[Federal Register Volume 88, Number 163 (Thursday, August 24, 2023)]
[Rules and Regulations]
[Pages 57891-57894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18222]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0577; FRL-11274-01-OCSPP]


Imazapyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
imazapyr in or on rice, bran and rice, grain. BASF Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 24, 2023. Objections and 
requests for hearings must be received on or before October 23, 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-2022-0577, is available at 
https://www.regulations.gov or in-person 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).

[[Page 57892]]

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 Federal Register 
Office'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-2022-0577 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 23, 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-2022-0577, 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 2E9009) by BASF Corporation, 26 Davis Drive, Research 
Triangle Park, NC 27709-3528. The petition requested that 40 CFR 
180.500 be amended by establishing tolerances for residues of the 
herbicide imazapyr, (2-[4,5-dihydro- 4-methyl-4-(1-methylethyl)-5-oxo-
1H-imidazol-2- yl]-3-pyridinecarboxylic acid), in or on rice, bran at 
0.2 parts per million (ppm) and rice, grain at 0.06 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.
    Based upon review of the data supporting the petition, EPA is 
establishing one tolerance at a different level than requested by the 
registrant. The reason 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 imazapyr including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with imazapyr 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.
    No hazard was identified for imazapyr in the toxicity database, 
i.e., no toxicity was demonstrated in acceptable guideline studies 
generally up to the highest doses tested of 250-1,000 mg/kg/day. The 
data also show that there is no evidence of neurotoxicity, 
immunotoxicity, genotoxicity, or carcinogenicity. Further, no adverse 
developmental effects or adverse reproductive effects were detected in 
well-conducted guideline studies. Therefore, EPA concluded that 
dietary, occupational, and residential exposures to imazapyr do not 
pose a significant human health risk. Although there is potential for 
exposure to imazapyr, no hazard was identified from the well-conducted 
toxicity studies. No adverse effects were observed in the submitted 
toxicological studies regardless of the route of exposure or the 
species tested. Therefore, risk assessments are not required. 
Furthermore, the toxicology database is considered to be adequate, and 
no additional studies are required.
    Specific information on the studies received and the nature of the 
adverse effects caused by imazapyr as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document titled ``Imazapyr Human Health Risks 
Assessment for the Establishment of Permanent Tolerances for Residues 
in/on Rice'' (hereinafter ``Imazapyr Human Health Risk Assessment'') on 
pages 12-15 in docket ID number EPA-HQ-OPP-2022-0577.

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.

[[Page 57893]]

PODs are developed based on a careful analysis of the doses in each 
toxicological study to determine the the NOAEL and the 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 
points of departure (PODs) were selected for imazapyr.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to imazapyr, EPA considered exposure under the petitioned-for 
tolerances as well as all existing imazapyr tolerances in 40 CFR 
180.500. There is likely to be dietary exposure to imazapyr 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 
imazapyr.
    2. Dietary exposure from drinking water. While there is no 
additional exposure expected from imazapyr tolerances for rice because 
it is for import only, there is likely to be dietary exposure to 
imazapyr 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 imazapyr.
    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).
    Imazapyr is currently registered in the United States for 
application in/around the home (homeowner application permitted) and to 
noncropland areas, aquatic sites, grasslands, and imidazolinone-
tolerant field corn. Due to the low toxicity of imazapyr, quantitative 
exposure assessments are not required. Residential exposure to imazapyr 
is not expected to increase with this tolerance because these 
tolerances are for import only. EPA concludes with reasonable certainty 
that non-occupational exposures to imazapyr 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 imazapyr and any other substances. For the purposes of 
this action, therefore, EPA has not assumed that imazapyr has 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 Agency 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. No hazard was identified from the toxicity studies. 
No adverse effects were observed in the submitted toxicological studies 
regardless of the route of exposure or the species tested. The 
toxicology database for imazapyr is considered to be adequate. No 
additional toxicological studies are required, and no additional safety 
factors to protect children are needed and EPA is not retaining the 10X 
safety factor.

E. Determination of Safety

    Taking into account the available data for imazapyr, EPA has 
concluded that given the lack of 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 
imazapyr.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography with tandem mass spectroscopy (LC/MS/MS), method SOP-
PA.0288) is available for tolerance enforcement.
    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 not established a MRL for imazapyr in or on rice.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance for rice, bran at 0.15 ppm rather 
than at 0.2 ppm as requested by the petitioner. The rice, bran 
tolerance is based on the highest average field trial residue (0.031 
ppm) and the median rice bran processing factor of 3.2x. (0.031 ppm x 
3.2 = 0.099 ppm). The tolerance is being established at 0.15 ppm 
because that is the rounding class after 0.1 ppm. For the rice grain 
tolerance of 0.06 ppm, EPA used the Organization for Economic Co-
operation and Development (OECD) maximum residue limit (MRL) 
calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of imazapyr (2-
[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-3-
pyridinecarboxylic acid), in or on rice, bran at 0.15 ppm and rice, 
grain at 0.06 ppm.

[[Page 57894]]

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: August 18, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended 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.  180.500, amend the table in paragraph (a) by:
0
a. Adding a heading for the table;
0
b. Adding in alphabetical order the entries ``Rice, bran'' and ``Rice, 
grain''; and
0
c. Revising footnote 1.
    The additions and revision read as follows:


Sec.  180.500   Imazapyr; tolerances for residues.

    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
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                                * * * * *
Rice, bran \1\.............................................         0.15
Rice, grain \1\............................................         0.06
 
                                * * * * *
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\1\ There are no U.S. registrations as of August 24, 2023.

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[FR Doc. 2023-18222 Filed 8-23-23; 8:45 am]
BILLING CODE 6560-50-P