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 Environmental Protection Agency 40 CFR Part 180
[EPA-HQ-OPP-2020-0113; FRL-8751-01-OCSPP]
 AGENCY: Environmental Protection Agency (EPA).
 ACTION: Final rule.
 SUMMARY: This regulation establishes a tolerance with regional registrations for residues of florasulam in or on grass, forage, fodder and hay, group 17. The Interregional Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
 DATES: This regulation is effective August 11, 2021. Objections and requests for hearings must be received on or before October 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 docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2020-0113, is 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 (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Due to the public health emergency, 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, Acting Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: 
                        *RDFRNotices@epa.gov.*


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.*( print page 43965) C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2020-0113 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 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 number EPA-HQ-OPP-2020-0113, 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 
                    *https://www.epa.gov/​dockets/​where-send-comments-epa-dockets.*
                     Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at 
                    *http://www.epa.gov/​dockets.* II. Summary of Petitioned-For Tolerance In the 
                    **Federal Register**
                     of June 24, 2020 (85 FR 37806) (FRL-10010-82) and in the 
                    **Federal Register**
                     of August 5, 2020 (85 FR 47330) (FRL-10012-32), 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 0E8821) by IR-4, Rutgers, the State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540. These petitions requested that 40 CFR 180.633 be amended by establishing tolerances with regional registrations for residues of the herbicide florasulam, 
                    *N*
                    -(2, 6-difluorophenyl)-8-fluoro-5-methoxy (1, 2, 4) triazole (1, 5-
                    *c*)pyrimidine-2-sulfonamide, in or on grass, forage at 0.01 parts per million (ppm); and grass, hay at 0.02 ppm. Those documents referenced a summary of the petition prepared by Corteva Agriscience, the registrant, which is available in the docket, 
                    *https://www.regulations.gov/​document/​EPA-HQ-OPP-2020-0113-0003.*
                     There were no comments received in response to these notices of filings. EPA is establishing a tolerance for the crop group rather than separate tolerances for forage and hay. The reason for this change is explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .” Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for florasulam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with florasulam follows. In an effort to streamline its publications in the 
                    **Federal Register**
                    *,*
                     EPA is not reprinting sections of the rule that would repeat what has been previously published in tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular pesticide chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary and duplicative. 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 florasulam, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to florasulam 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.*
                     The Toxicological Profile of florasulam remains unchanged from the Toxicological Profile in Unit III.A. of the July 25, 2018 rulemaking (83 FR 35141) (FRL-9979-81). Refer to that section for a discussion of the Toxicological Profile of florasulam. *Toxicological Points of Departure/Levels of Concern.*
                     The Toxicological Points of Departure/Levels of Concern used for the safety assessment remain unchanged from Unit III.B. of the July 25, 2018 rulemaking. For a summary, refer to that discussion. *Exposure assessment.*
                     Much of the exposure assessment remains the same, although updates have occurred to accommodate 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, see Unit III.C. of the July 25, 2018 rulemaking. EPA's dietary exposure assessments have been updated to include the additional exposure from the new uses of florasulam on grass seedlings, grasses grown for seed, and to add a default processing factor of 7.7x for oat bran that was previously omitted. All other assumptions in the exposure assessments for florasulam remain the same as in the July 25, 2018 rulemaking, including tolerance level residues, the other default processing factors, and 100% crop treated. Additionally, the proposed new use restricts the feeding of or grazing of livestock on grass treated with florasulam; therefore, 40 CFR 180.6(a)(3) continues to apply. *Drinking water and non-occupational exposures.*
                     Drinking water exposures are 
                    ( print page 43966)
                    not impacted by the new uses, and thus have not changed since the last assessment. There were no changes to the drinking water analysis due to the estimated drinking water concentrations (EDWC) for terrestrial applications that were approximately 500- to 1,200-fold lower than concern levels. Therefore, the Agency has concluded that previous EDWCs are adequate. Residential (non-occupational) exposures are also not impacted by the new uses. There are no new proposed residential uses for florasulam at this time; however, there are registered uses of florasulam on turfgrass, including residential lawns, golf courses, sports fields, sod farms and commercial turfgrass areas. Because all current florasulam labels with turf uses require handlers to wear personal protective equipment, EPA assumes that florasulam is applied by professional applicators, not residential (homeowner) applicators. Therefore, the current assessment does not consider exposure to residential handlers. This is different than the assessment supporting the July 25, 2018 rule, which relied on a 2009 assessment that included inhalation exposure to residential handlers. EPA's policy has changed since 2009 to reflect the assumption described above regarding labels that require personal protective equipment. Post-application residential exposures were considered as part of the assessment. Due to lack of a dermal endpoint, only the incidental oral exposures for children 1 to less than 2 years old from use on residential turf were assessed. Margins of exposure (MOEs) ranged from 25,000 for hand-to-mouth short-term exposure to 11,000,000 for incidental soil ingestion short-term exposure and were not of concern. More detailed information about the Agency's analysis can be found at 
                    *http://www.regulations.gov*
                     in the document titled “Florasulam: Draft Human Health Risk Assessment for Registration Review” in docket ID number EPA-HQ-OPP-2020-0113. *Cumulative exposures.*
                     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. “EPA's assessment of cumulative exposures has not changed since the July 25, 2018 rulemaking. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not found a common mechanism of toxicity as to florasulam and any other substances and florasulam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that florasulam has a common mechanism of toxicity with other substances. *Safety Factor for Infants and Children.*
                     The scientific information underpinning EPA's prior safety factor determination remains unchanged from the July 25, 2018 rulemaking. Therefore, EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor. See Unit III.D. of the July 25, 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 PAD (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 MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. An acute dietary risk assessment was not conducted as toxicological effects attributable to a single dose were not identified. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD: They are less than 1% of the cPAD for the U.S. population and all population subgroups. Florasulam is classified as “Not Likely to be Carcinogenic to Humans;” therefore, a cancer dietary exposure analysis was not performed. Short-term aggregated risk included the incidental oral exposures and the average dietary exposures from food and drinking water sources. Short-term aggregated risk estimates for the most highly exposed child population, children 1 to less than 2 years old, results in an MOE of 17,000 and is not of concern because it is greater than the level of concern of 100. As stated in the July 25, 2018 rule, florasulam is not registered for any use patterns that would result in intermediate-term residential exposure due to the intermittent nature of applications. Because there is no intermediate-term residential exposure and chronic dietary exposure has been assessed under the appropriately protective cPAD, EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for florasulam. 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 florasulam residues. More detailed information about the Agency's analysis can be found at 
                    *http://www.regulations.gov*
                     in the document titled “Florasulam: Human Health Risk Assessment for the Proposed New Use on Seedlings and Grasses Grown for Seed” in docket ID number EPA-HQ-OPP-2020-0113. IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A. of the July 25, 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). The Codex has not established MRLs for residues of florasulam in/on grasses. C. Revisions to Petitioned-For Tolerances After the NOF was published, the petitioner revised their tolerance request to establish a tolerance for grass, forage, fodder and hay, group 17 at 0.02 ppm. The Agency determined that the residue data support that tolerance and therefore is establishing the tolerance for the crop group. V. Conclusion Therefore, regional tolerances are established for residues of florasulam, 
                    *N*
                    -(2, 6-difluorophenyl)-8-fluoro-5-methoxy (1, 2, 4) triazole (1, 5-
                    *c*)pyrimidine-2-sulfonamide, in or on grass, forage, fodder and hay, group 17 at 0.02 ppm. VI. Statutory and Executive Order Reviews This action establishes a tolerance 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 
                    ( print page 43967)
                    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 to 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 tolerance 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: July 29, 2021. 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 § 180.633, add paragraph (c) to read as follows: § 180.633
  
 (c) 
                            *Tolerances with regional registrations.*
                             Tolerances are established for residues of the herbicide florasulam, including its metabolites and degradates, in or on the commodities in table 2 to this paragraph (c). Compliance with the tolerance levels specified in table 2 is to be determined by measuring only florasulam, 
                            *N*
                            -(2, 6-difluorophenyl)-8-fluoro-5-methoxy (1, 2, 4) triazole (1, 5-
                            *c*)pyrimidine-2-sulfonamide, in or on the commodities: Table 2 to Paragraph (
                                c
                                )
Commodity
Parts per
                                     millionGrass, forage, fodder and hay, group 17
0.02


[FR Doc. 2021-16969 Filed 8-10-21; 8:45 am] BILLING CODE 6560-50-P