
[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 [www.gpo.gov]
[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 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and the OPP Docket is (202) 566-1744. 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; 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, 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Summary of Petitioned-For 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, https://www.regulations.gov. 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 https://www.regulations.gov 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

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: 
[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).
    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)
------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
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


