E6-12591. Inert Ingredient; Revocation of the Tetrahydrofurfuryl Alcohol (THFA) Tolerance Exemption

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is revoking, 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 “Tetrahydrofurfuryl alcohol” (THFA) under 40 CFR 180.910, and establishes a limited tolerance for THFA under 40 CFR 180.1263. The regulatory action 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. This regulatory action counts as a tolerance reassessment toward the August 2006 review deadline.

DATES:

This rule is effective February 9, 2008.

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0251. 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 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 telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Karen Angulo, Registration Division (7505P), 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. 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 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 also 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.

C. Can I File an Objection or Hearing Request?

-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-2006-0251 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 October 10, 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-2006-0251, 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 (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 Drive, 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].

II. Background and Statutory Findings

A. What Action is the Agency Taking?

-On April 12, 2006, EPA published in the Federal Register (71 FR 18689; FRL-7771-3) proposed actions for the inert ingredient tetrahydrofurfuryl alcohol (THFA). This final rule revokes the exemption from the requirement of a tolerance for THFA under 40 CFR 180.910 and establishes a limited tolerance exemption for THFA under 40 CFR 180.1263. In evaluating THFA, EPA 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, including significant developmental and reproductive effects from repeated oral exposures. 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 Agency concluded that THFA's unlimited tolerance exemption under 40 CFR 180.910 does not meet the safety requirements of FFDCA section 408(b)(2), and proposed the revocation of the tolerance exemption 18 months after the publication of the final rule in the Federal Register. In the same document, EPA proposed to establish a new exemption under 40 CFR 180.1263 for applications to cotton, use with herbicides with one application to wheat and barley prior to the pre-boot stage, for use as a seed treatment, and applications at the time of planting.

-EPA's responses to comments received on the proposed rule are given in Unit II.B. EPA maintains its conclusion that THFA's tolerance exemption under 40 CFR 180.910 does not meet the safety standard of FFDCA section 408(b)(2), therefore, this tolerance exemption is revoked in this final rule. The revocation will take effect 18 months after the publication date of this final rule in the Federal Register.

- EPA has evaluated the scope of the new limited THFA tolerance exemption under 40 CFR 180.1263 and has added limited uses on canola, soybeans, and field corn, and has clarified that applications will now be permitted prior to planting. EPA finds that exempting THFA with the limitations in 40 CFR 180.1263 will be safe for the general population including infants and children.

B. EPA's Responses to Comments

-1. Applications at the time of planting. Several commentors requested the proposed use of THFA “at-plant” be expanded to include all applications prior to planting. EPA agrees. The proposed limitation “For application at the time of planting.” under 40 CFR 180.1263 is replaced with “For applications prior to planting and at the time of planting.” This includes uses such as applications made in preparation for the planting of the crop, in the furrow during planting of seeds and transplants, and to the soil surface at the time of planting. This small expansion of the proposed limitation is in keeping with the uses of currently registered pesticide products containing THFA. Considering THFA's physical-chemical properties and biodegradation potential in the environment, the new limitation does not change EPA's safety finding for the new 40 CFR 180.1263.

-2. Requests to expand uses, and establish application rates and pre-harvest intervals. One commentor stated that EPA does not have to restrict the crops that THFA can be applied to if the Agency would set either a maximum THFA percentage limit in pesticide concentrates, or a maximum THFA percentage limit for dilute product rates applied to food crops. In addition, several commentors suggested the establishment of pre-harvest intervals as a way to limit or eliminate the potential for residues of THFA on harvested commodities.

-In determining whether uses of THFA could be maintained, the Agency evaluated the uses of all currently registered pesticide products that contained THFA. The products were registered for applications to a very large number of crops and most permitted multiple applications (e.g., six) including on the day of harvest. For many pesticide products, the quantity of THFA in formulation was unusually high, with more than half containing 75 - 98 % THFA. The Agency discussed its toxicity concerns for THFA with the registrants of these pesticide products, and the large majority elected to reformulate their products with another solvent. Of the pesticide products that continued to contain THFA, EPA determined that the safety finding could be made for their uses and crafted the limitations of the new tolerance exemption under 40 CFR 180.1263 to include only those uses. The available reliable information on THFA's physical-chemical properties and biodegradation potential in soil was considered in making the safety finding for the uses described in the new exemption. The uses in the new exemption 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.

-EPA believes that defining the scope of a tolerance exemption for THFA requires a cautious approach considering the significant toxicity concerns. THFA's toxicity profile is more similar to pesticide active ingredients or safeners than to minimal risk inert ingredients. Therefore, certain supporting data typically required for active ingredients and safeners may also be necessary for petitions requesting applications of THFA to most growing food crops (especially applications to edible parts). Considering THFA's significant reproductive and developmental toxicity and lack of neurotoxicity data (a sub-chronic study reported whole body spasms), EPA does not believe it can pick a safe maximum application rate or pre-harvest interval in the absence of the appropriate acceptable guideline studies (such as crop residue data) normally used by EPA to set these use limitations. Unfortunately, the Agency does not have acceptable, reliable crop residue data that could assist in setting THFA application rates and pre-harvest intervals.

-Several commentors requested that 40 CFR 180.1263 permit the application of THFA to many crops, such as all cereal grains in crop group 15. Considering the chemical's toxicity profile, EPA does not believe it has the necessary data to broadly grant more uses of THFA now without knowing exact application scenarios. EPA needs to evaluate the uses of a pesticide product in order to estimate the potential for residues of THFA and determine whether residue data may be necessary. In the future, 40 CFR 180.1263 will be amended if the Agency receives a petition that is supported by data and information sufficient for the request, and the Agency determines that the safety finding can be made for these new and/or expanded uses. EPA suggests that parties interested in petitioning for new and/or expanded uses of THFA first consult with the Agency to determine data needs.

-Several commentors requested 40 CFR 180.1263 include two early season (pre-bloom) applications in herbicides on soybeans, canola, and field corn. The Agency evaluated the requested application scenarios for these crops and determined that the FQPA safety finding could be made for these limited early season uses.

-3. Availability of acceptable crop residue data for THFA. All commenters asserted that a residue study (MRID 56444) provides sufficient data to demonstrate the rapid rate of decline of THFA residues from treated crops, and that the results of this study support the use of THFA on all crops. EPA disagrees that any reliable data have been submitted to the Agency concerning residues on food resulting from applications of pesticide products containing THFA. The study identified by the commentors, MRID 56444, was developed by Chemagro in 1972 and submitted to EPA in 1973 by Quaker Oats Company. The three crops used (alfalfa, Roma variety tomato, and soybeans in pod) do not represent the broad range of crops requested by the commentors. It is not an acceptable study for a number of reasons. MRID 56444 is an unpublished summary of data (one page per crop) that lacks documentation about how the study was conducted or method validation, and does not include a discussion of the study results. The data are considered to be of low reliability because of the low rates of recoveries. It appears that sampling was done at 0, 4, and 24 hours after application of THFA. The results on Roma variety tomato between the 4 and 24 hour sampling times were contradictory and no discussion was provided. No results for the 24th hour sample were included in the comments submitted by Penn Specialty Chemicals, Inc. The study MRID 56444 is considered unacceptable and cannot be used to support a tolerance or tolerance exemption for THFA.

-The Agency disagrees with the commentors who asserted that THFA is naturally occurring, and is sufficiently volatile that it will not be available for uptake into plants and treated crops. An acceptable plant metabolism study that would describe the potential for plant uptake of THFA is not available to the Agency. In addition, EPA cannot locate any reliable information that THFA is a naturally occurring substance and is ubiquitous in the environment, as the commentor inferred. On the contrary, Quaker Oats stated that THFA is produced commercially by catalytic hydrogenation of furfural or furfuryl alcohol.

-4. Use of DEEM in the THFA assessment. All commentors objected to Agency's use of the inert ingredient screening level DEEM as a basis for its decision to limit the uses of THFA, and they proposed refinements that support their THFA use proposals. The Agency's regulatory decision that the current unlimited THFA tolerance exemption under 40 CFR 180.910 does not meet the safety requirements of FFDCA section 408(b)(2) was based on a consideration of the significant hazard profile of THFA rather than the result of the inert ingredient screening level DEEM. The results of the screening level DEEM was provided in the Public Docket for informational purposes in order to provide some information regarding the potential for exposure from the use of THFA on food crops under the unlimited 40 CFR 180.910 tolerance exemption. It should be noted that while the inert ingredient DEEM screening model is designed to be conservative, it is not conservative enough to cover the registered uses of THFA under the 40 CFR 180.910 tolerance exemption because the quantity of THFA in the formulations of many pesticide products was quite high, with more than half containing 75 - 98 % THFA.

-EPA disagrees with the commentors who asserted that the Agency must refine the inert ingredient DEEM with the dissipation and decline data they calculated from MRID 56444. The inert ingredient DEEM is used as a screening level model only, and refinements to the screening model are inappropriate and do not meet the standards of sound science. Residue decline data are used in refined exposure modeling and assessments, which were not performed for THFA because the remaining supported registered uses included in 40 CFR 180.1263 did not need a refined exposure assessment. Also, EPA will not consider the results of MRID 56444 in any future refined exposure modeling because the study is unacceptable (see above).

C. 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 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 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.

D. When do These Actions Become Effective?

-The revocation of the tolerance exemption for THFA under 40 CFR 180.910 becomes effective 18 months after the publication date of this final rule in the Federal Register. Any commodities listed in the regulatory text of this document that are treated with the pesticide chemical subject to this final rule, and that are in the channels of trade following the tolerance exemption revocations, shall be subject to FFDCA section 408(1)(5), as established by the FQPA. Under this section, any residue of the pesticide chemical 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 chemical 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 an exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide chemical was applied to such food.

-The establishment of the new tolerance exemption for THFA under 40 CFR 180.1263 becomes effective on the publication date of this final rule in the Federal Register.

E. 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 revokes one inert ingredient tolerance exemption which is counted as a tolerance reassessment toward the August 2006, review deadline under FFDCA section 408(q), as amended by FQPA in 1996.

VI. Statutory and Executive Order Reviews

-In this final rule, EPA is establishing and revoking specific tolerance exemptions established under section 408(d) of FFDCA. The Office of Management and Budget (OMB) has exempted this type of action 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 final 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances 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. This analysis was published on December 17, 1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticide listed in this rule, the Agency hereby certifies that this final action will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with pesticides containing the ingredients being revoked in this notice. Furthermore, for the pesticide named in this final rule, the Agency knows of no extraordinary circumstances that exist as to the present revocations that would change the EPA's previous analysis. 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 FFDCA. For these same reasons, the Agency has determined that this final 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 final 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 final rule.

IV. 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 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 the 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: Juky 26, 2006.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

-Therefore, 40 CFR chapter I is 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. In § 180.910, the table is amended by revising the entry for Tetrahydrofurfuryl alcohol 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 February 9, 2008	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 applications prior to planting and 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, and two applications to canola and soybeans pre-bloom.

(e) For use in herbicides with two applications to field corn up to 24 inches tall (V 5 stage).