Source: https://www.federalregister.gov/documents/2007/02/28/E7-3118/2-propenoic-acid-methyl-ester-polymer-with-ethenyl-acetate-hydrolyzed-sodium-salts-tolerance
Timestamp: 2018-03-22 10:50:09
Document Index: 630926963

Matched Legal Cases: ['art 178', 'art 180', 'art 178', 'art 178', 'art 178', 'art 2', '§\u2009180']

Federal Register :: 2-Propenoic Acid, Methyl Ester, Polymer with Ethenyl Acetate, Hydrolyzed, Sodium Salts; Tolerance Exemption
A Rule by the Environmental Protection Agency on 02/28/2007
This regulation is effective February 28, 2007. Objections and requests for hearings must be received on or before April 30, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
EPA-HQ-OPP-2006-0603 FRL-8114-9
https://www.federalregister.gov/d/E7-3118 https://www.federalregister.gov/d/E7-3118
This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts (CAS Reg. No. 886993-11-9) when used as an inert ingredient in a pesticide chemical formulation. MonoSol, LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA) requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0603. 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 http://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 Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.
In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this “Federal Register” document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. You may Start Printed Page 8914also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/​ecfr.
Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0603 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 April 30, 2007.
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-2006-0603, by one of the following methods.
In the Federal Register of July 26, 2006 (71 FR 42393) (FRL-8079-5), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 6E7085) by MonoSol, LLC, 1701 County Line Road, Portage, IN 46368. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts; CAS Reg. No. 886993-11-9. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing.
1. The polymer, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, 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, sodium, and oxygen.
5. The polymer is manufactured or imported from monomers and/or Start Printed Page 8915reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
Additionally, the polymer, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's number average MW is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000.
Thus, 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts.
For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is 36,200 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts 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.
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 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts and any other substances and 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts 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 http://www.epa.gov/​pesticides/​cumulative.
Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts.
There is no available evidence that 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts is an endocrine disruptor.
The Agency is not aware of any country requiring a tolerance for 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.
Accordingly, EPA finds that exempting residues of 2-propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts from the requirement of a tolerance will be safe.
This final rule establishes an exemption from the tolerance requirement under section 408(d) of the 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, Start Printed Page 8916entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
Authority: 1 U.S.C. 321(q), 346a and 371.
2. In § 180.960 the table is amended by alphabetically adding a polymer to read as follows:
2-Propenoic acid, methyl ester, polymer with ethenyl acetate, hydrolyzed, sodium salts. 886993-11-9
[FR Doc. E7-3118 Filed 2-27-07; 8:45 am]