Isopyrazam; Pesticide Tolerances, 24071-24076 [2017-10765]

Download as PDF Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 1, 2017. Michael Goodis, 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: ■ VerDate Sep<11>2014 15:57 May 24, 2017 Jkt 241001 Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.632, amend the table in paragraph (a) as follows: ■ a. Remove the entry for ‘‘Almond’’. ■ b. Add alphabetically the entries for ‘‘hop, dried cones’’; ‘‘nuts, tree, group 14–12’’; ‘‘pineapple’’; and ‘‘tea, dried’’. ■ c. Add a footnote at the end of the table. The additions read as follows: ■ § 180.632 Fenazaquin; Tolerances for residues. (a) * * * Parts per million Commodity * * * * Hop, dried cones .......................... * 30.0 * * * * Pineapple 1 .................................... Nuts, Tree, Group 14–12 ............. Tea, dried 1 ................................... * 0.20 0.02 9.0 1 There are no U.S. registrations as of May 25, 2017 for use on pineapple and tea. * * * * * [FR Doc. 2017–10751 Filed 5–24–17; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2016–0143; FRL–9960–76] Isopyrazam; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of isopyrazam in or on pepper, bell; tomato; and vegetable, cucurbit, subgroup 9A. Syngenta Crop Protection, LLC, requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: This regulation is effective May 25, 2017. Objections and requests for hearings must be received on or before July 24, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2016–0143, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency ADDRESSES: PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 24071 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 http://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: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2016–0143 in the subject line on the first page of your submission. All E:\FR\FM\25MYR1.SGM 25MYR1 24072 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before July 24, 2017. 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– 2016–0143, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http:// www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of August 29, 2016 (81 FR 59165) (FRL–9950–22), 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 5E8433) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.654 be amended by establishing tolerances for residues of the fungicide isopyrazam, in or on cucurbit crop subgroup 9A at 0.3 parts per million (ppm); pepper, bell at 0.6 ppm; and tomato at 0.5 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http:// 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 is VerDate Sep<11>2014 15:57 May 24, 2017 Jkt 241001 establishing a lower tolerance than was requested for pepper, bell and is revising the commodity terminology for vegetable, cucurbit, subgroup 9A. The reasons for these changes are explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .’’ Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for isopyrazam including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with isopyrazam 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 oral toxicity studies in the rat, mouse, rabbit and dog demonstrate that the primary target organ for isopyrazam is the liver (increased organ weight and centrilobular hepatocyte hypertrophy). Liver toxicity is usually accompanied by reductions in bodyweight and food consumption. Isopyrazam did not cause reproductive toxicity. Effects seen in the PO 00000 Frm 00074 Fmt 4700 Sfmt 4700 offspring (decreased bodyweight during lactation and increase liver weight at weaning) in the rat reproduction study occurred at the same doses that cause general toxicity in the parents. Developmental effects described as small eyes and/or microphthalmia were observed in both the Himalayan and New Zealand rabbit strains. However, in the Himalayan strain, the intraocular abnormalities occur in the absence of maternal toxicity while in the New Zealand strain, the ocular abnormalities occurred at doses that were maternally toxic. Developmental effects observed in the rat (increased post-implantation loss, reduced fetal weight, and a non- or incomplete ossification or retardation of ossification) occurred at doses that also produced maternal toxicity (mortality, decreased body weights, body weight gains, and food consumption, increased liver weights and microscopic findings in the liver). No evidence of specific neurotoxicity was seen in acute and subchronic oral neurotoxicity studies in rats. Clinical signs seen in two subchronic dog studies (side-to-side head wobble, ataxia, reduced stability) are consistent with neurotoxic effects. However, detailed and specific neuropathological analyses were not conducted for the dog studies (i.e., functional observational battery, motor activity, detailed histopathology with special stains). Consequently, there is uncertainty regarding whether the effects seen in the dog studies are in fact signs of neurotoxicity. However, clear no observed adverse effect levels (NOAELs)/lowest adverse effect levels (LOAELs) were established for both subchronic dog studies. The point of departure selected for the acute dietary assessment is based on clinical signs seen on day 2 in one of four males in the subchronic dog study. This study provides the lowest NOAEL in the database (most sensitive endpoint) for a single dose effect. The dose used for the chronic dietary risk assessment is eight times lower than the dose at which clinical effects were seen at four weeks in the second subchronic dog study. There is no evidence of immunotoxicity based on a 28-day dietary immunotoxicity study in mice. The LOAEL for immunotoxicity was not identified and the NOAEL for immunotoxicity was 1,356 milligrams/ kilograms (mg/kg). Isopyrazam is classified as ‘‘Likely to be Carcinogenic to Humans’’ based on increased incidence of uterine endometrial adenocarcinomas and liver hepatocellular adenomas in female rats and increased incidence of thyroid follicular cell adenomas and/or E:\FR\FM\25MYR1.SGM 25MYR1 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations carcinomas in male rats. Isopyrazam is not carcinogenic in the mouse. There is no evidence of genotoxicity, mutagenicity, or clastogenicity in the in vivo and in vitro studies. There are no structural relationships with other known carcinogens. A linear low-dose approach (Q1*) was used to extrapolate experimental animal tumor data for the quantification of human cancer risk. Isopyrazam is of low acute toxicity by the oral, dermal, and inhalation routes and is not a skin or eye irritant. Specific information on the studies received and the nature of the adverse effects caused by isopyrazam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in document ‘‘Isopyrazam: Human Health Risk Assessment for the Establishment of Tolerances with No U.S. Registrations in/on Cucurbit Vegetables Crop Subgroup 9A, Bell Pepper and Tomato Imported from Belgium, Greece, Italy, Spain and the United Kingdom’’ in docket ID number EPA–HQ–OPP–2016– 0143. 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 reference values 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 http:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. A VerDate Sep<11>2014 15:57 May 24, 2017 Jkt 241001 summary of the toxicological endpoints for isopyrazam used for human risk assessment is discussed in Table 1 of the final rule published in the Federal Register of December 27, 2013 (78 FR 78740) (FRL–9903–53). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isopyrazam, EPA considered exposure under the petitioned-for tolerances as well as all existing isopyrazam tolerances in 40 CFR 180.654. EPA assessed dietary exposures from isopyrazam 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. Such effects were identified for isopyrazam. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, maximum residues from field trials conducted at the maximum use rates were used to estimate isopyrazam residues of concern and 100 percent crop treated (PCT) assumptions were used. Dietary Exposure Evaluation Model (DEEM) default processing factors were used for all processed commodities including dried apple (8.0), apple juice/cider (1.3), dried banana/plantain (3.9), peanut butter (1.89), dried tomato (14.3), tomato juice (1.5), tomato paste (5.4), and tomato puree (3.3). In the absence of peanut processing data, the maximum theoretical concentration factor was used for peanut oil (2.8). ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 2003–2008 NHANES/ WWEIA. As to residue levels in food, EPA used the average residues from field trials conducted at the maximum use rates were used to estimate isopyrazam and the same processing factors and PCT assumptions as in the acute dietary exposure analysis. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that isopyrazam should be classified as ‘‘Likely to be Carcinogenic to Humans’’ and a linear approach has been used to quantify cancer risk. In evaluating the cancer risk, EPA used the same residue levels, processing factors and PCT assumptions as in the chronic dietary exposure analysis. PO 00000 Frm 00075 Fmt 4700 Sfmt 4700 24073 iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use PCT information in the dietary assessment for isopyrazam. Maximum or average residue levels from field trials conducted at the maximum use rates were assumed for all food commodities. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. 2. Dietary exposure from drinking water. An assessment of residues in drinking water is not needed for isopyrazam because there is no drinking water exposure for isopyrazam uses, which are all non-domestic. 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). Isopyrazam is not registered for any specific use patterns that would result in residential exposure. 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 isopyrazam to share a common mechanism of toxicity with any other substances, and isopyrazam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that isopyrazam does not have a common mechanism of toxicity with other substances. For information regarding EPA’s procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA’s Web site at http://www2.epa.gov/ E:\FR\FM\25MYR1.SGM 25MYR1 24074 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations pesticide-science-and-assessingpesticide-risks/cumulative-assessmentrisk-pesticides. 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 additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There are no residual uncertainties for pre- and/or postnatal susceptibility even though qualitative susceptibility was observed in the range-finding developmental studies in rabbits. Developmental effects (eye abnormalities) were observed in the absence of maternal toxicity in two range finding developmental toxicity studies in the Himalayan rabbit. However, the eye effects were only observed at relatively high doses (200– 400 mg/kg/day) with clear NOAELs/ LOAELs established for the developmental effects. Developmental effects observed in the rat (increased post-implantation loss, reduced fetal weight and non-or incomplete ossification or retardation of ossification) occurred only at doses that also produced maternal toxicity (mortality, decreased body weights, body weight gains, and food consumption). There was no evidence of increased susceptibility in a 2generation reproduction study following pre- or postnatal exposure to isopyrazam. There was also no evidence of neuropathology or abnormalities in the development of the fetal nervous system from the available toxicity studies conducted with isopyrazam. Clear NOAELs/LOAELs were established for the developmental effects observed in rats and rabbits as well as for the offspring effects (increased liver weights) seen in the 2generation reproduction study and a dose-response relationship for the effects of concern is well characterized. The dose used for the acute dietary risk assessment (30 mg/kg/day), based on effects seen in the subchronic dog study, is protective of the developmental VerDate Sep<11>2014 15:57 May 24, 2017 Jkt 241001 effects seen in rats (44.5 mg/kg/day) and rabbits (200 mg/kg/day). Based on these considerations, there are no residual uncertainties for pre- and/or postnatal susceptibility. 3. Conclusion. EPA has determined that reliable data show the safety of 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 isopyrazam is complete. ii. As discussed in Unit III.A, there is no indication that isopyrazam is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. iii. As discussed in Unit III.D.2, there are no residual uncertainties for preand/or post-natal susceptibility. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and maximum or average residue levels from field trials conducted at the maximum use rates. There are no currently registered or proposed occupational or residential uses of isopyrazam in the U.S. and adequate residue data are available. These assessments will not underestimate the exposure and risks posed by isopyrazam. 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. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to isopyrazam at the 95th percentile will occupy 4.7% of the aPAD for children 1–2 years old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isopyrazam from food will utilize 5.0% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. There are no residential uses for isopyrazam. PO 00000 Frm 00076 Fmt 4700 Sfmt 4700 3. Short- and intermediate-term risk. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure (which includes both food and water and is considered to be a background exposure level). Isopyrazam is not registered in the United States. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for isopyrazam. 4. Aggregate cancer risk for U.S. population. Using the exposure assumptions discussed in this unit for cancer exposure, the cancer dietary risk estimate for the U.S. population is 3 × 10¥6. EPA generally considers cancer risks (expressed as the probability of an increased cancer case) in the range of 1 in 1 million (or 1 × 10¥6) or less to be negligible. The precision that can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the logarithmic scale; for example, risks falling between 3 × 10¥7 and 3 × 10¥6 are expressed as risks in the range of 10¥6. Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark level of concern of the range of 10¥6 until the calculated risk exceeds approximately 3 × 10¥6. This is particularly the case where some conservatism is maintained in the exposure assessment. For isopyrazam, EPA’s exposure assessment assumes average residues of concern from field trials reflecting the maximum use rates, default processing factors, the maximum theoretical concentration for residues in peanut oil, and 100 PCT, which is highly conservative. Accordingly, EPA has concluded the cancer risk from exposure to isopyrazam falls within the range of 10¥6 and is thus negligible. 5. Determination of safety. Based on these risk assessments, 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 isopyrazam residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (GRM006.01B) is available to enforce E:\FR\FM\25MYR1.SGM 25MYR1 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations the tolerance expression. 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 MRLs for isopyrazam in or on vegetable, cucurbit, subgroup 9A; pepper, bell; and tomato. C. Revisions to Petitioned-For Tolerances Based on the residue levels observed in the field trial studies, EPA is establishing a tolerance of 0.50 ppm in or on pepper, bell in lieu of the 0.6 ppm as requested by the petitioner. The tolerance requested for Cucurbit Crop Group 9A is also being established as Vegetable, cucurbit, subgroup 9A, which is the standard commodity description for these commodities. The petitioned-for tolerances for residues of isopyrazam in/on cucurbit crop group 9A (0.3 ppm) and tomato (0.5 ppm) are set at 0.30 ppm and 0.50 ppm, respectively, consistent with the current practices for setting tolerances. V. Conclusion Therefore, tolerances are established for residues of isopyrazam, (3(difluoromethyl)-1-methyl-N-[1,2,3,4tetrahydro-9-(1-methylethyl)-1,4methano-naphthalen-5-yl]-1H-pyrazole4-carboxamide), determined as the sum of its syn-isomer (3-(difluoromethyl)-1methyl-N-[(1RS, 4SR, 9RS)-1,2,3,4- VerDate Sep<11>2014 15:57 May 24, 2017 Jkt 241001 tetrahydro-9-(1-methylethyl)-1,4methanonaphthalen-5-yl]-1H-pyrazole4-carboxamide) and anti-isomer (3(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4-tetrahydro-9-(1methylethyl)-1,4-methano-naphthalen5-yl]-1H-pyrazole-4-carboxamide), in or on vegetable, cucurbit, subgroup 9A at 0.30 ppm; pepper, bell at 0.50 ppm; and tomato at 0.50 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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 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 PO 00000 Frm 00077 Fmt 4700 Sfmt 4700 24075 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: April 25, 2017. Michael Goodis, 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. In § 180.654, add alphabetically the entries ‘‘Pepper, bell’’, ‘‘Tomato’’, and ‘‘Vegetable, cucurbit, subgroup 9A’’ to the table in paragraph (a), and revise footnote 1 at the end of the table to read as follows: ■ § 180.654 Isopyrazam; tolerances for residues. (a) * * * E:\FR\FM\25MYR1.SGM 25MYR1 24076 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW., Washington, DC 20472, (202) 646–4149. * * * * * SUPPLEMENTARY INFORMATION: The NFIP 1 ............................ Pepper, bell 0.50 Tomato 1 .................................... 0.50 enables property owners to purchase Federal flood insurance that is not Vegetable, cucurbit, subgroup 9A 1 ........................................ 0.30 otherwise generally available from private insurers. In return, communities 1 There are no U.S. registrations for use of agree to adopt and administer local isopyrazam on these commodities. floodplain management measures aimed * * * * * at protecting lives and new construction [FR Doc. 2017–10765 Filed 5–24–17; 8:45 am] from future flooding. Section 1315 of BILLING CODE 6560–50–P the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood DEPARTMENT OF HOMELAND insurance unless an appropriate public SECURITY body adopts adequate floodplain management measures with effective Federal Emergency Management enforcement measures. The Agency communities listed in this document no longer meet that statutory requirement 44 CFR Part 64 for compliance with program regulations, 44 CFR part 59. [Docket ID FEMA–2017–0002; Internal Agency Docket No. FEMA–8481] Accordingly, the communities will be suspended on the effective date in the Suspension of Community Eligibility third column. As of that date, flood insurance will no longer be available in AGENCY: Federal Emergency the community. We recognize that some Management Agency, DHS. of these communities may adopt and ACTION: Final rule. submit the required documentation of legally enforceable floodplain SUMMARY: This rule identifies management measures after this rule is communities where the sale of flood published but prior to the actual insurance has been authorized under suspension date. These communities the National Flood Insurance Program will not be suspended and will continue (NFIP) that are scheduled for to be eligible for the sale of NFIP flood suspension on the effective dates listed insurance. A notice withdrawing the within this rule because of suspension of such communities will be noncompliance with the floodplain published in the Federal Register. management requirements of the In addition, FEMA publishes a Flood program. If the Federal Emergency Insurance Rate Map (FIRM) that Management Agency (FEMA) receives identifies the Special Flood Hazard documentation that the community has Areas (SFHAs) in these communities. adopted the required floodplain The date of the FIRM, if one has been management measures prior to the published, is indicated in the fourth effective suspension date given in this column of the table. No direct Federal rule, the suspension will not occur and financial assistance (except assistance a notice of this will be provided by publication in the Federal Register on a pursuant to the Robert T. Stafford Disaster Relief and Emergency subsequent date. Also, information Assistance Act not in connection with a identifying the current participation flood) may be provided for construction status of a community can be obtained or acquisition of buildings in identified from FEMA’s Community Status Book SFHAs for communities not (CSB). The CSB is available at https:// participating in the NFIP and identified www.fema.gov/national-floodfor more than a year on FEMA’s initial insurance-program-community-statusFIRM for the community as having book. flood-prone areas (section 202(a) of the DATES: The effective date of each Flood Disaster Protection Act of 1973, community’s scheduled suspension is 42 U.S.C. 4106(a), as amended). This the third date (‘‘Susp.’’) listed in the prohibition against certain types of third column of the tables in the Federal assistance becomes effective for amendment. the communities listed on the date FOR FURTHER INFORMATION CONTACT: If shown in the last column. The you want to determine whether a Administrator finds that notice and particular community was suspended public comment procedures under 5 on the suspension date or for further U.S.C. 553(b), are impracticable and information, contact Patricia Suber, unnecessary because communities listed Commodity VerDate Sep<11>2014 15:57 May 24, 2017 Parts per million Jkt 241001 PO 00000 Frm 00078 Fmt 4700 Sfmt 4700 in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days. National Environmental Policy Act. FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) does not apply. Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place. Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132. Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988. Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. List of Subjects in 44 CFR Part 64 Flood insurance, Floodplains. Accordingly, 44 CFR part 64 is amended as follows: PART 64—[AMENDED] 1. The authority citation for Part 64 continues to read as follows: ■ Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376. E:\FR\FM\25MYR1.SGM 25MYR1

Agencies

[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Rules and Regulations]
[Pages 24071-24076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10765]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0143; FRL-9960-76]


Isopyrazam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
isopyrazam in or on pepper, bell; tomato; and vegetable, cucurbit, 
subgroup 9A. Syngenta Crop Protection, LLC, requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 25, 2017. Objections and 
requests for hearings must be received on or before July 24, 2017, 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-2016-0143, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://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: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0143 in the subject line on the first 
page of your submission. All

[[Page 24072]]

objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before July 24, 2017. 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-2016-0143, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 29, 2016 (81 FR 59165) (FRL-9950-
22), 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 
5E8433) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 
18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.654 
be amended by establishing tolerances for residues of the fungicide 
isopyrazam, in or on cucurbit crop subgroup 9A at 0.3 parts per million 
(ppm); pepper, bell at 0.6 ppm; and tomato at 0.5 ppm. That document 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, LLC, the registrant, which is available in the docket, 
http://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 is 
establishing a lower tolerance than was requested for pepper, bell and 
is revising the commodity terminology for vegetable, cucurbit, subgroup 
9A. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue . . 
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for isopyrazam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with isopyrazam 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 oral toxicity studies in the rat, mouse, 
rabbit and dog demonstrate that the primary target organ for isopyrazam 
is the liver (increased organ weight and centrilobular hepatocyte 
hypertrophy). Liver toxicity is usually accompanied by reductions in 
bodyweight and food consumption. Isopyrazam did not cause reproductive 
toxicity. Effects seen in the offspring (decreased bodyweight during 
lactation and increase liver weight at weaning) in the rat reproduction 
study occurred at the same doses that cause general toxicity in the 
parents. Developmental effects described as small eyes and/or 
microphthalmia were observed in both the Himalayan and New Zealand 
rabbit strains. However, in the Himalayan strain, the intraocular 
abnormalities occur in the absence of maternal toxicity while in the 
New Zealand strain, the ocular abnormalities occurred at doses that 
were maternally toxic. Developmental effects observed in the rat 
(increased post-implantation loss, reduced fetal weight, and a non- or 
incomplete ossification or retardation of ossification) occurred at 
doses that also produced maternal toxicity (mortality, decreased body 
weights, body weight gains, and food consumption, increased liver 
weights and microscopic findings in the liver).
    No evidence of specific neurotoxicity was seen in acute and 
subchronic oral neurotoxicity studies in rats. Clinical signs seen in 
two subchronic dog studies (side-to-side head wobble, ataxia, reduced 
stability) are consistent with neurotoxic effects. However, detailed 
and specific neuropathological analyses were not conducted for the dog 
studies (i.e., functional observational battery, motor activity, 
detailed histopathology with special stains). Consequently, there is 
uncertainty regarding whether the effects seen in the dog studies are 
in fact signs of neurotoxicity. However, clear no observed adverse 
effect levels (NOAELs)/lowest adverse effect levels (LOAELs) were 
established for both subchronic dog studies. The point of departure 
selected for the acute dietary assessment is based on clinical signs 
seen on day 2 in one of four males in the subchronic dog study. This 
study provides the lowest NOAEL in the database (most sensitive 
endpoint) for a single dose effect. The dose used for the chronic 
dietary risk assessment is eight times lower than the dose at which 
clinical effects were seen at four weeks in the second subchronic dog 
study.
    There is no evidence of immunotoxicity based on a 28-day dietary 
immunotoxicity study in mice. The LOAEL for immunotoxicity was not 
identified and the NOAEL for immunotoxicity was 1,356 milligrams/
kilograms (mg/kg).
    Isopyrazam is classified as ``Likely to be Carcinogenic to Humans'' 
based on increased incidence of uterine endometrial adenocarcinomas and 
liver hepatocellular adenomas in female rats and increased incidence of 
thyroid follicular cell adenomas and/or

[[Page 24073]]

carcinomas in male rats. Isopyrazam is not carcinogenic in the mouse. 
There is no evidence of genotoxicity, mutagenicity, or clastogenicity 
in the in vivo and in vitro studies. There are no structural 
relationships with other known carcinogens. A linear low-dose approach 
(Q1*) was used to extrapolate experimental animal tumor data 
for the quantification of human cancer risk.
    Isopyrazam is of low acute toxicity by the oral, dermal, and 
inhalation routes and is not a skin or eye irritant.
    Specific information on the studies received and the nature of the 
adverse effects caused by isopyrazam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Isopyrazam: Human Health Risk 
Assessment for the Establishment of Tolerances with No U.S. 
Registrations in/on Cucurbit Vegetables Crop Subgroup 9A, Bell Pepper 
and Tomato Imported from Belgium, Greece, Italy, Spain and the United 
Kingdom'' in docket ID number EPA-HQ-OPP-2016-0143.

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 reference values 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for 
isopyrazam used for human risk assessment is discussed in Table 1 of 
the final rule published in the Federal Register of December 27, 2013 
(78 FR 78740) (FRL-9903-53).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isopyrazam, EPA considered exposure under the petitioned-
for tolerances as well as all existing isopyrazam tolerances in 40 CFR 
180.654. EPA assessed dietary exposures from isopyrazam 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. Such effects were identified 
for isopyrazam. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, maximum residues from field trials conducted at the maximum use 
rates were used to estimate isopyrazam residues of concern and 100 
percent crop treated (PCT) assumptions were used. Dietary Exposure 
Evaluation Model (DEEM) default processing factors were used for all 
processed commodities including dried apple (8.0), apple juice/cider 
(1.3), dried banana/plantain (3.9), peanut butter (1.89), dried tomato 
(14.3), tomato juice (1.5), tomato paste (5.4), and tomato puree (3.3). 
In the absence of peanut processing data, the maximum theoretical 
concentration factor was used for peanut oil (2.8).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used the average 
residues from field trials conducted at the maximum use rates were used 
to estimate isopyrazam and the same processing factors and PCT 
assumptions as in the acute dietary exposure analysis.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that isopyrazam should be classified as ``Likely to be 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk. In evaluating the cancer risk, EPA used the same 
residue levels, processing factors and PCT assumptions as in the 
chronic dietary exposure analysis.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use PCT information in the dietary assessment for 
isopyrazam. Maximum or average residue levels from field trials 
conducted at the maximum use rates were assumed for all food 
commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. An assessment of residues 
in drinking water is not needed for isopyrazam because there is no 
drinking water exposure for isopyrazam uses, which are all non-
domestic.
    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). Isopyrazam is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 
isopyrazam to share a common mechanism of toxicity with any other 
substances, and isopyrazam does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that isopyrazam does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's procedures for cumulating effects from 
substances found to have a common mechanism of toxicity, see EPA's Web 
site at http://www2.epa.gov/

[[Page 24074]]

pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-
risk-pesticides.

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 additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There are no residual 
uncertainties for pre- and/or postnatal susceptibility even though 
qualitative susceptibility was observed in the range-finding 
developmental studies in rabbits. Developmental effects (eye 
abnormalities) were observed in the absence of maternal toxicity in two 
range finding developmental toxicity studies in the Himalayan rabbit. 
However, the eye effects were only observed at relatively high doses 
(200-400 mg/kg/day) with clear NOAELs/LOAELs established for the 
developmental effects. Developmental effects observed in the rat 
(increased post-implantation loss, reduced fetal weight and non-or 
incomplete ossification or retardation of ossification) occurred only 
at doses that also produced maternal toxicity (mortality, decreased 
body weights, body weight gains, and food consumption). There was no 
evidence of increased susceptibility in a 2-generation reproduction 
study following pre- or postnatal exposure to isopyrazam. There was 
also no evidence of neuropathology or abnormalities in the development 
of the fetal nervous system from the available toxicity studies 
conducted with isopyrazam. Clear NOAELs/LOAELs were established for the 
developmental effects observed in rats and rabbits as well as for the 
offspring effects (increased liver weights) seen in the 2-generation 
reproduction study and a dose-response relationship for the effects of 
concern is well characterized. The dose used for the acute dietary risk 
assessment (30 mg/kg/day), based on effects seen in the subchronic dog 
study, is protective of the developmental effects seen in rats (44.5 
mg/kg/day) and rabbits (200 mg/kg/day). Based on these considerations, 
there are no residual uncertainties for pre- and/or postnatal 
susceptibility.
    3. Conclusion. EPA has determined that reliable data show the 
safety of 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 isopyrazam is complete.
    ii. As discussed in Unit III.A, there is no indication that 
isopyrazam is a neurotoxic chemical and there is no need for a 
developmental neurotoxicity study or additional uncertainty factors to 
account for neurotoxicity.
    iii. As discussed in Unit III.D.2, there are no residual 
uncertainties for pre-and/or post-natal susceptibility.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and maximum or average residue levels from field trials 
conducted at the maximum use rates. There are no currently registered 
or proposed occupational or residential uses of isopyrazam in the U.S. 
and adequate residue data are available. These assessments will not 
underestimate the exposure and risks posed by isopyrazam.

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.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
isopyrazam at the 95th percentile will occupy 4.7% of the aPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
isopyrazam from food will utilize 5.0% of the cPAD for children 1-2 
years old, the population group receiving the greatest exposure. There 
are no residential uses for isopyrazam.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
risk is assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure (which includes both food and 
water and is considered to be a background exposure level). Isopyrazam 
is not registered in the United States. Because there is no short- or 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD, no 
further assessment of short- or intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
short- and intermediate-term risk for isopyrazam.
    4. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions discussed in this unit for cancer exposure, the cancer 
dietary risk estimate for the U.S. population is 3 x 10-6. 
EPA generally considers cancer risks (expressed as the probability of 
an increased cancer case) in the range of 1 in 1 million (or 1 x 
10-6) or less to be negligible. The precision that can be 
assumed for cancer risk estimates is best described by rounding to the 
nearest integral order of magnitude on the logarithmic scale; for 
example, risks falling between 3 x 10-7 and 3 x 
10-6 are expressed as risks in the range of 10-6. 
Considering the precision with which cancer hazard can be estimated, 
the conservativeness of low-dose linear extrapolation, and the rounding 
procedure described above, cancer risk should generally not be assumed 
to exceed the benchmark level of concern of the range of 
10-6 until the calculated risk exceeds approximately 3 x 
10-6. This is particularly the case where some conservatism 
is maintained in the exposure assessment. For isopyrazam, EPA's 
exposure assessment assumes average residues of concern from field 
trials reflecting the maximum use rates, default processing factors, 
the maximum theoretical concentration for residues in peanut oil, and 
100 PCT, which is highly conservative. Accordingly, EPA has concluded 
the cancer risk from exposure to isopyrazam falls within the range of 
10-6 and is thus negligible.
    5. Determination of safety. Based on these risk assessments, 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 isopyrazam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (GRM006.01B) is available to 
enforce

[[Page 24075]]

the tolerance expression. 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 MRLs for isopyrazam in or on 
vegetable, cucurbit, subgroup 9A; pepper, bell; and tomato.

C. Revisions to Petitioned-For Tolerances

    Based on the residue levels observed in the field trial studies, 
EPA is establishing a tolerance of 0.50 ppm in or on pepper, bell in 
lieu of the 0.6 ppm as requested by the petitioner. The tolerance 
requested for Cucurbit Crop Group 9A is also being established as 
Vegetable, cucurbit, subgroup 9A, which is the standard commodity 
description for these commodities. The petitioned-for tolerances for 
residues of isopyrazam in/on cucurbit crop group 9A (0.3 ppm) and 
tomato (0.5 ppm) are set at 0.30 ppm and 0.50 ppm, respectively, 
consistent with the current practices for setting tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of isopyrazam, 
(3-(difluoromethyl)-1-methyl-N-[1,2,3,4-tetrahydro-9-(1-methylethyl)-
1,4-methano-naphthalen-5-yl]-1H-pyrazole-4-carboxamide), determined as 
the sum of its syn-isomer (3-(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 
9RS)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-methanonaphthalen-5-yl]-
1H-pyrazole-4-carboxamide) and anti-isomer (3-(difluoromethyl)-1-
methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-
methano-naphthalen-5-yl]-1H-pyrazole-4-carboxamide), in or on 
vegetable, cucurbit, subgroup 9A at 0.30 ppm; pepper, bell at 0.50 ppm; 
and tomato at 0.50 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the 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 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: April 25, 2017.
Michael Goodis,
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. In Sec.  180.654, add alphabetically the entries ``Pepper, bell'', 
``Tomato'', and ``Vegetable, cucurbit, subgroup 9A'' to the table in 
paragraph (a), and revise footnote 1 at the end of the table to read as 
follows:


Sec.  180.654  Isopyrazam; tolerances for residues.

    (a) * * *

[[Page 24076]]



------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pepper, bell \1\...........................................         0.50
Tomato \1\.................................................         0.50
Vegetable, cucurbit, subgroup 9A \1\.......................         0.30
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of isopyrazam on these
  commodities.

* * * * *
[FR Doc. 2017-10765 Filed 5-24-17; 8:45 am]
BILLING CODE 6560-50-P