80 FR 66801 - Rimsulfuron; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 210 (October 30, 2015)
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66801-66805 | |
| FR Document | 2015-27790 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Rules and Regulations] [Pages 66801-66805] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27790] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2013-0035; FRL-9912-31] Rimsulfuron; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of rimsulfuron in or on sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover. E.I. du Pont de Nemours and Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 30, 2015. Objections and requests for hearings must be received on or before December 29, 2015, 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-2013-0035, 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: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [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. To access the Office of Chemical Safety and Pollution Prevention (OCSPP) test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' 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-2013-0035 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 December 29, 2015. 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-2013-0035, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392- 9), 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 2F8131) by E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898. The petition requested that 40 CFR 180.478 be amended by establishing tolerances for residues of the herbicide rimsulfuron, N-((4,6-dimethoxypyrimidin-2-yl)aminocarbonyl)-3- (ethylsulfonyl)-2-pyridinesulfonamide, in or on sorghum, forage; sorghum, grain; and sorghum, stover at 0.01 parts per million (ppm). That document referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, 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 proposed commodity definitions. EPA has also revised the chemical name nomenclature for rimsulfuron in the tolerance expression. 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 [[Page 66802]] 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 rimsulfuron including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with rimsulfuron 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. Rimsulfuron has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is moderately irritating to the eye, non- irritating to the skin, and is not a skin sensitizer. In subchronic and chronic toxicity studies in rats, toxic effects included decreased body weight, decreased body weight gain, increased relative liver and absolute kidney weights, and diuresis. In the subchronic study in mice, increased red blood cell and hemoglobin, and decreased body weight gain and food efficiency were observed. In the chronic study in mice, decreased body weight, increased incidences of dilation and cysts in the glandular stomach, and degeneration of the testicular artery and tunica albuginea were observed. In the subchronic study in dogs, diuresis was indicated by urinary volume, platelet concentration, and kidney weights accompanied by decreased urinary osmolality. In the chronic study in dogs, increased absolute liver and kidney weights, increased seminiferous tubule degeneration, and increased number of spermatid giant cells present in epididymides in males were observed. In both sexes, decreases in mean body weights and body weight gain, and increases in serum cholesterol levels, alkaline phosphatase activity, absolute liver weight, relative liver, and relative kidney weights were observed. In the developmental toxicity study in rats, no toxicity was seen at the highest dose tested. In the developmental toxicity study in rabbits (in which both maternal and fetal death were observed), and in the 2-generation reproduction toxicity study in rats (in which decreases in body weight gain were observed in both parents and offspring), developmental and offspring effects were seen in the presence of maternal/systemic toxicity at the same dose levels. In the acute and subchronic neurotoxicity studies, no evidence of neurotoxicity was observed. In the immunotoxicity study, no evidence of immunosuppression was observed. In the mutagenicity studies, no evidence of clastogenicity or mutagenicity was observed. Rimsulfuron is classified as ``Not Likely to be Carcinogenic to Humans'' based on lack of evidence of carcinogenicity in rats and mice studies. Specific information on the studies received and the nature of the adverse effects caused by rimsulfuron 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 ``Rimsulfuron. Human Health Risk Assessment for Proposed Section 3 Use on Acetolactase Synthase (ALS) Tolerant Grain Sorghum'' at pp. 27-32 in docket ID number EPA-HQ-OPP- 2013-0035. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population- adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for rimsulfuron used for human risk assessment is shown in Table 1 of this unit. Table 1--Summary of Toxicological Doses and Endpoints for Rimsulfuron for Use in Human Health Risk Assessment ---------------------------------------------------------------------------------------------------------------- Point of departure Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects safety factors risk assessment ---------------------------------------------------------------------------------------------------------------- Acute dietary (All populations).. No endpoint attributable to a single dose identified. ---------------------------------------------------------------------------------------------------------------- Chronic dietary (All populations) NOAEL = 11.8 mg/kg/ Chronic RfD = 0.118 Combined Chronic/Carcinogenicity-- day mg/kg/day. Rat. UFA = 10x........... cPAD = 0.118 mg/kg/ LOAEL = 121 mg/kg/day in males; UFH = 10x........... day. 568 mg/kg/day in females . FQPA SF = 1x........ (NOAEL = 163 mg/kg/day in females), based on decreased body weight gains and liver effects. ---------------------------------------------------------------------------------------------------------------- FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day = milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. cPAD = chronic population adjusted dose. 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). [[Page 66803]] C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to rimsulfuron, EPA considered exposure under the petitioned- for tolerances as well as all existing rimsulfuron tolerances in 40 CFR 180.478. EPA assessed dietary exposures from rimsulfuron in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for rimsulfuron; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed that rimsulfuron residues were present at tolerance levels in all commodities for which tolerances have been established or proposed, and that 100% of those crops were treated with rimsulfuron. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that rimsulfuron 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 rimsulfuron. 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 rimsulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of rimsulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM- GW), the estimated drinking water concentrations (EDWCs) of rimsulfuron for chronic exposures for non-cancer assessments are estimated to be 0.38 parts per billion (ppb) for surface water and 19.7 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 19.7 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). Rimsulfuron 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 rimsulfuron to share a common mechanism of toxicity with any other substances, and rimsulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that rimsulfuron 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://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 Federal 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. In the developmental toxicity study in rats, no developmental toxicity was seen at the highest dose tested. In the developmental toxicity study in rabbits and in the 2-generation reproductive study in rats, developmental and offspring toxicity were seen only in the presence of maternal/systemic toxicity. Consequently, there is no evidence of quantitative or qualitative increased susceptibility following pre- and/or postnatal exposures. 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 rimsulfuron is complete. ii. There is no indication that rimsulfuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional Uncertainty Factor (UF) to account for neurotoxicity. iii. There is no evidence that rimsulfuron 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 rimsulfuron in drinking water. These assessments will not underestimate the exposure and risks posed by rimsulfuron. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified [[Page 66804]] and no acute dietary endpoint was selected. Therefore, rimsulfuron is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to rimsulfuron from food and water will utilize 1.4% of the cPAD for all infants less than 1-year old, the population group receiving the greatest exposure. There are no residential uses for rimsulfuron. 3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there are no residential uses, no short- or intermediate- term aggregate risk assessments were conducted. 4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, rimsulfuron 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 rimsulfuron residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Method DuPont-32277, a high performance liquid chromatography with tandem mass spectroscopy (HPLC/ MS/MS)) 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]ov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established MRLs for rimsulfuron. C. Revisions to Petitioned-For Tolerances The Agency is revising the proposed commodity definitions of ``sorghum, forage'' to ``sorghum, grain, forage''; ``sorghum, grain'' to ``sorghum, grain, grain''; and ``sorghum, stover'' to ``sorghum, grain, stover''. The tolerance expression is revised to reflect the preferred chemical name for rimsulfuron using CAS nomenclature. V. Conclusion Therefore, tolerances are established for residues of rimsulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino]carbonyl]-3-(ethylsulfonyl)-2- pyridinesulfonamide, in or on sorghum, grain, forage; sorghum, grain, grain; and sorghum, grain, stover at 0.01 ppm. 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 tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This 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: October 21, 2015. G. Jeffrey Herndon, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: [[Page 66805]] 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. 180.478, revise paragraph (a) and add alphabetically the following commodities to the table in paragraph (a) to read as follows: Sec. 180.478 Rimsulfuron; tolerances for residues. (a) General. Tolerances are established for residues of the herbicide rimsulfuron, including its metabolites and degradates, in or on the commodities in the following table. Compliance with the tolerance levels specified in the following table is to be determined by measuring only rimsulfuron, N-[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]-3-(ethylsulfonyl)-2-pyridinesulfonamide. ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Sorghum, grain, forage...................................... 0.01 Sorghum, grain, grain....................................... 0.01 Sorghum, grain, stover...................................... 0.01 * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-27790 Filed 10-29-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Rules and Regulations 66801
* * * * * pesticide manufacturer. The following instructions for submitting comments.
[FR Doc. 2015–27788 Filed 10–29–15; 8:45 am] list of North American Industrial Do not submit electronically any
BILLING CODE 6560–50–P Classification System (NAICS) codes is information you consider to be CBI or
not intended to be exhaustive, but rather other information whose disclosure is
provides a guide to help readers restricted by statute.
ENVIRONMENTAL PROTECTION determine whether this document • Mail: OPP Docket, Environmental
AGENCY applies to them. Potentially affected Protection Agency Docket Center (EPA/
entities may include: DC), (28221T), 1200 Pennsylvania Ave.
40 CFR Part 180 • Crop production (NAICS code 111). NW., Washington, DC 20460–0001.
[EPA–HQ–OPP–2013–0035; FRL–9912–31] • Animal production (NAICS code • Hand Delivery: To make special
112). arrangements for hand delivery or
Rimsulfuron; Pesticide Tolerances • Food manufacturing (NAICS code delivery of boxed information, please
311). follow the instructions at http://
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS www.epa.gov/dockets/contacts.html.
Agency (EPA). code 32532). Additional instructions on
ACTION: Final rule. commenting or visiting the docket,
B. How can I get electronic access to
along with more information about
SUMMARY: This regulation establishes other related information?
dockets generally, is available at
tolerances for residues of rimsulfuron in You may access a frequently updated http://www.epa.gov/dockets.
or on sorghum, grain, forage; sorghum, electronic version of EPA’s tolerance
grain, grain; and sorghum, grain, stover. regulations at 40 CFR part 180 through II. Summary of Petitioned-For
E.I. du Pont de Nemours and Company the Government Printing Office’s e-CFR Tolerance
requested these tolerances under the site at http://www.ecfr.gov/cgi-bin/text- In the Federal Register of July 19,
Federal Food, Drug, and Cosmetic Act idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 2013 (78 FR 43115) (FRL–9392–9), EPA
(FFDCA). 40tab_02.tpl. To access the Office of issued a document pursuant to FFDCA
DATES: This regulation is effective Chemical Safety and Pollution section 408(d)(3), 21 U.S.C. 346a(d)(3),
October 30, 2015. Objections and Prevention (OCSPP) test guidelines announcing the filing of a pesticide
requests for hearings must be received referenced in this document petition (PP 2F8131) by E.I. du Pont de
on or before December 29, 2015, and electronically, please go to http:// Nemours and Company, 1007 Market
must be filed in accordance with the www.epa.gov/ocspp and select ‘‘Test Street, Wilmington, DE 19898. The
instructions provided in 40 CFR part Methods and Guidelines.’’ petition requested that 40 CFR 180.478
178 (see also Unit I.C. of the be amended by establishing tolerances
C. How can I file an objection or hearing
SUPPLEMENTARY INFORMATION). for residues of the herbicide
request?
ADDRESSES: The docket for this action, rimsulfuron, N-((4,6-
identified by docket identification (ID) Under FFDCA section 408(g), 21 dimethoxypyrimidin-2-
number EPA–HQ–OPP–2013–0035, is U.S.C. 346a, any person may file an yl)aminocarbonyl)-3-(ethylsulfonyl)-2-
available at http://www.regulations.gov objection to any aspect of this regulation pyridinesulfonamide, in or on sorghum,
or at the Office of Pesticide Programs and may also request a hearing on those forage; sorghum, grain; and sorghum,
Regulatory Public Docket (OPP Docket) objections. You must file your objection stover at 0.01 parts per million (ppm).
in the Environmental Protection Agency or request a hearing on this regulation That document referenced a summary of
Docket Center (EPA/DC), West William in accordance with the instructions the petition prepared by E.I. du Pont de
Jefferson Clinton Bldg., Rm. 3334, 1301 provided in 40 CFR part 178. To ensure Nemours and Company, the registrant,
Constitution Ave. NW., Washington, DC proper receipt by EPA, you must which is available in the docket,
20460–0001. The Public Reading Room identify docket ID number EPA–HQ– http://www.regulations.gov. There were
is open from 8:30 a.m. to 4:30 p.m., OPP–2013–0035 in the subject line on no comments received in response to
Monday through Friday, excluding legal the first page of your submission. All the notice of filing.
holidays. The telephone number for the objections and requests for a hearing Based upon review of the data
Public Reading Room is (202) 566–1744, must be in writing, and must be supporting the petition, EPA has revised
and the telephone number for the OPP received by the Hearing Clerk on or the proposed commodity definitions.
Docket is (703) 305–5805. Please review before December 29, 2015. Addresses for EPA has also revised the chemical name
the visitor instructions and additional mail and hand delivery of objections nomenclature for rimsulfuron in the
information about the docket available and hearing requests are provided in 40 tolerance expression. The reasons for
at http://www.epa.gov/dockets. CFR 178.25(b). these changes are explained in Unit
In addition to filing an objection or IV.C.
FOR FURTHER INFORMATION CONTACT:
hearing request with the Hearing Clerk
Susan Lewis, Registration Division III. Aggregate Risk Assessment and
as described in 40 CFR part 178, please
(7505P), Office of Pesticide Programs, Determination of Safety
submit a copy of the filing (excluding
Environmental Protection Agency, 1200
any Confidential Business Information Section 408(b)(2)(A)(i) of FFDCA
Pennsylvania Ave. NW., Washington,
(CBI)) for inclusion in the public docket. allows EPA to establish a tolerance (the
DC 20460–0001; main telephone
Information not marked confidential legal limit for a pesticide chemical
number: (703) 305–7090; email address:
pursuant to 40 CFR part 2 may be residue in or on a food) only if EPA
RDFRNotices@epa.gov.
disclosed publicly by EPA without prior determines that the tolerance is ‘‘safe.’’
SUPPLEMENTARY INFORMATION: Section 408(b)(2)(A)(ii) of FFDCA
notice. Submit the non-CBI copy of your
Lhorne on DSK5TPTVN1PROD with RULES
I. General Information objection or hearing request, identified defines ‘‘safe’’ to mean that ‘‘there is a
by docket ID number EPA–HQ–OPP– reasonable certainty that no harm will
A. Does this action apply to me? 2013–0035, by one of the following result from aggregate exposure to the
You may be potentially affected by methods: pesticide chemical residue, including
this action if you are an agricultural • Federal eRulemaking Portal: http:// all anticipated dietary exposures and all
producer, food manufacturer, or www.regulations.gov. Follow the online other exposures for which there is
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![66804 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Rules and Regulations
and no acute dietary endpoint was organization in trade agreements to the requirements of the Regulatory
selected. Therefore, rimsulfuron is not which the United States is a party. EPA Flexibility Act (RFA) (5 U.S.C. 601 et
expected to pose an acute risk. may establish a tolerance that is seq.), do not apply.
2. Chronic risk. Using the exposure different from a Codex MRL; however, This final rule directly regulates
assumptions described in this unit for FFDCA section 408(b)(4) requires that growers, food processors, food handlers,
chronic exposure, EPA has concluded EPA explain the reasons for departing and food retailers, not States or tribes,
that chronic exposure to rimsulfuron from the Codex level. The Codex has not
nor does this action alter the
from food and water will utilize 1.4% of established MRLs for rimsulfuron.
relationships or distribution of power
the cPAD for all infants less than 1-year C. Revisions to Petitioned-For and responsibilities established by
old, the population group receiving the Tolerances Congress in the preemption provisions
greatest exposure. There are no
The Agency is revising the proposed of FFDCA section 408(n)(4). As such,
residential uses for rimsulfuron.
commodity definitions of ‘‘sorghum, the Agency has determined that this
3. Short- and intermediate-term risk.
Short- and intermediate-term aggregate forage’’ to ‘‘sorghum, grain, forage’’; action will not have a substantial direct
exposure takes into account short- and ‘‘sorghum, grain’’ to ‘‘sorghum, grain, effect on States or tribal governments,
intermediate-term residential exposure grain’’; and ‘‘sorghum, stover’’ to on the relationship between the national
plus chronic exposure to food and water ‘‘sorghum, grain, stover’’. The tolerance government and the States or tribal
(considered to be a background expression is revised to reflect the governments, or on the distribution of
exposure level). preferred chemical name for power and responsibilities among the
Because there are no residential uses, rimsulfuron using CAS nomenclature. various levels of government or between
no short- or intermediate-term aggregate the Federal Government and Indian
V. Conclusion
risk assessments were conducted. tribes. Thus, the Agency has determined
Therefore, tolerances are established that Executive Order 13132, entitled
4. Aggregate cancer risk for U.S.
for residues of rimsulfuron, N-[[(4,6- ‘‘Federalism’’ (64 FR 43255, August 10,
population. Based on the lack of
dimethoxy-2- 1999) and Executive Order 13175,
evidence of carcinogenicity in two
pyrimidinyl)amino]carbonyl]-3- entitled ‘‘Consultation and Coordination
adequate rodent carcinogenicity studies,
(ethylsulfonyl)-2-pyridinesulfonamide, with Indian Tribal Governments’’ (65 FR
rimsulfuron is not expected to pose a
in or on sorghum, grain, forage; 67249, November 9, 2000) do not apply
cancer risk to humans.
5. Determination of safety. Based on sorghum, grain, grain; and sorghum, to this final rule. In addition, this final
these risk assessments, EPA concludes grain, stover at 0.01 ppm. rule does not impose any enforceable
that there is a reasonable certainty that VI. Statutory and Executive Order duty or contain any unfunded mandate
no harm will result to the general Reviews as described under Title II of the
population, or to infants and children Unfunded Mandates Reform Act of 1995
This final rule establishes tolerances
from aggregate exposure to rimsulfuron (UMRA) (2 U.S.C. 1501 et seq.).
under FFDCA section 408(d) in
residues. response to a petition submitted to the This action does not involve any
IV. Other Considerations Agency. The Office of Management and technical standards that would require
Budget (OMB) has exempted these types Agency consideration of voluntary
A. Analytical Enforcement Methodology of actions from review under Executive consensus standards pursuant to section
Adequate enforcement methodology Order 12866, entitled ‘‘Regulatory 12(d) of the National Technology
(Method DuPont-32277, a high Planning and Review’’ (58 FR 51735, Transfer and Advancement Act of 1995
performance liquid chromatography October 4, 1993). Because this final rule (NTTAA) (15 U.S.C. 272 note).
with tandem mass spectroscopy (HPLC/ has been exempted from review under
VII. Congressional Review Act
MS/MS)) is available to enforce the Executive Order 12866, this final rule is
tolerance expression. The method may not subject to Executive Order 13211, Pursuant to the Congressional Review
be requested from: Chief, Analytical entitled ‘‘Actions Concerning Act (5 U.S.C. 801 et seq.), EPA will
Chemistry Branch, Environmental Regulations That Significantly Affect submit a report containing this rule and
Science Center, 701 Mapes Rd., Ft. Energy Supply, Distribution, or Use’’ (66 other required information to the U.S.
Meade, MD 20755–5350; telephone FR 28355, May 22, 2001) or Executive Senate, the U.S. House of
number: (410) 305–2905; email address: Order 13045, entitled ‘‘Protection of Representatives, and the Comptroller
residuemethods@epa.gov. Children from Environmental Health General of the United States prior to
Risks and Safety Risks’’ (62 FR 19885, publication of the rule in the Federal
B. International Residue Limits
April 23, 1997). This final rule does not Register. This action is not a ‘‘major
In making its tolerance decisions, EPA contain any information collections rule’’ as defined by 5 U.S.C. 804(2).
seeks to harmonize U.S. tolerances with subject to OMB approval under the
international standards whenever Paperwork Reduction Act (PRA) (44 List of Subjects in 40 CFR Part 180
possible, consistent with U.S. food U.S.C. 3501 et seq.), nor does it require
safety standards and agricultural any special considerations under Environmental protection,
practices. EPA considers the Executive Order 12898, entitled Administrative practice and procedure,
international maximum residue limits ‘‘Federal Actions to Address Agricultural commodities, Pesticides
(MRLs) established by the Codex Environmental Justice in Minority and pests, Reporting and recordkeeping
Alimentarius Commission (Codex), as Populations and Low-Income requirements.
required by FFDCA section 408(b)(4). Populations’’ (59 FR 7629, February 16, Dated: October 21, 2015.
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The Codex Alimentarius is a joint 1994). G. Jeffrey Herndon,
United Nations Food and Agriculture Since tolerances and exemptions that
Director, Registration Division, Office of
Organization/World Health are established on the basis of a petition Pesticide Programs.
Organization food standards program, under FFDCA section 408(d), such as
and it is recognized as an international the tolerances in this final rule, do not Therefore, 40 CFR chapter I is
food safety standards-setting require the issuance of a proposed rule, amended as follows:
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![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Rules and Regulations 66805
PART 180—[AMENDED] ADDRESSES: The docket for this action, or request a hearing on this regulation
identified by docket identification (ID) in accordance with the instructions
■ 1. The authority citation for part 180 number EPA–HQ–OPP–2014–0600, is provided in 40 CFR part 178. To ensure
continues to read as follows: available at http://www.regulations.gov proper receipt by EPA, you must
Authority: 21 U.S.C. 321(q), 346a and 371. or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Regulatory Public Docket (OPP Docket) OPP–2014–0600 in the subject line on
■ 2. In § 180.478, revise paragraph (a)
in the Environmental Protection Agency the first page of your submission. All
and add alphabetically the following
Docket Center (EPA/DC), West William objections and requests for a hearing
commodities to the table in paragraph
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
(a) to read as follows:
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
§ 180.478 Rimsulfuron; tolerances for 20460–0001. The Public Reading Room before December 29, 2015. Addresses for
residues. is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
(a) General. Tolerances are Monday through Friday, excluding legal and hearing requests are provided in 40
established for residues of the herbicide holidays. The telephone number for the CFR 178.25(b).
rimsulfuron, including its metabolites Public Reading Room is (202) 566–1744, In addition to filing an objection or
and degradates, in or on the and the telephone number for the OPP hearing request with the Hearing Clerk
commodities in the following table. Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
Compliance with the tolerance levels the visitor instructions and additional submit a copy of the filing (excluding
specified in the following table is to be information about the docket available any Confidential Business Information
determined by measuring only at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
rimsulfuron, N-[[(4,6-dimethoxy-2- FOR FURTHER INFORMATION CONTACT:
Information not marked confidential
pyrimidinyl)amino] carbonyl]-3- Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be
(ethylsulfonyl)-2-pyridinesulfonamide. (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
Environmental Protection Agency, 1200
Parts per objection or hearing request, identified
Commodity Pennsylvania Ave. NW., Washington,
million by docket ID number EPA–HQ–OPP–
DC 20460–0001; main telephone
2014–0600, by one of the following
number: (703) 305–7090; email address:
methods:
* * * * * RDFRNotices@epa.gov. • Federal eRulemaking Portal: http://
Sorghum, grain, forage ............... 0.01 SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
Sorghum, grain, grain ................. 0.01 instructions for submitting comments.
Sorghum, grain, stover ............... 0.01 I. General Information
Do not submit electronically any
A. Does this action apply to me? information you consider to be CBI or
* * * * *
You may be potentially affected by other information whose disclosure is
* * * * * this action if you are an agricultural restricted by statute.
[FR Doc. 2015–27790 Filed 10–29–15; 8:45 am] producer, food manufacturer, or • Mail: OPP Docket, Environmental
BILLING CODE 6560–50–P pesticide manufacturer. The following Protection Agency Docket Center (EPA/
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
ENVIRONMENTAL PROTECTION not intended to be exhaustive, but rather • Hand Delivery: To make special
AGENCY provides a guide to help readers arrangements for hand delivery or
determine whether this document delivery of boxed information, please
40 CFR Part 180 applies to them. Potentially affected follow the instructions at http://
entities may include: www.epa.gov/dockets/contacts.html.
[EPA–HQ–OPP–2014–0600; FRL–9933–25]
• Crop production (NAICS code 111). Additional instructions on commenting
Teflubenzuron; Pesticide Tolerances • Animal production (NAICS code or visiting the docket, along with more
112). information about dockets generally, is
AGENCY: Environmental Protection • Food manufacturing (NAICS code available at http://www.epa.gov/
Agency (EPA). 311). dockets.
ACTION: Final rule. • Pesticide manufacturing (NAICS II. Summary of Petitioned-for Tolerance
code 32532).
SUMMARY: This regulation establishes In the Federal Register of January 28,
tolerances for residues of teflubenzuron B. How can I get electronic access to 2015 (80 FR 4525) (FRL–9921–55), EPA
[N-[[(3,5-dichloro-2,4- other related information? issued a document pursuant to FFDCA
difluorophenyl)amino]carbonyl]-2,6- You may access a frequently updated section 408(d)(3), 21 U.S.C. 346a(d)(3),
difluorobenzamide] in or on multiple electronic version of EPA’s tolerance announcing the filing of a pesticide
commodities which are identified and regulations at 40 CFR part 180 through petition (PP 4E8230) by BASF
discussed later in this document. BASF the Government Publishing Office’s e- Corporation, 26 Davis Dr., Research
Corporation requested these tolerances CFR site at http://www.ecfr.gov/cgi-bin/ Triangle Park, NC 27709. The petition
under the Federal Food, Drug, and text-idx?&c=ecfr&tpl=/ecfrbrowse/ requested that 40 CFR part 180 be
Cosmetic Act (FFDCA). Title40/40tab_02.tpl. amended by establishing tolerances for
DATES: This regulation is effective residues of the insecticide
October 30, 2015. Objections and C. How can I file an objection or hearing teflubenzuron, in or on apple at 0.5
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requests for hearings must be received request? parts per million (ppm); apple, wet
on or before December 29, 2015, and Under FFDCA section 408(g), 21 pomace at 0.8 ppm; broccoli at 0.2 ppm;
must be filed in accordance with the U.S.C. 346a, any person may file an cattle, meat byproducts at 0.01 ppm;
instructions provided in 40 CFR part objection to any aspect of this regulation cattle, muscle at 0.01 ppm; cauliflower
178 (see also Unit I.C. of the and may also request a hearing on those at 0.01 ppm; citrus, oil at 90 ppm;
SUPPLEMENTARY INFORMATION). objections. You must file your objection coffee, bean, green at 0.6 ppm; corn,
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Document Created: 2015-12-14 15:29:39
Document Modified: 2015-12-14 15:29:39
| 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 October 30, 2015. Objections and requests for hearings must be received on or before December 29, 2015, 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 | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 80 FR 66801 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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