Acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), hydrolyzed; Tolerance Exemption, 52616-52619 [E8-20984]

Download as PDF 52616 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations Commodity Parts per million Watercress, upland ................... Wax jambu ................................ Yacon, tuber ............................. 0.2 0.2 0.2 * * * * * 13. Section 180.368 is amended by alphabetically adding the following commodities to the table in paragraph (a)(1) to read as follows: I § 180.368 Metolachlor; tolerances for residues. (a) * * * (1) * * * Commodity * * * * Dill ............................................. * * * * Grass, forage ............................ Grass, hay ................................ * * * * Okra .......................................... * * * * Spinach ..................................... Tomato ...................................... * * * * Parts per million * 0.50 * SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of acetic acid ethenyl ester, polymer with sodium 2methyl-2-[(1-oxo-2-propen-1-yl)amino]1-propanesulfonate (1:1), hydrolyzed (CAS No. 924892–37–5); when used as an inert ingredient in a pesticide chemical formulation. Celanese Ltd. 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 acetic acid ethenyl ester, polymer with sodium 2–methyl–2-[(1oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), hydrolyzed on food or feed commodities. This regulation is effective September 10, 2008. Objections and requests for hearings must be received * 0.50 on or before November 10, 2008, and * must be filed in accordance with the 0.50 instructions provided in 40 CFR part 0.10 178 (see also Unit I.C. of the * SUPPLEMENTARY INFORMATION). 10 0.20 * * * * * 14. Section 180.427 is amended by revising the section heading and paragraph (a) to read as follows: DATES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2008–0475. All documents in the docket are listed in the docket index § 180.427 Tau-Fluvalinate; tolerances for available at https://www.regulations.gov. residues. Although listed in the index, some (a) General. Tolerances are information is not publicly available, established for residues of the e.g., Confidential Business Information insecticide tau-fluvalinate, cyano-(3(CBI) or other information whose phenoxyphenyl)methyl N-[2-chloro-4disclosure is restricted by statute. (trifluoromethyl)phenyl]-D-valinate, in Certain other material, such as or on the following food commodities: copyrighted material, is not placed on the Internet and will be publicly Parts per Commodity million available only in hard copy form. Publicly available docket materials are Honey ....................................... 0.02 available in the electronic docket at https://www.regulations.gov, or, if only * * * * * available in hard copy, at the OPP [FR Doc. E8–20993 Filed 9–9–08; 8:45 am] Regulatory Public Docket in Rm. S– BILLING CODE 6560–50–S 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. ENVIRONMENTAL PROTECTION to 4 p.m., Monday through Friday, AGENCY excluding legal holidays. The Docket Facility telephone number is (703) 305– 40 CFR Part 180 5805. ADDRESSES: I jlentini on PROD1PC65 with RULES [EPA–HQ–OPP–2008–0475; FRL–8380–1] FOR FURTHER INFORMATION CONTACT: Acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), hydrolyzed; Tolerance Exemption Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: VerDate Aug<31>2005 16:26 Sep 09, 2008 Jkt 214001 Karen Samek, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 347–8825; e-mail address: samek.karen@epa.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 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 electronically available documents at https:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at https:// www.gpoaccess.gov/ecfr. C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, 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. 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–2008–0475 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 November 10, 2008. E:\FR\FM\10SER1.SGM 10SER1 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations jlentini on PROD1PC65 with RULES 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–2008–0475, 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 July 9, 2008 (73 FR 39289) (FRL–8371–2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 8E7364) filed by Celanese Ltd., 1601 West LBJ Freeway, Dallas, TX 75234. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of acetic acid ethenyl ester, polymer with sodium 2methyl-2-[(1-oxo-2-propen-1-yl)amino]1-propanesulfonate (1:1), hydrolyzed; CAS No. 924892–37–5. 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 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 VerDate Aug<31>2005 16:26 Sep 09, 2008 Jkt 214001 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 section 408(b)(2)(D) of 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 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). Acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), hydrolyzed conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 52617 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 of 61,000 daltons 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, acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), hydrolyzed 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 acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), hydrolyzed. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), hydrolyzed 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 acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), hydrolyzed is 61,000 daltons. Generally, a polymer of this size would be poorly E:\FR\FM\10SER1.SGM 10SER1 52618 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations absorbed through the intact gastrointestinal tract or through intact human skin. Since acetic acid ethenyl ester, polymer with sodium 2-methyl-2[(1-oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), hydrolyzed 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 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.’’ For the purposes of this tolerance action, EPA has not assumed that acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), hydrolyzed has a common mechanism of toxicity with other substances, based on the anticipated absence of mammalian toxicity. 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. jlentini on PROD1PC65 with RULES 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 database unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), hydrolyzed, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VerDate Aug<31>2005 16:26 Sep 09, 2008 Jkt 214001 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 acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), hydrolyzed. 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 Tolerances The Agency is not aware of any country requiring a tolerance for acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), hydrolyzed nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time. IX. Conclusion Accordingly, EPA finds that exempting residues of acetic acid ethenyl ester, polymer with sodium 2methyl-2-[(1-oxo-2-propen-1-yl)amino]1-propanesulfonate (1:1), hydrolyzed 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 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 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) (Public Law 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 E:\FR\FM\10SER1.SGM 10SER1 Federal Register / Vol. 73, No. 176 / Wednesday, September 10, 2008 / Rules and Regulations document, compared to the general population. DEPARTMENT OF HOMELAND SECURITY XI. Congressional Review Act Federal Emergency Management Agency jlentini on PROD1PC65 with RULES 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). 44 CFR Part 65 [Docket No. FEMA–B–1001] Changes in Flood Elevation Determinations Federal Emergency Management Agency, DHS. ACTION: Interim rule. AGENCY: SUMMARY: This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be List of Subjects in 40 CFR Part 180 calculated from the modified BFEs for new buildings and their contents. Environmental protection, Administrative practice and procedure, DATES: These modified BFEs are Agricultural commodities, Pesticides currently in effect on the dates listed in and pests, Reporting and recordkeeping the table below and revise the Flood Insurance Rate Maps (FIRMs) in effect requirements. prior to this determination for the listed Dated: August 29, 2008. communities. From the date of the second Donald R. Stubbs, publication of these changes in a Acting Director, Registration Division, Office newspaper of local circulation, any of Pesticide Programs. person has ninety (90) days in which to I Therefore, 40 CFR chapter I is request through the community that the amended as follows: Mitigation Assistant Administrator of FEMA reconsider the changes. The PART 180—[AMENDED] modified BFEs may be changed during the 90-day period. I 1. The authority citation for part 180 ADDRESSES: The modified BFEs for each continues to read as follows: community are available for inspection Authority: 21 U.S.C. 321(q), 346a and 371. at the office of the Chief Executive Officer of each community. The I 2. In §180.960, the table is amended respective addresses are listed in the by adding alphabetically the following table below. polymer to read as follows: FOR FURTHER INFORMATION CONTACT: § 180.960 Polymers; exemptions from the William R. Blanton, Jr., Engineering requirement of a tolerance. Management Branch, Mitigation Directorate, Federal Emergency * * * * * Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3151. Polymer CAS No. SUPPLEMENTARY INFORMATION: The * * * * * modified BFEs are not listed for each community in this interim rule. Acetic acid ethenyl ester, However, the address of the Chief polymer with sodium 2Executive Officer of the community methyl-2-[(1-oxo-2-propenwhere the modified BFE determinations 1-yl)amino]-1are available for inspection is provided. propanesulfonate (1:1), Any request for reconsideration must hydrolyzed, minimum numbe based on knowledge of changed ber average molecular weight (in amu), 61,000 .... 924892–37–5 conditions or new scientific or technical * * * * * data. The modifications are made pursuant to section 201 of the Flood Disaster [FR Doc. E8–20984 Filed 9–9–08; 8:45 am] Protection Act of 1973, 42 U.S.C. 4105, BILLING CODE 6560–50–S and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65. VerDate Aug<31>2005 16:26 Sep 09, 2008 Jkt 214001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 52619 For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals. The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP). These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by the other Federal, State, or regional entities. The changed BFEs are in accordance with 44 CFR 65.4. National Environmental Policy Act. This interim rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601–612, a regulatory flexibility analysis is not required. Regulatory Classification. This interim rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. Executive Order 13132, Federalism. This interim rule involves no policies that have federalism implications under Executive Order 13132, Federalism. Executive Order 12988, Civil Justice Reform. This interim rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 65 Flood insurance, Floodplains, Reporting and recordkeeping requirements. I Accordingly, 44 CFR part 65 is amended to read as follows: PART 65—[AMENDED] 1. The authority citation for part 65 continues to read as follows: I Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. E:\FR\FM\10SER1.SGM 10SER1

Agencies

[Federal Register Volume 73, Number 176 (Wednesday, September 10, 2008)]
[Rules and Regulations]
[Pages 52616-52619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20984]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0475; FRL-8380-1]


Acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-
oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), hydrolyzed; 
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 acetic acid ethenyl ester, polymer with 
sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate 
(1:1), hydrolyzed (CAS No. 924892-37-5); when used as an inert 
ingredient in a pesticide chemical formulation. Celanese Ltd. 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 acetic acid ethenyl ester, polymer with sodium 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), 
hydrolyzed on food or feed commodities.

DATES: This regulation is effective September 10, 2008. Objections and 
requests for hearings must be received on or before November 10, 2008, 
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-2008-0475. 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: Karen Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; e-mail address: samek.karen@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 electronically available documents at 
https://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at https://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR site at https://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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. 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-2008-0475 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 November 10, 2008.

[[Page 52617]]

    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-2008-0475, 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 July 9, 2008 (73 FR 39289) (FRL-8371-2), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
announcing the receipt of a pesticide petition (PP 8E7364) filed by 
Celanese Ltd., 1601 West LBJ Freeway, Dallas, TX 75234. The petition 
requested that 40 CFR 180.960 be amended by establishing an exemption 
from the requirement of a tolerance for residues of acetic acid ethenyl 
ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonate (1:1), hydrolyzed; CAS No. 924892-37-5. 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 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 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 section 408(b)(2)(D) of 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 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). Acetic acid ethenyl ester, polymer with 
sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate 
(1:1), hydrolyzed 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 of 61,000 daltons 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, acetic acid ethenyl ester, polymer with sodium 2-methyl-2-
[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), hydrolyzed 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 acetic acid ethenyl ester, polymer with sodium 2-methyl-2-
[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), hydrolyzed.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that acetic acid ethenyl ester, polymer with 
sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate 
(1:1), hydrolyzed 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 acetic acid 
ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1-
yl)amino]-1-propanesulfonate (1:1), hydrolyzed is 61,000 daltons. 
Generally, a polymer of this size would be poorly

[[Page 52618]]

absorbed through the intact gastrointestinal tract or through intact 
human skin. Since acetic acid ethenyl ester, polymer with sodium 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1), 
hydrolyzed 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

    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.'' For the purposes 
of this tolerance action, EPA has not assumed that acetic acid ethenyl 
ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonate (1:1), hydrolyzed has a common mechanism of toxicity 
with other substances, based on the anticipated absence of mammalian 
toxicity. 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.

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 database unless EPA concludes that 
a different margin of safety will be safe for infants and children. Due 
to the expected low toxicity of acetic acid ethenyl ester, polymer with 
sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate 
(1:1), hydrolyzed, 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 acetic acid ethenyl ester, polymer 
with sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate 
(1:1), hydrolyzed.

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 Tolerances

    The Agency is not aware of any country requiring a tolerance for 
acetic acid ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-
propen-1-yl)amino]-1-propanesulfonate (1:1), hydrolyzed nor have any 
CODEX Maximum Residue Levels (MRLs) been established for any food crops 
at this time.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of acetic acid 
ethenyl ester, polymer with sodium 2-methyl-2-[(1-oxo-2-propen-1-
yl)amino]-1-propanesulfonate (1:1), hydrolyzed 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) (Public Law 
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

[[Page 52619]]

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: August 29, 2008.
Donald R. Stubbs,
Acting 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. In Sec. 180.960, the table is amended by adding alphabetically the 
following polymer to read as follows:


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

* * * * *

------------------------------------------------------------------------
                         Polymer                              CAS No.
------------------------------------------------------------------------
                                * * * * *
Acetic acid ethenyl ester, polymer with sodium 2-methyl-     924892-37-5
 2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate
 (1:1), hydrolyzed, minimum number average molecular
 weight (in amu), 61,000................................
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E8-20984 Filed 9-9-08; 8:45 am]
 BILLING CODE 6560-50-S