1,2-Ethanediamine, N, 30407-30410 [2012-12110]

Download as PDF Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations a. Redesignate paragraph (a) as (a)(1); and ■ b. Add paragraph (a)(2). The amendments read as follows: This regulation is effective May 23, 2012. Objections and requests for hearings must be received on or before July 23, 2012, and must be filed in accordance with the instructions § 180.561 Acibenzolar- S -methyl; provided in 40 CFR part 178 (see also tolerances for residues. Unit I.C. of the SUPPLEMENTARY (a) General. INFORMATION). (1) * * * ADDRESSES: The docket for this action, (2) Tolerances are established for identified by docket identification (ID) residues of acibenzolar- S -methyl, number EPA–HQ–OPP–2012–0014, is benzo(1,2,3)thiadiazole-7-carbothioic available either electronically through acid- S -methyl ester, including its metabolites and degradates, in or on the https://www.regulations.gov or in hard copy at the OPP Docket in the commodities in the table below. Environmental Protection Agency Compliance with the tolerance levels Docket Center (EPA/DC), located in EPA specified below is to be determined by West, Rm. 3334, 1301 Constitution Ave. measuring only those acibenzolar- S NW., Washington, DC 20460–0001. The -methyl residues convertible to Public Reading Room is open from benzo(1,2,3)thiadiazole-7-carboxylic 8:30 a.m. to 4:30 p.m., Monday through acid (CGA–210007), expressed as the Friday, excluding legal holidays. The Stoichiometric equivalent of telephone number for the Public acibenzolar- S -methyl, in or on the following raw agricultural commodities. Reading Room is (202) 566–1744, and the telephone number for the OPP Expiration/ Docket is (703) 305–5805. Please review Parts per Commodity revocation the visitor instructions and additional million date information about the docket available Apple ................. 0.05 12/31/2015 at https://www.epa.gov/dockets. Grapefruit .......... 0.05 12/31/2015 FOR FURTHER INFORMATION CONTACT: Pear .................. 0.05 12/31/2015 Anthony Britten, Registration Division (7505P), Office of Pesticide Programs, * * * * * Environmental Protection Agency, 1200 [FR Doc. 2012–12410 Filed 5–22–12; 8:45 am] Pennsylvania Ave. NW., Washington, BILLING CODE 6560–50–P DC 20460–0001; telephone number: (703) 308–8179; email address: britten.anthony@epa.gov. ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: AGENCY I. General Information 40 CFR Part 180 A. Does this action apply to me? [EPA–HQ–OPP–2012–0014; FRL–9349–1] You may be potentially affected by 1,2-Ethanediamine, N1-(2-aminoethyl)-, this action if you are an agricultural producer, food manufacturer, or polymer with 2, 4-diisocyanato-1pesticide manufacturer. Potentially methylbenzene; Tolerance Exemption affected entities may include, but are AGENCY: Environmental Protection not limited to: Agency (EPA). • Crop production (NAICS code 111). • Animal production (NAICS code ACTION: Final rule. 112). SUMMARY: This regulation establishes an • Food manufacturing (NAICS code exemption from the requirement of a 311). tolerance for residues of 1,2• Pesticide manufacturing (NAICS ethanediamine, N1-(2-aminoethyl)-, code 32532). polymer with 2,4-diisocyanato-1This listing is not intended to be methylbenzene, when used as an inert exhaustive, but rather provides a guide ingredient in a pesticide chemical for readers regarding entities likely to be formulation. ICR, Inc., on behalf of affected by this action. Other types of Triton Systems, Inc., submitted a entities not listed in this unit could also petition to EPA under the Federal Food, be affected. The North American Drug, and Cosmetic Act (FFDCA), Industrial Classification System requesting an exemption from the (NAICS) codes have been provided to requirement of a tolerance. This assist you and others in determining regulation eliminates the need to whether this action might apply to establish a maximum permissible level certain entities. If you have any for residues of 1,2-ethanediamine, N1questions regarding the applicability of (2-aminoethyl)-, polymer with 2,4this action to a particular entity, consult diisocyanato-1-methylbenzene on food the person listed under FOR FURTHER or feed commodities. INFORMATION CONTACT. srobinson on DSK4SPTVN1PROD with RULES ■ VerDate Mar<15>2010 16:20 May 22, 2012 Jkt 226001 DATES: PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 30407 B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// ecfr.gpoaccess.gov/cgi/t/text/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 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–2012–0014 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 July 23, 2012. 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 that does not contain 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2012–0014, by one of the following methods. • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. II. Background and Statutory Findings In the Federal Register of April 4, 2012 (77 FR 20334) (FRL–9340–4), EPA E:\FR\FM\23MYR1.SGM 23MYR1 30408 Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations srobinson on DSK4SPTVN1PROD with RULES issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 1E7912) filed by ICR, Inc., 1330 Dillon Heights Avenue, Baltimore, MD 21228– 1199 on behalf of Triton Systems, Inc., 200 Turnpike Road, Chelmsford, MA 01824. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 1,2-ethanediamine, N1-(2aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene (CAS Reg. No. 35297–61–1). 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 in response to this notice. 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 VerDate Mar<15>2010 16:20 May 22, 2012 Jkt 226001 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). 1,2-ethanediamine, N1-(2aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene 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 Toxic Substance Control Act (TSCA) Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer’s number average MW is greater than 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 (less than 5% oligomeric material below MW 1,000. Thus, 1,2-ethanediamine, N1-(2aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene 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 1,2ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1methylbenzene. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 1,2ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1methylbenzene 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 1,2-ethanediamine, N1(2-aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene is greater than 1 million daltons Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 1,2-ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene conforms 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 1, 2ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1methylbenzene to share a common mechanism of toxicity with any other substances, and 1,2-ethanediamine, N1(2-aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1,2ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1- E:\FR\FM\23MYR1.SGM 23MYR1 Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations methylbenzene 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 https:// 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 1,2-ethanediamine, N1-(2aminoethyl)-polymer with 2,4diisocyanato-1-methylbenzene. 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 1,2-ethanediamine, N1-(2aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene. VIII. Other Considerations srobinson on DSK4SPTVN1PROD with RULES 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 U.N. 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; VerDate Mar<15>2010 16:20 May 22, 2012 Jkt 226001 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 1,2-ethanediamine, N1-(2aminoethyl)-, polymer with 2,4diisocyanato-1-methylbenzene. IX. Conclusion Accordingly, EPA finds that exempting residues of 1,2ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1methylbenzene from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these 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 to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 30409 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) (Pub. L. 104–4). 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 The Congressional Review Act, 5, U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. 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 this rule in the Federal Register. This rule 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 E:\FR\FM\23MYR1.SGM 23MYR1 30410 Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 / Rules and Regulations and pests, Reporting and recordkeeping requirements. PART 180—[AMENDED] Dated: May 11, 2012. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. ■ entry which reads in part ‘‘1, 2Ethanediamine, polymer * * *.’’ 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, the table is amended by alphabetically adding the following entry immediately above the existing ■ Therefore, 40 CFR chapter I is amended as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Polymer CAS No. * * * * * * 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, minimum number average molecular weight (in amu), one million .............................................................................................................................................. * * * * [FR Doc. 2012–12110 Filed 5–22–12; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 36 [CC Docket No. 80–286; FCC 12–49] Jurisdictional Separations and Referral to the Federal-State Joint Board Federal Communications Commission. ACTION: Interim rule. AGENCY: Jurisdictional separations is the process by which incumbent local exchange carriers (incumbent LECs) apportion regulated costs between the intrastate and interstate jurisdictions. In this document, the Commission extends the current freeze of part 36 category relationships and jurisdictional cost allocation factors used in jurisdictional separations until June 30, 2014. Extending the freeze will allow the Commission to provide stability for carriers that must comply with the Commission’s separations rules while the Federal-State Joint Board completes its analysis of, and recommendations for, interim and comprehensive reform of the jurisdictional separations process. DATES: Effective June 22, 2012. FOR FURTHER INFORMATION CONTACT: Daniel Ball, Attorney Advisor, at 202– 418–1577, Pricing Policy Division, Wireline Competition Bureau. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Report and Order (R&O) in CC Docket No. 80– 286, FCC 12–49, released on May 8, 2012. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY–A257, 445 12th Street SW., Washington, DC 20554. srobinson on DSK4SPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 16:20 May 22, 2012 Jkt 226001 * * 1. Jurisdictional separations is the process by which incumbent LECs apportion regulated costs between the intrastate and interstate jurisdictions. 2. The 2001 Separations Freeze Order, 66 FR 33202, June 21, 2001, froze all part 36 category relationships and allocation factors for price cap carriers and all allocation factors for rate-ofreturn carriers. Rate-of-return carriers had the option to freeze their category relationships at the outset of the freeze. The freeze was originally established July 1, 2001 for a period of five years, or until the Commission completed separations reform, whichever occurred first. The 2006 Separations Freeze Extension Order, 71 FR 29843, May 24, 2006, extended the freeze for three years or until the Commission completed separations reform, whichever occurred first. The 2009 Separations Freeze Extension Order, 74 FR 23955, May 22, 2009, extended the freeze until June 30, 2010. The 2010 Separations Freeze Extension Order, 75 FR 30301, June 1, 2010, extended the freeze until June 30, 2011. The 2011 Separations Freeze Extension Order, 76 FR 30840, May 27, 2011, extended the freeze until June 30, 2012. 3. The NPRM proposed extending the current freeze of part 36 category relationships and jurisdictional cost allocation factors used in jurisdictional separations, which freeze would otherwise expire on June 30, 2012, until June 30, 2014. The R&O adopts that proposal. The extension will allow the Commission to continue to work with the Federal-State Joint Board on Separations to achieve comprehensive separations reform. Pending comprehensive reform, the Commission concludes that the existing freeze should be extended on an interim basis to avoid the imposition of undue administrative burdens on incumbent LECs. The overwhelming majority of PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 * 35297–61–1 * parties filing comments in response to the NPRM supported extension of the freeze. 4. The extended freeze will be implemented as described in the 2001 Separations Freeze Order. Specifically, price-cap carriers would use the same relationships between categories of investment and expenses within part 32 accounts and the same jurisdictional allocation factors that have been in place since the inception of the current freeze on July 1, 2001. Rate-of-return carriers would use the same frozen jurisdictional allocation factors, and would use the same frozen category relationships if they had opted previously to freeze those as well. 5. As required by the Regulatory Flexibility Act, the Commission certifies that these regulatory amendments will not have a significant impact on small business entities. Paperwork Reduction Act (PRA) 6. The R&O does not propose any new or modified information collections subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104–13. In addition, therefore, it does not contain any new, modified, or proposed ‘‘information collection burden for small business concerns with fewer than 25 employees,’’ pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107–198, 44 U.S.C. 3506(c)(4). 7. The Commission will send a copy of the R&O in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A). Ordering Clauses 8. Pursuant to sections 1, 4(i) and (j), 214(e), 254, and 410 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 214(e), 254, and 410, the R&O is E:\FR\FM\23MYR1.SGM 23MYR1

Agencies

[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Rules and Regulations]
[Pages 30407-30410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12110]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0014; FRL-9349-1]


1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2, 4-
diisocyanato-1-methylbenzene; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of 1,2-ethanediamine, N1-(2-aminoethyl)-, 
polymer with 2,4-diisocyanato-1-methylbenzene, when used as an inert 
ingredient in a pesticide chemical formulation. ICR, Inc., on behalf of 
Triton Systems, Inc., submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of 1,2-
ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-
methylbenzene on food or feed commodities.

DATES: This regulation is effective May 23, 2012. Objections and 
requests for hearings must be received on or before July 23, 2012, 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-2012-0014, is available either 
electronically through https://www.regulations.gov or in hard copy at 
the OPP Docket in the Environmental Protection Agency Docket Center 
(EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805. Please review 
the visitor instructions and additional information about the docket 
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anthony Britten, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8179; email address: britten.anthony@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://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-2012-0014 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 
July 23, 2012. 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 that does not contain 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2012-0014, by one of the following methods.
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 4, 2012 (77 FR 20334) (FRL-9340-
4), EPA

[[Page 30408]]

issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
announcing the receipt of a pesticide petition (PP 1E7912) filed by 
ICR, Inc., 1330 Dillon Heights Avenue, Baltimore, MD 21228-1199 on 
behalf of Triton Systems, Inc., 200 Turnpike Road, Chelmsford, MA 
01824. The petition requested that 40 CFR 180.960 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of 1,2-ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-
diisocyanato-1-methylbenzene (CAS Reg. No. 35297-61-1). 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 in response to this notice.
    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). 1,2-ethanediamine, N1-(2-aminoethyl)-, 
polymer with 2,4-diisocyanato-1-methylbenzene 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 Toxic Substance Control Act 
(TSCA) Chemical Substance Inventory or manufactured under an applicable 
TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW is greater than 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, 1,2-ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-
diisocyanato-1-methylbenzene 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 1,2-ethanediamine, N1-(2-
aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that 1,2-ethanediamine, N1-(2-aminoethyl)-, 
polymer with 2,4-diisocyanato-1-methylbenzene 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 1,2-ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-
diisocyanato-1-methylbenzene is greater than 1 million daltons 
Generally, a polymer of this size would be poorly absorbed through the 
intact gastrointestinal tract or through intact human skin. Since 1,2-
ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-
methylbenzene conforms 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 1, 2-ethanediamine, N1-(2-aminoethyl)-, polymer 
with 2,4-diisocyanato-1-methylbenzene to share a common mechanism of 
toxicity with any other substances, and 1,2-ethanediamine, N1-(2-
aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
1,2-ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-

[[Page 30409]]

methylbenzene 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 https://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 1,2-ethanediamine, N1-(2-
aminoethyl)-polymer with 2,4-diisocyanato-1-methylbenzene. 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 1,2-ethanediamine, N1-(2-aminoethyl)-
, polymer with 2,4-diisocyanato-1-methylbenzene.

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 U.N. 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 1,2-ethanediamine, N1-(2-
aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 1,2-
ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-
methylbenzene from the requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these 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 to section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes, 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) (Pub. L. 
104-4).
    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

    The Congressional Review Act, 5, U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this rule in the Federal 
Register. This rule 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

[[Page 30410]]

and pests, Reporting and recordkeeping requirements.

    Dated: May 11, 2012.
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, the table is amended by alphabetically adding the 
following entry immediately above the existing entry which reads in 
part ``1, 2-Ethanediamine, polymer * * *.''


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

* * * * *

------------------------------------------------------------------------
                       Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with           35297-61-1
 2,4-diisocyanato-1-methylbenzene, minimum number
 average molecular weight (in amu), one million.....
 
                              * * * * * * *
------------------------------------------------------------------------


[FR Doc. 2012-12110 Filed 5-22-12; 8:45 am]
BILLING CODE 6560-50-P
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