Rule2024-16544
Pendimethalin; Pesticide Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 31, 2024
Effective
July 31, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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).
Full Text
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<title>Federal Register, Volume 89 Issue 147 (Wednesday, July 31, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#21736567736f4e5548424452614451400f464e57"><span class="__cf_email__" data-cfemail="d4869092869abba0bdb7b1a794b1a4b5fab3bba2">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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 <a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#deacbbadb7baabbbb3bbaab6b1baad9ebbaebff0b9b1a8"><span class="__cf_email__" data-cfemail="d6a4b3a5bfb2a3b3bbb3a2beb9b2a596b3a6b7f8b1b9a0">[email protected]</span></a>.
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.
[[Page 61354]]
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
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* * * * *
Fig........................................................ 0.1
Fig, dried................................................. 3
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2024-16544 Filed 7-30-24; 8:45 am]
BILLING CODE 6560-50-P
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