[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Rules and Regulations]
[Pages 61351-61354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16544]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2023-0308; FRL-12049-01-OCSPP]


Pendimethalin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pendimethalin in or on fig and fig, dried. BASF Corporation has 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective July 31, 2024. Objections and 
requests for hearings must be received on or before September 30, 2024 
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-2023-0308, 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 for the OPP Docket is (202) 566-1744. Please review 
the visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, 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-2023-0308, 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 
September 30, 2024. 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-2023-0308, 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.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.
     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.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 19, 2023 (88 FR 87733) (FRL-
10579-11), 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 
2F9038) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the herbicide pendimethalin, 
including its metabolites and degradates, in or on the raw agricultural 
commodities fig at 0.1 parts per million (ppm) and fig, dried at 3.0 
ppm. That document referenced a summary of the petition prepared by 
BASF, the registrant, which is available in the docket at https://www.regulations.gov.
    The December 19, 2023, notice of filing supersedes a notice of 
filing published in the Federal Register of July 26, 2023 (88 FR 48179) 
(FRL-10579-06), which was based on an earlier version of the same 
petition (2F9038) requesting tolerances for tropical and subtropical 
fruit, medium to large fruit, edible peel subgroup 23B at 0.1 ppm and 
fig, dried fruit at 3.0 ppm; and an inadvertent tolerance for cilantro, 
fresh leaves at 0.1 ppm. Following that July 2023 publication, BASF 
amended its petition to request tolerances only for fig and fig, dried, 
as noticed in the December 2023 publication.
    No comments were received in response to the December 19, 2023, and 
the July 26, 2023, notices of filing.
    Based upon review of the data supporting the petition and in 
accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA 
has modified the level at which one of the tolerances is being 
established. 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

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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 pendimethalin including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with pendimethalin 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.
    In the Federal Register of February 16, 2018 (83 FR 6975) (FRL-
9973-03) and October 25, 2019 (84 FR 57336) (FRL-10000-06), EPA 
published tolerance rulemakings for pendimethalin in which EPA 
concluded, based on the available information, that there is a 
reasonable certainty that no harm would result from aggregate exposure 
to pendimethalin 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 pendimethalin, see Unit III.A. of the October 25, 2019, 
rulemaking.
    Toxicological points of departure/Levels of concern. For a summary 
of the Toxicological Points of Departure/Levels of Concern for 
pendimethalin used for human health risk assessment, please reference 
Unit III.B. of the February 16, 2018, rulemaking.
    Exposure assessment. Much of the exposure assessment for 
pendimethalin remains unchanged from the discussion in Unit III.C. of 
the October 25, 2019, rulemaking, except as described below.
    Dietary exposure from food and feed uses. EPA's dietary exposure 
assessments have been updated to include the additional exposure from 
the proposed new uses on fresh and dried fig. The acute and chronic 
dietary (food and drinking water) exposure assessments in support of 
the proposed fresh and dried fig uses were conducted using the Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID) Version 4.02. This software uses 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 assumed 100 percent crop treated (PCT), tolerance-
level residues for all crops, and maximum anticipated residues to 
address all residues of concern in ruminant commodities.
    Drinking water and non-occupational exposures. The drinking water 
numbers have not changed as a result of the proposed fresh and dried 
fig uses. For a detailed summary of the drinking water analysis for 
pendimethalin used for the human health risk assessment, please 
reference Unit III.C.2. of the October 25, 2019, rulemaking.
    There are no residential exposures expected from the currently 
proposed uses; however, pendimethalin is currently registered for 
residential usage on gardens, golf course turf, lawns, and ornamentals. 
The highest anticipated short-term aggregate exposure scenarios for 
children and adults did not present risks of concern (i.e., margins of 
exposure (MOEs) are > the level of concern (LOC) of 30). Intermediate-
term exposures to pendimethalin are not likely because of the 
intermittent nature of applications by homeowners (e.g., garden 
sprays). Long-term aggregate exposure is not anticipated for 
residential uses.
    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 The Agency has 
utilized this framework for pendimethalin and determined that although 
pendimethalin shares some chemical and/or toxicological characteristics 
(e.g., chemical structure or apical endpoint) with other pesticides, 
the toxicological database does not support a testable hypothesis for a 
common mechanism of action. No further data are required to determine 
that no common mechanism of toxicity exists for pendimethalin, and 
other pesticides and no further cumulative evaluation is necessary for 
pendimethalin.
    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 October 25, 2019, 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 
aggregate exposure estimates to the acute population adjusted dose 
(aPAD) and chronic population adjusted dose (cPAD). For linear cancer 
risks, EPA calculates the lifetime probability of acquiring cancer 
given the estimated aggregate exposure. Short-, intermediate-, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the appropriate points of 
departure (PODs) to ensure that an adequate MOE exists.
    The results of the acute dietary analysis for food and drinking 
water at the 95th percentile of exposure shows that the acute dietary 
risk estimates are below the Agency's level of concern (<100% of the 
aPAD) for all population subgroups and were estimated at <1% of the 
aPAD for the U.S. general population and 2.1% of the aPAD for the most 
highly exposed population subgroup (infants <1 years old). The results 
of the chronic dietary analysis for food and drinking water indicate 
that the chronic dietary risk estimates are below the Agency's level of 
concern (<100% of the cPAD) for all population subgroups and were 
estimated at <1% of the cPAD for the U.S. general population and 2.3% 
of the cPAD for the most highly exposed population subgroup (children 1 
to 2 years old).
    Acute aggregate exposure is anticipated to occur from dietary 
exposure in food and drinking water only. There are no risks of concern 
for acute dietary exposure and thus no risks of concern for acute 
aggregate exposure. Short-term aggregate risk assessment was performed 
since there is potential

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for post-application exposure from the existing uses in residential 
settings. The highest anticipated short-term aggregate exposure 
scenarios for children and adults did not present risks of concern 
(i.e., MOEs are >LOC of 30). Intermediate-term exposures to 
pendimethalin are not likely because of the intermittent nature of 
applications by homeowners (e.g., garden sprays). Long-term aggregate 
exposure is not anticipated for residential uses. Therefore, chronic 
aggregate risk estimates for pendimethalin include food and drinking 
water only, and are equivalent to the chronic dietary risk estimates, 
and are below HED's LOC. Pendimethalin is classified as a ``possible 
human carcinogen.'' However, the chronic dietary risk assessment is 
considered to be protective of any cancer effects; therefore, a 
separate quantitative cancer dietary risk assessment is not required. 
The chronic reference dose (cRfD)/cPAD is considered to be protective 
of all chronic toxicity, including carcinogenicity, that could result 
from exposure to pendimethalin. Since there are no chronic aggregate 
risks of concern, there are no cancer aggregate risks of concern.
    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 pendimethalin residues. More detailed information 
on the subject action to establish tolerances in or on fig commodities 
can be found in the document titled ``Pendimethalin--Human Health Risk 
Assessment to Support the Proposed New Use on Fig.'' available at 
https://www.regulations.gov in docket ID number EPA-HQ-OPP-2023-0308.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical enforcement methodology, gas chromatography 
with electron capture detection (GC/ECD), 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). 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 any MRLs for pendimethalin for the crops covered by this 
action.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance for fig, dried at 3 ppm rather 
than 3.0 ppm to be consistent with Organisation for Economic 
Cooperation and Development (OECD) rounding class practices.

V. Conclusion

    Therefore, tolerances are established for residues of pendimethalin 
in or on the raw agricultural commodities fig at 0.1 parts per million 
(ppm) and fig, dried at 3 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 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.


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    Dated: July 19, 2024.
Charles Smith,
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.  180.361, amend paragraph (a)(1) by designating the table as 
``Table 1 to Paragraph (a)(1)'' and adding to newly designated table 1, 
in alphabetical order, the entries ``Fig'' and ``Fig, dried'' to read 
as follows:


Sec.  180.361  Pendimethalin; tolerances for residues.

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

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fig........................................................          0.1
Fig, dried.................................................            3
 
                                * * * * *
------------------------------------------------------------------------

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[FR Doc. 2024-16544 Filed 7-30-24; 8:45 am]
BILLING CODE 6560-50-P