Isotianil; Pesticide Tolerances, 58623-58627 [2019-23385]

Download as PDF Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Rules and Regulations 58623 TABLE 7 TO SUBPART KKKKK OF PART 63—CONTINUOUS COMPLIANCE WITH EMISSION LIMITATIONS AND WORK PRACTICE STANDARDS—Continued As stated in § 63.8620, you must demonstrate continuous compliance with each emission limitation and work practice standard that applies to you according to the following table: For each . . . For the following . . . You must demonstrate continuous compliance by . . . Or by . . . vii. Developing and maintaining records for each sanitaryware shuttle kiln, as specified in § 63.8640. telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: [FR Doc. 2019–22812 Filed 10–31–19; 8:45 am] BILLING CODE 6560–50–P I. General Information ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2018–0047; FRL–10000–79] Isotianil; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes a tolerance for residues of isotianil in or on banana. Bayer CropScience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective November 1, 2019. Objections and requests for hearings must be received on or before December 31, 2019, 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–2018–0047, 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 is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main SUMMARY: VerDate Sep<11>2014 16:01 Oct 31, 2019 Jkt 250001 A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Publishing Office’s eCFR site at https://www.ecfr.gov/cgi-bin/ text-idx?&c=ecfr&tpl=/ecfrbrowse/ Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https://www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2018–0047 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 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 before December 31, 2019. 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– 2018–0047, 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/contacts.html. 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 April 11, 2018 (83 FR 15528) (FRL–9975–57), 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 7E8656) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the fungicide isotianil in or on banana at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by E:\FR\FM\01NOR1.SGM 01NOR1 58624 Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Rules and Regulations Bayer CropScience, the registrant, which is available in the docket, https:// www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has recommended the tolerance be set at 0.02 ppm in or on banana. The reason for this change is explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .’’ Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for isotianil including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with isotianil follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Subchronic and chronic studies indicate that the liver is the primary VerDate Sep<11>2014 16:01 Oct 31, 2019 Jkt 250001 target organ for isotianil in all species except for rats, in which the primary target organ for isotianil was the forestomach. Liver effects include organ weight increases, histopathology alterations, and associated enzyme and cholesterol increases. Hyperplasia was observed in the forestomach of rats in longer duration studies. Kidney effects, seen in dogs and rats, included chronic nephropathy and organ weight increases with longer exposure durations. Altered hematological profiles and spleen weight changes were also seen near the limit dose in longer duration studies of dogs and rats. Skin effects/hair loss were seen at high doses, but either occurred above the lowest-observedadverse-effect-level (LOAEL) or were considered not adverse. Lung bronchiolization of the alveolar wall was observed in the longer duration dietary rat studies. No evidence of neurotoxicity was observed in the isotianil guideline studies. The database does not include any guideline neurotoxicity studies but limited functional observational battery and motor activity-related measurements were incorporated in the design of the available subchronic and chronic rat and dog guideline studies. No signs of neurotoxicity were noted at any dose in the database. Evidence of quantitative susceptibility was observed in the developmental rabbit and two-generation rat reproductive toxicity studies. The 2generation reproductive toxicity study in rats showed no parental or reproductive effects up to the highest dose tested; however, both generations of offspring exhibited decreased body weight in both sexes. Decreased fetal weights were observed in the absence of maternal toxicity in the developmental rabbit study. The immunotoxicity study was waived based on the available hazard and exposure data. There was a slight increase in liver tumors in male mice at the highest dose tested, but the rat carcinogenicity study did not show an increased incidence of tumors in either sex. Studies showed no evidence of mutagenicity or genotoxicity. Therefore, isotianil is classified as ‘‘not likely to be carcinogenic to humans.’’ Additional studies were available for the select metabolites of isotianil, DCITacid and anthranilonitrile. In a subchronic rat oral toxicity study, DCITacid showed no evidence of toxic effects up to 349 mg/kg and DCIT-acid was not mutagenic with or without metabolic PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 activation. A developmental study with DCIT-acid noted toxicity in both the maternal (mortality, clinical signs) and fetal (decreased fetal weight) groups at 250 mg/kg, with a no-observed-adverseeffect-level (NOAEL) of 50 mg/kg. Anthranilonitrile was not mutagenic with or without metabolic activation. Specific information on the studies received and the nature of the adverse effects caused by isotianil as well as the NOAEL and the LOAEL from the toxicity studies can be found at https:// www.regulations.gov in document ‘‘Isotianil. Human Health Risk Assessment of the Proposed Tolerance for Residues on Imported Bananas without a U.S. Registration’’ on pages 21–25 in docket ID number EPA–HQ– OPP–2018–0047. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of the reference value for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A summary of the toxicological endpoint for isotianil used for human risk assessment is shown in Table 1 of this unit. E:\FR\FM\01NOR1.SGM 01NOR1 Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Rules and Regulations 58625 TABLE 1—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINT FOR ISOTIANIL FOR USE IN HUMAN HEALTH RISK ASSESSMENT Point of departure and uncertainty/safety factors Exposure/scenario PAD for risk assessment Acute dietary (General population, including females 13 to 49 years of age). Chronic dietary (All populations) ........ Study and toxicological effects An appropriate endpoint was not identified for acute exposure. NOAEL = 27 mg/kg/day UFA = 10× UFH = 10× FQPA SF = 1× cPAD = 0.27 mg/kg/day Cancer (Oral, dermal, inhalation) ...... Chronic Dog LOAEL = 107/110 (M/F) mg/kg/day based on clinical chemistry, hematology, liver weight and histopathology, spleen weight and appearance, increased hematopoiesis, and kidney weight and histopathology. Classification: ‘‘Not Likely to be Carcinogenic to Humans.’’ FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. NOAEL = no-observedadverse-effect-level. PAD = population adjusted dose (c = chronic). UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isotianil, EPA considered exposure under the petitioned-for tolerance. EPA assessed the dietary exposure to isotianil in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for isotianil; therefore, a quantitative acute dietary exposure assessment was unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM–FCID) Version 3.16, which uses food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, ‘‘What We Eat in America’’ (NHANES/WWEIA) from 2003 through 2008. As to residue levels in food, EPA used the tolerance value for parent isotianil (0.02 ppm) plus the maximum observed residue value of the DCIT-acid metabolite from the magnitude of the residue study. The maximum DCIT-acid residue observed in the magnitude of the residue study was <0.010 ppm, so the total isotianil residue estimate used in the chronic assessment was 0.030 ppm. It is EPA’s typical practice to include plantains in dietary assessments that include bananas, so EPA used the banana residue data to estimate a value for residues of isotianil in/on plantains. The chronic assessment made use of EPA’s 2018 default processing factor for dried bananas and dried plantains (processing factor of 4.8x). HED VerDate Sep<11>2014 16:01 Oct 31, 2019 Jkt 250001 assumed 100% crop treated (PCT) for all commodities in the chronic assessment. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that isotianil does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk was unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for isotianil. Tolerance level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. Isotianil is not registered for use in the U.S. Therefore, residues are not expected in groundwater or surface water sources of drinking water, and no exposure to isotianil through drinking water is anticipated. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Isotianil is not currently registered for any uses that could result in residential exposures. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found isotianil to share a common mechanism of toxicity with any other substances, and isotianil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 isotianil does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at https:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10x) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10x, or uses a different safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Quantitative susceptibility was observed in the 2-generation rat reproductive toxicity study in rats and in the developmental rabbit study. In the rat reproduction study, decreased pup body weights were observed in the absence of parental toxicity. The developmental rabbit study noted decreased fetal weights in the absence of maternal effects at the highest dose tested (1,000 mg/kg/day). Although susceptibility was observed, clear NOAELs were observed and the doses selected for risk assessment are protective of the observed susceptibility; therefore, there are no residual uncertainties with respect to pre- or postnatal toxicity. 3. Conclusion. EPA has determined that reliable data show the safety of E:\FR\FM\01NOR1.SGM 01NOR1 58626 Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Rules and Regulations infants and children would be adequately protected if the FQPA SF were reduced to 1x. That decision is based on the following findings: i. The toxicity database for isotianil is complete. ii. There is no indication that isotianil is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There was evidence of quantitative susceptibility in the database, observed in the rabbit developmental toxicity study and the rat reproductive toxicity study; however, the degree of concern is low because clear NOAELs were identified, and the endpoint selected for risk assessment is protective of the observed susceptibility. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. These assessments will not underestimate the exposure and risks posed by isotianil. E. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. There are no residential uses for isotianil, and therefore aggregate exposure and risk estimates are equivalent to dietary exposure and risk estimates, which are not of concern. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, isotianil is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isotianil from food is not of concern for the general U.S. population and all population subgroups. The population subgroup that received the greatest exposure estimate was the children 1 to 2 years old subgroup, which utilized <1% of the cPAD. There are no residential uses for VerDate Sep<11>2014 16:01 Oct 31, 2019 Jkt 250001 isotianil, so aggregate risk is equivalent to dietary risk, and is not of concern. 3. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, isotianil is not expected to pose a cancer risk to humans. 4. Determination of safety. Based on this risk assessment, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to isotianil residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Method 01390, a high-performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS method) is adequate to measure residues of isotianil in/on plant matrices. Method 01390 has a limit of quantification (LOQ) of 0.01 ppm for isotianil. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@ epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established an MRL for isotianil. C. Revisions to Petitioned-For Tolerances The petitioner’s requested tolerance of 0.01 ppm for residues of isotianil in/on banana is based on magnitude of the residue data collected for bagged bananas. EPA standard practice is to use PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 unbagged banana residue data for tolerance establishment. Based on magnitude of the residue data collected for unbagged bananas and the Organization for Economic Development and Cooperation (OECD) tolerance calculation procedure, EPA is establishing a tolerance of 0.02 ppm for residues of isotianil in or on banana. V. Conclusion Therefore, tolerances are established for residues of isotianil in or on banana at 0.02 ppm. VI. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not E:\FR\FM\01NOR1.SGM 01NOR1 Federal Register / Vol. 84, No. 212 / Friday, November 1, 2019 / Rules and Regulations have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: October 10, 2019. Daniel Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Add § 180.708 to subpart C to read as follows: ■ § 180.708 Isotianil; tolerances for residues. (a) General. Tolerances are established for residues of isotianil, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the VerDate Sep<11>2014 16:01 Oct 31, 2019 Jkt 250001 tolerance level specified in the table in this paragraph (a) is to be determined by measuring only isotianil (3,4-dichloroN-(2-cyanophenyl)-5isothiazolecarboxamide) in or on the commodity. Commodity Parts per million Banana 1 ......................... 0.02 1 There are no U.S. registrations for bananas as of November 1, 2019. (b) [Reserved] [FR Doc. 2019–23385 Filed 10–31–19; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL SERVICES AGENCY 40 CFR Part 282 [EPA–R01–UST–2019–0421; FRL–10001– 60–Region 1] New Hampshire: Final Approval of State Underground Storage Tank Program Revisions, Codification, and Incorporation by Reference Environmental Services Agency (EPA). ACTION: Direct final rule. AGENCY: Pursuant to the Resource Conservation and Recovery Act (RCRA or Act), the Environmental Services Agency (EPA) is taking direct final action to approve revisions to the State of New Hampshire’s Underground Storage Tank (UST) program submitted by the New Hampshire Department of Environmental Services (NH DES). This action also codifies EPA’s approval of New Hampshire’s State program and incorporates by reference those provisions of the State regulations that we have determined meet the requirements for approval. The provisions will be subject to EPA’s inspection and enforcement authorities under sections 9005 and 9006 of RCRA Subtitle I and other applicable statutory and regulatory provisions. DATES: This rule is effective December 31, 2019, unless EPA receives adverse comment by December 2, 2019. If EPA receives adverse comments, it will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register, as of December 31, 2019, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. ADDRESSES: Submit your comments by one of the following methods: SUMMARY: PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 58627 1. Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. 2. Email: hanamoto.susan@epa.gov. 3. Mail: Susan Hanamoto, RCRA Waste Management, UST, and Pesticides Section; Land, Chemicals, and Redevelopment Division; EPA Region 1, 5 Post Office Square, Suite 100, (Mail Code 07–1), Boston, MA 02109–3912. 4. Hand Delivery or Courier: Deliver your comments to Susan Hanamoto, RCRA Waste Management, UST, and Pesticides Section; Land, Chemicals, and Redevelopment Division; EPA Region 1, 5 Post Office Square, Suite 100, (Mail Code 07–1), Boston, MA 02109–3912. Such deliveries are only accepted during the Regional Office’s normal hours of operation. Instructions: Direct your comments to Docket ID No. EPA–R01–UST–2019– 0421. EPA’s policy is that all comments received will be included in the public docket without change and may be available online at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through https:// www.regulations.gov, or email. The Federal website, https:// www.regulations.gov, is an ‘‘anonymous access’’ system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https:// www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and also with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties, and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the https:// www.regulations.gov index. Although listed in the index, some information might not be publicly available, e.g., CBI or other information whose disclosure is E:\FR\FM\01NOR1.SGM 01NOR1

Agencies

[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Rules and Regulations]
[Pages 58623-58627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23385]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0047; FRL-10000-79]


Isotianil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
isotianil in or on banana. Bayer CropScience requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 1, 2019. Objections and 
requests for hearings must be received on or before December 31, 2019, 
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-2018-0047, 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2018-0047 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 
December 31, 2019. 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-2018-0047, 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/contacts.html. 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 April 11, 2018 (83 FR 15528) (FRL-9975-
57), 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 
7E8656) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle 
Park, NC 27709. The petition requested that 40 CFR part 180 be amended 
by establishing a tolerance for residues of the fungicide isotianil in 
or on banana at 0.01 parts per million (ppm). That document referenced 
a summary of the petition prepared by

[[Page 58624]]

Bayer CropScience, the registrant, which is available in the docket, 
https://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
recommended the tolerance be set at 0.02 ppm in or on banana. The 
reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for isotianil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with isotianil follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Subchronic and chronic studies indicate that the liver is the 
primary target organ for isotianil in all species except for rats, in 
which the primary target organ for isotianil was the forestomach. Liver 
effects include organ weight increases, histopathology alterations, and 
associated enzyme and cholesterol increases. Hyperplasia was observed 
in the forestomach of rats in longer duration studies. Kidney effects, 
seen in dogs and rats, included chronic nephropathy and organ weight 
increases with longer exposure durations. Altered hematological 
profiles and spleen weight changes were also seen near the limit dose 
in longer duration studies of dogs and rats. Skin effects/hair loss 
were seen at high doses, but either occurred above the lowest-observed-
adverse-effect-level (LOAEL) or were considered not adverse. Lung 
bronchiolization of the alveolar wall was observed in the longer 
duration dietary rat studies.
    No evidence of neurotoxicity was observed in the isotianil 
guideline studies. The database does not include any guideline 
neurotoxicity studies but limited functional observational battery and 
motor activity-related measurements were incorporated in the design of 
the available subchronic and chronic rat and dog guideline studies. No 
signs of neurotoxicity were noted at any dose in the database.
    Evidence of quantitative susceptibility was observed in the 
developmental rabbit and two-generation rat reproductive toxicity 
studies. The 2-generation reproductive toxicity study in rats showed no 
parental or reproductive effects up to the highest dose tested; 
however, both generations of offspring exhibited decreased body weight 
in both sexes. Decreased fetal weights were observed in the absence of 
maternal toxicity in the developmental rabbit study. The immunotoxicity 
study was waived based on the available hazard and exposure data.
    There was a slight increase in liver tumors in male mice at the 
highest dose tested, but the rat carcinogenicity study did not show an 
increased incidence of tumors in either sex. Studies showed no evidence 
of mutagenicity or genotoxicity. Therefore, isotianil is classified as 
``not likely to be carcinogenic to humans.''
    Additional studies were available for the select metabolites of 
isotianil, DCIT-acid and anthranilonitrile. In a subchronic rat oral 
toxicity study, DCIT-acid showed no evidence of toxic effects up to 349 
mg/kg and DCIT-acid was not mutagenic with or without metabolic 
activation. A developmental study with DCIT-acid noted toxicity in both 
the maternal (mortality, clinical signs) and fetal (decreased fetal 
weight) groups at 250 mg/kg, with a no-observed-adverse-effect-level 
(NOAEL) of 50 mg/kg. Anthranilonitrile was not mutagenic with or 
without metabolic activation.
    Specific information on the studies received and the nature of the 
adverse effects caused by isotianil as well as the NOAEL and the LOAEL 
from the toxicity studies can be found at https://www.regulations.gov in 
document ``Isotianil. Human Health Risk Assessment of the Proposed 
Tolerance for Residues on Imported Bananas without a U.S. 
Registration'' on pages 21-25 in docket ID number EPA-HQ-OPP-2018-0047.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of the reference value for risk assessment. PODs are 
developed based on a careful analysis of the doses in each 
toxicological study to determine the dose at which no adverse effects 
are observed (the NOAEL) and the lowest dose at which adverse effects 
of concern are identified (the LOAEL). Uncertainty/safety factors are 
used in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a 
reference dose (RfD)--and a safe margin of exposure (MOE). For non-
threshold risks, the Agency assumes that any amount of exposure will 
lead to some degree of risk. Thus, the Agency estimates risk in terms 
of the probability of an occurrence of the adverse effect expected in a 
lifetime. For more information on the general principles EPA uses in 
risk characterization and a complete description of the risk assessment 
process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoint for isotianil used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 58625]]



    Table 1--Summary of Toxicological Dose and Endpoint for Isotianil for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/        PAD for risk       Study and toxicological effects
                                      safety factors          assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General                     An appropriate endpoint was not identified for acute exposure.
 population, including females 13
 to 49 years of age).
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 27 mg/kg/day  cPAD = 0.27 mg/kg/   Chronic Dog LOAEL = 107/110 (M/F)
                                   UFA = 10x...........   day.                 mg/kg/day based on clinical
                                   UFH = 10x...........                        chemistry, hematology, liver
                                   FQPA SF = 1x........                        weight and histopathology, spleen
                                                                               weight and appearance, increased
                                                                               hematopoiesis, and kidney weight
                                                                               and histopathology.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)           Classification: ``Not Likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (c =
  chronic). UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isotianil, EPA considered exposure under the petitioned-for 
tolerance. EPA assessed the dietary exposure to isotianil in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for isotianil; therefore, a 
quantitative acute dietary exposure assessment was unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEM-FCID) Version 3.16, which 
uses food consumption data from the U.S. Department of Agriculture's 
(USDA's) National Health and Nutrition Examination Survey, ``What We 
Eat in America'' (NHANES/WWEIA) from 2003 through 2008. As to residue 
levels in food, EPA used the tolerance value for parent isotianil (0.02 
ppm) plus the maximum observed residue value of the DCIT-acid 
metabolite from the magnitude of the residue study. The maximum DCIT-
acid residue observed in the magnitude of the residue study was <0.010 
ppm, so the total isotianil residue estimate used in the chronic 
assessment was 0.030 ppm. It is EPA's typical practice to include 
plantains in dietary assessments that include bananas, so EPA used the 
banana residue data to estimate a value for residues of isotianil in/on 
plantains. The chronic assessment made use of EPA's 2018 default 
processing factor for dried bananas and dried plantains (processing 
factor of 4.8x). HED assumed 100% crop treated (PCT) for all 
commodities in the chronic assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that isotianil does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk was unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
isotianil. Tolerance level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. Isotianil is not 
registered for use in the U.S. Therefore, residues are not expected in 
groundwater or surface water sources of drinking water, and no exposure 
to isotianil through drinking water is anticipated.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Isotianil is not currently registered for any uses that could 
result in residential exposures.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found isotianil to share a common mechanism of toxicity 
with any other substances, and isotianil does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that isotianil does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure, unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10x, or uses a different safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Quantitative susceptibility 
was observed in the 2-generation rat reproductive toxicity study in 
rats and in the developmental rabbit study. In the rat reproduction 
study, decreased pup body weights were observed in the absence of 
parental toxicity. The developmental rabbit study noted decreased fetal 
weights in the absence of maternal effects at the highest dose tested 
(1,000 mg/kg/day). Although susceptibility was observed, clear NOAELs 
were observed and the doses selected for risk assessment are protective 
of the observed susceptibility; therefore, there are no residual 
uncertainties with respect to pre- or postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of

[[Page 58626]]

infants and children would be adequately protected if the FQPA SF were 
reduced to 1x. That decision is based on the following findings:
    i. The toxicity database for isotianil is complete.
    ii. There is no indication that isotianil is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There was evidence of quantitative susceptibility in the 
database, observed in the rabbit developmental toxicity study and the 
rat reproductive toxicity study; however, the degree of concern is low 
because clear NOAELs were identified, and the endpoint selected for 
risk assessment is protective of the observed susceptibility.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. These assessments will not 
underestimate the exposure and risks posed by isotianil.

E. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    There are no residential uses for isotianil, and therefore 
aggregate exposure and risk estimates are equivalent to dietary 
exposure and risk estimates, which are not of concern.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
isotianil is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
isotianil from food is not of concern for the general U.S. population 
and all population subgroups. The population subgroup that received the 
greatest exposure estimate was the children 1 to 2 years old subgroup, 
which utilized <1% of the cPAD. There are no residential uses for 
isotianil, so aggregate risk is equivalent to dietary risk, and is not 
of concern.
    3. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, isotianil is not expected to pose a cancer risk to humans.
    4. Determination of safety. Based on this risk assessment, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to isotianil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method 01390, a high-performance 
liquid chromatography with tandem mass spectrometry (HPLC-MS/MS method) 
is adequate to measure residues of isotianil in/on plant matrices. 
Method 01390 has a limit of quantification (LOQ) of 0.01 ppm for 
isotianil.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established an MRL for isotianil.

C. Revisions to Petitioned-For Tolerances

    The petitioner's requested tolerance of 0.01 ppm for residues of 
isotianil in/on banana is based on magnitude of the residue data 
collected for bagged bananas. EPA standard practice is to use unbagged 
banana residue data for tolerance establishment. Based on magnitude of 
the residue data collected for unbagged bananas and the Organization 
for Economic Development and Cooperation (OECD) tolerance calculation 
procedure, EPA is establishing a tolerance of 0.02 ppm for residues of 
isotianil in or on banana.

V. Conclusion

    Therefore, tolerances are established for residues of isotianil in 
or on banana at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not

[[Page 58627]]

have a substantial direct effect on States or tribal governments, on 
the relationship between the national government and the States or 
tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, 
August 10, 1999) and Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000) do not apply to this action. In addition, this action does not 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 10, 2019.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Add Sec.  180.708 to subpart C to read as follows:


Sec.  180.708  Isotianil; tolerances for residues.

    (a) General. Tolerances are established for residues of isotianil, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance level specified in the 
table in this paragraph (a) is to be determined by measuring only 
isotianil (3,4-dichloro-N-(2-cyanophenyl)-5-isothiazolecarboxamide) in 
or on the commodity.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Banana \1\...........................................               0.02
------------------------------------------------------------------------
\1\ There are no U.S. registrations for bananas as of November 1, 2019.

    (b) [Reserved]

[FR Doc. 2019-23385 Filed 10-31-19; 8:45 am]
BILLING CODE 6560-50-P
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