Pesticide Tolerances; Implementing Registration Review Decisions for Certain Pesticides (Capric (Decanoic) Acid, Caprylic (Octanoic) Acid, and Pelargonic (Nonanoic) Acid)

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 might apply to them:

• Restaurant kitchen cleaning service (NAICS code 561720);
• Milk production, dairy cattle (NAICS code 112120);
• Food manufacturing (NAICS code 311);
• Pesticide manufacturing (NAICS code 32532); and
• Food processing machinery and equipment merchant wholesalers (NAICS code 423830).

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 several tolerance actions that the Agency previously determined were necessary or appropriate during registration review for the pesticide active ingredients identified in Unit III. The tolerance actions for each pesticide active ingredient are described in Unit III. and may include but are not limited to the following types of actions:

• Revising tolerance expressions;
• Modifying commodity definitions;
• Updating crop groupings;
• Removing expired tolerances;
• Revoking tolerances that are no longer needed; and
• Harmonizing tolerances with the Codex Alimentarius Commission (Codex) Maximum Residue Levels (MRLs).

Although it may not have been identified in the registration review of a particular pesticide, this rule may include proposals to reflect the Agency's 2019 adoption of the Organization of Economic Cooperation and Development (OECD) Rounding Class Practice. Where applicable, these adjustments are proposed for specific pesticides as reflected in the proposed regulatory text.

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

Pursuant to section 408(e) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), EPA is proposing the tolerance actions in this rulemaking that the Agency previously determined were necessary or appropriate during the registration review conducted under FIFRA, 7 U.S.C. 136 et seq. FFDCA section 408(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.

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.

E. What can I do if I want the Agency to maintain a tolerance that the Agency proposes to revoke?

This proposed rule provides a 60-day public comment period that allows any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives such a comment within the 60-day period, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under FFDCA section 408(f), if needed. The order would specify data needed and the timeframes for submission of the data and would require that within 90 days, some person or persons, notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

After considering comments that are received in response to this proposed rule, EPA will issue a final rule. At the time of the final rule, you may file an objection or request a hearing on the action taken in the final rule. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. After the filing deadline specified in the final rule, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

II. Background

A. What is a tolerance?

A “tolerance” represents the maximum level for residues of a pesticide chemical legally allowed in or on food, which includes raw agricultural commodities and processed foods and feed for animals. Under the FFDCA, residues of a pesticide chemical that are not covered by a tolerance or exemption from the requirement of a tolerance are considered unsafe. See21 U.S.C. 346a(a)(1). Foods containing unsafe residues are deemed adulterated and may not be distributed in interstate commerce. See21 U.S.C. 331(a) and 342(a)(2)(B). Consequently, for a food-use pesticide ( i.e., a pesticide use that is likely to result in residues in or on food) to be sold and distributed, the pesticide must not only have appropriate tolerances or exemptions under the FFDCA, but also must be registered under FIFRA. Food-use pesticides not registered in the United States must have tolerances or exemptions in order for commodities treated with those pesticides to be imported into the United States. For additional information about tolerances, go to https://www.epa.gov/pesticide-tolerances/about-pesticide-tolerances.

B. Why does EPA consider international residue limits?

When establishing a tolerance for residues of a pesticide, EPA must determine whether Codex has established a MRL for that pesticide. See21 U.S.C. 346a(b)(4). Additionally, as part of the registration review of a pesticide (see Unit II.C.), EPA determines whether international MRLs exist for commodities and chemicals for which U.S. tolerances have been established. Where appropriate, EPA's intention is to harmonize U.S. tolerances with those international MRLs to facilitate trade. EPA's effort to harmonize with international MRLs is summarized in the tolerance reassessment section of the individual Human Health Draft Risk Assessments that support the pesticide registration review.

C. What is registration review?

Under FIFRA section 3(g), 7 U.S.C. 136a(g), EPA is required to periodically review all registered pesticides and determine if those pesticides continue to meet the standard for registration under FIFRA. See also 40 CFR 155.40(a). The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides can continue to be used without causing unreasonable adverse effects on human health and the environment. As part of the registration review of a pesticide, EPA also evaluates whether existing tolerances are safe, whether any changes to existing tolerances are necessary or appropriate, and whether any new tolerances are necessary to cover residues from registered pesticides. In addition, any tolerance changes identified as necessary or appropriate during registration review of a pesticide are summarized in the registration review decision documents for each pesticide active ingredient or registration review case ( e.g., in the Proposed Interim Decision (PID), Proposed Final Decision (PFD), Interim Decision (ID) and Final Decision (FD)). These documents can be found in the public docket that has been opened for each pesticide, which is available online at https://www.regulations.gov, using the docket ID number listed in Unit III. for each pesticide active ingredient included in this proposed action. Additional information about pesticide registration review is available at https://www.epa.gov/pesticide-reevaluation .

D. What are “Safety Findings”?

EPA has assessed the individual risks from exposure to the pesticide active ingredients identified and discussed in Unit III., taking into consideration all reliable data on toxicity and exposure, including for infants and children, and has included a safety finding under FFDCA section 408(b) for the proposed tolerance actions. Based on the supporting risk assessments and registration review documents, which demonstrate that the aggregate exposure for each individual chemical is below the Agency's level of concern, EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to residues of the pesticide active ingredients identified and discussed in Unit III. Thus, EPA has determined that the proposed tolerances for residues of the pesticide active ingredients identified and discussed in Unit III. are safe.

Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expressions. Chemical specific safety findings are discussed in detail in the human health risk assessments conducted to support the registration review of each specific pesticide active ingredient or registration review case. The human health risk assessments can be found in the public docket that has been opened for each pesticide, which is available online at https://www.regulations.gov using the docket ID number listed in Unit III.

E. How does EPA's policy on children's health apply to tolerance actions?

EPA's Policy on Children's Health (October 5, 2021) requires EPA to protect children from environmental exposures by consistently and explicitly considering early life exposures (from conception, infancy, early childhood and through adolescence until 21 years of age) and lifelong health in all human health decisions through identifying and integrating children's health data and information when conducting risk assessments. https://www.epa.gov/system/files/documents/2021-10/2021-policy-on-childrens-health.pdf.

FFDCA section 408(b)(2)(C) 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 . . .” (FFDCA 408(b)(2)(C)). 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 these proposed tolerance actions. The Agency's consideration is documented in the pesticide specific registration review decision documents. See the pesticide specific discussions in Unit III. and the chemical specific registration review documents that are available in the pesticide specific docket as identified in Unit III.

III. Proposed Tolerance Actions

EPA is proposing to take the specific tolerance actions identified in this unit and as described in the March 2022 Combined PWP/PID. Capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic (nonanoic) acid are registered for antimicrobial use as a sanitizer on food processing and dairy equipment. As a result of those uses, residues of these chemicals may be found in food that come into contact with treated surfaces; thus, that use is categorized as an “indirect food use” that requires a tolerance or exemption. Absent information supporting a conclusion that no residues would be available for transfer to food, a tolerance or tolerance exemption is required for capric (decanoic) acid, caprylic (octanoic) acid, and pelargonic (nonanoic) acid.

However, the Agency is now proposing to amend these established tolerance exemptions because they include outdated application rate limits. Because the latest evaluations of these pesticides determined that there are no dietary risks of concern, the application rate limits on the tolerance exemptions are no longer necessary. Additionally, the Agency is proposing to remove several duplicative tolerance exemptions that were not initially identified in the combined PWP/PID but are justified by the same science rationale as described in the combined PWP/PID.

A. 40 CFR 180.940; Capric (Decanoic) Acid

As noted in the March 2022 PWP/PID, there are exemptions from the requirement of a tolerance under 40 CFR 180.940 (b) and (c) for residues of capric (decanoic) acid when applied to dairy-processing equipment and food processing equipment and utensils, with the limitation that the end-use concentration of capric (decanoic) acid does not exceed 90 ppm (section b), and 234 ppm (section c). After the issuance of the PWP/PID, it was found that an exemption from the requirement of a tolerance for capric (decanoic acid) exists in section (a) as well with the limitation that the end-use concentration of caprylic (octanoic) acid is not to exceed 100 ppm. EPA, on its own initiative is therefore proposing to remove the redundant exemptions and limits for capric (decanoic) acid under 40 CFR 180.940 (b) and (c) entirely, and to remove the 100 ppm limit for capric (decanoic) acid from 180.940(a). As discussed in Unit II.D., EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to capric (decanoic acid) residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available.

B. 40 CFR 180.940; Caprylic (Octanoic) Acid

As noted in the March 2022 PWP/PID, there are exemptions from the requirement of a tolerance under 40 CFR 180.940 (b), and (c) for residues of caprylic (octanoic) acid when applied to dairy-processing equipment and food processing equipment and utensils, with the limitation that the end-use concentration of caprylic (octanoic) acid does not exceed 176 ppm (section b), and 234 ppm (section c). After the issuance of the PWP/PID, it was found that two exemptions from the requirement of a tolerance for caprylic (octanoic acid) exist in section (a) as well with limitations that the end-use concentration of caprylic (octanoic) acid is not to exceed 52 ppm and 100 ppm. EPA, on its own initiative is therefore proposing to remove the redundant exemptions and limits for caprylic (octanoic) acid from 40 CFR 180.940 (b) and (c) entirely, and to remove the 100 ppm limits for caprylic (octanoic) acid from 180.940(a). As discussed in Unit II.D., EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to caprylic (octanoic) acid residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available.

C. 40 CFR 180.940; Pelargonic (Nonanoic) Acid

As noted in the March 2022 PWP/PID, there are exemptions from the requirement of a tolerance under 40 CFR 180.940(a), (b), and (c) for residues of pelargonic (nonanoic) acid when applied to dairy-processing equipment and food processing equipment and utensils, with the limitation that the end-use concentration of pelargonic (nonanoic) acid does not exceed 100 ppm (section a) and 90 ppm (sections b and c). EPA, on its own initiative is therefore proposing to remove the redundant exemptions and limits for pelargonic (nonanoic) acid from 40 CFR 180.940 (b) and (c) entirely, and to remove the 100 ppm limit for pelargonic (nonanoic) acid from 180.940(a). As discussed in Unit II.D., EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to pelargonic (nonanoic) acid residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available.

D. 40 CFR 180.1159(c); Pelargonic (Nonanoic Acid)

Also outlined in the March 2022 PWP/PID, there is an exemption from the requirement of a tolerance for residues of pelargonic (nonanoic) acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of pelargonic (nonanoic) acid as an antimicrobial treatment in solutions containing a diluted end-use concentration of pelargonic (nonanoic) acid on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants, with a limitation of 170 ppm. EPA, on its own initiative, is therefore proposing to remove the limit of 170 ppm under 40 CFR 180.1159(c) for pelargonic (nonanoic) acid. As discussed in Unit II.D., EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to pelargonic (nonanoic) acid residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available.

E. 40 CFR 180.1225; Capric (Decanoic) Acid

As outlined in the March 2022 PWP/PID, there is an exemption from the requirement of a tolerance for residues of capric (decanoic) acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of capric (decanoic) acid as an antimicrobial treatment in solutions containing a diluted end-use concentration of capric (decanoic) acid on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers, and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants, with the limitation of 170 ppm. EPA, on its own initiative, is therefore proposing to remove the limit of 170 ppm under 40 CFR 180.1225 for capric (decanoic) acid. As discussed in Unit II.D., EPA concludes there is a reasonable certainty that no harm will result to the general population, or specifically to infants and children, from aggregate exposure to capric (decanoic) acid residues. The proposed tolerance changes are considered safe and adequate enforcement methodology is available.

IV. Proposed Effective and Expiration Date(s)

EPA is proposing that these tolerance actions would be effective on the date of publication of the final rule in the Federal Register . However, for actions in the final rule that lower or revoke existing tolerances, EPA is proposing an expiration date for the existing tolerance of six months after the date of publication of the final rule in the Federal Register , to allow a reasonable interval for producers in exporting members of the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the requirements.

V. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/regulations/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. This exemption also applies to tolerance revocations for which extraordinary circumstances do not exist. As such, this exemption applies to the tolerance revocations in this proposed rule because the Agency knows of no extraordinary circumstances that warrant reconsideration of this exemption for those proposed tolerance revocations.

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.

For the pesticides named in this rulemaking, EPA concludes that there is no reasonable expectation that residues of the pesticides for tolerances listed in this rulemaking for revocation will be found on the commodities discussed in this rulemaking, and the Agency knows of no extraordinary circumstances that exist as to the present proposed rule that would change EPA's previous analyses.

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.

Therefore, the EPA proposes 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 § 180.940 by:

a. In table 1 in paragraph (a):

i. Removing the entries for “Decanoic acid”; Nonanoic acid”; and “Octanoic acid”;

ii. Adding in alphabetical order the entries “Capric (decanoic) acid”; “Caprylic (octanoic) acid”; and “Pelargonic (nonanoic) acid”;

b. In the table in paragraph (b) removing the entries for “Decanoic acid”; “Nonanoic acid”; and “Octanoic acid”; and

c. In the table in paragraph (c) removing the entries in paragraph (c) for “Decanoic acid”; “Nonanoic acid”; and “Octanoic acid”.

The additions read as follows:

(a) * * *