Acetic Acid Ethenyl Ester, Polymer with 1-Ethenyl-2-Pyrrolidinone; Tolerance Exemption, 58518-58521 [E6-16184]

Download as PDF 58518 Federal Register / Vol. 71, No. 192 / Wednesday, October 4, 2006 / Rules and Regulations regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.’’ This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final 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: September 25, 2006. Lois Rossi, Director, Registration Division, Office Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.468 is amended by alphabetically adding the commodity to the table in the undesignated text to read as follows: erjones on PROD1PC72 with RULES I §180.468 Flumetsulam: tolerances for residues. * * * VerDate Aug<31>2005 * * 14:25 Oct 03, 2006 Jkt 211001 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. Beans (dry) ........... 0.05 to 4 p.m., Monday through Friday, * * * * * excluding legal holidays. The Docket Facility telephone number is (703) 305– [FR Doc. E6–16271 Filed 10–3–06; 8:45 am] 5805. BILLING CODE 6560–50–S FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division (7505P), Office of Pesticide Programs, ENVIRONMENTAL PROTECTION Environmental Protection Agency, 1200 AGENCY Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 40 CFR Part 180 (703) 308–8380; e-mail address: [EPA–HQ–OPP–2006–0368; FRL–8092–5] gandhi.bipin@epa.gov. SUPPLEMENTARY INFORMATION: Acetic Acid Ethenyl Ester, Polymer with 1-Ethenyl-2-Pyrrolidinone; I. General Information Tolerance Exemption A. Does this Action Apply to Me? AGENCY: Environmental Protection You may be potentially affected by Agency (EPA). this action if you are an agricultural ACTION: Final rule. producer, food manufacturer, or SUMMARY: This regulation establishes an pesticide manufacturer. Potentially exemption from the requirement of a affected entities may include, but are tolerance for residues of acetic acid not limited to: ethenyl ester, polymer with 1-ethenyl-2• Crop production (NAICS code 111). • Animal production (NAICS code pyrrolidinone; when used as an inert 112). ingredient in a pesticide chemical • Food manufacturing (NAICS code formulation. BASF Corporation 311). submitted a petition to EPA under the • Pesticide manufacturing (NAICS Federal Food, Drug, and Cosmetic Act code 32532). (FFDCA), as amended by the Food This listing is not intended to be Quality Protection Act of 1996 (FQPA) exhaustive, but rather provides a guide requesting an exemption from the for readers regarding entities likely to be requirement of a tolerance. This affected by this action. Other types of regulation eliminates the need to entities not listed in this unit could also establish a maximum permissible level be affected. The North American for residues of acetic acid ethenyl ester, Industrial Classification System polymer with 1-ethenyl-2(NAICS) codes have been provided to pyrrolidinone. assist you and others in determining DATES: This regulation is effective whether this action might apply to October 4, 2006. Objections and certain entities. If you have any requests for hearings must be received questions regarding the applicability of on or before December 4, 2006, and this action to a particular entity, consult must be filed in accordance with the the person listed under FOR FURTHER instructions provided in 40 CFR part INFORMATION CONTACT. 178 (see also Unit I.C. of the B. How Can I Access Electronic Copies SUPPLEMENTARY INFORMATION). of this Document? ADDRESSES: EPA has established a docket for this action under docket In addition to accessing an electronic identification (ID) number EPA–HQ– copy of this Federal Register document OPP–2006–0368. All documents in the through the electronic docket at https:// docket are listed in the index for the www.regulations.gov, you may access docket. Although listed in the index, this ‘‘Federal Register’’ document some information is not publicly electronically through the EPA Internet available, e.g., Confidential Business under the ‘‘Federal Register’’ listings at Information (CBI) or other information https://www.epa.gov/fedrgstr. You may whose disclosure is restricted by statute. also access a frequently updated Certain other material, such as electronic version of 40 CFR part 180 copyrighted material, is not placed on through the Government Printing the Internet and will be publicly Office’s pilot e-CFR site at https:// available only in hard copy form. www.gpoaccess.gov/ecfr. Publicly available docket materials are C. Can I File an Objection or Hearing available in the electronic docket at Request? https://www.regulations.gov, or, if only available in hard copy, at the OPP Under section 408(g) of FFDCA, as Regulatory Public Docket in Rm. S– amended by FQPA, any person may file 4400, One Potomac Yard (South Bldg.), an objection to any aspect of this PO 00000 Commodity Frm 00034 Fmt 4700 Parts per million Sfmt 4700 E:\FR\FM\04OCR1.SGM 04OCR1 Federal Register / Vol. 71, No. 192 / Wednesday, October 4, 2006 / Rules and Regulations regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2006–0368 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 December 4, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA–HQ–OPP–2006–0368, 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’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. erjones on PROD1PC72 with RULES II. Background and Statutory Findings In the Federal Registerof June 28, 2006 (71 FR 36792) (FRL–8073–3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104–170), announcing the filing of a pesticide petition (PP 6E7063) by BASF Corporation, 100 Campus Dr., Florham Park, NJ 07932. 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 1-ethenyl-2-pyrrolidinone (CAS No. 25086–89–9). That notice included a summary of the petition prepared by VerDate Aug<31>2005 14:25 Oct 03, 2006 Jkt 211001 the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...’’ and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ‘‘inert’’ is not intended to imply non-toxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 58519 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 that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). 1. The polymer, acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone, 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, nitrogen 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, acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). E:\FR\FM\04OCR1.SGM 04OCR1 58520 Federal Register / Vol. 71, No. 192 / Wednesday, October 4, 2006 / Rules and Regulations 7. The polymer’s number average MW of 35,000 is greater than 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. Thus, acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone meets all 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 1ethenyl-2-pyrrolidinone. erjones on PROD1PC72 with RULES V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that acetic acid ethenyl ester, polymer with 1ethenyl-2-pyrrolidinone could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational, nondietary exposure was possible. The number average MW of acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone is 35,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone conforms to the criteria that identifies a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular chemical’s residues and ‘‘other substances that have a common mechanism of toxicity.’’ EPA does not have, at this time, available data to determine whether acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone and any other substances and acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone does not appear to produce a toxic metabolite as VerDate Aug<31>2005 14:25 Oct 03, 2006 Jkt 211001 produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at https:// www.epa.gov/pesticides/cumulative. VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the 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 1-ethenyl-2pyrrolidinone, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for acetic acid ethenyl ester, polymer with 1ethenyl-2-pyrrolidinone nor have any CODEX Maximum Residue Levels PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 (MRLs) been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104–4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, E:\FR\FM\04OCR1.SGM 04OCR1 Federal Register / Vol. 71, No. 192 / Wednesday, October 4, 2006 / Rules and Regulations erjones on PROD1PC72 with RULES or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.’’ ‘‘Policies that have federalism implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any ‘‘tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.’’ This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the VerDate Aug<31>2005 14:25 Oct 03, 2006 Jkt 211001 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: September 25, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: I PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: I Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.960, the table is amended by adding the following entry in alphabetically order to read as follows: I § 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * Polymer * * Acetic acid ethenyl ester, polymer with 1-ethenyl-2pyrrolidinone * * CAS No. * * * 25086–89–9 * * * [FR Doc. E6–16184 Filed 10–3–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 281 [EPA–R01–UST–2006–0622; FRL–8226–5] New Hampshire: Final Approval of Underground Storage Tank Program Revisions Environmental Protection Agency (EPA). ACTION: Immediate final rule. AGENCY: SUMMARY: The State of New Hampshire has amended the regulations previously approved by EPA under Subtitle I of the Resource Conservation and Recovery Act (RCRA). EPA has determined that PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 58521 these amendments satisfy all requirements needed for program approval and is approving the State’s changes through this immediate final action. EPA is publishing this rule to approve the changes without a prior tentative determination because we believe this action is not controversial and do not expect comments that oppose it. Unless we get written comments which oppose this approval during the comment period, the decision to approve New Hampshire’s amendments to its underground storage tank (UST) program will take effect as provided below. If we receive comments that oppose this action, we will publish a document in the Federal Register withdrawing this rule before it takes effect, and the separate document in the proposed rules section of this Federal Register will serve as the proposal to approve the amendments. DATES: This approval will become effective on December 4, 2006, unless EPA receives adverse written comment by November 3, 2006. If EPA receives such comment, it will publish a timely withdrawal of this immediate final rule in the Federal Register and inform the public that this approval will not take immediate effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R01– UST–2006–0622, by one of the following methods: • www.regulations.gov: Follow the on-line instructions for submitting comments. • E-mail: hanamoto.susan@epa.gov. • Mail: Susan Hanamoto, Office of Underground Storage Tanks, EPA Region I, One Congress Street, Suite 1100 (Mail Code: HBO), Boston, MA 02114–2023. • Hand Delivery: Susan Hanamoto, Office of Underground Storage Tanks, EPA Region I, One Congress Street, Suite 1100 (Mail Code: HBO), Boston, MA 02114–2023. Such deliveries are only accepted during the EPA’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Docket ID No. EPA–R01–UST–2006– 0622. EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise E:\FR\FM\04OCR1.SGM 04OCR1

Agencies

[Federal Register Volume 71, Number 192 (Wednesday, October 4, 2006)]
[Rules and Regulations]
[Pages 58518-58521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-16184]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0368; FRL-8092-5]


Acetic Acid Ethenyl Ester, Polymer with 1-Ethenyl-2-
Pyrrolidinone; 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 
1-ethenyl-2-pyrrolidinone; when used as an inert ingredient in a 
pesticide chemical formulation. BASF Corporation submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA) requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of acetic acid ethenyl ester, polymer with 1-ethenyl-2-
pyrrolidinone.

DATES: This regulation is effective October 4, 2006. Objections and 
requests for hearings must be received on or before December 4, 2006, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0368. All documents in the 
docket are listed in the index for the docket. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as 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: Bipin Gandhi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8380; e-mail address: gandhi.bipin@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings 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 pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this

[[Page 58519]]

regulation and may also request a hearing on those objections. The EPA 
procedural regulations which govern the submission of objections and 
requests for hearings appear in 40 CFR part 178. You must file your 
objection or request a hearing on this regulation in accordance with 
the instructions provided in 40 CFR part 178. To ensure proper receipt 
by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0368 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 December 4, 2006.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0368, 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'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 Registerof June 28, 2006 (71 FR 36792) (FRL-8073-3), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA (Public Law 104-170), announcing the filing of a 
pesticide petition (PP 6E7063) by BASF Corporation, 100 Campus Dr., 
Florham Park, NJ 07932. 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 1-
ethenyl-2-pyrrolidinone (CAS No. 25086-89-9). That notice included a 
summary of the petition prepared by the petitioner. There were no 
comments in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing an exemption from the 
requirement of a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue...'' and specifies 
factors EPA is to consider in establishing an exemption.

III. Inert Ingredient Definition

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

IV. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be shown that the risks from aggregate 
exposure to pesticide chemical residues under reasonably foreseeable 
circumstances will pose no appreciable risks to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a finite tolerance is not necessary to ensure that there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the inert ingredient, an exemption from the requirement of 
a tolerance may be established.
    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. In the case of certain chemical substances that 
are defined as polymers, the Agency has established a set of criteria 
to identify categories of polymers that should present minimal or no 
risk. The definition of a polymer is given in 40 CFR 723.250(b). The 
following exclusion criteria for identifying these low-risk polymers 
are described in 40 CFR 723.250(d).
    1. The polymer, acetic acid ethenyl ester, polymer with 1-ethenyl-
2-pyrrolidinone, 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, nitrogen 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, acetic acid ethenyl ester, polymer with 
1-ethenyl-2-pyrrolidinone, also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).

[[Page 58520]]

    7. The polymer's number average MW of 35,000 is greater than 10,000 
daltons. The polymer contains less than 2% oligomeric material below MW 
500 and less than 5% oligomeric material below MW 1,000.
    Thus, acetic acid ethenyl ester, polymer with 1-ethenyl-2-
pyrrolidinone meets all 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 1-ethenyl-2-pyrrolidinone.

V. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that acetic acid ethenyl ester, polymer with 
1-ethenyl-2-pyrrolidinone 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 1-ethenyl-2-pyrrolidinone is 35,000 
daltons. Generally, a polymer of this size would be poorly absorbed 
through the intact gastrointestinal tract or through intact human skin. 
Since acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone 
conforms to the criteria that identifies a low-risk polymer, there are 
no concerns for risks associated with any potential exposure scenarios 
that are reasonably foreseeable. The Agency has determined that a 
tolerance is not necessary to protect the public health.

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.'' EPA does not 
have, at this time, available data to determine whether acetic acid 
ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone has a common 
mechanism of toxicity with other substances. Unlike other pesticides 
for which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to acetic acid ethenyl ester, polymer with 1-ethenyl-2-
pyrrolidinone and any other substances and acetic acid ethenyl ester, 
polymer with 1-ethenyl-2-pyrrolidinone does not appear to produce a 
toxic metabolite as produced by other substances. For the purposes of 
this tolerance action, therefore, EPA has not assumed that acetic acid 
ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone has a common 
mechanism of toxicity with other substances. For information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at https://www.epa.gov/pesticides/cumulative.

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

    Section 408 of FFDCA provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the 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 1-
ethenyl-2-pyrrolidinone, EPA has not used a safety factor analysis to 
assess the risk. For the same reasons the additional tenfold safety 
factor is unnecessary.

VIII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no 
harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of acetic acid ethenyl ester, polymer 
with 1-ethenyl-2-pyrrolidinone.

IX. Other Considerations

A. Endocrine Disruptors

    There is no available evidence that acetic acid ethenyl ester, 
polymer with 1-ethenyl-2-pyrrolidinone is an endocrine disruptor.

B. Analytical Enforcement Methodology

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

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone nor 
have any CODEX Maximum Residue Levels (MRLs) been established for any 
food crops at this time.

X. Conclusion

    Accordingly, EPA finds that exempting residues of acetic acid 
ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone from the 
requirement of a tolerance will be safe.

XI. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States,

[[Page 58521]]

or on the distribution of power and responsibilities among the various 
levels of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This action does not alter the relationships or distribution of 
power and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of FFDCA. For these same reasons, the 
Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 25, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


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


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

* * * * *

------------------------------------------------------------------------
                  Polymer                              CAS No.
------------------------------------------------------------------------
                                * * * * *
Acetic acid ethenyl ester, polymer with 1-  25086-89-9
 ethenyl-2-pyrrolidinone
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E6-16184 Filed 10-3-06; 8:45 am]
BILLING CODE 6560-50-S
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