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Start Preamble
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Final rule.
SUMMARY:
This regulation establishes tolerances for residues of novaluron in or on multiple crops that are 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 21, 2022. Objections and requests for hearings must be received on or before November 21, 2022, 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-2021-0153, is available at https://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 and the OPP Docket is (202) 566-1744. For the latest status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Acting Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address: RDFRNotices@epa.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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 Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0153 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 21, 2022. 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-2021-0153, by one of the following methods:
• Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. Start Printed Page 57616 346a(d)(3), announcing the filing of a pesticide petition (PP 0E8882) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.598 be amended by establishing tolerances for residues of the insecticide novaluron in or on individual crops of proposed Crop Subgroup 6-XXA: Edible podded bean legume vegetable subgroup at 0.7 parts per million (ppm); individual crops of proposed Crop Subgroup 6-XXB: Edible podded pea legume vegetable subgroup at 2 ppm; individual crops of Proposed Crop Subgroup 6-XXC: Succulent shelled bean subgroup at 0.7 ppm; individual crops of Proposed Crop Subgroup 6-XXD: Succulent shelled pea subgroup at 0.05 ppm; individual crops of Proposed Crop Subgroup 6-XXE: Dried shelled bean, except soybean at 0.3 ppm; individual crops of Proposed Crop Subgroup 6-XXF: Dried shelled pea subgroup at 0.1 ppm; and Pea, forage at 15 ppm. The petition also requested to amend 40 CFR part 180 by removing established tolerances for residues of novaluron, including its metabolites and degradates, in or on Bean, dry, seed at 0.30 ppm, and Bean, succulent at 0.70 ppm. That document referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. One comment was received from the United States Department of Agriculture in support of the notice of filing.
In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-12-OCSPP) 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 0E8882) by IR-4, North Carolina State University, 1730 Varsity Drive, Venture IV, Suite 210, Raleigh, NC 27606. The petition requested that 40 CFR 180.598 be amended by establishing tolerances for residues of the insecticide novaluron in or on the following raw agricultural commodities: Bean, phaseolus, forage at 15 ppm; Cowpea, forage at 15 ppm; Pea, field, forage at 15 ppm; Bean, phaseolus, hay at 80 ppm; Cowpea, hay at 80 ppm; and Pea, field, hay at 80 ppm. That document referenced a summary of the petition, which is available in the docket, https://www.regulations.gov. No substantive comments were received in response to the notice.
Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is modifying many of the commodity definitions to be consistent with Agency terminology. The tolerance levels being established are the same as the petition requested.
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 therein, 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 novaluron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with novaluron 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 for 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 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 tolerance rulemakings for novaluron in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to novaluron and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rulemaking, as they remain unchanged.
In addition, EPA has conducted a human health risk assessment in support of registration review for novaluron. That document, “Novaluron: Draft Human Health Risk Assessment to Support Registration Review” dated March 24, 2020, along with the Novaluron Interim Registration Review Decision, are available in docket ID number EPA-HQ-OPP-2015-0171 and are referenced below.
Toxicological profile. For a discussion of the Toxicological Profile of novaluron, see Unit III.A. of the novaluron tolerance rulemaking published in the Federal Register of July 22, 2015 (80 FR 43329) (FRL-9929-57) as well as the Novaluron: Draft Human Health Risk Assessment to Support Registration Review and Novaluron Interim Registration Review Decision.
Toxicological points of departure/Levels of concern. For a summary of the Toxicological Points of Departure/Levels of Concern for novaluron used for human health risk assessment, please reference Unit III.B. of the July 22, 2015, rulemaking as well as the Novaluron: Draft Human Health Risk Assessment to Support Registration Review and Novaluron Interim Registration Review Decision.
Exposure assessment. EPA's dietary exposure assessments have been updated to include the additional exposure from the proposed new uses of novaluron on the commodities identified in this action. An acute dietary exposure assessment was not performed as there are no toxicological effects attributable to a single exposure (dose). A partially refined chronic dietary (food and drinking water) exposure and risk assessment was conducted that incorporated tolerance-level residues for the proposed new uses. The chronic dietary exposure and risk assessment also incorporated average percent crop treated (PCT) data for several registered commodities as well as projected PCT data for the proposed Field Pea and Cowpea feed commodities. For the remaining commodities, 100 PCT was assumed. Anticipated residues for meat, milk, hog, and poultry commodities were incorporated as well. A cancer dietary assessment was not conducted because novaluron is classified as “not likely to be carcinogenic to humans.”
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, Start Printed Page 57617 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.
Updated average percent crop treated values were used for the following crops that are currently registered for novaluron: apples (10%), broccoli (1%), cabbage (5%), cantaloupe (1%), cauliflower (1%), cherries (1%), cotton (5%), dry beans/peas (1%), peaches (1%), peanuts (5%), pears (25%), peppers (5%), plums/prunes (1%), potatoes (5%), pumpkins (1%), sorghum (1%), squash (1%), strawberries (45%), sugarcane (1%), sweet corn (1%), tomatoes (2.5%), and watermelons (1%).
In most cases, EPA uses available data from the 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 figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5% as the average PCT value, respectively. 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.
Projected PCT was used for Field Pea and Cowpea feed commodities (10%). EPA estimates the projected PCT, also known as the percent crop treated of a new use (PCTn), based on the PCT of the dominant pesticide ( i.e., the one with the greatest PCT) used on that crop over the three most recent years of available data. Comparisons are only made among pesticides of the same pesticide types ( e.g., the dominant insecticide on the crop is selected for comparison with a new insecticide). The PCTs included in the analysis may be for the same pesticide or for different pesticides since the same or different pesticides may dominate for each year. Typically, EPA uses USDA NASS as the source for raw PCT data because it is publicly available and does not have to be calculated from available data sources. When a specific use site is not surveyed by USDA NASS, EPA uses other appropriate public data or private market research to calculate the PCTn.
The average PCT of the market leader(s) is appropriate for use in the chronic dietary risk assessment. This method of estimating a PCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial five years of actual use. The predominant factors that bear on whether the estimated PCTn could be exceeded are (1) the extent of pest pressure on the crops in question; (2) the pest spectrum of the new pesticide in comparison with the market; and (3) resistance concerns with the market leaders. EPA has examined the relevant data and concludes that it is unlikely that the actual PCT with novaluron on the Field Pea and Cowpea feed commodities will exceed the PCTn within the next 5 years.
The Agency believes that Conditions a, b, and c discussed above 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 novaluron may be applied in a particular area.
Drinking water and non-occupational exposures. The previously recommended estimated drinking water concentrations (EDWCs) remain current and are considered protective potential drinking water residue levels anticipated from the proposed tolerances. As stated in Unit III of the novaluron tolerance rulemaking published in the Federal Register of August 13, 2020 (85 FR 49261) (FRL-10011-78), the chronic dietary exposure and risk assessment incorporate the highest total estimated drinking water concentration (EDWC) of 8.4 parts per billion directly into this dietary assessment. The residential exposure assessment has not changed since the July 22, 2015, rulemaking because there are no proposed new residential uses. For a summary of the residential exposure analysis for novaluron used for the human health risk assessment, please reference Unit III.C.3. of the July 22, 2015, rulemaking.
Cumulative exposure. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to novaluron and any other substances and novaluron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that novaluron has a common Start Printed Page 57618 mechanism of toxicity with other substances.
Safety factor for infants and children. EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the July 22, 2015, 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 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.
An acute dietary exposure assessment was not performed as there were no toxicological effects attributable to a single exposure (dose) observed in available oral toxicity studies, including maternal toxicity in the developmental toxicity studies. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 29% of the cPAD for children 1 to 2 years old, the group with the highest exposure. The combined short- and intermediate-term food, water, and residential exposures result in aggregate margins of exposures of 3,800 for adults and 280 for children 1 to 2 years old. These MOEs are greater than the level of concern of 100 and are therefore not of concern. Novaluron is classified as “Not Likely to Be Carcinogenic to Humans”; therefore, EPA does not expect novaluron exposures to pose an aggregate cancer risk.
Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to novaluron residues. More detailed information on this action can be found in the document titled “Novaluron. Human Health Risk Assessment for Petition for Individual Commodities of Proposed Crop Subgroup 6-XXA: Vegetable, legume, bean, edible podded, subgroup 6-xxA; Proposed Crop Subgroup 6-XXB: Vegetable, legume, pea, edible podded, subgroup 6-xxB; Proposed Crop Subgroup 6-XXC: Vegetable, legume, bean, succulent shelled, subgroup 6-xxC; Proposed Crop Subgroup 6-XXD: Vegetable, legume, pea, succulent shelled, subgroup 6-xxD; Proposed Crop Subgroup 6-XXE: Vegetable, legume, bean, dried shelled, subgroup 6-xxE; Proposed Crop Subgroup 6-XXF: Vegetable, legume, pea, dried shelled, subgroup 6-xxF; Proposed Crop Subgroup 7-XXA: Vegetable, legume, forage and hay, except soybean group 7-xxA, forage; and Proposed Crop Subgroup 7-XXA: Vegetable, legume, forage and hay, except soybean group 7-xxA, hay” in docket ID EPA-HQ-OPP-2021-0153.
IV. Other Considerations
A. Analytical Enforcement Methodology
For a discussion of the available analytical enforcement method, see Unit IV.A. of the July 22, 2015, 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 U.S. and Codex levels are harmonized for edible-podded and succulent shelled beans at 0.7 ppm. Using the Organization for Economic Cooperation and Development (OECD) calculator for the dried shelled beans, except soybean, subgroup gives a recommended tolerance level of 0.3 ppm, which is higher than the established Codex MRL of 0.1 ppm for “beans (dry).” The Agency is not lowering the tolerance level to harmonize with Codex because doing so could cause U.S. growers to have violative residues despite legal use of novaluron according to the label. There are no Codex MRLs for any of the other commodities identified in this action.
V. Conclusion
Therefore, tolerances are established for residues of novaluron in or on Bean, adzuki, dry seed at 0.3 ppm; Bean, African yam, dry seed at 0.3 ppm; Bean, American potato, dry seed at 0.3 ppm; Bean, asparagus, dry seed at 0.3 ppm; Bean, asparagus edible podded at 0.7 ppm; Bean, black, dry seed at 0.3 ppm; Bean, broad, dry seed at 0.3 ppm; Bean, broad, succulent shelled at 0.7 ppm; Bean, catjang, dry seed at 0.3 ppm; Bean, catjang edible podded at 0.7 ppm; Bean, catjang, succulent shelled at 0.7 ppm; Bean, cranberry, dry seed at 0.3 ppm; Bean, dry bean, dry seed at 0.3 ppm; Bean, field, dry seed at 0.3 ppm; Bean, French, dry seed at 0.3 ppm; Bean, French, edible podded at 0.7 ppm; Bean, garden, dry seed at 0.3 ppm; Bean, garden, edible podded at 0.7 ppm; Bean, goa, dry seed at 0.3 ppm; Bean, goa, edible podded at 0.7 ppm; Bean, goa, succulent shelled at 0.7 ppm; Bean, great northern, dry seed at 0.3 ppm; Bean, green, dry seed at 0.3 ppm; Bean, green, edible podded at 0.7 ppm; Bean, guar, dry seed at 0.3 ppm; Bean, guar, edible podded at 0.7 ppm; Bean, horse gram, dry seed at 0.3 ppm; Bean, kidney, dry seed at 0.3 ppm; Bean, kidney, edible podded at 0.7 ppm; Bean, lablab, dry seed at 0.3 ppm; Bean, lablab, edible podded at 0.7 ppm; Bean, lablab, succulent shelled at 0.7 ppm; Bean, lima, dry seed at 0.3 ppm; Bean, lima, succulent shelled at 0.7 ppm; Bean, morama, dry seed at 0.3 ppm; Bean, moth, dry seed at 0.3 ppm; Bean, moth, edible podded at 0.7 ppm; Bean, moth, succulent shelled at 0.7 ppm; Bean, mung, dry seed at 0.3 ppm; Bean, mung, edible podded at 0.7 ppm; Bean, navy, dry seed at 0.3 ppm; Bean, navy, edible podded at 0.7 ppm; Bean, phaseolus, forage at 15 ppm; Bean, phaseolus, hay at 80 ppm; Bean, pink, dry seed at 0.3 ppm; Bean, pinto, dry seed at 0.3 ppm; Bean, red, dry seed at 0.3 ppm; Bean, rice, dry seed at 0.3 ppm; Bean, rice, edible podded at 0.7 ppm; Bean, scarlet runner, dry seed at 0.3 ppm; Bean, scarlet runner, edible podded at 0.7 ppm; Bean, scarlet runner, succulent shelled at 0.7 ppm; Bean, snap, edible podded at 0.7 ppm; Bean, sword, dry seed at 0.3 ppm; Bean, sword, edible podded at 0.7 ppm; Bean, tepary, dry seed at 0.3 ppm; Bean, urd, dry seed at 0.3 ppm; Bean, urd, edible podded at 0.7 ppm; Bean, wax, edible podded at 0.7 ppm; Bean, wax, succulent shelled at 0.7 ppm; Bean, yardlong, dry seed at 0.3 ppm; Bean, yardlong, edible podded at 0.7 ppm; Bean, yellow, dry seed at 0.3 ppm; Chickpea, dry seed at 0.1 ppm; Chickpea, edible podded at 2 ppm; Chickpea, succulent shelled at 0.05 ppm; Cowpea, dry seed at 0.3 ppm; Cowpea, edible podded at 0.7 ppm; Cowpea, forage at 15 ppm; Cowpea, hay at 80 ppm; Cowpea, succulent shelled at 0.7 ppm; Jackbean, dry seed at 0.3 ppm; Jackbean, edible podded at 0.7 ppm; Jackbean, succulent shelled at 0.7 ppm; Lentil, dry seed at 0.1 ppm; Lentil, edible podded at 2 ppm; Lentil, succulent shelled at 0.05 ppm; Longbean, Chinese, dry seed at 0.3 ppm; Longbean, Chinese, edible podded at 0.7 ppm; Lupin, Andean, dry seed at 0.3 ppm; Lupin, Andean, succulent shelled Start Printed Page 57619 at 0.7 ppm; Lupin, blue, dry seed at 0.3 ppm; Lupin, blue, succulent shelled at 0.7 ppm; Lupin, grain, dry seed at 0.3 ppm; Lupin, grain, succulent shelled at 0.7 ppm; Lupin, sweet, dry seed at 0.3 ppm; Lupin, sweet, succulent shelled at 0.7 ppm; Lupin, white sweet, dry seed at 0.3 ppm; Lupin, white sweet, succulent shelled at 0.7 ppm; Lupin, white, dry seed at 0.3 ppm; Lupin, white, succulent shelled at 0.7 ppm; Lupin, yellow, dry seed at 0.3 ppm; Lupin, yellow, succulent shelled at 0.7 ppm; Pea, blackeyed, dry seed at 0.3 ppm; Pea, blackeyed, succulent shelled at 0.7 ppm; Pea, crowder, dry seed at 0.3 ppm; Pea, crowder, succulent shelled at 0.7 ppm; Pea, dry, dry seed at 0.1 ppm; Pea, dwarf, edible podded at 2 ppm; Pea, English, succulent shelled at 0.05 ppm; Pea, field, dry seed at 0.1 ppm; Pea, field, forage at 15 ppm; Pea, field, hay at 80 ppm; Pea, garden, dry seed at 0.1 ppm; Pea, garden, succulent shelled at 0.05 ppm; Pea, grass, dry seed at 0.1 ppm; Pea, grass, edible podded at 2 ppm; Pea, green, dry seed at 0.1 ppm; Pea, green, edible podded at 2 ppm; Pea, green, succulent shelled at 0.05 ppm; Pea, pigeon, dry seed at 0.1 ppm; Pea, pigeon, edible podded at 2 ppm; Pea, pigeon, succulent shelled at 0.05 ppm; Pea, snap, edible podded at 2 ppm; Pea, snow, edible podded at 2 ppm; Pea, southern, dry seed at 0.3 ppm; Pea, southern, succulent shelled at 0.7 ppm; Pea, sugar snap, edible podded at 2 ppm; Pea, winged, dry seed at 0.3 ppm; Pea, winged, edible podded at 0.7 ppm; Soybean, vegetable, dry seed at 0.3 ppm; Soybean, vegetable, edible podded at 0.7 ppm; Soybean, vegetable, succulent shelled at 0.7 ppm; Velvetbean, dry seed at 0.3 ppm; Velvetbean, edible podded at 0.7 ppm; Velvetbean, succulent shelled at 0.7 ppm.
Additionally, the established tolerances on Bean, dry, seed and Bean, succulent are removed as unnecessary.
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 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 tolerances 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).
Start List of SubjectsList of Subjects in 40 CFR Part 180
- Environmental protection
- Administrative practice and procedure
- Agricultural commodities
- Pesticides, and pests
- Reporting and recordkeeping requirements
Dated: September 15, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter 1 as follows:
Start PartPART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD
End Part Start Amendment Part1. The authority citation for part 180 continues to read as follows:
End Amendment Part Start Amendment Part2. In § 180.598, amend the Table 1 to Paragraph (a) by:
End Amendment Part Start Amendment Parta. Adding in alphabetical order the entries “Bean, adzuki, dry seed”; “Bean, African yam, dry seed”; “Bean, American potato, dry seed”; “Bean, asparagus, dry seed”; “Bean, asparagus, edible podded”; “Bean, black, dry seed”; “Bean, broad, dry seed”; “Bean, broad, succulent shelled”; “Bean, catjang, dry seed”; “Bean, catjang edible podded”; “Bean, catjang, succulent shelled”; “Bean, cranberry, dry seed”; and “Bean, dry bean, dry seed”.
End Amendment Part Start Amendment Partb. Removing the entry for “Bean, dry, seed”.
End Amendment Part Start Amendment Partc. Adding in alphabetical order the entries “Bean, field, dry seed”; “Bean, French, dry seed”; “Bean, French, edible podded”; “Bean, garden, dry seed”; “Bean, garden, edible podded”; “Bean, goa, dry seed”; “Bean, goa, edible podded”; “Bean, goa, succulent shelled”; “Bean, great northern, dry seed”; “Bean, green, dry seed”; “Bean, green, edible podded”; “Bean, guar, dry seed”; “Bean, guar, edible podded”; “Bean, horse gram, dry seed”; “Bean, kidney, dry seed”; “Bean, kidney, edible podded”; “Bean, lablab, dry seed”; “Bean, lablab, edible podded”; “Bean, lablab, succulent shelled”; “Bean, lima, dry seed”; “Bean, lima, succulent shelled”; “Bean, morama, dry seed”; “Bean, moth, dry seed”; “Bean, moth, edible podded”; “Bean, moth, succulent shelled”; “Bean, mung, dry seed”; “Bean, mung, edible podded”; “Bean, navy, dry seed”; “Bean, navy, edible podded”; “Bean, phaseolus, forage”; “Bean, phaseolus, hay”; “Bean, pink, dry seed”; “Bean, pinto, dry seed”; “Bean, red, dry seed”; “Bean, rice, dry Start Printed Page 57620 seed”; “Bean, rice, edible podded”; “Bean, scarlet runner, dry seed”; “Bean, scarlet runner, edible podded”; “Bean, scarlet runner, succulent shelled”; and “Bean, snap, edible podded”.
End Amendment Part Start Amendment Partd. Removing the entry for “Bean, succulent”.
End Amendment Part Start Amendment Parte. Adding in alphabetical order the entries “Bean, sword, dry seed”; “Bean, sword, edible podded”; “Bean, tepary, dry seed”; “Bean, urd, dry seed”; “Bean, urd, edible podded”; “Bean, wax, edible podded”; “Bean, wax, succulent shelled”; “Bean, yardlong, dry seed”; “Bean, yardlong, edible podded”; “Bean, yellow, dry seed”; “Chickpea, dry seed”; “Chickpea, edible podded”; “Chickpea, succulent shelled”; “Cowpea, dry seed”; “Cowpea, edible podded”; “Cowpea, forage”; “Cowpea, hay”; “Cowpea, succulent shelled”; “Jackbean, dry seed”; “Jackbean, edible podded”; “Jackbean, succulent shelled”; “Lentil, dry seed”; “Lentil, edible podded”; “Lentil, succulent shelled”; “Longbean, Chinese, dry seed”; “Longbean, Chinese, edible podded”; “Lupin, Andean, dry seed”; “Lupin, Andean, succulent shelled”; “Lupin, blue, dry seed”; “Lupin, blue, succulent shelled”; “Lupin, grain, dry seed”; “Lupin, grain, succulent shelled”; “Lupin, sweet, dry seed”; “Lupin, sweet, succulent shelled”; “Lupin, white sweet, dry seed”; “Lupin, white sweet, succulent shelled”; “Lupin, white, dry seed”; “Lupin, white, succulent shelled”; “Lupin, yellow, dry seed”; “Lupin, yellow, succulent shelled”; “Pea, blackeyed, dry seed”; “Pea, blackeyed, succulent shelled”; “Pea, crowder, dry seed”; “Pea, crowder, succulent shelled”; “Pea, dry, dry seed”; “Pea, dwarf, edible podded”; “Pea, English, succulent shelled”; “Pea, field, dry seed”; “Pea, field, forage”; “Pea, field, hay”; “Pea, garden, dry seed”; “Pea, garden, succulent shelled”; “Pea, grass, dry seed”; “Pea, grass, edible podded”; “Pea, green, dry seed”; “Pea, green, edible podded”; “Pea, green, succulent shelled”; “Pea, pigeon, dry seed”; “Pea, pigeon, edible podded”; “Pea, pigeon, succulent shelled”; “Pea, snap, edible podded”; “Pea, snow, edible podded”; “Pea, southern, dry seed”; “Pea, southern, succulent shelled”; “Pea, sugar snap, edible podded”; “Pea, winged, dry seed”; “Pea, winged, edible podded”; “Soybean, vegetable, dry seed”; “Soybean, vegetable, edible podded”; “Soybean, vegetable, succulent shelled”; “Velvetbean, dry seed”; “Velvetbean, edible podded”; and “Velvetbean, succulent shelled”.
End Amendment PartThe additions read as follows:
Novaluron; tolerances for residues.(a) * * *
Table 1 to Paragraph ( a )
Commodity Parts per million * * * * * Bean, adzuki, dry seed 0.3 Bean, African yam, dry seed 0.3 Bean, American potato, dry seed 0.3 Bean, asparagus, dry seed 0.3 Bean, asparagus, edible podded 0.7 Bean, black, dry seed 0.3 Bean, broad, dry seed 0.3 Bean, broad, succulent shelled 0.7 Bean, catjang, dry seed 0.3 Bean, catjang edible podded 0.7 Bean, catjang, succulent shelled 0.7 Bean, cranberry, dry seed 0.3 Bean, dry bean, dry seed 0.3 Bean, field, dry seed 0.3 Bean, French, dry seed 0.3 Bean, French, edible podded 0.7 Bean, garden, dry seed 0.3 Bean, garden, edible podded 0.7 Bean, goa, dry seed 0.3 Bean, goa, edible podded 0.7 Bean, goa, succulent shelled 0.7 Bean, great northern, dry seed 0.3 Bean, green, dry seed 0.3 Bean, green, edible podded 0.7 Bean, guar, dry seed 0.3 Bean, guar, edible podded 0.7 Bean, horse gram, dry seed 0.3 Bean, kidney, dry seed 0.3 Bean, kidney, edible podded 0.7 Bean, lablab, dry seed 0.3 Bean, lablab, edible podded 0.7 Bean, lablab, succulent shelled 0.7 Bean, lima, dry seed 0.3 Bean, lima, succulent shelled 0.7 Bean, morama, dry seed 0.3 Bean, moth, dry seed 0.3 Bean, moth, edible podded 0.7 Bean, moth, succulent shelled 0.7 Bean, mung, dry seed 0.3 Bean, mung, edible podded 0.7 Bean, navy, dry seed 0.3 Bean, navy, edible podded 0.7 Bean, phaseolus, forage 15 Bean, phaseolus, hay 80 Bean, pink, dry seed 0.3 Bean, pinto, dry seed 0.3 Bean, red, dry seed 0.3 Bean, rice, dry seed 0.3 Bean, rice, edible podded 0.7 Bean, scarlet runner, dry seed 0.3 Bean, scarlet runner, edible podded 0.7 Bean, scarlet runner, succulent shelled 0.7 Bean, snap, edible podded 0.7 Bean, sword, dry seed 0.3 Bean, sword, edible podded 0.7 Bean, tepary, dry seed 0.3 Bean, urd, dry seed 0.3 Bean, urd, edible podded 0.7 Bean, wax, edible podded 0.7 Bean, wax, succulent shelled 0.7 Bean, yardlong, dry seed 0.3 Bean, yardlong, edible podded 0.7 Bean, yellow, dry seed 0.3 * * * * * Chickpea, dry seed 0.1 Chickpea, edible podded 2 Chickpea, succulent shelled 0.05 * * * * * Cowpea, dry seed 0.3 Cowpea, edible podded 0.7 Cowpea, forage 15 Cowpea, hay 80 Cowpea, succulent shelled 0.7 * * * * * Jackbean, dry seed 0.3 Jackbean, edible podded 0.7 Jackbean, succulent shelled 0.7 * * * * * Lentil, dry seed 0.1 Lentil, edible podded 2 Lentil, succulent shelled 0.05 Longbean, Chinese, dry seed 0.3 Longbean, Chinese, edible podded 0.7 Lupin, Andean, dry seed 0.3 Lupin, Andean, succulent shelled 0.7 Lupin, blue, dry seed 0.3 Lupin, blue, succulent shelled 0.7 Lupin, grain, dry seed 0.3 Lupin, grain, succulent shelled 0.7 Lupin, sweet, dry seed 0.3 Lupin, sweet, succulent shelled 0.7 Lupin, white sweet, dry seed 0.3 Lupin, white sweet, succulent shelled 0.7 Lupin, white, dry seed 0.3 Lupin, white, succulent shelled 0.7 Lupin, yellow, dry seed 0.3 Lupin, yellow, succulent shelled 0.7 * * * * * Pea, blackeyed, dry seed 0.3 Pea, blackeyed, succulent shelled 0.7 Pea, crowder, dry seed 0.3 Pea, crowder, succulent shelled 0.7 Pea, dry, dry seed 0.1 Pea, dwarf, edible podded 2 Pea, English, succulent shelled 0.05 Pea, field, dry seed 0.1 Pea, field, forage 15 Pea, field, hay 80 Pea, garden, dry seed 0.1 Pea, garden, succulent shelled 0.05 Pea, grass, dry seed 0.1 Pea, grass, edible podded 2 Pea, green, dry seed 0.1 Pea, green, edible podded 2 Pea, green, succulent shelled 0.05 Pea, pigeon, dry seed 0.1 Pea, pigeon, edible podded 2 Pea, pigeon, succulent shelled 0.05 Pea, snap, edible podded 2 Pea, snow, edible podded 2 Pea, southern, dry seed 0.3 Pea, southern, succulent shelled 0.7 Pea, sugar snap, edible podded 2 Pea, winged, dry seed 0.3 Pea, winged, edible podded 0.7 * * * * * Soybean, vegetable, dry seed 0.3 Soybean, vegetable, edible podded 0.7 Soybean, vegetable, succulent shelled 0.7 * * * * * Velvetbean, dry seed 0.3 Velvetbean, edible podded 0.7 Velvetbean, succulent shelled 0.7 * * * * *[FR Doc. 2022-20332 Filed 9-20-22; 8:45 am]
BILLING CODE 6560-50-P
Document Information
- Effective Date:
- 9/21/2022
- Published:
- 09/21/2022
- Department:
- Environmental Protection Agency
- Entry Type:
- Rule
- Action:
- Final rule.
- Document Number:
- 2022-20332
- Dates:
- This regulation is effective September 21, 2022. Objections and requests for hearings must be received on or before November 21, 2022, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
- Pages:
- 57615-57620 (6 pages)
- Docket Numbers:
- EPA-HQ-OPP-2021-0153, FRL-10187-01-OCSPP
- Topics:
- Administrative practice and procedure, Agricultural commodities, Environmental protection, Pesticides and pests, Reporting and recordkeeping requirements
- PDF File:
- 2022-20332.pdf
- Supporting Documents:
- » Novaluron. Chronic Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Proposed Tolerances of Novaluron in/on Individual Beans and Pea (edible podded, succulent, and dried shelled) Commodities Under the Proposed Crop Subgroups 6-XX A-F
- » Novaluron. Petition for Individual Commodities of Proposed Crop Subgroup 6-XXA: Vegetable, legume, bean, edible podded, subgroup 6-xxA; Proposed Crop Subgroup 6-XXB: Vegetable, legume, pea, edible podded, subgroup 6-xxB; Proposed Crop Subgroup 6-XXC: Vegetable, legume, bean, succulent shelled, subgroup 6-xxC; Proposed Crop Subgroup 6-XXD: Vegetable, legume, pea, succulent shelled, subgroup....
- » Novaluron. Human Health Risk Assessment for Petition for Individual Commodities of Proposed Crop Subgroup 6-XXA: Vegetable, legume, bean, edible podded, subgroup 6-xxA; Proposed Crop Subgroup 6-XXB: Vegetable, legume, pea, edible podded, subgroup 6-xxB; Proposed Crop Subgroup 6-XXC: Vegetable, legume, bean, succulent shelled, subgroup 6-xxC; Proposed Crop....
- » Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Novaluron
- » Interregional Research Project #4 Notice of Filing Pesticide Petition No. 0E8882 to establish a tolerance for residues of the insecticide novaluron, including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels is to be determined by measuring only novaluron, (N-3-chloro-4-1,1,2-trifluoro-2-(trifluoromethoxy)
- » Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Residues of Pesticide Chemicals in or on Various Commodities March 2022
- » Pesticide Product Registration: Receipt of Applications for New Uses-August 2021
- » Interregional Research Project #4 Notice of Filing Pesticide Petition No. 0E8882 to establish a tolerance for residues of the insecticide novaluron, including its metabolites and degradates, in or on the following commodities
- » Receipt of Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities-June 2021
- » Pesticide Product Registration: Applications for New Uses-June 2021
- CFR: (1)
- 40 CFR 180.598