2021-02516. Benzovindiflupyr; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of benzovindiflupyr in or on lowbush blueberries, ginseng, and sugar beet roots, leaves, and dried pulp. Interregional Research Project Number 4 (IR-4) and Syngenta Crop Protection requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective February 9, 2021. Objections and requests for hearings must be received on or before April 12, 2021, 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 dockets for this action, identified by docket identification (ID) numbers EPA-HQ-OPP-2020-0066 and EPA-HQ-OPP-2019-0586, are available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the OPP Docket is [phone].

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Marietta Echeverria, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: [phone]; 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 Government Publishing Office's e-CFR site at http://www.ecfr.gov/​cgi-bin/​text-idx?​&​c=​ecfr&​tpl=​/​ecfrbrowse/​Title40/​40tab_​02.tpl.

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 numbers EPA-HQ-OPP-2020-0066 and EPA-HQ-OPP-2019-0586 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 April 12, 2021. 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 numbers EPA-HQ-OPP-2020-0066 and EPA-HQ-OPP-2019-0586, 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/​contacts.html.

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 Tolerance

In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-54), 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 9E8806) by IR-4, IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of benzovindiflupyr (N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide) in or on the raw agricultural commodities Blueberry, lowbush at 2 parts per million (ppm) and Ginseng at 0.3 ppm. That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket EPA-HQ-OPP-2020-0066, http://www.regulations.gov. There were no comments received in response to the notice of filing.

In the Federal Register of February 4, 2020 (85 FR 6129) (FRL-10003-17), 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 9F8772) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC, 27419. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of benzovindiflupyr in or on the raw agricultural commodities Beet, sugar, dried pulp at 0.15 ppm; Beet, sugar, roots at 0.08 ppm; and Beet, sugar, tops at 0.06 ppm. That document referenced a summary of the petition prepared by Syngenta, the registrant, which is available in the docket EPA-HQ-OPP-2019-0586, http://www.regulations.gov. One relevant comment was received in response to the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA is establishing several tolerances at different levels than were petitioned for and is also modifying a commodity definition. The reason for these changes is explained in Unit IV.D.

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 benzovindiflupyr including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with benzovindiflupyr 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 rulemakings of 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 republishing the same sections is unnecessary. 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 a number of tolerance rulemakings for benzovindiflupyr, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to benzovindiflupyr and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological Profile. For a discussion of the Toxicological Profile of benzovindiflupyr, see Unit III.A. of the June 22, 2018 rulemaking (83 FR 29033) (FRL-9977-94).

Toxicological Points of Departure/Levels of Concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment, see Unit III.B. of the October 2, 2015 rulemaking (80 FR 59627) (FRL-9933-03).

Exposure Assessment. Much of the exposure assessment remains the same, although some updates have occurred to accommodate exposures from the petitioned-for tolerances and reflect changes to the non-dietary, non-occupational exposure assessment. The updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, see Unit III.C. of the June 22, 2018 rulemaking.

EPA's dietary exposure assessments have been updated to include the additional exposure from the new uses of benzovindiflupyr on lowbush blueberry, ginseng, and sugar beet. The assessment used the same assumptions concerning 100 percent crop treated and tolerance-level residues as the June 22, 2018 final rule. Drinking water exposures are not impacted by the new uses, and thus have not changed since the last assessment.

There have been two updates to the residential exposure assessment since the June 22, 2018 final rule. The updated assessment no longer assesses risks to residential handlers, since the label requirements for handlers to wear specific clothing and to use personal protective equipment (PPE) are presumed to indicate that these products are not intended for homeowner use; thus, there is no residential handler exposure. The consideration of the new turf use does not change previous conclusions about post-application risk exposures.

EPA's conclusions concerning cumulative risk remain unchanged from the June 22, 2018 rulemaking.

Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor. See Unit III.D. of the June 22, 2018 rulemaking for a discussion of the Agency's rationale for that determination.

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 the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

Acute dietary risks are below the Agency's level of concern of 100% of the aPAD: They are 44% of the aPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD: They are 19% of the cPAD for children 1 to 2 years old, the population subgroup with the highest exposure estimate. Because the chronic dietary risks are below EPA's level of concern, EPA also concludes that benzovindiflupyr will not pose a cancer risk. The short-term aggregate MOE (food, water, and residential) is 500 for children 1 to 2 years old. This MOE exceeds the target level of concern of 100, so it is not of concern. There are no intermediate or long-term residential exposures.

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 benzovindiflupyr residues. More detailed information about the Agency's analysis can be found at http://www.regulations.gov in the documents titled “Benzovindiflupyr. Human Health Risk Assessment for the Proposed New Food Use on Lowbush Blueberries and Ginseng and New Non-Food Uses.” in docket ID number EPA-HQ-OPP-2020-0066 and “Benzovindiflupyr. Human Health Risk Assessment for the Proposed New Use on Sugar Beets ” in docket ID number EPA-HQ-OPP-2019-0586.

IV. Other Considerations

A. Analytical Enforcement Methodology

For a discussion of the available analytical enforcement method, see Unit IV.A. of the June 22, 2018 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).

There are no benzovindiflupyr Codex MRLs established for blueberries, ginseng, or sugar beets.

C. Response to Comments

Although three comments were submitted to the docket in response to the February 4, 2020 Notice of Filing, only one specifically related to this tolerance action. The commenter requested that EPA deny Syngenta's request for tolerances for benzovindiflupyr on sugar beets out of a concern for the general health impacts of pesticides.

Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that the benzovindiflupyr tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

Based on available residue data and using the Organization for Economic Cooperation and Development (OECD) calculator, EPA has determined that it is appropriate to set the tolerance level for beet, sugar, dried pulp at 0.6 ppm rather than as proposed at 0.15 ppm. Also, the tolerance is being established on “Beet, sugar, leaves” rather than “Beet, sugar, tops” to be consistent with Agency nomenclature; this tolerance is being established at 0.07 ppm rather than 0.06 ppm.

V. Conclusion

Therefore, tolerances are established for residues of benzovindiflupyr in or on beet, sugar, dried pulp at 0.6 ppm; beet sugar, leaves at 0.07 ppm; beet, sugar, roots at 0.08 ppm; blueberry, lowbush at 2 ppm; and ginseng at 0.3 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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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 and modifications 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: November 30, 2020.

Marietta Echeverria,

Acting 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 § 180.686, amend paragraph (a) by designating the table as Table 1 to Paragraph (a) and adding, in alphabetical order, to newly designated Table 1 the entries “Beet, sugar, dried pulp”; “Beet, sugar, leaves”; “Beet, sugar, roots”; “Blueberry, lowbush”; and “Ginseng” to read as follows:

§ 180.686

Benzovindiflupyr; tolerances for residues.

(a) * * *

Table 1 to Paragraph (a)

Commodity	Parts per million
*    *    *    *    *
Beet, sugar, dried pulp	0.6
Beet, sugar, leaves	0.07
Beet, sugar, roots	0.08
Blueberry, lowbush	2
*    *    *    *    *
Ginseng	0.3
*    *    *    *    *

* * * * *