80 FR 77260 - Polyamide Ester Polymers; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 239 (December 14, 2015)
Federal Register Volume 80, Issue 239 (December 14, 2015)
| Page Range | 77260-77264 | |
| FR Document | 2015-30924 |
[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)] [Rules and Regulations] [Pages 77260-77264] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30924] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0451; FRL-9939-28] Polyamide Ester Polymers; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of several polyamide ester polymers as listed in this final rule. Spring Trading Co. on behalf of Croda, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of the listed chemicals on food or feed commodities. DATES: This regulation is effective December 14, 2015. Objections and requests for hearings must be received on or before February 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-2015-0451, 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: 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: [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 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. [[Page 77261]] C. 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-2015-0451 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 February 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-2015-0451, 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. Background and Statutory Findings In the Federal Register of Wednesday, August 26, 2015 (80 FR 51763) (FRL-9931-74), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN- 10834) filed by Spring Trading Co., 203 Dogwood Trl., Magnolia, TX 77354 (on behalf of Croda, Inc., 315 Cherry Ln., New Castle, DE 19720). The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of the following polyamide ester polymers: Fatty acids, C 18 - unsatd., dimers, polymers with ethylenediamine and stearyl alcohol (CAS Reg. No. 363162-42-9); fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol (CAS Reg. No. 678991-29-2); fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol (CAS Reg. No. 951153-32-5); Fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and ethylenediamine (CAS Reg. No. 1699751-19-3); Fatty acids, C18 -unsatd., dimers, polymers with cetyl alcohol., neopentyl glycol and trimethylenediamine (CAS Reg. No. 1699751-23-9); fatty acids, C18 -unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol (CAS Reg. No. 1699751-24-0); fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine (CAS Reg. No. 1699751-25-1); fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine (CAS Reg. No. 1699751-28-4); fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and trimethylenediamine (CAS Reg. No. 1699751-29-5); fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol (CAS Reg. No. 1699751-31-9) and fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and sorbitol (CAS Reg. No. 1685271-04-8). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. No comments were received by the Agency in response to the notice of filing. 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 exemption is ``safe.'' Section 408(c)(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 use 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 an exemption from the requirement of 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. . .'' and specifies factors EPA is to consider in establishing an exemption. III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown 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(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information 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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). The polyamide ester polymers listed in this final rule conform to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers. 1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. [[Page 77262]] 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. 7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6). Thus, polyamide ester polymers listed in this final rule (i.e., fatty acids, C18 -unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 - unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, polymers with 1- docosanol and ethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with cetyl alcohol., neopentyl glycol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with 1- docosanol, hexamethylenediamine and neopentyl glycol; and fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and sorbitol) meet the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on their conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation or dermal exposure to these polymers. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that these polymers could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW (in amu) of each of these polymers is 1,400 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since these polymers conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found these polymers to share a common mechanism of toxicity with any other substances, and these polymers does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that these polymers does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. VI. Additional Safety Factor for the Protection of Infants and Children Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of these polymers, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VII. Determination of Safety Based on the conformance to the criteria used to identify a low- risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of fatty acids, C18 -unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 - unsatd., dimers, polymers with 1-docosanol and ethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with cetyl alcohol, neopentyl glycol and trimethylenediamine; fatty acids, C18 - unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol; and fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol. VIII. Other Considerations A. Existing Exemptions From a Tolerance Not applicable. B. 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. C. 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, [[Page 77263]] 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 fatty acids, C18 -unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and ethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with cetyl alcohol, neopentyl glycol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C18 - unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with 1- docosanol, hexamethylenediamine and neopentyl glycol; or fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and sorbitol. IX. Conclusion Accordingly, EPA finds that exempting residues of fatty acids, C18 -unsatd., dimers, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol; fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and ethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with cetyl alcohol, neopentyl glycol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol; fatty acids, C18 - unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, polymers with 1-docosanol and trimethylenediamine; fatty acids, C18 -unsatd., dimers, hydrogenated, polymers with 1- docosanol, hexamethylenediamine and neopentyl glycol; and fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and sorbitol from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This action establishes 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) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). XI. 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: November 30, 2015. G. Jeffrey Herndon, 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. 180.960, alphabetically add the following polymers to the table to read as follows: Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * [[Page 77264]] ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * Fatty acids, C18-unsatd., dimers, polymers with 363162-42-9 ethylenediamine and stearyl alcohol, minimum number average molecular weight (in amu) 1,400................ Fatty acids, C18-unsatd., dimers, hydrogenated, polymers 678991-29-2 with ethylenediamine, neopentyl glycol and stearyl alcohol, minimum number average molecular weight (in amu) 1,400............................................. Fatty acids, C18-unsatd., dimers, hydrogenated, polymers 951153-32-5 with ethylenediamine and stearyl alcohol, minimum number average molecular weight (in amu) 1,400......... Fatty acids, C18-unsatd., dimers, polymers with 1- 1699751-19-3 docosanol and ethylenediamine, minimum number average molecular weight (in amu) 1,400........................ Fatty acids, C18-unsatd., dimers, polymers with cetyl 1699751-23-9 alcohol, neopentyl glycol and trimethylenediamine, minimum number average molecular weight (in amu) 1,400. Fatty acids, C18-unsatd., dimers, polymers with 1699751-24-0 hexamethylenediamine and stearyl alcohol, minimum number average molecular weight (in amu) 1,400......... Fatty acids, C18-unsatd., dimers, hydrogenated, polymers 1699751-25-1 with cetyl alcohol and ethylenediamine, minimum number average molecular weight (in amu) 1,400................ Fatty acids, C18-unsatd., dimers, hydrogenated, polymers 1699751-28-4 with neopentyl glycol, stearyl alcohol and trimethylenediamine, minimum number average molecular weight (in amu) 1,400.................................. Fatty acids, C18-unsatd., dimers, polymers with 1- 1699751-29-5 docosanol and trimethylenediamine, minimum number average molecular weight (in amu) 1,400................ Fatty acids, C18-unsatd., dimers, polymers with 1- 1699751-31-9 docosanol, hexamethylenediamine and neopentyl glycol, minimum number average molecular weight (in amu) 1,400. Fatty acids, C18-unsatd., dimers, polymers with 1685271-04-8 docosanoic acid, 1,3-propanediol and sorbitol, minimum number average molecular weight (in amu) 1,400......... * * * * * * * ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-30924 Filed 12-11-15; 8:45 am] BILLING CODE 6560-50-P
![77260 Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations
Paperwork Reduction Act (PRA) (44 List of Subjects in 40 CFR Part 180 requests for hearings must be received
U.S.C. 3501 et seq.), nor does it require Environmental protection, on or before February 12, 2016, and
any special considerations under Administrative practice and procedure, must be filed in accordance with the
Executive Order 12898, entitled Agricultural commodities, Pesticides instructions provided in 40 CFR part
‘‘Federal Actions to Address and pests, Reporting and recordkeeping 178 (see also Unit I.C. of the
Environmental Justice in Minority requirements. SUPPLEMENTARY INFORMATION).
Populations and Low-Income ADDRESSES: The docket for this action,
Dated: December 3, 2015.
Populations’’ (59 FR 7629, February 16, identified by docket identification (ID)
Susan Lewis,
1994). number EPA–HQ–OPP–2015–0451, is
Director, Registration Division, Office of
Since tolerances and exemptions that Pesticide Programs. available at http://www.regulations.gov
are established on the basis of a petition or at the Office of Pesticide Programs
Therefore, 40 CFR chapter I is Regulatory Public Docket (OPP Docket)
under FFDCA section 408(d), such as
amended as follows: in the Environmental Protection Agency
the tolerance in this final rule, do not
require the issuance of a proposed rule, Docket Center (EPA/DC), West William
PART 180—[AMENDED]
the requirements of the Regulatory Jefferson Clinton Bldg., Rm. 3334, 1301
Flexibility Act (RFA) (5 U.S.C. 601 et ■ 1. The authority citation for part 180 Constitution Ave. NW., Washington, DC
seq.), do not apply. continues to read as follows: 20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
This action directly regulates growers, Authority: 21 U.S.C. 321(q), 346a and 371.
Monday through Friday, excluding legal
food processors, food handlers, and food ■ 2. In § 180.155, add to the table in holidays. The telephone number for the
retailers, not States or tribes, nor does alphabetical order an entry for Public Reading Room is (202) 566–1744,
this action alter the relationships or ‘‘pomegranate’’ to read as follows: and the telephone number for the OPP
distribution of power and Docket is (703) 305–5805. Please review
responsibilities established by Congress § 180.155 1-Naphthaleneacetic acid;
tolerance for residues. the visitor instructions and additional
in the preemption provisions of FFDCA information about the docket available
section 408(n)(4). As such, the Agency (a) * * *
at http://www.epa.gov/dockets.
has determined that this action will not
Parts per FOR FURTHER INFORMATION CONTACT:
have a substantial direct effect on States Commodity million
or tribal governments, on the Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
relationship between the national
Environmental Protection Agency, 1200
government and the States or tribal * * * * *
Pomegranate .............................. 0.05 Pennsylvania Ave. NW., Washington,
governments, or on the distribution of
DC 20460–0001; main telephone
power and responsibilities among the
* * * * * number: (703) 305–7090; email address:
various levels of government or between
RDFRNotices@epa.gov.
the Federal Government and Indian
tribes. Thus, the Agency has determined * * * * * SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–31309 Filed 12–11–15; 8:45 am]
that Executive Order 13132, entitled I. General Information
BILLING CODE 6560–50–P
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175, A. Does this action apply to me?
entitled ‘‘Consultation and Coordination ENVIRONMENTAL PROTECTION You may be potentially affected by
with Indian Tribal Governments’’ (65 FR AGENCY this action if you are an agricultural
67249, November 9, 2000) do not apply producer, food manufacturer, or
to this action. In addition, this action 40 CFR Part 180 pesticide manufacturer. The following
does not impose any enforceable duty or list of North American Industrial
[EPA–HQ–OPP–2015–0451; FRL–9939–28]
contain any unfunded mandate as Classification System (NAICS) codes is
described under Title II of the Unfunded Polyamide Ester Polymers; Tolerance not intended to be exhaustive, but rather
Mandates Reform Act (UMRA) (2 U.S.C. Exemption provides a guide to help readers
1501 et seq.). determine whether this document
AGENCY: Environmental Protection applies to them. Potentially affected
This action does not involve any
Agency (EPA). entities may include:
technical standards that would require
ACTION: Final rule.
Agency consideration of voluntary • Crop production (NAICS code 111).
consensus standards pursuant to section SUMMARY: This regulation establishes an • Animal production (NAICS code
12(d) of the National Technology exemption from the requirement of a 112).
Transfer and Advancement Act tolerance for residues of several • Food manufacturing (NAICS code
(NTTAA) (15 U.S.C. 272 note). polyamide ester polymers as listed in 311).
VII. Congressional Review Act this final rule. Spring Trading Co. on • Pesticide manufacturing (NAICS
behalf of Croda, Inc. submitted a code 32532).
Pursuant to the Congressional Review petition to EPA under the Federal Food,
Act (5 U.S.C. 801 et seq.), EPA will Drug, and Cosmetic Act (FFDCA), B. How can I get electronic access to
requesting an exemption from the other related information?
submit a report containing this rule and
mstockstill on DSK4VPTVN1PROD with RULES
other required information to the U.S. requirement of a tolerance. This You may access a frequently updated
Senate, the U.S. House of regulation eliminates the need to electronic version of 40 CFR part 180
Representatives, and the Comptroller establish a maximum permissible level through the Government Printing
General of the United States prior to for residues of the listed chemicals on Office’s e-CFR site at http://
publication of the rule in the Federal food or feed commodities. www.ecfr.gov/cgi-bin/text-
Register. This action is not a ‘‘major DATES: This regulation is effective idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
rule’’ as defined by 5 U.S.C. 804(2). December 14, 2015. Objections and 40tab_02.tpl.
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![Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations 77263
and it is recognized as an international hydrogenated, polymers with neopentyl relationship between the national
food safety standards-setting glycol, stearyl alcohol and government and the States or tribal
organization in trade agreements to trimethylenediamine; fatty acids, C18- governments, or on the distribution of
which the United States is a party. EPA unsatd., dimers, polymers with 1- power and responsibilities among the
may establish a tolerance that is docosanol and trimethylenediamine; various levels of government or between
different from a Codex MRL; however, fatty acids, C18-unsatd., dimers, the Federal Government and Indian
FFDCA section 408(b)(4) requires that hydrogenated, polymers with 1- tribes. Thus, the Agency has determined
EPA explain the reasons for departing docosanol, hexamethylenediamine and that Executive Order 13132, entitled
from the Codex level. neopentyl glycol; and fatty acids, C18- ‘‘Federalism’’ (64 FR 43255, August 10,
The Codex has not established a MRL unsatd., dimers, polymers with 1999) and Executive Order 13175,
for fatty acids, C18-unsatd., dimers, docosanoic acid, 1,3-propanediol and entitled ‘‘Consultation and Coordination
polymers with ethylenediamine and sorbitol from the requirement of a with Indian Tribal Governments’’ (65 FR
stearyl alcohol; fatty acids, C18-unsatd., tolerance will be safe. 67249, November 9, 2000) do not apply
dimers, hydrogenated, polymers with to this action. In addition, this action
ethylenediamine, neopentyl glycol and X. Statutory and Executive Order
Reviews does not impose any enforceable duty or
stearyl alcohol; fatty acids, C18-unsatd., contain any unfunded mandate as
dimers, hydrogenated, polymers with This action establishes a tolerance described under Title II of the Unfunded
ethylenediamine and stearyl alcohol; under FFDCA section 408(d) in Mandates Reform Act (UMRA) (2 U.S.C.
fatty acids, C18-unsatd., dimers, response to a petition submitted to the 1501 et seq.).
polymers with 1-docosanol and Agency. The Office of Management and
This action does not involve any
ethylenediamine; fatty acids, C18- Budget (OMB) has exempted these types
of actions from review under Executive technical standards that would require
unsatd., dimers, polymers with cetyl
Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary
alcohol, neopentyl glycol and
Planning and Review’’ (58 FR 51735, consensus standards pursuant to section
trimethylenediamine; fatty acids, C18-
October 4, 1993). Because this action 12(d) of the National Technology
unsatd., dimers, polymers with
has been exempted from review under Transfer and Advancement Act
hexamethylenediamine and stearyl
Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note).
alcohol; fatty acids, C18-unsatd., dimers,
hydrogenated, polymers with cetyl not subject to Executive Order 13211, XI. Congressional Review Act
alcohol and ethylenediamine; fatty entitled ‘‘Actions Concerning
acids, C18-unsatd., dimers, Regulations That Significantly Affect Pursuant to the Congressional Review
hydrogenated, polymers with neopentyl Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will
glycol, stearyl alcohol and FR 28355, May 22, 2001) or Executive submit a report containing this rule and
trimethylenediamine; fatty acids, C18- Order 13045, entitled ‘‘Protection of other required information to the U.S.
unsatd., dimers, polymers with 1- Children from Environmental Health Senate, the U.S. House of
docosanol and trimethylenediamine; Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller
fatty acids, C18-unsatd., dimers, April 23, 1997). This action does not General of the United States prior to
hydrogenated, polymers with 1- contain any information collections publication of the rule in the Federal
docosanol, hexamethylenediamine and subject to OMB approval under the Register. This action is not a ‘‘major
neopentyl glycol; or fatty acids, C18- Paperwork Reduction Act (PRA) (44 rule’’ as defined by 5 U.S.C. 804(2).
unsatd., dimers, polymers with U.S.C. 3501 et seq.), nor does it require List of Subjects in 40 CFR Part 180
docosanoic acid, 1,3-propanediol and any special considerations under
sorbitol. Executive Order 12898, entitled Environmental protection,
‘‘Federal Actions to Address Administrative practice and procedure,
IX. Conclusion Agricultural commodities, Pesticides
Environmental Justice in Minority
Accordingly, EPA finds that Populations and Low-Income and pests, Reporting and recordkeeping
exempting residues of fatty acids, C18- Populations’’ (59 FR 7629, February 16, requirements.
unsatd., dimers, polymers with 1994). Dated: November 30, 2015.
ethylenediamine and stearyl alcohol; Since tolerances and exemptions that G. Jeffrey Herndon,
fatty acids, C18-unsatd., dimers, are established on the basis of a petition Director Registration Division, Office of
hydrogenated, polymers with under FFDCA section 408(d), such as Pesticide Programs.
ethylenediamine, neopentyl glycol and the tolerance in this final rule, do not
stearyl alcohol; fatty acids, C18-unsatd., require the issuance of a proposed rule, Therefore, 40 CFR chapter I is
dimers, hydrogenated, polymers with the requirements of the Regulatory amended as follows:
ethylenediamine and stearyl alcohol; Flexibility Act (RFA) (5 U.S.C. 601 et PART 180—[AMENDED]
fatty acids, C18-unsatd., dimers, seq.), do not apply.
polymers with 1-docosanol and This action directly regulates growers, ■ 1. The authority citation for part 180
ethylenediamine; fatty acids, C18- food processors, food handlers, and food continues to read as follows:
unsatd., dimers, polymers with cetyl retailers, not States or tribes, nor does
alcohol, neopentyl glycol and this action alter the relationships or Authority: 21 U.S.C. 321(q), 346a and 371.
trimethylenediamine; fatty acids, C18- distribution of power and ■ 2. In § 180.960, alphabetically add the
unsatd., dimers, polymers with responsibilities established by Congress following polymers to the table to read
hexamethylenediamine and stearyl in the preemption provisions of FFDCA as follows:
mstockstill on DSK4VPTVN1PROD with RULES
alcohol; fatty acids, C18-unsatd., dimers, section 408(n)(4). As such, the Agency
hydrogenated, polymers with cetyl has determined that this action will not § 180.960 Polymers; exemptions from the
alcohol and ethylenediamine; fatty have a substantial direct effect on States requirement of a tolerance.
acids, C18-unsatd., dimers, or tribal governments, on the * * * * *
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![77264 Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / Rules and Regulations
Polymer CAS No.
* * * * * * *
Fatty acids, C18-unsatd., dimers, polymers with ethylenediamine and stearyl alcohol, minimum number average molecular
weight (in amu) 1,400 ...................................................................................................................................................................... 363162–42–9
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with ethylenediamine, neopentyl glycol and stearyl alcohol, minimum
number average molecular weight (in amu) 1,400 .......................................................................................................................... 678991–29–2
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with ethylenediamine and stearyl alcohol, minimum number average
molecular weight (in amu) 1,400 ..................................................................................................................................................... 951153–32–5
Fatty acids, C18-unsatd., dimers, polymers with 1-docosanol and ethylenediamine, minimum number average molecular weight
(in amu) 1,400 .................................................................................................................................................................................. 1699751–19–3
Fatty acids, C18-unsatd., dimers, polymers with cetyl alcohol, neopentyl glycol and trimethylenediamine, minimum number aver-
age molecular weight (in amu) 1,400 .............................................................................................................................................. 1699751–23–9
Fatty acids, C18-unsatd., dimers, polymers with hexamethylenediamine and stearyl alcohol, minimum number average molecular
weight (in amu) 1,400 ...................................................................................................................................................................... 1699751–24–0
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with cetyl alcohol and ethylenediamine, minimum number average
molecular weight (in amu) 1,400 ..................................................................................................................................................... 1699751–25–1
Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with neopentyl glycol, stearyl alcohol and trimethylenediamine, min-
imum number average molecular weight (in amu) 1,400 ................................................................................................................ 1699751–28–4
Fatty acids, C18-unsatd., dimers, polymers with 1-docosanol and trimethylenediamine, minimum number average molecular
weight (in amu) 1,400 ...................................................................................................................................................................... 1699751–29–5
Fatty acids, C18-unsatd., dimers, polymers with 1-docosanol, hexamethylenediamine and neopentyl glycol, minimum number av-
erage molecular weight (in amu) 1,400 ........................................................................................................................................... 1699751–31–9
Fatty acids, C18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol, minimum number average molec-
ular weight (in amu) 1,400 ............................................................................................................................................................... 1685271–04–8
* * * * * * *
* * * * * determination criteria regarding and the Magnuson-Stevens Act to
[FR Doc. 2015–30924 Filed 12–11–15; 8:45 am] inseason adjustments and applies to provide U.S. fishing vessels with a
BILLING CODE 6560–50–P Atlantic tunas General category reasonable opportunity to harvest the
(commercial) permitted vessels and ICCAT-recommended quota.
Highly Migratory Species (HMS)
Inseason Transfer to the General
DEPARTMENT OF COMMERCE Charter/Headboat category permitted
Category
vessels when fishing commercially for
National Oceanic and Atmospheric BFT. Earlier this year, NMFS implemented
Administration a final rule that increased the U.S. BFT
DATES: The quota transfer is effective
quota and subquotas per ICCAT
January 1, 2016. The General category
50 CFR Part 635 Recommendation 14–05 (80 FR 52198,
retention limit adjustment is effective
August 28, 2015). The base quota for the
[Docket No. 150121066–5717–02] January 1, 2016, through March 31,
General category is 466.7 mt. See
2016.
§ 635.27(a). Each of the General category
RIN 0648–XE327 FOR FURTHER INFORMATION CONTACT: time periods (January, June through
Atlantic Highly Migratory Species; Sarah McLaughlin or Brad McHale, August, September, October through
Atlantic Bluefin Tuna Fisheries 978–281–9260. November, and December) is allocated a
SUPPLEMENTARY INFORMATION: portion of the annual General category
AGENCY: National Marine Fisheries Regulations implemented under the quota. Although it is called the
Service (NMFS), National Oceanic and authority of the Atlantic Tunas ‘‘January’’ subquota, the regulations
Atmospheric Administration (NOAA), Convention Act (ATCA; 16 U.S.C. 971 et allow the General category fishery under
Commerce. seq.) and the Magnuson-Stevens Fishery this quota to continue until the
ACTION: Temporary rule; inseason Conservation and Management Act subquota is reached or March 31,
General category bluefin tuna quota (Magnuson-Stevens Act; 16 U.S.C. 1801 whichever comes first. Based on the
transfer and retention limit adjustment. et seq.) governing the harvest of BFT by General category base quota of 466.7 mt,
persons and vessels subject to U.S. the subquotas for each time period are
SUMMARY: NMFS is transferring 24.3 jurisdiction are found at 50 CFR part as follows: 24.7 mt for January; 233.3 mt
metric tons (mt) of Atlantic bluefin tuna 635. Section 635.27 subdivides the U.S. for June through August; 123.7 mt for
(BFT) quota from the General category BFT quota recommended by the September; 60.7 mt for October through
December 2016 subquota period to the International Commission for the November; and 24.3 mt for December.
January 2016 subquota period (from Conservation of Atlantic Tunas (ICCAT) Any unused General category quota
January 1 through March 31, 2016, or among the various domestic fishing rolls forward within the fishing year,
until the available subquota for this categories, per the allocations which coincides with the calendar year,
period is reached, whichever comes established in the 2006 Consolidated from one time period to the next, and
mstockstill on DSK4VPTVN1PROD with RULES
first). NMFS also is adjusting the Highly Migratory Species Fishery is available for use in subsequent time
Atlantic tunas General category BFT Management Plan (2006 Consolidated periods.
daily retention limit for the January HMS FMP) (71 FR 58058, October 2,
2016 subquota period to three large 2006), as amended by Amendment 7 to Quota Transfer
medium or giant BFT from the default the 2006 Consolidated HMS FMP Under § 635.27(a)(9), NMFS has the
retention limit of one. This action is (Amendment 7) (79 FR 71510, December authority to transfer quota among
based on consideration of the regulatory 2, 2014). NMFS is required under ATCA fishing categories or subcategories, after
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Document Created: 2015-12-14 13:47:26
Document Modified: 2015-12-14 13:47:26
| 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 December 14, 2015. Objections and requests for hearings must be received on or before February 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). | |
| Contact | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 80 FR 77260 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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