[Federal Register Volume 88, Number 13 (Friday, January 20, 2023)]
[Rules and Regulations]
[Pages 3664-3668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00949]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0787; FRL-10504-01-OCSPP]


Fluridone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluridone in or on multiple commodities which are identified and 
discussed later in this document. SePRO Corporation requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 20, 2023. Objections and 
requests for hearings must be received on or before March 21, 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-2021-0787, 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 and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-2875; 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

[[Page 3665]]

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-2021-0787 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 
March 21, 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 notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2021-0787, 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//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 Tolerances

    In the Federal Registers of March 22, 2022 (87 FR 16133) (FRL-9410-
11) and June 22, 2022 (87 FR 37287) (FRL-9410-02), EPA issued documents 
pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing 
the filing of pesticide petitions (PP 1F8940 and PP 2F8996, 
respectively) by SePRO Corporation, 11550 N. Meridian Street, Suite 
600, Carmel, IN 46032. The petitions requested that 40 CFR part 180.420 
be amended by establishing tolerances for residues of the herbicide 
fluridone in or on the raw agricultural commodities of Berry and small 
fruit, group 13-07; Fruit, citrus, group 10-10; Fruit, pome, group 11-
10; Tropical and subtropical, small fruit, edible peel subgroup 23A; 
Tropical and subtropical, medium and large fruit, smooth, inedible 
peel, subgroup 24B; Hop, dried cones; Nut, tree, group 14-12; and Rice, 
grain at 0.1 parts per million (ppm) (PP 1F8940); Animal feed, 
nongrass, group 18 and Grass, forage, fodder and hay, group 17 at 0.15 
ppm (PP 1F8940); and Peanut at 0.1 ppm and Peanut, hay at 0.15 ppm (PP 
2F8996). The petitions also requested to remove the existing tolerances 
for indirect or inadvertent residues of the herbicide fluridone, 
including its metabolites and degradates, from 40 CFR 180.420(d) in or 
on Berry, group 13; Fruit, citrus, group 10; Fruit, pome, group 11; 
Hop, dried cones; Nut, tree, group 14 at 0.1 ppm; Animal feed, 
nongrass, group 18 and Grass, forage at 0.15 ppm (PP 1F8940); and the 
existing time-limited tolerances for residues of the herbicide 
fluridone, including its metabolites and degrades, from 40 CFR 
180.420(b) in or on Peanut and Peanut, hay at 0.1 ppm (PP 2F8996). 
Those documents referenced summaries of the petitions prepared by SePRO 
Corporation, which are available in the docket, https://www.regulations.gov. Comments were received in response to the March 
22, 2022, Notice of Filing (PP 1F8940). EPA's response to these 
comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
is removing the following individual commodities from 40 CFR 
180.420(a)(2), because the new crop group/subgroup tolerances 
established in this action will cover these commodities: pistachio (in 
crop group 14-12), tangerine (in crop group 10-10), pomegranate (in 
crop subgroup 24B), and avocado (in crop group 24B). Additionally, 
based on standard commodity definitions, EPA is updating the 
petitioned-for commodity definition ``Tropical and subtropical, medium 
and large fruit, smooth, inedible peel, subgroup 24B'' to ``Tropical 
and subtropical, medium to large fruit, smooth, inedible peel, subgroup 
24B.''

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 fluridone, including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with fluridone follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections of the rule that would repeat 
what has been previously published in 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

[[Page 3666]]

making its safety determination for the new rulemaking.
    EPA has previously published tolerance rulemakings in 2016, 2020, 
and 2022 for fluridone in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to fluridone and established tolerances 
for residues of that chemical. EPA is incorporating previously 
published sections from these rulemakings as described further in this 
rule, as they remain unchanged.
    Toxicological profile. For a discussion of the toxicological 
profile for fluridone, see Unit III.A. of the May 18, 2020, final rule 
(85 FR 29633) (FRL-10007-09).
    Toxicological points of departure/Levels of concern. For a summary 
of the toxicological points of departure and levels of concern for 
fluridone used for the human health risk assessment, see Unit III.B. of 
the February 17, 2016, final rule (81 FR 7982) (FRL-9941-69).
    Exposure assessment. EPA's dietary exposure assessments have been 
updated to include the additional exposure from the petitioned-for 
tolerances for fluridone. Acute and chronic unrefined dietary exposure 
assessments were performed for fluridone that incorporated tolerance-
level residues, 100% crop treated (PCT) assumptions, default processing 
factors, and empirical processing factors where available. These 
assessments were revised to reflect the updated Dietary Exposure 
Evaluation Model software with the Food Commodity Intake Database 
(DEEM-FCID), Version 4.02, which incorporates 2005-2010 consumption 
data from the United States Department of Agriculture (USDA) National 
Health and Nutrition Examination Survey, What We Eat in America 
(NHANES/WWEIA). The acute and chronic estimated drinking water 
concentrations (EDWCs) of 150 parts per billion (ppb) and 107 ppb, 
respectively, are unchanged from the May 18, 2020, final rule and were 
directly incorporated into the dietary assessments. A cancer dietary 
assessment was not conducted as fluridone is classified as ``not 
likely'' to be a human carcinogen. The residential exposure assessment 
also has not changed since the May 18, 2020, final rule because there 
are no proposed new residential uses. For a summary of the dietary 
exposure from drinking water and non-dietary exposure, see Unit III.C. 
of the May 18, 2020, final rule.
    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 based 
on a common mechanism of toxicity, EPA has not found fluridone to share 
a common mechanism of toxicity with any other substances, and fluridone 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that fluridone does not have 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 18, 2020, final rule 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 
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 (POD) to ensure that an adequate margin 
of exposure (MOE) exists. For linear cancer risks, EPA calculates the 
lifetime probability of acquiring cancer given the estimated aggregate 
exposure.
    Acute dietary risks are below the Agency's level of concern: 2.5% 
of the aPAD for all infants (<1 year old), the population group 
receiving the greatest exposure. Chronic dietary risks are below the 
Agency's level of concern: 7.6% of the cPAD for all infants (<1 year 
old), the population group receiving the greatest exposure. The 
combined short-term food, water, and residential exposures result in 
aggregate MOEs of 1,300 for adults and 1,800 for children. The Agency's 
level of concern for fluridone is an MOE of 100 or below, and these 
MOEs are therefore not of concern. Because there is no intermediate-
term residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for fluridone. Finally, EPA has concluded that 
fluridone 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 that there is a reasonable certainty that no harm 
will result to the general population, or to infants and children, from 
aggregate exposure to fluridone residues. Detailed information on this 
action can be found in the document titled ``Fluridone. Human Health 
Risk Assessment for the Section 3 Registration Action on Pome Fruit 
(Crop Group 11-10); Berry and Small Fruit (Crop Group 13-07); Grass 
Forage (Crop Group 17); Non-grass Animal Feed (Crop Group 18); Tropical 
and Subtropical, Small Fruit, Edible Peel (Crop Subgroup 23A); Rice; 
Peanut; Hops; and Crop Group Conversions/Expansions.'' in docket ID 
EPA-HQ-OPP-2021-0787.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available in the Pesticide 
Analytical Manual (PAM) Volume II to enforce the tolerance expression 
in plant and animal commodities. A Quick, Easy, Cheap, Effective, 
Rugged, and Safe (QuEChERS) multiresidue method (Method No. A0013-02) 
is also available for determining residues of fluridone in various crop 
commodities, except acidic commodities. This QuEChERS method is 
considered marginally adequate for determining residues in acidic 
commodities. These methods 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). Codex has not established MRLs for fluridone.

C. Response to Comments

    Two comments were received in response to the Notice of Filing 
published in the Federal Register of March 22, 2022 (87 FR 16133) (FRL-
9410-11). Neither comment was

[[Page 3667]]

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.

V. Conclusion

    Therefore, tolerances are established for residues of fluridone 
under 40 CFR 180.420(a)(2) in or on the following raw agricultural 
commodities: Animal feed, nongrass, group 18 at 0.15 ppm; Berry and 
small fruit, group 13-07 at 0.1 ppm; Fruit, citrus, group 10-10 at 0.1 
ppm; Fruit, pome, group 11-10 at 0.1 ppm; Grass, forage, fodder and 
hay, group 17 at 0.15 ppm; Hop, dried cones at 0.1 ppm; Nut, tree, 
group 14-12 at 0.1 ppm; Peanut at 0.1 ppm; Peanut, hay at 0.15 ppm; 
Rice, grain at 0.1 ppm; Tropical and subtropical, small fruit, edible 
peel subgroup 23A at 0.1 ppm; and Tropical and subtropical, medium to 
large fruit, smooth, inedible peel subgroup 24B at 0.1 ppm.
    In addition, EPA is removing the established tolerances for 
indirect or inadvertent residues of fluridone under 40 CFR 180.420(d) 
in or on the following commodities: Animal feed, nongrass, group 18 at 
0.15 ppm; Berry, group 13 at 0.1 ppm; Fruit, citrus, group 10 at 0.1 
ppm; Fruit, pome, group 11 at 0.1 ppm; Grass, forage at 0.15 ppm; Hop, 
dried cones at 0.1 ppm; and Nut, tree, group 14 at 0.1 ppm. 
Additionally, EPA is removing the established Section 18 emergency 
exemption tolerances under 40 CFR 180.420(b) in or on Peanut and 
Peanut, hay at 0.1 ppm. Finally, EPA is removing the established 
tolerances from 40 CFR 180.420(a)(2) in or on the following individual 
raw agricultural commodities as they are redundant with the established 
crop group/subgroup tolerances being established in this rulemaking: 
Avocado, Pistachio, Pomegranate, and Tangerine at 0.1 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes 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 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 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: January 13, 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 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.  180.420:
0
a. In paragraph (a)(2) amend the table by:
0
i. Removing the entry for ``Avocado'';
0
ii. Adding in alphabetical order the entries ``Animal feed, nongrass, 
group 18''; ``Berry and small fruit, group 13-07''; ``Fruit, citrus, 
group 10-10''; ``Fruit, pome, group 11-10''; ``Grass, forage, fodder 
and hay, group 17''; ``Hop, dried cones''; ``Nut, tree, group 14-12''; 
``Peanut''; ``Peanut, hay ``;
0
iii. Removing the entries for ``Pistachio'' and ``Pomegranate'';
0
iv. Adding in alphabetical order the entry ``Rice, grain'';
0
v. Removing the entry for ``Tangerine'';
0
vi. Adding in alphabetical order the entries ``Tropical and 
subtropical, small fruit, edible peel, subgroup 23A''; and ``Tropical 
and subtropical, medium to large fruit, smooth, inedible peel, subgroup 
24B''.
0
b. Removing and reserving paragraph (b).
0
c. In paragraph (d), amend the table by removing the entries for 
``Animal feed, nongrass, group 18''; ``Berry, group 13''; ``Fruit, 
citrus, group 10''; ``Fruit, pome, group 11''; ``Grass, forage''; 
``Hop, dried cones''; and ``Nut, tree, group 14''
    The additions read as follows:

[[Page 3668]]

Sec.  180.420  Fluridone; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18............................         0.15
Berry and small fruit, group 13-07.........................          0.1
 
                              * * * * * * *
Fruit, citrus, group 10-10.................................          0.1
Fruit, pome, group 11-10...................................          0.1
 
                              * * * * * * *
Grass, forage, fodder and hay, group 17....................         0.15
 
                              * * * * * * *
Hop, dried cones...........................................          0.1
 
                              * * * * * * *
Nut, tree, group 14-12.....................................          0.1
Peanut.....................................................          0.1
Peanut, hay................................................         0.15
 
                              * * * * * * *
Rice, grain................................................          0.1
 
                              * * * * * * *
Tropical and subtropical, small fruit, edible peel,                  0.1
 subgroup 23A..............................................
Tropical and subtropical, medium to large fruit, smooth,             0.1
 inedible peel, subgroup 24B...............................
------------------------------------------------------------------------

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[FR Doc. 2023-00949 Filed 1-19-23; 8:45 am]
BILLING CODE 6560-50-P