E6-5883. Mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where the alkyl group is even numbered and in the C6-C12 range; Proposed Revocation of Pesticide Inert Ingredient Tolerance Exemption

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

This document proposes to revoke, under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(e)(1), the existing exemption from the requirement of a tolerance for residues of the inert ingredient mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where the alkyl group is even numbered and in the C6-C12 range under 40 CFR 180.920 because EPA cannot determine that it meets the safety requirements of FFDCA section 408(b)(2). The regulatory action proposed in this document contributes toward the Agency's tolerance reassessment requirements under FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances that were in existence on August 2, 1996. The regulatory action proposed in this document pertains to the proposed revocation of 1 tolerance which would be counted as tolerance reassessment toward the August 2006 review deadline.

DATES:

Comments must be received on or before June 19, 2006. Revocation would be effective 18 months after publication of the final rule.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0253, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: OPP Regulatory Public Docket, Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is [phone].
• Important Note: OPP will be moving to a new location the first week of May 2006. As a result, from Friday, April 28 to Friday, May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any deliveries at the Crystal Mall #2 address and this facility will be closed to the public. Beginning on May 8, 2006, the OPP Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202. The mail code for the mailing address will change to (7502P), but will otherwise remain the same. The OPP Regulatory Public Docket telephone number and hours of operation will remain the same after the move.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2006-0253. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://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 protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., 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 at the location identified under “Delivery” and “Important Note.” The hours of operation for this docket facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Karen Angulo, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II. 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. What Should I Consider as I Prepare My Comments for EPA?

-1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

-2. Tips for preparing your comments. When submitting comments, remember to:

-i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

- ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

-iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

-iv. Describe any assumptions and provide any technical information and/or data that you used.

-v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

-vi. Provide specific examples to illustrate your concerns and suggest alternatives.

-vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

-viii. Make sure to submit your comments by the comment period deadline identified.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

-EPA is now in the process of reassessing all inert ingredient exemptions from the requirement of a tolerance (tolerance exemptions) established prior to August 2, 1996, as required by the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q). Under section 408(q), tolerance reassessment may lead to regulatory action under section 408(e)(1). When taking action under section 408(e)(1), EPA may leave a tolerance exemption in effect only if the Agency determines that the tolerance exemption is safe.

-The existing tolerance exemption under 40 CFR 180.920 for the inert ingredient mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where the alkyl group is even numbered and in the C6-C12 range allows for its use as a defoaming agent at not more than 0.5% of pesticide formulation. Due to potential risk from use of these perfluoroalkyl phosphates EPA is proposing to revoke the tolerance exemption at 180.920 under FFDCA section 408(e)(1) because the Agency is unable to determine that the tolerance exemption meets the safety requirements of FFDCA section 408(c)(2).

-It has been demonstrated that compounds containing perfluoroalkyl chains (PFAC), such as the perfluoroalkyl phosphates described in § 180.920 will undergo degradation (chemical, microbial, or photolytic) of the non-fluorinated portion of the molecule leaving the remaining perfluorinated acid untouched (Ref.: A. Remde and R. Debus, Biodegradability of Fluorinated Surfactants Under Aerobic and Anaerobic Conditions, Chemosphere, 32(8), 1563-1574 (1996)). Among the degradation compounds that can be produced is perfluorooctanoic acid (PFOA). Further degradation of the perfluoroalkyl residual compounds is extremely difficult.

-EPA has received significant and troubling data on PFOA. Biological sampling recently revealed the presence of PFOA in fish, birds, and mammals, including humans, across the United States and in other countries. The widespread distribution of the chemical suggests that PFOA may bioaccumulate. PFOA has shown liver, developmental, and reproductive toxicity at very low dose levels in exposed laboratory animals (Ref.: (AR226-1093) Seed, Jennifer. Hazard Assessment of Perfluorooctanoic Acid and Its Salts-USEPA/EPA/RAD. Washington, DC. November 4, 2002.).

-EPA issued a draft preliminary risk assessment on PFOA in April 2003, and simultaneously initiated an enforceable consent agreement (ECA) process under section 4 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2603, and 40 CFR part 790 to develop information on the sources of PFOA in the environment and the pathways leading to exposure in order to reduce uncertainties in the assessment. (68 FR 18626, April 16, 2003 (FRL-7303-8)). The ECA process and PFOA risk assessment activity are still underway.

-On January 25, 2006, EPA invited fluoropolymer and telomer manufacturers doing business in the United States to participate in a global stewardship program on PFOA and related chemicals. Participating companies will commit to reducing PFOA, PFOA precursors (meaning chemicals that can degrade to PFOA), and higher homologues from facility emissions and product content by 95 percent no later than 2010, and to work toward eliminating these chemicals from emissions and product content no later than 2015. More information on the global stewardship program, the enforceable consent agreement process, the PFOA risk assessment, and PFOA in general is found at: http://www.epa.gov/​oppt/​pfoa.

-On March 7, 2006, EPA published a proposal to amend the polymer exemption rule to exclude certain perfluorinated polymers (71 FR 11484, March 7, 2006, FRL-7735-5). EPA believes this change to the current regulation is necessary because, based on recent information, including the data on PFOA and the potential for these perfluorinated polymers to degrade to PFOA, EPA can no longer conclude that these polymers will not present an unreasonable risk to human health or the environment, which is the determination necessary to support an exemption under section 5(h)(4) of TSCA, 15 U.S.C. 2604(h)(4), such as the Polymer Exemption Rule.

-Because (1) PFOA and other PFACs are produced from the degradation of the perfluoroalkyl phosphates described in § 180.920 and (2) the potential risks to human health and the environment associated with PFOA, EPA is unable to determine that there is a reasonable certainty that no harm will result from exposure residues of the perfluoroalkyl phosphates described in § 180.920. Therefore, the tolerance exemption does not meet requirements of FFDCA section 408(c)(2), and EPA is proposing to revoke this tolerance exemption in § 180.920 in accordance with FFDCA section 408(e)(1).

B. What is the Agency's Authority for Taking this Action?

-A tolerance represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408(e) of FFDCA, 21 U.S.C. 346a(e) authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Pursuant to section 408(c)(2), in action under section 408(e)(1), EPA may leave in effect an exemption from the requirement for a tolerance only if the Agency determines that the exemption is safe. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under section 402(a) of the FFDCA, 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States.

C. When do These Actions Become Effective?

-EPA is proposing to revoke the current tolerance exemption Mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where the alkyl group is even numbered and in the C6-C12 range in 40 CFR 180.920 effective 18 months after the date of publication of the final rule in the Federal Register. Any commodities listed in this proposal treated with pesticide products containing the inert ingredient, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residues of these pesticide chemicals in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:

1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and

2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?

-By law, EPA is required by August 2006 to reassess the tolerances and exemptions from tolerances that were in existence on August 2, 1996. This document proposes to revoke one inert ingredient tolerance exemption, which will be counted in a final rule as a tolerance reassessment toward the August 2006 review deadline under FFDCA section 408(q), as amended by FQPA in 1996.

III. Are the Proposed Actions Consistent with International Obligations?

-The tolerance revocation in this proposal is not discriminatory and is designed to ensure that both domestically-produced and imported foods meet the food safety standard established by the FFDCA. The same food safety standards apply to domestically produced and imported foods.

-EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. It is EPA's policy to harmonize U.S. tolerances with Codex MRLs to the extent possible, provided that the MRLs achieve the level of protection required under FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Decision documents. EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov. On the Home Page select “Laws, Regulations, and Dockets,” then select “Regulations and Proposed Rules” and then look up the entry for this document under “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr.

IV. Statutory and Executive Order Reviews

-This proposed rule establishes a tolerance 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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 proposed 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).

-Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this proposed rule, the Agency hereby certifies that this proposed action will not have a significant negative economic impact on a substantial number of small entities. Specifically, the Agency has concluded in a memorandum dated May 25, 2001 that for import tolerance revocation there is a negligible joint probability of certain defined conditions holding simultaneously which would indicate an RFA/SBREFA concern and require more analysis. (This Agency document is available in the docket of this proposed rule). Furthermore, for the pesticide named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change the EPA's previous analysis. Any comments about the Agency's determination should be submitted to the EPA along with comments on the proposal, and will be addressed prior to issuing a final rule.

-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 proposed 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 proposed 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 proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

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

Dated: April 12, 2006.

Donald R. Stubbs,

Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

PART 180—[AMENDED]

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

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

-2. Section 180.920 is amended by revising the entry for Mono- and bis-(1H, 1H, 2H, 2H- perfluoroalkyl) phosphates where the alkyl group is even numbered and in the C6-C12 range in the table as follows:

§ 180.920

Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.

* * *

Inert ingredients	Limits	Uses
*    *    *    *    *    *     *
Mono- and bis-(1H, 1H, 2H, 2H-perfluoroalkyl) phosphates where the alkyl group is even numbered and in the C6-C12 range	Expires [insert date 18 months after the date of publication of the final rule in the Federal Register] Not more than 0.5% of pesticide formulation.	Defoaming agent.
*    *    *    *    *    *     *