Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Rules and Regulations 95485 ENVIRONMENTAL PROTECTION Pennsylvania Ave. NW., Washington, notice. Submit the non-CBI copy of your AGENCY DC 20460–0001; main telephone objection or hearing request, identified number: (703) 305–7090; email address: by docket ID number EPA–HQ–OPP– 40 CFR Part 180 [email protected]. 2015–0776 and EPA–HQ–OPP–2015– [EPA–HQ–OPP–2015–0776 and EPA–HQ– SUPPLEMENTARY INFORMATION: 0831, by one of the following methods: • OPP–2015–0831; FRL–9955–82] I. General Information Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online Methyl Isobutyrate and Isobutyl A. Does this action apply to me? instructions for submitting comments. Isobutyrate; Exemption From the You may be potentially affected by Do not submit electronically any Requirement of a Tolerance this action if you are an agricultural information you consider to be CBI or AGENCY: Environmental Protection producer, food manufacturer, or other information whose disclosure is Agency (EPA). pesticide manufacturer. The following restricted by statute. • ACTION: Final rule. list of North American Industrial Mail: OPP Docket, Environmental Classification System (NAICS) codes is Protection Agency Docket Center (EPA/ SUMMARY: This regulation establishes not intended to be exhaustive, but rather DC), (28221T), 1200 Pennsylvania Ave. exemptions from the requirement of a provides a guide to help readers NW., Washington, DC 20460–0001. tolerance for residues of methyl determine whether this document • Hand Delivery: To make special isobutyrate (CAS Reg. No. 547–63–7) applies to them. Potentially affected arrangements for hand delivery or and for residues of isobutyl isobutyrate entities may include: delivery of boxed information, please • (CAS Reg. No. 97–85–8) when used as Crop production (NAICS code 111). follow the instructions at http:// • inert ingredients (solvents) applied to Animal production (NAICS code www.epa.gov/dockets/contacts.html. growing crops or raw agricultural 112). commodities after harvest. Jeneil • Food manufacturing (NAICS code Additional instructions on Biosurfactant Company submitted a 311). commenting or visiting the docket, petition to EPA under the Federal Food, • Pesticide manufacturing (NAICS along with more information about Drug, and Cosmetic Act (FFDCA), code 32532). dockets generally, is available at http:// requesting establishment of an www.epa.gov/dockets. B. How can I get electronic access to exemption from the requirement of a other related information? II. Petition for Exemption tolerance. This regulation eliminates the need to establish a maximum You may access a frequently updated In the Federal Register of March 16, permissible level for residues of methyl electronic version of 40 CFR part 180 2016 (81 FR 14030) (FRL–9942–86), isobutyrate and isobutyl isobutyrate through the Government Printing EPA issued a document pursuant to when used in accordance with the Office’s e-CFR site at http:// FFDCA section 408, 21 U.S.C. 346a, conditions. www.ecfr.gov/cgi-bin/text- announcing the filing of two pesticide idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ petitions (PP IN–10848 & PP IN–10850) DATES: This regulation is effective 40tab_02.tpl. by Jeneil Biosurfactant Company, 400 N. December 28, 2016. Objections and Dekora Woods Blvd., Saukville, WI requests for hearings must be received C. How can I file an objection or hearing 53080. The petitions requested that 40 on or before February 27, 2017, and request? CFR 180.910 be amended by must be filed in accordance with the Under FFDCA section 408(g), 21 establishing two exemptions from the instructions provided in 40 CFR part U.S.C. 346a, any person may file an requirement of a tolerance: One for 178 (see also Unit I.C. of the objection to any aspect of this regulation residues of methyl isobutyrate (CAS SUPPLEMENTARY INFORMATION). and may also request a hearing on those Reg. No. 547–63–7) (PP IN–10848) and ADDRESSES: The docket for this action, objections. You must file your objection one for isobutyl isobutyrate (CAS Reg. identified by docket identification (ID) or request a hearing on this regulation No. 97–85–8) (PP IN–10850), when used number EPA–HQ–OPP–2015–0776 and in accordance with the instructions as inert ingredients (solvents) applied to EPA–HQ–OPP–2015–0831, is available provided in 40 CFR part 178. To ensure growing crops or raw agricultural at http://www.regulations.gov or at the proper receipt by EPA, you must commodities after harvest. That Office of Pesticide Programs Regulatory identify docket ID number EPA–HQ– document referenced a summary of each Public Docket (OPP Docket) in the OPP–2015–0776 and EPA–HQ–OPP– petition prepared by Jeneil Biosurfactant Environmental Protection Agency 2015–0831 in the subject line on the Company, the petitioner, which are Docket Center (EPA/DC), West William first page of your submission. All available in the respective dockets (PP Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing IN–10848 in docket ID number EPA– Constitution Ave. NW., Washington, DC must be in writing, and must be HQ–OPP–2015–0776 and PP IN–10850 20460–0001. The Public Reading Room received by the Hearing Clerk on or in docket ID number EPA–HQ–OPP– is open from 8:30 a.m. to 4:30 p.m., before February 27, 2017. Addresses for 2015–0831), http://www.regulations.gov. Monday through Friday, excluding legal mail and hand delivery of objections Comments were received in response to holidays. The telephone number for the and hearing requests are provided in 40 the notice of filing, requesting the denial Public Reading Room is (202) 566–1744, CFR 178.25(b). of these petitions based only generally and the telephone number for the OPP In addition to filing an objection or on a concern for the use of ‘‘toxic Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk chemicals’’ in or on food. Because the the visitor instructions and additional as described in 40 CFR part 178, please commenters did not provide any information about the docket available submit a copy of the filing (excluding information upon which to evaluate at http://www.epa.gov/dockets. any Confidential Business Information these specific inert ingredient tolerance FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket. exemptions and because EPA has Michael Goodis, Registration Division Information not marked confidential determined that such exemptions would (7505P), Office of Pesticide Programs, pursuant to 40 CFR part 2 may be be safe, EPA is not denying the petition Environmental Protection Agency, 1200 disclosed publicly by EPA without prior as requested. VerDate Sep<11>2014 16:15 Dec 27, 2016 Jkt 241001 PO 00000 Frm 00089 Fmt 4700 Sfmt 4700 E:\FR\FM\28DER1.SGM 28DER1 sradovich on DSK3GMQ082PROD with RULES 95486 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Rules and Regulations III. Inert Ingredient Definition EPA is able to determine that a finite No repeat-dose studies of methyl Inert ingredients are all ingredients tolerance is not necessary to ensure that isobutyrate were identified in a search that are not active ingredients as defined there is a reasonable certainty that no of the toxicological literature. In an 18- in 40 CFR 153.125 and include, but are harm will result from aggregate week oral gavage study in rats with not limited to, the following types of exposure to the inert ingredient, an isobutyl isobutyrate, there were no ingredients (except when they have a exemption from the requirement of a treatment related effects in hematology, pesticidal efficacy of their own): tolerance may be established. clinical chemistry parameters, Consistent with FFDCA section Solvents such as alcohols and urinalysis, histological examination, 408(c)(2)(A), and the factors specified in hydrocarbons; surfactants such as behavior, appearance, body weight, or FFDCA section 408(c)(2)(B), EPA has polyoxyethylene polymers and fatty food/water consumption. The NOAEL reviewed the available scientific data was 1,000 mg/kg/day; the highest dose acids; carriers such as clay and and other relevant information in tested. In a 90-day oral toxicity study in diatomaceous earth; thickeners such as support of this action. EPA has rats with isobutanol, treatment related carrageenan and modified cellulose; sufficient data to assess the hazards of effects were seen only at 1,000 mg/kg wetting, spreading, and dispersing and to make a determination on bw/day, and included hypoactivity, agents; propellants in aerosol aggregate exposure for methyl which was significant during week one dispensers; microencapsulating agents; isobutyrate and isobutyl isobutyrate and decreased markedly after week 4, and emulsifiers. The term ‘‘inert’’ is not including exposure resulting from the and lower body weight gain (18% below intended to imply nontoxicity; the exemption established by this action. that of control rats) in males during ingredient may or may not be EPA’s assessment of exposures and risks week one. The NOAEL was 316 mg/kg chemically active. Generally, EPA has associated with methyl isobutyrate and bw/day. exempted inert ingredients from the isobutyl isobutyrate follows. In a 90-day study toxicity study in requirement of a tolerance based on the rats exposed to isobutanol in drinking A. Toxicological Profile low toxicity of the individual inert water, no effects on body weight, food/ ingredients. EPA has evaluated the available water consumption, and clinical signs of IV. Aggregate Risk Assessment and toxicity data and considered their toxicity and organ weights (livers, Determination of Safety validity, completeness, and reliability as kidneys, adrenal glands, and testes) well as the relationship of the results of were observed at doses up to 1,450 mg/ Section 408(c)(2)(A)(i) of FFDCA the studies to human risk. EPA has also kg/day.