2023-12926. Glufosinate; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of glufosinate in or on tropical and subtropical, medium to large fruit, edible peel, subgroup 23B; tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B; and tropical and subtropical, small fruit, inedible peel, subgroup 24A. The regulation also establishes tolerances with regional registrations in or on grass, forage and grass, hay. The Interregional Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective June 20, 2023. Objections and requests for hearings must be received on or before August 21, 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–2022–0014, is available online at http://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.

For the latest status information on EPA/DC services, docket access, visit 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; main telephone number: (202) 566–1030; email address: [e-mail].

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 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(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–2022–0014 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 August 21, 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–2022–0014, by one of the following methods:

• Federal eRulemaking Portal: http://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 http://www.epa.gov/​dockets.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

II. Summary of Petitioned-For Tolerances

In the Federal Register of October 24, 2022 (87 FR 64196) (FRL–9410–06–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 1E8960) by IR–4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.473 be amended to establish tolerances for residues of the herbicide glufosinate ammonium, determined by measuring the sum of glufosinate ammonium, butanoic acid, 2-amino-4-(hydroxymethylphosphinyl) monoammonium salt, and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl)butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or on the following raw agricultural commodities: tropical and subtropical, medium to large fruit, edible peel, subgroup 23B at 0.07 parts per million (ppm); tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B at 0.2 ppm; and tropical and subtropical, small fruit, inedible peel, subgroup 24A at 0.03 ppm. The petition also requested that 40 CFR 180.473 be amended to establish tolerances with regional registrations for residues of glufosinate ammonium in or on grass, forage at 0.15 ppm; and grass, hay at 0.2 ppm. Upon the establishment of those tolerances, the petition also requested that EPA remove the following tolerances from 40 CFR 180.473: avocado at 0.03 ppm; banana at 0.30 ppm; banana, pulp at 0.20 ppm; and fig at 0.07 ppm. The Notice of Filing referenced a summary of the petition prepared by IR–4, which is available in the docket at https://regulations.gov. No comments were received in response to the Notice of Filing.

Based upon review of the data supporting the petition, EPA is establishing two tolerances at a different level than the petitioner requested. In addition, EPA is establishing tolerances for glufosinate rather than glufosinate ammonium. 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 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 glufosinate including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with glufosinate follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published in 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 tolerance rulemakings for glufosinate in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to glufosinate and established tolerances for residues of that chemical. In this rulemaking, EPA is incorporating previously published sections from the September 21, 2022, rulemaking (87 FR 57621) (FRL–9521–01–OCSPP) as described further below, as they remain unchanged.

Toxicological Profile. For a discussion of the Toxicological Profile of glufosinate, see Unit III.A. of the September 21, 2022, rulemaking.

Toxicological Points of Departure/Levels of Concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the human risk assessment, see Unit III.B. of the September 21, 2022, rulemaking and pages 12–13 of the document titled “Glufosinate. Human Health Risk Assessment for Proposed New Use on tropical and subtropical, medium to large fruit, edible peel, subgroup 23B; tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B; tropical and subtropical, small fruit, inedible peel, subgroup 24A; and a new regional use on grass (seed crop)” (hereinafter “Glufosinate Human Health Risk Assessment”) in docket ID number EPA–HQ–OPP–2022–0014.

Exposure Assessment. Much of the exposure assessment remains the same, although updates have occurred to account for 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, please reference Unit III.C. of the September 21, 2022, rulemaking.

EPA's dietary exposure assessments have been updated to include the additional exposures from the new uses of glufosinate on tropical and subtropical, medium to large fruit, edible peel, subgroup 23B; tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B; and tropical and subtropical, small fruit, inedible peel, subgroup 24A; and a new regional use on grass (forage and hay). In conducting the acute dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food and Commodity Intake Database (DEEM–FCID) Version 4.02. This software uses the 2005–2010 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The acute dietary exposure assessment is unrefined, assuming tolerance level residues and 100 percent crop treated (PCT) for all crop and livestock commodities.

The chronic dietary exposure assessment also uses the DEEM–FCID Version 4.02 software with the NHANES/WWEIA data. The chronic dietary exposure assessment is refined and uses the same assumptions as Unit III.C.1.ii. in the September 21, 2022, rulemaking; specifically, anticipated residues based on average field trial residue levels for plant raw agricultural commodities, PCT information where available, and experimentally determined processing factors where available. Anticipated residues for livestock commodities were also calculated and incorporated into the assessment.

Anticipated residue and PCT information. For a discussion of the FFDCA requirements regarding use of anticipated residue and PCT information and the PCT assumptions used in the chronic dietary exposure assessment, see Unit III.C.1.iv. of the September 21, 2022, rulemaking.

Drinking Water Exposure. The new uses do not result in an increase in the estimated residue levels in drinking water, so EPA used the same estimated drinking water concentrations in the acute and chronic dietary exposure assessments as identified in Unit III.C.2. of the September 21, 2022, rulemaking.

Non-Occupational Exposure. There are no new proposed residential (non-occupational) uses for glufosinate at this time; however, glufosinate is currently registered for uses that could result in residential handler and post-application exposures, including use on lawn and turf as well as recreational sites such as golf courses. For a summary of those exposures, see Unit III.C.3. of the September 21, 2022, rulemaking.

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.” 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 glufosinate and any other substances, and glufosinate does not appear to produce a toxic metabolite produced by other substances. For purposes of this tolerance action, therefore, EPA has not assumed that glufosinate has a common mechanism of toxicity with other substances.

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 to 1X for acute dietary exposure. For all other exposure scenarios, EPA is retaining a 10X FQPA safety factor. See Unit III.D. of the September 21, 2022, rulemaking for a discussion of the Agency's rationale for that determination.

Aggregate Risk 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 to ensure that an adequate margin of exposure (MOE) exists.

Acute dietary risks are below the Agency's level of concern of 100% of the aPAD; they are 26% of the aPAD for females 13–49 years old, the only population subgroup for which an acute toxic effect was identified. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 66% of the cPAD for all infants, the most highly exposed population subgroup.

The short-term aggregate exposure assessment includes dietary (food and drinking water) and dermal exposure from high contact lawn activity on treated lawns for adults and dermal plus incidental oral exposure from high contact lawn activity on treated lawns for children 1 to less than 2 years old. The short-term aggregate MOE for adults is 4,600 and is not of concern because it is equal to or greater than the Agency's level of concern of 1,000. The short-term aggregate MOE for children 1 to less than 2 years old is 1,000. This is also not of concern because an MOE equal to or greater than the level of concern of 1,000 is not of concern.

Glufosinate is classified as “Not Likely To Be Carcinogenic to Humans” based on the lack of evidence of a treatment-related increase in tumors in two adequate rodent carcinogenicity studies.

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 glufosinate residues. More detailed information on this action can be found in the Glufosinate Human Health Risk Assessment in docket ID EPA–HQ–OPP–2022–0014.

IV. Other Considerations

A. Analytical Enforcement Methodology

For a discussion of the available analytical enforcement method for various crops, see Unit IV.A. of the September 21, 2022, rulemaking.

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 U.S. tolerance for glufosinate residues in or on tropical and subtropical, medium to large fruit, edible peel, subgroup 23B is harmonized with the corresponding Codex MRL at 0.1 ppm and the U.S. tolerance for glufosinate residues in or on tropical and subtropical, small fruit, inedible peel, subgroup 24A is harmonized with the corresponding Codex MRL at 0.1 ppm. Additionally, the U.S. tolerance for glufosinate residues in or on tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B is harmonized with the established Codex MRLs for banana and plantain at 0.2 ppm. The Codex MRLs for the other commodities in subgroup 24B are at 0.1 ppm. It is not possible to harmonize with the lower Codex MRLs for these commodities because doing so would put U.S. growers at risk of having violative residues despite legal use of the pesticide according to the label. There are no Codex MRLs for grass commodities.

C. Revisions to Petitioned-For Tolerances

A tolerance of 0.1 ppm is being established for tropical and subtropical, medium to large fruit, edible peel, subgroup 23B rather than 0.07 ppm as requested. A tolerance of 0.1 ppm is being established for tropical and subtropical, small fruit, inedible peel, subgroup 24A rather than 0.03 ppm as requested. EPA is establishing these tolerances at different levels than requested to harmonize with the Codex MRL.

In addition, EPA is establishing tolerances for glufosinate, rather than glufosinate ammonium as requested. As explained in Unit III.V. of the September 21, 2022, rulemaking, EPA revised the tolerance expressions for glufosinate in 40 CFR 180.473 to clarify that the tolerance for the active ingredient will be referred to as glufosinate ( i.e., the racemic mixture). Glufosinate is a racemic mixture of the D- and L-enantiomers, with the L-enantiomer being responsible for its herbicidal activity. Glufosinate can exist in multiple forms, including the acid, ammonium, and sodium forms; other salt forms of glufosinate may be possible as well. While there are presently only registrations for the ammonium form of glufosinate, future registration requests may be submitted for the acid, sodium, or other forms. The tolerances for glufosinate established in this action would cover all these forms.

D. International Trade Considerations

In this rule, EPA is establishing a tolerance for glufosinate residues in or on tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B at 0.2 ppm, which is lower than the established tolerance for banana at 0.30 ppm. The subgroup 24B tolerance of 0.2 ppm is supported by residue data provided by the petitioner at a new proposed use pattern/rate that is different than the use pattern/rate that supported the established tolerance of 0.30 ppm.

In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the WTO of the changes to these tolerances in order to satisfy its obligations under the Agreement. In addition, the SPS Agreement requires that Members provide a “reasonable interval” between the publication of a regulation subject to the Agreement and its entry into force to allow time for producers in exporting Member countries to adapt to the new requirement. Accordingly, EPA is establishing an expiration date for the existing banana tolerances to allow this tolerance to remain in effect for a period of six months after the effective date of this final rule. At the end of the six-month period, the banana tolerance will expire, as indicated in the regulatory text, and residues on banana must conform to the tolerance for tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B. This reduction in tolerance level is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods. The new tolerance level is supported by available residue data.

V. Conclusion

Therefore, tolerances are established for residues of glufosinate, (2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents, in or on tropical and subtropical, medium to large fruit, edible peel, subgroup 23B at 0.1 ppm; tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B at 0.2 ppm; and tropical and subtropical, small fruit, inedible peel, subgroup 24A at 0.1 ppm. Tolerances with regional registrations are being established for residues of glufosinate in or on grass, forage at 0.15 ppm; and grass, hay at 0.2 ppm.

Tolerances are also removed for the following commodities due to the establishment of tolerances for the above commodities: avocado at 0.1 ppm; banana at 0.30 ppm, which will expire six months after the effective date of this final rule, as explained above; banana, pulp at 0.20 ppm; and fig 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 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: June 13, 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

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

2. In § 180.473:

a. Amend Table 1 to Paragraph (a) by:

i. Removing the entry for “Avocado”;

ii. Revising the entry for “Banana”;

iii. Removing the entries for “Banana, pulp” and “Fig”; and

iv. Adding in alphabetical order the entries “Tropical and subtropical, medium to large fruit, edible peel, subgroup 23B”; “Tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B”; and “Tropical and subtropical, small fruit, inedible peel, subgroup 24A”;

b. Revising paragraph (c); and

c. Amending paragraph (d) by designating the table as table 3.

The additions and revisions read as follows:

§ 180.473

Glufosinate; tolerances for residues.

(a) * * *

Table 1 to Paragraph ( a )

Commodity	Parts per million
*         *         *         *         *         *         *
Banana 1	0.30
*         *         *         *         *         *         *
Tropical and subtropical, medium to large fruit, edible peel, subgroup 23B	0.1
Tropical and subtropical, medium to large fruit, smooth, inedible peel, subgroup 24B	0.2
*         *         *         *         *         *         *
Tropical and subtropical, small fruit, inedible peel, subgroup 24A	0.1
*         *         *         *         *         *         *
1  This tolerance expires on December 20, 2023.

* * * * *

(c) Tolerances with regional registrations. Tolerances with regional registrations are established for residues of glufosinate, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring the sum of glufosinate, (2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents.

Table 2 to Paragraph ( c )

Commodity	Parts per million
Grass, forage	0.15
Grass, hay	0.2

* * * * *