80 FR 76640 - Polyester Polyol Polymers; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 237 (December 10, 2015)
Federal Register Volume 80, Issue 237 (December 10, 2015)
| Page Range | 76640-76644 | |
| FR Document | 2015-30510 |
[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)] [Rules and Regulations] [Pages 76640-76644] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30510] [[Page 76640]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0465; FRL-9936-91] Polyester Polyol 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 D-glucitol, polymer with decanedioic acid, octadecanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D- glucitol, polymer with decanedioic acid and 1,3-propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3- propanediol, octadecanoate; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; and fatty acids, C18 - unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol when used as inert ingredients in a pesticide chemical formulation. 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 D-glucitol, polymer with decanedioic acid, octadecanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-propanediol, docosanoate; D- glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; and fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol on food or feed commodities. DATES: This regulation is effective December 10, 2015. Objections and requests for hearings must be received on or before February 8, 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-2015-0465, 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: 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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. 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-2015-0465 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 8, 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-2015-0465, 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 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-10830) filed by Spring Trading Company, 203 Dogwood Trl., Magnolia, TX 77354 (on behalf of Croda, [[Page 76641]] 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 D-glucitol, polymer with decanedioic acid, octadecanoate (CAS Reg. No. 68562-93-6); D-glucitol, polymer with decanedioic acid, docosanoate (CAS Reg. No. 943440-33-3); D-glucitol, polymer with decanedioic acid, docosanoate (CAS Reg. No. 1681043-28-6); D-glucitol, polymer with decanedioic acid and 1,3- propanediol, docosanoate (CAS Reg. No. 1681043-31-1); D-glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate (CAS Reg. No. 1681043-33-3); fatty acids, C 18 -unsatd., dimers, polymers with docosanoic acid and sorbitol (CAS Reg. No. 1685270-83-0); fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and stearic acid (CAS Reg. No. 1685270-84-1); fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid (CAS Reg. No. 1685270-99-8); fatty acids, C18 - unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid (CAS Reg, No. 1685271-01-5); fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol (CAS Reg. No. 1685271-02-6); and fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol. 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). D-Glucitol, polymer with decanedioic acid, octadecanoate; D- glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with 1,3- propanediol, sorbitol and stearic acid; fatty acids, C18 - unsatd., dimers, polymers with docosanoic acid and sorbitol; and fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol conform to the definition of a polymer given in 40 CFR 723.250(b) and meet 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. 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. Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer's minimum number average molecular weight is greater 1,000 Daltons. The oligomer content is less than 10% (w/w) below a number average molecular weight of 500 and less than 25% (w/w) below a number average molecular weight of 1,000. Thus, D-glucitol, polymer with decanedioic acid, octadecanoate; D- glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with 1,3- propanediol, sorbitol and stearic acid; fatty acids, C18 - unsatd., dimers, polymers with docosanoic acid and sorbitol; 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 [[Page 76642]] 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 molecular weight of each of these polymers is 1,100 Daltons. Generally, polymers 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 that 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 do 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 D-glucitol, polymer with decanedioic acid, octadecanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D- glucitol, polymer with decanedioic acid and 1,3-propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3- propanediol, octadecanoate; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; and fatty acids, C18 - unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol. VIII. Other Considerations A. Existing Exemptions From a Tolerance There are no existing tolerance exemptions for this polymer. 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, 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 D-glucitol, polymer with decanedioic acid, octadecanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3- propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; and fatty acids, C18 - unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and sorbitol. IX. Conclusion Accordingly, EPA finds that exempting residues of D-glucitol, polymer with decanedioic acid, octadecanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3- propanediol, docosanoate; D-glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid, 1,3- propanediol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid; fatty acids, C18 -unsatd., dimers, polymers with docosanoic acid and sorbitol; 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 [[Page 76643]] 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 23, 2015. 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. 180.960, add alphabetically the polymers to the table to read as follows: Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * D-Glucitol, polymer with decanedioic acid, 943440-33-3 docosanoate, minimum number average molecular weight (in amu) 1,100....................................... D-Glucitol, polymer with decanedioic acid, 1681043-28-6 docosanoate, minimum number average molecular weight (in amu) 1,100....................................... D-Glucitol, polymer with decanedioic acid, 68562-93-6 octadecanoate, minimum number average molecular weight (in amu) 1,100................................ D-Glucitol, polymer with decanedioic acid and 1,3- 1681043-31-1 propanediol, minimum number average molecular weight (in amu) 1,100....................................... D-Glucitol, polymer with decanedioic acid and 1,3- 1681043-33-3 propanediol, octadecanoate, minimum number average molecular weight (in amu) 1,100...................... * * * * * * * Fatty acids, C18-unsatd., dimers, polymers with 1685270-83-0 docosanoic acid and sorbitol, minimum number average molecular weight (in amu) 1,100...................... Fatty acids, C18-unsatd., dimers, polymers with 1685271-02-6 docosenoic acid and sorbitol, minimum number average molecular weight (in amu) 1,100...................... Fatty acids, C18-unsatd., dimers, polymers with 1685271-04-8 docosenoic acid, 1,3-propanediol and sorbitol, minimum number average molecular weight (in amu) 1,100................................................ Fatty acids, C18-unsatd., dimers, polymers with 1685270-84-1 docosanoic acid, 1,3-propanediol and stearic acid, minimum number average molecular weight (in amu) 1,100................................................ Fatty acids, C18-unsatd., dimers, polymers with 1,3- 1685271-01-5 propanediol, sorbitol and stearic acid............... Fatty acids, C18-unsatd., dimers, polymers with 1685270-99-8 sorbitol and stearic acid, minimum number average molecular weight (in amu) 1,100...................... * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2015-30510 Filed 12-9-15; 8:45 am] BILLING CODE 6560-50-P
![76640 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Rules and Regulations
ENVIRONMENTAL PROTECTION 1,3-propanediol and sorbitol on food or idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
AGENCY feed commodities. 40tab_02.tpl.
DATES: This regulation is effective C. Can I file an objection or hearing
40 CFR Part 180 December 10, 2015. Objections and request?
[EPA–HQ–OPP–2015–0465; FRL–9936–91] requests for hearings must be received
on or before February 8, 2016, and must Under FFDCA section 408(g), 21
Polyester Polyol Polymers; Tolerance be filed in accordance with the U.S.C. 346a, any person may file an
Exemption instructions provided in 40 CFR part objection to any aspect of this regulation
178 (see also Unit I.C. of the and may also request a hearing on those
AGENCY: Environmental Protection objections. You must file your objection
SUPPLEMENTARY INFORMATION).
Agency (EPA). or request a hearing on this regulation
ADDRESSES: The docket for this action,
ACTION: Final rule. in accordance with the instructions
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0465, is provided in 40 CFR part 178. To ensure
SUMMARY: This regulation establishes an
available at http://www.regulations.gov proper receipt by EPA, you must
exemption from the requirement of a
or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
tolerance for residues of D-glucitol,
Regulatory Public Docket (OPP Docket) OPP–2015–0465 in the subject line on
polymer with decanedioic acid,
in the Environmental Protection Agency the first page of your submission. All
octadecanoate; D-glucitol, polymer with
Docket Center (EPA/DC), West William objections and requests for a hearing
decanedioic acid, docosanoate; D-
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
glucitol, polymer with decanedioic acid,
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
docosanoate; D-glucitol, polymer with
20460–0001. The Public Reading Room before February 8, 2016. Addresses for
decanedioic acid and 1,3-propanediol,
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections
docosanoate; D-glucitol, polymer with
decanedioic acid and 1,3-propanediol, Monday through Friday, excluding legal and hearing requests are provided in 40
octadecanoate; fatty acids, C18-unsatd., holidays. The telephone number for the CFR 178.25(b).
In addition to filing an objection or
dimers, polymers with docosanoic acid Public Reading Room is (202) 566–1744,
hearing request with the Hearing Clerk
and sorbitol; fatty acids, C18-unsatd., and the telephone number for the OPP
as described in 40 CFR part 178, please
dimers, polymers with docosanoic acid, Docket is (703) 305–5805. Please review
submit a copy of the filing (excluding
1,3-propanediol and stearic acid; fatty the visitor instructions and additional
any Confidential Business Information
acids, C18-unsatd., dimers, polymers information about the docket available
(CBI)) for inclusion in the public docket.
with sorbitol and stearic acid; fatty at http://www.epa.gov/dockets.
Information not marked confidential
acids, C18-unsatd., dimers, polymers FOR FURTHER INFORMATION CONTACT:
pursuant to 40 CFR part 2 may be
with 1,3-propanediol, sorbitol and Susan Lewis, Registration Division disclosed publicly by EPA without prior
stearic acid; fatty acids, C18-unsatd., (7505P), Office of Pesticide Programs, notice. Submit the non-CBI copy of your
dimers, polymers with docosanoic acid Environmental Protection Agency, 1200 objection or hearing request, identified
and sorbitol; and fatty acids, C18- Pennsylvania Ave. NW., Washington, by docket ID number EPA–HQ–OPP–
unsatd., dimers, polymers with DC 20460–0001; main telephone 2015–0465, by one of the following
docosanoic acid, 1,3-propanediol and number: (703) 305–7090; email address: methods.
sorbitol when used as inert ingredients RDFRNotices@epa.gov. • Federal eRulemaking Portal: http://
in a pesticide chemical formulation. SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
Spring Trading Co., on behalf of Croda instructions for submitting comments.
Inc., submitted a petition to EPA under I. General Information
Do not submit electronically any
the Federal Food, Drug, and Cosmetic A. Does this action apply to me? information you consider to be CBI or
Act (FFDCA), requesting an exemption other information whose disclosure is
You may be potentially affected by
from the requirement of a tolerance. restricted by statute.
this action if you are an agricultural
This regulation eliminates the need to • Mail: OPP Docket, Environmental
producer, food manufacturer, or
establish a maximum permissible level Protection Agency Docket Center (EPA/
pesticide manufacturer. The following
for residues of D-glucitol, polymer with DC), (28221T), 1200 Pennsylvania Ave.
list of North American Industrial
decanedioic acid, octadecanoate; D- NW., Washington, DC 20460–0001.
Classification System (NAICS) codes is
glucitol, polymer with decanedioic acid, • Hand Delivery: To make special
not intended to be exhaustive, but rather
docosanoate; D-glucitol, polymer with arrangements for hand delivery or
provides a guide to help readers
decanedioic acid, docosanoate; D- delivery of boxed information, please
determine whether this document
glucitol, polymer with decanedioic acid follow the instructions at http://
applies to them. Potentially affected
and 1,3-propanediol, docosanoate; D- www.epa.gov/dockets/contacts.html.
entities may include:
glucitol, polymer with decanedioic acid • Crop production (NAICS code 111). Additional instructions on
and 1,3-propanediol, octadecanoate; • Animal production (NAICS code commenting or visiting the docket,
fatty acids, C18-unsatd., dimers, 112). along with more information about
polymers with docosanoic acid and • Food manufacturing (NAICS code dockets generally, is available at
sorbitol; fatty acids, C18-unsatd., dimers, 311). http://www.epa.gov/dockets.
polymers with docosanoic acid, 1,3- • Pesticide manufacturing (NAICS
propanediol and stearic acid; fatty acids, II. Background and Statutory Findings
code 32532).
C18-unsatd., dimers, polymers with In the Federal Register of August 26,
sorbitol and stearic acid; fatty acids, C18- B. How can I get electronic access to 2015 (80 FR 51763) (FRL–9931–74),
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unsatd., dimers, polymers with 1,3- other related information? EPA issued a document pursuant to
propanediol, sorbitol and stearic acid; You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
fatty acids, C18-unsatd., dimers, electronic version of 40 CFR part 180 announcing the receipt of a pesticide
polymers with docosanoic acid and through the Government Printing petition (PP IN–10830) filed by Spring
sorbitol; and fatty acids, C18-unsatd., Office’s e-CFR site at http:// Trading Company, 203 Dogwood Trl.,
dimers, polymers with docosanoic acid, www.ecfr.gov/cgi-bin/text- Magnolia, TX 77354 (on behalf of Croda,
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![Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Rules and Regulations 76643
Executive Order 12866, this action is in the preemption provisions of FFDCA submit a report containing this rule and
not subject to Executive Order 13211, section 408(n)(4). As such, the Agency other required information to the U.S.
entitled ‘‘Actions Concerning has determined that this action will not Senate, the U.S. House of
Regulations That Significantly Affect have a substantial direct effect on States Representatives, and the Comptroller
Energy Supply, Distribution, or Use’’ (66 or tribal governments, on the General of the United States prior to
FR 28355, May 22, 2001) or Executive relationship between the national publication of the rule in the Federal
Order 13045, entitled ‘‘Protection of government and the States or tribal Register. This action is not a ‘‘major
Children from Environmental Health governments, or on the distribution of rule’’ as defined by 5 U.S.C. 804(2).
Risks and Safety Risks’’ (62 FR 19885, power and responsibilities among the
April 23, 1997). This action does not various levels of government or between List of Subjects in 40 CFR Part 180
contain any information collections the Federal Government and Indian Environmental protection,
subject to OMB approval under the tribes. Thus, the Agency has determined Administrative practice and procedure,
Paperwork Reduction Act (PRA) (44 that Executive Order 13132, entitled Agricultural commodities, Pesticides
U.S.C. 3501 et seq.), nor does it require ‘‘Federalism’’ (64 FR 43255, August 10, and pests, Reporting and recordkeeping
any special considerations under 1999) and Executive Order 13175, requirements.
Executive Order 12898, entitled entitled ‘‘Consultation and Coordination
‘‘Federal Actions to Address with Indian Tribal Governments’’ (65 FR Dated: November 23, 2015.
Environmental Justice in Minority 67249, November 9, 2000) do not apply Susan Lewis,
Populations and Low-Income to this action. In addition, this action Director, Registration Division, Office of
Populations’’ (59 FR 7629, February 16, does not impose any enforceable duty or Pesticide Programs.
1994). contain any unfunded mandate as Therefore, 40 CFR chapter I is
Since tolerances and exemptions that described under Title II of the Unfunded amended as follows:
are established on the basis of a petition Mandates Reform Act (UMRA) (2 U.S.C.
under FFDCA section 408(d), such as 1501 et seq.). PART 180—[AMENDED]
the tolerance in this final rule, do not This action does not involve any
require the issuance of a proposed rule, technical standards that would require ■ 1. The authority citation for part 180
the requirements of the Regulatory Agency consideration of voluntary continues to read as follows:
Flexibility Act (RFA) (5 U.S.C. 601 et consensus standards pursuant to section
seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
12(d) of the National Technology
This action directly regulates growers, Transfer and Advancement Act ■ 2. In § 180.960, add alphabetically the
food processors, food handlers, and food (NTTAA) (15 U.S.C. 272 note). polymers to the table to read as follows:
retailers, not States or tribes, nor does
this action alter the relationships or XI. Congressional Review Act § 180.960 Polymers; exemptions from the
distribution of power and Pursuant to the Congressional Review requirement of a tolerance.
responsibilities established by Congress Act (5 U.S.C. 801 et seq.), EPA will * * * * *
Polymer CAS No.
* * * * * * *
D-Glucitol, polymer with decanedioic acid, docosanoate, minimum number average molecular weight (in amu) 1,100 .............. 943440–33–3
D-Glucitol, polymer with decanedioic acid, docosanoate, minimum number average molecular weight (in amu) 1,100 .............. 1681043–28–6
D-Glucitol, polymer with decanedioic acid, octadecanoate, minimum number average molecular weight (in amu) 1,100 ........... 68562–93–6
D-Glucitol, polymer with decanedioic acid and 1,3-propanediol, minimum number average molecular weight (in amu) 1,100 .... 1681043–31–1
D-Glucitol, polymer with decanedioic acid and 1,3-propanediol, octadecanoate, minimum number average molecular weight
(in amu) 1,100 .............................................................................................................................................................................. 1681043–33–3
* * * * * * *
Fatty acids, C18-unsatd., dimers, polymers with docosanoic acid and sorbitol, minimum number average molecular weight (in
amu) 1,100 ................................................................................................................................................................................... 1685270–83–0
Fatty acids, C18-unsatd., dimers, polymers with docosenoic acid and sorbitol, minimum number average molecular weight (in
amu) 1,100 ................................................................................................................................................................................... 1685271–02–6
Fatty acids, C18-unsatd., dimers, polymers with docosenoic acid, 1,3-propanediol and sorbitol, minimum number average mo-
lecular weight (in amu) 1,100 ...................................................................................................................................................... 1685271–04–8
Fatty acids, C18-unsatd., dimers, polymers with docosanoic acid, 1,3-propanediol and stearic acid, minimum number average
molecular weight (in amu) 1,100 ................................................................................................................................................. 1685270–84–1
Fatty acids, C18-unsatd., dimers, polymers with 1,3-propanediol, sorbitol and stearic acid ........................................................... 1685271–01–5
Fatty acids, C18-unsatd., dimers, polymers with sorbitol and stearic acid, minimum number average molecular weight (in amu)
1,100 ............................................................................................................................................................................................ 1685270–99–8
* * * * * * *
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[FR Doc. 2015–30510 Filed 12–9–15; 8:45 am]
BILLING CODE 6560–50–P
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![76644 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Rules and Regulations
DEPARTMENT OF HOMELAND and Mitigation Administration, Federal Act, 5 U.S.C. 601–612, a regulatory
SECURITY Emergency Management Agency, 500 C flexibility analysis is not required.
Street SW., Washington, DC 20472, Regulatory Classification. This final
Federal Emergency Management (202) 646–4064, or (email) rule is not a significant regulatory action
Agency Luis.Rodriguez3@fema.dhs.gov. under the criteria of section 3(f) of
SUPPLEMENTARY INFORMATION: The Executive Order 12866 of September 30,
44 CFR Part 67 1993, Regulatory Planning and Review,
Federal Emergency Management Agency
[Docket ID FEMA–2015–0001] (FEMA) makes the final determinations 58 FR 51735.
listed below for the modified BFEs for Executive Order 13132, Federalism.
Final Flood Elevation Determinations each community listed. These modified This final rule involves no policies that
elevations have been published in have federalism implications under
AGENCY: Federal Emergency Executive Order 13132.
Management Agency, DHS. newspapers of local circulation and
ninety (90) days have elapsed since that Executive Order 12988, Civil Justice
ACTION: Final rule. Reform. This final rule meets the
publication. The Deputy Associate
Administrator for Mitigation has applicable standards of Executive Order
SUMMARY: Base (1% annual-chance)
resolved any appeals resulting from this 12988.
Flood Elevations (BFEs) and modified
BFEs are made final for the notification. List of Subjects in 44 CFR Part 67
communities listed below. The BFEs This final rule is issued in accordance Administrative practice and
and modified BFEs are the basis for the with section 110 of the Flood Disaster procedure, Flood insurance, Reporting
floodplain management measures that Protection Act of 1973, 42 U.S.C. 4104, and recordkeeping requirements.
each community is required either to and 44 CFR part 67. FEMA has
adopt or to show evidence of being developed criteria for floodplain Dated: November 18, 2015.
already in effect in order to qualify or management in floodprone areas in Roy E. Wright,
remain qualified for participation in the accordance with 44 CFR part 60. Deputy Associate Administrator for Insurance
National Flood Insurance Program and Mitigation, Department of Homeland
Interested lessees and owners of real
(NFIP). Security, Federal Emergency Management
property are encouraged to review the Agency.
DATES: The date of issuance of the Flood proof Flood Insurance Study and FIRM
Insurance Rate Map (FIRM) showing available at the address cited below for Accordingly, 44 CFR part 67 is
BFEs and modified BFEs for each each community. The BFEs and amended as follows:
community. This date may be obtained modified BFEs are made final in the
communities listed below. Elevations at PART 67—[AMENDED]
by contacting the office where the maps
are available for inspection as indicated selected locations in each community ■ 1. The authority citation for part 67
in the table below. are shown. continues to read as follows:
ADDRESSES: The final BFEs for each National Environmental Policy Act.
Authority: 42 U.S.C. 4001 et seq.;
community are available for inspection This final rule is categorically excluded Reorganization Plan No. 3 of 1978, 3 CFR,
at the office of the Chief Executive from the requirements of 44 CFR part 1978 Comp., p. 329; E.O. 12127, 44 FR 19367,
Officer of each community. The 10, Environmental Consideration. An 3 CFR, 1979 Comp., p. 376.
respective addresses are listed in the environmental impact assessment has
table below. not been prepared. § 67.11 [Amended]
FOR FURTHER INFORMATION CONTACT: Luis Regulatory Flexibility Act. As flood ■ 2. The tables published under the
Rodriguez, Chief, Engineering elevation determinations are not within authority of § 67.11 are amended as
Management Branch, Federal Insurance the scope of the Regulatory Flexibility follows:
* Elevation in feet
(NGVD)
+ Elevation in feet
(NAVD) Communities
Flooding source(s) Location of referenced elevation # Depth in feet affected
above ground
∧ Elevation in
meters (MSL)
Modified
Montgomery County, Pennsylvania (All Jurisdictions)
Docket No.: FEMA–B–1175
Blair Mill Run ............................ At the Pennypack Creek confluence ................................... +211 Borough of Hatboro, Town-
ship of Horsham, Town-
ship of Upper Moreland.
At the downstream side of County Line Road .................... +261
Blair Mill Run Tributary ............. At the upstream side of West Monument Avenue .............. +228 Borough of Hatboro.
At the downstream side of East County Line Road ........... +252
Huntingdon Valley Creek .......... Approximately 800 feet downstream of Red Lion Road ..... +120 Borough of Bryn Athyn,
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Township of Lower
Moreland.
Approximately 0.9 mile upstream of Byberry Road ............ +267
Meadow Brook .......................... At the Pennypack Creek confluence ................................... +118 Township of Abington, Town-
ship of Lower Moreland.
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Document Created: 2015-12-14 13:29:35
Document Modified: 2015-12-14 13:29:35
| 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 10, 2015. Objections and requests for hearings must be received on or before February 8, 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 76640 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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