Florasulam; Pesticide Tolerances, 35141-35147 [2018-15916]

Download as PDF 35141 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations TEXAS—2015 8-HOUR OZONE NAAQS [Primary and Secondary] Designation Classification Designated area 1 Date 2 * * * * San Antonio, TX ................................................................................................. Bexar County. * Rest of State: * * * 9/24/2018 * 9/24/2018 * * * * Bandera County .......................................................................................... 9/24/2018 * * * * Comal County ............................................................................................. 9/24/2018 * * * * Guadalupe County ...................................................................................... 9/24/2018 * * * * Kendall County ............................................................................................ 9/24/2018 * * * * Medina County ............................................................................................ 9/24/2018 * * * * Wilson County ............................................................................................. 9/24/2018 * * * * Nonattainment .. * * * * * Atascosa County ......................................................................................... * Date 2 Type 9/24/2018 Type * Marginal. * * * * * * * * * * * * * * * * * * * Attainment/ Unclassifiable. * Attainment/ Unclassifiable. * Attainment/ Unclassifiable. * Attainment/ Unclassifiable. * Attainment/ Unclassifiable. * Attainment/ Unclassifiable. * Attainment/ Unclassifiable. * 1 Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the boundaries of any area of Indian country in this table, including any area of Indian country located in the larger designation area. The inclusion of any Indian country in the designation area is not a determination that the state has regulatory authority under the Clean Air Act for such Indian country. 2 This date is August 3, 2018, unless otherwise noted. 40 CFR Part 180 This regulation is effective July 25, 2018. Objections and requests for hearings must be received on or before September 24, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). [EPA–HQ–OPP–2017–0226; FRL–9979–81] ADDRESSES: DATES: [FR Doc. 2018–15919 Filed 7–24–18; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY Florasulam; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. daltland on DSKBBV9HB2PROD with RULES AGENCY: This regulation establishes tolerances for residues of florasulam in or on teff forage, teff grain, teff hay, and teff straw. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). SUMMARY: VerDate Sep<11>2014 16:20 Jul 24, 2018 Jkt 244001 The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2017–0226, 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 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 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 Goodis, 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 E:\FR\FM\25JYR1.SGM 25JYR1 35142 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations 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). daltland on DSKBBV9HB2PROD with RULES 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–2017–0226 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 September 24, 2018. 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– 2017–0226, 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/ VerDate Sep<11>2014 16:20 Jul 24, 2018 Jkt 244001 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 October 23, 2017 (82 FR 49020) (FRL–9967–37), 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 7E8549) by IR–4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide florasulam N(2,6-difluorophenyl)-8-fluoro-5-methoxy (1,2,4)triazolo(1,5-c)pyrimidine-2sulfonamide in or on the raw agricultural commodities teff, forage at 0.05 parts per million (ppm); teff, grain at 0.01 ppm; teff, straw at 0.05 ppm; and teff, hay at 0.05 ppm. That document referenced a summary of the petition prepared by Dow AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. EPA’s response to this comment is discussed 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. . . .’’ PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 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 florasulam including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with florasulam 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. There was slight nephrotoxicity (increased kidney weights, hypertrophy, and degeneration/regeneration and inflammation of the descending portion of proximal tubules) observed in the kidneys of rats (both sexes) after subchronic exposure to florasulam (90 days) at or greater than 500 milligrams/ kilogram/day (mg/kg/day). Chronic exposure in rats led to slight nephrotoxicity (increased kidney weights, hypertrophy, and slight multifocal mineralization of the papilla) at 250 and 500 mg/kg/day in males only. Additionally, at 500 mg/kg/day, papillary necrosis and hyperplasia of the transitional epithelium (papilla) were observed in the kidney (males). Decreases in body weight and body weight gain were also observed in females after subchronic (500 mg/kg/ day) and chronic exposure (250 mg/kg/ day). Liver toxicity was observed in dogs (both sexes) in the form of increased alkaline phosphatase activity (59–127%), increased liver weights, hypertrophy, and hepatic vacuolation at 50 mg/kg/day after 90 days. After 1 year, there were increases in alkaline phosphatase (233–783%) in dogs (both sexes) but no changes in liver weights or gross or microscopic pathology at 50 mg/kg/day. Additionally, there were decreases in body weight, body weight gain and food consumption, as well as vacuolation of the zona reticularis and zona fasciculate in the adrenal gland (consistent with fatty change) in both sexes. There were no adverse effects noted after subchronic/chronic exposure to florasulam in mice up to the limit dose of 1,000 mg/kg/day. There was no evidence of developmental toxicity or indications of E:\FR\FM\25JYR1.SGM 25JYR1 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations neonatal sensitivity in the developmental and reproduction toxicity studies (rats and rabbits). In the rat developmental toxicity study, decreased body weights and decreased food consumption were observed. There were also slight decreases observed in fetal body weight and delays in ossification observed in fetuses at the high dose. However, the minor differences were not considered adverse since there was no clear dose-response relationship and the values (both findings) fell within historical control values. Furthermore, the findings were attributed to the associated decreases in maternal body weights. There were no treatment-related effects observed in dams or offspring in the developmental toxicity study in rabbits. In the reproduction toxicity study in rats, there were decreased body weights, body weight gains, and food consumption, as well as increased kidney weights and hypertrophy in both sexes at 500 mg/kg/ day. Additionally, at 500 mg/kg/day, transient decreases in pup body weights were observed on post-natal day 4 preculling (F1 and F2 males) and post-natal day 7 (F1 females and F2 males and females); however, by post-natal day 21, all treated groups were similar to controls. The decreases observed were associated with decreased maternal body weight and food consumption and were transient in nature; thus, they were not considered adverse. Dermal exposure to florasulam did not result in systemic toxicity up to the limit dose of 1,000 mg/kg/day. There is no evidence of neurotoxicity, mutagenicity, or carcinogenicity after exposure to florasulam. In addition, there is no evidence of endocrine related toxicity. Specific information on the studies received and the nature of the adverse effects caused by florasulam 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 the document titled ‘‘Florasulam: Human Health Risk Assessment for proposed use on Turfgrass’’ (‘‘2009 Florasulam Turfgrass Assessment’’) on pages 35–39 in docket ID number EPA–HQ–OPP–2017–0226. The Agency is relying on this risk assessment because the toxicological profile for florasulam has not changed since that risk assessment was conducted and as indicated in a more recent assessment for use on teff, the Agency has concluded that registering use on teff would not alter the Agency’s previously assessed exposure estimates for florasulam. See ‘‘Florasulam: Human Health Risk Assessment for Proposed Use on Teff’’ (Dec. 6, 2017) (‘‘2017 Florasulam Teff Assessment’’), which can also be found in http:// www.regulations.gov in docket ID number EPA–HQ–OPP–2017–0226. B. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies 35143 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 summary of the toxicological endpoints for florasulam used for human risk assessment is shown in Table 1 of this unit. TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLORASULAM 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 No appropriate endpoint identified. Chronic dietary (All populations) NOAEL = 5 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.05 mg/kg/day. cPAD = 0.05 mg/kg/ day. Chronic toxicity—dogs. LOAEL = 50 mg/kg/day, based on decreased body weights (17%), body weight gains (68%), and food consumption in the females; adverse liver alterations; slight vacuolation of the zona reticularis and zona fasciculata in the adrenal gland (fatty change) in both sexes. Incidental oral short-term (1–30 days). daltland on DSKBBV9HB2PROD with RULES Acute dietary (All populations) .. NOAEL = 5 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100 Subchronic toxicity—dogs. LOAEL = 50 mg/kg/day based on hepatotoxicity (increases in alkaline phosphatase activity and hepatic vacuolation) observed in both sexes. Inhalation short-term (1–30 days). Oral study NOAEL = 5 mg/kg/day (inhalation absorption rate = 100%). UFA = 10x UFH = 10x FQPA SF = 1x LOC for MOE = 100 Subchronic toxicity—dogs. LOAEL = 50 mg/kg/day based on hepatotoxicity (increases in alkaline phosphatase activity and hepatic vacuolation) observed in both sexes. VerDate Sep<11>2014 16:20 Jul 24, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\FR\FM\25JYR1.SGM 25JYR1 35144 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FLORASULAM FOR USE IN HUMAN HEALTH RISK ASSESSMENT—Continued Exposure/scenario Cancer (Oral, dermal, inhalation). Point of departure and uncertainty/safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Not Likely to be Carcinogenic to Humans. 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). daltland on DSKBBV9HB2PROD with RULES C. Exposure Assessment 1. Dietary exposure from food and feed uses. EPA’s most recent quantitative dietary assessment was conducted in connection with the registration of turfgrass uses for florasulam. See 2009 Florasulam Turfgrass Assessment. That document considered dietary exposure for residues of florasulam in food associated with the all existing florasulam tolerances in 40 CFR 180.633 as described in Unit III.C.1. of the 2007 rulemaking establishing those tolerances. 72 FR 55073 (Sept. 28, 2007). EPA has determined that approval of the use on teff will not change those dietary exposure estimates for residues of florasulam in or on food. The Agency expects residues on teff to be similar to those residues in or on wheat because of the similarity in use pattern and application rates. Teff is prepared like other whole grains, such as rice and barley, and may also be used to make flour in a manner similar to wheat and other cereal grains. As a flour, the Agency expects that teff will likely substitute in the diet for cereal grain foods rather than add to dietary exposure. With respect to livestock commodities, residues of florasulam in teff livestock feeds are expected to be similar to those in other forages, hays, and silages for which florasulam is currently registered. Therefore, there would be no increase in the livestock dietary burden should teff be substituted in the livestock diet for other hays and silages; residues in meat, milk, poultry and eggs will remain the same. 2. Dietary exposure from drinking water. In the 2009 Florasulam Turfgrass Assessment, the Agency used screeninglevel water exposure models in the dietary exposure analysis and risk assessment for florasulam in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of florasulam. Further information regarding EPA drinking VerDate Sep<11>2014 16:20 Jul 24, 2018 Jkt 244001 water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. To arrive at the total EDWC (estimated drinking water concentrations), the maximum surface water and ground water values for the parent was added to the maximum surface water and ground water value for the major degradate. Based on the FQPA Index Reservoir Screening Tool (FIRST), and Screening Concentration in Ground Water (SCI–GROW) models, the estimated drinking water concentrations (EDWCs) of florasulam use on turfgrass for chronic exposures are estimated to be 1.36 parts per billion (ppb) for surface water and 0.06 ppb for ground water. The Agency has concluded that the teff use will not increase drinking water exposure estimates because the teff use pattern is similar to the use patterns on wheat and barley. The wheat and barley use patterns yield EDWCs that are approximately nine times lower than the use on turfgrass and thus would not be used to assess dietary exposure. Therefore, the Agency used the same modeled estimates of drinking water concentrations from the 2009 Florasulam Turfgrass Assessment: For the chronic dietary risk assessment, the water concentration of value 1.36 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, termiticides, and flea and tick control on pets). Florasulam is currently registered for the following uses that could result in residential exposures: Turf. The new use on teff is not a residential use. Therefore, EPA is relying on its 2009 Florasulam Turfgrass Assessment to assess residential exposures. EPA assessed residential exposure using the following assumptions: Short-term PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 inhalation exposure is expected to handlers as a result of applying florasulam to turf. There is no shortterm dermal endpoint for florasulam, and therefore, no dermal risks were assessed for residential handlers. The scenarios assessed for handlers was mixing/loading/applying florasulam to turf with various application equipment. For post-application, the Agency determined there is a potential for exposure from entering florasulamtreated residential areas, such as lawns, sports fields, and golf courses that could lead to post-application exposures to adults and children. No short-term dermal point of departure was identified for florasulam. Therefore, no dermal risks were assessed for residential postapplication exposures. The Agency assumed that inhalation exposures are minimal following outdoor applications of an active ingredient with low vapor pressure. Since the proposed use of florasulam include only outdoor applications and florasulam has a low vapor pressure, post-application inhalation exposures and risks were not assessed. The scenario resulting in the highest exposure was short-term incidental oral risks for toddlers after applications of florasulam to lawns. The exposure scenarios include hand to mouth, object to mouth, incidental soil ingestion and the combination of all three of these scenarios. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://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 E:\FR\FM\25JYR1.SGM 25JYR1 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES substances that have a common mechanism of toxicity.’’ EPA has not found florasulam to share a common mechanism of toxicity with any other substances, and florasulam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that florasulam does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at http:// 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. There was no evidence of developmental toxicity or indications of neonatal sensitivity in the developmental and reproduction toxicity studies (rats and rabbits). In the rat developmental toxicity study (750 mg/kg/day) body weights were decreased by 4–6% during gestation days 6–19, resulting in a 16% decrease in body weight gains during treatment (gestation days 6–16); food consumption was also decreased (not statistically analyzed) by 6–13% during the treatment period. Additionally, at this dose, absolute and relative (to body weight) kidney weights were increased (p<= 0.05) by 8 and 12%, respectively. At 250 and 750 mg/kg/day, slight decreases (3–4%) were observed in fetal body weight. Additionally, there were delays in ossification observed in fetuses at 750 mg/kg/day. However, the minor differences were not considered adverse since there was no clear doseresponse and the values (both findings) fell within historical control values. VerDate Sep<11>2014 16:20 Jul 24, 2018 Jkt 244001 Furthermore, the findings were attributed to the associated decreases in maternal body weights. There were no treatment-related effects observed in dams or offspring in the developmental toxicity study in rabbits. In the reproduction toxicity study in rats, there were decreased body weights, body weight gains, and food consumption, as well as increased kidney weights and hypertrophy in both sexes at 500 mg/kg/ day. Additionally, at 500 mg/kg/day, transient decreases in pup body weights were observed on post-natal day 4 preculling (F1 and F2 males) and post-natal day 7 (F1 females and F2 males and females); however, by post-natal day 21, all treated groups were similar to controls. The decreases observed were associated with decreased maternal body weight and food consumption and were transient in nature; thus, they were not considered adverse 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 florasulam is complete. ii. There is no indication that florasulam is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. There is no evidence that florasulam results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. 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 florasulam in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by florasulam. 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 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 35145 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 selected. Therefore, florasulam 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 florasulam from food and water will utilize less than 1% of the cPAD for all population groups. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of florasulam 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). Florasulam 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 florasulam. 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 children, 98,000 for the general U.S. population, and 114,000 for adult females. Because EPA’s level of concern for florasulam 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, florasulam 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 E:\FR\FM\25JYR1.SGM 25JYR1 35146 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for florasulam. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, florasulam 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 florasulam residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (capillary gas chromatography and mass selective detection (GC–MSD)) is available to enforce 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 a MRL for florasulam on teff. daltland on DSKBBV9HB2PROD with RULES C. Response to Comments A single comment was received that appeared to be in support of the petition and read in part that ‘‘the proposed regulation of pesticide residuals is . . . a very reasonable proposal.’’ The commenter also expressed concern regarding the consequences for not VerDate Sep<11>2014 16:20 Jul 24, 2018 Jkt 244001 meeting the residue levels. The commenter’s concern is outside the scope of this rulemaking, which is concerned with assessing the safety of these tolerances. V. Conclusion Therefore, tolerances are established for residues of florasulam, including its metabolites and degradates, in or on teff, forage at 0.05 ppm; teff, grain at 0.01 ppm; teff, hay at 0.05 ppm; and teff, straw at 0.05 ppm. In addition, in accordance with Agency policy, EPA is revising the introductory language in paragraph (a) to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of florasulam not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression. 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), nor is it considered a regulatory action under Executive Order 13771, entitled ‘‘Reducing Regulations and Controlling Regulatory Costs’’ (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 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. E:\FR\FM\25JYR1.SGM 25JYR1 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES Dated: July 16, 2018. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for Therefore, 40 CFR chapter I is suspension on the effective dates listed amended as follows: within this rule because of noncompliance with the floodplain PART 180—[AMENDED] management requirements of the program. If the Federal Emergency ■ 1. The authority citation for part 180 Management Agency (FEMA) receives continues to read as follows: documentation that the community has Authority: 21 U.S.C. 321(q), 346a and 371. adopted the required floodplain ■ 2. In § 180.633: management measures prior to the ■ i. Revise paragraph (a) introductory effective suspension date given in this text; and rule, the suspension will not occur and ■ ii. Add alphabetically the a notice of this will be provided by commodities ‘‘Teff, forage,’’ ‘‘Teff, publication in the Federal Register on a grain,’’ ‘‘Teff, hay,’’ and ‘‘Teff, straw’’ to subsequent date. Also, information the table in paragraph (a). identifying the current participation The revision and additions read as status of a community can be obtained follows: from FEMA’s Community Status Book (CSB). The CSB is available at https:// § 180.633 Florasulam; tolerances for www.fema.gov/national-floodresidues. insurance-program-community-status(a) General. Tolerances are book. established for residues of the herbicide DATES: The effective date of each florasulam, including its metabolites community’s scheduled suspension is and degradates, in or on the the third date (‘‘Susp.’’) listed in the commodities below. Compliance with the tolerance levels specified below is to third column of the following tables. FOR FURTHER INFORMATION CONTACT: If be determined by measuring only you want to determine whether a florasulam, N-(2, 6-difluorophenyl)-8particular community was suspended fluoro-5-methoxy (1, 2, 4) triazole (1, 5on the suspension date or for further c)pyrimidine-2-sulfonamide, in or on information, contact Adrienne L. the commodities. Sheldon, PE, CFM, Federal Insurance and Mitigation Administration, Federal Parts per Commodity million Emergency Management Agency, 400 C Street SW, Washington, DC 20472, (202) 212–3966. * * * * * SUPPLEMENTARY INFORMATION: The NFIP Teff, forage ............................... 0.05 Teff, grain ................................. 0.01 enables property owners to purchase Teff, hay .................................... 0.05 Federal flood insurance that is not Teff, straw ................................. 0.05 otherwise generally available from private insurers. In return, communities * * * * * agree to adopt and administer local floodplain management measures aimed * * * * * at protecting lives and new construction [FR Doc. 2018–15916 Filed 7–24–18; 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 insurance unless an appropriate public DEPARTMENT OF HOMELAND body adopts adequate floodplain SECURITY management measures with effective enforcement measures. The Federal Emergency Management communities listed in this document no Agency longer meet that statutory requirement for compliance with program 44 CFR Part 64 regulations, 44 CFR part 59. [Docket ID FEMA–2018–0002: Internal Accordingly, the communities will be Agency Docket No. FEMA–8539] suspended on the effective date in the third column. As of that date, flood Suspension of Community Eligibility insurance will no longer be available in the community. We recognize that some AGENCY: Federal Emergency of these communities may adopt and Management Agency, DHS. submit the required documentation of ACTION: Final rule. legally enforceable floodplain VerDate Sep<11>2014 16:20 Jul 24, 2018 Jkt 244001 SUMMARY: PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 35147 management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register. In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA’s initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed 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 E:\FR\FM\25JYR1.SGM 25JYR1

Agencies

[Federal Register Volume 83, Number 143 (Wednesday, July 25, 2018)]
[Rules and Regulations]
[Pages 35141-35147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15916]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0226; FRL-9979-81]


Florasulam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
florasulam in or on teff forage, teff grain, teff hay, and teff straw. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 25, 2018. Objections and 
requests for hearings must be received on or before September 24, 2018, 
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-2017-0226, 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 Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following

[[Page 35142]]

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-2017-0226 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 
September 24, 2018. 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-2017-0226, 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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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 
7E8549) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR part 180 be amended by establishing tolerances 
for residues of the herbicide florasulam N-(2,6-difluorophenyl)-8-
fluoro-5-methoxy (1,2,4)triazolo(1,5-c)pyrimidine-2-sulfonamide in or 
on the raw agricultural commodities teff, forage at 0.05 parts per 
million (ppm); teff, grain at 0.01 ppm; teff, straw at 0.05 ppm; and 
teff, hay at 0.05 ppm. That document referenced a summary of the 
petition prepared by Dow AgroSciences, the registrant, which is 
available in the docket, http://www.regulations.gov. A comment was 
received on the notice of filing. EPA's response to this comment is 
discussed 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 florasulam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with florasulam 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.
    There was slight nephrotoxicity (increased kidney weights, 
hypertrophy, and degeneration/regeneration and inflammation of the 
descending portion of proximal tubules) observed in the kidneys of rats 
(both sexes) after subchronic exposure to florasulam (90 days) at or 
greater than 500 milligrams/kilogram/day (mg/kg/day). Chronic exposure 
in rats led to slight nephrotoxicity (increased kidney weights, 
hypertrophy, and slight multi-focal mineralization of the papilla) at 
250 and 500 mg/kg/day in males only. Additionally, at 500 mg/kg/day, 
papillary necrosis and hyperplasia of the transitional epithelium 
(papilla) were observed in the kidney (males). Decreases in body weight 
and body weight gain were also observed in females after subchronic 
(500 mg/kg/day) and chronic exposure (250 mg/kg/day). Liver toxicity 
was observed in dogs (both sexes) in the form of increased alkaline 
phosphatase activity (59-127%), increased liver weights, hypertrophy, 
and hepatic vacuolation at 50 mg/kg/day after 90 days. After 1 year, 
there were increases in alkaline phosphatase (233-783%) in dogs (both 
sexes) but no changes in liver weights or gross or microscopic 
pathology at 50 mg/kg/day. Additionally, there were decreases in body 
weight, body weight gain and food consumption, as well as vacuolation 
of the zona reticularis and zona fasciculate in the adrenal gland 
(consistent with fatty change) in both sexes. There were no adverse 
effects noted after subchronic/chronic exposure to florasulam in mice 
up to the limit dose of 1,000 mg/kg/day.
    There was no evidence of developmental toxicity or indications of

[[Page 35143]]

neonatal sensitivity in the developmental and reproduction toxicity 
studies (rats and rabbits). In the rat developmental toxicity study, 
decreased body weights and decreased food consumption were observed. 
There were also slight decreases observed in fetal body weight and 
delays in ossification observed in fetuses at the high dose. However, 
the minor differences were not considered adverse since there was no 
clear dose-response relationship and the values (both findings) fell 
within historical control values. Furthermore, the findings were 
attributed to the associated decreases in maternal body weights. There 
were no treatment-related effects observed in dams or offspring in the 
developmental toxicity study in rabbits. In the reproduction toxicity 
study in rats, there were decreased body weights, body weight gains, 
and food consumption, as well as increased kidney weights and 
hypertrophy in both sexes at 500 mg/kg/day. Additionally, at 500 mg/kg/
day, transient decreases in pup body weights were observed on post-
natal day 4 pre-culling (F1 and F2 males) and post-natal day 7 (F1 
females and F2 males and females); however, by post-natal day 21, all 
treated groups were similar to controls. The decreases observed were 
associated with decreased maternal body weight and food consumption and 
were transient in nature; thus, they were not considered adverse.
    Dermal exposure to florasulam did not result in systemic toxicity 
up to the limit dose of 1,000 mg/kg/day. There is no evidence of 
neurotoxicity, mutagenicity, or carcinogenicity after exposure to 
florasulam. In addition, there is no evidence of endocrine related 
toxicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by florasulam 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 the document titled ``Florasulam: Human Health 
Risk Assessment for proposed use on Turfgrass'' (``2009 Florasulam 
Turfgrass Assessment'') on pages 35-39 in docket ID number EPA-HQ-OPP-
2017-0226. The Agency is relying on this risk assessment because the 
toxicological profile for florasulam has not changed since that risk 
assessment was conducted and as indicated in a more recent assessment 
for use on teff, the Agency has concluded that registering use on teff 
would not alter the Agency's previously assessed exposure estimates for 
florasulam. See ``Florasulam: Human Health Risk Assessment for Proposed 
Use on Teff'' (Dec. 6, 2017) (``2017 Florasulam Teff Assessment''), 
which can also be found in http://www.regulations.gov in docket ID 
number EPA-HQ-OPP-2017-0226.

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 florasulam used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Florasulam 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 endpoint identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 5 mg/kg/day.  Chronic RfD = 0.05   Chronic toxicity--dogs.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 50 mg/kg/day, based on
                                   UFH = 10x...........  cPAD = 0.05 mg/kg/    decreased body weights (17%),
                                   FQPA SF = 1x........   day.                 body weight gains (68%), and food
                                                                               consumption in the females;
                                                                               adverse liver alterations; slight
                                                                               vacuolation of the zona
                                                                               reticularis and zona fasciculata
                                                                               in the adrenal gland (fatty
                                                                               change) in both sexes.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1-30   NOAEL = 5 mg/kg/day.  LOC for MOE = 100..  Subchronic toxicity--dogs.
 days).                            UFA = 10x...........                       LOAEL = 50 mg/kg/day based on
                                   UFH = 10x...........                        hepatotoxicity (increases in
                                   FQPA SF = 1x........                        alkaline phosphatase activity and
                                                                               hepatic vacuolation) observed in
                                                                               both sexes.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1-30 days)  Oral study NOAEL = 5  LOC for MOE = 100..  Subchronic toxicity--dogs.
                                    mg/kg/day                                 LOAEL = 50 mg/kg/day based on
                                    (inhalation                                hepatotoxicity (increases in
                                    absorption rate =                          alkaline phosphatase activity and
                                    100%).                                     hepatic vacuolation) observed in
                                   UFA = 10x...........                        both sexes.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------

[[Page 35144]]

 
Cancer (Oral, dermal, inhalation)  Not Likely to be Carcinogenic to Humans.
----------------------------------------------------------------------------------------------------------------
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. EPA's most recent 
quantitative dietary assessment was conducted in connection with the 
registration of turfgrass uses for florasulam. See 2009 Florasulam 
Turfgrass Assessment. That document considered dietary exposure for 
residues of florasulam in food associated with the all existing 
florasulam tolerances in 40 CFR 180.633 as described in Unit III.C.1. 
of the 2007 rulemaking establishing those tolerances. 72 FR 55073 
(Sept. 28, 2007). EPA has determined that approval of the use on teff 
will not change those dietary exposure estimates for residues of 
florasulam in or on food. The Agency expects residues on teff to be 
similar to those residues in or on wheat because of the similarity in 
use pattern and application rates. Teff is prepared like other whole 
grains, such as rice and barley, and may also be used to make flour in 
a manner similar to wheat and other cereal grains. As a flour, the 
Agency expects that teff will likely substitute in the diet for cereal 
grain foods rather than add to dietary exposure. With respect to 
livestock commodities, residues of florasulam in teff livestock feeds 
are expected to be similar to those in other forages, hays, and silages 
for which florasulam is currently registered. Therefore, there would be 
no increase in the livestock dietary burden should teff be substituted 
in the livestock diet for other hays and silages; residues in meat, 
milk, poultry and eggs will remain the same.
    2. Dietary exposure from drinking water. In the 2009 Florasulam 
Turfgrass Assessment, the Agency used screening-level water exposure 
models in the dietary exposure analysis and risk assessment for 
florasulam in drinking water. These simulation models take into account 
data on the physical, chemical, and fate/transport characteristics of 
florasulam. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    To arrive at the total EDWC (estimated drinking water 
concentrations), the maximum surface water and ground water values for 
the parent was added to the maximum surface water and ground water 
value for the major degradate. Based on the FQPA Index Reservoir 
Screening Tool (FIRST), and Screening Concentration in Ground Water 
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs) 
of florasulam use on turfgrass for chronic exposures are estimated to 
be 1.36 parts per billion (ppb) for surface water and 0.06 ppb for 
ground water.
    The Agency has concluded that the teff use will not increase 
drinking water exposure estimates because the teff use pattern is 
similar to the use patterns on wheat and barley. The wheat and barley 
use patterns yield EDWCs that are approximately nine times lower than 
the use on turfgrass and thus would not be used to assess dietary 
exposure. Therefore, the Agency used the same modeled estimates of 
drinking water concentrations from the 2009 Florasulam Turfgrass 
Assessment: For the chronic dietary risk assessment, the water 
concentration of value 1.36 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, 
termiticides, and flea and tick control on pets).
    Florasulam is currently registered for the following uses that 
could result in residential exposures: Turf. The new use on teff is not 
a residential use. Therefore, EPA is relying on its 2009 Florasulam 
Turfgrass Assessment to assess residential exposures. EPA assessed 
residential exposure using the following assumptions: Short-term 
inhalation exposure is expected to handlers as a result of applying 
florasulam to turf. There is no short-term dermal endpoint for 
florasulam, and therefore, no dermal risks were assessed for 
residential handlers. The scenarios assessed for handlers was mixing/
loading/applying florasulam to turf with various application equipment.
    For post-application, the Agency determined there is a potential 
for exposure from entering florasulam-treated residential areas, such 
as lawns, sports fields, and golf courses that could lead to post-
application exposures to adults and children. No short-term dermal 
point of departure was identified for florasulam. Therefore, no dermal 
risks were assessed for residential post-application exposures.
    The Agency assumed that inhalation exposures are minimal following 
outdoor applications of an active ingredient with low vapor pressure. 
Since the proposed use of florasulam include only outdoor applications 
and florasulam has a low vapor pressure, post-application inhalation 
exposures and risks were not assessed. The scenario resulting in the 
highest exposure was short-term incidental oral risks for toddlers 
after applications of florasulam to lawns. The exposure scenarios 
include hand to mouth, object to mouth, incidental soil ingestion and 
the combination of all three of these scenarios.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://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

[[Page 35145]]

substances that have a common mechanism of toxicity.''
    EPA has not found florasulam to share a common mechanism of 
toxicity with any other substances, and florasulam does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
florasulam does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://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. There was no evidence of 
developmental toxicity or indications of neonatal sensitivity in the 
developmental and reproduction toxicity studies (rats and rabbits). In 
the rat developmental toxicity study (750 mg/kg/day) body weights were 
decreased by 4-6% during gestation days 6-19, resulting in a 16% 
decrease in body weight gains during treatment (gestation days 6-16); 
food consumption was also decreased (not statistically analyzed) by 6-
13% during the treatment period. Additionally, at this dose, absolute 
and relative (to body weight) kidney weights were increased (p<= 0.05) 
by 8 and 12%, respectively. At 250 and 750 mg/kg/day, slight decreases 
(3-4%) were observed in fetal body weight. Additionally, there were 
delays in ossification observed in fetuses at 750 mg/kg/day. However, 
the minor differences were not considered adverse since there was no 
clear dose-response and the values (both findings) fell within 
historical control values. Furthermore, the findings were attributed to 
the associated decreases in maternal body weights. There were no 
treatment-related effects observed in dams or offspring in the 
developmental toxicity study in rabbits. In the reproduction toxicity 
study in rats, there were decreased body weights, body weight gains, 
and food consumption, as well as increased kidney weights and 
hypertrophy in both sexes at 500 mg/kg/day. Additionally, at 500 mg/kg/
day, transient decreases in pup body weights were observed on post-
natal day 4 pre-culling (F1 and F2 males) and post-natal day 7 (F1 
females and F2 males and females); however, by post-natal day 21, all 
treated groups were similar to controls. The decreases observed were 
associated with decreased maternal body weight and food consumption and 
were transient in nature; thus, they were not considered adverse
    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 florasulam is complete.
    ii. There is no indication that florasulam is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that florasulam results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    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 florasulam 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 
florasulam.

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 selected. Therefore, 
florasulam 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 
florasulam from food and water will utilize less than 1% of the cPAD 
for all population groups. Based on the explanation in Unit III.C.3., 
regarding residential use patterns, chronic residential exposure to 
residues of florasulam 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).
    Florasulam 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 florasulam.
    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 
children, 98,000 for the general U.S. population, and 114,000 for adult 
females. Because EPA's level of concern for florasulam 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, 
florasulam 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

[[Page 35146]]

risk is necessary, and EPA relies on the chronic dietary risk 
assessment for evaluating intermediate-term risk for florasulam.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, florasulam 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 florasulam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromatography and 
mass selective detection (GC-MSD)) is available to enforce 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: 
[email protected].

B. International Residue Limits

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

C. Response to Comments

    A single comment was received that appeared to be in support of the 
petition and read in part that ``the proposed regulation of pesticide 
residuals is . . . a very reasonable proposal.'' The commenter also 
expressed concern regarding the consequences for not meeting the 
residue levels. The commenter's concern is outside the scope of this 
rulemaking, which is concerned with assessing the safety of these 
tolerances.

V. Conclusion

    Therefore, tolerances are established for residues of florasulam, 
including its metabolites and degradates, in or on teff, forage at 0.05 
ppm; teff, grain at 0.01 ppm; teff, hay at 0.05 ppm; and teff, straw at 
0.05 ppm.
    In addition, in accordance with Agency policy, EPA is revising the 
introductory language in paragraph (a) to clarify (1) that, as provided 
in FFDCA section 408(a)(3), the tolerance covers metabolites and 
degradates of florasulam not specifically mentioned; and (2) that 
compliance with the specified tolerance levels is to be determined by 
measuring only the specific compounds mentioned in the tolerance 
expression. EPA has determined that it is reasonable to make this 
change final without prior proposal and opportunity for comment, 
because public comment is not necessary, in that the change has no 
substantive effect on the tolerance, but rather is merely intended to 
clarify the existing tolerance expression.

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), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not 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.



[[Page 35147]]


    Dated: July 16, 2018.
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.  180.633:
0
i. Revise paragraph (a) introductory text; and
0
ii. Add alphabetically the commodities ``Teff, forage,'' ``Teff, 
grain,'' ``Teff, hay,'' and ``Teff, straw'' to the table in paragraph 
(a).
    The revision and additions read as follows:


Sec.  180.633  Florasulam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide florasulam, including its metabolites and degradates, in or 
on the commodities below. Compliance with the tolerance levels 
specified below is to be determined by measuring only florasulam, N-(2, 
6-difluorophenyl)-8-fluoro-5-methoxy (1, 2, 4) triazole (1, 5-
c)pyrimidine-2-sulfonamide, in or on the commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Teff, forage...............................................         0.05
Teff, grain................................................         0.01
Teff, hay..................................................         0.05
Teff, straw................................................         0.05
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-15916 Filed 7-24-18; 8:45 am]
BILLING CODE 6560-50-P