2,5-Furandione, polymer With ethenylbenzene, Reaction Products With polyethylene-polypropylene glycol 2-aminopropyl Me ether; Tolerance Exemption, 78748-78751 [2013-31108]

Download as PDF 78748 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations tkelley on DSK3SPTVN1PROD with RULES 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 final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (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 of 1995 (NTTAA) (15 U.S.C. 272 note). V. 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, VerDate Mar<15>2010 18:49 Dec 26, 2013 Jkt 232001 Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 19, 2013. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. § 180.430 [Amended] 2. In § 180.430, in the table to paragraph (b), amend the entries for grass, forage and grass, hay by revising the expiration dates ‘‘12/31/13’’ to read ‘‘12/31/16.’’ ■ § 180.434 [Amended] 3. In § 180.434, in the table to paragraph (b), amend the entry for avocado by revising the expiration date ‘‘12/31/13’’ to read ‘‘12/31/16.’’ ■ § 180.517 [Amended] 4. In § 180.517, in the table to paragraph (b), amend the entries for rutabaga and turnip by revising the expiration dates ‘‘12/31/13’’ to read ‘‘12/ 31/16.’’ ■ § 180.572 [Amended] 5. In § 180.572, in the table to paragraph (b), amend the entries for timothy, forage and timothy, hay by revising the expiration dates ‘‘12/31/13’’ to read ‘‘12/31/16.’’ ■ [FR Doc. 2013–30877 Filed 12–26–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2013–0540; FRL–9902–90] 2,5-Furandione, polymer With ethenylbenzene, Reaction Products With polyethylene-polypropylene glycol 2-aminopropyl Me ether; Tolerance Exemption Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylenepolypropylene glycol 2-aminopropyl Me ether; minimum number average SUMMARY: PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 molecular weight (in amu), 14,000 (CASRN 162568–32–3); when used as an inert ingredient in a pesticide chemical formulation. Huntsman Corp. 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 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2-aminopropyl Me ether on food or feed commodities. DATES: This regulation is effective December 27, 2013. Objections and requests for hearings must be received on or before February 25, 2014, 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–2013–0540, 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), EPA West 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: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; 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). E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations • 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:// ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. tkelley on DSK3SPTVN1PROD with RULES 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–2013–0540 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 25, 2014. 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 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 nonCBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP–2013–0540, 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 Confidential Business Information (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. VerDate Mar<15>2010 18:49 Dec 26, 2013 Jkt 232001 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 September 12, 2013 (78 FR 56187) (FRL–9399–7), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (IN– 10607) filed by Huntsman Corp., 8600 Gosling Rd., The Woodlands, TX 77381. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylenepolypropylene glycol 2-aminopropyl Me ether. That notice included a summary of the petition prepared by the petitioner and solicited comments on the petitioner’s request. The Agency did not receive any comments. 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 PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 78749 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). 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2-aminopropyl Me ether conforms 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. 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 E:\FR\FM\27DER1.SGM 27DER1 78750 Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations consisting of a CF3- or longer chain length as specified in 40 CFR 723.250(d)(6). Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 8. The polymer’s number average MW is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. Thus, 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2aminopropyl Me ether meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2-aminopropyl Me ether. tkelley on DSK3SPTVN1PROD with RULES IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2,5furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2aminopropyl Me ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2-aminopropyl Me ether is 14,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2,5furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2aminopropyl Me ether 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.’’ VerDate Mar<15>2010 18:49 Dec 26, 2013 Jkt 232001 EPA has not found 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylenepolypropylene glycol 2-aminopropyl Me ether to share a common mechanism of toxicity with any other substances, and 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2aminopropyl Me ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2-aminopropyl Me ether 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 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2aminopropyl Me ether, 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 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2-aminopropyl Me ether. VIII. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylene-polypropylene glycol 2aminopropyl Me ether. IX. Conclusion Accordingly, EPA finds that exempting residues of 2,5-furandione, polymer with ethenylbenzene, reaction products with polyethylenepolypropylene glycol 2-aminopropyl Me ether from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This final rule 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 rules from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant E:\FR\FM\27DER1.SGM 27DER1 tkelley on DSK3SPTVN1PROD with RULES Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Rules and Regulations to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note). 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 final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of 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, or otherwise have any unique impacts on local governments. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). Although this action does not 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), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or lowincome populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this VerDate Mar<15>2010 18:49 Dec 26, 2013 Jkt 232001 78751 document, compared to the general population. DEPARTMENT OF HEALTH AND HUMAN SERVICES XI. Congressional Review Act Centers for Medicare & Medicaid Services 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: December 17, 2013. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.960, in the table, alphabetically add the following polymer before the entry for ‘‘Hexadecyl acrylate-acrylic acid copolymer * * *’’ to read as follows: ■ § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Polymer CAS No. * * * 2,5-Furandione, polymer with ethenylbenzene, reaction products with polyethylenepolypropylene glycol 2aminopropyl Me ether; minimum number average molecular weight (in amu), 14,000 ............................... * * * * * 162568–32–3 * BILLING CODE 6560–50–P Frm 00059 Fmt 4700 [CMS–1454–F] RIN 0938–AR70 Medicare Program; Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records Arrangements Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. AGENCY: This final rule revises the exception to the physician self-referral law that permits certain arrangements involving the donation of electronic health records items and services. Specifically, this final rule extends the expiration date of the exception to December 31, 2021, excludes laboratory companies from the types of entities that may donate electronic health records items and services, updates the provision under which electronic health records software is deemed interoperable, removes the electronic prescribing capability requirement, and clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services. DATES: With the exception of the amendment to § 411.357(w)(13), this regulation is effective on March 27, 2014. The amendment to § 411.357(w)(13) is effective on December 31, 2013. FOR FURTHER INFORMATION CONTACT: Lisa Ohrin, (410) 786–8852. SUPPLEMENTARY INFORMATION: SUMMARY: I. Executive Summary A. Purpose of the Regulatory Action * [FR Doc. 2013–31108 Filed 12–26–13; 8:45 am] PO 00000 42 CFR Part 411 Sfmt 4700 Section 1877 of the Social Security Act (the Act), codified at 42 U.S.C. 1395nn, also known as the physician self-referral statute: (1) prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership interest or compensation arrangement), unless the requirements of an exception are satisfied; and (2) prohibits the entity from submitting claims to Medicare for those referred services, unless the requirements of an E:\FR\FM\27DER1.SGM 27DER1

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[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78748-78751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31108]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0540; FRL-9902-90]


2,5-Furandione, polymer With ethenylbenzene, Reaction Products 
With polyethylene-polypropylene glycol 2-aminopropyl Me ether; 
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 2,5-furandione, polymer with 
ethenylbenzene, reaction products with polyethylene-polypropylene 
glycol 2-aminopropyl Me ether; minimum number average molecular weight 
(in amu), 14,000 (CASRN 162568-32-3); when used as an inert ingredient 
in a pesticide chemical formulation. Huntsman Corp. 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 2,5-furandione, polymer with ethenylbenzene, reaction 
products with polyethylene-polypropylene glycol 2-aminopropyl Me ether 
on food or feed commodities.

DATES: This regulation is effective December 27, 2013. Objections and 
requests for hearings must be received on or before February 25, 2014, 
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-2013-0540, 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), EPA West 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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).

[[Page 78749]]

     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://ecfr.gpoaccess.gov/cgi/t/text/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-2013-0540 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 25, 2014. 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 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-2013-0540, 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 Confidential Business 
Information (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 September 12, 2013 (78 FR 56187) (FRL-
9399-7), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (IN-10607) filed 
by Huntsman Corp., 8600 Gosling Rd., The Woodlands, TX 77381. The 
petition requested that 40 CFR 180.960 be amended by establishing an 
exemption from the requirement of a tolerance for residues of 2,5-
furandione, polymer with ethenylbenzene, reaction products with 
polyethylene-polypropylene glycol 2-aminopropyl Me ether. That notice 
included a summary of the petition prepared by the petitioner and 
solicited comments on the petitioner's request. The Agency did not 
receive any comments.
    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). 2,5-furandione, polymer with 
ethenylbenzene, reaction products with polyethylene-polypropylene 
glycol 2-aminopropyl Me ether conforms 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.
    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

[[Page 78750]]

consisting of a CF3- or longer chain length as specified in 40 CFR 
723.250(d)(6).
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    8. The polymer's number average MW is greater than or equal to 
10,000 daltons. The polymer contains less than 2% oligomeric material 
below MW 500 and less than 5% oligomeric material below MW 1,000.
    Thus, 2,5-furandione, polymer with ethenylbenzene, reaction 
products with polyethylene-polypropylene glycol 2-aminopropyl Me ether 
meets the criteria for a polymer to be considered low risk under 40 CFR 
723.250. Based on its conformance to the criteria in this unit, no 
mammalian toxicity is anticipated from dietary, inhalation, or dermal 
exposure to 2,5-furandione, polymer with ethenylbenzene, reaction 
products with polyethylene-polypropylene glycol 2-aminopropyl Me ether.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that 2,5-furandione, polymer with 
ethenylbenzene, reaction products with polyethylene-polypropylene 
glycol 2-aminopropyl Me ether could be present in all raw and processed 
agricultural commodities and drinking water, and that non-occupational 
non-dietary exposure was possible. The number average MW of 2,5-
furandione, polymer with ethenylbenzene, reaction products with 
polyethylene-polypropylene glycol 2-aminopropyl Me ether is 14,000 
daltons. Generally, a polymer of this size would be poorly absorbed 
through the intact gastrointestinal tract or through intact human skin. 
Since 2,5-furandione, polymer with ethenylbenzene, reaction products 
with polyethylene-polypropylene glycol 2-aminopropyl Me ether 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 2,5-furandione, polymer with ethenylbenzene, 
reaction products with polyethylene-polypropylene glycol 2-aminopropyl 
Me ether to share a common mechanism of toxicity with any other 
substances, and 2,5-furandione, polymer with ethenylbenzene, reaction 
products with polyethylene-polypropylene glycol 2-aminopropyl Me ether 
does not appear to produce a toxic metabolite produced by other 
substances. For the purposes of this tolerance action, therefore, EPA 
has assumed that 2,5-furandione, polymer with ethenylbenzene, reaction 
products with polyethylene-polypropylene glycol 2-aminopropyl Me ether 
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 2,5-furandione, polymer 
with ethenylbenzene, reaction products with polyethylene-polypropylene 
glycol 2-aminopropyl Me ether, 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 2,5-furandione, polymer with 
ethenylbenzene, reaction products with polyethylene-polypropylene 
glycol 2-aminopropyl Me ether.

VIII. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to 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 2,5-furandione, polymer 
with ethenylbenzene, reaction products with polyethylene-polypropylene 
glycol 2-aminopropyl Me ether.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2,5-furandione, 
polymer with ethenylbenzene, reaction products with polyethylene-
polypropylene glycol 2-aminopropyl Me ether from the requirement of a 
tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule 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 rules from review under 
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 
FR 51735, October 4, 1993). Because this final rule has been exempted 
from review under Executive Order 12866, this final rule is not subject 
to Executive Order 13211, entitled ``Actions Concerning Regulations 
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it involve any 
technical standards that would require Agency consideration of 
voluntary consensus standards pursuant

[[Page 78751]]

to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
    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 final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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, or otherwise have any unique 
impacts on local governments. Thus, the Agency has determined that 
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 
1999) and Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000) do not apply to this final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (2 U.S.C. 1501 et seq.).
    Although this action does not 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), EPA seeks to achieve 
environmental justice, the fair treatment and meaningful involvement of 
any group, including minority and/or low-income populations, in the 
development, implementation, and enforcement of environmental laws, 
regulations, and policies. As such, to the extent that information is 
publicly available or was submitted in comments to EPA, the Agency 
considered whether groups or segments of the population, as a result of 
their location, cultural practices, or other factors, may have atypical 
or disproportionately high and adverse human health impacts or 
environmental effects from exposure to the pesticide discussed in this 
document, compared to the general population.

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: December 17, 2013.
Lois Rossi,
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, in the table, alphabetically add the following 
polymer before the entry for ``Hexadecyl acrylate-acrylic acid 
copolymer * * *'' to read as follows:


Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------
 
                                * * * * *
2,5-Furandione, polymer with ethenylbenzene, reaction        162568-32-3
 products with polyethylene-polypropylene glycol 2-
 aminopropyl Me ether; minimum number average molecular
 weight (in amu), 14,000................................
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2013-31108 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P