Rule2024-02092
Saflufenacil; Pesticide Tolerances
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
February 2, 2024
Effective
February 2, 2024
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of saflufenacil in or on corn, field, forage; corn, field, stover; and corn, field, milled byproducts; and amends the existing commodity definition for Crop Group 16 to Crop Group 16-22. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 89 Issue 23 (Friday, February 2, 2024)</title>
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[Federal Register Volume 89, Number 23 (Friday, February 2, 2024)]
[Rules and Regulations]
[Pages 7291-7294]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02092]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0868; FRL-11673-01-OCSPP]
Saflufenacil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
saflufenacil in or on corn, field, forage; corn, field, stover; and
corn, field, milled byproducts; and amends the existing commodity
definition for Crop Group 16 to Crop Group 16-22. BASF Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective February 2, 2024. Objections and
requests for hearings must be received on or before April 2, 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-2022-0868, 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 the OPP Docket is (202) 566-1744. For the latest
status information on EPA/DC services, docket access, visit <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#81d3c5c7d3cfeef5e8e2e4f2c1e4f1e0afe6eef7"><span class="__cf_email__" data-cfemail="93c1d7d5c1ddfce7faf0f6e0d3f6e3f2bdf4fce5">[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-2022-0868 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
April 2, 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-2022-0868, 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.
<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">https://www.epa.gov/dockets</a>.
Additional instructions on commenting or visiting the docket,
[[Page 7292]]
along with more information about dockets generally, is available at
<a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of July 5, 2023 (88 FR 42935) (FRL-10579-
05-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
2F9019) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709. The petition requested that 40 CFR
180.649(a)(1) be amended by establishing tolerances for residues of the
herbicide saflufenacil, including its metabolites and degradates, in or
on Corn, field, forage at 0.3 parts per million (ppm), Corn, field,
milled byproducts at 0.125 ppm, and Corn, field, stover at 5.0 ppm. The
petition also requested to amend the existing commodity definition in
40 CFR 180.649(a)(1) for residues of the herbicide saflufenacil,
including its metabolites and degradates, in or on ``Grain, cereal,
forage, fodder and straw group 16 (except barley and wheat straw)'' to
``Grain, cereal, forage, hay, stover, and straw group 16-22 (except
field corn forage, field corn stover, barley straw, wheat straw, and
chia straw)'' unchanged at 0.1 ppm. That document referenced a summary
of the petition prepared by BASF Corporation, the registrant, which is
available in the docket, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. There were no
comments received in response to the notice 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 made modifications to the proposed tolerance values and commodity
definitions. The reasons for these changes are explained 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 in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for saflufenacil including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with saflufenacil 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 a tolerance rulemaking in 2015 for
saflufenacil in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to saflufenacil and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from that rulemaking as described further
in this rulemaking, as they remain unchanged.
Toxicological profile. For a discussion of the toxicological
profile for saflufenacil, see Unit III.A. of the saflufenacil tolerance
rulemaking published in the Federal Register of November 25, 2015 (80
FR 73663) (FRL-9936-71).
Toxicological points of departure/Levels of concern. A summary of
the toxicological points of departure and levels of concern for
saflufenacil used for human health risk assessment is discussed in Unit
III.B. of the November 25, 2015, rulemaking.
Exposure assessment. Much of the exposure assessment remains
unchanged from the November 2015 rulemaking, although updates have
occurred to accommodate the exposures from the petitioned-for
tolerances. These updates are discussed in this section; for a
description of the rest of the EPA approach to and assumptions for the
exposure assessment, see Unit III.C of the November 25, 2015,
rulemaking.
EPA's dietary exposure assessments have been updated to include the
additional exposure from the petitioned-for tolerances for
saflufenacil. Acute and chronic dietary exposure assessments were
performed for saflufenacil that incorporated tolerance-level residues,
100% crop treated (CT) assumptions, and default processing factors.
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 133 parts per billion (ppb) and 120 ppb,
respectively, are unchanged from the November 25, 2015, rulemaking and
were directly incorporated into the dietary assessments. A cancer
dietary assessment was not conducted as saflufenacil is classified as
``not likely'' to be a human carcinogen. Saflufenacil is not registered
for any specific use patterns that would result in residential
exposure. Therefore, a quantitative residential exposure assessment was
not conducted.
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.'' EPA has not
found saflufenacil to share a common mechanism of toxicity with any
other substances, and saflufenacil does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that saflufenacil does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
Safety factor for infants and children. EPA continues to conclude
that there are reliable data to support the
[[Page 7293]]
reduction of the Food Quality Protection Act (FQPA) safety factor from
10X to 1X. See Unit III.D. of the November 25, 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 the 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 (PODs) to ensure that an adequate
margin of exposure (MOE) exists.
Acute dietary (food and drinking water) risks are below the
Agency's level of concern of 100% of the acute population adjusted dose
(aPAD); they are <1% of the aPAD for all infants less than 1 year old,
the population group receiving the greatest exposure. Chronic dietary
(food and drinking water) risks are below the Agency's level of concern
of 100% of the chronic population adjusted dose (cPAD); they are 26% of
the cPAD for all infants less than 1 year old, the population group
receiving the greatest exposure. There is no short- or intermediate-
term residential exposure expected since there are no proposed or
previously registered residential uses of saflufenacil. Therefore, the
acute and chronic aggregate risks consist only of the dietary risks
from food and water only, and as stated above, are below the Agency's
level of concern. Based on the lack of evidence of carcinogenicity in
two adequate rodent carcinogenicity studies, saflufenacil is not
expected to pose a cancer risk to humans.
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 saflufenacil residues, including its metabolites
and degradates. More detailed information about the Agency's analysis
can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document titled
``Saflufenacil. Human Health Risk Assessment for Proposed New and
Amended Uses on Field Corn Commodities, Post-Harvest and Fallow'' in
docket ID number EPA-HQ-OPP-2022-0868.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high-performance liquid
chromatography with tandem mass spectroscopy detection (HPLC-MS/MS)
Method D0603/04) 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#e59780968c8190808880918d8a8196a5809584cb828a93"><span class="__cf_email__" data-cfemail="f88a9d8b919c8d9d959d8c90979c8bb89d8899d69f978e">[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). The Codex has not established MRLs for saflufenacil
for feed items of raw agricultural commodities. Therefore,
harmonization of MRLs and U.S. tolerances is not an issue at this time.
C. Revisions to Petitioned-For Tolerances
EPA is revising the tolerance level proposed for corn, field,
forage from 0.3 ppm to 0.4 ppm based on field trial residues values and
the combined residue calculation. The tolerance level proposed for
corn, field, stover is also being revised from 5.0 ppm to 5 ppm based
on the Organization for Economic Co-operation and Development (OECD)
rounding class practice. EPA is also revising the tolerance level
proposed for corn, field, milled byproducts from 0.125 ppm to 0.2 ppm
to adjust for degree of exaggeration and the OECD rounding class. Also,
EPA is revising the proposed commodity definition ``Grain, cereal,
forage, hay, stover, and straw group 16-22 (except field corn forage,
field corn stover, barley straw, wheat straw, and chia straw)'' to the
following definitions to align better with the Agency's current
preferred commodity vocabulary: ``Grain, cereal, forage, hay, stover,
and straw, group 16-22, forage, except corn, field, forage''; ``Grain,
cereal, forage, hay, stover, and straw, group 16-22, hay''; ``Grain,
cereal, forage, hay, stover, and straw, group 16-22, stover, except
corn, field, stover''; and ``Grain, cereal, forage, hay, stover, and
straw, group 16-22, straw, except barley, chia, and wheat, straw.''
V. Conclusion
Therefore, tolerances are established for residues of saflufenacil,
including its metabolites and degradates, in or on Corn, field, forage
at 0.4 ppm; Corn, field, milled byproducts at 0.2 ppm; Corn, field,
stover at 5 ppm; Grain, cereal, forage, hay, stover, and straw, group
16-22, forage, except corn, field, forage at 0.1 ppm; Grain, cereal,
forage, hay, stover, and straw, group 16-22, hay at 0.1 ppm; Grain,
cereal, forage, hay, stover, and straw, group 16-22, stover, except
corn, field, stover at 0.1 ppm; and Grain, cereal, forage, hay, stover,
and straw, group 16-22, straw, except barley, chia, and wheat, straw at
0.1 ppm. In addition, EPA is removing the established tolerance in or
on Grain, cereal, forage, fodder and straw group 16 (except barley and
wheat straw) 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 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 tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the
[[Page 7294]]
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 30, 2024.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA amends 40
CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.649, amend the table in paragraph (a)(1) by:
0
a. Adding in alphabetical order the entries ``Corn, field, forage'';
``Corn, field, milled byproducts''; and ``Corn, field, stover''.
0
b. Removing the entry for ``Grain, cereal, forage, fodder and straw
group 16 (except barley and wheat straw)''.
0
c. Adding in alphabetical order the entries ``Grain, cereal, forage,
hay, stover, and straw, group 16-22, forage, except corn, field,
forage''; ``Grain, cereal, forage, hay, stover, and straw, group 16-22,
hay''; ``Grain, cereal, forage, hay, stover, and straw, group 16-22,
stover, except corn, field, stover''; and ``Grain, cereal, forage, hay,
stover, and straw, group 16-22, straw, except barley, chia, and wheat,
straw''.
The additions read as follows:
Sec. 180.649 Saflufenacil; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Corn, field, forage......................................... 0.4
Corn, field, milled byproducts.............................. 0.2
Corn, field, stover......................................... 5
* * * * * * *
Grain, cereal, forage, hay, stover, and straw, group 16-22, 0.1
forage, except corn, field, forage.........................
Grain, cereal, forage, hay, stover, and straw, group 16-22, 0.1
hay........................................................
Grain, cereal, forage, hay, stover, and straw, group 16-22, 0.1
stover, except corn, field, stover.........................
Grain, cereal, forage, hay, stover, and straw, group 16-22, 0.1
straw, except barley, chia, and wheat, straw...............
* * * * * * *
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* * * * *
[FR Doc. 2024-02092 Filed 2-1-24; 8:45 am]
BILLING CODE 6560-50-P
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