Sulfentrazone; Pesticide Tolerances

SUPPLEMENTARY INFORMATION:

I. Executive Summary

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).

If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

B. What action is the Agency taking?

EPA is proposing to establish tolerances for residues of the herbicide sulfentrazone in or on Corn, pop, grain at 0.15 parts per million (ppm) and Corn, pop, stover at 0.3 ppm. EPA had previously registered the use of sulfentrazone on field corn and established tolerances on Corn, field, grain at 0.15 ppm, and Corn, field, stover at 0.30 ppm. As part of that process, the use on popcorn was added to the sulfentrazone label (same use pattern as field corn), but, in error, separate tolerances on Corn, pop, grain and Corn, pop, stover were not established. EPA is now proposing to establish the tolerances required to support the use on popcorn and rectify this oversight.

C. What is EPA's authority for taking this action?

Section 408(e) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), authorizes EPA to establish, modify, or revoke tolerances or exemptions from the requirement of a tolerance on its own initiative. Prior to issuing the final regulation, FFDCA section 408(e)(2) requires EPA to issue a notice of proposed rulemaking for a 60-day public comment period, unless the Administrator for good cause finds that it would be in the public interest to have a shorter period and states the reasons in the rulemaking.

FFDCA section 408(b)(2)(A)(i) 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. . . .”

D. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

II. Aggregate Risk Assessment and Determination of Safety

Consistent with 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, consistent with FFDCA section 408(b)(2), for tolerances for residues of sulfentrazone on Corn, pop, grain and Corn, pop, stover. EPA's assessment of exposures and risks associated with establishing these tolerances follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance actions involving the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between the 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 several tolerance rulemakings for sulfentrazone in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to sulfentrazone and established tolerances for residues of that chemical. EPA is incorporating previously published sections of those rulemakings that remain unchanged, as described further in this rulemaking. Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by sulfentrazone, can be found in the document titled “Sulfentrazone—Human Health Risk Assessment for the Establishment of Tolerances for Residues in/on Pop Corn Commodities” which is available in the docket for this action at https://www.regulations.gov.

Toxicological profile. For a discussion of the Toxicological Profile of sulfentrazone, see Unit III.A. of the rulemaking published in the Federal Register of April 13, 2018 (83 FR 15977 (FRL-9975-77)).

Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment of sulfentrazone, see Unit III.B. of the rulemaking published in the Federal Register of September 12, 2014 (79 FR 54620 (FRL-9915-47)).

Exposure assessment. Much of the exposure assessment remains unchanged from the rulemaking published in the April 13, 2018, rulemaking, see Unit III.C., although the new exposure assessment incorporates the additional dietary exposure from the proposed tolerances.

In conducting both the acute and chronic dietary exposure assessments, EPA used the Dietary Exposure Evaluation Model, Food Consumption Intake Database (DEEM-FCID, ver.4.02), which incorporates consumption data from United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, NHANES/WWEIA; 2005-2010. As to residue levels in food, EPA assumed tolerance-level residues, 100 percent crop treated (PCT), and EPA default processing factors. EPA has concluded that sulfentrazone does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

Anticipated residue and percent crop treated information. EPA did not use anticipated residue or PCT information in the dietary assessment for sulfentrazone. Tolerance-level residues and 100 PCT were assumed for all food commodities.

Drinking water and non-occupational exposures. For a summary of the drinking water numbers used, see Unit III.C.2. of the April 13, 2018, rulemaking. An acute estimated drinking water concentration (EDWC) of 134 parts per billion (ppb) and a chronic EDWC of 98 ppb were used in the acute and chronic dietary exposure assessments, respectively.

Sulfentrazone is currently registered for the following uses that could result in residential exposures: Residential home lawns/turf and recreational turf, such as golf courses. For a summary of the assumptions used for residential exposures, see Unit III.C.3. of the April 13, 2018, rulemaking.

The recommended adult residential exposure scenario for use in the aggregate assessment reflects short-term dermal exposure from applications to turf via backpack sprayer. The recommended residential exposure scenario for use in the combined short- and intermediate-term aggregate assessment for children ages 1 to 2 years old reflects dermal and hand-to-mouth exposures from post-application exposure to turf applications.

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 sulfentrazone and any other substances. For the purposes of this action, therefore, EPA has not assumed that sulfentrazone has a common mechanism of toxicity with other substances.

Safety factor for infants and children. EPA continues to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the Food Quality Protection Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for that decision are articulated in Unit III.D. of the April 13, 2018, rulemaking.

Aggregate risks and determination of safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population-adjusted dose (aPAD) and 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 (food and drinking water) risks are below the Agency's level of concern of 100% of the aPAD; the risk estimate is 1.1% of the aPAD for all infants less than 1-year-old and 6.4% of the aPAD for females 13 to 49 years old, the population groups with the highest risk estimate. Chronic dietary (food and drinking water) risks are below the Agency's level of concern of 100% of the cPAD; they utilize 7.6% of the cPAD for all infants less than 1-year-old, the population group receiving the greatest exposure.

The combined short-term food, water, and residential exposures result in an aggregate MOE of 490 for adults. The combined short- and intermediate-term food, water, and residential exposures result in an aggregate MOE of 260 for children 1 to 2 years old, the population subgroup for children with the greatest exposure. MOEs below 100 are of concern; these MOEs are above 100 and therefore are not of concern.

Because sulfentrazone is classified as “not likely to be carcinogenic to humans,” EPA has concluded that aggregate exposure to sulfentrazone is not likely to pose a cancer risk.

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 sulfentrazone residues.

III. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology, gas chromatography (GC), is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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).

No Codex MRLs have been established for sulfentrazone on popcorn.

IV. Conclusion

Tolerances are proposed for residues of sulfentrazone on Corn, pop, grain at 0.15 ppm and Corn, pop, stover at 0.3 ppm.

V. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review

This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), because it proposes to establish or modify a pesticide tolerance or a tolerance exemption under FFDCA section 408.

B. Paperwork Reduction Act (PRA)

This action does not impose an information collection burden under the PRA 44 U.S.C. 3501 et seq., because it does not contain any information collection activities.

C. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, EPA concludes that the impact of concern for this action is any significant adverse economic impact on small entities and that the Agency is certifying that this action will not have a significant economic impact on a substantial number of small entities because the action has no net burden on small entities subject to this rulemaking. This determination takes into account an EPA analysis for tolerance establishments and modifications that published in the Federal Register of May 4, 1981 (46 FR 24950 (FRL-1809-5)) and for tolerance revocations on December 17, 1997 (62 FR 66020 (FRL-5753-1)). Additionally, in a 2001 memorandum, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. See Memorandum from Denise Keehner, Division Director, Biological and Economic Analysis Division, Office of Pesticide Programs, entitled “RFA/SBREFA Certification for Import Tolerance Revocation” and dated May 25, 2001, which is available in docket ID No. EPA-HQ-OPP-2005-0322 at https://www.regulations.gov.

Any comments about the Agency's determination for this rulemaking should be submitted to EPA along with comments on the proposed rule and will be addressed in the final rule.

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866 (See Unit V.A.), and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, EPA's 2021 Policy on Children's Health applies to this action as discussed in Unit II.D. generally, and in Unit III. in the context of the individual chemicals addressed in this action.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act (NTTAA)

This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All

EPA believes that the human health and environmental conditions that exist prior to this action do not result in disproportionate and adverse effects on communities with EJ concerns as described in Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR 25251, April 26, 2023). Furthermore, EPA believes that this action is not likely to result in new disproportionate and adverse effects on communities with environmental justice concerns. As discussed in more detail in the pesticide specific risk assessments conducted as part of the registration review for each pesticide identified in Unit III., EPA has considered the safety risks for the pesticides subject to this rulemaking and in the context of the tolerance actions set out in this rulemaking. See also Unit I.D.3.

For the reasons set forth in the preamble, EPA is proposing to amend 40 CFR chapter I as follows:

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

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

2. Amend § 180.498, by revising table 2 to paragraph (a)(2) by adding, in alphabetical order, the commodities “Corn, pop, grain”; and “Corn, pop, stover” to read as follows:

(a) * * *

(2) * * *