2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated; Tolerance Exemption, 41135-41138 [2011-17391]

Download as PDF Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Rules and Regulations [FR Doc. 2011–17467 Filed 7–12–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2011–0327; FRL–8878–4] 2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2propenoic acid and sodium 2-methyl-2[(1-oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated; Tolerance Exemption Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated (also known here as: ‘‘the Polymer’’); when used as an inert ingredient in a pesticide chemical formulation under 40 CFR 180.960. Akzo Nobel Surface Chemistry LLC, 909 Mueller Avenue, Chattanooga, TN 37406 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 ‘‘the Polymer’’ on food or feed commodities. DATES: This regulation is effective July 13, 2011. Objections and requests for hearings must be received on or before September 12, 2011, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). SUMMARY: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2011–0327. All documents in the docket are listed in the docket index available at https://www.regulations.gov. 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 copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. mstockstill on DSK4VPTVN1PROD with RULES ADDRESSES: VerDate Mar<15>2010 16:32 Jul 12, 2011 Jkt 223001 Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Mark Dow, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5533; e-mail address: dow.mark@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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. Can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation PO 00000 Frm 00095 Fmt 4700 Sfmt 4700 41135 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–2011–0327 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 September 12, 2011. 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–2011–0327, 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 20, 2011 (76 FR 22069) (FRL–8869–7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 1E7834) filed by Akzo Nobel Surface Chemistry LLC, 909 Mueller Avenue, Chattanooga, TN 37406. 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,phenylmethyl ester, polymer with 2propenoic acid and sodium 2-methyl-2[(1-oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)- E:\FR\FM\13JYR1.SGM 13JYR1 41136 Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES initiated (CASRN 1246766–57–3). That notice included a summary of the petition prepared by the petitioner and solicited comments on the petitioner’s request. The Agency did not receive any comments. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *’’ and specifies factors EPA is to consider in establishing an exemption. III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered VerDate Mar<15>2010 16:32 Jul 12, 2011 Jkt 223001 available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 2-Propenoic acid, 2-methyl,phenylmethyl ester, polymer with 2propenoic acid and sodium 2-methyl-2[(1-oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)initiated conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers. 1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. 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 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, ‘‘the Polymer’’ 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 ‘‘the Polymer’’. PO 00000 Frm 00096 Fmt 4700 Sfmt 4700 IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2propenoic acid and sodium 2-methyl-2[(1-oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)initiated 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 ‘‘the Polymer’’ is 1,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since ‘‘the Polymer’’ conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA has not found ‘‘the Polymer’’ to share a common mechanism of toxicity with any other substances, and ‘‘the Polymer’’ does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that ‘‘the Polymer’’ 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 E:\FR\FM\13JYR1.SGM 13JYR1 Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Rules and Regulations children. Due to the expected low toxicity of ‘‘the Polymer’’, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VII. Determination of Safety Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-Propenoic acid, 2-methyl, phenylmethyl ester, polymer with 2propenoic acid and sodium 2-methyl-2[(1-oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)initiated. 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 ‘‘the Polymer’’. mstockstill on DSK4VPTVN1PROD with RULES IX. Conclusion Accordingly, EPA finds that exempting residues of 2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid and sodium 2methyl-2-[(1-oxo-2-propen-1-yl)amino]1-propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated from the requirement of a tolerance will be safe. VerDate Mar<15>2010 16:32 Jul 12, 2011 Jkt 223001 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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of 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 PO 00000 Frm 00097 Fmt 4700 Sfmt 4700 41137 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 and pests, Reporting and recordkeeping requirements. Dated: June 27, 2011. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. E:\FR\FM\13JYR1.SGM 13JYR1 41138 Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Rules and Regulations ■ 2. In § 180.960, the table is amended by adding alphabetically the following polymers to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Polymer * * * CAS No. * * * 2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-2-[(1-oxo-2propen-1-yl)amino]-1-propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated minimum number average molecular weight > 1,000 Daltons; maximum number average molecular weight 10,000 Daltons. * * * * * [FR Doc. 2011–17391 Filed 7–12–11; 8:45 am] FOR FURTHER INFORMATION CONTACT: BILLING CODE 6560–50–P Carlita Ballard, Office of International Policy, Fuel Economy and Consumer Programs, NHTSA, 1200 New Jersey Avenue, SE., West Building, Room W43–439, Washington, DC 20590, by electronic mail to carlita.ballard@dot.gov. Ms. Ballard’s telephone number is (202) 366–5222. Her fax number is (202) 493–2990. SUPPLEMENTARY INFORMATION: DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 544 [Docket No.: NHTSA–2011–0016] RIN 2127–AK90 Insurer Reporting Requirements; List of Insurers Required To File Reports National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION: Final rule. AGENCY: This final rule amends 49 CFR Part 544, Insurer Reporting Requirements. This Part specifies the requirements for annual insurer reports and lists in appendices those passenger motor vehicle insurers that are required to file reports on their motor vehicle theft loss experiences. An insurer included in any of these appendices must file three copies of its report for the 2008 calendar year before October 25, 2011. If the passenger motor vehicle insurers remain listed, they must submit reports by each subsequent October 25. DATES: This final rule becomes effective on August 12, 2011. Insurers listed in the appendices are required to submit reports on or before October 25, 2011. If you wish to submit a petition for reconsideration of this rule, your petition must be received by August 29, 2011. ADDRESSES: Petitions for reconsideration should refer to the docket number and be submitted to: Administrator, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., West Building, Room W41–307, Washington, DC 20590. mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 16:32 Jul 12, 2011 Jkt 223001 I. Background Pursuant to 49 U.S.C. 33112, Insurer reports and information, NHTSA requires certain passenger motor vehicle insurers to file an annual report with the agency. Each insurer’s report includes information about thefts and recoveries of motor vehicles, the rating rules used by the insurer to establish premiums for comprehensive coverage, the actions taken by the insurer to reduce such premiums, and the actions taken by the insurer to reduce or deter theft. Pursuant to 49 U.S.C. Section 33112(f), the following insurers are subject to the reporting requirements: (1) Issuers of motor vehicle insurance policies whose total premiums account for 1 percent or more of the total premiums of motor vehicle insurance issued within the United States; (2) issuers of motor vehicle insurance policies whose premiums account for 10 percent or more of total premiums written within any one state and; (3) rental and leasing companies with a fleet of 20 or more vehicles not covered by theft insurance policies issued by insurers of motor vehicles, other than any governmental entity. Pursuant to its statutory exemption authority, the agency exempted certain passenger motor vehicle insurers from the reporting requirements. A. Small Insurers of Passenger Motor Vehicles Section 33112(f)(2) provides that the agency shall exempt small insurers of passenger motor vehicles if NHTSA PO 00000 Frm 00098 Fmt 4700 Sfmt 4700 * * CASRN 1246766–57–3 * finds that such exemptions will not significantly affect the validity or usefulness of the information in the reports, either nationally or on a stateby-state basis. The term ‘‘small insurer’’ is defined, in Section 33112(f)(1)(A) and (B), as an insurer whose premiums for motor vehicle insurance issued directly or through an affiliate, including pooling arrangements established under state law or regulation for the issuance of motor vehicle insurance, account for less than 1 percent of the total premiums for all forms of motor vehicle insurance issued by insurers within the United States. However, that section also stipulates that if an insurance company satisfies this definition of a ‘‘small insurer,’’ but accounts for 10 percent or more of the total premiums for all motor vehicle insurance issued in a particular state, the insurer must report about its operations in that state. In the final rule establishing the insurer reports requirement (49 CFR part 544; 52 FR 59, January 2, 1987), NHTSA exercised its exemption authority by listing in Appendix A each insurer that must report because it had at least 1 percent of the motor vehicle insurance premiums nationally. Listing the insurers subject to reporting, instead of each insurer exempted from reporting because it had less than 1 percent of the premiums nationally, is administratively simpler, since the former group is much smaller than the latter. In Appendix B, NHTSA lists those insurers required to report for particular states because each insurer had a 10 percent or greater market share of motor vehicle premiums in those states. In the January 1987 final rule, the agency stated that it would update Appendices A and B annually. NHTSA updates the appendices based on data voluntarily provided by insurance companies to A.M. Best, which A.M. Best 1 publishes in its State/Line Report 1 A.M. Best Company is a well-recognized source of insurance company ratings and information. 49 E:\FR\FM\13JYR1.SGM 13JYR1

Agencies

[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Rules and Regulations]
[Pages 41135-41138]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17391]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0327; FRL-8878-4]


2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-
propenoic acid and sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium 
salt (1:2)-initiated; 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-, 
phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), 
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated (also 
known here as: ``the Polymer''); when used as an inert ingredient in a 
pesticide chemical formulation under 40 CFR 180.960. Akzo Nobel Surface 
Chemistry LLC, 909 Mueller Avenue, Chattanooga, TN 37406 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 ``the Polymer'' on food or feed commodities.

DATES: This regulation is effective July 13, 2011. Objections and 
requests for hearings must be received on or before September 12, 2011, 
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-2011-0327. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. 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 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 at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Mark Dow, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5533; e-mail address: dow.mark@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-2011-0327 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 
September 12, 2011. 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-2011-0327, 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 20, 2011 (76 FR 22069) (FRL-8869-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the receipt of a pesticide petition (PP 1E7834) filed 
by Akzo Nobel Surface Chemistry LLC, 909 Mueller Avenue, Chattanooga, 
TN 37406. 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-,phenylmethyl ester, polymer 
with 2-propenoic acid and sodium 2-methyl-2-[(1-oxo-2-propen-1-
yl)amino]-1-propanesulfonate (1:1), peroxydisulfuric acid 
([HO)S(O)2]202) sodium salt (1:2)-

[[Page 41136]]

initiated (CASRN 1246766-57-3). That notice included a summary of the 
petition prepared by the petitioner and solicited comments on the 
petitioner's request. The Agency did not receive any comments. Section 
408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the 
requirement for a tolerance (the legal limit for a pesticide chemical 
residue in or on a food) only if EPA determines that the exemption is 
``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines ``safe'' to mean 
that ``there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue, including all 
anticipated dietary exposures and all other exposures for which there 
is reliable information.'' This includes exposure through drinking 
water and use in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing an exemption from the 
requirement of a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue * * *'' and 
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be shown that the risks from aggregate 
exposure to pesticide chemical residues under reasonably foreseeable 
circumstances will pose no appreciable risks to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. In the case of certain chemical substances that 
are defined as polymers, the Agency has established a set of criteria 
to identify categories of polymers expected to present minimal or no 
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the 
exclusion criteria for identifying these low-risk polymers are 
described in 40 CFR 723.250(d). 2-Propenoic acid, 2-methyl-
,phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), 
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated 
conforms to the definition of a polymer given in 40 CFR 723.250(b) and 
meets the following criteria that are used to identify low-risk 
polymers.
    1. The polymer is not a cationic polymer nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. The polymer does contain as an integral part of its composition 
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or 
reactants that are already included on the TSCA Chemical Substance 
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number 
average molecular weight (MW) greater than or equal to 10,000 daltons.
    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 1,000 and less 
than 10,000 daltons. The polymer contains less than 10% oligomeric 
material below MW 500 and less than 25% oligomeric material below MW 
1,000, and the polymer does not contain any reactive functional groups.
    Thus, ``the Polymer'' 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 ``the Polymer''.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that 2-Propenoic acid, 2-methyl-, 
phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), 
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated 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 ``the Polymer'' is 1,000 daltons. 
Generally, a polymer of this size would be poorly absorbed through the 
intact gastrointestinal tract or through intact human skin. Since ``the 
Polymer'' conform to the criteria that identify a low-risk polymer, 
there are no concerns for risks associated with any potential exposure 
scenarios that are reasonably foreseeable. The Agency has determined 
that a tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA has not found ``the Polymer'' to share a common mechanism of 
toxicity with any other substances, and ``the Polymer'' does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
``the Polymer'' 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

[[Page 41137]]

children. Due to the expected low toxicity of ``the Polymer'', EPA has 
not used a safety factor analysis to assess the risk. For the same 
reasons the additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no 
harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of 2-Propenoic acid, 2-methyl-, 
phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), 
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated.

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 ``the Polymer''.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2-Propenoic acid, 
2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid and sodium 
2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), 
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated 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 tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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 and pests, Reporting and 
recordkeeping requirements.

    Dated: June 27, 2011.
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.


[[Page 41138]]



0
2. In Sec.  180.960, the table is amended by adding alphabetically the 
following polymers to read as follows:


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

* * * * *

------------------------------------------------------------------------
              Polymer                              CAS No.
------------------------------------------------------------------------
 
                              * * * * * * *
2-Propenoic acid, 2-methyl-,         CASRN 1246766-57-3
 phenylmethyl ester, polymer with 2-
 propenoic acid and sodium 2-methyl-
 2-[(1-oxo-2-propen-1-yl)amino]-1-
 propanesulfonate (1:1),
 peroxydisulfuric acid
 ([HO)S(O)2]202) sodium salt (1:2)-
 initiated minimum number average
 molecular weight > 1,000 Daltons;
 maximum number average molecular
 weight 10,000 Daltons.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2011-17391 Filed 7-12-11; 8:45 am]
BILLING CODE 6560-50-P
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