Oxirane, Phenyl, Polymer With Oxirane, Monooctyl Ether; Tolerance Exemption, 71676-71679 [2014-28384]

Download as PDF 71676 Federal Register / Vol. 79, No. 232 / Wednesday, December 3, 2014 / Rules and Regulations compliance year (originally 2013 and now 2016). In these cases, the EPA will re-vintage the previously recorded 2012 and 2013 allowances into 2015 and 2016 allowances, respectively, consistent with the Court’s order tolling CSAPR’s compliance deadlines. The EPA will then record adjustments as needed to bring the re-vintaged, previously recorded allocations up to the 2015 and 2016 allocations described in this NODA. Allowance tracking system accounts will be briefly frozen while the re-vintaging and adjustments are carried out. List of Subjects 40 CFR Part 97 Environmental protection, Administrative practice and procedure, Air pollution control, Electric power plants, Nitrogen oxides, Reporting and recordkeeping requirements, Sulfur dioxide. Dated: November 21, 2014. Reid P. Harvey, Director, Clean Air Markets Division. [FR Doc. 2014–28281 Filed 12–2–14; 8:45 am] BILLING CODE 6560–50–P 40 CFR Part 180 [EPA–HQ–OPP–2014–0682; FRL–9918–41] Oxirane, Phenyl, Polymer With Oxirane, Monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl ether; when used as an inert ingredient in a pesticide chemical formulation. Envonik Corporation 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 oxirane, phenyl, polymer with oxirane, monooctyl ether on food or feed commodities. DATES: This regulation is effective December 3, 2014. Objections and requests for hearings must be received on or before February 2, 2015, and must be filed in accordance with the instructions provided in 40 CFR part tkelley on DSK3SPTVN1PROD with RULES VerDate Sep<11>2014 16:13 Dec 02, 2014 Jkt 235001 The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0682, 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 (RD) (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: ADDRESSES: I. General Information ENVIRONMENTAL PROTECTION AGENCY SUMMARY: 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at http:// www.ecfr.gov/cgi-bin/textidx?&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 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 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–2014–0682 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 2, 2015. 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– 2014–0682, 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 October 15, 2014 (79 FR 61844) (FRL–9917–24), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN–10751) filed by Envonik Corporation, P.O. Box 1299, Hopewell, VA 23860. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of oxirane, phenyl, polymer with oxirane, monooctyl ether; 83653–00–3. That document included a summary of the petition prepared by the petitioner and solicited comments on the E:\FR\FM\03DER1.SGM 03DER1 Federal Register / Vol. 79, No. 232 / Wednesday, December 3, 2014 / Rules and Regulations tkelley on DSK3SPTVN1PROD with RULES petitioner’s request. One comment was received for a notice of filing from a private citizen. 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, VerDate Sep<11>2014 16:13 Dec 02, 2014 Jkt 235001 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). Oxirane, phenyl, polymer with oxirane, monooctyl ether; 83653– 00–3 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 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 of 1,200 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, oxirane, phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl ether. PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 71677 IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that oxirane, phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl ether is 1,200 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since oxirane, phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl ether to share a common mechanism of toxicity with any other substances, and oxirane, phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl 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 E:\FR\FM\03DER1.SGM 03DER1 71678 Federal Register / Vol. 79, No. 232 / Wednesday, December 3, 2014 / Rules and Regulations children. Due to the expected low toxicity of oxirane, phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl 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. tkelley on DSK3SPTVN1PROD with RULES 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 oxirane, phenyl, polymer with oxirane, monooctyl ether. C. Comments One comment was received for a notice of filing from a private citizen who opposed any pesticide product that leaves a residue above 0.00. The Agency understands the commenter’s concerns and recognizes that some individuals believe that no residue of pesticides should be allowed. However, under the existing legal framework provided by FFDCA section 408, EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets VerDate Sep<11>2014 16:13 Dec 02, 2014 Jkt 235001 the safety standard imposed by the statute. IX. Conclusion Accordingly, EPA finds that exempting residues of oxirane, phenyl, polymer with oxirane, monooctyl ether from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children From Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 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 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). 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 24, 2014. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.960, alphabetically add the following polymer to the table to read as follows: ■ § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Polymer CAS No. * * * * * Oxirane, phenyl, polymer with oxirane, monooctyl ether, minimum average molecular weight (in amu) 1,200 ........... 83653–00–3 * E:\FR\FM\03DER1.SGM * 03DER1 * * * Federal Register / Vol. 79, No. 232 / Wednesday, December 3, 2014 / Rules and Regulations [FR Doc. 2014–28384 Filed 12–2–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA–HQ–SFUND–2001–0002; FRL–9920– 08–Region–2] National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Consolidated Iron and Metal Superfund Site AGENCY: Environmental Protection Agency. ACTION: Final rule. The Environmental Protection Agency (EPA), Region 2, announces the deletion of the Consolidated Iron and Metal Superfund Site (Site) located in the City of Newburgh, Orange County, New York, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of New York, through the New York State Department of Environmental Conservation (NYSDEC), have determined that all appropriate response actions under CERCLA, other than operation, maintenance, and fiveyear reviews, have been completed. However, this deletion does not preclude future actions under Superfund. DATES: This action is effective on December 3, 2014. ADDRESSES: Docket: EPA has established a docket for this action under Docket Identification No. EPA–HQ–SFUND– 2001–0002. All documents in the docket are listed on the http:// www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http:// www.regulations.gov or in hard copy at the Site information repositories. Locations, contacts, phone numbers and viewing hours are: U.S. Environmental Protection Agency, Region 2, Superfund tkelley on DSK3SPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 16:13 Dec 02, 2014 Jkt 235001 Records Center, 290 Broadway, 18th Floor, New York, NY 10007–1866, Phone: 212–637–4308, Hours: Monday to Friday from 9:00 a.m. to 5:00 p.m. and Newburgh Free Library, Consolidated Iron and Metal Site Repository File, 124 Grand Street, Newburgh, NY 12550, Phone: 845–563– 3600, Hours: Monday & Thursday from 9:00 a.m. to 9:00 p.m., Tuesday, Wednesday, & Friday from 9:00 a.m. to 5:00 p.m., Saturday from 10:00 a.m. to 3:00 p.m. FOR FURTHER INFORMATION CONTACT: Michael Negrelli, Remedial Project Manager, U.S. Environmental Protection Agency, Region 2, Emergency and Remedial Response Division, 290 Broadway, 20th Floor, New York, NY 10007–1866; (212) 637–4248; negrelli.mike@epa.gov. The site to be deleted from the NPL is: Consolidated Iron and Metal Superfund Site, City of Newburgh, Orange County, New York. A Notice of Intent to Delete for this Site was published in the Federal Register FRL–9917–27–Region– 2 on October 1, 2014, (79 FR 59182). The closing date for comments on the Notice of Intent to Delete was October 30, 2014. No adverse public comments were received and therefore no response to comments was required. The deletion action is appropriate. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Deletion from the NPL does not preclude further remedial action. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system. Deletion of a site from the NPL does not affect responsible party liability in the unlikely event that future conditions warrant further actions. SUPPLEMENTARY INFORMATION: List of Subjects in 40 CFR Part 300 Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and record keeping requirements, Superfund, Water pollution control, Water supply. Dated: November 18, 2014. Judith A. Enck, Regional Administrator, EPA, Region 2. For the reasons set out in the preamble, 40 CFR part 300 is amended as follows: PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 71679 PART 300—NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION CONTINGENCY PLAN 1. The authority citation for part 300 continues to read as follows: ■ Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601–9657; E.O. 12777, 56 FR 54757, 3 CFR 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR 1987 Comp., p. 193. 2. Table 1 of Appendix B to part 300 is amended by removing ‘‘NY’’, ‘‘Consolidated Iron and Metal’’, ‘‘Newburgh’’. ■ [FR Doc. 2014–28445 Filed 12–2–14; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 447 CMS–2315–F] RIN 0938–AQ37 Medicaid Program; Disproportionate Share Hospital Payments—Uninsured Definition Centers for Medicare & Medicaid Services (CMS), HHS. AGENCY: ACTION: Final rule. This final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under the Social Security Act (the Act). Under this limitation, DSH payments to a hospital cannot exceed the uncompensated costs of furnishing hospital services by the hospital to individuals who are Medicaid-eligible or ‘‘have no health insurance (or other source of third party coverage) for the services furnished during the year.’’ This rule provides that, in auditing DSH payments, the quoted test will be applied on a service-specific basis; so that the calculation of uncompensated care for purposes of the hospital-specific DSH limit will include the cost of each service furnished to an individual by that hospital for which the individual had no health insurance or other source of third party coverage. SUMMARY: DATES: Effective December 31, 2014. FOR FURTHER INFORMATION CONTACT: Robert Weaver, 410–786–5914; or Rory Howe, (410) 786–4878. SUPPLEMENTARY INFORMATION: E:\FR\FM\03DER1.SGM 03DER1

Agencies

[Federal Register Volume 79, Number 232 (Wednesday, December 3, 2014)]
[Rules and Regulations]
[Pages 71676-71679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28384]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2014-0682; FRL-9918-41]


Oxirane, Phenyl, Polymer With Oxirane, Monooctyl 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 oxirane, phenyl, polymer with oxirane, 
monooctyl ether; when used as an inert ingredient in a pesticide 
chemical formulation. Envonik Corporation 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 oxirane, phenyl, polymer with oxirane, monooctyl ether on 
food or feed commodities.

DATES: This regulation is effective December 3, 2014. Objections and 
requests for hearings must be received on or before February 2, 2015, 
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-2014-0682, 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 
(RD) (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-2014-0682 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 2, 2015. 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-2014-0682, 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 October 15, 2014 (79 FR 61844) (FRL-
9917-24), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-
10751) filed by Envonik Corporation, P.O. Box 1299, Hopewell, VA 23860. 
The petition requested that 40 CFR 180.960 be amended by establishing 
an exemption from the requirement of a tolerance for residues of 
oxirane, phenyl, polymer with oxirane, monooctyl ether; 83653-00-3. 
That document included a summary of the petition prepared by the 
petitioner and solicited comments on the

[[Page 71677]]

petitioner's request. One comment was received for a notice of filing 
from a private citizen.
    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). Oxirane, phenyl, polymer with oxirane, 
monooctyl ether; 83653-00-3 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 
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 of 1,200 is greater than 1,000 
and less than 10,000 daltons. The polymer contains less than 10% 
oligomeric material below MW 500 and less than 25% oligomeric material 
below MW 1,000, and the polymer does not contain any reactive 
functional groups.
    Thus, oxirane, phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl ether.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that oxirane, phenyl, polymer with oxirane, 
monooctyl 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 oxirane, phenyl, 
polymer with oxirane, monooctyl ether is 1,200 daltons. Generally, a 
polymer of this size would be poorly absorbed through the intact 
gastrointestinal tract or through intact human skin. Since oxirane, 
phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl 
ether to share a common mechanism of toxicity with any other 
substances, and oxirane, phenyl, polymer with oxirane, monooctyl 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 oxirane, phenyl, polymer with oxirane, monooctyl 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

[[Page 71678]]

children. Due to the expected low toxicity of oxirane, phenyl, polymer 
with oxirane, monooctyl 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 oxirane, phenyl, polymer with 
oxirane, monooctyl 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 oxirane, phenyl, polymer 
with oxirane, monooctyl ether.

C. Comments

    One comment was received for a notice of filing from a private 
citizen who opposed any pesticide product that leaves a residue above 
0.00. The Agency understands the commenter's concerns and recognizes 
that some individuals believe that no residue of pesticides should be 
allowed. However, under the existing legal framework provided by FFDCA 
section 408, EPA is authorized to establish pesticide tolerances or 
exemptions where persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
the statute.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of oxirane, phenyl, 
polymer with oxirane, monooctyl ether from the requirement of a 
tolerance will be safe.

X. Statutory and Executive Order Reviews

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

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 24, 2014.
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, alphabetically add the following polymer to the 
table to read as follows:


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

* * * * *

------------------------------------------------------------------------
                          Polymer                              CAS No.
------------------------------------------------------------------------
 
                                * * * * *
Oxirane, phenyl, polymer with oxirane, monooctyl ether,       83653-00-3
 minimum average molecular weight (in amu) 1,200...........
 
                                * * * * *
------------------------------------------------------------------------


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[FR Doc. 2014-28384 Filed 12-2-14; 8:45 am]
BILLING CODE 6560-50-P