E6-5399. Tetrahydrofurfuryl Alcohol (THFA); Proposed Action on Tolerance Exemption

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

This document proposes under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(e)(1) to revoke the existing exemption from the requirement of a tolerance for residues of the inert ingredient tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No. 97-99-4) under 40 CFR 180.910 because it does not meet the safety requirements of FFDCA section 408(b)(2). While EPA has determined that dietary risks from use of THFA exceed the Agency's level of concern, limited uses of THFA may be permitted. Therefore, EPA is also proposing to establish for THFA an exemption from the requirement of a tolerance under 40 CFR 180.1263 that includes use limitations. 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 one tolerance which would be counted as tolerance reassessment toward the August 2006 review deadline.

DATES:

Comments must be received on or before June 12, 2006.

ADDRESSES:

Submit your comments, identified by Docket identification number (ID) No. EPA-HQ-OPP-2006-0251, by one of the following methods:

• http:/ /www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail. Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery. Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-2006-0251. The docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the docket facility is [phone]. Such deliveries are only accepted during the Docket'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-HQ- OPP-2006-0251. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulatioris.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 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 public 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. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.

Docket. All documents in the docket are listed in the regulations.gov 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, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov/​ or in hard copy at the Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This Docket Facility is open 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: 703-306-0404; 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 www.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.

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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.

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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 FFDCA section 408(q), as amended by the FQPA. Inert ingredient chemicals must meet a high safety standard in order to merit an exemption from the numerical residue limitations that are imposed in a tolerance.

-1. In evaluating the inert ingredient THFA, the Agency has determined that dietary risks of concern may result from the use of THFA under the current tolerance exemption in 40 CFR 180.910, which allows an unlimited amount of THFA to be applied to growing crops and raw agricultural commodities after harvest.

-The hazard characterization of THFA shows effects of concern. Consistent systemic effects from repeated dermal and oral exposure to THFA include decreased body weight and body weight gain. Effects were consistent over species and routes of exposure. While no neurotoxicity studies were performed, whole body spasms were reported in the subchronic inhalation study

.

-Developmental and reproductive effects of concern have been identified. Alterations in the male reproductive system from subchronic exposure to THFA also indicates a concern for alterations in the developing male reproductive system. The available data show there is evidence of increased susceptibility (both quantitative and qualitative) of the offspring after in utero exposure to THFA, including decreased fetal body weights.

-The screening level dietary exposure assessment showed that the risks were above the Agency's level of concern for the general population and the most highly exposed sub-population (children 1 to 2 years old). Because of these risk levels, the unlimited exemption from a tolerance as is currently granted to THFA under 40 CFR 180.910 does not meet the safety requirements of FFDCA section 408(b)(2). Therefore, EPA is proposing to revoke the existing THFA tolerance exemption, revocation to be effective 18 months after publication of the final rule.

-The assessment documents for THFA are available electronically under EPA-HQ-OPP-2006-0251 at http://www.regulations.gov.

2. EPA has identified uses of THFA that do not pose risks of concern. EPA is proposing to establish a tolerance exemption under § 180.1263 that permits:

(1) Use as a seed treatment,

(2) Application at the time of planting,

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(3) Application to cotton, and,

(4) Use in herbicides with one application to wheat and barley prior to the pre-boot stage.

These limitations significantly reduce the number of times that THFA may be applied per season - often to one application only -- and, therefore, reduce the potential for dietary exposures below the Agency's level of concern. Contributions to surface/drinking water are not anticipated from the use of THFA-containing pesticide products under the proposed use limitations considering THFA's physical-chemical properties and biodegradation potential in the environment. No residential risks of concern are anticipated at this time for the new tolerance exemption.

i. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

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 THFA and any other substances and THFA 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 THFA 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/.

ii. Determination of safety for U.S. population, infants and children. Considering that dietary (food and drinking water) and residential risks are not of concern under the use limitations of the new exemption, EPA finds that exempting THFA with the limitations in § 180.1263 will be safe for the general population including infants and children.

iii. Analytical enforcement methodology. An analytical method is not required for the new tolerance exemption for enforcement purposes because the Agency is establishing an exemption from the requirement of a tolerance.

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 of FFDCA, 21 U.S.C. 346a, as amended by the FQPA of 1996, Public Law 104-170, 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. 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 THFA's current tolerance exemption in 40 CFR 180.910, 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 THFA, 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.

EPA is proposing that the establishment of a new tolerance exemption under § 180.1263 for use of THFA will become effective on the date of publication of the final rule in the Federal Register. Applications for new pesticide products that include THFA will be subject to the limitations of the new tolerance exemption as of the date of publication of the final rule in the Federal Register.

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 place an 18 month expiration date on 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 (0MB) 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 0MB 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 0MB 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 6, 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 180.910 is amended by revising the entry for Tetrahydrofurfuryl alcohol in the table to read as follows:

§ 180.910

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

* * * * *

Inert ingredients	Limits	Uses
*    *    *     *    *    *    *
Tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No 97-99-4)	Expires [insert date 18 months after date of publication of the Final rule in the Federal Register]	Solvent/cosolvent
*    *    *    *    *    *    *

* * * * *

3. Section 180.1263 is added to subpart D to read as follows:

§ 180.1263

Tetrahydrofurfuryl alcohol; exemption from the requirement of a tolerance.

Tetrahydrofurfuryl alcohol (THFA, CAS Reg. No. 97-99-4) is exempt from the requirement of a tolerance in or on all raw agricultural commodities when used in accordance with good agricultural practices as an inert ingredient applied only:

(a) For use as a seed treatment.

(b) For application at the time of planting.

(c) For use on cotton.

(d) For use in herbicides with one application to wheat and barley prior to the pre-boot stage.