2-Propenoic Acid, 2-Methyl-, Polymer with Ethenylbenzene, 2-Ethylhexyl 2-Propenoate, 2-Hydroxyethyl 2-Propenoate, N-(Hydroxymethyl) -2-Methyl-2-Propenamide and Methyl 2-Methyl-2-Propenoate, Ammonium Salt; Tolerance Exemption, 42291-42295 [E6-11951]

Download as PDF rwilkins on PROD1PC63 with RULES_1 Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations 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), 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 the 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.’’ ‘‘Policies that have federalism implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any ‘‘tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and VerDate Aug<31>2005 16:29 Jul 25, 2006 Jkt 208001 responsibilities between the Federal Government and Indian tribes.’’ This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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 and pests, Reporting and recordkeeping requirements. Dated: July 10, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371 2. In § 180.960 the table is amended by alphabetically adding a polymer to read as follow: I § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * Polymer * * PO 00000 Frm 00051 CAS No. * 2H-Azepin-2-one, 1ethenylhexahydro-, homopolymer * * Fmt 4700 [FR Doc. E6–11953 Filed 7–25–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2006–0556; FRL–8077–5] 2-Propenoic Acid, 2-Methyl-, Polymer with Ethenylbenzene, 2-Ethylhexyl 2Propenoate, 2-Hydroxyethyl 2Propenoate, N-(Hydroxymethyl) -2Methyl-2-Propenamide and Methyl 2Methyl-2-Propenoate, Ammonium Salt; Tolerance Exemption Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2- methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt when used as an inert ingredient in a pesticide chemical formulation. E. I. du Pont de Nemours and Company, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA) requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt. DATES: This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2006–0556. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as ADDRESSES: * * * 25189–83–7 * Sfmt 4700 * * 42291 E:\FR\FM\26JYR1.SGM 26JYR1 42292 Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket athttps://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–8380; e-mail address:gandhi.bipin@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information rwilkins on PROD1PC63 with RULES_1 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 Access Electronic Copies of this Document? In addition to accessing an electronic copy of this Federal Register document through the electronic docket at https:// www.regulations.gov, you may access this ‘‘Federal Register’’ document electronically through the EPA Internet under the ‘‘Federal Register’’ listings athttps://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing VerDate Aug<31>2005 16:29 Jul 25, 2006 Jkt 208001 Office’s pilot e-CFR site at https:// www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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–2006–0556 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006. 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 that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA–HQ–OPP–2006–0556, 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 Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket’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 telephone number is (703) 305– 5805. II. Background and Statutory Findings In the Federal Register of April 26, 2006 (71 FR 24693) (FRL–8066–3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104– 170), announcing the filing of a pesticide petition (PP 6E7037) by E. I. du Pont de Nemours and Company, Inc., 1007 Market St., Wilmington, DE 19898. PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt; CAS Reg. No. 146753–99–3. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance 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 in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the 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. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ‘‘inert’’ is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the E:\FR\FM\26JYR1.SGM 26JYR1 Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations rwilkins on PROD1PC63 with RULES_1 low toxicity of the individual inert ingredients. IV. 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 section 408(b)(2)(D) of the FFDCA, 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 that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer, 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt, does contain as an integral part of its VerDate Aug<31>2005 16:29 Jul 25, 2006 Jkt 208001 composition the atomic elements carbon, hydrogen, nitrogen and oxygen. 3. The polymer, 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt, 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, 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt, is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer, 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt, 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, 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt, is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. Additionally, the polymer, 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The number average molecular weight (MW) of polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt, is 29,296 which is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 42293 Thus, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoicacid, 2-methyl, polymer with ethenylbenzene, 2ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt could be present in all raw and processed agricultural commodities and drinking water, and that nonoccupational non-dietary exposure was possible. The number average MW of 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt is 29296 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt 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. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular chemical’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ E:\FR\FM\26JYR1.SGM 26JYR1 42294 Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations rwilkins on PROD1PC63 with RULES_1 EPA does not have, at this time, available data to determine whether 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt and any other substances and 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2-propenoic acid, 2methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt has 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 the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at https:// www.epa.gov/pesticides/cumulative. VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2- VerDate Aug<31>2005 16:29 Jul 25, 2006 Jkt 208001 propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, 2-methyl, polymer with ethenylbenzene, 2ethylhexyl 2-propenoate, 2hydroxyethyl 2-propenoate, N(hydroxymethyl) -2-methyl-2propenamide and methyl 2-methyl-2propenoate, ammonium salt. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for 2propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2propenoate, 2-hydroxyethyl 2propenoate, N-(hydroxymethyl) -2methyl-2-propenamide and methyl 2methyl-2-propenoate, ammonium salt from the requirement of a tolerance will be safe. PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement 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 types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). 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); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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), 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 the 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. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input E:\FR\FM\26JYR1.SGM 26JYR1 Federal Register / Vol. 71, No. 143 / Wednesday, July 26, 2006 / Rules and Regulations rwilkins on PROD1PC63 with RULES_1 by State and local officials in the development of regulatory policies that have federalism implications.’’ ‘‘Policies that have federalism implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any ‘‘tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.’’ This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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 VerDate Aug<31>2005 16:29 Jul 25, 2006 Jkt 208001 ‘‘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: July 10, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.960 is amended by adding alphabetically to the table a polymer to read as follows: I § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Polymer * * * CAS No. * 2-Propenoic Acid, 2-Methyl-, Polymer with Ethenylbenzene, 2-Ethylhexyl 2-Propenoate, 2-Hydroxyethyl 2-Propenoate, N(Hydroxymethyl) -2-Methyl-2Propenamide and Methyl 2Methyl-2-Propenoate, Ammonium Salt * * * * * 146753–99– 3 * [FR Doc. E6–11951 Filed 7–25–06; 8:45 am] BILLING CODE 6560–50–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 42 CFR Part 63a RIN 0925–AA28 National Institutes of Health Training Grants National Institutes of Health, Department of Health and Human Services. ACTION: Final rule. AGENCY: SUMMARY: The National Institutes of Health (NIH) is amending the current regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training. PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 42295 Effective Date: This final rule is effective August 25, 2006. FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892, telephone 301–496–4607 (not a toll-free number). SUPPLEMENTARY INFORMATION: On October 17, 2000, Congress enacted the Children’s Health Act of 2000, Public Law 106–310. Title X, section 1002, of this law amended the Public Health Service (PHS) Act by adding section 452G (42 U.S.C. 285g–10). Section 452G directs the Director of the National Institute of Child Health and Human Development, after consultation with the Administrator of the Health Resources and Services Administration, to support activities to provide for an increase in the number and size of institutional training grants to institutions supporting pediatric training. We are amending the current regulations codified at 42 CFR part 63a, ‘‘National Institutes of Health Training Grants,’’ to implement this pediatric research training grants authority. More specifically, we are amending part 63a to reference section 452G of the PHS Act in the authority section and in paragraph (a)(2) of § 63a.1 of the regulations, and update information in the 18th, 19th, and 20th undesignated paragraphs of § 63a.11. We announced our intention to amend the training grants regulations by publishing the notice of proposed rulemaking (NPRM), ‘‘National Institutes of Health Training Grants,’’ in the Federal Register of January 28, 2005 (70 FR 4080–4081). The NPRM provided for a 60-day public comment period. The comment period expired on March 29, 2005. We received no comments. Therefore, the amending action reflected in this final rule is the same as what we proposed in the NPRM. We provide the following as public information. DATES: Executive Order 12866 Executive Order 12866, Regulatory Planning and Review, requires that all regulatory actions reflect consideration of the costs and benefits they generate, and that they meet certain standards, such as avoiding the imposition of unnecessary burdens on the affected public. If a regulatory action is deemed to fall within the scope of the definition of the term ‘‘significant regulatory action’’ contained in section 3(f) of the Order, prepublication review by the Office of Management and Budget’s Office of Information and Regulatory E:\FR\FM\26JYR1.SGM 26JYR1

Agencies

[Federal Register Volume 71, Number 143 (Wednesday, July 26, 2006)]
[Rules and Regulations]
[Pages 42291-42295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-11951]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0556; FRL-8077-5]


2-Propenoic Acid, 2-Methyl-, Polymer with Ethenylbenzene, 2-
Ethylhexyl 2-Propenoate, 2-Hydroxyethyl 2-Propenoate, N-(Hydroxymethyl) 
-2-Methyl-2-Propenamide and Methyl 2-Methyl-2-Propenoate, Ammonium 
Salt; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of 2-propenoic acid, 2- methyl-, polymer 
with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-
propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-
methyl-2-propenoate, ammonium salt when used as an inert ingredient in 
a pesticide chemical formulation. E. I. du Pont de Nemours and Company, 
Inc. submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA) requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of 2-propenoic acid, 2-methyl-, polymer 
with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-
propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-
methyl-2-propenoate, ammonium salt.

DATES: This regulation is effective July 26, 2006. Objections and 
requests for hearings must be received on or before September 25, 2006, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0556. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as

[[Page 42292]]

copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available in the electronic docket athttps://
www.regulations.gov, or, if only available in hard copy, at the OPP 
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is 
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The Docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8380; e-mail address:gandhi.bipin@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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings athttps://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2006-0556 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before September 25, 2006.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0556, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket'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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of April 26, 2006 (71 FR 24693) (FRL-8066-
3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA (Public Law 104-170), announcing the 
filing of a pesticide petition (PP 6E7037) by E. I. du Pont de Nemours 
and Company, Inc., 1007 Market St., Wilmington, DE 19898. The petition 
requested that 40 CFR 180.960 be amended by establishing an exemption 
from the requirement of a tolerance for residues of 2-propenoic acid, 
2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-
hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide 
and methyl 2-methyl-2-propenoate, ammonium salt; CAS Reg. No. 146753-
99-3. That notice included a summary of the petition prepared by the 
petitioner. There were no comments in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance 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 in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of the 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. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the

[[Page 42293]]

low toxicity of the individual inert ingredients.

IV. 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 section 408(b)(2)(D) of the FFDCA, 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 that should present 
minimal or no risk. The definition of a polymer is given in 40 CFR 
723.250(b). The following exclusion criteria for identifying these low 
risk polymers are described in 40 CFR 723.250(d).
    1. The polymer, 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt, is not a cationic polymer nor is it 
reasonably anticipated to become a cationic polymer in a natural 
aquatic environment.
    2. The polymer, 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt, does contain as an integral part of its 
composition the atomic elements carbon, hydrogen, nitrogen and oxygen.
    3. The polymer, 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt, 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, 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt, is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer, 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt, 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, 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt, is not a water absorbing polymer with a 
number average molecular weight (MW) greater than or equal to 10,000 
daltons.
    Additionally, the polymer, 2-propenoic acid, 2-methyl-, polymer 
with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-
propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-
methyl-2-propenoate, ammonium salt, also meets as required the 
following exemption criteria specified in 40 CFR 723.250(e).
    7. The number average molecular weight (MW) of polymer, 2-propenoic 
acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-
propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-
propenamide and methyl 2-methyl-2-propenoate, ammonium salt, is 29,296 
which is greater than or equal to 10,000 daltons. The polymer contains 
less than 2% oligomeric material below MW 500 and less than 5% 
oligomeric material below MW 1,000.
    Thus, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-
ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) 
-2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt 
meet all the criteria for a polymer to be considered low risk under 40 
CFR 723.250. Based on its conformance to the above criteria, no 
mammalian toxicity is anticipated from dietary, inhalation, or dermal 
exposure to 2-propenoicacid, 2-methyl-, polymer with ethenylbenzene, 2-
ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) 
-2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium 
salt.

V. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that 2-propenoic acid, 2-methyl-, polymer 
with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-
propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-
methyl-2-propenoate, ammonium salt could be present in all raw and 
processed agricultural commodities and drinking water, and that non-
occupational non-dietary exposure was possible. The number average MW 
of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-
ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) 
-2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt 
is 29296 daltons. Generally, a polymer of this size would be poorly 
absorbed through the intact gastrointestinal tract or through intact 
human skin. Since 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt 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.

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.''

[[Page 42294]]

EPA does not have, at this time, available data to determine whether 2-
propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-
propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-
propenamide and methyl 2-methyl-2-propenoate, ammonium salt has a 
common mechanism of toxicity with other substances. Unlike other 
pesticides for which EPA has followed a cumulative risk approach based 
on a common mechanism of toxicity, EPA has not made a common mechanism 
of toxicity finding as to 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt and any other substances and 2-propenoic 
acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-
propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-
propenamide and methyl 2-methyl-2-propenoate, ammonium salt does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has not assumed 
that 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-
ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) 
-2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt 
has 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 the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website at https://www.epa.gov/pesticides/
cumulative.

VII. Additional Safety Factor for the Protection of Infants and 
Children

    Section 408 of FFDCA provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA concludes that a different 
margin of safety will be safe for infants and children. Due to the 
expected low toxicity of 2-propenoic acid, 2-methyl-, polymer with 
ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, 
N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-
propenoate, ammonium salt, EPA has not used a safety factor analysis to 
assess the risk. For the same reasons the additional tenfold safety 
factor is unnecessary.

VIII. Determination of Safety

    Based on the conformance to the criteria used to identify a low 
risk polymer, EPA concludes that there is a reasonable certainty of no 
harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of 2-propenoic acid, 2-methyl-, polymer 
with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-
propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-
methyl-2-propenoate, ammonium salt.

IX. Other Considerations

A. Endocrine Disruptors

    There is no available evidence that 2-propenoic acid, 2-methyl-, 
polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 
2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-
methyl-2-propenoate, ammonium salt is an endocrine disruptor.

B. Analytical Enforcement Methodology

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

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 2-
propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-
propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-
propenamide and methyl 2-methyl-2-propenoate, ammonium salt nor have 
any CODEX Maximum Residue Levels (MRLs) been established for any food 
crops at this time.

X. Conclusion

    Accordingly, EPA finds that exempting residues of 2-propenoic acid, 
2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-
hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide 
and methyl 2-methyl-2-propenoate, ammonium salt from the requirement of 
a tolerance will be safe.

XI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement 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 types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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), 
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 the 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input

[[Page 42295]]

by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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 and pests, Reporting and 
recordkeeping requirements.

    Dated: July 10, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.960 is amended by adding alphabetically to the table a 
polymer to read as follows:


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

* * * * *

------------------------------------------------------------------------
                  Polymer                              CAS No.
------------------------------------------------------------------------
                                * * * * *
2-Propenoic Acid, 2-Methyl-, Polymer with   146753-99-3
 Ethenylbenzene, 2-Ethylhexyl 2-
 Propenoate, 2-Hydroxyethyl 2-Propenoate,
 N-(Hydroxymethyl) -2-Methyl-2-Propenamide
 and Methyl 2-Methyl-2-Propenoate,
 Ammonium Salt
                                * * * * *
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[FR Doc. E6-11951 Filed 7-25-06; 8:45 am]
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