Dinotefuran; Pesticide Tolerances 311)

Federal Register / Vol. 84, No. 183 / Friday, September 20, 2019 / Rules and Regulations 49475

* * * * * list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. [FR Doc. 2019–19986 Filed 9–19–19; 8:45 am] Classification System (NAICS) codes is NW, Washington, DC 20460–0001. BILLING CODE 6560–50–P not intended to be exhaustive, but rather • Hand Delivery: To make special provides a guide to help readers arrangements for hand delivery or determine whether this document delivery of boxed information, please ENVIRONMENTAL PROTECTION applies to them. Potentially affected follow the instructions at http:// AGENCY entities may include: www.epa.gov/dockets/contacts.html. • Crop production (NAICS code 111). 40 CFR Part 180 • Additional instructions on Animal production (NAICS code commenting or visiting the docket, [EPA–HQ–OPP–2018–0424; FRL–9994–82] 112). • along with more information about Food manufacturing (NAICS code dockets generally, is available at http:// Dinotefuran; Pesticide Tolerances 311). www.epa.gov/dockets. • Pesticide manufacturing (NAICS AGENCY: Environmental Protection code 32532). II. Summary of Petitioned-For Agency (EPA). Tolerance ACTION: Final rule. B. How can I get electronic access to other related information? In the Federal Register of August 14, SUMMARY: This regulation establishes You may access a frequently updated 2018 (83 FR 40272) (FRL–9981–10), tolerances for residues of dinotefuran in electronic version of EPA’s tolerance EPA issued a document pursuant to or on persimmon. Mitsui Chemicals regulations at 40 CFR part 180 through FFDCA section 408(d)(3), 21 U.S.C. Agro, Inc., c/o Landis International, Inc. the Government Printing Office’s e-CFR 346a(d)(3), announcing the filing of a requested these tolerances under the site at http://www.ecfr.gov/cgi-bin/text- pesticide petition (PP 8E8687) by Mitsui Federal Food, Drug, and Cosmetic Act idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Chemicals Agro, Inc., c/o Landis (FFDCA). 40tab_02.tpl. International, Inc., P.O. Box 5126, DATES: This regulation is effective Valdosta, GA 31603–5126. The petition September 20, 2019. Objections and C. How can I file an objection or hearing requested that 40 CFR part 180.603 be requests for hearings must be received request? amended by establishing tolerances for on or before November 19, 2019 and Under FFDCA section 408(g), 21 residues of the insecticide dinotefuran ′ ″ must be filed in accordance with the U.S.C. 346a, any person may file an (N-methyl-N -nitro-N ;-[(tetrahydro-3- instructions provided in 40 CFR part objection to any aspect of this regulation furanyl)methyl)] guanidine) and 178 (see also Unit I.C. of the and may also request a hearing on those metabolites DN (1-methyl-3-(tetrahydro- SUPPLEMENTARY INFORMATION). objections. You must file your objection 3-furylmethyl)guanidine) and UF (1- methyl-3-(tetrahydro-3-furylmethyl)- ADDRESSES: The docket for this action, or request a hearing on this regulation identified by docket identification (ID) in accordance with the instructions urea), in or on persimmon at 2 parts per number EPA–HQ–OPP–2018–0424, is provided in 40 CFR part 178. To ensure million (ppm). That document available at http://www.regulations.gov proper receipt by EPA, you must referenced a summary of the petition or at the Office of Pesticide Programs identify docket ID number EPA–HQ– prepared by Mitsui Chemicals Agro, Regulatory Public Docket (OPP Docket) OPP–2018–0424 in the subject line on Inc., c/o Landis International, Inc., the in the Environmental Protection Agency the first page of your submission. All registrant, which is available in the Docket Center (EPA/DC), West William objections and requests for a hearing docket, http://www.regulations.gov. Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing and must be received Two comments were received on the Constitution Ave. NW, Washington, DC by the Hearing Clerk on or before notice of filing; however, neither 20460–0001. The Public Reading Room November 19, 2019. Addresses for mail comment is relevant to this action. is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and III. Aggregate Risk Assessment and Monday through Friday, excluding legal hearing requests are provided in 40 CFR Determination of Safety holidays. The telephone number for the 178.25(b). Public Reading Room is (202) 566–1744, In addition to filing an objection or Section 408(b)(2)(A)(i) of FFDCA and the telephone number for the OPP hearing request with the Hearing Clerk allows EPA to establish a tolerance (the Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please legal limit for a pesticide chemical the visitor instructions and additional submit a copy of the filing (excluding residue in or on a food) only if EPA information about the docket available any Confidential Business Information determines that the tolerance is ‘‘safe.’’ at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a FOR FURTHER INFORMATION CONTACT: Information not marked confidential reasonable certainty that no harm will Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior result from aggregate exposure to the (7505P), Office of Pesticide Programs, pesticide chemical residue, including Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your objection or hearing request, identified all anticipated dietary exposures and all Pennsylvania Ave. NW, Washington, DC other exposures for which there is 20460–0001; main telephone number: by docket ID number EPA–HQ–OPP– 2018–0424, by one of the following reliable information.’’ This includes (703) 305–7090; email address: exposure through drinking water and in [email protected]. methods: • Federal eRulemaking Portal: http:// residential settings but does not include SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online occupational exposure. Section I. General Information instructions for submitting comments. 408(b)(2)(C) of FFDCA requires EPA to Do not submit electronically any give special consideration to exposure A. Does this action apply to me? information you consider to be CBI or of infants and children to the pesticide You may be potentially affected by other information whose disclosure is chemical residue in establishing a this action if you are an agricultural restricted by statute. tolerance and to ‘‘ensure that there is a producer, food manufacturer, or • Mail: OPP Docket, Environmental reasonable certainty that no harm will pesticide manufacturer. The following Protection Agency Docket Center (EPA/ result to infants and children from

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aggregate exposure to the pesticide histopathological lesions in these Persimmon on page 18 in docket ID chemical residue . . . .’’ organs. In addition, the developmental number EPA–HQ–OPP–2018–0424. Consistent with FFDCA section immunotoxicity study showed no B. Toxicological Points of Departure/ 408(b)(2)(D), and the factors specified in effects on functionality of the immune Levels of Concern FFDCA section 408(b)(2)(D), EPA has system in rats following exposure to reviewed the available scientific data dinotefuran at the limit dose during the Once a pesticide’s toxicological and other relevant information in prenatal, postnatal, and post-weaning profile is determined, EPA identifies support of this action. EPA has periods. Because of the lack of toxicological points of departure (POD) sufficient data to assess the hazards of immunotoxicity seen in the and levels of concern to use in and to make a determination on immunotoxicity studies in mice, rats, evaluating the risk posed by human aggregate exposure for dinotefuran and developing rats, the thymus weight exposure to the pesticide. For hazards including exposure resulting from the changes seen in dogs and the spleen that have a threshold below which there tolerances established by this action. weight changes seen in mice and rats in is no appreciable risk, the toxicological EPA’s assessment of exposures and risks the subchronic and chronic oral studies POD is used as the basis for derivation associated with dinotefuran follows. were not considered to be of reference values for risk assessment. PODs are developed based on a careful A. Toxicological Profile toxicologically relevant. No systemic or neurotoxic effects analysis of the doses in each EPA has evaluated the available were seen following repeated dermal toxicological study to determine the toxicity data and considered its validity, applications at the limit dose to rats in dose at which no adverse effects are completeness, and reliability as well as the 28-day dermal toxicity study. Also, observed (the NOAEL) and the lowest the relationship of the results of the no systemic or portal of entry effects dose at which adverse effects of concern studies to human risk. EPA has also were seen following repeated inhalation are identified (the LOAEL). Uncertainty/ considered available information exposure at the maximum obtainable safety factors are used in conjunction concerning the variability of the concentrations to rats in the 28-day with the POD to calculate a safe sensitivities of major identifiable inhalation study. In the developmental exposure level—generally referred to as subgroups of consumers, including toxicity study in rats, no maternal or a population-adjusted dose (PAD) or a infants and children. developmental toxicity was seen at the reference dose (RfD)—and a safe margin Dinotefuran is a neonicotinoid of exposure (MOE). For non-threshold pesticide and acts as an agonist on limit dose. In rabbits, maternal toxicity manifested as clinical signs of risks, the Agency assumes that any insect nicotinic acetylcholine receptors. amount of exposure will lead to some Typically, low to moderate levels of neurotoxicity, but no developmental toxicity was seen. In the reproduction degree of risk. Thus, the Agency neonicotinoids, such as dinotefuran, estimates risk in terms of the probability activate the nicotinic acetylcholine study in rats, parental, offspring, and reproductive toxicity was seen at the of an occurrence of the adverse effect receptors causing stimulation of the expected in a lifetime. For more peripheral nervous system (PNS). High limit dose. Parental toxicity included decreased body weight weights/gains, information on the general principles levels of neonicotinoids (agonists) can EPA uses in risk characterization and a overstimulate the PNS, maintaining transient decrease in food consumption, and decreased thyroid weights. complete description of the risk cation channels in the open state which assessment process, see http:// blocks the action potential and leads to Offspring toxicity was characterized as decreased forelimb grip strength or www2.epa.gov/pesticide-science-and- paralysis. assessing-pesticide-risks/assessing- The main target organ of toxicity for hindlimb grip strength in the F1 pups. There was no adverse effect on human-health-risk-pesticides. dinotefuran is the nervous system, but A summary of the toxicological reproductive performance at any dose. effects on the nervous system were only endpoints for dinotefuran used for In the developmental neurotoxicity observed at high doses. Nervous system human risk assessment is discussed in study, no maternal or offspring toxicity toxicity was manifested as clinical signs Unit III.B of the final rule published in was seen at any dose including the limit and decreased motor activity seen after the Federal Register of April 10, 2013 dose. acute dosing (in both rats and rabbits); (78 FR 21267) (FRL–9381–5). changes in motor activity are consistent Dinotefuran is classified as ‘‘Not with effects on the nicotinic cholinergic Likely to be Carcinogenic to Humans’’ C. Exposure Assessment nervous system seen after repeated based on lack of evidence of 1. Dietary exposure from food and dosing. The other significant effects carcinogenicity in rats and mice in two feed uses. In evaluating dietary were decreases in body weight and/or adequate rodent carcinogenicity studies. exposure to dinotefuran, EPA body weight gain, but even these effects There was no evidence of mutagenicity considered exposure under the occurred at or near the limit dose. in both the in vivo and in vitro assays. petitioned-for tolerances as well as all Changes in spleen and thymus weights Dinotefuran has low acute toxicity by existing dinotefuran tolerances in 40 were seen in mice, rats, and dogs oral, dermal, and inhalation exposure CFR 180.603. EPA assessed dietary following subchronic and chronic routes. It does not irritate the eye but exposures from dinotefuran in food as dietary exposures. However, these causes a low level of skin irritation; it follows: weight changes were not corroborated is not a dermal sensitizer. i. Acute exposure. Quantitative acute with alterations in hematology Specific information on the studies dietary exposure and risk assessments parameters, histopathological lesions in received and the nature of the adverse are performed for a food-use pesticide, these organs, or toxicity to the effects caused by dinotefuran as well as if a toxicological study has indicated the hematopoietic system. Furthermore, in the no-observed-adverse-effect-level possibility of an effect of concern the immunotoxicity studies in rats and (NOAEL) and the lowest-observed- occurring as a result of a 1-day or single mice, no effects on T-cell dependent adverse-effect-level (LOAEL) from the exposure. antibody response (TDAR) were seen toxicity studies can be found at http:// Such effects were identified for when tested up to the limit dose. There www.regulations.gov in document dinotefuran. In estimating acute dietary were also no changes in spleen and Human Health Risk Assessment to exposure, EPA used food consumption thymus weight, and there were no Support New Use on Imported information from the United States

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Department of Agriculture (USDA) occupational, non-dietary exposure D. Safety Factor for Infants and 2003–2008 National Health and (e.g., for lawn and garden pest control, Children Nutrition Examination Survey, What We indoor pest control, termiticides, and 1. In general. Section 408(b)(2)(C) of Eat in America, (NHANES/WWEIA). As flea and tick control on pets). FFDCA provides that EPA shall apply to residue levels in food, EPA assumed Dinotefuran is currently registered for an additional tenfold (10X) margin of 100 percent crop treated (PCT) and the following uses that could result in safety for infants and children in the tolerance-level residues for all current residential exposures: Turf, case of threshold effects to account for crops. ornamentals, vegetable gardens, roach prenatal and postnatal toxicity and the ii. Chronic exposure. In conducting and ant bait, pet spot-ons, indoor completeness of the database on toxicity the chronic dietary exposure assessment aerosol sprays, crack and crevice sprays, and exposure unless EPA determines EPA used the food consumption data etc. EPA assessed residential exposure based on reliable data that a different from the USDA 2003–2008 NHANES/ using the following assumptions: margin of safety will be safe for infants WWEIA. As to residue levels in food, Because no dermal or inhalation and children. This additional margin of EPA assumed 100 PCT and tolerance- safety is commonly referred to as the level residues for all current crops. endpoints were chosen for dinotefuran, iii. Cancer. Based on the data residential handler and post-application FQPA Safety Factor (SF). In applying summarized in Unit III.A., EPA has residential dermal and inhalation this provision, EPA either retains the concluded that dinotefuran does not exposure scenarios were not assessed. default value of 10X, or uses a different pose a cancer risk to humans. Therefore, As a result, risk assessments were only additional safety factor when reliable a dietary exposure assessment for the completed for post-application data available to EPA support the choice purpose of assessing cancer risk is scenarios in which incidental oral of a different factor. unnecessary. exposures are expected. Children (ages 2. Prenatal and postnatal sensitivity. iv. Anticipated residue and percent 1 to < 2 years old) may receive short- In the prenatal studies, no maternal or crop treated (PCT) information. EPA did term hand-to-mouth exposures from developmental toxicity was seen at the not use anticipated residue and/or PCT post-application exposure to fogger limit dose in rats. In rabbits, maternal information in the dietary assessment application in indoor rooms or areas. toxicity manifested as clinical signs of for dinotefuran. Tolerance level residues Children (ages 1 to < 2 years old) may neurotoxicity, but no developmental toxicity was seen. In the rat and/or 100 PCT were assumed for all receive intermediate- and chronic/long- reproduction study, parental, offspring, food commodities. term hand-to-mouth exposures from and reproductive toxicity was seen at 2. Dietary exposure from drinking post-application exposure to spot-on water. The Agency used screening level the limit dose. Parental toxicity application to dogs (small). The post- included decreased body weight gain, water exposure models in the dietary application exposure and risk estimates exposure analysis and risk assessment transient decrease in food consumption, for all existing residential uses resulted for dinotefuran in drinking water. These and decreased thyroid weights. in risk estimates that are not of concern simulation models take into account Offspring toxicity was characterized as (MOEs ranged from 1,200 to 4,600). data on the physical, chemical, and fate/ a decreased forelimb grip strength or Further information regarding EPA transport characteristics of dinotefuran. hindlimb grip strength in the F1 pups. standard assumptions and generic Further information regarding EPA There was no adverse effect on drinking water models used in pesticide inputs for residential exposures may be reproductive performance at any dose. exposure assessment can be found at found at http://www.epa.gov/pesticides/ In the developmental neurotoxicity http://www.epa.gov/oppefed1/models/ trac/science/trac6a05.pdf. study, no maternal or offspring toxicity water/index.htm. 4. Cumulative effects from substances was seen at any dose including the limit Based on the Pesticide Root Zone with a common mechanism of toxicity. dose. Model/Variable Volume Water Model Section 408(b)(2)(D)(v) of FFDCA 3. Conclusion. EPA has determined (PRZM/VVWM), Pesticide Flooded requires that, when considering whether that reliable data show the safety of Application Model (PFAM), and to establish, modify, or revoke a infants and children would be Pesticide Root Zone Model Ground tolerance, the Agency consider adequately protected if the FQPA SF Water (PRZM GW), the estimated ‘‘available information’’ concerning the were reduced to 1X. That decision is drinking water concentrations (EDWCs) cumulative effects of a particular based on the following findings: of dinotefuran for acute exposures are pesticide’s residues and ‘‘other i. The toxicity database for estimated to be 84 parts per billion substances that have a common dinotefuran is complete. (ppb) for surface water and 154 ppb for mechanism of toxicity.’’ ii. The neurotoxic potential of ground water, and for chronic exposures dinotefuran has been adequately EPA has not found dinotefuran to for non-cancer assessments are considered. Dinotefuran is a share a common mechanism of toxicity estimated to be 19.5 ppb for surface neonicotinoid and has a neurotoxic water and 132 ppb for ground water. with any other substances, and mode of pesticidal action. Consistent Modeled estimates of drinking water dinotefuran does not appear to produce with the mode of action, changes in concentrations were directly entered a toxic metabolite produced by other motor activity were seen in repeat-dose into the dietary exposure model. For substances. For the purposes of this studies, including the subchronic acute dietary risk assessment, the water tolerance action, therefore, EPA has neurotoxicity study. Additionally, concentration value of 154 ppb was assumed that dinotefuran does not have decreased grip strength and brain used to assess the contribution to a common mechanism of toxicity with weight were observed in the offspring of drinking water. For chronic dietary risk other substances. For information a multi-generation reproduction study assessment, the water concentration of regarding EPA’s efforts to determine albeit at doses close to the limit dose. value 132 ppb was used to assess the which chemicals have a common For these reasons, a developmental contribution to drinking water. mechanism of toxicity and to evaluate neurotoxicity (DNT) study was required. 3. From non-dietary exposure. The the cumulative effects of such The DNT study did not show evidence term ‘‘residential exposure’’ is used in chemicals, see EPA’s website at http:// of a unique sensitivity of the developing this document to refer to non- www.epa.gov/pesticides/cumulative. nervous system; no effects on

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neurobehavioral parameters were seen residential exposure, and the Agency population, or to infants and children in the offspring at any dose, including has determined that it is appropriate to from aggregate exposure to dinotefuran the limit dose. aggregate chronic exposure through food residues. iii. As discussed in Unit III.D.2., there and water with short-term residential IV. Other Considerations is no evidence that dinotefuran results exposures to dinotefuran. in increased susceptibility in in utero Using the exposure assumptions A. Analytical Enforcement Methodology rats or rabbits in the prenatal described in this unit for short-term Adequate enforcement methodology, developmental studies or in young rats exposures, EPA has concluded the a high-performance liquid in the 2-generation reproduction study. combined food, water, and short-term chromatography/tandem mass iv. There are no residual uncertainties residential exposures result in aggregate spectrometry (HPLC/MS/MS) method identified in the exposure databases. MOEs of 740. Because EPA’s level of for the determination of residues of The dietary food exposure assessments concern for dinotefuran is a MOE of 100 dinotefuran, and the metabolites DN were performed based on 100 PCT and or below, these MOEs are not of and UF; an HPLC/ultraviolet (UV) tolerance-level residues, corrected for concern. detection method for the determination 4. Intermediate- and long-term risk. additional residues which are of of residues of dinotefuran; and HPLC/ Intermediate- and long-term aggregate concern for the risk assessment only. MS and HPLC/MS/MS methods for the exposure takes into account EPA made conservative (protective) determination of DN and UF) is intermediate- and long-term residential assumptions in the ground and surface available to enforce the tolerance exposure plus chronic exposure to food water modeling used to assess exposure expression. to dinotefuran in drinking water. EPA and water (considered to be a The method may be requested from: used similarly conservative assumptions background exposure level). Chief, Analytical Chemistry Branch, Dinotefuran is currently registered for to assess post-application exposure of Environmental Science Center, 701 uses that could result in intermediate- children. These assessments will not Mapes Rd., Ft. Meade, MD 20755–5350; term residential exposure, and the underestimate the exposure and risks telephone number: (410) 305–2905; Agency has determined that it is posed by dinotefuran. email address: residuemethods@ appropriate to aggregate chronic epa.gov. E. Aggregate Risks and Determination of exposure through food and water with Safety intermediate- and long-term residential B. International Residue Limits EPA determines whether acute and exposures to dinotefuran. In making its tolerance decisions, EPA chronic dietary pesticide exposures are Using the exposure assumptions seeks to harmonize U.S. tolerances with safe by comparing aggregate exposure described in this unit for intermediate- international standards whenever estimates to the acute PAD (aPAD) and and long-term exposures, EPA has possible, consistent with U.S. food chronic PAD (cPAD). For linear cancer concluded that the combined food, safety standards and agricultural risks, EPA calculates the lifetime water, and intermediate- and long-term practices. EPA considers the probability of acquiring cancer given the residential exposures result in an international maximum residue limits estimated aggregate exposure. Short-, aggregate MOE of 1,400 for children 1 to (MRLs) established by the Codex intermediate-, and chronic-term risks < 2 years old from background dietary Alimentarius Commission (Codex), as are evaluated by comparing the exposures and post-application hand-to- required by FFDCA section 408(b)(4). estimated aggregate food, water, and mouth exposures from pet spot-on The Codex Alimentarius is a joint residential exposure to the appropriate applications to small dogs. Although United Nations Food and Agriculture PODs to ensure that an adequate MOE adults are expected to also have long- Organization/World Health exists. term post-application exposures to Organization food standards program, 1. Acute risk. Using the exposure dinotefuran due to the pet spot-on and it is recognized as an international assumptions discussed in this unit for treatments, quantitative dermal and food safety standards-setting acute exposure, the acute dietary inhalation assessments are not required organization in trade agreements to exposure from food and water to since there was no dermal and which the United States is a party. EPA dinotefuran will occupy 10% of the inhalation hazard identified in the may establish a tolerance that is aPAD for children 1–2 years old, the toxicity database and oral exposure is different from a Codex MRL; however, population group receiving the greatest not anticipated for adults. Therefore, the FFDCA section 408(b)(4) requires that exposure. intermediate- and chronic/long-term EPA explain the reasons for departing 2. Chronic risk. Using the exposure aggregate assessment for adults is from the Codex level. assumptions described in this unit for equivalent to the chronic dietary The Codex has not established an chronic exposure, EPA has concluded exposure and risk assessment for the MRL for residues of dinotefuran on that chronic exposure to dinotefuran most highly exposed adult population persimmons. from food and water will utilize 4.8% of subgroup, adults 20–49 years old, and is the cPAD for children 1–2 years old, the not of concern. Because EPA’s level of V. Conclusion population group receiving the greatest concern for dinotefuran is a MOE of 100 Therefore, tolerances are established exposure. Based on the explanation in or below, these MOEs are not of for residues of dinotefuran, N-methyl- Unit III.C.3., regarding residential use concern. N ′-nitro-N ″-[(tetrahydro-3- patterns, chronic residential exposure to 5. Aggregate cancer risk for U.S. furanyl)methyl)] guanidine and residues of dinotefuran is expected. population. Based on the lack of metabolites DN (1-methyl-3-(tetrahydro- 3. Short-term risk. Short-term evidence of carcinogenicity in two 3-furmethyl)guanidine) and UF (1- aggregate exposure takes into account adequate rodent carcinogenicity studies, methyl-3-(tetrahydro-3-furmethyl)-urea), short-term residential exposure plus dinotefuran is not expected to pose a in or on persimmon at 2 ppm. chronic exposure to food and water cancer risk to humans. (considered to be a background 6. Determination of safety. Based on VI. Statutory and Executive Order exposure level). these risk assessments, EPA concludes Reviews Dinotefuran is currently registered for that there is a reasonable certainty that This action establishes tolerances uses that could result in short-term no harm will result to the general under FFDCA section 408(d) in

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response to a petition submitted to the Mandates Reform Act (UMRA) (2 U.S.C. ENVIRONMENTAL PROTECTION Agency. The Office of Management and 1501 et seq.). AGENCY Budget (OMB) has exempted these types This action does not involve any 40 CFR Part 300 of actions from review under Executive technical standards that would require Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary [EPA–HQ–SFUND–1999–0010; FRL–9999– Planning and Review’’ (58 FR 51735, consensus standards pursuant to section 76–Region 8] October 4, 1993). Because this action 12(d) of the National Technology has been exempted from review under National Oil and Hazardous Executive Order 12866, this action is Transfer and Advancement Act Substances Pollution Contingency not subject to Executive Order 13211, (NTTAA) (15 U.S.C. 272 note). Plan; National Priorities List: Partial entitled ‘‘Actions Concerning VII. Congressional Review Act Deletion of the Vasquez Boulevard and Regulations That Significantly Affect I–70 Superfund Site Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review AGENCY: Environmental Protection Act (5 U.S.C. 801 et seq.), EPA will FR 28355, May 22, 2001); Executive Agency (EPA). Order 13045, entitled ‘‘Protection of submit a report containing this rule and ACTION: Final rule. Children from Environmental Health other required information to the U.S. Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of SUMMARY: The Environmental Protection April 23, 1997); or Executive Order Representatives, and the Comptroller Agency (EPA) Region 8 announces the 13771, entitled ‘‘Reducing Regulations General of the United States prior to deletion of the operable unit 1 (OU1) of and Controlling Regulatory Costs’’ (82 publication of the rule in the Federal the Vasquez Boulevard and I–70 FR 9339, February 3, 2017). This action Register. This action is not a ‘‘major Superfund Site (Site) located in the City does not contain any information rule’’ as defined by 5 U.S.C. 804(2). and County of Denver, CO, from the collections subject to OMB approval National Priorities List (NPL). The NPL, under the Paperwork Reduction Act List of Subjects in 40 CFR Part 180 promulgated pursuant to section 105 of (PRA) (44 U.S.C. 3501 et seq.), nor does Environmental protection, the Comprehensive Environmental it require any special considerations Response, Compensation, and Liability Administrative practice and procedure, under Executive Order 12898, entitled Act (CERCLA) of 1980, as amended, is ‘‘Federal Actions to Address Agricultural commodities, Pesticides an appendix of the National Oil and Environmental Justice in Minority and pests, Reporting and recordkeeping Hazardous Substances Pollution Populations and Low-Income requirements. Contingency Plan (NCP). This partial Populations’’ (59 FR 7629, February 16, Dated: August 8, 2019. deletion pertains only to OU1, the 1994). Michael Goodis, residential portion of the Site. The operable unit 2 (OU2) and operable unit Since tolerances and exemptions that Director, Registration Division, Office of are established on the basis of a petition Pesticide Programs. 3 (OU3) will remain on the NPL and are under FFDCA section 408(d), such as not being considered for deletion as part the tolerance in this final rule, do not Therefore, 40 CFR chapter I is of this action. The EPA and the State of require the issuance of a proposed rule, amended as follows: Colorado, through the Colorado the requirements of the Regulatory Department of Public Health and Flexibility Act (RFA) (5 U.S.C. 601 et PART 180—[AMENDED] Environment (CDPHE), have determined seq.), do not apply. that all appropriate response actions ■ This action directly regulates growers, 1. The authority citation for part 180 under CERCLA, other than operation food processors, food handlers, and food continues to read as follows: and maintenance, monitoring and five- retailers, not States or tribes, nor does Authority: 21 U.S.C. 321(q), 346a and 371. year reviews, have been completed. this action alter the relationships or However, the deletion of these parcels distribution of power and ■ 2. In § 180.603, add alphabetically the does not preclude future actions under responsibilities established by Congress entry ‘‘Persimmon’’ to the table in Superfund. in the preemption provisions of FFDCA paragraph (a)(1) to read as follows: DATES: This action is effective section 408(n)(4). As such, the Agency September 20, 2019. § 180.603 Dinotefuran; tolerances for has determined that this action will not ADDRESSES: EPA has established a residues. have a substantial direct effect on States docket for this action under Docket or tribal governments, on the (a) * * * Identification No. EPA–HQ–SFUND– relationship between the national 1999–0010. All documents in the docket government and the States or tribal Commodity Parts per are listed on the http:// governments, or on the distribution of million www.regulations.gov website. Although power and responsibilities among the listed in the index, some information is various levels of government or between not publicly available, I.e., Confidential the Federal Government and Indian ***** Business Information or other Persimmon 1 ...... 2 tribes. Thus, the Agency has determined information whose disclosure is that Executive Order 13132, entitled restricted by statute. Certain other ***** ‘‘Federalism’’ (64 FR 43255, August 10, material, such as copyrighted material, 1999) and Executive Order 13175, 1 There are no U.S. registrations for use of is not placed on the internet and will be entitled ‘‘Consultation and Coordination dinotefuran on this commodity. publicly available only in hard copy with Indian Tribal Governments’’ (65 FR * * * * * form. Publicly available docket 67249, November 9, 2000) do not apply [FR Doc. 2019–18015 Filed 9–19–19; 8:45 am] materials are available electronically to this action. In addition, this action through http://www.regulations.gov or BILLING CODE 6560–50–P does not impose any enforceable duty or in hard copy at the site information contain any unfunded mandate as repositories. Locations, contacts, phone described under Title II of the Unfunded numbers and viewing hours are: U.S.

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