Rule2023-16613
Imazapic; 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
August 7, 2023
Effective
August 7, 2023
Issuing agencies
Environmental Protection Agency
Abstract
This regulation establishes tolerances for residues of imazapic in or on rice, bran and rice, grain. BASF requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Full Text
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<title>Federal Register, Volume 88 Issue 150 (Monday, August 7, 2023)</title>
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[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Rules and Regulations]
[Pages 52040-52042]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16613]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2022-0576; FRL-11129-01-OCSPP]
Imazapic; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
imazapic in or on rice, bran and rice, grain. BASF requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 7, 2023. Objections and
requests for hearings must be received on or before October 6, 2023,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2022-0576, 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. 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; telephone number: (202) 566-1030; email address:
<a href="/cdn-cgi/l/email-protection#b9ebfdffebf7d6cdd0dadccaf9dcc9d897ded6cf"><span class="__cf_email__" data-cfemail="a6f4e2e0f4e8c9d2cfc5c3d5e6c3d6c788c1c9d0">[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, 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-2022-0576 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
October 6, 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-2022-0576, 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/where-send-comments-epa-dockets">https://www.epa.gov/dockets/where-send-comments-epa-dockets</a>.
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>.
II. Summary of Petitioned-For Tolerance
In the Federal Register of September 23, 2022 (87 FR 58047) (FRL-
9410-05-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 2E9008) by BASF Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR part
180.490 be amended by establishing tolerances for residues of the
herbicide imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-methyl-3-pyridinecarboxylic acid), in or on rice, bran
at 0.2 parts per million (ppm), and rice, grain at 0.05 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.
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 imazapic
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including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
imazapic follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Endpoints were previously selected for imazapic; however, the
toxicological database was reevaluated as part of Registration Review.
The no-observed adverse-effect level (NOAEL) and lowest-observed
adverse-effect level (LOAEL) for the chronic oral toxicity study in
dogs were updated to reflect current practices in hazard evaluation.
The NOAEL is now 501 and 534 mg/kg/day in males and females,
respectively. The LOAEL is now 1,141 and 1,092 in males and females,
respectively, based on decreased body weight, increased incidence of
salivation and emesis, changes in hematological parameters, red blood
cell morphology findings, changes in clinical chemistry parameters,
gross pathology in the bone marrow, and histopathological findings.
Adverse effects in the database were only noted in two studies at doses
that are not considered relevant for human health risk assessment (>500
mg/kg/day). Therefore, no endpoints were selected for imazapic and a
quantitative assessment is not needed.
Specific information on the studies received and the nature of the
adverse effects caused by imazapic as well as the NOAEL and LOAEL from
the toxicity studies can be found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in
document titled ``Imazapic Human Health Risk Assessment to Support the
Establishment of a Tolerance without U.S. Registration in/on Rice''
(hereafter ``Imazapic Human Health Risk Assessment'' on pages 11-13 in
docket ID number EPA-HQ-OPP-2022-0576).
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
Since no effects were seen in any guideline toxicity studies at
doses relevant for human health risk assessment, no toxicological PODs
were selected for imazapic.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to imazapic, EPA considered exposure under the petitioned-for
tolerances as well as all existing imazapic tolerances in 40 CFR
180.490. There is likely to be dietary exposure to imazapic from its
use as a pesticide on imported and domestic food. Should exposure
occur, however, minimal to no risk is expected for the general U.S.
population, including infants and children, due to the low toxicity of
imazapic.
2. Dietary exposure from drinking water. While there is no
additional exposures expected from imazapic tolerances for rice because
it is for import only, there is likely to be dietary exposure to
imazapic in drinking water from its registered uses as a pesticide on
domestic crops. Should exposure occur, however, minimal to no risk is
expected for the general U.S. population, including infants and
children, due to the low toxicity of imazapic.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Imazapic is
registered for domestic uses that could result in residential exposure,
including residential spot-treatment for weed control on/in walkways,
driveways and gravel pathways. In a residential setting, residential
adult handlers may be exposed while handling imazapic and both adults
and children may be exposed following outdoor applications. Due to the
low toxicity of imazapic, quantitative exposure assessments are not
required. Residential exposure to imazamic is not expected to increase
with this tolerance because this tolerance if for import only. EPA
concludes with reasonable certainty that non-occupational exposures to
imazapic do not pose a significant human health risk.
4. Cumulative effects from substances with a common mechanism of
toxicity. 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 made a common mechanism of toxicity
finding as to imazapicand any other substances and imazapic does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this action, therefore, EPA has not assumed that
imazamox, imazapic, and imazethapyr have a common mechanism of toxicity
with other substances. Further information regarding EPA Pesticide
Commulative Risk Assessment can be found at <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework</a>.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Conclusion. In the available guideline studies, imazapic
exhibited
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very low toxicity in mammalian systems, and no effects were seen at
doses relevant for human health risk assessment. The database for
imazapic is complete. No additional toxicological studies are currently
required, and no additional safety factors to protect children are
needed.
E. Determination of Safety
Taking into account the available data for imazapic, EPA has
concluded that given the low toxicity of this substance, no risks of
concern are expected. Therefore, 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
imazapic.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (capillary electrophoresis CE
methods (CE method M 3114 and CE method M 2379)) is available for
tolerance enforcement. Residues are confirmed by liquid chromatography
(LC)/mass spectrometry (MS) analysis.
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#20524553494455454d4554484f4453604550410e474f56"><span class="__cf_email__" data-cfemail="bbc9dec8d2dfceded6decfd3d4dfc8fbdecbda95dcd4cd">[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 established an MRL for residues of imazapic in or on
rice, grain at 0.05 ppm which is the same level as the tolerance being
established for imazapic in or on rice, grain in the United States.
Codex has not established an MRL for imazapic in or on rice, bran.
V. Conclusion
Therefore, tolerances are established for residues of imazapic, (2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
methyl-3-pyridinecarboxylic acid) in or on rice, bran at 0.2 ppm and
rice, grain at 0.05 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.
Dated: July 25, 2023.
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. Amend Sec. 180.490 by adding paragraph (a)(3) to read as follows:
Sec. 180.490 Imazapic; tolerances for residues.
(a) * * *
(3) Tolerances are established for residues of the herbicide
imazapic, including its metabolites and degradates, in or on the
commodities listed in the following table. Compliance with the
tolerance levels specified is to be determined by measuring only
imazapic (2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-
2-yl]-5-methyl-3-pyridinecarboxylic acid).
Table 3 to Paragraph (a)(3)
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Parts per
Commodity million
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Rice, bran............................................ 0.2
Rice, grain........................................... 0.05
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* * * * *
[FR Doc. 2023-16613 Filed 8-4-23; 8:45 am]
BILLING CODE 6560-50-P
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