Fluazinam; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of fluazinam in or on multiple commodities that are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective September 20, 2021. Objections and requests for hearings must be received on or before November 19, 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-2020-0245, 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, 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.

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-2020-0245 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 November 19, 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-2020-0245, 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 September 30, 2020 (85 FR 61681) (FRL-10014-74), 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 0E8827) 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 the establishment of tolerances in 40 CFR 180.574 for residues of the herbicide fluazinam in or on multiple commodities. For a complete list, please refer to the September 30, 2020 notification (85 FR 61681) (FRL-10014-74). Additionally, the petitioner proposed removing established tolerances for residues of fluazinam in or on the raw agricultural commodities; vegetable, legume, edible podded, subgroup 6A, except pea at 0.10 ppm; pea and bean, succulent shelled, subgroup 6B, except pea at 0.04 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, except pea at 0.02 ppm; vegetable, brassica leafy, group 5, except cabbage at 0.01 ppm; and turnip, greens at 0.01 ppm. That document referenced a summary of the petition prepared by ISK Biosciences, the registrant, which is available in the docket, http://www.regulations.gov. Two comments were received in response to the notice of filing. One was about geographic pesticide concentration but not about fluazinam specifically, and the other was associated with a different chemical.

Based upon review of the data supporting the petition, EPA is establishing tolerances at different levels than petitioned-for and modified some of the commodity definitions used. 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 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 fluazinam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluazinam 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 fluazinam, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to fluazinam 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 fluazinam, see Unit III.A. of the April 8, 2016 rulemaking (81 FR 20545) (FRL-9942-99).

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 November 7, 2012 rulemaking (77 FR 66723) (FRL-9366-6).

Exposure assessment. Much of the exposure assessment remains the same, although some updates have occurred to accommodate exposures from the petitioned-for tolerances. The updates are discussed in this section.

The acute dietary analysis is based on tolerance-level residues for all commodities and uses high-end residue estimates for the metabolite 3-[[4-amino-3-[[3-chloro-5- (trifloromethyl)-2-pyridinyl]amino]-2-nitro-6-(trifluoromethyl) phenyl] thio]-2-(beta-Dglucopyranosyloxy) propionic acid), known as AMGT. In addition, the acute assessment assumes 100 percent crop treated (PCT) and incorporates modeled EDWCs that account for both parent fluazinam and its transformation products. The chronic dietary analysis is based on tolerance level residues for all commodities except apples. For apples, the average field trial value was used. As with the acute assessment, the chronic assessment incorporates high-end estimates for AMGT and default processing factors for all relevant processed commodities without a separate tolerance, and modeled EDWCs that account for both parent and transformation products. The chronic assessment also incorporated PCT data.

Anticipated residue and PCT information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
• Condition c: Data are available on pesticide use and food consumption in a particular area, and the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The following average PCT estimates were used in the chronic dietary risk assessments for the crops that are currently registered for fluazinam: Apples (<1%), beans (5%), cabbage (<1%), carrots (<1%), dry beans/peas (<2.5%), lima beans (5%), onions (<1%), peanuts (<2.5%), potatoes (15%), pumpkin (<1%), and soybeans (<1%).

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figures for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which fluazinam may be applied in a particular area.

Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fluazinam in drinking water. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the FQPA Index Reservoir Screening Tool (FIRST) and Pesticide Root Zone Model for Groundwater (PRZM-GW), EPA used an EDWC of 226 ppb for the acute dietary assessment and 141 ppb in the chronic dietary risk assessment.

Non-occupational exposure. See Unit III.C.3. of the April 8, 2016 rulemaking for a discussion of non-dietary exposure, which included residential exposures to golf course turf.

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

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 April 8, 2016 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 aggregate exposure estimates to the acute population adjusted dose (aPAD) and 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 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 37% of the aPAD for females 13 to 49 years old, the population subgroup with the highest risk estimate. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD: they are 88% of the cPAD for all infants, the population subgroup with the highest exposure estimate. The short-term aggregate risk assessments resulted in MOEs that are greater than the Agency's level of concern of 100 and therefore are not of concern. The MOEs are 381 for children 6 to less than 11 years old; 470 for youths 11 to less than 16 years old; and 420 for adults. Intermediate-term and long-term residential exposures are not expected.

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 fluazinam residues. More detailed information about the Agency's analysis can be found at http://www.regulations.gov in the document titled “Fluazinam. Human Health Risk Assessment for the Proposed Use on Individual Commodities of Proposed Crop Subgroup 6-19B; Edible Podded Pea Legume Vegetable Subgroup, Crop Subgroup 6-19D: Succulent Shelled Pea Subgroup, Crop Subgroup 6-19F: Dried Shelled Pea Subgroup, Crop Subgroup 8-10A: Tomato Subgroup, Papaya, and Crop Group Conversions.” in docket ID number EPA-HQ-OPP-2020-0245.

IV. Other Considerations

A. Analytical Enforcement Methodology

For a discussion of the available analytical enforcement method, see Unit IV.A of the April 8, 2016 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). No Codex MRLs have been established for fluazinam.

C. Revisions to Petitioned-For Tolerances

Most of the proposed commodity definitions have been modified to be consistent with Agency nomenclature. In addition, EPA adjusted the tolerances for the edible podded bean commodities by removing the trailing zero to be consistent with the OECD Rounding Practice.

V. Conclusion

Therefore, tolerances are established for residues of fluazinam in or on Bean, adzuki, dry seed at 0.02 ppm; Bean, American potato, dry seed at 0.02 ppm; Bean, asparagus, edible podded at 0.1 ppm; Bean, asparagus, dry seed at 0.02 ppm; Bean, black, dry seed at 0.02 ppm; Bean, broad, dry seed at 0.02 ppm; Bean, broad, succulent shelled at 0.04 ppm; Bean, catjang, edible podded at 0.1 ppm; Bean, catjang, dry seed at 0.02 ppm; Bean, catjang, succulent shelled at 0.04 ppm; Bean, cranberry, dry seed at 0.02 ppm; Bean, dry, dry seed at 0.02 ppm; Bean, field, dry seed at 0.02 ppm; Bean, French, dry seed at 0.02 ppm; Bean, French, edible podded at 0.1 ppm; Bean, garden, dry seed at 0.02 ppm; Bean, garden, edible podded at 0.1 ppm; Bean, goa, dry seed at 0.02 ppm; Bean, goa, edible podded at 0.1 ppm; Bean, goa, succulent shelled at 0.04 ppm; Bean, great northern, dry seed at 0.02 ppm; Bean, green, dry seed at 0.02 ppm; Bean, green, edible podded at 0.1 ppm; Bean, guar, dry seed at 0.02 ppm; Bean, guar, edible podded at 0.1 ppm; Bean, kidney, dry seed at 0.02 ppm; Bean, kidney, edible podded at 0.1 ppm; Bean, lablab, dry seed at 0.02 ppm; Bean, lablab, edible podded at 0.1 ppm; Bean, lablab, succulent shelled at 0.04 ppm; Bean, lima, dry seed at 0.02 ppm; Bean, lima, succulent shelled at 0.04 ppm; Bean, morama, dry seed at 0.02 ppm; Bean, moth, dry seed at 0.02 ppm; Bean, moth, edible podded at 0.1 ppm; Bean, moth, succulent shelled at 0.04 ppm; Bean, mung, dry seed at 0.02 ppm; Bean, mung, edible podded at 0.1 ppm; Bean, navy, dry seed at 0.02 ppm; Bean, navy, edible podded at 0.1 ppm; Bean, pink, dry seed at 0.02 ppm; Bean, pinto, dry seed at 0.02 ppm; Bean, red, dry seed at 0.02 ppm; Bean, rice, dry seed at 0.02 ppm; Bean, rice, edible podded at 0.1 ppm; Bean, scarlet runner, dry seed at 0.02 ppm; Bean, scarlet runner, edible podded at 0.1 ppm; Bean, scarlet runner, succulent shelled at 0.04 ppm; Bean, snap, edible podded at 0.1 ppm; Bean, sword, dry seed at 0.02 ppm; Bean, sword, edible podded at 0.1 ppm; Bean, tepary, dry seed at 0.02 ppm; Bean, urd, dry seed at 0.02 ppm; Bean, urd, edible podded at 0.1 ppm; Bean, wax, edible podded at 0.1 ppm; Bean, wax, succulent shelled at 0.04 ppm; Bean, yardlong, dry seed at 0.02 ppm; Bean, yardlong, edible podded at 0.1 ppm; Bean, yellow, dry seed at 0.02 ppm; Brassica, leafy greens, subgroup 4-16B at 0.01 ppm; Chickpea, dry seed at 0.04 ppm; Chickpea, edible podded at 0.15 ppm; Chickpea, succulent shelled at 0.03 ppm; Cowpea, dry seed at 0.02 ppm; Cowpea, edible podded at 0.1 ppm; Cowpea, succulent shelled at 0.04 ppm; Gram, horse, dry seed at 0.02 ppm; Grass pea, dry seed at 0.04 ppm; Grass pea, edible podded at 0.15 ppm; Jackbean, dry seed at 0.02 ppm; Jackbean, edible podded at 0.1 ppm; Jackbean, succulent shelled at 0.04 ppm; Kohlrabi at 0.01 ppm; Lentil, dry seed at 0.04 ppm; Lentil, edible podded at 0.15 ppm; Lentil, succulent shelled at 0.03 ppm; Longbean, Chinese, dry seed at 0.02 ppm; Longbean, Chinese, edible podded at 0.1 ppm; Lupin, Andean, dry seed at 0.02 ppm; Lupin, Andean, succulent shelled at 0.04 ppm; Lupin, blue, dry seed at 0.02 ppm; Lupin, blue, succulent shelled at 0.04 ppm; Lupin, grain, dry seed at 0.02 ppm; Lupin, grain, succulent shelled at 0.04 ppm; Lupin, sweet white, dry seed at 0.02 ppm; Lupin, sweet white, succulent shelled at 0.04 ppm; Lupin, sweet, dry seed at 0.02 ppm; Lupin, sweet, succulent shelled at 0.04 ppm; Lupin, white, dry seed at 0.02 ppm; Lupin, white, succulent shelled at 0.04 ppm; Lupin, yellow, dry seed at 0.02 ppm; Lupin, yellow, succulent shelled at 0.04 ppm; Papaya at 3 ppm; Pea, blackeyed, dry seed at 0.02 ppm; Pea, blackeyed, succulent shelled at 0.04 ppm; Pea, crowder, dry seed at 0.02 ppm; Pea, crowder, succulent shelled at 0.04 ppm; Pea, dry, dry seed at 0.04 ppm; Pea, dwarf, edible podded at 0.15 ppm; Pea, English, succulent shelled at 0.03 ppm; Pea, field, dry seed at 0.04 ppm; Pea, field, hay at 40 ppm; Pea, field, vines at 6 ppm; Pea, garden, dry seed at 0.04 ppm; Pea, garden, succulent shelled at 0.03 ppm; Pea, green, dry seed at 0.04 ppm; Pea, green, edible podded at 0.15 ppm; Pea, green, succulent shelled at 0.03 ppm; Pea, pigeon, dry seed at 0.04 ppm; Pea, pigeon, edible podded at 0.15 ppm; Pea, pigeon, succulent shelled at 0.03 ppm; Pea, snap, edible podded at 0.15 ppm; Pea, snow, edible podded at 0.15 ppm; Pea, southern, dry seed at 0.02 ppm; Pea, southern, succulent shelled at 0.04 ppm; Pea, sugar snap, edible podded at 0.15 ppm; Pea, winged, dry seed at 0.02 ppm; Pea, winged, edible podded at 0.1 ppm; Soybean, vegetable, dry seed at 0.02 ppm; Soybean, vegetable, edible podded at 0.1 ppm; Soybean, vegetable, succulent shelled at 0.04 ppm; Tomato subgroup 8-10A at 1.5 ppm; Vegetable, brassica, head and stem, group 5-16, except cabbage at 0.01 ppm; Velvetbean, dry seed at 0.02 ppm; Velvetbean, edible podded at 0.1 ppm; Velvetbean, succulent shelled at 0.04 ppm; and Yam bean, African, dry seed at 0.02 ppm.

Additionally, the following tolerances are removed as unnecessary: Pea and bean, dried shelled, except soybean, subgroup 6C, except pea; Pea and bean, succulent shelled, subgroup 6B, except pea; Turnip, greens; Vegetable, brassica, leafy, group 5, except cabbage; and Vegetable, legume, edible podded, subgroup 6A, except pea.

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 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

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 § 180.574, revising the table to paragraph (a)(1) to read as follows: