82 FR 24067 - Fenazaquin; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 100 (May 25, 2017)
Federal Register Volume 82, Issue 100 (May 25, 2017)
| Page Range | 24067-24071 | |
| FR Document | 2017-10751 |
[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)] [Rules and Regulations] [Pages 24067-24071] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10751] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0029 FRL-9961-99] Fenazaquin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of fenazaquin in or on hop, dried cones; nuts, tree, group 14-12; pineapple; and tea, dried. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 25, 2017. Objections and requests for hearings must be received on or before July 24, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0029, 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. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0029 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 July 24, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0029, 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 Tolerances In the Federal Registers of March 16, 2016 (81 FR 14030) (FRL-9942- 86); May 19, 2016 (81 FR 31581) (FRL-9946-02); and August 12, 2016 (81 FR 53379) (FRL-9949-53) EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 6F8442, PP 5F8429, and PP 6E8466) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569. The petitions requested that 40 CFR 180.632 be amended by establishing tolerances for residues of the miticide/insecticide fenazaquin, 4-[2-[4-(1,1- dimethylethyl)phenyl]ethoxy]quinazoline, in or on hops at 30 parts per million (ppm) (PP 6F8442); nuts, tree, group 14-12 at 0.02 ppm (PP 5F8429); pineapple at 0.2 ppm (PP 6E8466); and tea at 9 ppm (PP 6E8466). The petitions also requested that the existing tolerance for almond at 0.2 ppm be removed upon establishment of the above tolerance for nut, tree group 14-12. Those documents referenced summaries of the petitions prepared by Gowan Company, the registrant, which are available in the docket, http://www.regulations.gov. Comments were received on the Notices of Filing. EPA's response to these comments is discussed in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including [[Page 24068]] 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 fenazaquin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fenazaquin follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The most consistently observed effects of fenazaquin exposure across species, sexes, and treatment durations were decreases in body weight, food consumption, and food efficiency. These effects were consistent with the commonly observed effects for compounds that disrupt mitochondrial electron transport system. Fenazaquin is a member of this class of chemicals. Fenazaquin did not produce developmental effects in rats and rabbits with prenatal exposure. It also did not cause reproductive effects, although it produced decreased body weight in the offspring at a dose where maternal body reduction also occurred in the reproduction study. The available data did not demonstrate clear neurotoxicity, immunotoxicity, or genotoxicity. The data in the immunotoxicity study showed an increased incidence of ataxia/hypo-activity with gavage dosing, but the effects were judged to be resulting from general malaise. Fenazaquin is also classified as not likely to be carcinogenic to humans, based on a lack of treatment-related cancer effects in two carcinogenicity studies. Specific information on the studies received and the nature of the adverse effects caused by fenazaquin 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, ``Fenazaquin (044501); Human Health Risk Assessment in Support of Proposed Uses on tree nuts, group 14-12, and Hops, Dried Cones'' in pp. 11-17 in docket ID number EPA-HQ-OPP- 2016-0029. B. Toxicological Points of Departure/Levels of Concern Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level--generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides. A summary of the toxicological endpoints for fenazaquin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of May 6, 2015 (80 FR 25953) (FRL- 9925-97). C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fenazaquin, EPA considered exposure under the petitioned- for tolerances as well as all existing fenazaquin tolerances in 40 CFR 180.632. EPA assessed dietary exposures from fenazaquin in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for fenazaquin. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues, default processing factors, and 100 percent crop treated (PCT) for all proposed and registered uses. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used DEEM-FCID, Version 3.16 software with 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance level residues, default processing factors, and 100 PCT for all proposed and registered uses. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that fenazaquin 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 or PCT information in the dietary assessment for fenazaquin. Tolerance level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. In drinking water, the residues of concern are fenazaquin (parent) and two metabolites: Metabolite M29 or 2-(4-{2-[(2-hydroxyquinazolin-4- yl)oxy]ethyl{time} phenyl)-2-methylpropanoic acid and its tautomer 2- methyl-2-(4-{2-[(2-oxo-1,2-dihydroquinazolin-4- yl)oxy]ethyl{time} phenyl)propanoic acid; and Metabolite 1 or 4-[2-(4- tert-butyl-phenyl)-ethoxy]-quinazolin-2-ol and its tautomer 4-[2-(4- tert-butylphenyl)ethoxy]quinazolin-2(1H)-one. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fenazaquin in drinking water. These [[Page 24069]] simulation models take into account data on the physical, chemical, and fate/transport characteristics of fenazaquin. 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. Based on the Pesticide in Water Calculator (PWC version 1.52), the estimated drinking water concentrations (EDWCs) of fenazaquin and its metabolites of concern for acute exposures are estimated to be 23.8 parts per billion (ppb) for surface water and 1.112 ppb for ground water, for chronic exposures for non-cancer assessments are estimated to be 3.19 ppb for surface water and 0.891 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 23.8 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 3.19 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). Fenazaquin is currently registered for the following uses that could result in residential exposures: Ornamental plants. There is a potential for exposure associated with handler (i.e., mixing, loading and applying), as well as post-application exposure from the use of fenazaquin on ornamental plants. However, for residential exposure associated with handlers, all registered fenazaquin product labels with residential use sites (e.g., ornamental plants) require that handlers wear specific clothing (e.g., long-sleeve shirt/long pants/chemical resistant gloves) and/or use personal protective equipment (PPE). Therefore, the Agency has made the assumption that these products are not for homeowner use, and has not conducted a quantitative residential handler assessment. With respect to the potential residential post-application exposure from the use of fenazaquin on ornamental plants, since there is (1) no adverse systemic hazard via the dermal route of exposure; (2) inhalation exposures are typically negligible in outdoor settings; and (3) there is no incidental oral exposure expected from fenazaquin use on ornamental plants, a residential post-application assessment is unnecessary. Furthermore, since the extent to which young children engage in activities associated with these areas or utilize these areas for prolonged periods of play is low, significant non-dietary ingestion exposure is not expected. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' Unlike other pesticides, for which EPA followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fenazaquin and any other substances, and fenazaquin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fenazaquin 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. D. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. Susceptibility/sensitivity in the developing animals was evaluated in developmental toxicity studies in rats and rabbits as well as a reproduction and fertility study in rats. The data showed no evidence of increased sensitivity/ susceptibility in the developing fetuses or young animals. Clear NOAELs and LOAELs are available for all the parental and offspring effects. 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 fenazaquin is complete. ii. The available data do not provide evidence that fenazaquin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. There is no evidence that fenazaquin 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 fenazaquin in drinking water. These assessments will not underestimate the exposure and risks posed by fenazaquin. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fenazaquin will occupy 11% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure. [[Page 24070]] 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fenazaquin from food and water will utilize 9.6% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure, when the additional uses for hops, dried cones and nuts, tree, group 14-12 are considered. The chronic exposure will increase to 9.9% of the cPAD for children 1-2 years old, when tea and pineapple are also assessed (See ``Fenazaquin, Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments to Support Use of the Insecticide (Without Section 3 Registration) on Imported Tea and Imported Pineapple'' in docket ID number EPA-HQ-OPP-2016-0029). Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fenazaquin is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there is no dermal endpoint and no potential short-term residential inhalation or incidental oral exposure to fenazaquin, a short-term risk is not expected. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because there is no dermal endpoint and no potential intermediate-term inhalation or oral residential exposure to fenazaquin, an intermediate-term risk is not expected. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fenazaquin is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fenazaquin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, high-performance liquid chromatography with positive ion electrospray ionization with tandem mass spectrometric detection (LC-MS/MS), is available to enforce the tolerance expression. However, for tea, residues were analyzed using gas chromatography with mass spectrometry (GC-MS) in selected ion monitoring mode. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established MRLs for fenazaquin in/on hop, dried cones; nuts, tree, group 14-12; pineapple; or tea, dried. C. Response to Comments The majority of comments submitted to this docket concerned chemicals or actions not associated with the fenazaquin petitions. One comment was submitted by the Center for Biological Diversity (CBD) in response to the Notice of Filing for PP 6F8442 and PP 5F8429 and was primarily concerned about environmental risks and Agency compliance with any relevant obligations under the Endangered Species Act. This comment is not relevant to the Agency's evaluation of safety of the fenazaquin tolerances; section 408 of the FFDCA focuses on potential harms to human health, not effects on the environment. The three remaining comments were anonymous public comments submitted in response to the Notice of Filing, which stated, in part, to ``Deny this petition. It is harmful and is a toxic chemical''; ``there is insufficient information on all facets of hazard from this toxic chemical''; and ``We, as Americans, do not need or want any more EPA regulations.'' The Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops; however, these comments provide no supporting information upon which to evaluate the safety of pesticide. The existing legal framework provided by section 408 of the 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. The Agency has evaluated the available information and determined that these tolerances are safe. V. Conclusion Therefore, tolerances are established for residues of fenazaquin, including its metabolites and degradates, in or on hop, dried cones at 30 ppm; nuts, tree, group 14-12 at 0.02 ppm; pineapple at 0.20 ppm; and tea, dried at 9.0 ppm. In addition, the Agency is removing the separate tolerance for almonds as it is unnecessary because almond is a commodity covered by the crop group tolerances for nuts, tree, group 14-12. 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 [[Page 24071]] Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 1, 2017. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. 0 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. 180.632, amend the table in paragraph (a) as follows: 0 a. Remove the entry for ``Almond''. 0 b. Add alphabetically the entries for ``hop, dried cones''; ``nuts, tree, group 14-12''; ``pineapple''; and ``tea, dried''. 0 c. Add a footnote at the end of the table. The additions read as follows: Sec. 180.632 Fenazaquin; Tolerances for residues. (a) * * * ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ * * * * * Hop, dried cones............................................. 30.0 ------------------------------------------------------------------------ * * * * * Pineapple \1\................................................ 0.20 Nuts, Tree, Group 14-12...................................... 0.02 Tea, dried \1\............................................... 9.0 ------------------------------------------------------------------------ \1\ There are no U.S. registrations as of May 25, 2017 for use on pineapple and tea. * * * * * [FR Doc. 2017-10751 Filed 5-24-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations 24067
Parts per SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
Commodity million www.regulations.gov. Follow the online
I. General Information
instructions for submitting comments.
A. Does this action apply to me? Do not submit electronically any
* * * * * information you consider to be CBI or
Olive ...................................... 0.01 You may be potentially affected by
other information whose disclosure is
this action if you are an agricultural
restricted by statute.
* * * * * producer, food manufacturer, or
• Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
* * * * * list of North American Industrial
[FR Doc. 2017–10763 Filed 5–24–17; 8:45 am] DC), (28221T), 1200 Pennsylvania Ave.
Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
BILLING CODE 6560–50–P not intended to be exhaustive, but rather • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
determine whether this document delivery of boxed information, please
ENVIRONMENTAL PROTECTION applies to them. Potentially affected
AGENCY follow the instructions at http://
entities may include: www.epa.gov/dockets/contacts.html.
• Crop production (NAICS code 111). Additional instructions on commenting
40 CFR Part 180
• Animal production (NAICS code or visiting the docket, along with more
[EPA–HQ–OPP–2016–0029 FRL–9961–99] 112). information about dockets generally, is
• Food manufacturing (NAICS code available at http://www.epa.gov/
Fenazaquin; Pesticide Tolerances 311). dockets.
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
code 32532). II. Summary of Petitioned-For
Agency (EPA). Tolerances
ACTION: Final rule. B. How can I get electronic access to
In the Federal Registers of March 16,
other related information?
SUMMARY: This regulation establishes 2016 (81 FR 14030) (FRL–9942–86);
tolerances for residues of fenazaquin in You may access a frequently updated May 19, 2016 (81 FR 31581) (FRL–9946–
or on hop, dried cones; nuts, tree, group electronic version of EPA’s tolerance 02); and August 12, 2016 (81 FR 53379)
14–12; pineapple; and tea, dried. Gowan regulations at 40 CFR part 180 through (FRL–9949–53) EPA issued documents
Company requested these tolerances the Government Printing Office’s e-CFR pursuant to FFDCA section 408(d)(3), 21
under the Federal Food, Drug, and site at http://www.ecfr.gov/cgi-bin/text- U.S.C. 346a(d)(3), announcing the filing
Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ of pesticide petitions (PP 6F8442, PP
DATES: This regulation is effective May 40tab_02.tpl. 5F8429, and PP 6E8466) by Gowan
25, 2017. Objections and requests for C. How can I file an objection or hearing Company, P.O. Box 5569, Yuma, AZ
hearings must be received on or before request? 85366–5569. The petitions requested
July 24, 2017, and must be filed in that 40 CFR 180.632 be amended by
Under FFDCA section 408(g), 21 establishing tolerances for residues of
accordance with the instructions
U.S.C. 346a, any person may file an the miticide/insecticide fenazaquin, 4-
provided in 40 CFR part 178 (see also
objection to any aspect of this regulation [2-[4-(1,1-dimethylethyl)
Unit I.C. of the SUPPLEMENTARY
and may also request a hearing on those phenyl]ethoxy]quinazoline, in or on
INFORMATION).
objections. You must file your objection hops at 30 parts per million (ppm) (PP
ADDRESSES: The docket for this action, or request a hearing on this regulation 6F8442); nuts, tree, group 14–12 at 0.02
identified by docket identification (ID) in accordance with the instructions ppm (PP 5F8429); pineapple at 0.2 ppm
number EPA–HQ–OPP–2016–0029, is provided in 40 CFR part 178. To ensure (PP 6E8466); and tea at 9 ppm (PP
available at http://www.regulations.gov proper receipt by EPA, you must 6E8466). The petitions also requested
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– that the existing tolerance for almond at
Regulatory Public Docket (OPP Docket) OPP–2016–0029 in the subject line on 0.2 ppm be removed upon
in the Environmental Protection Agency the first page of your submission. All establishment of the above tolerance for
Docket Center (EPA/DC), West William objections and requests for a hearing nut, tree group 14–12. Those documents
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be referenced summaries of the petitions
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or prepared by Gowan Company, the
20460–0001. The Public Reading Room before July 24, 2017. Addresses for mail registrant, which are available in the
is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and docket, http://www.regulations.gov.
Monday through Friday, excluding legal hearing requests are provided in 40 CFR Comments were received on the Notices
holidays. The telephone number for the 178.25(b). of Filing. EPA’s response to these
Public Reading Room is (202) 566–1744, In addition to filing an objection or comments is discussed in Unit IV.C.
and the telephone number for the OPP hearing request with the Hearing Clerk
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please III. Aggregate Risk Assessment and
the visitor instructions and additional submit a copy of the filing (excluding Determination of Safety
information about the docket available any Confidential Business Information Section 408(b)(2)(A)(i) of FFDCA
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. allows EPA to establish a tolerance (the
FOR FURTHER INFORMATION CONTACT: Information not marked confidential legal limit for a pesticide chemical
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be residue in or on a food) only if EPA
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior determines that the tolerance is ‘‘safe.’’
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your Section 408(b)(2)(A)(ii) of FFDCA
Pennsylvania Ave. NW., Washington, objection or hearing request, identified defines ‘‘safe’’ to mean that ‘‘there is a
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP– reasonable certainty that no harm will
number: (703) 305–7090; email address: 2016–0029, by one of the following result from aggregate exposure to the
RDFRNotices@epa.gov. methods: pesticide chemical residue, including
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![24068 Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations
all anticipated dietary exposures and all cancer effects in two carcinogenicity 180.632. EPA assessed dietary
other exposures for which there is studies. exposures from fenazaquin in food as
reliable information.’’ This includes Specific information on the studies follows:
exposure through drinking water and in received and the nature of the adverse i. Acute exposure. Quantitative acute
residential settings, but does not include effects caused by fenazaquin as well as dietary exposure and risk assessments
occupational exposure. Section the no-observed-adverse-effect-level are performed for a food-use pesticide,
408(b)(2)(C) of FFDCA requires EPA to (NOAEL) and the lowest-observed- if a toxicological study has indicated the
give special consideration to exposure adverse-effect-level (LOAEL) from the possibility of an effect of concern
of infants and children to the pesticide toxicity studies can be found at http:// occurring as a result of a 1-day or single
chemical residue in establishing a www.regulations.gov in document, exposure.
tolerance and to ‘‘ensure that there is a ‘‘Fenazaquin (044501); Human Health Such effects were identified for
reasonable certainty that no harm will Risk Assessment in Support of Proposed fenazaquin. In estimating acute dietary
result to infants and children from Uses on tree nuts, group 14–12, and exposure, EPA used the Dietary
aggregate exposure to the pesticide Hops, Dried Cones’’ in pp. 11–17 in Exposure Evaluation Model software
chemical residue . . . .’’ docket ID number EPA–HQ–OPP–2016– with the Food Commodity Intake
Consistent with FFDCA section 0029. Database (DEEM–FCID) Version 3.16.
408(b)(2)(D), and the factors specified in This software uses 2003–2008 food
B. Toxicological Points of Departure/ consumption data from the U.S.
FFDCA section 408(b)(2)(D), EPA has Levels of Concern
reviewed the available scientific data Department of Agriculture’s (USDA’s)
Once a pesticide’s toxicological National Health and Nutrition
and other relevant information in
profile is determined, EPA identifies Examination Survey, What We Eat in
support of this action. EPA has
toxicological points of departure (POD) America, (NHANES/WWEIA). As to
sufficient data to assess the hazards of
and levels of concern to use in residue levels in food, EPA assumed
and to make a determination on evaluating the risk posed by human tolerance level residues, default
aggregate exposure for fenazaquin exposure to the pesticide. For hazards processing factors, and 100 percent crop
including exposure resulting from the that have a threshold below which there treated (PCT) for all proposed and
tolerances established by this action. is no appreciable risk, the toxicological registered uses.
EPA’s assessment of exposures and risks POD is used as the basis for derivation ii. Chronic exposure. In conducting
associated with fenazaquin follows. of reference values for risk assessment. the chronic dietary exposure assessment
A. Toxicological Profile PODs are developed based on a careful EPA used DEEM–FCID, Version 3.16
analysis of the doses in each software with 2003–2008 food
EPA has evaluated the available toxicological study to determine the consumption data from the USDA’s
toxicity data and considered its validity, dose at which no adverse effects are NHANES/WWEIA. As to residue levels
completeness, and reliability as well as observed (the NOAEL) and the lowest in food, EPA assumed tolerance level
the relationship of the results of the dose at which adverse effects of concern residues, default processing factors, and
studies to human risk. EPA has also are identified (the LOAEL). Uncertainty/ 100 PCT for all proposed and registered
considered available information safety factors are used in conjunction uses.
concerning the variability of the with the POD to calculate a safe iii. Cancer. Based on the data
sensitivities of major identifiable exposure level—generally referred to as summarized in Unit III.A., EPA has
subgroups of consumers, including a population-adjusted dose (PAD) or a concluded that fenazaquin does not
infants and children. reference dose (RfD)—and a safe margin pose a cancer risk to humans. Therefore,
The most consistently observed of exposure (MOE). For non-threshold a dietary exposure assessment for the
effects of fenazaquin exposure across risks, the Agency assumes that any purpose of assessing cancer risk is
species, sexes, and treatment durations amount of exposure will lead to some unnecessary.
were decreases in body weight, food degree of risk. Thus, the Agency iv. Anticipated residue and percent
consumption, and food efficiency. estimates risk in terms of the probability crop treated (PCT) information. EPA did
These effects were consistent with the of an occurrence of the adverse effect not use anticipated residue or PCT
commonly observed effects for expected in a lifetime. For more information in the dietary assessment
compounds that disrupt mitochondrial information on the general principles for fenazaquin. Tolerance level residues
electron transport system. Fenazaquin is EPA uses in risk characterization and a and 100 PCT were assumed for all food
a member of this class of chemicals. complete description of the risk commodities.
Fenazaquin did not produce assessment process, see http:// 2. Dietary exposure from drinking
developmental effects in rats and rabbits www2.epa.gov/pesticide-science-and- water. In drinking water, the residues of
with prenatal exposure. It also did not assessing-pesticide-risks/assessing- concern are fenazaquin (parent) and two
cause reproductive effects, although it human-health-risk-pesticides. metabolites: Metabolite M29 or 2-(4-{2-
produced decreased body weight in the A summary of the toxicological [(2-hydroxyquinazolin-4-
offspring at a dose where maternal body endpoints for fenazaquin used for yl)oxy]ethyl}phenyl)-2-
reduction also occurred in the human risk assessment is discussed in methylpropanoic acid and its tautomer
reproduction study. The available data Unit III.B. of the final rule published in 2-methyl-2-(4-{2-[(2-oxo-1,2-
did not demonstrate clear neurotoxicity, the Federal Register of May 6, 2015 (80 dihydroquinazolin-4-
immunotoxicity, or genotoxicity. The FR 25953) (FRL–9925–97). yl)oxy]ethyl}phenyl)propanoic acid;
data in the immunotoxicity study and Metabolite 1 or 4-[2-(4-tert-butyl-
showed an increased incidence of C. Exposure Assessment phenyl)-ethoxy]-quinazolin-2-ol and its
ataxia/hypo-activity with gavage dosing, 1. Dietary exposure from food and tautomer 4-[2-(4-tert-
but the effects were judged to be feed uses. In evaluating dietary butylphenyl)ethoxy]quinazolin-2(1H)-
resulting from general malaise. exposure to fenazaquin, EPA considered one. The Agency used screening-level
Fenazaquin is also classified as not exposure under the petitioned-for water exposure models in the dietary
likely to be carcinogenic to humans, tolerances as well as all existing exposure analysis and risk assessment
based on a lack of treatment-related fenazaquin tolerances in 40 CFR for fenazaquin in drinking water. These
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![Federal Register / Vol. 82, No. 100 / Thursday, May 25, 2017 / Rules and Regulations 24071
Flexibility Act (RFA) (5 U.S.C. 601 et Authority: 21 U.S.C. 321(q), 346a and 371. Docket Center (EPA/DC), West William
seq.), do not apply. ■ 2. In § 180.632, amend the table in Jefferson Clinton Bldg., Rm. 3334, 1301
This action directly regulates growers, paragraph (a) as follows: Constitution Ave. NW., Washington, DC
food processors, food handlers, and food ■ a. Remove the entry for ‘‘Almond’’. 20460–0001. The Public Reading Room
retailers, not States or tribes, nor does ■ b. Add alphabetically the entries for is open from 8:30 a.m. to 4:30 p.m.,
this action alter the relationships or ‘‘hop, dried cones’’; ‘‘nuts, tree, group Monday through Friday, excluding legal
distribution of power and 14–12’’; ‘‘pineapple’’; and ‘‘tea, dried’’. holidays. The telephone number for the
responsibilities established by Congress ■ c. Add a footnote at the end of the Public Reading Room is (202) 566–1744,
in the preemption provisions of FFDCA table. and the telephone number for the OPP
section 408(n)(4). As such, the Agency The additions read as follows: Docket is (703) 305–5805. Please review
has determined that this action will not the visitor instructions and additional
have a substantial direct effect on States § 180.632 Fenazaquin; Tolerances for information about the docket available
or tribal governments, on the residues.
at http://www.epa.gov/dockets.
relationship between the national (a) * * * FOR FURTHER INFORMATION CONTACT:
government and the States or tribal Michael L. Goodis, P.E., Registration
governments, or on the distribution of Parts per
Commodity Division (7505P), Office of Pesticide
power and responsibilities among the million
Programs, Environmental Protection
various levels of government or between Agency, 1200 Pennsylvania Ave. NW.,
the Federal Government and Indian * * * * * Washington, DC 20460–0001; main
tribes. Thus, the Agency has determined Hop, dried cones .......................... 30.0 telephone number: (703) 305–7090;
that Executive Order 13132, entitled email address: RDFRNotices@epa.gov.
‘‘Federalism’’ (64 FR 43255, August 10,
* * * * * SUPPLEMENTARY INFORMATION:
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination Pineapple 1 .................................... 0.20 I. General Information
Nuts, Tree, Group 14–12 ............. 0.02
with Indian Tribal Governments’’ (65 FR
Tea, dried 1 ................................... 9.0 A. Does this action apply to me?
67249, November 9, 2000) do not apply
to this action. In addition, this action 1 There
are no U.S. registrations as of May You may be potentially affected by
does not impose any enforceable duty or 25, 2017 for use on pineapple and tea. this action if you are an agricultural
contain any unfunded mandate as * * * * * producer, food manufacturer, or
described under Title II of the Unfunded [FR Doc. 2017–10751 Filed 5–24–17; 8:45 am] pesticide manufacturer. The following
Mandates Reform Act (UMRA) (2 U.S.C. BILLING CODE 6560–50–P
list of North American Industrial
1501 et seq.). Classification System (NAICS) codes is
This action does not involve any not intended to be exhaustive, but rather
technical standards that would require ENVIRONMENTAL PROTECTION provides a guide to help readers
Agency consideration of voluntary AGENCY determine whether this document
consensus standards pursuant to section applies to them. Potentially affected
12(d) of the National Technology 40 CFR Part 180 entities may include:
Transfer and Advancement Act [EPA–HQ–OPP–2016–0143; FRL–9960–76]
• Crop production (NAICS code 111).
(NTTAA) (15 U.S.C. 272 note). • Animal production (NAICS code
Isopyrazam; Pesticide Tolerances 112).
VII. Congressional Review Act • Food manufacturing (NAICS code
Pursuant to the Congressional Review AGENCY: Environmental Protection 311).
Act (5 U.S.C. 801 et seq.), EPA will Agency (EPA). • Pesticide manufacturing (NAICS
submit a report containing this rule and ACTION: Final rule. code 32532).
other required information to the U.S. B. How can I get electronic access to
Senate, the U.S. House of SUMMARY: This regulation establishes
tolerances for residues of isopyrazam in other related information?
Representatives, and the Comptroller
General of the United States prior to or on pepper, bell; tomato; and You may access a frequently updated
publication of the rule in the Federal vegetable, cucurbit, subgroup 9A. electronic version of EPA’s tolerance
Register. This action is not a ‘‘major Syngenta Crop Protection, LLC, regulations at 40 CFR part 180 through
rule’’ as defined by 5 U.S.C. 804(2). requested these tolerances under the the Government Printing Office’s e-CFR
Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text-
List of Subjects in 40 CFR Part 180 (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
Environmental protection, DATES: This regulation is effective May 40tab_02.tpl.
Administrative practice and procedure, 25, 2017. Objections and requests for C. How can I file an objection or hearing
Agricultural commodities, Pesticides hearings must be received on or before request?
and pests, Reporting and recordkeeping July 24, 2017, and must be filed in
requirements. Under FFDCA section 408(g), 21
accordance with the instructions
Dated: May 1, 2017.
U.S.C. 346a, any person may file an
provided in 40 CFR part 178 (see also
objection to any aspect of this regulation
Michael Goodis, Unit I.C. of the SUPPLEMENTARY
and may also request a hearing on those
Director, Registration Division, Office of INFORMATION).
objections. You must file your objection
Pesticide Programs.
ADDRESSES: The docket for this action, or request a hearing on this regulation
■Therefore, 40 CFR chapter I is identified by docket identification (ID) in accordance with the instructions
amended as follows: number EPA–HQ–OPP–2016–0143, is provided in 40 CFR part 178. To ensure
available at http://www.regulations.gov proper receipt by EPA, you must
PART 180—[AMENDED]
or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
■ 1. The authority citation for part 180 Regulatory Public Docket (OPP Docket) OPP–2016–0143 in the subject line on
continues to read as follows: in the Environmental Protection Agency the first page of your submission. All
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Document Created: 2018-11-08 08:53:05
Document Modified: 2018-11-08 08:53:05
| 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 May 25, 2017. Objections and requests for hearings must be received on or before July 24, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 24067 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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