83 FR 12265 - Flutianil; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 55 (March 21, 2018)
Federal Register Volume 83, Issue 55 (March 21, 2018)
| Page Range | 12265-12269 | |
| FR Document | 2018-05640 |
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)] [Rules and Regulations] [Pages 12265-12269] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-05640] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0817; FRL-9974-32] Flutianil; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of flutianil in or on multiple commodities that are identified and discussed later in this document and an exemption for indirect or inadvertent residues of flutianil on other crops rotated into fields previously treated with flutianil. OAT AGRIO Company, Ltd. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 21, 2018. Objections and requests for hearings must be received on or before May 21, 2018, 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-2015-0817, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 [[Page 12266]] 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-2015-0817 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 May 21, 2018. 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-2015-0817, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Summary of Petitioned-For Tolerance In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944- 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 5F8408) by OAT AGRIO Company, Ltd, 1-3-1 Kanda Ogawa-machi, Chiyoda-ku, Tokyo 101-0052, Japan. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide flutianil, (2Z)-2-[2-fluoro-5-(trifluoromethyl)phenyl]sulfanyl-2-[3-(2- methoxyphenyl)thiazolidin-2-ylidene]acetonitrile, in or on apple, fruit at 0.2 parts per million (ppm); apple, juice at 0.03 ppm; apple, wet pomace at 2 ppm; cantaloupe at 0.07 ppm; cherry, fruit at 0.4 ppm; cucumber at 0.02 ppm; grape, fruit at 0.7 ppm; grape, juice at 0.2 ppm; grape, raisins at 0.3 ppm; squash at 0.03 ppm; and strawberry, fruit at 0.3 ppm. That document referenced a summary of the petition prepared by OAT AGRIO Company Ltd., the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comments is discussed in Unit IV.C. Following the publication of this notice, the petitioner revised its petition by revising commodity terms to be consistent with the terminology EPA uses for commodities, removing certain processed commodities for which specific tolerances are not needed, amending tolerance levels, and requesting an exemption to cover inadvertent residues. EPA published a notice in the Federal Register of October 12, 2017 (82 FR 47422) (FRL-9967-09), pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing OAT AGRIO Company's amended pesticide petition (PP 5F8408). Superseding the original petition, the revised petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide flutianil in or on apple at 0.15 parts per million (ppm); apple, wet pomace at 0.30 ppm; cantaloupe at 0.07 ppm; cherry at 0.40 ppm; cucumber at 0.20; ppm; grape at 0.70 ppm; squash at 0.05 ppm; and strawberry at 0.50 ppm. Additionally, OAT AGRIO Company requested that an exemption from the requirement of a tolerance be established in 40 CFR 180 for indirect or inadvertent residues of fungicide, flutianil in or on all food commodities for which tolerances are not separately established. Comments were received on the notice 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 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. . . .'' Similarly, FFDCA section 408(c)(2) authorizes EPA to establish an exemption from the requirement of a tolerance only if EPA determines the exemption is ``safe'', which has the same definition for exemptions as for tolerances and requires consideration of the same exposures and factors as for tolerances. 21 U.S.C. 346a(c)(2)(B). 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 [[Page 12267]] sufficient data to assess the hazards of and to make a determination on aggregate exposure for flutianil including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flutianil follows. 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. No single or repeated dose study performed by any route of exposure produced an adverse effect following flutianil exposure below, at, or above the limit dose (1,000 mg/kg/day). The only toxic effect of flutianil exposure in the rat 28-day, 90-day, or 104-day oral toxicity studies was associated with hyaline droplet formation in the renal proximal tubular cells of males. No toxicity was observed in the female rats dosed up to the limit dose for comparable time periods. An immunohistochemical staining demonstrated that the hyaline droplets in the proximal tubular cells were related to the presence of alpha- 2[micro]-globulin, which is not relevant for human toxicity. Based on the link to alpha-2[micro]-globulin and the lack of any degenerative or other associated effects, the hyaline droplet was not considered biologically relevant to humans. No toxicity was seen in the developmental, reproductive, neurotoxic, or immunotoxic studies for flutianil. No dermal or systemic toxicity was observed at the limit dose in the rat 28-day dermal toxicity study. Nevertheless, in the rat 28-day inhalation toxicity study, increased lung weights in females and histopathological findings of minimal nasal mucous cell hypertrophy/hyperplasia and minimal lung centriacinar inflammation in males and females were observed at the highest dose tested. These observations were consistent with response to aerosol exposure to an airway irritant. The nasal mucous cell hypertrophy/hyperplasia is considered the physiological response of these cells to irritant; however, the increased lung weights and cellular inflammation reflect some degree of edema in air spaces, and inflammation in the lung could affect airway responsiveness and pulmonary function. Therefore, the increased lung weights in females and lung lesions in both sexes were considered adverse effects. Flutianil is classified as ``Not Likely to be Carcinogenic to Humans'' based on lack of evidence of carcinogenicity in rats and mice and no evidence of mutagenicity. Flutianil produced no genotoxicity. Specific information on the studies received and the nature of the adverse effects caused by flutianil 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 ``Flutianil. Draft Human Risk Assessment to Support New Uses for a New Active Ingredient, Flutianil on Apple, Cantaloupe, Cherry, Cucumber, Grape, Summer Squash, and Strawberry'' dated November 1, 2017 in docket ID number EPA-HQ-OPP- 2015-0817. Based on the analysis of the available flutianil toxicological studies, there is no adverse toxicity from oral exposures seen in any of the required submitted toxicology studies. No toxicity endpoint and point of departure for regulating dietary exposure is established for the human health risk assessment. There are no registered or proposed residential uses at this time for flutianil; therefore, residential handler and post-application exposure and risk were not assessed. Flutianil is proposed for use on a variety of crops. Humans could potentially be exposed to flutianil residues in food because flutianil may be applied directly to growing crops. These applications can also result in flutianil reaching surface and ground water, both of which can serve as sources of drinking water. There are no proposed uses in residential settings; therefore, there are no anticipated residential exposures. Based on the toxicological profile of flutianil, EPA has concluded that the FFDCA requirements to retain an additional safety factor for protection of infants and children and to consider cumulative effects do not apply. Section 408(b)(2)(C) of the FFDCA (21 U.S.C. 346a) requires an additional tenfold margin of safety in the case of threshold risks, which are not present in this case. Section 408(b)(2)(D)(v) of the FFDCA requires consideration of information concerning cumulative effects of substances that have a common mechanism of toxicity, which flutianil does not have. Based on the available data indicating a lack of adverse effects from exposure to flutianil, 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 flutianil. IV. Other Considerations A. Analytical Enforcement Methodology The gas chromatography-mass spectrometry detector (GC/MSD) is used to measure and evaluate the chemical flutianil on apples, cantaloupe, cherry, cucumber, squash, and strawberry. The high performance liquid chromatography with tandem mass spectral detection (LCMS/MS) is used to measure and evaluate the chemical flutianil and the metabolite OC-56635 in grapes. Adequate enforcement methodology (gas chromatography) is available to enforce the tolerance expression. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for flutianil. C. Response to Comments Several comments were received, although many simply expressed concern about the use of pesticides on food generally. While EPA recognizes that some individuals oppose the use of pesticides in or on food, the FFDCA authorizes EPA to establish tolerances or exemptions where it determines that doing so is safe. As required by the FFDCA, EPA conducted a comprehensive assessment of flutianil, including its potential for carcinogenicity. Based on its assessment of the available data, the Agency believes that given the observed lack of toxicity of this chemical, no risks of concern are expected. Therefore, EPA concludes that the tolerances and exemption are safe and can be supported. The commenters did not provide any information to indicate otherwise. [[Page 12268]] Some comments (i.e., comments from the Center for Biological Diversity (CBD)) were not relevant to this action because they raised issues concerning compliance with the Endangered Species Act (ESA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which is not relevant to the determination needed to support tolerance actions under the FFDCA. Comments were received on the potential of flutianil to harm humans based on the human health and environmental toxicity findings of the European Food Safety Authority (EFSA). Although concerns were raised in the EFSA report about the potential for carcinogenicity and reproductive toxicity of flutianil, EPA has received additional data on flutianil supporting the Agency's conclusions of a lack of carcinogenicity or reproductive toxicity. Therefore, EPA concludes that it has sufficient data to address the concerns raised by the EFSA assessment and support its safety finding for flutianil. For further information concerning these studies, see the ``Final Registration Decision for the New Active Ingredient Flutianil: A Fungicide for Use on Apples, Cantaloupes, Cherries, Cucumbers, Grapes, Squash, and Strawberries'' [Docket ID Number EPA-HQ-OPP-2015-0817]. V. Conclusion Although the lack of toxicity supports a safety finding for an exemption from the requirement of tolerance for all crops. EPA is establishing numerical tolerances for residues resulting from direct applications to certain commodities because the petitioner requested them for international trade purposes. Therefore, tolerances are established for residues of flutianil, (2Z)-2-[2-fluoro-5- (trifluoromethy)phenyl]sulfanyl-2-[3-(2-methoxyphenyl)thiazolidin-2- ylidene]acetonitrile, in or on apple at 0.15 ppm; apple, wet pomace at 0.30 ppm; cantaloupe at 0.07 ppm; cherry at 0.40 ppm; cucumber at 0.20 ppm; grape at 0.70 ppm; squash at 0.05 ppm; and strawberry at 0.50 ppm. Additionally, an exemption from the requirement of a tolerance is established for indirect or inadvertent residues of flutianil, (2Z)-2- [2-fluoro-5-(trifluoromethy)phenyl]sulfanyl-2-[3-(2- methoxyphenyl)thiazolidin-2-ylidene]acetonitrile, in or on all food commodities, except for those commodities with tolerances established. VI. Statutory and Executive Order Reviews This action establishes tolerances and an exemption from the requirement of a tolerance 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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 tolerances and exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 8, 2018. Richard P. Keigwin, Jr., Director, 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. Add Sec. 180.697 to subpart C to read as follows: Sec. [emsp14]180.697 Flutianil; tolerances for residues. (a) General. Tolerances are established for the combined residues of the fungicide flutianil, including its metabolites and degradates in or on food commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only flutianil, (2Z)-2-[2-fluoro-5-(trifluoromethyl)phenyl]sulfanyl-2-[3-(2- methoxyphenyl)thiazolidin-2-ylidene]acetonitrile in or on the following commodities: ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Apple....................................................... 0.15 Apple, wet pomace........................................... 0.30 Cantaloupe.................................................. 0.07 [[Page 12269]] Cherry...................................................... 0.40 Cucumber.................................................... 0.20 Grape....................................................... 0.70 Squash...................................................... 0.05 Strawberry.................................................. 0.50 ------------------------------------------------------------------------ (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] 0 3. Add Sec. 180.1354 to subpart D to read as follows: Sec. [emsp14]180.1354 Flutianil; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for indirect and inadvertent residues of the fungicide flutianil, including its metabolites and degradates, in or on all food commodities not listed in Sec. 180.697(a), when residues are present therein as a result of uptake by crops rotated into fields containing the crops in Sec. 180.697(a) that were previously treated with flutianil. [FR Doc. 2018-05640 Filed 3-20-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations 12265
germane to this action; therefore, no tribes. Thus, the Agency has determined Parts per
Commodity
further response from the Agency is that Executive Order 13132, entitled million
required. ‘‘Federalism’’ (64 FR 43255, August 10,
V. Conclusion 1999) and Executive Order 13175,
* * * * *
entitled ‘‘Consultation and Coordination Fruit, citrus, group 10–10 ............. 9.0
Therefore, tolerances are amended for with Indian Tribal Governments’’ (65 FR
residues of aluminum tris (O- 67249, November 9, 2000) do not apply * * * * *
ethylphosphonate), in or on fruit, citrus, to this action. In addition, this action
group 10–10 at 9.0 ppm.
does not impose any enforceable duty or * * * * *
VI. Statutory and Executive Order contain any unfunded mandate as [FR Doc. 2018–05642 Filed 3–20–18; 8:45 am]
Reviews described under Title II of the Unfunded BILLING CODE 6560–50–P
This action amends and expands an Mandates Reform Act (UMRA) (2 U.S.C.
existing crop group tolerance under 1501 et seq.).
FFDCA section 408(d) in response to a ENVIRONMENTAL PROTECTION
This action does not involve any
petition submitted to the Agency. The AGENCY
technical standards that would require
Office of Management and Budget Agency consideration of voluntary 40 CFR Part 180
(OMB) has exempted these types of consensus standards pursuant to section
actions from review under Executive 12(d) of the National Technology [EPA–HQ–OPP–2015–0817; FRL–9974–32]
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
Planning and Review’’ (58 FR 51735, Flutianil; Pesticide Tolerances
(NTTAA) (15 U.S.C. 272 note).
October 4, 1993). Because this action AGENCY: Environmental Protection
has been exempted from review under VII. Congressional Review Act Agency (EPA).
Executive Order 12866, this action is ACTION: Final rule.
not subject to Executive Order 13211, Pursuant to the Congressional Review
entitled ‘‘Actions Concerning Act (5 U.S.C. 801 et seq.), EPA will SUMMARY: This regulation establishes
Regulations That Significantly Affect submit a report containing this rule and tolerances for residues of flutianil in or
Energy Supply, Distribution, or Use’’ (66 other required information to the U.S. on multiple commodities that are
FR 28355, May 22, 2001) or Executive Senate, the U.S. House of identified and discussed later in this
Order 13045, entitled ‘‘Protection of Representatives, and the Comptroller document and an exemption for indirect
Children from Environmental Health General of the United States prior to or inadvertent residues of flutianil on
Risks and Safety Risks’’ (62 FR 19885, publication of the rule in the Federal other crops rotated into fields
April 23, 1997). This action does not Register. This action is not a ‘‘major previously treated with flutianil. OAT
contain any information collections rule’’ as defined by 5 U.S.C. 804(2). AGRIO Company, Ltd. requested these
subject to OMB approval under the List of Subjects in 40 CFR Part 180 tolerances under the Federal Food,
Paperwork Reduction Act (PRA) (44 Drug, and Cosmetic Act (FFDCA).
U.S.C. 3501 et seq.), nor does it require Environmental protection, DATES: This regulation is effective
any special considerations under Administrative practice and procedure, March 21, 2018. Objections and requests
Executive Order 12898, entitled Agricultural commodities, Pesticides for hearings must be received on or
‘‘Federal Actions to Address and pests, Reporting and recordkeeping before May 21, 2018, and must be filed
Environmental Justice in Minority requirements. in accordance with the instructions
Populations and Low-Income provided in 40 CFR part 178 (see also
Populations’’ (59 FR 7629, February 16, Dated: March 7, 2018.
Unit I.C. of the SUPPLEMENTARY
1994). Michael Goodis,
INFORMATION).
Since tolerances and exemptions that Director, Registration Division, Office of
are established on the basis of a petition Pesticide Programs. ADDRESSES: The docket for this action,
under FFDCA section 408(d), such as identified by docket identification (ID)
the tolerance in this final rule, do not Therefore, 40 CFR chapter I is number EPA–HQ–OPP–2015–0817, is
require the issuance of a proposed rule, amended as follows: available at http://www.regulations.gov
the requirements of the Regulatory or at the Office of Pesticide Programs
PART 180—[AMENDED] Regulatory Public Docket (OPP Docket)
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply. in the Environmental Protection Agency
This action directly regulates growers, ■ 1. The authority citation for part 180 Docket Center (EPA/DC), West William
food processors, food handlers, and food continues to read as follows: Jefferson Clinton Bldg., Rm. 3334, 1301
retailers, not States or tribes, nor does Authority: 21 U.S.C. 321(q), 346a and 371. Constitution Ave. NW, Washington, DC
this action alter the relationships or 20460–0001. The Public Reading Room
distribution of power and ■ 2. In § 180.415, is open from 8:30 a.m. to 4:30 p.m.,
responsibilities established by Congress ■ a. Remove the entry for ‘‘Fruit, citrus, Monday through Friday, excluding legal
in the preemption provisions of FFDCA group 10’’ from the table in paragraph holidays. The telephone number for the
section 408(n)(4). As such, the Agency (a). Public Reading Room is (202) 566–1744,
has determined that this action will not and the telephone number for the OPP
■ b. Add alphabetically an entry to the Docket is (703) 305–5805. Please review
have a substantial direct effect on States
table in paragraph (a) for ‘‘Fruit, citrus,
sradovich on DSK3GMQ082PROD with RULES
or tribal governments, on the the visitor instructions and additional
relationship between the national group 10–10’’. information about the docket available
government and the States or tribal The addition reads as follows: at http://www.epa.gov/dockets.
governments, or on the distribution of FOR FURTHER INFORMATION CONTACT:
§ 180.415 Aluminum tris (O- Michael L. Goodis, Registration Division
power and responsibilities among the
ethylphosphonate); tolerances for residues.
various levels of government or between (7505P), Office of Pesticide Programs,
the Federal Government and Indian (a) * * * Environmental Protection Agency, 1200
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Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified October 12, 2017 (82 FR 47422) (FRL–
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP– 9967–09), pursuant to FFDCA section
(703) 305–7090; email address: 2015–0817, by one of the following 408(d)(3), 21 U.S.C. 346a(d)(3),
RDFRNotices@epa.gov. methods: announcing OAT AGRIO Company’s
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// amended pesticide petition (PP 5F8408).
www.regulations.gov. Follow the online Superseding the original petition, the
I. General Information instructions for submitting comments. revised petition requested that 40 CFR
A. Does this action apply to me? Do not submit electronically any part 180 be amended by establishing
information you consider to be CBI or tolerances for residues of the fungicide
You may be potentially affected by other information whose disclosure is flutianil in or on apple at 0.15 parts per
this action if you are an agricultural restricted by statute. million (ppm); apple, wet pomace at
producer, food manufacturer, or • Mail: OPP Docket, Environmental 0.30 ppm; cantaloupe at 0.07 ppm;
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ cherry at 0.40 ppm; cucumber at 0.20;
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. ppm; grape at 0.70 ppm; squash at 0.05
Classification System (NAICS) codes is NW, Washington, DC 20460–0001. ppm; and strawberry at 0.50 ppm.
not intended to be exhaustive, but rather • Hand Delivery: To make special Additionally, OAT AGRIO Company
provides a guide to help readers arrangements for hand delivery or requested that an exemption from the
determine whether this document delivery of boxed information, please requirement of a tolerance be
applies to them. Potentially affected follow the instructions at http:// established in 40 CFR 180 for indirect
entities may include: www.epa.gov/dockets/contacts.html. or inadvertent residues of fungicide,
• Crop production (NAICS code 111). Additional instructions on commenting flutianil in or on all food commodities
• Animal production (NAICS code or visiting the docket, along with more for which tolerances are not separately
112). information about dockets generally, is established. Comments were received
• Food manufacturing (NAICS code available at http://www.epa.gov/ on the notice of filing. EPA’s response
311). dockets. to these comments is discussed in Unit
• Pesticide manufacturing (NAICS IV.C.
code 32532). II. Summary of Petitioned-For
Tolerance III. Aggregate Risk Assessment and
B. How can I get electronic access to Determination of Safety
In the Federal Register of April 25,
other related information?
2016 (81 FR 24044) (FRL–9944–86), Section 408(b)(2)(A)(i) of FFDCA
You may access a frequently updated EPA issued a document pursuant to allows EPA to establish a tolerance (the
electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C. legal limit for a pesticide chemical
regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a residue in or on a food) only if EPA
the Government Printing Office’s e-CFR pesticide petition (PP 5F8408) by OAT determines that the tolerance is ‘‘safe.’’
site at http://www.ecfr.gov/cgi-bin/text- AGRIO Company, Ltd, 1–3–1 Kanda Section 408(b)(2)(A)(ii) of FFDCA
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Ogawa-machi, Chiyoda-ku, Tokyo 101– defines ‘‘safe’’ to mean that ‘‘there is a
40tab_02.tpl. 0052, Japan. The petition requested that reasonable certainty that no harm will
40 CFR part 180 be amended by result from aggregate exposure to the
C. How can I file an objection or hearing
establishing tolerances for residues of pesticide chemical residue, including
request?
the fungicide flutianil, (2Z)-2-[2-fluoro- all anticipated dietary exposures and all
Under FFDCA section 408(g), 21 5-(trifluoromethyl)phenyl]sulfanyl-2-[3- other exposures for which there is
U.S.C. 346a, any person may file an (2-methoxyphenyl)thiazolidin-2- reliable information.’’ This includes
objection to any aspect of this regulation ylidene]acetonitrile, in or on apple, fruit exposure through drinking water and in
and may also request a hearing on those at 0.2 parts per million (ppm); apple, residential settings, but does not include
objections. You must file your objection juice at 0.03 ppm; apple, wet pomace at occupational exposure. Section
or request a hearing on this regulation 2 ppm; cantaloupe at 0.07 ppm; cherry, 408(b)(2)(C) of FFDCA requires EPA to
in accordance with the instructions fruit at 0.4 ppm; cucumber at 0.02 ppm; give special consideration to exposure
provided in 40 CFR part 178. To ensure grape, fruit at 0.7 ppm; grape, juice at of infants and children to the pesticide
proper receipt by EPA, you must 0.2 ppm; grape, raisins at 0.3 ppm; chemical residue in establishing a
identify docket ID number EPA–HQ– squash at 0.03 ppm; and strawberry, tolerance and to ‘‘ensure that there is a
OPP–2015–0817 in the subject line on fruit at 0.3 ppm. That document reasonable certainty that no harm will
the first page of your submission. All referenced a summary of the petition result to infants and children from
objections and requests for a hearing prepared by OAT AGRIO Company Ltd., aggregate exposure to the pesticide
must be in writing, and must be the registrant, which is available in the chemical residue. . . .’’
received by the Hearing Clerk on or docket, http://www.regulations.gov. One Similarly, FFDCA section 408(c)(2)
before May 21, 2018. Addresses for mail comment was received on the notice of authorizes EPA to establish an
and hand delivery of objections and filing. EPA’s response to this comments exemption from the requirement of a
hearing requests are provided in 40 CFR is discussed in Unit IV.C. tolerance only if EPA determines the
178.25(b). Following the publication of this exemption is ‘‘safe’’, which has the
In addition to filing an objection or notice, the petitioner revised its petition same definition for exemptions as for
hearing request with the Hearing Clerk by revising commodity terms to be tolerances and requires consideration of
as described in 40 CFR part 178, please consistent with the terminology EPA the same exposures and factors as for
sradovich on DSK3GMQ082PROD with RULES
submit a copy of the filing (excluding uses for commodities, removing certain tolerances. 21 U.S.C. 346a(c)(2)(B).
any Confidential Business Information processed commodities for which Consistent with FFDCA section
(CBI)) for inclusion in the public docket. specific tolerances are not needed, 408(b)(2)(D), and the factors specified in
Information not marked confidential amending tolerance levels, and FFDCA section 408(b)(2)(D), EPA has
pursuant to 40 CFR part 2 may be requesting an exemption to cover reviewed the available scientific data
disclosed publicly by EPA without prior inadvertent residues. EPA published a and other relevant information in
notice. Submit the non-CBI copy of your notice in the Federal Register of support of this action. EPA has
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![12268 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations
Some comments (i.e., comments from VI. Statutory and Executive Order 67249, November 9, 2000) do not apply
the Center for Biological Diversity Reviews to this action. In addition, this action
(CBD)) were not relevant to this action This action establishes tolerances and does not impose any enforceable duty or
because they raised issues concerning an exemption from the requirement of a contain any unfunded mandate as
compliance with the Endangered tolerance under FFDCA section 408(d) described under Title II of the Unfunded
Species Act (ESA) and the Federal in response to a petition submitted to Mandates Reform Act (UMRA) (2 U.S.C.
Insecticide, Fungicide, and Rodenticide the Agency. The Office of Management 1501 et seq.).
Act (FIFRA), which is not relevant to and Budget (OMB) has exempted these This action does not involve any
the determination needed to support types of actions from review under technical standards that would require
tolerance actions under the FFDCA. Executive Order 12866, entitled Agency consideration of voluntary
‘‘Regulatory Planning and Review’’ (58 consensus standards pursuant to section
Comments were received on the 12(d) of the National Technology
potential of flutianil to harm humans FR 51735, October 4, 1993). Because
this action has been exempted from Transfer and Advancement Act
based on the human health and (NTTAA) (15 U.S.C. 272 note).
review under Executive Order 12866,
environmental toxicity findings of the
this action is not subject to Executive VII. Congressional Review Act
European Food Safety Authority
Order 13211, entitled ‘‘Actions Pursuant to the Congressional Review
(EFSA). Although concerns were raised
Concerning Regulations That Act (5 U.S.C. 801 et seq.), EPA will
in the EFSA report about the potential Significantly Affect Energy Supply,
for carcinogenicity and reproductive submit a report containing this rule and
Distribution, or Use’’ (66 FR 28355, May other required information to the U.S.
toxicity of flutianil, EPA has received 22, 2001); Executive Order 13045,
additional data on flutianil supporting Senate, the U.S. House of
entitled ‘‘Protection of Children from Representatives, and the Comptroller
the Agency’s conclusions of a lack of Environmental Health Risks and Safety
carcinogenicity or reproductive toxicity. General of the United States prior to
Risks’’ (62 FR 19885, April 23, 1997); or publication of the rule in the Federal
Therefore, EPA concludes that it has Executive Order 13771, entitled Register. This action is not a ‘‘major
sufficient data to address the concerns ‘‘Reducing Regulations and Controlling rule’’ as defined by 5 U.S.C. 804(2).
raised by the EFSA assessment and Regulatory Costs’’ (82 FR 9339, February
support its safety finding for flutianil. 3, 2017). This action does not contain List of Subjects in 40 CFR Part 180
For further information concerning any information collections subject to Environmental protection,
these studies, see the ‘‘Final Registration OMB approval under the Paperwork Administrative practice and procedure,
Decision for the New Active Ingredient Reduction Act (PRA) (44 U.S.C. 3501 et Agricultural commodities, Pesticides
Flutianil: A Fungicide for Use on seq.), nor does it require any special and pests, Reporting and recordkeeping
Apples, Cantaloupes, Cherries, considerations under Executive Order requirements.
Cucumbers, Grapes, Squash, and 12898, entitled ‘‘Federal Actions to
Dated: March 8, 2018.
Strawberries’’ [Docket ID Number EPA– Address Environmental Justice in
Richard P. Keigwin, Jr.,
HQ–OPP–2015–0817]. Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16, Director, Office of Pesticide Programs.
V. Conclusion 1994). Therefore, 40 CFR chapter I is
Since tolerances and exemptions that amended as follows:
Although the lack of toxicity supports are established on the basis of a petition
a safety finding for an exemption from under FFDCA section 408(d), such as PART 180—[AMENDED]
the requirement of tolerance for all the tolerances and exemption in this
crops. EPA is establishing numerical ■ 1. The authority citation for part 180
final rule, do not require the issuance of
tolerances for residues resulting from continues to read as follows:
a proposed rule, the requirements of the
direct applications to certain Regulatory Flexibility Act (RFA) (5 Authority: 21 U.S.C. 321(q), 346a and 371.
commodities because the petitioner U.S.C. 601 et seq.), do not apply. ■ 2. Add § 180.697 to subpart C to read
requested them for international trade This action directly regulates growers, as follows:
purposes. Therefore, tolerances are food processors, food handlers, and food
established for residues of flutianil, retailers, not States or tribes, nor does § 180.697 Flutianil; tolerances for
this action alter the relationships or residues.
(2Z)-2-[2-fluoro-5-
(trifluoromethy)phenyl]sulfanyl-2-[3-(2- distribution of power and (a) General. Tolerances are
methoxyphenyl)thiazolidin-2- responsibilities established by Congress established for the combined residues of
in the preemption provisions of FFDCA the fungicide flutianil, including its
ylidene]acetonitrile, in or on apple at
section 408(n)(4). As such, the Agency metabolites and degradates in or on food
0.15 ppm; apple, wet pomace at 0.30
has determined that this action will not commodities in the table below.
ppm; cantaloupe at 0.07 ppm; cherry at
have a substantial direct effect on States Compliance with the tolerance levels
0.40 ppm; cucumber at 0.20 ppm; grape specified below is to be determined by
at 0.70 ppm; squash at 0.05 ppm; and or tribal governments, on the
relationship between the national measuring only flutianil, (2Z)-2-[2-
strawberry at 0.50 ppm. fluoro-5-
government and the States or tribal
Additionally, an exemption from the governments, or on the distribution of (trifluoromethyl)phenyl]sulfanyl-2-[3-(2-
requirement of a tolerance is established power and responsibilities among the methoxyphenyl)thiazolidin-2-
for indirect or inadvertent residues of various levels of government or between ylidene]acetonitrile in or on the
sradovich on DSK3GMQ082PROD with RULES
flutianil, (2Z)-2-[2-fluoro-5- the Federal Government and Indian following commodities:
(trifluoromethy)phenyl]sulfanyl-2-[3-(2- tribes. Thus, the Agency has determined
methoxyphenyl)thiazolidin-2- that Executive Order 13132, entitled Parts per
Commodity million
ylidene]acetonitrile, in or on all food ‘‘Federalism’’ (64 FR 43255, August 10,
commodities, except for those 1999) and Executive Order 13175, Apple ........................................... 0.15
commodities with tolerances entitled ‘‘Consultation and Coordination Apple, wet pomace ..................... 0.30
established. with Indian Tribal Governments’’ (65 FR Cantaloupe ................................. 0.07
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![Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Rules and Regulations 12269
Parts per in the Environmental Protection Agency the first page of your submission. All
Commodity million Docket Center (EPA/DC), West William objections and requests for a hearing
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
Cherry ......................................... 0.40 Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or
Cucumber ................................... 0.20 20460–0001. The Public Reading Room before May 21, 2018. Addresses for mail
Grape .......................................... 0.70
is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and
Squash ........................................ 0.05
Strawberry .................................. 0.50 Monday through Friday, excluding legal hearing requests are provided in 40 CFR
holidays. The telephone number for the 178.25(b).
(b) Section 18 emergency exemptions. Public Reading Room is (202) 566–1744, In addition to filing an objection or
[Reserved] 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
(c) Tolerances with regional
the visitor instructions and additional submit a copy of the filing (excluding
registrations. [Reserved]
information about the docket available any Confidential Business Information
(d) Indirect or inadvertent residues.
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
[Reserved]
FOR FURTHER INFORMATION CONTACT: Information not marked confidential
■ 3. Add § 180.1354 to subpart D to read Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be
as follows: (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
§ 180.1354 Flutianil; exemption from the objection or hearing request, identified
requirement of a tolerance. Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP–
An exemption from the requirement 2017–0211, by one of the following
of a tolerance is established for indirect (703) 305–7090; email address:
RDFRNotices@epa.gov. methods:
and inadvertent residues of the • Federal eRulemaking Portal: http://
fungicide flutianil, including its SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
metabolites and degradates, in or on all I. General Information instructions for submitting comments.
food commodities not listed in Do not submit electronically any
§ 180.697(a), when residues are present A. Does this action apply to me? information you consider to be CBI or
therein as a result of uptake by crops You may be potentially affected by other information whose disclosure is
rotated into fields containing the crops this action if you are an agricultural restricted by statute.
in § 180.697(a) that were previously producer, food manufacturer, or • Mail: OPP Docket, Environmental
treated with flutianil. pesticide manufacturer. The following Protection Agency Docket Center (EPA/
[FR Doc. 2018–05640 Filed 3–20–18; 8:45 am] list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
BILLING CODE 6560–50–P Classification System (NAICS) codes is NW, Washington, DC 20460–0001.
not intended to be exhaustive, but rather • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
ENVIRONMENTAL PROTECTION determine whether this document delivery of boxed information, please
AGENCY applies to them. Potentially affected follow the instructions at http://
entities may include: www.epa.gov/dockets/contacts.html.
40 CFR Part 180 • Crop production (NAICS code 111). Additional instructions on
• Animal production (NAICS code commenting or visiting the docket,
[EPA–HQ–OPP–2017–0211; FRL–9973–11]
112). along with more information about
S-Metolachlor; Pesticide Tolerances • Food manufacturing (NAICS code dockets generally, is available at http://
311). www.epa.gov/dockets.
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
II. Summary of Petitioned-For
Agency (EPA). code 32532).
Tolerance
ACTION: Final rule. B. How can I get electronic access to In the Federal Register of September
SUMMARY: This regulation establishes other related information? 15, 2017 (82 FR 43352) (FRL–9965–43),
tolerances for residues of S-metolachlor You may access a frequently updated EPA issued a document pursuant to
in or on sugarcane, cane and sugarcane electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
molasses. Syngenta Crop Protection regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
requested these tolerances under the the Government Printing Office’s e-CFR pesticide petition (PP 6F8519) by
Federal Food, Drug, and Cosmetic Act site at http://www.ecfr.gov/cgi-bin/text- Syngenta Crop Protection, LLC, P.O.
(FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Box 18300, Greensboro, NC 27419. The
40tab_02.tpl. petition requested that 40 CFR part 180
DATES: This regulation is effective
be amended by establishing tolerances
March 21, 2018. Objections and requests C. How can I file an objection or hearing for residues of the herbicide
for hearings must be received on or request? S-metolachlor in or on sugarcane at 0.4
before May 21, 2018, and must be filed Under FFDCA section 408(g), 21 parts per million (ppm) and sugarcane
in accordance with the instructions U.S.C. 346a, any person may file an molasses at 1.5 ppm. That document
provided in 40 CFR part 178 (see also objection to any aspect of this regulation referenced a summary of the petition
Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those prepared by Syngenta Crop Protection,
INFORMATION).
sradovich on DSK3GMQ082PROD with RULES
objections. You must file your objection the registrant, which is available in the
ADDRESSES: The docket for this action, or request a hearing on this regulation docket, http://www.regulations.gov. A
identified by docket identification (ID) in accordance with the instructions comment was received on the notice of
number EPA–HQ–OPP–2017–0211, is provided in 40 CFR part 178. To ensure filing. EPA’s response to this comment
available at http://www.regulations.gov proper receipt by EPA, you must is discussed in Unit IV.C.
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– Based upon review of the data
Regulatory Public Docket (OPP Docket) OPP–2017–0211 in the subject line on supporting the petition, EPA is
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Document Created: 2018-03-21 00:45:29
Document Modified: 2018-03-21 00:45:29
| 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 March 21, 2018. Objections and requests for hearings must be received on or before May 21, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: | |
| FR Citation | 83 FR 12265 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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