Alcohols, C>14, 38096-38101 [2016-13794]

Download as PDF 38096 Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0858; FRL–9946–16] Alcohols, C>14, Ethoxylated; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: I. General Information This regulation amends an exemption from the requirement of a tolerance for residues of a-alkyl-whydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons, and a alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and a minimum number average molecular weight (in amu) 1,100 (herein referred to as ‘‘AAAs’’ (alkyl alcohol alkoxylates)) to include alcohols, C>14, ethoxylated, Chemical Abstract Service Registry Number (CAS Reg. No.) 251553–55–6 when used as an inert ingredient (surfactant) in pesticide formulations. Baker Petrolite LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of alcohols, C>14, ethoxylated. SUMMARY: This regulation is effective June 13, 2016. Objections and requests for hearings must be received on or before August 12, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2015–0858, is available at https://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 mstockstill on DSK3G9T082PROD with RULES DATES: VerDate Sep<11>2014 16:33 Jun 10, 2016 Jkt 238001 information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY 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 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/textidx?&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–2015–0858 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 August 12, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 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– 2015–0858, by one of the following methods: • Federal eRulemaking Portal: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Petition for Exemption In the Federal Register of August 5, 2009 (74 FR 38935) (FRL–8430–1), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 9E7534) by The Joint Inerts Task Force (JITF), Cluster Support Team Number 1 (CST1), c/o CropLife America, 1156 15th Street NW., Suite 400, Washington, DC 20005. The petition requested that 40 CFR 180.910, 40 CFR 180.930, 40 CFR 180.940(a), and 40 CFR 180.960 be amended by establishing exemptions from the requirement of a tolerance for residues of a group of substances known as AAAs. The exemptions narratively describe the subject chemical as a-alkylw-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and specify the individual chemicals covered by the exemptions by a listing of CAS Reg. Nos. The current petition seeks to expand these exemptions by adding an additional chemical, alcohols, C>14, ethoxylated, identified by CAS Reg. No. 251553–55– 6. In the Federal Register of March 16, 2016 (81 FR 14032) (FRL– 9942–86), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346A, announcing the filing of a pesticide petition (IN–10889) by Baker Petrolite LLC (12645 W. Airport Blvd., Sugar Land, TX 77478). The petition requested E:\FR\FM\13JNR1.SGM 13JNR1 Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations that 40 CFR 180.910, 180.930, 180.940(a), and 180.960 be amended by modifying the exemption from the requirement of a tolerance for residues of AAAs by adding residues of alcohols, C>14, ethoxylated which meets the chemical identity a-alkyl-whydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons. In cases where the minimum number average molecular weight is 1,100 or more, the request is to include the alcohols, C>14, ethoxylated under 40 CFR 180.960. For lower the molecular weights the request is to amend the existing exemption from the requirement of a tolerance under 40 CFR 180.910, 180.930, and 180.940(a). Based upon review of the data supporting the petition, EPA has confirmed that the requested CAS Reg. No. is acceptable for consideration under the currently approved descriptor. This determination is based on the Agency’s risk assessment which can be found at https:// www.regulations.gov in document ‘‘IN– 10544. Requesting to Amend the Exemption from the Requirement of a Tolerance for a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons, and a-alkyl- w-hydroxypoly (oxypropylene) and/or poly(oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and a minimum number average molecular weight (in amu) 1,100, under 40 CFR 180.910, 180.930, 180.940(a) or 180.960.’’ in docket ID number EPA–HQ–OPP–2013–2010. mstockstill on DSK3G9T082PROD with RULES III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ‘‘inert’’ is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. VerDate Sep<11>2014 16:33 Jun 10, 2016 Jkt 238001 IV. Aggregate Risk Assessment and Determination of Safety Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for 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. . . .’’ EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), 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 AAAs including exposure resulting from the exemption established by this action. EPA’s assessment of exposures and risks associated with AAAs follows. The Agency agrees with the petitioner that alcohols, C>14, ethoxylated, CAS Reg. No. 251553–55–6, is an AAA PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 38097 having a molecular structure conforming to the chemical description given in the tolerance exemption expression, i.e., a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and which do not contain additional structural elements that are not included within the tolerance exemption expression description. In 2009, in establishing the exemption for the AAAs, EPA assessed their safety generally using worst case exposure assumptions. (August 5, 2009 (74 FR 38935)). EPA concluded that that assessment showed that exempting the AAAs from the requirement from a tolerance would be safe. Inclusion of additional chemicals described above in the risk assessment for the AAAs would in no way alter that prior risk assessment given the generic findings on toxicity and the worst case exposure assumptions used in that risk assessment. Accordingly, based on the findings in that earlier rule, EPA has determined that there is a reasonable certainty that no harm to any population subgroup, including infants and children, will result from aggregate exposure to AAAs, by including the additional chemicals described above, under reasonably foreseeable circumstances. Therefore, the amendment of an exemption from the requirement of a tolerance under 40 CFR 180.910, 180.930, 180.940(a), and 180.960, for residues of AAAs to include the chemical described above is safe under FFDCA section 408. V. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. 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 E:\FR\FM\13JNR1.SGM 13JNR1 38098 Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations 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 not established a MRL for AAAs. C. Response to Comments No comments have been received. VI. Conclusions Therefore, the exemptions from the requirement of a tolerance under 40 CFR 180.910, 180.930, 180.940(a), and 180.960 for a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers when used as an inert ingredient as a surfactant in pesticide formulations applied to growing crops, animals, or food contact surfaces are amended to add the CAS Reg. No. 251553–55–6 to the description of AAAs. VII. Statutory and Executive Order Reviews mstockstill on DSK3G9T082PROD with RULES This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any VerDate Sep<11>2014 16:33 Jun 10, 2016 Jkt 238001 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 section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VIII. 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 31, 2016. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.910, the table is amended by revising the following inert ingredient(s) to read as follows: ■ § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * E:\FR\FM\13JNR1.SGM * * 13JNR1 * * 38099 Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations Inert ingredients Limits Uses * * * * * a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons (CAS Reg. Nos.: 9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035– 85–2; 9038–29–3; 9038–43–1; 9040–05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8; 25231–21–4; 251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2; 31726–34–8; 34398–01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6; 37311–02–7; 37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7; 59112–62–8; 60828–78–6; 61702–78–1; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4; 61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793–60–2; 64366–70–7; 64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9: 66455–15–0; 67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131–39–5; 68131–40–8; 68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0; 68213–24–1; 68238–81–3; 68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439–45–2; 68439–46–3; 68439–48–5; 68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2; 68439–54–3; 68458–88–8;. 68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3; 68551–14–4; 68603–20–3; 68603–25–8; 68920–66–1; 68920–69–4; 68937–66–6; 68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5; 69013–18–9; 69013–19–0; 69227–20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5; 70879–83–3; 70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0; 72108–90–8; 72484–69–6; 72854–13–8; 72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6; 74499–34–6; 78330–19–5; 78330–20–8; 78330–21–9; 78330–23–1; 79771–03–2; 84133–50–6; 85422–93–1; 97043–91–9; 97953–22–5; 102782–43–4; 103331–86–8; 103657–84–7; 103657–85–8; 103818–93–5; 103819–03–0; 106232–83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810– 33–4; 120313–48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2; 139626–71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0; 157707– 43–2; 159653–49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–19–9; 161025–21–4; 161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7; 196823–11–7; 287935– 46–0; 288260–45–7; 303176–75–2; 954108–36–2) * .................. * Surfactants, related adjuvants of surfactants. * * * * * Inert ingredients Limits Uses * * * * * a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons (CAS Reg. Nos.: 9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035– 85–2; 9038–29–3; 9038–43–1; 9040–05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8; 25231–21–4; 251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2; 31726–34–8; 34398–01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6; 37311–02–7; 37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7; 59112–62–8; 60828–78–6; 61702–78–1; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4; 61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793–60–2; 64366–70–7; 64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9: 66455–15–0; 67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131–39–5; 68131–40–8; 68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0; 68213–24–1; 68238–81–3; 68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439–45–2; 68439–46–3; 68439–48–5; 68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2; 68439–54–3; 68458–88–8; 68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3; 68551–14–4; 68603–20–3; 68603–25–8; 68920–66–1; 68920–69–4; 68937–66–6; 68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5; 69013–18–9; 69013–19–0; 69227–20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5; 70879–83–3; 70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0; 72108–90–8; 72484–69–6; 72854–13–8; 72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6; 74499–34–6; 78330–19–5; 78330–20–8; 78330–21–9; 78330–23–1; 79771–03–2; 84133–50–6; 85422–93–1; 97043–91–9; 97953–22–5; 102782–43–4; 103331–86–8; 103657–84–7; 103657–85–8; 103818–93–5; 103819–03–0; 106232–83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810–33–4; 120313– 48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2; 139626–71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0; 157707–43–2; 159653– 49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–19–9; 161025–21–4; 161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7; 196823–11–7; 287935–46–0; 288260– 45–7; 303176–75–2; 954108–36–2). * .................. * Surfactants, related adjuvants of surfactants. 3. In § 180.930, the table is amended by revising the following inert ingredients to read as follows: mstockstill on DSK3G9T082PROD with RULES ■ * VerDate Sep<11>2014 * 16:33 Jun 10, 2016 * § 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance. * * * * * Jkt 238001 * PO 00000 * * Frm 00039 Fmt 4700 * Sfmt 4700 E:\FR\FM\13JNR1.SGM * 13JNR1 * 38100 Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations § 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions). 4. In § 180.940, the table is amended by revising the following entry to the table in paragraph (a): ■ (a) * * * Pesticide chemical CAS Reg. No. * * a-alkyl-w-hydroxypoly (oxypropylene) and/ or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons (CAS Reg. No 251553–55– 6). * * * * 9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035–85–2; 9038–29–3; 9038–43–1; 9040–05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8; 25231–21–4; 251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2; 31726–34–8; 34398–01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6; 37311–02–7; 37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7; 59112–62–8; 60828–78–6; 61702–78–1; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4; 61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793–60–2; 64366–70–7; 64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9: 66455–15–0; 67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131–39–5; 68131–40–8; 68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0; 68213–24–1; 68238–81–3; 68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439–45–2; 68439–46–3; 68439–48–5; 68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2; 68439–54–3; 68458–88–8; 68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3; 68551–14–4; 68603–20–3; 68603–25–8; 68920–66–1; 68920–69–4; 68937–66–6; 68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5; 69013–18–9; 69013–19–0; 69227–20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5; 70879–83–3; 70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0; 72108–90–8; 72484–69–6; 72854–13–8; 72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6; 74499–34–6; 78330–19–5; 78330–20–8; 78330–21–9; 78330–23–1; 79771–03–2; 84133–50–6; 85422–93–1; 97043–91–9; 97953–22–5; 102782–43–4; 103331–86–8; 103657–84–7; 103657–85–8; 103818–93–5; 103819–03–0; 106232– 83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810–33–4; 120313–48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2; 139626– 71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0; 157707–43–2; 159653–49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901– 19–9; 161025–21–4; 161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7; 196823–11–7; 287935–46–0; 288260–45–7; 303176–75–2; 954108– 36–2. * * * * * * * * * Limits * * * * § 180.960; Polymers; exemptions from the requirement of a tolerance. 5. In § 180.960, the table is amended by revising the following entry to read as follows: ■ CAS No. * * a-alkyl-w-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and a minimum number average molecular weight (in amu) 1,100 mstockstill on DSK3G9T082PROD with RULES Polymer * * * * * 9002–92–0; 9004–95–9; 9004–98–2; 9005–00–9; 9035–85–2; 9038–29–3; 9038–43–1; 9040– 05–5; 9043–30–5; 9087–53–0; 25190–05–0; 24938–91–8; 25231–21–4; 251553–55–6; 26183–52–8; 26468–86–0; 26636–39–5; 27252–75–1; 27306–79–2; 31726–34–8; 34398– 01–1; 34398–05–5; 37251–67–5; 37311–00–5; 37311–01–6; 37311–02–7; 37311–04–9; 39587–22–9; 50861–66–0; 52232–09–4; 52292–17–8; 52609–19–5; 57679–21–7; 59112– 62–8; 60828–78–6; 61702–78–1; 61725–89–1; 61791–13–7; 61791–20–6; 61791–28–4; 61804–34–0; 61827–42–7; 61827–84–7; 62648–50–4; 63303–01–5; 63658–45–7; 63793– 60–2; 64366–70–7; 64415–24–3; 64415–25–4; 64425–86–1; 65104–72–5; 65150–81–4; 66455–14–9: 66455–15–0; 67254–71–1; 67763–08–0; 68002–96–0; 68002–97–1; 68131– 39–5; 68131–40–8; 68154–96–1; 68154–97–2; 68154–98–3; 68155–01–1; 68213–23–0; 68213–24–1; 68238–81–3; 68238–82–4; 68409–58–5; 68409–59–6; 68439–30–5; 68439– 45–2; 68439–46–3; 68439–48–5; 68439–49–6; 68439–50–9; 68439–51–0; 68439–53–2; 68439–54–3; 68458–88–8; 68526–94–3; 68526–95–4; 68551–12–2; 68551–13–3; 68551– 14–4; 68603–20–3; 68603–25–8; 68920–66–1; 68920–69–4; 68937–66–6; 68951–67–7; 68954–94–9; 68987–81–5; 68991–48–0; 69011–36–5; 69013–18–9; 69013–19–0; 69227– 20–9; 69227–21–0; 69227–22–1; 69364–63–2; 70750–27–5; 70879–83–3; 70955–07–6; 71011–10–4; 71060–57–6; 71243–46–4; 72066–65–0; 72108–90–8; 72484–69–6; 72854– 13–8; 72905–87–4; 73018–31–2; 73049–34–0; 74432–13–6; 74499–34–6; 78330–19–5; 78330–20–8; 78330–21–9; 78330–23–1; 79771–03–2; 84133–50–6; 85422–93–1; 97043– 91–9; 97953–22–5; 102782–43–4; 103331–86–8; 103657–84–7; 103657–85–8; 103818–93– 5; 103819–03–0; 106232–83–1; 111905–54–5; 116810–31–2; 116810–32–3; 116810–33–4; 120313–48–6; 120944–68–5; 121617–09–2; 126646–02–4; 126950–62–7; 127036–24–2; 139626–71–4; 152231–44–2; 154518–36–2; 157627–86–6; 157627–88–8; 157707–41–0; 157707–43–2; 159653–49–3; 160875–66–1; 160901–20–2; 160901–09–7; 160901–19–9; 161025–21–4; 161025–22–5; 166736–08–9; 169107–21–5; 172588–43–1; 176022–76–7; 196823–11–7; 287935–46–0; 288260–45–7; 303176–75–2; 954108–36–2. * VerDate Sep<11>2014 * 16:33 Jun 10, 2016 * Jkt 238001 PO 00000 * Frm 00040 Fmt 4700 * Sfmt 4700 E:\FR\FM\13JNR1.SGM * 13JNR1 * Federal Register / Vol. 81, No. 113 / Monday, June 13, 2016 / Rules and Regulations [FR Doc. 2016–13794 Filed 6–10–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2015–0350; FRL–9946–48] D-glucurono-6-deoxy-L-manno-Dglucan, Acetate, Calcium Magnesium Potassium Sodium Salt (Diutan Gum); Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of D-glucurono-6deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum) Chemical Abstract Service Registration Number ((CAS Reg. No.) 595585–15–2) when used as an inert ingredient stabilizer/suspension agent applied to crops pre- and postharvest and to food contact surfaces. Keller and Heckman on behalf of CP Kelco U.S., Inc submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of D-glucurono-6-deoxy-Lmanno-D-glucan, acetate, calcium magnesium potassium sodium salt (diutan gum). DATES: This regulation is effective June 13, 2016. Objections and requests for hearings must be received on or before August 12, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2015–0350, is available at https://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 mstockstill on DSK3G9T082PROD with RULES ADDRESSES: VerDate Sep<11>2014 16:33 Jun 10, 2016 Jkt 238001 the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. 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 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to https:// www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines.’’ C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2015–0350 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 August 12, 2016. Addresses for mail and hand delivery of objections PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 38101 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– 2015–0350, by one of the following methods: • Federal eRulemaking Portal: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Petition for Exemption In the Federal Register of Monday, April 25, 2016 (81 FR 24046) (FRL– 9944–86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN–10815) by Keller and Heckman LLP (1001 G Street NW., Suite 500 West, Washington, DC 20001), on behalf of CP Kelco U.S., Inc (3100 Cumberland Blvd., Suite 600, Atlanta, GA 30339). The petition requested that 40 CFR 180.910 and 40 CFR 180.940 be amended by establishing an exemption from the requirement of a tolerance for residues of D-glucurono-6-deoxy-L-manno-Dglucan, acetate, calcium magnesium potassium sodium salt (diutan gum) (CAS Reg. No. 595585–15–2) when used as an inert ingredient stabilizer/ suspension agent in pesticide formulations applied to crops pre- and post-harvest and to food contact surfaces. That document referenced a summary of the petition prepared by Keller and Heckman on behalf of CP Kelco U.S., Inc., the petitioner, which is available in the docket, https:// www.regulations.gov. There were no E:\FR\FM\13JNR1.SGM 13JNR1

Agencies

[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Rules and Regulations]
[Pages 38096-38101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13794]



[[Page 38096]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0858; FRL-9946-16]


Alcohols, C>14, Ethoxylated; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation amends an exemption from the requirement of a 
tolerance for residues of [alpha]-alkyl-[omega]-hydroxypoly 
(oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain 
contains a minimum of six carbons, and [alpha] alkyl-[omega]-
hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the 
alkyl chain contains a minimum of six carbons and a minimum number 
average molecular weight (in amu) 1,100 (herein referred to as ``AAAs'' 
(alkyl alcohol alkoxylates)) to include alcohols, C>14, 
ethoxylated, Chemical Abstract Service Registry Number (CAS Reg. No.) 
251553-55-6 when used as an inert ingredient (surfactant) in pesticide 
formulations. Baker Petrolite LLC submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment 
to an existing exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of alcohols, C>14, ethoxylated.

DATES: This regulation is effective June 13, 2016. Objections and 
requests for hearings must be received on or before August 12, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0858, is available at https://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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://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-2015-0858 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 
August 12, 2016. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0858, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 5, 2009 (74 FR 38935) (FRL-8430-
1), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 9E7534) by The 
Joint Inerts Task Force (JITF), Cluster Support Team Number 1 (CST1), 
c/o CropLife America, 1156 15th Street NW., Suite 400, Washington, DC 
20005. The petition requested that 40 CFR 180.910, 40 CFR 180.930, 40 
CFR 180.940(a), and 40 CFR 180.960 be amended by establishing 
exemptions from the requirement of a tolerance for residues of a group 
of substances known as AAAs. The exemptions narratively describe the 
subject chemical as [alpha]-alkyl-[omega]-hydroxypoly (oxypropylene) 
and/or poly (oxyethylene) polymers where the alkyl chain contains a 
minimum of six carbons and specify the individual chemicals covered by 
the exemptions by a listing of CAS Reg. Nos. The current petition seeks 
to expand these exemptions by adding an additional chemical, alcohols, 
C>14, ethoxylated, identified by CAS Reg. No. 251553-55-6.
    In the Federal Register of March 16, 2016 (81 FR 14032) (FRL- 9942-
86), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346A, announcing the filing of a pesticide petition (IN-10889) by Baker 
Petrolite LLC (12645 W. Airport Blvd., Sugar Land, TX 77478). The 
petition requested

[[Page 38097]]

that 40 CFR 180.910, 180.930, 180.940(a), and 180.960 be amended by 
modifying the exemption from the requirement of a tolerance for 
residues of AAAs by adding residues of alcohols, C>14, 
ethoxylated which meets the chemical identity [alpha]-alkyl-[omega]-
hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the 
alkyl chain contains a minimum of six carbons. In cases where the 
minimum number average molecular weight is 1,100 or more, the request 
is to include the alcohols, C>14, ethoxylated under 40 CFR 
180.960. For lower the molecular weights the request is to amend the 
existing exemption from the requirement of a tolerance under 40 CFR 
180.910, 180.930, and 180.940(a).
    Based upon review of the data supporting the petition, EPA has 
confirmed that the requested CAS Reg. No. is acceptable for 
consideration under the currently approved descriptor. This 
determination is based on the Agency's risk assessment which can be 
found at https://www.regulations.gov in document ``IN-10544. Requesting 
to Amend the Exemption from the Requirement of a Tolerance for [alpha]-
alkyl-[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) 
polymers where the alkyl chain contains a minimum of six carbons, and 
[alpha]-alkyl- [omega]-hydroxypoly (oxypropylene) and/or 
poly(oxyethylene) polymers where the alkyl chain contains a minimum of 
six carbons and a minimum number average molecular weight (in amu) 
1,100, under 40 CFR 180.910, 180.930, 180.940(a) or 180.960.'' in 
docket ID number EPA-HQ-OPP-2013-2010.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for 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. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), 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 AAAs including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with AAAs follows.
    The Agency agrees with the petitioner that alcohols, 
C>14, ethoxylated, CAS Reg. No. 251553-55-6, is an AAA 
having a molecular structure conforming to the chemical description 
given in the tolerance exemption expression, i.e., [alpha]-alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers 
where the alkyl chain contains a minimum of six carbons and which do 
not contain additional structural elements that are not included within 
the tolerance exemption expression description. In 2009, in 
establishing the exemption for the AAAs, EPA assessed their safety 
generally using worst case exposure assumptions. (August 5, 2009 (74 FR 
38935)). EPA concluded that that assessment showed that exempting the 
AAAs from the requirement from a tolerance would be safe. Inclusion of 
additional chemicals described above in the risk assessment for the 
AAAs would in no way alter that prior risk assessment given the generic 
findings on toxicity and the worst case exposure assumptions used in 
that risk assessment. Accordingly, based on the findings in that 
earlier rule, EPA has determined that there is a reasonable certainty 
that no harm to any population subgroup, including infants and 
children, will result from aggregate exposure to AAAs, by including the 
additional chemicals described above, under reasonably foreseeable 
circumstances. Therefore, the amendment of an exemption from the 
requirement of a tolerance under 40 CFR 180.910, 180.930, 180.940(a), 
and 180.960, for residues of AAAs to include the chemical described 
above is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

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

[[Page 38098]]

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 not established a MRL for AAAs.

C. Response to Comments

    No comments have been received.

VI. Conclusions

    Therefore, the exemptions from the requirement of a tolerance under 
40 CFR 180.910, 180.930, 180.940(a), and 180.960 for [alpha]-alkyl-
[omega]-hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers 
when used as an inert ingredient as a surfactant in pesticide 
formulations applied to growing crops, animals, or food contact 
surfaces are amended to add the CAS Reg. No. 251553-55-6 to the 
description of AAAs.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. 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 31, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.910, the table is amended by revising the following 
inert ingredient(s) to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

[[Page 38099]]



------------------------------------------------------------------------
             Inert ingredients                Limits          Uses
------------------------------------------------------------------------
                              * * * * * * *
[alpha]-alkyl-[omega]-hydroxypoly           ..........  Surfactants,
 (oxypropylene) and/or poly (oxyethylene)                related
 polymers where the alkyl chain contains a               adjuvants of
 minimum of six carbons (CAS Reg. Nos.:                  surfactants.
 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 24938-91-8; 25231-21-4; 251553-55-6;
 26183-52-8; 26468-86-0; 26636-39-5; 27252-
 75-1; 27306-79-2; 31726-34-8; 34398-01-1;
 34398-05-5; 37251-67-5; 37311-00-5; 37311-
 01-6; 37311-02-7; 37311-04-9; 39587-22-9;
 50861-66-0; 52232-09-4; 52292-17-8; 52609-
 19-5; 57679-21-7; 59112-62-8; 60828-78-6;
 61702-78-1; 61725-89-1; 61791-13-7; 61791-
 20-6; 61791-28-4; 61804-34-0; 61827-42-7;
 61827-84-7; 62648-50-4; 63303-01-5; 63658-
 45-7; 63793-60-2; 64366-70-7; 64415-24-3;
 64415-25-4; 64425-86-1; 65104-72-5; 65150-
 81-4; 66455-14-9: 66455-15-0; 67254-71-1;
 67763-08-0; 68002-96-0; 68002-97-1; 68131-
 39-5; 68131-40-8; 68154-96-1; 68154-97-2;
 68154-98-3; 68155-01-1; 68213-23-0; 68213-
 24-1; 68238-81-3; 68238-82-4; 68409-58-5;
 68409-59-6; 68439-30-5; 68439-45-2; 68439-
 46-3; 68439-48-5; 68439-49-6; 68439-50-9;
 68439-51-0; 68439-53-2; 68439-54-3; 68458-
 88-8;.
 68526-94-3; 68526-95-4; 68551-12-2; 68551-
 13-3; 68551-14-4; 68603-20-3; 68603-25-8;
 68920-66-1; 68920-69-4; 68937-66-6; 68951-
 67-7; 68954-94-9; 68987-81-5; 68991-48-0;
 69011-36-5; 69013-18-9; 69013-19-0; 69227-
 20-9; 69227-21-0; 69227-22-1; 69364-63-2;
 70750-27-5; 70879-83-3; 70955-07-6; 71011-
 10-4; 71060-57-6; 71243-46-4; 72066-65-0;
 72108-90-8; 72484-69-6; 72854-13-8; 72905-
 87-4; 73018-31-2; 73049-34-0; 74432-13-6;
 74499-34-6; 78330-19-5; 78330-20-8; 78330-
 21-9; 78330-23-1; 79771-03-2; 84133-50-6;
 85422-93-1; 97043-91-9; 97953-22-5;
 102782-43-4; 103331-86-8; 103657-84-7;
 103657-85-8; 103818-93-5; 103819-03-0;
 106232-83-1; 111905-54-5; 116810-31-2;
 116810-32-3; 116810-33-4; 120313-48-6;
 120944-68-5; 121617-09-2; 126646-02-4;
 126950-62-7; 127036-24-2; 139626-71-4;
 152231-44-2; 154518-36-2; 157627-86-6;
 157627-88-8; 157707-41-0; 157707-43-2;
 159653-49-3; 160875-66-1; 160901-20-2;
 160901-09-7; 160901-19-9; 161025-21-4;
 161025-22-5; 166736-08-9; 169107-21-5;
 172588-43-1; 176022-76-7; 196823-11-7;
 287935-46-0; 288260-45-7; 303176-75-2;
 954108-36-2)
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.930, the table is amended by revising the following 
inert ingredients to read as follows:


Sec.  180.930  Inert ingredients applied to animals; exemptions from 
the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
             Inert ingredients                Limits          Uses
------------------------------------------------------------------------
                              * * * * * * *
[alpha]-alkyl-[omega]-hydroxypoly           ..........  Surfactants,
 (oxypropylene) and/or poly (oxyethylene)                related
 polymers where the alkyl chain contains a               adjuvants of
 minimum of six carbons (CAS Reg. Nos.:                  surfactants.
 9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 24938-91-8; 25231-21-4; 251553-55-6;
 26183-52-8; 26468-86-0; 26636-39-5; 27252-
 75-1; 27306-79-2; 31726-34-8; 34398-01-1;
 34398-05-5; 37251-67-5; 37311-00-5; 37311-
 01-6; 37311-02-7; 37311-04-9; 39587-22-9;
 50861-66-0; 52232-09-4; 52292-17-8; 52609-
 19-5; 57679-21-7; 59112-62-8; 60828-78-6;
 61702-78-1; 61725-89-1; 61791-13-7; 61791-
 20-6; 61791-28-4; 61804-34-0; 61827-42-7;
 61827-84-7; 62648-50-4; 63303-01-5; 63658-
 45-7; 63793-60-2; 64366-70-7; 64415-24-3;
 64415-25-4; 64425-86-1; 65104-72-5; 65150-
 81-4; 66455-14-9: 66455-15-0; 67254-71-1;
 67763-08-0; 68002-96-0; 68002-97-1; 68131-
 39-5; 68131-40-8; 68154-96-1; 68154-97-2;
 68154-98-3; 68155-01-1; 68213-23-0; 68213-
 24-1; 68238-81-3; 68238-82-4; 68409-58-5;
 68409-59-6; 68439-30-5; 68439-45-2; 68439-
 46-3; 68439-48-5; 68439-49-6; 68439-50-9;
 68439-51-0; 68439-53-2; 68439-54-3; 68458-
 88-8; 68526-94-3; 68526-95-4; 68551-12-2;
 68551-13-3; 68551-14-4; 68603-20-3; 68603-
 25-8; 68920-66-1; 68920-69-4; 68937-66-6;
 68951-67-7; 68954-94-9; 68987-81-5; 68991-
 48-0; 69011-36-5; 69013-18-9; 69013-19-0;
 69227-20-9; 69227-21-0; 69227-22-1; 69364-
 63-2; 70750-27-5; 70879-83-3; 70955-07-6;
 71011-10-4; 71060-57-6; 71243-46-4; 72066-
 65-0; 72108-90-8; 72484-69-6; 72854-13-8;
 72905-87-4; 73018-31-2; 73049-34-0; 74432-
 13-6; 74499-34-6; 78330-19-5; 78330-20-8;
 78330-21-9; 78330-23-1; 79771-03-2; 84133-
 50-6; 85422-93-1; 97043-91-9; 97953-22-5;
 102782-43-4; 103331-86-8; 103657-84-7;
 103657-85-8; 103818-93-5; 103819-03-0;
 106232-83-1; 111905-54-5; 116810-31-2;
 116810-32-3; 116810-33-4; 120313-48-6;
 120944-68-5; 121617-09-2; 126646-02-4;
 126950-62-7; 127036-24-2; 139626-71-4;
 152231-44-2; 154518-36-2; 157627-86-6;
 157627-88-8; 157707-41-0; 157707-43-2;
 159653-49-3; 160875-66-1; 160901-20-2;
 160901-09-7; 160901-19-9; 161025-21-4;
 161025-22-5; 166736-08-9; 169107-21-5;
 172588-43-1; 176022-76-7; 196823-11-7;
 287935-46-0; 288260-45-7; 303176-75-2;
 954108-36-2).
 
                              * * * * * * *
------------------------------------------------------------------------


[[Page 38100]]


0
4. In Sec.  180.940, the table is amended by revising the following 
entry to the table in paragraph (a):


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

    (a) * * *

----------------------------------------------------------------------------------------------------------------
             Pesticide chemical                                    CAS Reg. No.                         Limits
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
[alpha]-alkyl-[omega]-hydroxypoly            9002-92-0; 9004-95-9; 9004-98-2; 9005-00-9; 9035-85-2;
 (oxypropylene) and/or poly (oxyethylene)     9038-29-3; 9038-43-1; 9040-05-5; 9043-30-5; 9087-53-0;
 polymers where the alkyl chain contains a    25190-05-0; 24938-91-8; 25231-21-4; 251553-55-6; 26183-
 minimum of six carbons (CAS Reg. No 251553-  52-8; 26468-86-0; 26636-39-5; 27252-75-1; 27306-79-2;
 55-6).                                       31726-34-8; 34398-01-1; 34398-05-5; 37251-67-5; 37311-
                                              00-5; 37311-01-6; 37311-02-7; 37311-04-9; 39587-22-9;
                                              50861-66-0; 52232-09-4; 52292-17-8; 52609-19-5; 57679-
                                              21-7; 59112-62-8; 60828-78-6; 61702-78-1; 61725-89-1;
                                              61791-13-7; 61791-20-6; 61791-28-4; 61804-34-0; 61827-
                                              42-7; 61827-84-7; 62648-50-4; 63303-01-5; 63658-45-7;
                                              63793-60-2; 64366-70-7; 64415-24-3; 64415-25-4; 64425-
                                              86-1; 65104-72-5; 65150-81-4; 66455-14-9: 66455-15-0;
                                              67254-71-1; 67763-08-0; 68002-96-0; 68002-97-1; 68131-
                                              39-5; 68131-40-8; 68154-96-1; 68154-97-2; 68154-98-3;
                                              68155-01-1; 68213-23-0; 68213-24-1; 68238-81-3; 68238-
                                              82-4; 68409-58-5; 68409-59-6; 68439-30-5; 68439-45-2;
                                              68439-46-3; 68439-48-5; 68439-49-6; 68439-50-9; 68439-
                                              51-0; 68439-53-2; 68439-54-3; 68458-88-8; 68526-94-3;
                                              68526-95-4; 68551-12-2; 68551-13-3; 68551-14-4; 68603-
                                              20-3; 68603-25-8; 68920-66-1; 68920-69-4; 68937-66-6;
                                              68951-67-7; 68954-94-9; 68987-81-5; 68991-48-0; 69011-
                                              36-5; 69013-18-9; 69013-19-0; 69227-20-9; 69227-21-0;
                                              69227-22-1; 69364-63-2; 70750-27-5; 70879-83-3; 70955-
                                              07-6; 71011-10-4; 71060-57-6; 71243-46-4; 72066-65-0;
                                              72108-90-8; 72484-69-6; 72854-13-8; 72905-87-4; 73018-
                                              31-2; 73049-34-0; 74432-13-6; 74499-34-6; 78330-19-5;
                                              78330-20-8; 78330-21-9; 78330-23-1; 79771-03-2; 84133-
                                              50-6; 85422-93-1; 97043-91-9; 97953-22-5; 102782-43-4;
                                              103331-86-8; 103657-84-7; 103657-85-8; 103818-93-5;
                                              103819-03-0; 106232-83-1; 111905-54-5; 116810-31-2;
                                              116810-32-3; 116810-33-4; 120313-48-6; 120944-68-5;
                                              121617-09-2; 126646-02-4; 126950-62-7; 127036-24-2;
                                              139626-71-4; 152231-44-2; 154518-36-2; 157627-86-6;
                                              157627-88-8; 157707-41-0; 157707-43-2; 159653-49-3;
                                              160875-66-1; 160901-20-2; 160901-09-7; 160901-19-9;
                                              161025-21-4; 161025-22-5; 166736-08-9; 169107-21-5;
                                              172588-43-1; 176022-76-7; 196823-11-7; 287935-46-0;
                                              288260-45-7; 303176-75-2; 954108-36-2.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
5. In Sec.  180.960, the table is amended by revising the following 
entry to read as follows:


Sec.  180.960;  Polymers; exemptions from the requirement of a 
tolerance.

------------------------------------------------------------------------
           Polymer                              CAS No.
------------------------------------------------------------------------
                              * * * * * * *
[alpha]-alkyl-[omega]-         9002-92-0; 9004-95-9; 9004-98-2; 9005-00-
 hydroxypoly (oxypropylene)     9; 9035-85-2; 9038-29-3; 9038-43-1; 9040-
 and/or poly (oxyethylene)      05-5; 9043-30-5; 9087-53-0; 25190-05-0;
 polymers where the alkyl       24938-91-8; 25231-21-4; 251553-55-6;
 chain contains a minimum of    26183-52-8; 26468-86-0; 26636-39-5;
 six carbons and a minimum      27252-75-1; 27306-79-2; 31726-34-8;
 number average molecular       34398-01-1; 34398-05-5; 37251-67-5;
 weight (in amu) 1,100          37311-00-5; 37311-01-6; 37311-02-7;
                                37311-04-9; 39587-22-9; 50861-66-0;
                                52232-09-4; 52292-17-8; 52609-19-5;
                                57679-21-7; 59112-62-8; 60828-78-6;
                                61702-78-1; 61725-89-1; 61791-13-7;
                                61791-20-6; 61791-28-4; 61804-34-0;
                                61827-42-7; 61827-84-7; 62648-50-4;
                                63303-01-5; 63658-45-7; 63793-60-2;
                                64366-70-7; 64415-24-3; 64415-25-4;
                                64425-86-1; 65104-72-5; 65150-81-4;
                                66455-14-9: 66455-15-0; 67254-71-1;
                                67763-08-0; 68002-96-0; 68002-97-1;
                                68131-39-5; 68131-40-8; 68154-96-1;
                                68154-97-2; 68154-98-3; 68155-01-1;
                                68213-23-0; 68213-24-1; 68238-81-3;
                                68238-82-4; 68409-58-5; 68409-59-6;
                                68439-30-5; 68439-45-2; 68439-46-3;
                                68439-48-5; 68439-49-6; 68439-50-9;
                                68439-51-0; 68439-53-2; 68439-54-3;
                                68458-88-8; 68526-94-3; 68526-95-4;
                                68551-12-2; 68551-13-3; 68551-14-4;
                                68603-20-3; 68603-25-8; 68920-66-1;
                                68920-69-4; 68937-66-6; 68951-67-7;
                                68954-94-9; 68987-81-5; 68991-48-0;
                                69011-36-5; 69013-18-9; 69013-19-0;
                                69227-20-9; 69227-21-0; 69227-22-1;
                                69364-63-2; 70750-27-5; 70879-83-3;
                                70955-07-6; 71011-10-4; 71060-57-6;
                                71243-46-4; 72066-65-0; 72108-90-8;
                                72484-69-6; 72854-13-8; 72905-87-4;
                                73018-31-2; 73049-34-0; 74432-13-6;
                                74499-34-6; 78330-19-5; 78330-20-8;
                                78330-21-9; 78330-23-1; 79771-03-2;
                                84133-50-6; 85422-93-1; 97043-91-9;
                                97953-22-5; 102782-43-4; 103331-86-8;
                                103657-84-7; 103657-85-8; 103818-93-5;
                                103819-03-0; 106232-83-1; 111905-54-5;
                                116810-31-2; 116810-32-3; 116810-33-4;
                                120313-48-6; 120944-68-5; 121617-09-2;
                                126646-02-4; 126950-62-7; 127036-24-2;
                                139626-71-4; 152231-44-2; 154518-36-2;
                                157627-86-6; 157627-88-8; 157707-41-0;
                                157707-43-2; 159653-49-3; 160875-66-1;
                                160901-20-2; 160901-09-7; 160901-19-9;
                                161025-21-4; 161025-22-5; 166736-08-9;
                                169107-21-5; 172588-43-1; 176022-76-7;
                                196823-11-7; 287935-46-0; 288260-45-7;
                                303176-75-2; 954108-36-2.
 
                              * * * * * * *
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[[Page 38101]]

[FR Doc. 2016-13794 Filed 6-10-16; 8:45 am]
BILLING CODE 6560-50-P
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