Cyazofamid; Pesticide Tolerances, 5600-5605 [2016-01993]

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Ruble, Secretary. BILLING CODE 7710–FW–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0263; FRL–9940–46] Cyazofamid; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes tolerances for residues of cyazofamid in or on the herb subgroup 19A and the bulb vegetable group 3–07. Interregional Research Project Number 4 (IR–4) requested the herb subgroup 19A tolerances, and ISK Biosciences requested the bulb vegetable group 3–07 tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 3, 2016. Objections and requests for hearings must be received SUMMARY: Frm 00028 Fmt 4700 The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2015–0263, 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Susan Lewis, 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? [FR Doc. 2016–01947 Filed 2–2–16; 8:45 am] PO 00000 on or before April 4, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). Sfmt 4700 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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. E:\FR\FM\03FER1.SGM 03FER1 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 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–2015–0263 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 April 4, 2016. 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– 2015–0263, 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. tkelley on DSK3SPTVN1PROD with RULES II. Summary of Petitioned-For Tolerance In the Federal Register of May 20, 2015 (80 FR 28925) (FRL–9927–39), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions: One by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077 (PP 5F8352) that requested to establish VerDate Sep<11>2014 17:35 Feb 02, 2016 Jkt 238001 tolerances in 40 CFR 180.601 for residues of the fungicide cyazofamid and its metabolite (4-chloro-5-(4methylphenyl)-1H-imidazole-2carbonitrile) in or on bulb vegetables (crop group 3–07) at 2.0 parts per million (ppm); and one by IR–4, 500 College Road East, Suite 201W, Princeton, NJ 08540 (PP 5E8350) that requested to establish tolerances in 40 CFR 180.601 for residues of the fungicide cyazofamid in or on the herb subgroup 19A at 90 ppm and also to remove the existing tolerances for residues of cyazofamid and its metabolite in or on basil, dried leaves at 90 ppm and basil, fresh leaves at 30 ppm upon approval of the herb subgroup 19A tolerances. That document referenced summaries of the two petitions prepared by ISK Biosciences, the registrant, which is available in the docket, https:// www.regulations.gov. There were no comments received in response to the notices of filing. 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 cyazofamid including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with cyazofamid follows. PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 5601 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. The target organ for cyazofamid in rats is the kidney, with an increased incidence of basophilic tubules, increased urinary volume, pH, and protein noted in male rats after subchronic exposure. Female rats were less sensitive, with only a marginal increase in urinary volume, and pH. These findings were noted in a 90-day oral toxicity study, and similar findings were noted in the 28-day oral toxicity range-finding study in rats. In the twogeneration reproductive study in rats, there was an increased incidence of inflammation and nephropathy in the high-dose male rats as compared to the controls. Basophilic tubules are indicative of a regenerative process, but they can be more difficult to identify in older animals (i.e., tubular basophilia can be obscured by nephropathy or included as part of the nephropathy constellation). No kidney effects were observed in the chronic oral toxicity study in rats; however, this study did not test up to doses as high as those eliciting kidney effects in the subchronic and two-generation reproduction toxicity studies. The only relevant finding in the dog was an incidence of parathyroid cysts in males at the limit dose in the chronic study. The pre- and post-natal toxicology database for cyazofamid includes rat and rabbit developmental toxicity studies and a two-generation reproduction toxicity study in rats. The prenatal developmental study in rats showed evidence of increased quantitative susceptibility following in utero exposure as a marginally increased incidence of bent ribs was noted in fetuses at the limit dose, whereas no maternal toxicity was noted. No adverse effects were seen in a route-specific dermal toxicity study. Skin lesions were observed in males following oral exposure in the mouse carcinogenicity study, and are thought to be caused by an allergic reaction to systemic exposure because they did not occur following exposure via the dermal route. Cyazofamid is classified as ‘‘not likely to be carcinogenic to humans’’ based on the lack of evidence for carcinogenicity in mice and rats and a lack of mutagenic potential. E:\FR\FM\03FER1.SGM 03FER1 5602 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations Specific information on the studies received and the nature of the adverse effects caused by cyazofamid 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 https:// www.regulations.gov in the document titled, ‘‘Cyazofamid. Human Health Risk Assessment for Proposed New Uses on Use on Crop Subgroup 19A, Peppers and Tomatoes Grown in Greenhouses, and on Bulb Vegetables Crop Group 03– 07’’ on pp. 32 in docket ID number EPA–HQ–OPP–2015–0263. 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 the NOAEL and the LOAEL are identified. 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 endpoints for cyazofamid used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CYAZOFAMID FOR USE IN HUMAN HEALTH RISK ASSESSMENT Exposure/Scenario Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (All Populations) No appropriate toxicological effect attributable to a single dose was observed. Therefore, a dose and endpoint were not identified for this risk assessment. Chronic dietary (All populations) NOAEL= 94.8 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x NOAEL= 171 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Oral study NOAEL= 171 mg/kg/day. UFA = 10x UFH = 10x FQPA SF = 1x Incidental oral short-term (1 to 30 days). Inhalation short-term (1 to 30 days). Cancer (Oral, dermal, inhalation). Chronic RfD = 0.948 mg/kg/day. cPAD = 0.948 mg/ kg/day. 18-Month Mouse Oral Carcinogenicity. LOAEL = 985 mg/kg/day based on increased skin lesions. LOC for MOE = 100 Co-critical 90-Day and chronic oral toxicity studies in rats. LOAEL= 295 mg/kg based on increased incidence of basophilic tubules in the kidneys, increased urinary volume, pH, & protein. LOC for MOE = 100 Co-critical 90-Day and chronic oral toxicity studies in rats. LOAEL= 295 mg/kg based on increased incidence of basophilic tubules in the kidneys, increased urinary volume, pH, & protein. Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of treatment-related tumors in two adequate rodent carcinogenicity studies. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). tkelley on DSK3SPTVN1PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to cyazofamid, EPA considered exposure under the petitioned-for tolerances as well as all existing cyazofamid tolerances in 40 CFR 180.601. EPA assessed dietary exposures from cyazofamid 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 VerDate Sep<11>2014 17:35 Feb 02, 2016 Jkt 238001 exposure. No such effects were identified in the toxicological studies for cyazofamid; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the 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). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all commodities. PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that cyazofamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for cyazofamid. Tolerance-level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. Available environmental fate studies suggest cyazofamid is not very E:\FR\FM\03FER1.SGM 03FER1 tkelley on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations mobile and quickly degrades into a number of degradation products under different environmental conditions. The highest estimated chronic drinking water concentrations resulted from modeling which assumed application of 100% molar conversion of the parent into the terminal degradate CTCA. EPA used these estimates of CTCA (4-chloro5-p-tolylimidazole-2-carboxylic acid) in its dietary exposure assessments, a conservative approach that likely overestimates the exposure contribution from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for cyazofamid and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyazofamid and its degradates. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www2.epa.gov/ pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of the degradate CTCA for chronic exposures are estimated to be 133.5 parts per billion (ppb) for surface water and 211 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 211 ppb was used to assess the contribution to drinking water. 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, termiticide, and flea and tick control on pets). Cyazofamid is currently registered for use on turf at golf courses, sod farms, seed farms, college and professional sports fields, residential and commercial lawns, and on ornamental plants in landscapes and those grown in commercial greenhouses and nurseries. EPA assessed residential exposure using the following scenarios: • Adult handlers. The worst-case scenario was determined to be shortterm inhalation exposures from mixing, loading, and applying cyazofamid to turf; and • Children. The worst-case scenario was determined to be short-term post- VerDate Sep<11>2014 17:35 Feb 02, 2016 Jkt 238001 application incidental oral exposure from hand-to-mouth activities on turf. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ standard-operating-proceduresresidential-pesticide. 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 cyazofamid to share a common mechanism of toxicity with any other substances, and cyazofamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyazofamid 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 Web site at https:// www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-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 Food Quality Protection Act Safety Factor (FQPA 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. The developmental rabbit and twogeneration reproduction toxicity study in rats did not show any evidence of increased susceptibility developmental or offspring, respectively. However, there was increased quantitative susceptibility in the rat developmental study; concentrations up to the limit PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 5603 dose did not cause maternal systemic toxicity, but there was an increased incidence of bent ribs. Concern is low based on the following: (1) The increase was marginal, (2) bent ribs are considered a variation rather than a malformation, (3) the effect was only seen at the limit dose, (4) there is a clear NOAEL for the effect, and (5) the selected endpoints address any concerns for this effect. 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 cyazofamid is complete. ii. There is no indication that cyazofamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. As noted in Section D.2., there was increased quantitative susceptibility in the rat developmental study, however, concern is low due to the reasons cited. 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. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyazofamid and its degradates in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyazofamid. 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. 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 E:\FR\FM\03FER1.SGM 03FER1 tkelley on DSK3SPTVN1PROD with RULES 5604 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations selected. Therefore, cyazofamid 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 cyazofamid from food and water will utilize 2% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of cyazofamid is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Cyazofamid is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to cyazofamid. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 14,000 for adults and 6,100 for children 1–2 years old. Because EPA’s level of concern for cyazofamid is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, cyazofamid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediateterm residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for cyazofamid. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, cyazofamid is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes VerDate Sep<11>2014 17:35 Feb 02, 2016 Jkt 238001 that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to cyazofamid residues. IV. Other Considerations A. Analytical Enforcement Methodology An enforcement method for non-fatty commodities is available, FDA’s Multiresidue Protocol D (without cleanup). The method completely recovers (≤80% recovery) cyazofamid and its metabolite (4-chloro-5-(4-methylphenyl)-1Himidazole-2-carbonitrile). In addition, the high-performance liquid chromatography method with ultraviolent light detection (HPLC/UV) method is acceptable for use as a single analyte enforcement method provided a confirmatory method such as the liquid chromatography method with tandem mass-spectrometric detection (LC/MS/ MS) method is used. 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 Aliment-arius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Aliment-arius 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. There are no Codex MRLs established for cyazofamid in/on the commodities included in this action. V. Conclusion Therefore, tolerances are established for residues of cyazofamid (4-chloro-2cyano-N,N-dimethyl-5-(4methylphenyl)-1H-imidazole-1sulfonamide) and is metabolite (4chloro-5-(4-methylphenyl)-1Himidazole-2-carbonitrile) in or on the PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 herb subgroup 19A at 90 ppm; and bulb vegetables, group 3–07 at 2.0 ppm. In addition, the existing tolerances for residues of cyazofamid and its metabolite (4-chloro-5-(4methylphenyl)-1H-imidazole-2carbonitrile) in or on basil, dried leaves and basil, fresh leaves are removed as unnecessary. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined E:\FR\FM\03FER1.SGM 03FER1 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 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). 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). Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 21, 2016. Susan Lewis, 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 § 180.601, in the table in paragraph (a): ■ a. Remove the entries for ‘‘Basil, dried leaves’’ and ‘‘Basil, fresh leaves’’. ■ b. Add alphabetically entries for ‘‘Bulb vegetables, group 3–07’’ and ‘‘Herb subgroup 19A’’. The additions read as follows: tkelley on DSK3SPTVN1PROD with RULES ■ § 180.601 Cyazofamid; tolerances for residues. (a) General. * * * VerDate Sep<11>2014 17:35 Feb 02, 2016 Jkt 238001 Commodity * * * * * Bulb vegetables, group 3–07 ... * * * 2.0 * * Herb subgroup 19A .................. * * * * * * * 90 * * * [FR Doc. 2016–01993 Filed 2–2–16; 8:45 am] BILLING CODE 6560–50–P 47 CFR Part 1 [GN Docket No. 09–51, WC Docket No. 07– 25; FCC 15–151] Pole Attachment Rates Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Commission builds on its prior efforts to harmonize pole attachment rates that cable and telecom service providers pay utility pole owners. The Communications Act of 1934, as amended (Act), contains two formulas for calculating pole attachment rates, a formula adopted in 1978 applicable to cable television systems solely providing cable service, and a formula adopted in 1996 applicable to telecommunications carriers providing telecommunications service. DATES: Effective April 1, 2016. ADDRESSES: You may submit comments, identified by WC Docket No. 07–245, GN Docket No. 09–51 and FCC 15–151, by any of the following methods: • Federal Communications Commission’s Web site: https:// apps.fcc.gov/ecfs/. Follow the instructions for submitting comments. • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: FCC504@fcc.gov or phone: 202–418–0530 or TTY: 202– 418–0432. FOR FURTHER INFORMATION CONTACT: Jonathan Reel, Wireline Competition Bureau, Competition Policy Division, (202) 418–0637, or send an email to jonathan.reel@fcc.gov. SUMMARY: List of Subjects in 40 CFR Part 180 This is a summary of the Commission’s Order on Reconsideration in GN Docket No. 09– 51, WC Docket No. 07–245, and FCC 15–151, adopted November 17, 2015 and released November 24, 2015. The full text of this document is available for public inspection during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY–A257, Washington, DC 20554. It is available on the Commission’s Web site at https:// www.fcc.gov. SUPPLEMENTARY INFORMATION: Parts per million FEDERAL COMMUNICATIONS COMMISSION VII. Congressional Review Act 5605 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 I. Introduction 1. In this Order on Reconsideration (Order), the Commission builds on its prior efforts to harmonize pole attachment rates that cable and telecom service providers pay utility pole owners. The Communications Act of 1934, as amended (Act), contains two formulas for calculating pole attachment rates, a formula adopted in 1978 applicable to cable television systems solely providing cable service, and a formula adopted in 1996 applicable to telecommunications carriers providing telecommunications service. Following the implementation of the 1996 Act through 2011, rates calculated using the telecom rate formula have typically been higher than rates calculated using the cable formula in similar circumstances. In 2011, the Commission revised the formulas as described in greater detail below to improve efficiency, reduce potentially excessive costs of network deployment and accelerate broadband buildout, and eliminate the wide disparity between the telecom and cable rate formulas. The 2011 revisions sought to bring the telecom and cable rates into parity. In the intervening time, the Commission has seen that its revisions did not fully achieve that objective. Today, the Commission takes the next logical step in achieving the goals set forth in 2011. 2. As detailed below, the Commission takes these actions in response to a Petition for Reconsideration or Clarification in this proceeding. The rule revisions that the Commission adopts amend the Commission’s rules by defining ‘‘cost,’’ for the purpose of calculating the rates that telecommunications carriers pay for pole attachments, as a percentage of fully allocated costs that will depend on whether the average number of attaching entities in a service area is 2, 3, 4, or 5. The rates that attachers pay to attach to poles are currently determined, among other things, by whether the attacher is a ‘‘cable television system solely . . . provid[ing] cable service’’ or a ‘‘telecommunications E:\FR\FM\03FER1.SGM 03FER1

Agencies

[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Rules and Regulations]
[Pages 5600-5605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01993]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0263; FRL-9940-46]


Cyazofamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
cyazofamid in or on the herb subgroup 19A and the bulb vegetable group 
3-07. Interregional Research Project Number 4 (IR-4) requested the herb 
subgroup 19A tolerances, and ISK Biosciences requested the bulb 
vegetable group 3-07 tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective February 3, 2016. Objections and 
requests for hearings must be received on or before April 4, 2016, 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-2015-0263, 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: Susan Lewis, 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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

[[Page 5601]]

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-2015-0263 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 
April 4, 2016. 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-2015-0263, 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 May 20, 2015 (80 FR 28925) (FRL-9927-
39), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of two pesticide petitions: 
One by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, 
Ohio 44077 (PP 5F8352) that requested to establish tolerances in 40 CFR 
180.601 for residues of the fungicide cyazofamid and its metabolite (4-
chloro-5-(4-methylphenyl)-1H-imidazole-2-carbonitrile) in or on bulb 
vegetables (crop group 3-07) at 2.0 parts per million (ppm); and one by 
IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540 (PP 
5E8350) that requested to establish tolerances in 40 CFR 180.601 for 
residues of the fungicide cyazofamid in or on the herb subgroup 19A at 
90 ppm and also to remove the existing tolerances for residues of 
cyazofamid and its metabolite in or on basil, dried leaves at 90 ppm 
and basil, fresh leaves at 30 ppm upon approval of the herb subgroup 
19A tolerances. That document referenced summaries of the two petitions 
prepared by ISK Biosciences, the registrant, which is available in the 
docket, https://www.regulations.gov. There were no comments received in 
response to the notices of filing.

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 cyazofamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with cyazofamid 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.
    The target organ for cyazofamid in rats is the kidney, with an 
increased incidence of basophilic tubules, increased urinary volume, 
pH, and protein noted in male rats after subchronic exposure. Female 
rats were less sensitive, with only a marginal increase in urinary 
volume, and pH. These findings were noted in a 90-day oral toxicity 
study, and similar findings were noted in the 28-day oral toxicity 
range-finding study in rats. In the two-generation reproductive study 
in rats, there was an increased incidence of inflammation and 
nephropathy in the high-dose male rats as compared to the controls. 
Basophilic tubules are indicative of a regenerative process, but they 
can be more difficult to identify in older animals (i.e., tubular 
basophilia can be obscured by nephropathy or included as part of the 
nephropathy constellation). No kidney effects were observed in the 
chronic oral toxicity study in rats; however, this study did not test 
up to doses as high as those eliciting kidney effects in the subchronic 
and two-generation reproduction toxicity studies. The only relevant 
finding in the dog was an incidence of parathyroid cysts in males at 
the limit dose in the chronic study.
    The pre- and post-natal toxicology database for cyazofamid includes 
rat and rabbit developmental toxicity studies and a two-generation 
reproduction toxicity study in rats. The prenatal developmental study 
in rats showed evidence of increased quantitative susceptibility 
following in utero exposure as a marginally increased incidence of bent 
ribs was noted in fetuses at the limit dose, whereas no maternal 
toxicity was noted.
    No adverse effects were seen in a route-specific dermal toxicity 
study. Skin lesions were observed in males following oral exposure in 
the mouse carcinogenicity study, and are thought to be caused by an 
allergic reaction to systemic exposure because they did not occur 
following exposure via the dermal route. Cyazofamid is classified as 
``not likely to be carcinogenic to humans'' based on the lack of 
evidence for carcinogenicity in mice and rats and a lack of mutagenic 
potential.

[[Page 5602]]

    Specific information on the studies received and the nature of the 
adverse effects caused by cyazofamid 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 https://www.regulations.gov in the document titled, ``Cyazofamid. Human Health 
Risk Assessment for Proposed New Uses on Use on Crop Subgroup 19A, 
Peppers and Tomatoes Grown in Greenhouses, and on Bulb Vegetables Crop 
Group 03-07'' on pp. 32 in docket ID number EPA-HQ-OPP-2015-0263.

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 the NOAEL and the LOAEL are identified. 
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 endpoints for cyazofamid used for 
human risk assessment is shown in Table 1 of this unit.


  Table 1--Summary of Toxicological Doses and Endpoints for Cyazofamid for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations)..      No appropriate toxicological effect attributable to a single dose was
                                     observed. Therefore, a dose and endpoint were not identified for this risk
                                                                     assessment.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 94.8 mg/kg/    Chronic RfD = 0.948  18-Month Mouse Oral
                                    day.                  mg/kg/day.           Carcinogenicity.
                                   UFA = 10x...........  cPAD = 0.948 mg/kg/  LOAEL = 985 mg/kg/day based on
                                   UFH = 10x...........   day.                 increased skin lesions.
                                   FQPA SF = 1x........
Incidental oral short-term (1 to   NOAEL= 171 mg/kg/day  LOC for MOE = 100..  Co-critical 90-Day and chronic
 30 days).                         UFA = 10x...........                        oral toxicity studies in rats.
                                   UFH = 10x...........                       LOAEL= 295 mg/kg based on
                                   FQPA SF = 1x........                        increased incidence of basophilic
                                                                               tubules in the kidneys, increased
                                                                               urinary volume, pH, & protein.
Inhalation short-term (1 to 30     Oral study NOAEL=     LOC for MOE = 100..  Co-critical 90-Day and chronic
 days).                             171 mg/kg/day.                             oral toxicity studies in rats.
                                   UFA = 10x...........                       LOAEL= 295 mg/kg based on
                                   UFH = 10x...........                        increased incidence of basophilic
                                   FQPA SF = 1x........                        tubules in the kidneys, increased
                                                                               urinary volume, pH, & protein.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)     Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                     absence of treatment-related tumors in two adequate rodent carcinogenicity
                                                                      studies.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 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 cyazofamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyazofamid tolerances in 40 CFR 
180.601. EPA assessed dietary exposures from cyazofamid 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 cyazofamid; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 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). As to residue levels in 
food, EPA assumed tolerance-level residues and 100 percent crop treated 
(PCT) for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that cyazofamid does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
cyazofamid. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. Available environmental 
fate studies suggest cyazofamid is not very

[[Page 5603]]

mobile and quickly degrades into a number of degradation products under 
different environmental conditions. The highest estimated chronic 
drinking water concentrations resulted from modeling which assumed 
application of 100% molar conversion of the parent into the terminal 
degradate CTCA. EPA used these estimates of CTCA (4-chloro-5-p-
tolylimidazole-2-carboxylic acid) in its dietary exposure assessments, 
a conservative approach that likely overestimates the exposure 
contribution from drinking water.
    The Agency used screening-level water exposure models in the 
dietary exposure analysis and risk assessment for cyazofamid and its 
degradates in drinking water. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
cyazofamid and its degradates. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of the 
degradate CTCA for chronic exposures are estimated to be 133.5 parts 
per billion (ppb) for surface water and 211 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 211 ppb was used to assess 
the contribution to drinking water.
    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, 
termiticide, and flea and tick control on pets).
    Cyazofamid is currently registered for use on turf at golf courses, 
sod farms, seed farms, college and professional sports fields, 
residential and commercial lawns, and on ornamental plants in 
landscapes and those grown in commercial greenhouses and nurseries. EPA 
assessed residential exposure using the following scenarios:
     Adult handlers. The worst-case scenario was determined to 
be short-term inhalation exposures from mixing, loading, and applying 
cyazofamid to turf; and
     Children. The worst-case scenario was determined to be 
short-term post-application incidental oral exposure from hand-to-mouth 
activities on turf.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 cyazofamid to share a common mechanism of 
toxicity with any other substances, and cyazofamid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyazofamid 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 Web site at https://www2.epa.gov/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 Food Quality 
Protection Act Safety Factor (FQPA 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. The developmental rabbit and 
two-generation reproduction toxicity study in rats did not show any 
evidence of increased susceptibility developmental or offspring, 
respectively. However, there was increased quantitative susceptibility 
in the rat developmental study; concentrations up to the limit dose did 
not cause maternal systemic toxicity, but there was an increased 
incidence of bent ribs. Concern is low based on the following: (1) The 
increase was marginal, (2) bent ribs are considered a variation rather 
than a malformation, (3) the effect was only seen at the limit dose, 
(4) there is a clear NOAEL for the effect, and (5) the selected 
endpoints address any concerns for this effect.
    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 cyazofamid is complete.
    ii. There is no indication that cyazofamid is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. As noted in Section D.2., there was increased quantitative 
susceptibility in the rat developmental study, however, concern is low 
due to the reasons cited.
    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. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to cyazofamid and its degradates in drinking water. 
EPA used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by cyazofamid.

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. 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

[[Page 5604]]

selected. Therefore, cyazofamid 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 
cyazofamid from food and water will utilize 2% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of cyazofamid is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Cyazofamid is 
currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to cyazofamid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 14,000 for adults 
and 6,100 for children 1-2 years old. Because EPA's level of concern 
for cyazofamid is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
cyazofamid is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
cyazofamid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyazofamid is not expected to pose a cancer risk to humans.
    6. 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 cyazofamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An enforcement method for non-fatty commodities is available, FDA's 
Multi-residue Protocol D (without cleanup). The method completely 
recovers (>80% recovery) cyazofamid and its metabolite (4-chloro-5-(4-
methylphenyl)-1H-imidazole-2-carbonitrile). In addition, the high-
performance liquid chromatography method with ultraviolent light 
detection (HPLC/UV) method is acceptable for use as a single analyte 
enforcement method provided a confirmatory method such as the liquid 
chromatography method with tandem mass-spectrometric detection (LC/MS/
MS) method is used.
    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 Aliment-arius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Aliment-arius 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.
    There are no Codex MRLs established for cyazofamid in/on the 
commodities included in this action.

V. Conclusion

    Therefore, tolerances are established for residues of cyazofamid 
(4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide) and is metabolite (4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile) in or on the herb subgroup 19A at 90 ppm; and 
bulb vegetables, group 3-07 at 2.0 ppm. In addition, the existing 
tolerances for residues of cyazofamid and its metabolite (4-chloro-5-
(4-methylphenyl)-1H-imidazole-2-carbonitrile) in or on basil, dried 
leaves and basil, fresh leaves are removed as unnecessary.

VI. Statutory and Executive Order Reviews

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

[[Page 5605]]

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: January 21, 2016.
Susan Lewis,
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.  180.601, in the table in paragraph (a):
0
a. Remove the entries for ``Basil, dried leaves'' and ``Basil, fresh 
leaves''.
0
b. Add alphabetically entries for ``Bulb vegetables, group 3-07'' and 
``Herb subgroup 19A''.
    The additions read as follows:


Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Bulb vegetables, group 3-07................................          2.0
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Herb subgroup 19A..........................................           90
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-01993 Filed 2-2-16; 8:45 am]
BILLING CODE 6560-50-P