[Federal Register Volume 88, Number 60 (Wednesday, March 29, 2023)]
[Rules and Regulations]
[Pages 18431-18434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06409]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0069; FRL-10792-01-OCSPP]


Trinexapac-ethyl; Pesticide Tolerance

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 multiple commodities discussed later in this 
document. 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 29, 2023. Objections and 
requests for hearings must be received on or before May 30, 2023, 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-2022-0069, is available at 
https://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 and the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Acting Director, 
Registration Division (7505T), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (202) 566-1030; 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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2022-0069 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 30, 2023. 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

[[Page 18432]]

notice. Submit the non-CBI copy of your objection or hearing request, 
identified by docket ID number EPA-HQ-OPP-2022-0069, by one of the 
following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 3, 2023 (88 FR 38) (FRL-9410-08-
OCSPP), 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 
1E8966) by IR-4, North Carolina State University, 1730 Varsity Drive, 
Venture IV, Suite 210, Raleigh, NC 27606. The January 3, 2023, document 
supersedes the document published on April 28, 2022 (87 FR 25178) (FRL-
9410-12-OCSPP). The petition requested that 40 CFR part 180 be amended 
by establishing tolerances for residues of trinexapac-ethyl in or on 
the raw agricultural commodities clover, forage at 8 parts per million 
(ppm) and clover, hay at 15 ppm. As a result of feeding clover that has 
been treated with trinexapac-ethyl to livestock, the following 
tolerances were proposed in livestock commodities: cattle, fat and 
cattle, meat at 0.03 ppm; cattle, meat byproducts at 0.1 ppm; egg at 
0.01 ppm; goat, fat and goat, meat at 0.03 ppm; goat, meat byproducts 
at 0.1 ppm; hog, meat byproducts at 0.1 ppm; milk at 0.01 ppm; horse, 
meat at 0.03 ppm; poultry, fat and poultry, meat at 0.01 ppm; poultry, 
meat byproducts at 0.1 ppm; sheep, fat and sheep, meat at 0.03 ppm; and 
sheep, meat byproducts at 0.1 ppm. That document referenced a summary 
of the petition, which is available in the docket, https://www.regulations.gov. A comment was received in response to the April 
28, 2022, notice of filing. EPA's response to the comment is discussed 
in Unit IV.C.

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 therein, 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's assessment of 
exposures and risks associated with trinexapac-ethyl follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemakings for the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemakings, and EPA considers referral back to those 
sections as sufficient to provide an explanation of the information EPA 
considered in making its safety determination for the new rulemaking.
    EPA has previously published tolerance rulemakings for trinexapac-
ethyl in which EPA concluded, based on the available information, that 
there is a reasonable certainty that no harm would result from 
aggregate exposure to trinexapac-ethyl and established tolerances for 
residues of that chemical. EPA is incorporating previously published 
sections from these rulemakings as described further in this 
rulemaking, as they remain unchanged.
    Toxicological profile. For a discussion of the Toxicological 
Profile of trinexapac-ethyl, see Unit III.A. of the trinexapac-ethyl 
tolerance rulemaking published in the Federal Register of May 20, 2015 
(80 FR 28843) (FRL-9926-62).
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
trinexapac-ethyl used for human health risk assessment, please 
reference Unit III.B. of the trinexapac-ethyl tolerance rulemaking 
published in the Federal Register of March 2, 2012 (77 FR 12740) (FRL-
9337-9).
    Exposure assessment. EPA's dietary exposure assessments have been 
updated to include the additional exposure from the proposed new 
regional use on clover as well for associated residues on animal 
commodities. The assessments were conducted with Dietary Exposure 
Evaluation Model software using the Food Commodity Intake Database 
(DEEM-FCID) Version 4.02, which uses the 2005-2010 food consumption 
data from the United States Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). The unrefined acute and chronic dietary 
exposure assessments used tolerance-level residues, EPA's default 
processing factors, and assumed 100 percent crop treated (PCT) for the 
registered commodities.
    Drinking water and non-occupational exposures. The drinking water 
numbers have not changed as a result of the new use on clover. For a 
detailed summary of the drinking water analysis for trinexapac-ethyl 
used for the human health risk assessment, please reference Unit 
III.C.2. of the May 20, 2015, rulemaking.
    Trinexapac-ethyl is currently registered for the following uses 
that could result in residential exposures: residential lawns, athletic 
fields, parks, and golf courses. For a detailed summary of the non-
occupational analysis for trinexapac-ethyl used for the human health 
risk assessment, please reference Unit III.C.3. of the May 20, 2015, 
rulemaking.
    Cumulative exposure. 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.'' Unlike other 
pesticides for which EPA has followed a cumulative risk approach

[[Page 18433]]

based on a common mechanism of toxicity, EPA has not made a common 
mechanism of toxicity finding as to trinexapac-ethyl and any other 
substances. For the purposes of this action, therefore, EPA has not 
assumed that trinexapac-ethyl has a common mechanism of toxicity with 
other substances.
    Safety factor for infants and children. EPA continues to conclude 
that there are reliable data to support the reduction of the Food 
Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit 
III.D. of the May 20, 2015, rulemaking for a discussion of the Agency's 
rationale for that determination.
    Aggregate risks and determination of safety. EPA determines whether 
acute and chronic dietary pesticide exposures are safe by comparing 
dietary exposure estimates to the acute population-adjusted dose (aPAD) 
and chronic population-adjusted dose (cPAD). Short-, intermediate-, and 
chronic-term aggregate risks are evaluated by comparing the estimated 
total food, water, and residential exposure to the appropriate points 
of departure to ensure that an adequate margin of exposure (MOE) 
exists.
    Acute dietary risks are below the Agency's level of concern of 100% 
of the aPAD; they are 2.5% of the aPAD for females 13 to 49 years old, 
the only population group of concern. Chronic dietary risks are below 
the Agency's level of concern of 100% of the cPAD; they are 6.8% of the 
cPAD for children 1 to 2 years old, the group with the highest 
exposure.
    Short-term aggregate (average dietary and residential turf 
exposures) MOEs for adults (235) and youth (4,500) are above EPA's 
level of concern of 100 and are not of concern. Trinexapac-ethyl is 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
EPA does not expect trinexapac-ethyl to pose a cancer risk from 
aggregate exposure.
    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. More detailed 
information on this action can be found in the document titled 
``Trinexapac-ethyl. Human Health Risk Assessment for the New Use on 
Clover (Seed Crop).'' in docket ID EPA-HQ-OPP-2022-0069.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the May 20, 2015, rulemaking.

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).
    There are no established Codex MRLs on clover forage and hay. There 
are established Codex MRLs for trinexapac-ethyl in or on livestock 
commodities. The U.S. tolerances are harmonized with Codex MRLs for 
ruminant and hog meat byproduct at 0.1 ppm. However, the ruminant and 
swine meat and fat tolerances increased to 0.03 ppm because there is 
the potential for secondary transfer of trinexapac-ethyl resides in 
ruminant meat from the new use on clover. Because the U.S. tolerances 
are higher based on the estimated livestock dietary burden, it is not 
possible to harmonize with the 0.01 ppm Codex MRL for ruminant and 
swine meat and fat commodities.

C. Response to Comments

    One comment was received on the notice of filing, which opposed EPA 
establishing the requested tolerances and objected to the presence of 
pesticide residues on crops. Although the Agency recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops, the existing legal framework provided by section 408 of the 
FFDCA authorizes EPA to establish tolerances when it determines that 
the tolerances are safe. Upon consideration of the validity, 
completeness, and reliability of the available data as well as other 
factors the FFDCA requires EPA to consider, EPA has determined that the 
trinexapac-ethyl tolerances are safe. The commenter has provided no 
information indicating that a safety determination cannot be supported.

V. Conclusion

    Therefore, tolerances are established for residues of trinexapac-
ethyl in or on egg at 0.01 ppm; milk at 0.01 ppm; poultry, fat at 0.01 
ppm; poultry, meat at 0.01 ppm; and poultry, meat byproducts at 0.1 
ppm. The following established tolerances for residues of trinexapac-
ethyl are revised to the specified levels: cattle, fat at 0.03 ppm; 
cattle, meat at 0.03 ppm; cattle, meat byproducts at 0.1 ppm; goat, fat 
at 0.03 ppm; goat, meat at 0.03 ppm; goat, meat byproducts at 0.1 ppm; 
hog, meat byproducts at 0.1 ppm; horse, meat at 0.03 ppm; sheep, fat at 
0.03 ppm; sheep, meat at 0.03 ppm; and sheep, meat byproducts at 0.1 
ppm. Additionally, tolerances with regional registrations are 
established for residues of trinexapac-ethyl in or on clover, forage at 
8 ppm and clover, hay at 15 ppm.
    As a housekeeping measure, EPA is removing the word ``imported'' 
from the commodity entry for ``Poppy, seed imported'', as unnecessary 
and redundant. Moreover, use of that adjective is not consistent with 
how EPA typically identifies tolerances for residues in or on imported 
commodities. The associated footnote 1 indicates that there are no U.S. 
registrations for use of trinexapac-ethyl on poppy seed; thus, the 
tolerance itself is intended to cover residues on imported commodities. 
Additionally, footnote 1 is being added to the table as identified in 
the March 15, 2018, final tolerance rule. The changes have no 
substantive effect and can be accomplished without further notice and 
comment.

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), or to 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

[[Page 18434]]

the tolerances 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: March 14, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter 1 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. Revise Sec.  180.662 to 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 table 1 to this paragraph (a). 
Compliance with the tolerance levels specified in table 1 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.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Barley, bran................................................         2.5
Barley, grain...............................................         2.0
Barley, hay.................................................         0.8
Barley, straw...............................................         0.4
Cattle, fat.................................................        0.03
Cattle, meat................................................        0.03
Cattle, meat byproducts.....................................         0.1
Egg.........................................................        0.01
Goat, fat...................................................        0.03
Goat, meat..................................................        0.03
Goat, meat byproducts.......................................         0.1
Grass, forage...............................................         1.5
Grass, hay..................................................         4.0
Grass, seed screenings......................................        40.0
Grass, straw................................................        10.0
Hog, fat....................................................        0.02
Hog, meat...................................................        0.02
Hog, meat by-products.......................................         0.1
Horse, fat..................................................        0.02
Horse, meat.................................................        0.03
Horse, meat byproducts......................................        0.04
Milk........................................................        0.01
Oat, forage.................................................         1.0
Oat, grain..................................................         4.0
Oat, hay....................................................         1.5
Oat, straw..................................................         0.9
Poppy, seed \1\.............................................           8
Poultry, fat................................................        0.01
Poultry, meat...............................................        0.01
Poultry, meat byproducts....................................         0.1
Rice, bran..................................................         1.5
Rice, grain.................................................         0.4
Rice, straw.................................................        0.07
Rice, wild, grain...........................................         0.4
Rye, bran...................................................         6.0
Rye, grain..................................................         4.0
Rye, hay....................................................         1.5
Rye, straw..................................................         0.9
Sheep, fat..................................................        0.03
Sheep, meat.................................................        0.03
Sheep, meat byproducts......................................         0.1
Sugarcane, cane.............................................         1.5
Sugarcane, molasses.........................................           5
Wheat, bran.................................................         6.0
Wheat, forage...............................................         1.0
Wheat, grain................................................         4.0
Wheat, hay..................................................         1.5
Wheat, middlings............................................        10.5
Wheat, straw................................................         0.9
------------------------------------------------------------------------
\1\ There are no U.S. registrations for Poppy, seed as of March 15,
  2018.

    (b) [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registrations, as defined in Sec.  180.1, are established for 
residues of trinexapac-ethyl, including its metabolites and degradates, 
in or on the commodities in table 2 to this paragraph (c). Compliance 
with the tolerance levels specified in table 2 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.

                        Table 2 to Paragraph (c)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Clover, forage..............................................           8
Clover, hay.................................................          15
------------------------------------------------------------------------

    (d) [Reserved]

[FR Doc. 2023-06409 Filed 3-28-23; 8:45 am]
BILLING CODE 6560-50-P


