Saflufenacil; Pesticide Tolerances, 52215-52220 [2014-20947]

Download as PDF Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations * * Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone * number: (703) 305–7090; email address: 0.06 RDFRNotices@epa.gov. 15 SUPPLEMENTARY INFORMATION: Parts per million Commodity * * Pea, dry, seed ...................... Pea, field, hay ....................... Pea, field, vines .................... * * * * * * * 4 * * 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). * [FR Doc. 2014–20928 Filed 9–2–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0622 and EPA–HQ– OPP–2014–0124; FRL–9912–91] Saflufenacil; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes and revises tolerances for residues of saflufenacil in or on multiple commodities which are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective September 3, 2014. Objections and requests for hearings must be received on or before November 3, 2014, 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 dockets for this action, identified by docket identification (ID) numbers EPA–HQ–OPP–2013–0622 and EPA–HQ–OPP–2014–0124, are 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: Lois Rossi, Registration Division (7505P), wreier-aviles on DSK5TPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:42 Sep 02, 2014 Jkt 232001 I. General Information 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. 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 numbers EPA–HQ– OPP–2013–0622 and EPA–HQ–OPP– 2014–0124 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 November 3, 2014. 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 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 52215 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– 2013–0622 and EPA–HQ–OPP–2014– 0124, 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 October 25, 2013 (78 FR 63938) (FRL–9901–96), 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 3F8192) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research Triangle Park, NC 27709–3528. The petition requested that 40 CFR 180.649 be amended by establishing tolerances for residues of the herbicide saflufenacil, 2-chloro-5[3,6-dihydro-3-methyl-2,6-dioxo-4(trifluoromethyl)-1(2H)-pyrimidinyl]-4fluoro-N-[[methyl(1-methylethyl)amino] sulfonyl]benzamide, and its metabolites, N-[2-chloro-5-(2,6-dioxo-4(trifluoromethyl)-3,6-dihydro-1(2H)pyrimidinyl)-4-fluorobenzoyl]-N′isopropylsulfamide and N-[4-chloro-2fluoro-5-({[(isopropylamino)sulfonyl ]amino}carbonyl)phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil, in or on grass, forage at 15 parts per million (ppm); grass, hay at 20 ppm; grass, seed screenings at 0.9 ppm; and grass, straw at 1.5 ppm and revising the livestock commodity tolerances for (cattle, goat, horse, and sheep): Fat from 0.01 ppm to 0.05 ppm; liver from 2.5 ppm to 45 ppm; and meat byproducts, except liver from 0.05 ppm to 0.5 ppm; hog, fat from 0.01 ppm to 0.05 ppm; hog, liver from 0.80 ppm to 45 ppm; and hog, meat byproducts, except liver from 0.02 ppm to 0.5 ppm. The same Federal Register document of October 25, 2013, also announced E:\FR\FM\03SER1.SGM 03SER1 wreier-aviles on DSK5TPTVN1PROD with RULES 52216 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations BASF Corporation’s filing of a pesticide petition (PP 3F8185) that requested 40 CFR 180.649 be amended by revising tolerances for saflufenacil and its metabolites in or on barley, grain from 0.10 ppm to 1.0 ppm; barley, straw from 0.10 ppm to 15.0 ppm; barley, bran from 0.10 ppm to 1.53 ppm; wheat, grain from 0.10 ppm to 0.6 ppm; and wheat, straw from 0.10 ppm to 6.0 ppm, included under the existing tolerances for ‘‘Grain, cereal, group 15’’ and ‘‘Grain, cereal, forage, fodder and straw group 16.’’ In addition, BASF Corporation requested to amend the existing commodity definition, ‘‘Grain, cereal, forage, fodder and straw group 16’’ to ‘‘Grain, cereal, forage, fodder and straw, group 16, except barley, rice and wheat straw’’ as well as amend the commodity definition, ‘‘Grain, cereal, group 15’’ to ‘‘Grain, cereal, group 15, except barley and wheat.’’ Finally, in the Federal Register of February 25, 2014 (79 FR 10458) (FRL– 9906–77), 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 4F8229) by BASF Corporation. The petition requested that 40 CFR 180.649 be amended by establishing tolerances for residues of the herbicide saflufenacil, 2chloro-5-[3,6-dihydro-3-methyl-2,6dioxo-4-(trifluoromethyl)-1(2H)pyrimidinyl]-4-fluoro-N-[[methyl(1methylethyl)amino]sulfonyl]benzamide, and its metabolites, N-[2-chloro-5-(2,6dioxo-4-(trifluoromethyl)-3,6-dihydro1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N′isopropylsulfamide and N-[4-chloro-2fluoro-5-({[(isopropylamino)sulfonyl] amino}carbonyl)phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil in or on olive at 0.03 ppm. These documents referenced summaries of the petitions prepared by BASF Corporation, the petitioner, which are available in the dockets, https:// www.regulations.gov. There were no comments received in response to these notices of filings. Based upon review of the supporting data, EPA has made modifications to the proposed tolerances which include: 1. Rounding the proposed tolerance for barley, bran. 2. Revising the commodity definition for crop group 16. 3. Decreasing the proposed tolerances for grass, seed screenings and grass, straw. 4. Increasing the existing tolerance for residues in or on grain, aspirated fractions. 5. Making several changes to the proposed livestock tolerances. The reasons for these changes are explained in Unit IV.C. VerDate Mar<15>2010 14:42 Sep 02, 2014 Jkt 232001 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 saflufenacil, including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with saflufenacil 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. In the Federal Register of February 21, 2014 (79 FR 9861) (FRL–9905–87), EPA published a final rule establishing tolerances for residues of the herbicide saflufenacil and its metabolites in or on sugarcane, fish, and shellfish commodities based on EPA’s conclusion that aggregate exposure to saflufenacil is safe for the general population, including infants and children. Since that rulemaking, there have been no additional tolerance actions for saflufenacil, nor has the toxicity profile for saflufenacil changed. Specific information on the studies received and the nature of the adverse effects caused by saflufenacil, as well as PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 the no-observed-adverse-effect-level (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies are discussed in that rulemaking which can be found in the docket under docket ID numbers EPA– HQ–OPP–2012–0775 and EPA–HQ– OPP–2013–0008. 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 lowest dose at which the LOAEL are identified. Uncertainty/safety factors (UFs) are used in conjunction with the POD to calculate a safe exposure level— generally referred to as a populationadjusted 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://www.epa.gov/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for saflufenacil used for human risk assessment is discussed in Unit III.B. of the February 21, 2014 Federal Register final rule. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to saflufenacil, EPA considered exposure under the petitioned-for tolerances as well as all existing saflufenacil tolerances in 40 CFR 180.649. EPA assessed dietary exposures from saflufenacil in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for saflufenacil. In estimating acute dietary exposure, EPA used food E:\FR\FM\03SER1.SGM 03SER1 wreier-aviles on DSK5TPTVN1PROD with RULES Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations consumption information from the United States Department of Agriculture National Health and Nutrition Examination Survey, What We Eat in America, (USDA NHANES/WWEIA, 2003–2008). As to residue levels in food, EPA assumed 100 percent crop treated (PCT), Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors, and tolerance-level or higher (i.e., tolerance levels adjusted to take into account metabolite levels) residues for all foods. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA NHANES/WWEIA, 2003–2008. As to residue levels in food, EPA made the same assumptions (adjusted tolerance-level residues and 100 PCT) as in the acute dietary exposure assessment. iii. Cancer. As indicated in the February 21, 2014 Federal Register final rule preamble for saflufenacil, EPA has concluded that saflufenacil 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 and/or PCT information in the dietary assessment for saflufenacil. Tolerance-level residues (or higher) and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for saflufenacil in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of saflufenacil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/oppefed1/models/ water/index.htm. Based on the Tier 1 Rice Model and Tier II Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of saflufenacil for acute exposures are estimated to be 133 parts per billion (ppb) for surface water and 69.2 ppb for ground water. Chronic exposures for non-cancer assessments are estimated to be 120 ppb for surface water and 51.5 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 133 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of VerDate Mar<15>2010 14:42 Sep 02, 2014 Jkt 232001 value 120 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). Saflufenacil is not registered for any specific use patterns that would result in residential exposure. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found saflufenacil to share a common mechanism of toxicity with any other substances, and saflufenacil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that saflufenacil 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:// www.epa.gov/pesticides/cumulative. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the 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. Increased fetal susceptibility was observed in the developmental toxicity studies in the rat and rabbit and in the 2-generation reproduction study in the rat. Developmental effects (decreased fetal body weights and increased skeletal variations in rats and increased PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 52217 liver porphyrins in rabbits) occurred at doses that were not maternally toxic in the developmental studies, indicating increased quantitative susceptibility. In the 2-generation reproductive toxicity study in rats, the reported offspring effects were more severe than the maternal effects at the same dose level, indicating evidence for increased qualitative susceptibility. An increased number of stillborn pups, decreased viability and lactation indices, decreased pre-weaning body weight and/or body-weight gain, and changes in hematological parameters occurred at the same dose level as maternal decrements in food intake, body weight, body-weight gain, and changes in hematological parameters and organ weights indicative of anemia. 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 saflufenacil is complete. ii. There is no indication that saflufenacil is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. The concern for increased susceptibility following prenatal or postnatal exposure is low because clear NOAELs/LOAELs were established for the developmental effects seen in rats and rabbits as well as for the offspring effects seen in the 2-generation reproductive toxicity study. Further, the dose-response relationship for the effects of concern is also well characterized and being used for assessing risks. None of the effects in the developmental or reproduction studies were attributable to a single exposure and, therefore, are not of concern for acute risk assessment. The chronic point of departure used for risk assessment is protective of any developmental and offspring effects observed in these studies. 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 saflufenacil in drinking water. These assessments will not underestimate the exposure and risks posed by saflufenacil. E:\FR\FM\03SER1.SGM 03SER1 52218 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations wreier-aviles on DSK5TPTVN1PROD with RULES E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to saflufenacil will occupy <1% of the aPAD for infants less than 1-year old, the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to saflufenacil from food and water will utilize 20% of the cPAD for infants less than 1-year old, the population group receiving the greatest exposure. There are no residential uses for saflufenacil. 3. Short and intermediate-term risk. Short and intermediate-term aggregate exposure takes into account short and intermediate-term residential exposures plus chronic exposure to food and water (considered to be a background exposure level). Because there is no short or 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 short-term risk), no further assessment of short or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for saflufenacil. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, saflufenacil is not expected to pose a cancer risk to humans. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to saflufenacil residues. VerDate Mar<15>2010 14:42 Sep 02, 2014 Jkt 232001 IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methods ‘‘D0603/02’’ and ‘‘L0073/01’’ (liquid chromatography/mass spectroscopy/ mass spectroscopy (LC–MS/MS)) are available to enforce the tolerance expression. These methods 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. There are MRLs established for residues of saflufenacil, measuring the levels of the parent only and not residues of the metabolites, as follows: 0.01 ppm in or on cereal grains, which includes barley, corn, and wheat; 0.05 ppm for maize fodder (dry), sorghum straw and fodder, dry; 0.05 ppm for barley straw and fodder, dry; 0.05 ppm for wheat straw and fodder, dry; 0.01 mammalian fats (except milk fats), which includes cattle, goat, hog, horse, and sheep; and 0.3 edible offal mammalian, which includes cattle, goat, hog, horse, and sheep. Harmonization between the Codex MRLs for cereal grains and the U.S. tolerances for barley, grain and wheat, grain and between the Codex MRL for barley straw and fodder, dry and the U.S. tolerance for barley, straw and between the Codex MRL for wheat straw and fodder, dry and the U.S. tolerance for wheat, straw is not possible as the U.S. use pattern (harvest-aide/ burndown application) results in significantly higher residues than the Codex use pattern (pre-emergence application). The higher residues PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 translate into higher residues of saflufenacil in animal byproducts than are covered by the corresponding Codex MRLs for livestock commodities under the Codex use pattern; therefore, U.S. tolerances for livestock commodities cannot be harmonized with Codex MRLs for corresponding livestock commodities. The U.S. tolerances for crop groups 15 and 16 are not harmonized with the Codex MRLs for cereal grains and straw and fodder because the compliance with the Codex MRLs involve measurement of residues of the parent only and not the metabolites, whereas the U.S. tolerance requires measurement of both, in order to be harmonized with Canadian tolerances. C. Revisions to Petitioned-for Tolerances EPA is making several revisions to the petitioned-for tolerances. These include the following. First, the petitioned value for barley bran is being rounded from 1.53 ppm to 1.5 ppm to be consistent with the current Organization for Economic Cooperation and Development (OECD) tolerancecalculation procedure. Second, the commodity definition ‘‘Grain, cereal, forage, fodder, and straw group 16 (except barley, wheat and rice straw)’’ is being revised to ‘‘Grain, cereal, forage, fodder and straw group 16 (except barley and wheat straw)’’ as the new use pattern (harvest aid/desiccant) was not proposed for rice. Third, the petitioner requested tolerance values for grass straw and seed screenings were based on data from trials in which the samples were harvested at a significantly shorter preharvest interval (PHI) than that listed on the label. Additional residue data reflecting the actual PHI listed on the label showed lower residue levels; therefore, the tolerance values for grass straw and seed screenings are being decreased. Fourth, the existing tolerance of 10 ppm for residues in or on grain, aspirated fractions is being increased to 50 ppm as a result of the new tolerances for cereal grains and based on available residues data. Finally, EPA is making several revisions to the proposed livestock tolerances which include: 1. Decreasing the proposed tolerances for cattle, goat, sheep, hog and horse fat from 0.05 ppm to 0.04 ppm and meat byproducts (except liver) from 0.05 ppm to 0.03 ppm. 2. Increasing the tolerances proposed for cattle, goat, sheep and horse liver from 45 ppm to 50 ppm. 3. Decreasing the tolerance proposed for hog liver from 45 ppm to 2.0 ppm. 4. Establishing tolerances for cattle, goat, sheep and horse meat at 0.02 ppm. E:\FR\FM\03SER1.SGM 03SER1 52219 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations 5. Retaining the currently established tolerances for hog, fat or hog, meat byproducts (except liver), instead of increasing them as requested. The tolerances being set for residues in livestock differ from the petitionedfor tolerances due to differences in calculation methods of the maximum reasonably balanced diets (MRBDs) with the results of the ruminant feeding study. It also appears that the petitioner over-estimated residues in hog commodities as a result of using the cattle MRDB. wreier-aviles on DSK5TPTVN1PROD with RULES V. Conclusion Therefore, tolerances are established for residues of saflufenacil, including its metabolites and degradates, as set forth in the regulatory text. Compliance with the plant tolerances is to be determined by measuring the sum of saflufenacil, 2chloro-5-[3,6-dihydro-3-methyl-2,6dioxo-4-(trifluoromethyl)-1(2H)pyrimidinyl]-4-fluoro-N-[[methyl(1methylethyl)amino]sulfonyl]benzamide, and its metabolites N-[2-chloro-5-(2,6dioxo-4-(trifluoromethyl)-3,6-dihydro1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N’isopropylsulfamide and N-[4-chloro-2fluoro-5-({[(isopropylamino) sulfonyl]amino}carbonyl)phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil. Compliance with the livestock tolerances is to be determined by measuring only saflufenacil, 2-chloro-5-[3,6-dioxo-4(trifluoromethyl)-3,6-dihydro-1(2H)pyrimidinyl)-4-fluoro-N-[[methyl(1methylethyl)amino]sulfonyl]benzamide. VI. Statutory and Executive Order Reviews This final rule 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 final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 VerDate Mar<15>2010 14:42 Sep 02, 2014 Jkt 232001 ‘‘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 final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (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). and pests, Reporting and recordkeeping requirements. Dated: August 25, 2014. Lois Rossi, 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 § 180.649: a. Remove the commodities ‘‘Grain, aspirated fractions,’’ ‘‘Grain, cereal, forage, fodder and straw group 16,’’ and ‘‘Grain, cereal, group 15’’ in the table in paragraph (a)(1). ■ b. Add alphabetically the following commodities to the table in paragraph (a)(1). ■ c. Revise the following commodities in the table in paragraph (a)(2). The amendments read as follows: ■ ■ § 180.649 Saflufenacil; tolerances for residues. (a) * * * (1) * * * Parts per million Commodity * * * Barley, bran ........................ Barley, grain ....................... Barley, straw ....................... * * 1.5 1.0 15 * * * Grain, aspirated grain fractions ................................. Grain, cereal, forage, fodder and straw group 16 (except barley and wheat straw) .............................. Grain, cereal, group 15 (except barley and wheat grain) ............................... * * * Grass, Grass, Grass, Grass, * * forage ...................... hay .......................... seed screenings ...... straw ....................... * * 15 20 0.15 0.15 * * * Olive .................................... * * 0.03 * * * Wheat, grain ....................... Wheat, straw ....................... * * 0.60 6.0 * * * (2) * * * * 50 0.10 0.03 * List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 Commodity Cattle, fat ............................ E:\FR\FM\03SER1.SGM 03SER1 Parts per million 0.04 52220 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Rules and Regulations Parts per million Commodity Cattle, Cattle, Cattle, cept liver .......................... meat ........................ meat byproducts, exliver .......................... 50 0.02 0.30 * * * Goat, fat .............................. Goat, liver ........................... Goat, meat .......................... Goat, meat byproducts, except liver .......................... * * * * Hog, liver ............................ * * 2.0 * * * Horse, fat ............................ Horse, liver ......................... Horse, meat ........................ Horse, meat byproducts, except liver ...................... * * 0.04 50 0.02 * * * Sheep, fat ........................... Sheep, liver ......................... Sheep, meat ....................... Sheep, meat byproducts, except liver ...................... * * * * * * 0.04 50 0.02 0.30 0.30 * 0.04 50 0.02 0.30 * [FR Doc. 2014–20947 Filed 9–2–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [EPA–R06–RCRA–2013–0624 FRL 9915–99– Region 6] Texas: Final Authorization of State Hazardous Waste Management Program Revision Environmental Protection Agency (EPA). ACTION: Direct final rule. AGENCY: The State of Texas has applied to the Environmental Protection Agency (EPA) for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA has determined that these changes satisfy all requirements needed to qualify for Final authorization, and is authorizing the State’s changes through this direct final action. The EPA is publishing this rule to authorize the changes without a prior proposal because we believe this action is not controversial and do not expect comments that oppose it. Unless we receive written comments which oppose this authorization during the comment period, the decision to authorize Texas’ changes to its hazardous waste program wreier-aviles on DSK5TPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 14:42 Sep 02, 2014 Jkt 232001 will take effect. If we receive comments that oppose this action, we will publish a document in the Federal Register withdrawing this rule before it takes effect, and a separate document in the proposed rules section of this Federal Register will serve as a proposal to authorize the changes. DATES: This final authorization will become effective on November 3, 2014 unless the EPA receives adverse written comment by October 3, 2014. If the EPA receives such comment, it will publish a timely withdrawal of this direct final rule in the Federal Register and inform the public that this authorization will not take effect. ADDRESSES: Submit your comments by one of the following methods: 1. Federal eRulemaking Portal: https://www.regulations.gov. Follow the on-line instructions for submitting comments. 2. Email: patterson.alima@epa.gov. 3. Mail: Alima Patterson, Region 6, Regional Authorization Coordinator, State/Tribal Oversight Section (6PD–O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202–2733. 4. Hand Delivery or Courier. Deliver your comments to Alima Patterson, Region 6, Regional Authorization Coordinator, State/Tribal Oversight Section (6PD–O), Multimedia Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202– 2733. Instructions: Do not submit information that you consider to be CBI or otherwise protected through regulations.gov, or email. The Federal regulations.gov Web site is an ‘‘anonymous access’’ system, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. You can view and copy Texas’ application and associated PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 publicly available materials from 8:30 a.m. to 4 p.m. Monday through Friday at the following locations: Texas Commission on Environmental Quality, (TCEQ) 12100 Park S. Circle, Austin Texas 78753–3087, (512) 239–6079 and EPA, Region 6, 1445 Ross Avenue, Dallas, Texas 75202–2733, phone number (214) 665–8533. Interested persons wanting to examine these documents should make an appointment with the office at least two weeks in advance. FOR FURTHER INFORMATION CONTACT: Alima Patterson, Region 6 Regional Authorization Coordinator, State/Tribal Oversight Section (6PD–O), Multimedia Planning and Permitting Division, (214) 665–8533, EPA Region 1445 Ross Avenue, Dallas, Texas 75202–2733, and Email address patterson.alima@epa.gov. SUPPLEMENTARY INFORMATION: A. Why are revisions to State programs necessary? States which have received final authorization from the EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask the EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to the EPA’s regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279. B. What decisions have we made in this rule? We conclude that the State of Texas’ application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant the State of Texas Final Authorization to operate its hazardous waste program with the changes described in the authorization application. The State of Texas has responsibility for permitting treatment, storage, and disposal facilities within its borders (except in Indian Country) and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that the EPA promulgates under the authority of HSWA take effect in authorized States before they are E:\FR\FM\03SER1.SGM 03SER1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Rules and Regulations]
[Pages 52215-52220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20947]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0622 and EPA-HQ-OPP-2014-0124; FRL-9912-91]

Saflufenacil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and revises tolerances for
residues of saflufenacil in or on multiple commodities which are
identified and discussed later in this document. BASF Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective September 3, 2014. Objections and
requests for hearings must be received on or before November 3, 2014,
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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2013-0622 and EPA-HQ-OPP-2014-
0124, are 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: Lois Rossi, 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/Title40/40tab02.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 numbers EPA-HQ-OPP-2013-0622 and EPA-HQ-OPP-2014-0124 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 November 3, 2014. 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-2013-0622 and EPA-
HQ-OPP-2014-0124, 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 October 25, 2013 (78 FR 63938) (FRL-
9901-96), 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
3F8192) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR
180.649 be amended by establishing tolerances for residues of the
herbicide saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-
(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide, and its metabolites, N-[2-chloro-
5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-
fluorobenzoyl]-N'-isopropylsulfamide and N-[4-chloro-2-fluoro-5-
({[(isopropylamino)sulfonyl]amino{time} carbonyl)phenyl]urea,
calculated as the stoichiometric equivalent of saflufenacil, in or on
grass, forage at 15 parts per million (ppm); grass, hay at 20 ppm;
grass, seed screenings at 0.9 ppm; and grass, straw at 1.5 ppm and
revising the livestock commodity tolerances for (cattle, goat, horse,
and sheep): Fat from 0.01 ppm to 0.05 ppm; liver from 2.5 ppm to 45
ppm; and meat byproducts, except liver from 0.05 ppm to 0.5 ppm; hog,
fat from 0.01 ppm to 0.05 ppm; hog, liver from 0.80 ppm to 45 ppm; and
hog, meat byproducts, except liver from 0.02 ppm to 0.5 ppm.
The same Federal Register document of October 25, 2013, also
announced

[[Page 52216]]

BASF Corporation's filing of a pesticide petition (PP 3F8185) that
requested 40 CFR 180.649 be amended by revising tolerances for
saflufenacil and its metabolites in or on barley, grain from 0.10 ppm
to 1.0 ppm; barley, straw from 0.10 ppm to 15.0 ppm; barley, bran from
0.10 ppm to 1.53 ppm; wheat, grain from 0.10 ppm to 0.6 ppm; and wheat,
straw from 0.10 ppm to 6.0 ppm, included under the existing tolerances
for ``Grain, cereal, group 15'' and ``Grain, cereal, forage, fodder and
straw group 16.'' In addition, BASF Corporation requested to amend the
existing commodity definition, ``Grain, cereal, forage, fodder and
straw group 16'' to ``Grain, cereal, forage, fodder and straw, group
16, except barley, rice and wheat straw'' as well as amend the
commodity definition, ``Grain, cereal, group 15'' to ``Grain, cereal,
group 15, except barley and wheat.''
Finally, in the Federal Register of February 25, 2014 (79 FR 10458)
(FRL-9906-77), 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 4F8229) by BASF Corporation. The petition requested that
40 CFR 180.649 be amended by establishing tolerances for residues of
the herbicide saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-
4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide, and its metabolites, N-[2-chloro-
5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-
fluorobenzoyl]-N'-isopropylsulfamide and N-[4-chloro-2-fluoro-5-
({[(isopropylamino)sulfonyl]amino{time} carbonyl)phenyl]urea,
calculated as the stoichiometric equivalent of saflufenacil in or on
olive at 0.03 ppm. These documents referenced summaries of the
petitions prepared by BASF Corporation, the petitioner, which are
available in the dockets, https://www.regulations.gov. There were no
comments received in response to these notices of filings.
Based upon review of the supporting data, EPA has made
modifications to the proposed tolerances which include:
1. Rounding the proposed tolerance for barley, bran.
2. Revising the commodity definition for crop group 16.
3. Decreasing the proposed tolerances for grass, seed screenings
and grass, straw.
4. Increasing the existing tolerance for residues in or on grain,
aspirated fractions.
5. Making several changes to the proposed livestock tolerances.
The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for saflufenacil, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with saflufenacil
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. In the Federal Register of February 21, 2014 (79 FR 9861)
(FRL-9905-87), EPA published a final rule establishing tolerances for
residues of the herbicide saflufenacil and its metabolites in or on
sugarcane, fish, and shellfish commodities based on EPA's conclusion
that aggregate exposure to saflufenacil is safe for the general
population, including infants and children. Since that rulemaking,
there have been no additional tolerance actions for saflufenacil, nor
has the toxicity profile for saflufenacil changed. Specific information
on the studies received and the nature of the adverse effects caused by
saflufenacil, as well as the no-observed-adverse-effect-level (NOAEL)
and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies are discussed in that rulemaking which can be found in the
docket under docket ID numbers EPA-HQ-OPP-2012-0775 and EPA-HQ-OPP-
2013-0008.

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 lowest dose at which the
LOAEL are identified. Uncertainty/safety factors (UFs) 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://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the
toxicological endpoints for saflufenacil used for human risk assessment
is discussed in Unit III.B. of the February 21, 2014 Federal Register
final rule.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to saflufenacil, EPA considered exposure under the petitioned-
for tolerances as well as all existing saflufenacil tolerances in 40
CFR 180.649. EPA assessed dietary exposures from saflufenacil in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for saflufenacil. In estimating acute dietary exposure, EPA used food

[[Page 52217]]

consumption information from the United States Department of
Agriculture National Health and Nutrition Examination Survey, What We
Eat in America, (USDA NHANES/WWEIA, 2003-2008). As to residue levels in
food, EPA assumed 100 percent crop treated (PCT), Dietary Exposure
Evaluation Model (DEEM) 7.81 default processing factors, and tolerance-
level or higher (i.e., tolerance levels adjusted to take into account
metabolite levels) residues for all foods.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA, 2003-2008. As to residue levels in food, EPA made the same
assumptions (adjusted tolerance-level residues and 100 PCT) as in the
acute dietary exposure assessment.
iii. Cancer. As indicated in the February 21, 2014 Federal Register
final rule preamble for saflufenacil, EPA has concluded that
saflufenacil 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 and/or PCT information in the dietary assessment
for saflufenacil. Tolerance-level residues (or higher) and 100 PCT were
assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for saflufenacil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of saflufenacil. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier 1 Rice Model and Tier II Pesticide Root Zone
Model Ground Water (PRZM GW), the estimated drinking water
concentrations (EDWCs) of saflufenacil for acute exposures are
estimated to be 133 parts per billion (ppb) for surface water and 69.2
ppb for ground water. Chronic exposures for non-cancer assessments are
estimated to be 120 ppb for surface water and 51.5 ppb for ground
water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 133 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 120 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).
Saflufenacil is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
saflufenacil to share a common mechanism of toxicity with any other
substances, and saflufenacil does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that saflufenacil 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://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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. Increased fetal
susceptibility was observed in the developmental toxicity studies in
the rat and rabbit and in the 2-generation reproduction study in the
rat. Developmental effects (decreased fetal body weights and increased
skeletal variations in rats and increased liver porphyrins in rabbits)
occurred at doses that were not maternally toxic in the developmental
studies, indicating increased quantitative susceptibility. In the 2-
generation reproductive toxicity study in rats, the reported offspring
effects were more severe than the maternal effects at the same dose
level, indicating evidence for increased qualitative susceptibility. An
increased number of stillborn pups, decreased viability and lactation
indices, decreased pre-weaning body weight and/or body-weight gain, and
changes in hematological parameters occurred at the same dose level as
maternal decrements in food intake, body weight, body-weight gain, and
changes in hematological parameters and organ weights indicative of
anemia.
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 saflufenacil is complete.
ii. There is no indication that saflufenacil is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. The concern for increased susceptibility following prenatal or
postnatal exposure is low because clear NOAELs/LOAELs were established
for the developmental effects seen in rats and rabbits as well as for
the offspring effects seen in the 2-generation reproductive toxicity
study. Further, the dose-response relationship for the effects of
concern is also well characterized and being used for assessing risks.
None of the effects in the developmental or reproduction studies were
attributable to a single exposure and, therefore, are not of concern
for acute risk assessment. The chronic point of departure used for risk
assessment is protective of any developmental and offspring effects
observed in these studies.
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 saflufenacil in drinking water. These assessments
will not underestimate the exposure and risks posed by saflufenacil.

[[Page 52218]]

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to saflufenacil will occupy <1% of the aPAD for infants less than 1-
year old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
saflufenacil from food and water will utilize 20% of the cPAD for
infants less than 1-year old, the population group receiving the
greatest exposure. There are no residential uses for saflufenacil.
3. Short and intermediate-term risk. Short and intermediate-term
aggregate exposure takes into account short and intermediate-term
residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Because there is no
short or 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 short-
term risk), no further assessment of short or intermediate-term risk is
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short-term risk for saflufenacil.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, saflufenacil is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to saflufenacil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods ``D0603/02'' and ``L0073/01'' (liquid
chromatography/mass spectroscopy/mass spectroscopy (LC-MS/MS)) are
available to enforce the tolerance expression. These methods 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.
There are MRLs established for residues of saflufenacil, measuring
the levels of the parent only and not residues of the metabolites, as
follows: 0.01 ppm in or on cereal grains, which includes barley, corn,
and wheat; 0.05 ppm for maize fodder (dry), sorghum straw and fodder,
dry; 0.05 ppm for barley straw and fodder, dry; 0.05 ppm for wheat
straw and fodder, dry; 0.01 mammalian fats (except milk fats), which
includes cattle, goat, hog, horse, and sheep; and 0.3 edible offal
mammalian, which includes cattle, goat, hog, horse, and sheep.
Harmonization between the Codex MRLs for cereal grains and the U.S.
tolerances for barley, grain and wheat, grain and between the Codex MRL
for barley straw and fodder, dry and the U.S. tolerance for barley,
straw and between the Codex MRL for wheat straw and fodder, dry and the
U.S. tolerance for wheat, straw is not possible as the U.S. use pattern
(harvest-aide/burndown application) results in significantly higher
residues than the Codex use pattern (pre-emergence application). The
higher residues translate into higher residues of saflufenacil in
animal byproducts than are covered by the corresponding Codex MRLs for
livestock commodities under the Codex use pattern; therefore, U.S.
tolerances for livestock commodities cannot be harmonized with Codex
MRLs for corresponding livestock commodities.
The U.S. tolerances for crop groups 15 and 16 are not harmonized
with the Codex MRLs for cereal grains and straw and fodder because the
compliance with the Codex MRLs involve measurement of residues of the
parent only and not the metabolites, whereas the U.S. tolerance
requires measurement of both, in order to be harmonized with Canadian
tolerances.

C. Revisions to Petitioned-for Tolerances

EPA is making several revisions to the petitioned-for tolerances.
These include the following. First, the petitioned value for barley
bran is being rounded from 1.53 ppm to 1.5 ppm to be consistent with
the current Organization for Economic Cooperation and Development
(OECD) tolerance-calculation procedure. Second, the commodity
definition ``Grain, cereal, forage, fodder, and straw group 16 (except
barley, wheat and rice straw)'' is being revised to ``Grain, cereal,
forage, fodder and straw group 16 (except barley and wheat straw)'' as
the new use pattern (harvest aid/desiccant) was not proposed for rice.
Third, the petitioner requested tolerance values for grass straw and
seed screenings were based on data from trials in which the samples
were harvested at a significantly shorter preharvest interval (PHI)
than that listed on the label. Additional residue data reflecting the
actual PHI listed on the label showed lower residue levels; therefore,
the tolerance values for grass straw and seed screenings are being
decreased. Fourth, the existing tolerance of 10 ppm for residues in or
on grain, aspirated fractions is being increased to 50 ppm as a result
of the new tolerances for cereal grains and based on available residues
data. Finally, EPA is making several revisions to the proposed
livestock tolerances which include:
1. Decreasing the proposed tolerances for cattle, goat, sheep, hog
and horse fat from 0.05 ppm to 0.04 ppm and meat byproducts (except
liver) from 0.05 ppm to 0.03 ppm.
2. Increasing the tolerances proposed for cattle, goat, sheep and
horse liver from 45 ppm to 50 ppm.
3. Decreasing the tolerance proposed for hog liver from 45 ppm to
2.0 ppm.
4. Establishing tolerances for cattle, goat, sheep and horse meat
at 0.02 ppm.

[[Page 52219]]

5. Retaining the currently established tolerances for hog, fat or
hog, meat byproducts (except liver), instead of increasing them as
requested.
The tolerances being set for residues in livestock differ from the
petitioned-for tolerances due to differences in calculation methods of
the maximum reasonably balanced diets (MRBDs) with the results of the
ruminant feeding study. It also appears that the petitioner over-
estimated residues in hog commodities as a result of using the cattle
MRDB.

V. Conclusion

Therefore, tolerances are established for residues of saflufenacil,
including its metabolites and degradates, as set forth in the
regulatory text. Compliance with the plant tolerances is to be
determined by measuring the sum of saflufenacil, 2-chloro-5-[3,6-
dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-
fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, and its
metabolites N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-
1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N'-isopropylsulfamide and N-[4-
chloro-2-fluoro-5-
({[(isopropylamino)sulfonyl]amino{time} carbonyl)phenyl]urea,
calculated as the stoichiometric equivalent of saflufenacil. Compliance
with the livestock tolerances is to be determined by measuring only
saflufenacil, 2-chloro-5-[3,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-
1(2H)-pyrimidinyl)-4-fluoro-N-[[methyl(1-
methylethyl)amino]sulfonyl]benzamide.

VI. Statutory and Executive Order Reviews

This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 final rule 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (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: August 25, 2014.
Lois Rossi,
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. 180.649:
0
a. Remove the commodities ``Grain, aspirated fractions,'' ``Grain,
cereal, forage, fodder and straw group 16,'' and ``Grain, cereal, group
15'' in the table in paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in
paragraph (a)(1).
0
c. Revise the following commodities in the table in paragraph (a)(2).
The amendments read as follows:

Sec. 180.649 Saflufenacil; tolerances for residues.

(a) * * *
(1) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Barley, bran............................................ 1.5
Barley, grain........................................... 1.0
Barley, straw........................................... 15

* * * * *
Grain, aspirated grain fractions........................ 50
Grain, cereal, forage, fodder and straw group 16 (except 0.10
barley and wheat straw)................................
Grain, cereal, group 15 (except barley and wheat grain). 0.03

* * * * *
Grass, forage........................................... 15
Grass, hay.............................................. 20
Grass, seed screenings.................................. 0.15
Grass, straw............................................ 0.15

* * * * *
Olive................................................... 0.03

* * * * *
Wheat, grain............................................ 0.60
Wheat, straw............................................ 6.0
------------------------------------------------------------------------

* * * * *
(2) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat............................................. 0.04

[[Page 52220]]

Cattle, liver........................................... 50
Cattle, meat............................................ 0.02
Cattle, meat byproducts, except liver................... 0.30

* * * * *
Goat, fat............................................... 0.04
Goat, liver............................................. 50
Goat, meat.............................................. 0.02
Goat, meat byproducts, except liver..................... 0.30

* * * * *
Hog, liver.............................................. 2.0

* * * * *
Horse, fat.............................................. 0.04
Horse, liver............................................ 50
Horse, meat............................................. 0.02
Horse, meat byproducts, except liver.................... 0.30

* * * * *
Sheep, fat.............................................. 0.04
Sheep, liver............................................ 50
Sheep, meat............................................. 0.02
Sheep, meat byproducts, except liver.................... 0.30
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-20947 Filed 9-2-14; 8:45 am]
BILLING CODE 6560-50-P

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