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: 
[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 established an MRL for trinexapac-ethyl in or on 
sugarcane at 0.5 ppm. This MRL is different than the tolerances 
established for trinexapac-ethyl in the United States. The United 
States is not able to harmonize its sugarcane tolerance with the Codex 
MRL; based on the reduction of the preharvest interval (PHI) from 28 to 
14 days on sugarcane, the field trial data indicate that use in 
accordance with the label results in residues may exceed tolerances if 
they were harmonized with Codex.

C. Response to Comments

    Two comments were received in response to the Notice of Filing. 
Neither comment was accompanied by any substantiation nor data 
supporting a conclusion that the tolerances being established in this 
action do not meet the FFDCA safety standard. Although EPA recognizes 
that some individuals would oppose any use of pesticides on food, 
section 408 of the FFDCA authorizes EPA to set tolerances for residues 
of pesticide chemicals in or on food when it determines that the 
tolerance meets the safety standard imposed by that statute. Upon 
review of the available information, EPA concludes that these 
tolerances would be safe.

D. Revisions to Petitioned-For Tolerances

    EPA is revising the tolerance expression to include the free and 
conjugated forms of the parent (trinexapac-ethyl) and acid. Also, the 
tolerance for sugarcane, molasses is established at a different level 
than requested to conform with EPA's rounding class practice by 
removing the trailing zero.

V. Conclusion

    Therefore, EPA is increasing tolerances for residues of trinexapac-
ethyl, ethyl 4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylate, including

[[Page 70064]]

its metabolites and degradates, in or on sugarcane, cane at 1.5 ppm, 
and sugarcane, molasses at 5 ppm.

VI. Statutory and Executive Order Reviews

    This action modifies existing 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), nor is it considered a 
regulatory action under 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: September 16, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA amends 40 
CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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.  180.662, amend paragraph (a) by:
0
i. Revising the Introductory text.
0
ii. Revising the existing entries in the table for ``Sugarcane, cane'' 
and ``Sugarcane, molasses''.
    The revisions read as follows:


Sec.  180.662  Trinexapac-ethyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant 
growth regulator, trinexapac-ethyl, including its 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 free and conjugated forms of both trinexapac-ethyl, 
ethyl 4-(cyclopropylhydroxymethylene)-3,5-dioxocyclohexanecarboxylate 
and trinexapac, 4-(cyclopropylhydroxymethylene)-3,5-
dioxocyclohexanecarboxylic acid, calculated as the stoichiometric 
equivalent of trinexapac-ethyl, in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane............................................          1.5
Sugarcane, molasses........................................            5
 
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[FR Doc. 2020-23040 Filed 11-3-20; 8:45 am]
BILLING CODE 6560-50-P