82 FR 31471 - Prosulfuron; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 129 (July 7, 2017)
Federal Register Volume 82, Issue 129 (July 7, 2017)
| Page Range | 31471-31476 | |
| FR Document | 2017-14315 |
[Federal Register Volume 82, Number 129 (Friday, July 7, 2017)] [Rules and Regulations] [Pages 31471-31476] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14315] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0218; FRL-9962-97] Prosulfuron; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of prosulfuron in or on grain, cereal, forage, fodder, and straw, group 16, stover; grain, cereal, forage, fodder, and straw, group 16, forage; grain, cereal, forage, fodder, and straw, group 16, hay; grain, cereal, forage, fodder, and straw, group 16, straw; and grain, cereal, group 15. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 7, 2017. Objections and requests for hearings must be received on or before September 5, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0218, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- 0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0218 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 5, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0218, 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. [[Page 31472]] II. Summary of Petitioned-For Tolerance In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946- 02), 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 6F8455) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.481 be amended by establishing tolerances for residues of the herbicide prosulfuron, (N- [[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3- trifluoropropyl)benzenesulfonamide), in or on grain, cereal, forage, fodder, and straw, group 16, fodder at 0.01 parts per million (ppm); grain, cereal, forage, fodder, and straw, group 16, forage at 0.10 ppm; grain, cereal, forage, fodder, and straw, group 16, hay at 0.20 ppm; grain, cereal, forage, fodder, and straw, group 16, straw at 0.02 ppm; and grain, cereal, group 15 at 0.01 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has revised the commodity definition from grain, cereal, forage, fodder, and straw, group 16, fodder to grain, cereal, forage, fodder, and straw, group 16, stover. The reason for this change is explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for prosulfuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with prosulfuron follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The most prevalent effect observed across species and study durations following administration of prosulfuron was decreased body weight observed in subchronic and chronic oral toxicity studies in rats and dogs. Additionally, subchronic and chronic oral toxicity studies in dogs showed decreased hematological parameters and hepatic toxicity. Evidence of neurotoxicity was observed in an acute neurotoxicity study but not in the subchronic neurotoxicity study. The neurological effects seen in the acute neurotoxicity study were transient, affecting primary sensorimotor and gait functions. In a developmental range-finding study in rabbits, ataxia, hypoactivity, and neuropathology were observed starting at doses of 150 mg/kg/day. However, these potential signs of neurotoxicity were not consistent with findings in the two main developmental studies in rabbits where there were no signs of neurotoxicity observed up to 200 mg/kg/day. Additionally, other repeated dosing studies in the rat, mouse, and dog did not show evidence of neurotoxicity. There is no evidence that prosulfuron is an immunotoxic chemical. Prosulfuron is classified as ``Not Likely to Be Carcinogenic to Humans'' based on the lack of evidence of carcinogenicity in mice and rats and no concern for mutagenicity. Prosulfuron has low acute toxicity by the oral, dermal, and inhalation routes of exposure, it is not considered an eye or skin irritant and it is not a skin sensitizer. There was no evidence from the developmental and reproductive studies of increased susceptibility in rat or rabbit fetuses. In the first of two rabbit developmental studies, there were no signs of maternal or developmental toxicity. The second rabbit (tested using higher doses than the first) and the rat developmental studies showed dose-related increases in small fetuses and skeletal effects but these occurred at maternally toxic doses. In the reproductive study in rats, decreases in body weights were noted for both the adults of the P 0 and P1 generations and for the F1 and F2 pups. Specific information on the studies received and the nature of the adverse effects caused by prosulfuron as well as the no-observed- adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect- level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Prosulfuron. Human Health Risk Assessment in Support of a Section 3 Petition for the Expansion of Crop Groups 15 and 16 to Include Permanent Tolerances for Residues of Prosulfuron in Rice, pages 9-12 in docket ID number EPA-HQ-OPP-2016- 0218. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for prosulfuron used for [[Page 31473]] human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Prosulfuron 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 (Females 13-49 NOAEL = 10 mg/kg/day Acute RfD = 0.1 mg/ Acute Neurotoxicity Study--Rat years of age) (General UFA = 10x........... kg/day. MRID 43387703 population including infants and UFH = 10x FQPA SF = aPAD = 0.1 mg/kg/ LOAEL = 250 mg/kg/day based on children). 1x. day. abnormal gait in females. Chronic dietary (All populations) NOAEL = 5.3 mg/kg/ Chronic RfD = 0.053 Subchronic Oral Toxicity Study-- day. mg/kg/day. Dog UFA = 10x........... cPAD = 0.053 mg/kg/ MRID 42685230 UFH = 10x........... day. LOAEL = 54 mg/kg/day based on FQPA SF = 1x........ decreased feed efficiency, hematological findings and hepatotoxicity in both sexes. ---------------------------------------------------------------------------------------------------------------- Cancer (Oral, dermal, inhalation) Prosulfuron is classified as ``Not Likely to Be Carcinogenic to Humans'' based on the lack of evidence of carcinogenicity in mice and rats and no concern for mutagenicity. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect- level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to prosulfuron, EPA considered exposure under the petitioned- for tolerances as well as all existing prosulfuron tolerances in 40 CFR 180.481. EPA assessed dietary exposures from prosulfuron 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 prosulfuron. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) Nationwide Health and Nutrition Examination Survey, What We Eat In America (NHANES/WWEIA) conducted from 2003-2008. As to residue levels in food, the acute dietary analysis was obtained from the Dietary Exposure Evaluation Model using the Food Commodity Intake Database (DEEM-FCID; version 3.18) and assumed 100 percent crop treated (PCT) and tolerance-level residues. ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA NHANES/ WWEIA conducted from 2003-2008. As to residue levels in food, the chronic dietary analysis was obtained from the DEEM-FCID; version 3.18 database and assumed 100 PCT and tolerance-level residues. iii. Cancer. EPA has concluded that prosulfuron 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 percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for prosulfuron. Tolerance-level residues and/or 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 prosulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of prosulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of prosulfuron for both acute exposures and chronic exposures for non- cancer assessments are estimated to be 37 parts per billion (ppb) for both surface water and ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute and chronic dietary risk assessment, the water concentration value of 37 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). Prosulfuron 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 prosulfuron to share a common mechanism of toxicity with any other substances, and prosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that prosulfuron 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulativeassessment-risk-pesticides. [[Page 31474]] D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for prosulfuron includes a developmental toxicity study in the rat, two developmental toxicity studies and a range- finding developmental study in the rabbit, and a 2-generation reproduction toxicity study in the rat. There was no evidence of increased susceptibility of fetuses or offspring in any of these studies. There were no maternal or fetal effects observed at any dose in the first of two rabbit developmental toxicity studies. In the second rabbit study and in the rat developmental toxicity study, a dose- related increase in small fetuses and skeletal effects was observed, but only in the presence of maternal toxicity (decreased body weight gain in the rat study; and increases in abortions, decreases in food consumption and decreased mean body weight gain in the rabbit study). In the developmental range-finding study in rabbits, ataxia, hypoactivity, and neuropathology were observed starting at doses of 150 mg/kg/day. However, these potential signs of neurotoxicity were not consistent with findings in the two main developmental studies in rabbits where there were no signs of neurotoxicity observed up to 200 mg/kg/day. In the 2-generation reproduction study in the rat, decreases in body weight were observed in the F1 and F2 offspring but these occurred at doses in which parental toxicity was also observed. There was no evidence of neurotoxicity to fetuses or offspring observed in any of the developmental or reproduction toxicity studies. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the Food Quality Protection Act Safety Factor (FQPA SF) were reduced to 1x. That decision is based on the following findings: i. The toxicity database for prosulfuron is complete. ii. Although there was evidence of neurotoxicity in the acute neurotoxicity study and the range-finding developmental toxicity rabbit study, the selected endpoints are protective of these effects since they were seen at dose levels in excess of those where systemic toxicity occurred and at doses at least 15-fold higher than the no- observed adverse effect levels (NOAELs) selected for risk assessment. Concern is also low since no neurotoxicity was observed in the rest of the prosulfuron toxicological database, including the subchronic neurotoxicity study in rats. iii. As discussed in Unit III.D.2., there is no evidence that prosulfuron 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 prosulfuron in drinking water. These assessments will not underestimate the exposure and risks posed by prosulfuron. 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 prosulfuron will occupy 6.4% of the aPAD for all infants (< 1 years old), the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to prosulfuron from food and water will utilize 3.9% of the cPAD for all infants (< 1 years old), the population group receiving the greatest exposure. There are no residential uses for prosulfuron. 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). A short-term adverse effect was identified; however, prosulfuron is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-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-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for prosulfuron. 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, prosulfuron is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for prosulfuron. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, prosulfuron 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 prosulfuron residues. [[Page 31475]] IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, Method AG-590C (a high performance liquid chromatography method with column switching and ultraviolet (UV) detection), 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 prosulfuron. C. Revisions to Petitioned-For Tolerances EPA has revised the commodity definition from ``grain, cereal, forage, fodder, and straw, group 16, fodder'' to ``grain, cereal, forage, fodder, and straw, group 16, stover'' to be consistent with the general food and feed commodity vocabulary EPA uses for tolerances and exemptions. V. Conclusion Therefore, tolerances are established for residues of prosulfuron, (N-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3- trifluoropropyl)benzenesulfonamide), including its metabolites and degradates, in or on grain, cereal, forage, fodder, and straw, group 16, stover at 0.01 ppm; grain, cereal, forage, fodder, and straw, group 16, forage at 0.10 ppm; grain, cereal, forage, fodder, and straw, group 16, hay at 0.20 ppm; grain, cereal, forage, fodder, and straw, group 16, straw at 0.02 ppm; and grain, cereal, group 15 at 0.01 ppm. In addition, EPA has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of prosulfuron 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). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 8, 2017. Michael L. 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. 180.481, paragraph (a) is revised to read as follows: Sec. 180.481 Prosulfuron; tolerances for residues. (a) General. Tolerances are established for residues of prosulfuron, [[Page 31476]] including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only prosulfuron (N-[[(4-methoxy-6- methyl-1,3,5-triazin-2-yl)amino]carbonyl]-2-(3,3,3-trifluoropropyl) benzenesulfonamide) in or on the commodity. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Grain, cereal, forage, fodder, and straw, group 16, 0.10 forage................................................. Grain, cereal, forage, fodder, and straw, group 16, hay. 0.20 Grain, cereal, forage, fodder, and straw, group 16, 0.01 stover................................................. Grain, cereal, forage, fodder, and straw, group 16, 0.02 straw.................................................. Grain, cereal, group 15................................. 0.01 ------------------------------------------------------------------------ * * * * * [FR Doc. 2017-14315 Filed 7-6-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations 31471
List of Subjects in 40 CFR Part 180 forage; grain, cereal, forage, fodder, and B. How can I get electronic access to
Environmental protection, straw, group 16, hay; grain, cereal, other related information?
Administrative practice and procedure, forage, fodder, and straw, group 16,
straw; and grain, cereal, group 15. You may access a frequently updated
Agricultural commodities, Pesticides electronic version of EPA’s tolerance
and pests, Reporting and recordkeeping Syngenta Crop Protection, LLC
requested these tolerances under the regulations at 40 CFR part 180 through
requirements. the Government Printing Office’s e-CFR
Federal Food, Drug, and Cosmetic Act
Dated: June 2, 2017. (FFDCA). site at http://www.ecfr.gov/cgi-bin/text-
Michael L. Goodis, idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Director, Registration Division, Office of DATES: This regulation is effective July 40tab_02.tpl.
Pesticide Programs. 7, 2017. Objections and requests for
hearings must be received on or before C. How can I file an objection or hearing
Therefore, 40 CFR chapter I is September 5, 2017, and must be filed in request?
amended as follows: accordance with the instructions Under FFDCA section 408(g), 21
PART 180—[AMENDED] provided in 40 CFR part 178 (see also U.S.C. 346a, any person may file an
Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation
■ 1. The authority citation for part 180 INFORMATION).
and may also request a hearing on those
continues to read as follows: ADDRESSES: The docket for this action, objections. You must file your objection
Authority: 21 U.S.C. 321(q), 346a and 371. identified by docket identification (ID) or request a hearing on this regulation
■ 2. In § 180.613, add alphabetically the number EPA–HQ–OPP–2016–0218, is in accordance with the instructions
following commodities ‘‘Pea and bean, available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
succulent shelled, subgroup 6B’’; ‘‘Pea or at the Office of Pesticide Programs proper receipt by EPA, you must
and bean, dried shelled, except soybean, Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
subgroup 6C’’; and ‘‘Vegetable, legume, in the Environmental Protection Agency OPP–2016–0218 in the subject line on
edible podded, subgroup 6A’’ to the Docket Center (EPA/DC), West William the first page of your submission. All
table in paragraph (a)(1) to read as Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
follows: Constitution Ave. NW., Washington, DC must be in writing, and must be
20460–0001. The Public Reading Room received by the Hearing Clerk on or
§ 180.613 Flonicamid; tolerances for is open from 8:30 a.m. to 4:30 p.m., before September 5, 2017. Addresses for
residues. Monday through Friday, excluding legal mail and hand delivery of objections
(a) * * * holidays. The telephone number for the and hearing requests are provided in 40
(1) * * * Public Reading Room is (202) 566–1744, CFR 178.25(b).
and the telephone number for the OPP In addition to filing an objection or
Parts per Docket is (703) 305–5805. Please review
Commodity hearing request with the Hearing Clerk
million
the visitor instructions and additional as described in 40 CFR part 178, please
information about the docket available submit a copy of the filing (excluding
* * * * * at http://www.epa.gov/dockets. any Confidential Business Information
Pea and bean, succulent shelled, FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket.
subgroup 6B .............................. 7.0 Michael L. Goodis, Registration Division Information not marked confidential
Pea and bean, dried shelled, ex- pursuant to 40 CFR part 2 may be
cept soybean, subgroup 6C ...... 3.0
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 disclosed publicly by EPA without prior
* * * * * Pennsylvania Ave. NW., Washington, notice. Submit the non-CBI copy of your
Vegetable, legume, edible pod- DC 20460–0001; main telephone objection or hearing request, identified
ded, subgroup 6A ..................... 4.0 number: (703) 305–7090; email address: by docket ID number EPA–HQ–OPP–
RDFRNotices@epa.gov. 2016–0218, by one of the following
* * * * *
SUPPLEMENTARY INFORMATION: methods:
• Federal eRulemaking Portal: http://
* * * * * I. General Information www.regulations.gov. Follow the online
[FR Doc. 2017–14339 Filed 7–6–17; 8:45 am]
A. Does this action apply to me? instructions for submitting comments.
BILLING CODE 6560–50–P
Do not submit electronically any
You may be potentially affected by information you consider to be CBI or
this action if you are an agricultural other information whose disclosure is
ENVIRONMENTAL PROTECTION producer, food manufacturer, or
AGENCY restricted by statute.
pesticide manufacturer. The following
list of North American Industrial • Mail: OPP Docket, Environmental
40 CFR Part 180 Classification System (NAICS) codes is Protection Agency Docket Center (EPA/
[EPA–HQ–OPP–2016–0218; FRL–9962–97] not intended to be exhaustive, but rather DC), (28221T), 1200 Pennsylvania Ave.
provides a guide to help readers NW., Washington, DC 20460–0001.
Prosulfuron; Pesticide Tolerances determine whether this document • Hand Delivery: To make special
applies to them. Potentially affected arrangements for hand delivery or
AGENCY: Environmental Protection
asabaliauskas on DSKBBXCHB2PROD with RULES
entities may include: delivery of boxed information, please
Agency (EPA).
• Crop production (NAICS code 111). follow the instructions at http://
ACTION: Final rule.
• Animal production (NAICS code www.epa.gov/dockets/contacts.html.
SUMMARY: This regulation establishes 112). Additional instructions on
tolerances for residues of prosulfuron in • Food manufacturing (NAICS code commenting or visiting the docket,
or on grain, cereal, forage, fodder, and 311). along with more information about
straw, group 16, stover; grain, cereal, • Pesticide manufacturing (NAICS dockets generally, is available at http://
forage, fodder, and straw, group 16, code 32532). www.epa.gov/dockets.
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![31472 Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations
II. Summary of Petitioned-For aggregate exposure to the pesticide rabbit fetuses. In the first of two rabbit
Tolerance chemical residue. . . .’’ developmental studies, there were no
Consistent with FFDCA section signs of maternal or developmental
In the Federal Register of May 19, 408(b)(2)(D), and the factors specified in toxicity. The second rabbit (tested using
2016 (81 FR 31581) (FRL–9946–02), FFDCA section 408(b)(2)(D), EPA has higher doses than the first) and the rat
EPA issued a document pursuant to reviewed the available scientific data developmental studies showed dose-
FFDCA section 408(d)(3), 21 U.S.C. and other relevant information in related increases in small fetuses and
346a(d)(3), announcing the filing of a support of this action. EPA has skeletal effects but these occurred at
pesticide petition (PP 6F8455) by sufficient data to assess the hazards of maternally toxic doses. In the
Syngenta Crop Protection, LLC, P.O. and to make a determination on reproductive study in rats, decreases in
Box 18300, Greensboro, NC 27419. The aggregate exposure for prosulfuron body weights were noted for both the
petition requested that 40 CFR 180.481 including exposure resulting from the adults of the P0 and P1 generations and
be amended by establishing tolerances tolerances established by this action. for the F1 and F2 pups.
for residues of the herbicide EPA’s assessment of exposures and risks Specific information on the studies
prosulfuron, (N-[[(4-methoxy-6-methyl- associated with prosulfuron follows. received and the nature of the adverse
1,3,5-triazin-2-yl)amino]carbonyl]-2- effects caused by prosulfuron as well as
(3,3,3- A. Toxicological Profile
the no-observed-adverse-effect-level
trifluoropropyl)benzenesulfonamide), in EPA has evaluated the available (NOAEL) and the lowest-observed-
or on grain, cereal, forage, fodder, and toxicity data and considered its validity, adverse-effect-level (LOAEL) from the
straw, group 16, fodder at 0.01 parts per completeness, and reliability as well as toxicity studies can be found at http://
million (ppm); grain, cereal, forage, the relationship of the results of the www.regulations.gov in document
fodder, and straw, group 16, forage at studies to human risk. EPA has also Prosulfuron. Human Health Risk
0.10 ppm; grain, cereal, forage, fodder, considered available information Assessment in Support of a Section 3
and straw, group 16, hay at 0.20 ppm; concerning the variability of the Petition for the Expansion of Crop
grain, cereal, forage, fodder, and straw, sensitivities of major identifiable Groups 15 and 16 to Include Permanent
group 16, straw at 0.02 ppm; and grain, subgroups of consumers, including Tolerances for Residues of Prosulfuron
cereal, group 15 at 0.01 ppm. That infants and children. The most in Rice, pages 9–12 in docket ID number
document referenced a summary of the prevalent effect observed across species EPA–HQ–OPP–2016–0218.
petition prepared by Syngenta Crop and study durations following
administration of prosulfuron was B. Toxicological Points of Departure/
Protection, LLC, the registrant, which is Levels of Concern
available in the docket, http:// decreased body weight observed in
www.regulations.gov. There were no subchronic and chronic oral toxicity Once a pesticide’s toxicological
comments received in response to the studies in rats and dogs. Additionally, profile is determined, EPA identifies
notice of filing. subchronic and chronic oral toxicity toxicological points of departure (POD)
studies in dogs showed decreased and levels of concern to use in
Based upon review of the data hematological parameters and hepatic evaluating the risk posed by human
supporting the petition, EPA has revised toxicity. Evidence of neurotoxicity was exposure to the pesticide. For hazards
the commodity definition from grain, observed in an acute neurotoxicity that have a threshold below which there
cereal, forage, fodder, and straw, group study but not in the subchronic is no appreciable risk, the toxicological
16, fodder to grain, cereal, forage, neurotoxicity study. The neurological POD is used as the basis for derivation
fodder, and straw, group 16, stover. The effects seen in the acute neurotoxicity of reference values for risk assessment.
reason for this change is explained in study were transient, affecting primary PODs are developed based on a careful
Unit IV.C. sensorimotor and gait functions. In a analysis of the doses in each
III. Aggregate Risk Assessment and developmental range-finding study in toxicological study to determine the
Determination of Safety rabbits, ataxia, hypoactivity, and dose at which no adverse effects are
neuropathology were observed starting observed (the NOAEL) and the lowest
Section 408(b)(2)(A)(i) of FFDCA at doses of 150 mg/kg/day. However, dose at which adverse effects of concern
allows EPA to establish a tolerance (the these potential signs of neurotoxicity are identified (the LOAEL). Uncertainty/
legal limit for a pesticide chemical were not consistent with findings in the safety factors are used in conjunction
residue in or on a food) only if EPA two main developmental studies in with the POD to calculate a safe
determines that the tolerance is ‘‘safe.’’ rabbits where there were no signs of exposure level—generally referred to as
Section 408(b)(2)(A)(ii) of FFDCA neurotoxicity observed up to 200 mg/kg/ a population-adjusted dose (PAD) or a
defines ‘‘safe’’ to mean that ‘‘there is a day. Additionally, other repeated dosing reference dose (RfD)—and a safe margin
reasonable certainty that no harm will studies in the rat, mouse, and dog did of exposure (MOE). For non-threshold
result from aggregate exposure to the not show evidence of neurotoxicity. risks, the Agency assumes that any
pesticide chemical residue, including There is no evidence that prosulfuron is amount of exposure will lead to some
all anticipated dietary exposures and all an immunotoxic chemical. Prosulfuron degree of risk. Thus, the Agency
other exposures for which there is is classified as ‘‘Not Likely to Be estimates risk in terms of the probability
reliable information.’’ This includes Carcinogenic to Humans’’ based on the of an occurrence of the adverse effect
exposure through drinking water and in lack of evidence of carcinogenicity in expected in a lifetime. For more
residential settings, but does not include mice and rats and no concern for information on the general principles
asabaliauskas on DSKBBXCHB2PROD with RULES
occupational exposure. Section mutagenicity. Prosulfuron has low acute EPA uses in risk characterization and a
408(b)(2)(C) of FFDCA requires EPA to toxicity by the oral, dermal, and complete description of the risk
give special consideration to exposure inhalation routes of exposure, it is not assessment process, see http://
of infants and children to the pesticide considered an eye or skin irritant and it www2.epa.gov/pesticide-science-
chemical residue in establishing a is not a skin sensitizer. andassessing-pesticide-risks/assessing-
tolerance and to ‘‘ensure that there is a There was no evidence from the human-health-risk-pesticides.
reasonable certainty that no harm will developmental and reproductive studies A summary of the toxicological
result to infants and children from of increased susceptibility in rat or endpoints for prosulfuron used for
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![Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations 31475
IV. Other Considerations straw at 0.02 ppm; and grain, cereal, section 408(n)(4). As such, the Agency
group 15 at 0.01 ppm. has determined that this action will not
A. Analytical Enforcement Methodology In addition, EPA has revised the have a substantial direct effect on States
Adequate enforcement methodology, tolerance expression to clarify (1) that, or tribal governments, on the
Method AG–590C (a high performance as provided in FFDCA section 408(a)(3), relationship between the national
liquid chromatography method with the tolerance covers metabolites and government and the States or tribal
column switching and ultraviolet (UV) degradates of prosulfuron not governments, or on the distribution of
detection), is available to enforce the specifically mentioned; and (2) that power and responsibilities among the
tolerance expression. compliance with the specified tolerance various levels of government or between
The method may be requested from: levels is to be determined by measuring the Federal Government and Indian
Chief, Analytical Chemistry Branch, only the specific compounds mentioned tribes. Thus, the Agency has determined
Environmental Science Center, 701 in the tolerance expression. EPA has that Executive Order 13132, entitled
Mapes Rd., Ft. Meade, MD 20755–5350; determined that it is reasonable to make ‘‘Federalism’’ (64 FR 43255, August 10,
telephone number: (410) 305–2905; this change final without prior proposal 1999) and Executive Order 13175,
email address: residuemethods@ and opportunity for comment, because entitled ‘‘Consultation and Coordination
epa.gov. public comment is not necessary, in that with Indian Tribal Governments’’ (65 FR
the change has no substantive effect on 67249, November 9, 2000) do not apply
B. International Residue Limits
the tolerance, but rather is merely to this action. In addition, this action
In making its tolerance decisions, EPA intended to clarify the existing tolerance does not impose any enforceable duty or
seeks to harmonize U.S. tolerances with expression. contain any unfunded mandate as
international standards whenever described under Title II of the Unfunded
possible, consistent with U.S. food VI. Statutory and Executive Order
Reviews Mandates Reform Act (UMRA) (2 U.S.C.
safety standards and agricultural 1501 et seq.).
practices. EPA considers the This action establishes tolerances This action does not involve any
international maximum residue limits under FFDCA section 408(d) in
technical standards that would require
(MRLs) established by the Codex response to a petition submitted to the
Agency consideration of voluntary
Alimentarius Commission (Codex), as Agency. The Office of Management and
consensus standards pursuant to section
required by FFDCA section 408(b)(4). Budget (OMB) has exempted these types
12(d) of the National Technology
The Codex Alimentarius is a joint of actions from review under Executive
Transfer and Advancement Act
United Nations Food and Agriculture Order 12866, entitled ‘‘Regulatory
(NTTAA) (15 U.S.C. 272 note).
Organization/World Health Planning and Review’’ (58 FR 51735,
Organization food standards program, October 4, 1993). Because this action VII. Congressional Review Act
and it is recognized as an international has been exempted from review under Pursuant to the Congressional Review
food safety standards-setting Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
organization in trade agreements to not subject to Executive Order 13211, submit a report containing this rule and
which the United States is a party. EPA entitled ‘‘Actions Concerning other required information to the U.S.
may establish a tolerance that is Regulations That Significantly Affect
Senate, the U.S. House of
different from a Codex MRL; however, Energy Supply, Distribution, or Use’’ (66
Representatives, and the Comptroller
FFDCA section 408(b)(4) requires that FR 28355, May 22, 2001) or Executive
General of the United States prior to
EPA explain the reasons for departing Order 13045, entitled ‘‘Protection of
publication of the rule in the Federal
from the Codex level. Children from Environmental Health
Register. This action is not a ‘‘major
The Codex has not established a MRL Risks and Safety Risks’’ (62 FR 19885,
rule’’ as defined by 5 U.S.C. 804(2).
for prosulfuron. April 23, 1997). This action does not
contain any information collections List of Subjects in 40 CFR Part 180
C. Revisions to Petitioned-For subject to OMB approval under the
Tolerances Environmental protection,
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure,
EPA has revised the commodity U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
definition from ‘‘grain, cereal, forage, any special considerations under and pests, Reporting and recordkeeping
fodder, and straw, group 16, fodder’’ to Executive Order 12898, entitled requirements.
‘‘grain, cereal, forage, fodder, and straw, ‘‘Federal Actions to Address
group 16, stover’’ to be consistent with Environmental Justice in Minority Dated: June 8, 2017.
the general food and feed commodity Populations and Low-Income Michael L. Goodis,
vocabulary EPA uses for tolerances and Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
exemptions. 1994). Pesticide Programs.
Since tolerances and exemptions that Therefore, 40 CFR chapter I is
V. Conclusion are established on the basis of a petition amended as follows:
Therefore, tolerances are established under FFDCA section 408(d), such as
for residues of prosulfuron, (N-[[(4- the tolerance in this final rule, do not PART 180—[AMENDED]
methoxy-6-methyl-1,3,5-triazin-2- require the issuance of a proposed rule,
yl)amino]carbonyl]-2-(3,3,3- ■ 1. The authority citation for part 180
the requirements of the Regulatory
trifluoropropyl)benzenesulfonamide), continues to read as follows:
Flexibility Act (RFA) (5 U.S.C. 601 et
asabaliauskas on DSKBBXCHB2PROD with RULES
including its metabolites and seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
degradates, in or on grain, cereal, forage, This action directly regulates growers, ■ 2. In § 180.481, paragraph (a) is
fodder, and straw, group 16, stover at food processors, food handlers, and food revised to read as follows:
0.01 ppm; grain, cereal, forage, fodder, retailers, not States or tribes, nor does
and straw, group 16, forage at 0.10 ppm; this action alter the relationships or § 180.481 Prosulfuron; tolerances for
grain, cereal, forage, fodder, and straw, distribution of power and residues.
group 16, hay at 0.20 ppm; grain, cereal, responsibilities established by Congress (a) General. Tolerances are
forage, fodder, and straw, group 16, in the preemption provisions of FFDCA established for residues of prosulfuron,
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![31476 Federal Register / Vol. 82, No. 129 / Friday, July 7, 2017 / Rules and Regulations
including its metabolites and eligible petitioners in lieu of Amtrak to c. Timelines Established by the Final
degradates, in or on the commodities in operate not more than three long- Rule
the table below. Compliance with the distance routes (as defined in 49 U.S.C. The final rule establishes deadlines
tolerance levels specified below is to be 24102), and operated by Amtrak on the for filing petitions, filing bids, and the
determined by measuring only date of enactment of the Passenger Rail execution of contract(s) with winning
prosulfuron (N-[[(4-methoxy-6-methyl- Reform and Investment Act of 2015 bidders.
1,3,5-triazin-2-yl)amino]carbonyl]-2- (title XI of the Fixing America’s Surface As to the filing of petitions, § 269.7(b)
(3,3,3-trifluoropropyl) Transportation (FAST) Act, Pub. L. 114– of the final rule requires the filing of a
benzenesulfonamide) in or on the 94, 129 Stat. 1312, 1660–1664 (2015)). petition with FRA no later than 180
commodity. The final rule establishes a petition, days after the effective date of the final
notification, and bid process by which rule implementing the pilot program
Parts per FRA will evaluate, and ultimately
Commodity million (petition window). In the NPRM, FRA
select, bids to provide passenger rail proposed a 60 day petition window
Grain, cereal, forage, fodder, service over particular long-distance from the publication of the final rule.
and straw, group 16, for- routes. The final rule also, among other Several commenters stated the proposed
age .................................... 0.10 things, addresses FRA’s execution of a 60 day petition window should be
Grain, cereal, forage, fodder, contract with the winning bidder extended to 120 or 180 days. Other
and straw, group 16, hay .. 0.20 awarding the right and obligation to commenters stated the petition window
Grain, cereal, forage, fodder, provide intercity passenger rail service should remain 60 days. Still other
and straw, group 16, sto- over the route, along with an operating
ver ..................................... 0.01
commenters stated the petition window
Grain, cereal, forage, fodder,
subsidy, subject to the 49 U.S.C. 24405 should be eliminated and the pilot
and straw, group 16, straw 0.02 grant conditions and such performance program should remain available
Grain, cereal, group 15 ........ 0.01 standards as the Secretary of indefinitely.
Transportation (Secretary) may require. After careful consideration of these
* * * * * comments, the final rule establishes a
b. Procedural History
[FR Doc. 2017–14315 Filed 7–6–17; 8:45 am] 180 day petition window, balancing the
BILLING CODE 6560–50–P By notice of proposed rulemaking need for sufficient time to produce
(NPRM) published on June 22, 2016 (81 quality petitions and bids with the
FR 40624), FRA proposed a competitive desire to encourage competition and
DEPARTMENT OF TRANSPORTATION passenger rail service pilot program in efficiently use Federal and Amtrak
response to a statutory mandate in resources. This extended time period
Federal Railroad Administration section 11307 of the FAST Act. In will ensure an eligible petitioner has an
response to a request for a public adequate amount of time to file a
49 CFR Part 269 hearing, FRA held a public hearing on petition. It is important to also note the
September 7, 2016. FRA also extended final rule establishes the effective date
[Docket No. FRA–2016–0023; Notice No. 4] of the final rule as the trigger for the 180
the comment period for the NPRM to
RIN 2130–AC60 October 7, 2016 to allow time for day period (rather than the date the final
interested parties to submit written rule is published, as proposed in the
Competitive Passenger Rail Service comments in response to information NPRM). This change effectively gives
Pilot Program provided at the public hearing. eligible petitioners 60 more days (in
AGENCY: Federal Railroad addition to the 180 days) to file a
FRA received comments from the petition. The final rule does not adopt
Administration (FRA), Department of American Association of Private
Transportation (DOT). the suggestion of some commenters that
Railroad Car Owners, the Association of the pilot program be ‘‘evergreen.’’ First,
ACTION: Final rule. Independent Passenger Rail Operators, the FAST Act does not require the pilot
the National Association of Railroad program to remain available
SUMMARY: This final rule implements a Passengers, Herzog Transit Services,
pilot program for competitive selection indefinitely. Second, an evergreen pilot
Corridor Capital, Iowa Pacific Holdings, program may unduly burden the FRA
of eligible petitioners in lieu of Amtrak Florida East Coast Industries, Erie
to operate not more than three long- and Amtrak by imposing an indefinite
Lackawanna Railroad, the North regulatory burden to maintain program
distance routes operated by Amtrak. The Carolina Department of Transportation,
final rule is required by statute. readiness. Finally, FRA believes
the National Railroad Passenger competition is best fostered by a limited
DATES: This final rule is effective on Corporation (Amtrak), the Brotherhood
September 5, 2017. duration petition window allowing FRA
of Maintenance of Way Employees to evaluate multiple bidders competing
FOR FURTHER INFORMATION CONTACT: Division/International Brotherhood of
Brandon White, Office of Railroad for the same route.
Teamsters, the Brotherhood of Railroad When an eligible petitioner files a
Policy and Development, FRA, 1200 Signalmen, the International petition, under § 269.9(a) of the final
New Jersey Ave. SE., Washington, DC Association of Sheet Metal, Air, Rail, rule, FRA will notify the petitioner and
20590, (202) 493–1327, or Zeb Schorr, and Transportation Workers/Mechanical Amtrak of receipt of the petition, and
Office of Chief Counsel, FRA, 1200 New Division, the Transportation Trades publish a notice of receipt in the
Jersey Ave. SE., Mail Stop 10,
asabaliauskas on DSKBBXCHB2PROD with RULES
Department of the American Federation Federal Register, not later than 30 days
Washington, DC 20590, (202) 493–6072. of Labor-Congress of Industrial after receipt. See 49 U.S.C.
SUPPLEMENTARY INFORMATION: Organizations, and one individual. 24711(b)(1)(B)(i).
I. Background Comments are addressed in the Section 269.9(b) of the final rule
preamble. Some comments were addresses the filing of bids. This section
a. Executive Summary of Final Rule generally supportive of the NPRM, and requires both the bidder and Amtrak, if
This final rule implements a pilot other comments were generally Amtrak so chooses, to submit complete
program for competitive selection of unsupportive of the NPRM. bids to FRA not later than 120 days after
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Document Created: 2017-07-07 02:20:08
Document Modified: 2017-07-07 02:20:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective July 7, 2017. Objections and requests for hearings must be received on or before September 5, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 82 FR 31471 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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