81 FR 65917 - Fluopicolide; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 186 (September 26, 2016)
Federal Register Volume 81, Issue 186 (September 26, 2016)
| Page Range | 65917-65924 | |
| FR Document | 2016-23184 |
[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)] [Rules and Regulations] [Pages 65917-65924] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23184] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0791; FRL-9951-60] Fluopicolide; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation amends tolerances for residues of fluopicolide in or on potato, processed potato waste and vegetable, tuberous and corm, subgroup 1C and establishes a tolerance for residues of fluopicolide in or on potato, granules/flakes. Valent U.S.A. Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also assigns an expiration date to existing tolerances for potato, processed potato waste at 1.0 ppm and vegetable, tuberous and corm, subgroup 1C at 0.3 ppm. Lastly, this regulation establishes a time-limited tolerance on hop, dried cones. The time-limited tolerance is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The time-limited tolerance will expire and revoked on December 31, 2019. DATES: This regulation is effective September 26, 2016. Objections and requests for hearings must be received on or before November 25, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0791, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following 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 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-2015-0791 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 25, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0791, 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 Agency's Action A. Petitioned-For Tolerances In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942- 86) 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 5F8414) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596. The petition requested that 40 CFR 180.627 be amended by establishing tolerances for residues of the fungicide fluopicolide, 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2- pyridylmethyl]-benzamide, in or on potato, chips at 0.1 parts per million (ppm) and potato, granules/flakes at 0.15 ppm. That document referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is [[Page 65918]] available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C. 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 5F8414) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596. The petition requested that 40 CFR 180.627 be amended by amending tolerances for residues of the fungicide fluopicolide, 2,6- dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]-benzamide, in or on potato, processed potato waste at 0.25 ppm and vegetable, tuberous and corm, subgroup 1C at 0.10 ppm. That document referenced a summary of the petition prepared by Valent U.S.A. Corporation, the registrant, which is available in the docket, http://www.regulations.gov. Based upon review of the data supporting the petition, EPA is establishing tolerance levels for potato, processed potato waste and vegetable, tuberous and corm, subgroup 1C that differ from the petition requests and is not establishing a tolerance for residues on potato, chips. The reasons for these changes are explained in Unit IV.D. B. Tolerance for Use of Pesticide Under Emergency Exemption In response to a crisis exemption request filed under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) on behalf of the Michigan Department of Agriculture and Rural Development for the emergency use of fluopicolide to control downy mildew on hops grown in Michigan, EPA is establishing, pursuant to FFDCA section 408(l)(6), a time-limited tolerance for the use of fluopicolide on hop, dried cones at 30 ppm with an expiration date of December 31, 2019. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of fluopicolide on hops. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and the Agency decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non- routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although this time-limited tolerance expires and is revoked on December 31, 2019, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on hops after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by the time-limited tolerance at the time of that application. EPA will take action to revoke this time- limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions whether fluopicolide meets FIFRA's registration requirements for use in or on hops or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance serves as a basis for registration of fluopicolide by a State for Special Local Needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than Michigan to use this pesticide on hops under FIFRA sction 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for fluopicolide, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. 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 fluopicolide including exposure resulting from the tolerances established by this action. Fluopicolide shares a metabolite, 2,6-dichlorobenzamide (BAM), with another active ingredient, dichlobenil. Residues of BAM are considered to be of regulatory concern, and separate toxicity data and endpoints for risk assessment have been identified for BAM. Therefore, EPA has considered the aggregate, or combined risks, from food, water, and non- occupational exposure resulting from fluopicolide alone and BAM from all sources for this action. The BAM risk assessment considers residues resulting from both fluopicolide and dichlobenil uses. However, BAM residues generated from fluopicolide uses are expected to be significantly lower than BAM residues from dichlobenil uses. A. Fluopicolide In the Federal Register of August 6, 2014 (79 FR 45688) (FRL-9914- 37), EPA amended tolerances to raise the residue levels of fluopicolide in or on potato, processed potato waste to 1.0 ppm and vegetable, tuberous and corm, subgroup 1C to 0.3 ppm. In March of 2016, the EPA updated the dietary assessment for fluopicolide to account for the use of fluopicolide on hops under an emergency exemption. The March 2016 assessment considered the higher tolerance levels for potato, processed potato waste (1.0 ppm) and vegetable, tuberous and corm, subgroup 1C (0.3 ppm). Since this current action involves lowering the tolerances for potato, processed potato waste to 0.2 ppm and vegetable, tuberous and corm, subgroup 1C to 0.09 ppm, the EPA is relying upon the risk assessments and the findings made for fluopicolide in the August 6, 2014 Federal Register document, as well as an updated dietary risk assessment conducted for hops to support the lowering of the tolerances for potato, processed potato waste and vegetable, tuberous and corm, subgroup 1C. The toxicity profile and the points of departure for evaluating human health for fluopicolide have not changed since the August 6, 2014 rule. EPA conducted a dietary risk assessment to support the Section 18 registration for use of [[Page 65919]] fluopicolide on hops grown in Michigan in March 2016. The March 2016 assessment assumed the same exposure assumptions for assessing food exposure as discussed in Unit III.C. of the 2014 rule, where the analysis assumed 100 percent crop treated (PCT) and tolerance-level residues for all proposed/registered crops except for field corn/wheat grain (rotational crop tolerances) and tuberous and corm vegetables. For these crops, the residues of concern for risk assessment include metabolites that are not included in the tolerance expression, and the analysis assumed the highest combined residues from the field trials. However, the drinking water estimates used in 2016 are higher than those used in 2014 (24.14 ppb) based on the use of the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), where residues in ground water are now estimated to be 103 ppb. The March 2016 assessment resulted in slightly higher chronic dietary exposure estimates than the August 2014 dietary risk assessment (an increase from 13% to 14% chronic population-adjusted dose (cPAD)). Since the 2016 dietary risk assessment does not take into account the tolerance reductions for potato, processed potato waste (from 1.0 ppm to 0.2 ppm) and vegetable, tuberous and corm, subgroup 1C (from 0.3 ppm to 0.09 ppm) and estimates a higher drinking water concentration (24.14 ppb to 103 ppb), EPA expects the actual chronic dietary exposure estimates to be lower than 14%. The Agency has not made any new findings concerning cumulative exposure, nor has it identified any residual uncertainties to warrant changes to the Agency's August 6, 2014 FQPA safety factor determination. EPA concludes that reliable data continue to show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X based on the same findings found in the August 6, 2014 rule and supporting documents. Therefore, relying upon the findings made in the August 6, 2014, Federal Register document and the 2016 dietary risk assessment, 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 fluopicolide residues. For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer to the August 6, 2014, Federal Register document and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP- 2014-0225, as well as document titled ``Fluopicolide. Section 18 Registration for Application of Fluopicolide to Hops Grown in Michigan. Dietary Risk Assessment.'' dated March 24, 2016, in docket ID number EPA-HQ-OPP-2015-0791. However, since the August 6, 2014 action relied on a 2008 action for BAM, the EPA has updated the BAM assessment to revisit the percent crop treated (PCT) and account for updated food consumption data. EPA's assessment of exposures and risks associated with BAM follows. B. BAM 1. 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 toxicity profile for BAM has not changed since the 2008 assessment EPA conducted for BAM. Specific information on the studies received and the nature of the adverse effects caused by BAM 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 in ``2,6-Dichlorobenzamide (BAM). 2,6-Dichlorobenzamide (BAM) as a Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk Assessment for Proposed Uses of Rhubarb, Dichlobenil on Caneberries (Subgroup 13-07A), and Bushberries (Subgroup 13-07B).'' dated June 19, 2008, in docket ID number EPA-HQ-OPP-2007-0604. 2. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for BAM used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 20, 2011 (76 FR 22045) (FRL-8859-9). 3. Exposure Assessment a. Dietary exposure from food and feed uses. In evaluating dietary exposure to BAM, EPA considered exposure of BAM from petitioned-for tolerances discussed in this document, as well as all existing uses for both fluopicolide and dichlobenil. EPA assessed dietary exposures from BAM 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 from a 1-day or single exposure. Such effects were identified for BAM. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. EPA conducted a partially refined acute dietary exposure assessment for the metabolite BAM. As to residue levels in food, EPA assumed maximum BAM residue from either the fluopicolide or dichlobenil field trial data. Further, 100 PCT for all commodities was assumed except apples, blueberries, cherries, peaches, pears, and raspberries where EPA relied on PCT estimates based on use of dichlobenil on these commodities; fluopicolide is not registered for use on these commodities. DEEM default processing-factors were used for commodities where empirical processing data were not available. [[Page 65920]] ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used food consumption information from the USDA NHANES/ WWEIA 2003 to 2008 dietary survey. As to residue levels in food, EPA assumed maximum BAM residue from either fluopicolide or dichlobenil field trials and, further, the chronic assessment used 100 PCT for all commodities except apples. DEEM default processing-factors were used for commodities where empirical processing data were not available. iii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope- factor approach is utilized. EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to BAM. The carcinogenic potential of BAM has been evaluated in only one species, the rat. That study showed an increased incidence of hepatocellular adenomas in high-dose females that was marginally statistically significant. To be conservative, EPA has assumed that BAM's potential for carcinogenicity is similar to the parent having the greatest carcinogenic potential. Fluopicolide has been classified as not likely to be carcinogenic to humans; EPA classified dichlobenil as a Group C, possible human carcinogen, but determined that the chronic dietary risk assessment based on the cPAD would be protective of any potential cancer effects. EPA has assumed that BAM's carcinogenic potential is similar to that of dichlobenil, the parent compound having the greatest carcinogenicity potential. As with dichlobenil, the chronic dietary risk assessment based on the cPAD is expected to protect for any potential cancer effects. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.B.3.a.ii. For additional information, refer to the summary of the toxicological endpoints for BAM used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 20, 2011 (76 FR 22045) (FRL-8859-9). iv. Anticipated residue and percent crop treated (PCT) information. For the BAM dietary assessment, EPA used available anticipated residue levels and PCT information on apples, blueberries, cherries, peaches, pears, and raspberries where EPA relied on PCT estimates based on use of dichlobenil; fluopicolide is not registered for use on these commodities. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue. Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group. Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. In the acute dietary assessment for BAM, the Agency estimated the PCT from the existing dichlobenil uses as follows: Apple, 2.5%; blueberry, 2.5%; raspberry, 20%; cherry, 2.5%; peach, 2.5%; pear, 5%. In the chronic dietary assessment for BAM, the Agency estimated the PCT from the existing dichlobenil uses as follows: Apple, 1%. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%. The Agency believes that the three conditions discussed in Unit III.B.3.a.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which fluopicolide or dichlobenil may be applied in a particular area. b. Dietary exposure from drinking water. The Agency used screening- level water exposure models in the dietary exposure analysis and risk assessment for BAM in drinking water. The Agency used estimates of BAM resulting from the application of dichlobenil, as they were higher than those resulting from the application of fluopicolide. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of BAM. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide. [[Page 65921]] Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI- GROW) models, the estimated drinking water concentrations (EDWCs) of BAM resulting from application of dichlobenil for acute exposures are estimated to be 25.5 parts per billion (ppb) for surface water and 67.4 ppb for ground water. The EDWCs of BAM resulting from application of dichlobenil for chronic exposures for non-cancer assessments are estimated to be 10.5 ppb for surface water and 67.4 ppb for 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 of value 67.4 ppb was used to assess the contribution to drinking water. c. 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). Fluopicolide is currently registered for the following uses that could result in residential exposures: Residential turf grass, recreational sites, and ornamental plants and trees. EPA assessed residential exposure to BAM from fluopicolide uses using the following assumptions: Residential handlers may receive short-term dermal and inhalation exposure to BAM when mixing, loading, and applying the fluopicolide formulations. Residential post-application exposure via the dermal route is likely for adults and children entering treated lawns or treated gardens and during mowing and golfing activities. Children may experience exposure via incidental non-dietary ingestion (i.e., hand-to-mouth, object-to-mouth, and soil ingestion) during post- application activities on treated turf. Residential handler exposure to BAM resulting from the application of dichlobenil is not expected. While dichlobenil is currently registered for residential uses on ornamental plants, they are approved for professional applicator use only. Post-application exposure of adults and children to dichlobenil and BAM exposure from the use of dichlobenil products on ornamental plants is expected to be negligible and, therefore, was not assessed. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. d. 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.'' Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fluopicolide and any other substances. Fluopicolide shares a common metabolite, BAM, with dichlobenil. Quantification of risks for residues of BAM resulting from fluopicolide and dichlobenil was completed as part of this assessment; aggregate risks from BAM are not of concern. For the purposes of this tolerance action, EPA has not assumed that fluopicolide has 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/cumulative-assessment-risk-pesticides 4. Safety Factor for Infants and Children a. 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. b. Prenatal and postnatal sensitivity. For BAM, there is no evidence of quantitative susceptibility following in utero and/or postnatal exposure in the rabbit developmental toxicity study or in the 3-generation rat reproduction study. Qualitative susceptibility was not observed in the 3-generation reproduction study. Qualitative susceptibility was observed in the rabbit developmental toxicity study. Fetal effects (skeletal and visceral anomalies) and late-term abortions were observed. There is low concern for this qualitative susceptibility, because the fetal effects and late-term abortions have been well characterized and occurred at dose levels where significant maternal toxicity (severe body-weight gain decrements and decreased food consumption) was observed. Protection of the maternal effects also protects for any effects that may occur during development. There are not residual uncertainties concerning prenatal and postnatal toxicity for BAM. c. Conclusion. EPA has retained the 10X FQPA SF for BAM for those exposure scenarios that do not rely on dichlobenil toxicity data. These scenarios are acute dietary for the general population (including infants and children) and females 13-49 years of age, chronic dietary, and incidental oral non-dietary. Although EPA has developmental, reproduction, and subchronic and chronic toxicity studies for the metabolite BAM, and a structure activity analysis indicates EPA has identified its principal toxicological effects and level of toxicity, EPA is retaining the FQPA 10X SF due to remaining questions regarding the systemic neurotoxic potential of BAM (olfactory neurotoxicity) via the oral route of exposure and the use of a LOAEL in assessing acute dietary risk for the general population. For the dermal and inhalation routes of exposures, for which the Agency is relying on dichlobenil toxicity data, EPA has reduced the FQPA SF for BAM to 1X, based on a comparison of toxicity via the intraperitoneal route of exposure showing that higher doses of BAM are needed to induce levels of olfactory toxicity that are similar to those caused by dichlobenil. Olfactory toxicity, the most sensitive endpoint, was the endpoint chosen for these exposure scenarios. Other factors EPA considered in the FQPA SF decisions for BAM include the following: i. To compensate for deficiencies in the toxicology database for BAM, EPA performed a comparative analysis of the toxicity of BAM and the parent compounds, dichlobenil and fluopicolide, using the available animal data and DEREK analysis (Deductive Estimation of Risk from Existing Knowledge). DEREK is a toxicology application that uses structure-activity relationships to predict a broad range of toxicological properties based on a comprehensive analysis of a compound's molecular structure. Based on the available animal data and DEREK analyses, BAM does not appear to cause [[Page 65922]] different organ-specific toxicities compared to fluopicolide and dichlobenil. The kidney and liver toxicities are common to all three compounds. With respect to relative toxicity, conclusions from the evaluation of the animal studies appear to confirm that both fluopicolide and dichlobenil appear to be more or equally toxic compared to BAM. A full discussion of EPA's comparative toxicity analysis of BAM, dichlobenil and fluopicolide can be found at http://www.regulations.gov in the document Comparative Toxicity Using Derek Analysis for Dichlobenil, Fluopicolide and BAM in docket ID number EPA- HQ-OPP-2007-0604. Based on the results of the available animal data and the DEREK analysis, EPA concludes that the safety factors discussed in the previous paragraph are adequate. ii. For BAM, there is no evidence of quantitative susceptibility following in utero and/or postnatal exposure in the rabbit developmental toxicity study or in the 3-generation rat reproduction study. Qualitative susceptibility was not observed in the 3-generation reproduction study however, qualitative susceptibility was observed in the rabbit developmental toxicity study. Yet the concern for this qualitative susceptibility is low because the fetal effects and late- term abortions have been well characterized and occurred at dose levels where significant maternal toxicity (severe body-weight gain decrements and decreased food consumption) was observed. Protection of the maternal effects also protects for any effects that may occur during development. iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were refined using reliable PCT information and anticipated residue values calculated from residue field trial results. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to BAM in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by BAM. 5. 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. a. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to BAM will occupy 26% of the aPAD for females 13 to 49 years old, the population group receiving the greatest exposure. b. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to BAM from food and water will utilize 95% of the cPAD for all Infants (<1 year old), the population group receiving the greatest exposure. Based on the explanation in Unit III.B.3.c., regarding residential use patterns, chronic residential exposure to residues of BAM is not expected. c. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered a background exposure level). Fluopicolide, is currently registered for uses that could result in short-term residential exposure to BAM, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to BAM associated with the application of fluopicolide. As noted in Unit III.B.3.c above, EPA does not expect there to be residential exposures to BAM from use of dichlobenil. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 3200 for All Infants (<1 year old) and 5,400 for children 1 to 2 years old. Because EPA's level of concern for BAM is a MOE of 1,000 or below, these MOEs are not of concern. d. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered a background exposure level). An intermediate-term adverse effect was identified; however, fluopicolide is not registered for any use patterns that would result in intermediate-term residential exposure. Further, fluopicolide and dichlobenil are not registered for any use patterns that would result in intermediate-term residential exposure to BAM. 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 fluopicolide and its metabolite, BAM. e. Aggregate cancer risk for U.S. population. The Agency considers the chronic aggregate risk assessment, making use of the cPAD, to be protective of any aggregate cancer risk. See Unit III.B.5.b, Chronic risk, above. f. 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 residues of fluopicolide and its metabolite, BAM. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (liquid chromatography/tandem mass spectrometry (LC/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]. 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 [[Page 65923]] EPA explain the reasons for departing from the Codex level. The Codex has not established an MRL for fluopicolide on the subject commodities. C. Response to Comments EPA received one comment to the Notice of Filing that stated, in part, that the citizenry of this country do not want to eat any food items that have been polluted by these toxic chemicals and to deny this exemption. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework. D. Revisions to Petitioned-For Tolerances EPA revised the tolerance levels based on analysis of the residue field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures. Based on evaluation of the residue data and use of the OECD calculation procedures, the Agency modified the tolerance for the vegetable, tuberous and corm, subgroup 1C from the requested level of 0.10 ppm to 0.09 ppm. The Agency also modified the tolerance for potato, processed potato waste from the requested tolerance level of 0.25 ppm to 0.2 ppm (0.075 ppm maximum residue x 2.4 processing factor for wet peel). The EPA did not establish the requested tolerance for potato, chips because the tolerance for vegetable, tuberous and corm, subgroup 1C (0.09 ppm) will cover residues in or on potato chips (0.068 ppm estimated residue). E. International Trade Considerations In this rulemaking, EPA is reducing the tolerances for vegetable, tuberous and corm, subgroup 1C from 0.3 ppm to 0.09 ppm and potato, processed potato waste from 1.0 ppm to 0.2 ppm. The petitioner requested these reductions in order to harmonize tolerances with field trial data after the tolerances were increased in 2014 to support an early season soil application to potato, which has since then been restricted. The reduction is appropriate based on available data and residue levels resulting from registered use patterns. In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures Agreement, EPA notified the WTO of the request to revise these tolerances on July 19, 2016 as WTO notification G/SPS/N/USA/2861. In this action, EPA is allowing the existing higher tolerances to remain in effect for 6 months following the publication of this rule in order to allow a reasonable interval for producers in the exporting countries to adapt to the requirements of these modified tolerances. On March 27, 2017, those existing higher tolerances will expire, and the new reduced tolerances for vegetable, tuberous and corm, subgroup 1C and potato, processed potato waste will remain to cover residues of fluopicolide on those commodities. Before that date, residues of fluopicolide on those commodities would be permitted up to the higher tolerance levels; after that date, residues of fluopicolide on vegetable, tuberous and corm, subgroup 1C and potato, processed potato waste will need to comply with the new lower tolerance levels. This reduction in tolerance is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods. V. Conclusion Therefore, tolerances are established for residues of fluopicolide, 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]- benzamide, in or on vegetable, tuberous and corm, subgroup 1C at 0.09 ppm, potato, processed waste at 0.2 ppm, and potato, granules/flakes at 0.15 ppm. The Agency is adding an expiration date of March 27, 2017 to the existing tolerances for vegetable, tuberous and corm, subgroup 1C at 0.3 ppm and potato, processed potato waste at 1.0 ppm. Residues of fluopicolide will be covered by these higher tolerances until the expiration date, after which time, they will need to comply with the lower tolerances being established today. Lastly, this regulation establishes a time-limited tolerance for residues of fluopicolide in or on hop, dried cone at 30 ppm. 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). [[Page 65924]] 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: September 13, 2016. Daniel J. Rosenblatt, Acting 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. 180.627: 0 a. In the table in paragraph (a), add alphabetically entries for ``Potato, granules/flakes'' and ``Potato, processed potato waste,'' revise the existing entry for ``Potato, processed potato waste,'' and add an entry for ``Vegetable, tuberous and corm, subgroup 1C''; and 0 b. Revise paragraph (b). The additions and revisions read as follows: Sec. 180.627 Fluopicolide; tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Potato, granules/flakes..................................... 0.15 Potato, processed potato waste.............................. 0.2 Potato, processed potato waste.\1\.......................... 1.0 * * * * * Vegetable, tuberous and corm, subgroup 1C................... 0.09 Vegetable, tuberous and corm, subgroup 1C \1\............... 0.3 ------------------------------------------------------------------------ \1\ This tolerance expires on March 27, 2017. (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the fluopicolide, including its metabolites and degradates, in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance with the tolerance levels specified below is to be determined by measuring only fluopicolide [2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2- pyridinyl]methyl]benzamide] in or on the commodity. The tolerances expire on the date specified in the table. ------------------------------------------------------------------------ Parts per Commodity million Expiration date ------------------------------------------------------------------------ Hop, dried cones............ 30 December 31, 2019. ------------------------------------------------------------------------ * * * * * [FR Doc. 2016-23184 Filed 9-23-16; 8:45 am] BILLING CODE 6560-50-P
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to the timing requirement for submittal Docket Center (EPA/DC), West William proper receipt by EPA, you must
of an authorized tribe’s first list of Jefferson Clinton Bldg., Rm. 3334, 1301 identify docket ID number EPA–HQ–
impaired waters pursuant to Constitution Ave. NW., Washington, DC OPP–2015–0791 in the subject line on
§ 130.7(d)(1), the tribe’s first list is due 20460–0001. The Public Reading Room the first page of your submission. All
on the next listing cycle due date that is open from 8:30 a.m. to 4:30 p.m., objections and requests for a hearing
is at least 24 months from the later of Monday through Friday, excluding legal must be in writing, and must be
either: holidays. The telephone number for the received by the Hearing Clerk on or
(i) The date EPA approves the tribe’s Public Reading Room is (202) 566–1744, before November 25, 2016. Addresses
TAS application pursuant to this and the telephone number for the OPP for mail and hand delivery of objections
section; or Docket is (703) 305–5805. Please review and hearing requests are provided in 40
(ii) The date EPA-approved or EPA- the visitor instructions and additional CFR 178.25(b).
promulgated water quality standards information about the docket available In addition to filing an objection or
become effective for the tribe’s at http://www.epa.gov/dockets. hearing request with the Hearing Clerk
reservation waters. FOR FURTHER INFORMATION CONTACT: as described in 40 CFR part 178, please
[FR Doc. 2016–22882 Filed 9–23–16; 8:45 a.m.] Michael Goodis, Registration Division submit a copy of the filing (excluding
BILLING CODE 6560–50–P (7505P), Office of Pesticide Programs, any Confidential Business Information
Environmental Protection Agency, 1200 (CBI)) for inclusion in the public docket.
Pennsylvania Ave. NW., Washington, Information not marked confidential
ENVIRONMENTAL PROTECTION DC 20460–0001; main telephone pursuant to 40 CFR part 2 may be
AGENCY number: (703) 305–7090; email address: disclosed publicly by EPA without prior
RDFRNotices@epa.gov. notice. Submit the non-CBI copy of your
40 CFR Part 180 SUPPLEMENTARY INFORMATION:
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
[EPA–HQ–OPP–2015–0791; FRL–9951–60] I. General Information 2015–0791, by one of the following
Fluopicolide; Pesticide Tolerances A. Does this action apply to me? methods:
• Federal eRulemaking Portal: http://
AGENCY: Environmental Protection You may be potentially affected by www.regulations.gov. Follow the online
Agency (EPA). this action if you are an agricultural instructions for submitting comments.
ACTION: Final rule.
producer, food manufacturer, or Do not submit electronically any
pesticide manufacturer. The following information you consider to be CBI or
SUMMARY: This regulation amends list of North American Industrial other information whose disclosure is
tolerances for residues of fluopicolide in Classification System (NAICS) codes is restricted by statute.
or on potato, processed potato waste not intended to be exhaustive, but rather • Mail: OPP Docket, Environmental
and vegetable, tuberous and corm, provides a guide to help readers Protection Agency Docket Center (EPA/
subgroup 1C and establishes a tolerance determine whether this document DC), (28221T), 1200 Pennsylvania Ave.
for residues of fluopicolide in or on applies to them. Potentially affected NW., Washington, DC 20460–0001.
potato, granules/flakes. Valent U.S.A. entities may include: • Hand Delivery: To make special
Corporation requested these tolerances • Crop production (NAICS code 111). arrangements for hand delivery or
under the Federal Food, Drug, and • Animal production (NAICS code delivery of boxed information, please
Cosmetic Act (FFDCA). This regulation 112). follow the instructions at http://
also assigns an expiration date to • Food manufacturing (NAICS code www.epa.gov/dockets/contacts.html.
existing tolerances for potato, processed 311). Additional instructions on commenting
potato waste at 1.0 ppm and vegetable, • Pesticide manufacturing (NAICS or visiting the docket, along with more
tuberous and corm, subgroup 1C at 0.3 code 32532). information about dockets generally, is
ppm. Lastly, this regulation establishes B. How can I get electronic access to available at http://www.epa.gov/
a time-limited tolerance on hop, dried other related information? dockets.
cones. The time-limited tolerance is in
You may access a frequently updated II. Summary of Agency’s Action
response to EPA’s granting of an
electronic version of EPA’s tolerance
emergency exemption under the Federal A. Petitioned-For Tolerances
regulations at 40 CFR part 180 through
Insecticide, Fungicide, and Rodenticide In the Federal Register of March 16,
the Government Printing Office’s e-CFR
Act (FIFRA). The time-limited tolerance 2016 (81 FR 14030) (FRL–9942–86) EPA
site at http://www.ecfr.gov/cgi-bin/text-
will expire and revoked on December issued a document pursuant to FFDCA
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
31, 2019. section 408(d)(3), 21 U.S.C. 346a(d)(3),
40tab_02.tpl. To access the OCSPP test
DATES: This regulation is effective guidelines referenced in this document announcing the filing of a pesticide
September 26, 2016. Objections and electronically, please go to http:// petition (PP 5F8414) by Valent U.S.A.
requests for hearings must be received www.epa.gov/ocspp and select ‘‘Test Corporation, 1600 Riviera Avenue, Suite
on or before November 25, 2016, and Methods and Guidelines.’’ 200, Walnut Creek, CA 94596. The
must be filed in accordance with the petition requested that 40 CFR 180.627
instructions provided in 40 CFR part C. How can I file an objection or hearing be amended by establishing tolerances
178 (see also Unit I.C. of the request? for residues of the fungicide
SUPPLEMENTARY INFORMATION). Under FFDCA section 408(g), 21 fluopicolide, 2,6-dichloro-N-[3-chloro-5-
mstockstill on DSK3G9T082PROD with RULES
ADDRESSES: The docket for this action, U.S.C. 346a, any person may file an (trifluoromethyl)-2-pyridylmethyl]-
identified by docket identification (ID) objection to any aspect of this regulation benzamide, in or on potato, chips at 0.1
number EPA–HQ–OPP–2015–0791, is and may also request a hearing on those parts per million (ppm) and potato,
available at http://www.regulations.gov objections. You must file your objection granules/flakes at 0.15 ppm. That
or at the Office of Pesticide Programs or request a hearing on this regulation document referenced a summary of the
Regulatory Public Docket (OPP Docket) in accordance with the instructions petition prepared by Valent U.S.A.
in the Environmental Protection Agency provided in 40 CFR part 178. To ensure Corporation, the registrant, which is
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![65918 Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Rules and Regulations
available in the docket, http:// comment as provided in section aggregate exposure to the pesticide
www.regulations.gov. A comment was 408(l)(6) of FFDCA. Although this time- chemical residue . . . .’’
received on the notice of filing. EPA’s limited tolerance expires and is revoked Consistent with FFDCA section
response to this comment is discussed on December 31, 2019, under section 408(b)(2)(D), and the factors specified in
in Unit IV.C. 408(l)(5) of FFDCA, residues of the FFDCA section 408(b)(2)(D), EPA has
In the Federal Register of May 19, pesticide not in excess of the amounts reviewed the available scientific data
2016 (81 FR 31581) (FRL–9946–02) EPA specified in the tolerance remaining in and other relevant information in
issued a document pursuant to FFDCA or on hops after that date will not be support of this action. EPA has
section 408(d)(3), 21 U.S.C. 346a(d)(3), unlawful, provided the pesticide was sufficient data to assess the hazards of
announcing the filing of a pesticide applied in a manner that was lawful and to make a determination on
petition (PP 5F8414) by Valent U.S.A. under FIFRA, and the residues do not aggregate exposure for fluopicolide
Corporation, 1600 Riviera Avenue, Suite exceed a level that was authorized by including exposure resulting from the
200, Walnut Creek, CA 94596. The the time-limited tolerance at the time of tolerances established by this action.
petition requested that 40 CFR 180.627 that application. EPA will take action to Fluopicolide shares a metabolite, 2,6-
be amended by amending tolerances for revoke this time-limited tolerance dichlorobenzamide (BAM), with another
residues of the fungicide fluopicolide, earlier if any experience with, scientific active ingredient, dichlobenil. Residues
2,6-dichloro-N-[3-chloro-5- data on, or other relevant information of BAM are considered to be of
(trifluoromethyl)-2-pyridylmethyl]- on this pesticide indicate that the regulatory concern, and separate
benzamide, in or on potato, processed residues are not safe. toxicity data and endpoints for risk
potato waste at 0.25 ppm and vegetable, Because this time-limited tolerance is assessment have been identified for
tuberous and corm, subgroup 1C at 0.10 being approved under emergency BAM. Therefore, EPA has considered
ppm. That document referenced a conditions, EPA has not made any the aggregate, or combined risks, from
summary of the petition prepared by decisions whether fluopicolide meets food, water, and non-occupational
Valent U.S.A. Corporation, the FIFRA’s registration requirements for exposure resulting from fluopicolide
registrant, which is available in the use in or on hops or whether a alone and BAM from all sources for this
docket, http://www.regulations.gov. permanent tolerance for this use would action. The BAM risk assessment
Based upon review of the data be appropriate. Under these considers residues resulting from both
supporting the petition, EPA is circumstances, EPA does not believe fluopicolide and dichlobenil uses.
establishing tolerance levels for potato, that this time-limited tolerance serves as However, BAM residues generated from
processed potato waste and vegetable, a basis for registration of fluopicolide by fluopicolide uses are expected to be
tuberous and corm, subgroup 1C that a State for Special Local Needs under significantly lower than BAM residues
differ from the petition requests and is FIFRA section 24(c). Nor does this from dichlobenil uses.
not establishing a tolerance for residues tolerance serve as the basis for persons A. Fluopicolide
on potato, chips. The reasons for these in any State other than Michigan to use
changes are explained in Unit IV.D. this pesticide on hops under FIFRA In the Federal Register of August 6,
sction 18 absent the issuance of an 2014 (79 FR 45688) (FRL–9914–37),
B. Tolerance for Use of Pesticide Under EPA amended tolerances to raise the
Emergency Exemption emergency exemption applicable within
that State. For additional information residue levels of fluopicolide in or on
In response to a crisis exemption regarding the emergency exemption for potato, processed potato waste to 1.0
request filed under section 18 of the fluopicolide, contact the Agency’s ppm and vegetable, tuberous and corm,
Federal Insecticide, Fungicide, and Registration Division at the address subgroup 1C to 0.3 ppm. In March of
Rodenticide Act (FIFRA) on behalf of provided under FOR FURTHER 2016, the EPA updated the dietary
the Michigan Department of Agriculture INFORMATION CONTACT. assessment for fluopicolide to account
and Rural Development for the for the use of fluopicolide on hops
emergency use of fluopicolide to control III. Aggregate Risk Assessment and under an emergency exemption. The
downy mildew on hops grown in Determination of Safety March 2016 assessment considered the
Michigan, EPA is establishing, pursuant Section 408(b)(2)(A)(i) of FFDCA higher tolerance levels for potato,
to FFDCA section 408(l)(6), a time- allows EPA to establish a tolerance (the processed potato waste (1.0 ppm) and
limited tolerance for the use of legal limit for a pesticide chemical vegetable, tuberous and corm, subgroup
fluopicolide on hop, dried cones at 30 residue in or on a food) only if EPA 1C (0.3 ppm). Since this current action
ppm with an expiration date of determines that the tolerance is ‘‘safe.’’ involves lowering the tolerances for
December 31, 2019. Section 408(b)(2)(A)(ii) of FFDCA potato, processed potato waste to 0.2
As part of its evaluation of the defines ‘‘safe’’ to mean that ‘‘there is a ppm and vegetable, tuberous and corm,
emergency exemption application, EPA reasonable certainty that no harm will subgroup 1C to 0.09 ppm, the EPA is
assessed the potential risks presented by result from aggregate exposure to the relying upon the risk assessments and
residues of fluopicolide on hops. In pesticide chemical residue, including the findings made for fluopicolide in the
doing so, EPA considered the safety all anticipated dietary exposures and all August 6, 2014 Federal Register
standard in section 408(b)(2) of FFDCA, other exposures for which there is document, as well as an updated dietary
and the Agency decided that the reliable information.’’ This includes risk assessment conducted for hops to
necessary tolerance under section exposure through drinking water and in support the lowering of the tolerances
408(l)(6) of FFDCA would be consistent residential settings, but does not include for potato, processed potato waste and
with the safety standard and with occupational exposure. Section vegetable, tuberous and corm, subgroup
mstockstill on DSK3G9T082PROD with RULES
FIFRA section 18. Consistent with the 408(b)(2)(C) of FFDCA requires EPA to 1C.
need to move quickly on the emergency give special consideration to exposure The toxicity profile and the points of
exemption in order to address an urgent of infants and children to the pesticide departure for evaluating human health
non-routine situation and to ensure that chemical residue in establishing a for fluopicolide have not changed since
the resulting food is safe and lawful, tolerance and to ‘‘ensure that there is a the August 6, 2014 rule. EPA conducted
EPA is issuing this tolerance without reasonable certainty that no harm will a dietary risk assessment to support the
notice and opportunity for public result to infants and children from Section 18 registration for use of
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![Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Rules and Regulations 65923
EPA explain the reasons for departing available data and residue levels Planning, and Review’’ (58 FR 51735,
from the Codex level. The Codex has not resulting from registered use patterns. October 4, 1993). Because this action
established an MRL for fluopicolide on In accordance with the World Trade has been exempted from review under
the subject commodities. Organization’s (WTO) Sanitary and Executive Order 12866, this action is
Phytosanitary Measures Agreement, not subject to Executive Order 13211,
C. Response to Comments EPA notified the WTO of the request to entitled ‘‘Actions Concerning
EPA received one comment to the revise these tolerances on July 19, 2016 Regulations That Significantly Affect
Notice of Filing that stated, in part, that as WTO notification G/SPS/N/USA/ Energy Supply, Distribution, or Use’’ (66
the citizenry of this country do not want 2861. In this action, EPA is allowing the FR 28355, May 22, 2001) or Executive
to eat any food items that have been existing higher tolerances to remain in Order 13045, entitled ‘‘Protection of
polluted by these toxic chemicals and to effect for 6 months following the Children from Environmental Health
deny this exemption. The Agency publication of this rule in order to allow Risks and Safety Risks’’ (62 FR 19885,
understands the commenter’s concerns a reasonable interval for producers in April 23, 1997). This action does not
and recognizes that some individuals the exporting countries to adapt to the contain any information collections
believe that pesticides should be banned requirements of these modified subject to OMB approval under the
on agricultural crops. However, the tolerances. On March 27, 2017, those Paperwork Reduction Act (PRA) (44
existing legal framework provided by existing higher tolerances will expire, U.S.C. 3501 et seq.), nor does it require
section 408 of the Federal Food, Drug, and the new reduced tolerances for any special considerations under
and Cosmetic Act (FFDCA) states that vegetable, tuberous and corm, subgroup Executive Order 12898, entitled
tolerances may be set when persons 1C and potato, processed potato waste ‘‘Federal Actions to Address
seeking such tolerances or exemptions will remain to cover residues of Environmental Justice in Minority
have demonstrated that the pesticide fluopicolide on those commodities. Populations and Low-Income
meets the safety standard imposed by Before that date, residues of fluopicolide Populations’’ (59 FR 7629, February 16,
that statute. This citizen’s comment on those commodities would be 1994).
appears to be directed at the underlying permitted up to the higher tolerance Since tolerances and exemptions that
statute and not EPA’s implementation of levels; after that date, residues of are established on the basis of a petition
it; the citizen has made no contention fluopicolide on vegetable, tuberous and under FFDCA section 408(d), such as
that EPA has acted in violation of the corm, subgroup 1C and potato, the tolerance in this final rule, do not
statutory framework. processed potato waste will need to require the issuance of a proposed rule,
comply with the new lower tolerance the requirements of the Regulatory
D. Revisions to Petitioned-For levels. This reduction in tolerance is not Flexibility Act (RFA) (5 U.S.C. 601 et
Tolerances discriminatory; the same food safety seq.), do not apply.
standard contained in the FFDCA This action directly regulates growers,
EPA revised the tolerance levels based food processors, food handlers, and food
applies equally to domestically
on analysis of the residue field trial data retailers, not States or tribes, nor does
produced and imported foods.
using the Organization for Economic this action alter the relationships or
Cooperation and Development (OECD) V. Conclusion distribution of power and
tolerance calculation procedures. Based Therefore, tolerances are established responsibilities established by Congress
on evaluation of the residue data and for residues of fluopicolide, 2,6- in the preemption provisions of FFDCA
use of the OECD calculation procedures, dichloro-N-[3-chloro-5- section 408(n)(4). As such, the Agency
the Agency modified the tolerance for (trifluoromethyl)-2-pyridylmethyl]- has determined that this action will not
the vegetable, tuberous and corm, benzamide, in or on vegetable, tuberous have a substantial direct effect on States
subgroup 1C from the requested level of and corm, subgroup 1C at 0.09 ppm, or tribal governments, on the
0.10 ppm to 0.09 ppm. The Agency also potato, processed waste at 0.2 ppm, and relationship between the national
modified the tolerance for potato, potato, granules/flakes at 0.15 ppm. The government and the States or tribal
processed potato waste from the Agency is adding an expiration date of governments, or on the distribution of
requested tolerance level of 0.25 ppm to March 27, 2017 to the existing power and responsibilities among the
0.2 ppm (0.075 ppm maximum residue tolerances for vegetable, tuberous and various levels of government or between
× 2.4 processing factor for wet peel). The corm, subgroup 1C at 0.3 ppm and the Federal Government and Indian
EPA did not establish the requested potato, processed potato waste at 1.0 tribes. Thus, the Agency has determined
tolerance for potato, chips because the ppm. Residues of fluopicolide will be that Executive Order 13132, entitled
tolerance for vegetable, tuberous and covered by these higher tolerances until ‘‘Federalism’’ (64 FR 43255, August 10,
corm, subgroup 1C (0.09 ppm) will the expiration date, after which time, 1999) and Executive Order 13175,
cover residues in or on potato chips they will need to comply with the lower entitled ‘‘Consultation and Coordination
(0.068 ppm estimated residue). tolerances being established today. with Indian Tribal Governments’’ (65 FR
E. International Trade Considerations Lastly, this regulation establishes a 67249, November 9, 2000) do not apply
time-limited tolerance for residues of to this action. In addition, this action
In this rulemaking, EPA is reducing fluopicolide in or on hop, dried cone at does not impose any enforceable duty or
the tolerances for vegetable, tuberous 30 ppm. contain any unfunded mandate as
and corm, subgroup 1C from 0.3 ppm to described under Title II of the Unfunded
0.09 ppm and potato, processed potato VI. Statutory and Executive Order Mandates Reform Act (UMRA) (2 U.S.C.
waste from 1.0 ppm to 0.2 ppm. The Reviews 1501 et seq.).
mstockstill on DSK3G9T082PROD with RULES
petitioner requested these reductions in This action establishes tolerances This action does not involve any
order to harmonize tolerances with field under FFDCA section 408(d) in technical standards that would require
trial data after the tolerances were response to a petition submitted to the Agency consideration of voluntary
increased in 2014 to support an early Agency. The Office of Management and consensus standards pursuant to section
season soil application to potato, which Budget (OMB) has exempted these types 12(d) of the National Technology
has since then been restricted. The of actions from review under Executive Transfer and Advancement Act
reduction is appropriate based on Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note).
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![65924 Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Rules and Regulations
VII. Congressional Review Act PART 180—[AMENDED] Parts per
Commodity million
Pursuant to the Congressional Review ■ 1. The authority citation for part 180
Act (5 U.S.C. 801 et seq.), EPA will continues to read as follows: Potato, processed potato waste.1 1.0
submit a report containing this rule and Authority: 21 U.S.C. 321(q), 346a and 371.
other required information to the U.S. * * * * *
Senate, the U.S. House of ■ 2. In § 180.627: Vegetable, tuberous and corm,
■ a. In the table in paragraph (a), add subgroup 1C ........................... 0.09
Representatives, and the Comptroller Vegetable, tuberous and corm,
alphabetically entries for ‘‘Potato,
General of the United States prior to granules/flakes’’ and ‘‘Potato, processed subgroup 1C 1 ......................... 0.3
publication of the rule in the Federal potato waste,’’ revise the existing entry 1 This tolerance expires on March 27, 2017.
Register. This action is not a ‘‘major for ‘‘Potato, processed potato waste,’’
rule’’ as defined by 5 U.S.C. 804(2). and add an entry for ‘‘Vegetable, (b) Section 18 emergency exemptions.
tuberous and corm, subgroup 1C’’; and Time-limited tolerances specified in the
List of Subjects in 40 CFR Part 180 following table are established for
■ b. Revise paragraph (b).
Environmental protection, The additions and revisions read as residues of the fluopicolide, including
Administrative practice and procedure, follows: its metabolites and degradates, in or on
Agricultural commodities, Pesticides the specified agricultural commodities,
§ 180.627 Fluopicolide; tolerances for resulting from use of the pesticide
and pests, Reporting and recordkeeping residues. pursuant to FIFRA section 18
requirements. (a) * * * emergency exemptions. Compliance
Dated: September 13, 2016. with the tolerance levels specified
Daniel J. Rosenblatt, Parts per below is to be determined by measuring
Commodity million
Acting Director, Registration Division, Office only fluopicolide [2,6-dichloro-N-[[3-
of Pesticide Programs. chloro-5-(trifluoromethyl)-2-
* * * * * pyridinyl]methyl]benzamide] in or on
Therefore, 40 CFR chapter I is Potato, granules/flakes ............... 0.15 the commodity. The tolerances expire
amended as follows: Potato, processed potato waste 0.2 on the date specified in the table.
Parts per
Commodity Expiration date
million
Hop, dried cones ......................................................................................................................................... 30 December 31, 2019.
* * * * * DATES: This final rule is effective 14620; telephone number: (202) 554–
[FR Doc. 2016–23184 Filed 9–23–16; 8:45 am] September 26, 2016. 1404; email address: TSCA-Hotline@
BILLING CODE 6560–50–P ADDRESSES: The docket for this action, epa.gov.
identified by docket identification (ID)
SUPPLEMENTARY INFORMATION:
number EPA–HQ–OPPT–2009–0187, is
ENVIRONMENTAL PROTECTION available at http://www.regulations.gov I. Does this action apply to me?
AGENCY or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), You may be potentially affected by
40 CFR Part 711
Environmental Protection Agency this action if you manufacture
[EPA–HQ–OPPT–2009–0187; FRL–9952–64] Docket Center (EPA/DC), West William (including import and manufacture as a
Jefferson Clinton Bldg., Rm. 3334, 1301 byproduct) chemical substances listed
RIN 2070–AJ43 Constitution Ave. NW., Washington, on the TSCA Inventory. The following
DC. The Public Reading Room is open list of North American Industrial
Chemical Data Reporting; 2016 from 8:30 a.m. to 4:30 p.m., Monday Classification System (NAICS) codes is
Submission Period Extension through Friday, excluding legal not intended to be exhaustive, but rather
AGENCY: Environmental Protection holidays. The telephone number for the provides a guide to help readers
Agency (EPA). Public Reading Room is (202) 566–1744, determine whether this document
and the telephone number for the OPPT applies to them. Potentially affected
ACTION: Final rule.
Docket is (202) 566–0280. Please review entities may include but are not limited
SUMMARY: EPA is amending the Toxic the visitor instructions and additional to:
Substances Control Act (TSCA) information about the docket available
at http://www.epa.gov/dockets. • Chemical manufacturers (including
Chemical Data Reporting (CDR) importers) (NAICS codes 325 and
regulations by extending the submission FOR FURTHER INFORMATION CONTACT:
324110, e.g., chemical manufacturing
deadline for 2016 reports from For technical information contact: and processing and petroleum
September 30, 2016 to October 31, 2016. Susan Sharkey, Chemical Control
refineries).
This is a one-time extension for the Division (7405M), Office of Pollution
2016 submission period only. The CDR Prevention and Toxics, Environmental • Chemical users and processors who
mstockstill on DSK3G9T082PROD with RULES
regulations require manufacturers Protection Agency, 1200 Pennsylvania may manufacture a byproduct chemical
(including importers) of certain Ave. NW., Washington, DC 20460–0001; substance (NAICS codes 22, 322, 331,
chemical substances included on the telephone number: (202) 564–8789; and 3344, e.g., utilities, paper
TSCA Chemical Substance Inventory email address: Sharkey.susan@epa.gov. manufacturing, primary metal
(TSCA Inventory) to report current data For general information contact: The manufacturing, and semiconductor and
on the manufacturing, processing, and TSCA-Hotline, ABVI-Goodwill, 422 other electronic component
use of the chemical substances. South Clinton Ave., Rochester, NY manufacturing).
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Document Created: 2018-02-09 13:23:15
Document Modified: 2018-02-09 13:23:15
| 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 September 26, 2016. Objections and requests for hearings must be received on or before November 25, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 81 FR 65917 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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