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copy of the rule, to each House of the shall not postpone the effectiveness of PART 52—APPROVAL AND Congress and to the Comptroller General such rule or action. This action may not PROMULGATION OF of the United States. The EPA will be challenged later in proceedings to IMPLEMENTATION PLANS submit a report containing this action enforce its requirements. See section and other required information to the 307(b)(2). ■ 1. The authority citation for part 52 U.S. Senate, the U.S. House of continues to read as follows: List of Subjects in 40 CFR Part 52 Representatives, and the Comptroller Authority: 42 U.S.C. 7401 et seq. General of the United States prior to Environmental protection, Air publication of the rule in the Federal Subpart C—Alaska Register. A major rule cannot take effect pollution control, Carbon monoxide, until 60 days after it is published in the Incorporation by reference, ■ 2. In § 52.70, the table in paragraph (e) Federal Register. This action is not a Intergovernmental relations, Lead, is amended by: ‘‘major rule’’ as defined by 5 U.S.C. Nitrogen dioxide, Ozone, Particulate ■ a. Revising the entry for ‘‘III.II.D. CAA 804(2). matter, Reporting and recordkeeping Section 110 Infrastructure Certification Under section 307(b)(1) of the CAA, requirements, Sulfur oxides, Volatile Documentation and Supporting petitions for judicial review of this organic compounds. Documents’’; and action must be filed in the United States Authority: 42 U.S.C. 7401 et seq. ■ b. Adding an entry for ‘‘Infrastructure Court of Appeals for the appropriate Requirements—2015 Ozone NAAQS’’ at circuit by February 21, 2020. Filing a Dated: December 2, 2019. the end of the table. petition for reconsideration by the Chris Hladick, The revision and addition read as Administrator of this final rule does not Regional Administrator, Region 10. follows: affect the finality of this action for the purposes of judicial review nor does it For the reasons set forth in the § 52.70 Identification of plan. extend the time within which a petition preamble, 40 CFR part 52 is amended as * * * * * for judicial review may be filed and follows: (e) * * *

EPA-APPROVED ALASKA NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES

Applicable geographic or State Name of SIP provision nonattainment area submittal date EPA approval date Explanations

*******

State of Alaska Air Quality Control Plan: Volume III. Appendices

Section II. State Air Quality Control Program

******* III.II.D. CAA Section 110 In- Statewide ...... 10/25/2018 12/23/2019, [Insert Federal frastructure Certification Register citation]. Documentation and Sup- porting Documents.

******* Infrastructure Require- Statewide ...... 10/25/2018 12/23/2019, [Insert Federal Approves SIP for purposes of CAA ments—2015 Ozone Register citation]. section 110(a)(2)(A), (B), (C), NAAQS. (D)(i)(II), (D)(ii), (E), (F), (G), (H), (J), (K), (L), and (M) for the 2015 Ozone NAAQS.

[FR Doc. 2019–27159 Filed 12–20–19; 8:45 am] SUMMARY: This regulation establishes a be filed in accordance with the BILLING CODE 6560–50–P time-limited tolerance for residues of instructions provided in 40 CFR part fenpropathrin in or on fuzzy kiwifruit. 178 (see also Unit I.C. of the This action is in response to EPA’s SUPPLEMENTARY INFORMATION). ENVIRONMENTAL PROTECTION granting of an emergency exemption ADDRESSES: The docket for this action, AGENCY under the Federal , identified by docket identification (ID) , and Act (FIFRA) number EPA–HQ–OPP–2019–0358, is 40 CFR Part 180 authorizing use of the on fuzzy available at https://www.regulations.gov kiwifruit. This regulation establishes a or at the Office of Pesticide Programs [EPA–HQ–OPP–2019–0358; FRL–10001–86] maximum permissible level for residues Regulatory Public Docket (OPP Docket) of fenpropathrin in or on this in the Environmental Protection Agency Fenpropathrin; Pesticide Tolerances commodity. The time-limited tolerance Docket Center (EPA/DC), West William for Emergency Exemptions expires on December 31, 2022. Jefferson Clinton Bldg., Rm. 3334, 1301 AGENCY: Environmental Protection DATES: This regulation is effective Constitution Ave. NW, Washington, DC Agency (EPA). December 23, 2019. Objections and 20460–0001. The Public Reading Room requests for hearings must be received is open from 8:30 a.m. to 4:30 p.m., ACTION: Final rule. on or before February 21, 2020 and must Monday through Friday, excluding legal

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holidays. The telephone number for the OPP–2019–0358 in the subject line on precedents for the application of FFDCA Public Reading Room is (202) 566–1744, the first page of your submission. All section 408 and the safety standard to and the telephone number for the OPP objections and requests for a hearing other tolerances and exemptions. Docket is (703) 305–5805. Please review must be in writing and must be received Section 408(e) of FFDCA allows EPA to the visitor instructions and additional by the Hearing Clerk on or before establish a tolerance or an exemption information about the docket available February 21, 2020. Addresses for mail from the requirement of a tolerance on at https://www.epa.gov/dockets. and hand delivery of objections and its own initiative, i.e., without having FOR FURTHER INFORMATION CONTACT: hearing requests are provided in 40 CFR received any petition from an outside Michael Goodis, Registration Division 178.25(b). party. (7505P), Office of Pesticide Programs, In addition to filing an objection or Section 408(b)(2)(A)(i) of FFDCA Environmental Protection Agency, 1200 hearing request with the Hearing Clerk allows EPA to establish a tolerance (the Pennsylvania Ave. NW, Washington, DC as described in 40 CFR part 178, please legal limit for a pesticide chemical 20460–0001; main telephone number: submit a copy of the filing (excluding residue in or on a food) only if EPA (703) 305–7090; email address: any Confidential Business Information determines that the tolerance is ‘‘safe.’’ [email protected]. (CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(ii) of FFDCA Information not marked confidential defines ‘‘safe’’ to mean that ‘‘there is a SUPPLEMENTARY INFORMATION: pursuant to 40 CFR part 2 may be reasonable certainty that no harm will I. General Information disclosed publicly by EPA without prior result from aggregate exposure to the notice. Submit the non-CBI copy of your pesticide chemical residue, including A. Does this action apply to me? objection or hearing request, identified all anticipated dietary exposures and all You may be potentially affected by by docket ID number EPA–HQ–OPP– other exposures for which there is this action if you are an agricultural 2019–0358, by one of the following reliable information.’’ This includes producer, food manufacturer, or methods: exposure through drinking water and in pesticide manufacturer. The following • Federal eRulemaking Portal: residential settings but does not include list of North American Industrial https://www.regulations.gov. Follow the occupational exposure. Section Classification System (NAICS) codes is online instructions for submitting 408(b)(2)(C) of FFDCA requires EPA to not intended to be exhaustive, but rather comments. Do not submit electronically give special consideration to exposure provides a guide to help readers any information you consider to be CBI of infants and children to the pesticide determine whether this document or other information whose disclosure is chemical residue in establishing a applies to them. Potentially affected restricted by statute. tolerance and to ‘‘ensure that there is a entities may include: • Mail: OPP Docket, Environmental reasonable certainty that no harm will • Crop production (NAICS code 111). Protection Agency Docket Center (EPA/ result to infants and children from • Animal production (NAICS code DC), (28221T), 1200 Pennsylvania Ave. aggregate exposure to the pesticide 112). NW, Washington, DC 20460–0001. chemical residue. . . .’’ • Food manufacturing (NAICS code • Hand Delivery: To make special Section 18 of FIFRA authorizes EPA 311). arrangements for hand delivery or to exempt any Federal or State agency • Pesticide manufacturing (NAICS delivery of boxed information, please from any provision of FIFRA, if EPA code 32532). follow the instructions at https:// determines that ‘‘emergency conditions www.epa.gov/dockets/where-send- exist which require such exemption.’’ B. How can I get electronic access to comments-epa-dockets. Additional EPA has established regulations other related information? instructions on commenting or visiting governing such emergency exemptions You may access a frequently updated the docket, along with more information in 40 CFR part 166. electronic version of 40 CFR part 180 about dockets generally, is available at III. Emergency Exemption for through the Government Publishing https://www.epa.gov/dockets. Office’s e-CFR site at https:// Fenpropathrin on Fuzzy Kiwifruit and www.ecfr.gov/cgi-bin/text- II. Background and Statutory Findings FFDCA Tolerances idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ EPA, on its own initiative, in According to the Alabama Department 40tab_02.tpl. To access the OCSPP test accordance with FFDCA sections 408(e) of and Industries (ADAI), in guidelines referenced in this document and 408(l)(6) of, 21 U.S.C. 346a(e) and 2017 brown marmorated stink bug electronically, please go to https:// 346a(1)(6), is establishing a time-limited (BMSB) damage was observed in a small www.epa.gov/aboutepa/about-office- tolerance for residues of fenpropathrin, block of nursery stock plants. This chemical-safety-and-pollution- (alpha-cyano-3-phenoxy-benzyl 2,2,3,3 observation alerted the staff at the kiwi prevention-ocspp and select ‘‘Test tetramethylcyclopropanecarboxylate), in nursery to the potential of BMSB for the Guidelines for and Toxic or on fuzzy kiwifruit at 5 parts per 2018 crop season. ADAI claimed that in Substances.’’ million (ppm). This time-limited 2018, BMSB severely damaged the tolerance expires on December 31, 2022. kiwifruit crop, making it unmarketable. C. How can I file an objection or hearing Section 408(l)(6) of FFDCA requires ADAI estimated losses as high as 50% request? EPA to establish a time-limited for 2018 and projected 2019 losses to be Under section 408(g) of the Federal tolerance or exemption from the over $1.6 million without the use Food, Drug, and Cosmetic Act (FFDCA), requirement for a tolerance for pesticide requested under the section 18 21 U.S.C. 346a, any person may file an chemical residues in food that will emergency exemption. After having objection to any aspect of this regulation result from the use of a pesticide under reviewed the submission, EPA and may also request a hearing on those an emergency exemption granted by determined that an emergency condition objections. You must file your objection EPA under FIFRA section 18. Such exists for this State, and that the criteria or request a hearing on this regulation tolerances can be established without for approval of an emergency exemption in accordance with the instructions providing notice or period for public are met. provided in 40 CFR part 178. To ensure comment. EPA does not intend for its As part of its evaluation of the proper receipt by EPA, you must actions on FIFRA section 18 related emergency exemption application, EPA identify docket ID number EPA–HQ– time-limited tolerances to set binding assessed the potential risks presented by

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residues of fenpropathrin in or on fuzzy of this emergency exemption request Health and Nutrition Examination kiwifruit. In doing so, EPA considered and the time-limited tolerance for Survey, What We Eat in America the safety standard in FFDCA section residues of fenpropathrin on fuzzy (NHANES/WWEIA). As to residue levels 408(b)(2), and EPA decided that the kiwifruit at 5 ppm. EPA’s assessment of in food, EPA used tolerance level necessary tolerance under FFDCA exposures and risks associated with residues for some commodities and section 408(l)(6) would be consistent establishing the time-limited tolerance refined the assessment by incorporating with the safety standard and with follows. distributions of field trial values and FIFRA section 18. Consistent with the A. Toxicological Points of Departure/ Pesticide Data Program (PDP) need to move quickly on the emergency Levels of Concern monitoring data for other commodities. exemption in order to address an urgent, EPA translated data from some non-routine situation and to ensure that Once a pesticide’s toxicological commodities to other commodities the resulting food is safe and lawful, profile is determined, EPA identifies according to EPA’s guidance documents EPA is issuing this tolerance without toxicological points of departure (POD) for translating monitoring data and field notice and opportunity for public and levels of concern to use in trial data. EPA also included estimates comment as provided in FFDCA section evaluating the risk posed by human of percent crop treated in the 408(l)(6). Although this time-limited exposure to the pesticide. For hazards assessment. For most processed tolerance expires on December 31, 2022, that have a threshold below which there commodities, EPA used the Agency’s under FFDCA section 408(l)(5), residues is no appreciable risk, the toxicological 2018 default processing factors for those of the pesticide not in excess of the POD is used as the basis for derivation commodities for which they were amount specified in the tolerance of reference values for risk assessment. available. In some cases, EPA used remaining in or on fuzzy kiwifruit after PODs are developed based on a careful empirical processing factors. that date will not be unlawful, provided analysis of the doses in each ii. Chronic exposure. Based on the the pesticide was applied in a manner toxicological study to determine the available data for fenpropathrin, use of that was lawful under FIFRA, and the dose at which no adverse effects are the acute endpoint and dose for risk residues do not exceed a level that was observed (the NOAEL) and the lowest assessment is protective for repeated dose at which adverse effects of concern authorized by this time-limited dose exposure and risk. Therefore, only are identified (the LOAEL). Uncertainty/ tolerance at the time of that application. an acute dietary assessment was safety factors are used in conjunction EPA will take action to revoke this time- performed, which is considered with the POD to calculate a safe limited tolerance earlier if any protective of chronic dietary exposure. exposure level—generally referred to as experience with, scientific data on, or iii. Cancer. Based on the data cited in a population-adjusted dose (PAD) or a other relevant information on this Unit IV.A., EPA has concluded that reference dose (RfD)—and a safe margin pesticide indicate that the residues are fenpropathrin does not pose a cancer of exposure (MOE). For non-threshold not safe. risk to humans. Therefore, a dietary Because this time-limited tolerance is risks, the Agency assumes that any exposure assessment for the purpose of being approved under emergency amount of exposure will lead to some assessing cancer risk is unnecessary. conditions, EPA has not made any degree of risk. Thus, the Agency iv. Anticipated residue and percent decisions about whether fenpropathrin estimates risk in terms of the probability crop treated (PCT) information. Section meets FIFRA’s registration requirements of an occurrence of the adverse effect 408(b)(2)(E) of FFDCA authorizes EPA for use on fuzzy kiwifruit or whether a expected in a lifetime. For more to use available data and information on permanent tolerance for this use would information on the general principles the anticipated residue levels of be appropriate. Under these EPA uses in risk characterization and a pesticide residues in food and the actual circumstances, EPA does not believe complete description of the risk levels of pesticide residues that have that this time-limited tolerance decision assessment process, see https:// been measured in food. If EPA relies on serves as a basis for registration of www.epa.gov/pesticide-science-and- such information, EPA must require fenpropathrin by a State for special local assessing-pesticide-risks. needs under FIFRA section 24(c), nor A summary of the toxicological pursuant to FFDCA section 408(f)(1) does this tolerance by itself serve as the endpoints for fenpropathrin used for that data be provided 5 years after the authority for persons in any State other human risk assessment is discussed in tolerance is established, modified, or than Alabama to use this pesticide on Unit III.B. of the final rule published in left in effect, demonstrating that the the applicable crops under FIFRA the Federal Register of November 28, levels in food are not above the levels section 18, absent the issuance of an 2012 (77 FR 70904) (FRL–9366–1). anticipated. For the present action, EPA emergency exemption applicable within will issue such data call-ins as are B. Exposure Assessment that State. For additional information required by FFDCA section 408(b)(2)(E) regarding the emergency exemption for 1. Dietary exposure from food and and authorized under FFDCA section fenpropathrin, contact the Agency’s feed uses. In evaluating dietary 408(f)(1). Data will be required to be Registration Division at the address exposure to fenpropathrin, EPA submitted no later than 5 years from the provided under FOR FURTHER considered exposure under the time- date of issuance of these tolerances. INFORMATION CONTACT. limited tolerance established by this Section 408(b)(2)(F) of FFDCA states action as well as all existing that the Agency may use data on the IV. Aggregate Risk Assessment and fenpropathrin tolerances in 40 CFR actual percent of food treated for Determination of Safety 180.466. EPA assessed dietary assessing dietary risk only if: Consistent with the factors specified exposures from fenpropathrin in food as • Condition a: The data used are in FFDCA section 408(b)(2)(D), EPA has follows: reliable and provide a valid basis to reviewed the available scientific data i. Acute exposure. Acute effects were show what percentage of the food and other relevant information in identified for fenpropathrin. In derived from such crop is likely to support of this action. EPA has estimating acute dietary exposure, EPA contain the . sufficient data to assess the hazards of, used food consumption information • Condition b: The exposure estimate and to make a determination on, from the United States Department of does not underestimate exposure for any aggregate exposure expected as a result Agriculture (USDA) 2003–2008 National significant subpopulation group.

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• Condition c: Data are available on the regional consumption of food to conservative and appropriate to address pesticide use and food consumption in which fenpropathrin may be applied in use expansions, such as this use on a particular area, and the exposure a particular area. kiwifruit. For information regarding the estimate does not understate exposure 2. Dietary exposure from drinking EPA’s efforts to evaluate the risk of for the population in such area. water. The Agency used water solubility exposure to , refer to https:// In addition, the Agency must provide limit at 25 °C in the dietary exposure www.epa.gov/oppsrrd1/reevaluation/ for periodic evaluation of any estimates analysis and risk assessment for pyrethroids-.html. After all of used. To provide for the periodic fenpropathrin in drinking water. Further the chemical-specific interim decisions evaluation of the estimate of PCT as information regarding EPA drinking have been completed for the required by FFDCA section 408(b)(2)(F), water models used in pesticide class of pesticides, an update of the EPA may require registrants to submit exposure assessment can be found at cumulative risk assessment may be data on PCT. https://www.epa.gov/pesticide-science- performed in association with The Agency estimated the PCT for and-assessing-pesticide-risks/about- registration review. existing uses as follows: Apples, 15%; water-exposure-models-used-pesticide. apricots 2.5%; blueberries, 2.5%; The water solubility limit of C. Safety Factor for Infants and Children broccoli, 2.5%; Brussels sprouts, 10%; fenpropathrin at 25 °C is 10.3 parts per 1. In general. Section 408(b)(2)(C) of cabbage, 2.5%; cauliflower, 2.5%; billion (ppb). The limit of solubility was FFDCA provides that EPA shall apply cherries, 21%; cotton, 2.5%; cucumbers, directly entered into the dietary an additional tenfold (10X) margin of 2.5%; grapefruit, 35%; grapes, 10%; exposure model. For acute dietary risk safety for infants and children in the nectarines, 9%; oranges, 35%; peaches, assessment, the water concentration case of threshold effects to account for 9%; pears, 10%; plums, 2.5%; prune value of 10.3 ppb was used to assess the prenatal and postnatal toxicity and the plums, 2.5%; squash, 2.5%; contribution to drinking water. completeness of the database on toxicity strawberries, 50%; tangerines, 15%; 3. From non-dietary exposure. The and exposure unless EPA determines tomatoes, 10%; and watermelons, 2.5%. term ‘‘residential exposure’’ is used in based on reliable data that a different In most cases, EPA uses available data this document to refer to non- margin of safety will be safe for infants from United States Department of occupational, non-dietary exposure and children. This additional margin of Agriculture/National Agricultural (e.g., for lawn and garden , safety is commonly referred to as the Statistics Service (USDA/NASS), indoor pest control, termiticides, and FQPA Safety Factor (SF). In applying proprietary market surveys, and the flea and tick control on pets). this provision, EPA either retains the National Pesticide Use Database for the Fenpropathrin is not registered for any default value of 10X, or uses a different chemical/crop combination for the most specific use patterns that would result additional SF when reliable data recent 6 to 7 years. EPA uses a in residential exposure. available to EPA support the choice of maximum PCT for acute dietary risk Further information regarding EPA a different factor. analysis. The maximum PCT figure is standard assumptions and generic 2. Prenatal and postnatal sensitivity. the highest observed maximum value inputs for residential exposures may be Evidence of increased qualitative or reported within the recent 6 years of found at: https://www.epa.gov/ quantitative susceptibility of the available public and private market pesticide-science-and-assessing- offspring was not observed in any of the survey data for the existing use and pesticide-risks/standard-operating- available animal testing guideline rounded up to the nearest multiple of procedures-residential-pesticide. toxicity studies, including the 5%. 4. Cumulative effects from substances developmental neurotoxicity study The Agency estimated the PCT for with a common mechanism of toxicity. (DNT). new uses as follows: 100% for fuzzy Section 408(b)(2)(D)(v) of FFDCA 3. Conclusion. EPA has determined kiwifruit. requires that, when considering whether that reliable data show that the safety of The Agency believes that the three to establish, modify, or revoke a infants and children would be conditions discussed in Unit IV.B1.iv. tolerance, the Agency consider adequately protected if the required 10X have been met. With respect to ‘‘available information’’ concerning the FQPA SF were reduced to 3X for Condition a, PCT estimates are derived cumulative effects of a particular children less than 6 years old. For the from Federal and private market survey pesticide’s residues and ‘‘other general population, and including data, which are reliable and have a valid substances that have a common children greater than 6 years old, EPA basis. As to Conditions b and c, regional mechanism of toxicity.’’ is reducing the FQPA SF to 1X. That consumption information and The agency is required to consider the decision is based on the following consumption information for significant cumulative risks of chemicals sharing a findings: subpopulations is taken into account common mechanism of toxicity. The i. While the database is considered to through EPA’s computer-based model agency has determined that the be complete with respect to the for evaluating the exposure of pyrethroids and pyrethrins share a guideline toxicity studies for significant subpopulations including common mechanism group (see https:// fenpropathrin, EPA lacks additional several regional groups. Use of this www.regulations.gov; Docket ID EPA– data to fully characterize the potential consumption information in EPA’s risk HQ–OPP–2008–0489–0006). The for juvenile sensitivity to neurotoxic assessment process ensures that EPA’s members of this group share the ability effects of pyrethroids. In light of the exposure estimate does not understate to interact with voltage-gated sodium literature studies indicating a possibility exposure for any significant channels ultimately leading to of increased sensitivity in juvenile rats subpopulation group and allows the neurotoxicity. The cumulative risk at high doses, EPA identified a need, Agency to be reasonably certain that no assessment for the pyrethroids/ and requested proposals for, additional regional population is exposed to pyrethrins was published on Nov. 9, non-guideline studies to evaluate the residue levels higher than those 2011 (USEPA, 2011a) and is available at potential for sensitivity in juvenile rats. estimated by the Agency. Other than the https://www.regulations.gov; Docket ID A group of pyrethroid registrants is data available through national food EPA–HQ–OPP–2011–0746. No currently conducting those studies. consumption surveys, EPA does not cumulative risks of concern were Pending the results of those studies, have available reliable information on identified. This assessment was however, the available toxicity studies

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for fenpropathrin can be used to vitro pharmacodynamic data and in vivo D. Aggregate Risks and Determination of characterize toxic effects including data indicate that adult and juvenile rats Safety potential developmental and have similar responses to pyrethroids at EPA determines whether acute and reproductive toxicity, immunotoxicity, low doses and therefore juvenile chronic dietary pesticide exposures are and neurotoxicity. Acceptable sensitivity is not expected at relevant safe by comparing aggregate exposure developmental toxicity studies in rats environmental exposures. Further, data estimates to the acute PAD (aPAD) and and rabbits, reproduction studies in rats, also show that the rat is a conservative chronic PAD (cPAD). For linear cancer neurotoxicity studies (acute, model compared to the human based on risks, EPA calculates the lifetime subchronic, and developmental) in rats, species-specific pharmacodynamics of probability of acquiring cancer given the and immunotoxicity studies in rats are homologous sodium channel isoforms. estimated aggregate exposure. Short-, available. In addition, a route-specific The Agency has retained a 3X intermediate-, and chronic-term risks dermal toxicity study is available, and uncertainty factor to protect for are evaluated by comparing the the inhalation study has been waived. exposures of children less than 6 years ii. After reviewing the extensive body estimated aggregate food, water, and of age based on increased quantitative residential exposure to the appropriate of data and peer-reviewed literature on susceptibility seen in literature studies pyrethroids, the Agency has reached a PODs to ensure that an adequate MOE on pyrethroid pharmacokinetics (PKs), exists. number of conclusions regarding fetal and the increased quantitative juvenile and juvenile sensitivity for pyrethroids. 1. Acute risk. Using the exposure susceptibility observed in high dose assumptions discussed in this unit for Based on an evaluation of over 70 studies in the literature. guideline toxicity studies for 24 acute exposure, the acute dietary iv. There are no residual uncertainties exposure from food and water to pyrethroids submitted to the Agency, identified in the exposure databases. including prenatal developmental fenpropathrin will occupy 99.5% of the The Agency used tolerance level aPAD for children 1 to 2 years old, the toxicity studies in rats and rabbits, and residues for some commodities and pre- and postnatal multi-generation population group receiving the greatest refined the assessment by incorporating exposure. reproduction toxicity studies and DNTs distributions of field trial values and in rats in support of pyrethroid 2. Chronic risk. A chronic dietary Pesticide Data Program (PDP) exposure assessment was not conducted registrations, there is no evidence that monitoring data for other commodities. pyrethroids directly impact developing because the acute endpoint adequately EPA translated data from some protects against chronic effects. There fetuses. None of the studies show any commodities to other commodities indications of fetal toxicity at doses that are no residential uses for according to EPA’s guidance documents fenpropathrin. do not cause maternal toxicity. for translating monitoring data and field iii. Increased susceptibility was seen 3. Short-term risk. Short-term trial data. EPA also included estimates in offspring animals in the DNT study aggregate exposure takes into account of percent crop treated in the with the pyrethroid zeta- short-term residential exposure plus assessment. For most processed (decreased pup body weights) and DNT chronic exposure to food and water and reproduction studies with another commodities, EPA used the Agency’s (considered to be a background pyrethroid, beta- (decreased 2018 default processing factors for those exposure level). A short-term adverse body weights and tremors). However, commodities for which they were effect was identified; however, the reductions in body weight and the available. In some cases, EPA used fenpropathrin is not registered for any other non-specific effects occur at empirical processing factors. use patterns that would result in short- higher doses than neurotoxicity, the For this kiwifruit section 18 request, term residential exposure. Because there effect of concern for pyrethroids. The EPA updated the 2016 dietary exposure is no short-term residential exposure available developmental and assessment by including kiwifruit. As and acute dietary exposure has already reproduction guideline studies in rats residue data are not available for been assessed under the appropriately with zeta-cypermethrin did not show kiwifruit, the Agency translated grape protective aPAD (which is at least as increased sensitivity in the young to PDP data to kiwifruit. For section 18 protective as the POD used to assess neurotoxic effects. Overall, findings of requests, the Agency assumes the short-term risk), no further assessment increased sensitivity in juvenile animals proposed commodity will be treated to of short-term risk is necessary, and EPA in pyrethroid studies are rare. Therefore, a level of 100% across the country. As relies on the acute dietary risk the residual concern for the postnatal a result, 100% crop treated was assessment for evaluating short-term effects is reduced. High-dose LD50 assumed for kiwifruit. EPA also made risk for fenpropathrin. studies (studies assessing what dose refinements to the residue data for dried 4. Intermediate-term risk. results in lethality to 50% of the tested cranberry, dried mango, and dried Intermediate-term aggregate exposure population) in the scientific literature papaya. In the 2016 assessment, EPA takes into account intermediate-term indicate that pyrethroids can result in used tolerance level residues for these non-dietary, non-occupational exposure increased quantitative sensitivity to commodities. For this section 18 plus chronic exposure to food and water juvenile animals. Examination of request, EPA translated strawberry PDP (considered to be a background pharmacokinetic and pharmacodynamic data to dried cranberries, avocado field exposure level). Because no data indicates that the sensitivity trial data to dried mango, and avocado intermediate-term adverse effect was observed at high doses is related to field trial data to dried papaya. The identified, fenpropathrin is not expected pyrethroid age-dependent Agency assumed 100% crop treated for to pose an intermediate-term risk. pharmacokinetics—the activity of the three dried commodities: Cranberry, 5. Aggregate cancer risk for U.S. enzymes associated with the mango, and papaya. population. Based on the lack of metabolism of pyrethroids. EPA made a conservative (protective) evidence of carcinogenicity in two Furthermore, a rat physiologically-based assumption in the water concentration adequate rodent carcinogenicity studies, pharmacokinetic (PBPK) model predicts used to assess exposure to fenpropathrin fenpropathrin is not expected to pose a a 3-fold increase of pyrethroid in drinking water. These assessments cancer risk to humans. concentration in juveniles’ brains will not underestimate the exposure and 6. Determination of safety. Based on compared to adults at high doses. In risk posed by fenpropathrin. these risk assessments, EPA concludes

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that there is a reasonable certainty that Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary no harm will result to the general Planning and Review’’ (58 FR 51735, consensus standards pursuant to section population, or to infants and children, October 4, 1993). Because this action 12(d) of the National Technology from aggregate exposure to has been exempted from review under Transfer and Advancement Act fenpropathrin residues, including Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note). anticipated residues on fuzzy kiwifruit. not subject to Executive Order 13211, titled ‘‘Actions Concerning Regulations VIII. Congressional Review Act V. Other Considerations That Significantly Affect Energy Supply, Pursuant to the Congressional Review A. Analytical Enforcement Methodology Distribution, or Use’’ (66 FR 28355, May Act (5 U.S.C. 801 et seq.), EPA will Adequate enforcement methodology 22, 2001) or Executive Order 13045, submit a report containing this rule and utilizing gas chromatography with titled ‘‘Protection of Children from other required information to the U.S. electron capture detector (GC/ECD), Environmental Health Risks and Safety Senate, the U.S. House of Residue Method Numbers RM–22–4 Risks’’ (62 FR 19885, April 23, 1997), Representatives, and the Comptroller (plants) and RM–22A–1 (animals), is nor is it considered a regulatory action General of the United States prior to available to enforce the tolerance under Executive Order 13771, entitled publication of the rule in the Federal expression. ‘‘Reducing Regulations and Controlling Register. This action is not a ‘‘major Regulatory Costs,’’ (82 FR 9339, The method may be requested from: rule’’ as defined by 5 U.S.C. 804(2). Chief, Analytical Chemistry Branch, February 3, 2017). This action does not Environmental Science Center, 701 contain any information collections List of Subjects in 40 CFR Part 180 subject to OMB approval under the Mapes Rd., Ft. Meade, MD 20755–5350; Environmental protection, telephone number: (410) 305–2905; Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require Administrative practice and procedure, email address: residuemethods@ Agricultural commodities, Pesticides epa.gov. any special considerations under Executive Order 12898, titled ‘‘Federal and pests, Reporting and recordkeeping B. International Residue Limits Actions to Address Environmental requirements. In making its tolerance decisions, EPA Justice in Minority Populations and Dated: December 5, 2019. seeks to harmonize U.S. tolerances with Low-Income Populations’’ (59 FR 7629, Michael Goodis, February 16, 1994). international standards whenever Director, Registration Division, Office of possible, consistent with U.S. food Since tolerances and exemptions that Pesticide Programs. safety standards and agricultural are established in accordance with practices. EPA considers the FFDCA sections 408(e) and 408(l)(6), Therefore, 40 CFR chapter I is international maximum residue limits such as the tolerance in this final rule, amended as follows: (MRLs) established by the Codex do not require the issuance of a Alimentarius Commission (Codex), as proposed rule, the requirements of the PART 180—[AMENDED] required by FFDCA section 408(b)(4). Regulatory Flexibility Act (RFA) (5 The Codex Alimentarius is a joint U.S.C. 601 et seq.) do not apply. ■ 1. The authority citation for part 180 United Nations Food and Agriculture This action directly regulates growers, continues to read as follows: food processors, food handlers, and food Organization/World Health Authority: 21 U.S.C. 321(q), 346a and 371. Organization food standards program, retailers, not States or tribes, nor does and it is recognized as an international this action alter the relationships or ■ 2. In § 180.466, revise paragraph (b) to food safety standards-setting distribution of power and read as follows: organization in trade agreements to responsibilities established by Congress which the United States is a party. EPA in the preemption provisions of FFDCA § 180.466 Fenpropathrin; tolerances for may establish a tolerance that is section 408(n)(4). As such, the Agency residues. different from a Codex MRL; however, has determined that this action will not * * * * * have a substantial direct effect on States FFDCA section 408(b)(4) requires that (b) Section 18 emergency exemptions. or tribal governments, on the EPA explain the reasons for departing Time-limited tolerances specified in relationship between the National from the Codex level. Table 2 to this paragraph (b) are Government and the States or tribal The Codex has not established an established for residues of governments, or on the distribution of MRL for fenpropathrin on fuzzy fenpropathrin, (alpha-cyano-3-phenoxy- power and responsibilities among the kiwifruit. benzyl 2,2,3,3 tetramethylcyclopropane various levels of government or between carboxylate) in or on the specified VI. Conclusion the Federal Government and Indian agricultural commodities, resulting from tribes. Thus, the Agency has determined Therefore, a time-limited tolerance is use of the pesticide pursuant to FIFRA that Executive Order 13132, entitled established for residues of section 18 emergency exemptions. The ‘‘Federalism’’ (64 FR 43255, August 10, fenpropathrin, (alpha-cyano-3-phenoxy- tolerance expires on the date specified 1999) and Executive Order 13175, benzyl 2,2,3,3 in Table 2. tetramethylcyclopropanecarboxylate), in entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR or on kiwifruit, fuzzy at 5 ppm. This TABLE 2 TO PARAGRAPH (b) tolerance expires on December 31, 2022. 67249, November 9, 2000) do not apply to this action. In addition, this action VII. Statutory and Executive Order Parts per Expiration does not impose any enforceable duty or Commodity million date Reviews contain any unfunded mandate as This action establishes a tolerance described under Title II of the Unfunded Kiwifruit, fuzzy ... 5 12/31/2022 under FFDCA sections 408(e) and Mandates Reform Act (UMRA) (2 U.S.C. 408(l)(6). The Office of Management and 1501 et seq.). * * * * * Budget (OMB) has exempted these types This action does not involve any [FR Doc. 2019–27379 Filed 12–20–19; 8:45 am] of actions from review under Executive technical standards that would require BILLING CODE 6560–50–P

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