E8-20513. Hexythiazox; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation amends the established tolerances for combined residues of hexythiazox in or on citrus dried pulp; citrus oil; pome fruit, crop group 11; wet apple pomace; and meat byproducts of cattle, goat, horse, and sheep. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective September 10, 2008. Objections and requests for hearings must be received on or before November 10, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0507. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. 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 Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Olga Odiott, 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 those engaged in the following activities:

• 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 to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at 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 EPA's tolerance regulations at 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 FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2007-0507 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 as required by 40 CFR part 178 on or before November 10, 2008.

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 this copy, identified by docket ID number EPA-HQ-OPP-2007-0507, 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 Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

II. Petition for Tolerance

In the Federal Register of October 24, 2007 (72 FR 60367) (FRL-8154-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 7F7211 and PP 7F7223) by Gowan Company, 370 S. Main Street, Yuma, AZ 85364. The petitions requested that 40 CFR 180.448 be amended by revising the established tolerances for combined residues of the insecticide hexythiazox, trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as parent), in or on citrus dried pulp from 1.5 parts per million (ppm) to 0.6 ppm; and citrus oil from 0.9 ppm to 24 ppm (PP 7F7223); pome fruit, crop group 11 from 1.7 ppm to 0.25 ppm; wet apple pomace from 2.5 ppm to 0.40 ppm; and meat byproducts of cattle, goat, horse, and sheep from 0.12 ppm to 0.02 ppm (PP 7F7211). That notice referenced a summary of the petition prepared by Gowan Company, the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for combined residues of hexythiazox on citrus dried pulp; citrus oil; pome fruit, crop group 11; wet apple pomace; and meat byproducts of cattle, goat, horse, and sheep. EPA's assessment of exposures and risks associated with establishing tolerances follows.

On March 22, 2006 the Agency published in the Federal Register a final rule (71 FR 14409, FRL-7768-3) establishing tolerances for combined residues of hexythiazox on apple, wet pomace at 2.5 ppm; citrus, dried pulp at 1.5 ppm; citrus, oil at 0.90 ppm; fruit, pome, group 11 at 1.7 ppm; and cattle, goat, horse, and sheep meat by products at 0.12 ppm. The tolerances were based on an exaggerated use rate from the wettable powder (WP) formulation residue trials and the maximum factor by which the emulsifiable concentrate (EC) formulation exceeded the WP formulation in the apple side-by-side field trials. Since the tolerances were likely to overestimate actual expected residues following application of hexythiazox as labeled, the Agency requested an orange processing study and apple and pear field trial data for the EC formulation as conditions of registration.

On May 28, 2008 the Agency published in the Federal Register a final rule (73 FR 30498, FRL-8365-2) establishing tolerances for combined residues of hexythiazox on corn, field, grain at 0.02 ppm; corn, field, stover at 2.5 ppm; and corn, field, forage at 6.0 ppm.

When the Agency conducted the acute dietary risk assessments in support of the 2006 and 2008 tolerance actions it assumed residues of hexythiazox would be present in the aforementioned commodities at the currently published levels. For the chronic/cancer dietary assessments the Agency assumed that average field trial residue levels of hexythiazox would be present. The data submitted to fulfill the conditions of registration mentioned above indicate that with the exception of citrus oil, the subject petitioned-for tolerances should be reduced. Acute, chronic, and cancer dietary analyses conducted to address the increase in the citrus oil tolerance resulted in no exposure for all subpopulations and scenarios from citrus oil. Therefore, the increase in the orange oil tolerance from 0.90 to 24 ppm will not result in an increased dietary human health risk and the assumptions used for the 2006 and 2008 risk assessments remain appropriate. EPA relies upon those risk assessments and the findings made in the Federal Register documents in support of this action.

Based on the risk assessments discussed in the final rules published in the Federal Register of May 28, 2008 and March 22, 2006, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to hexythiazox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The Pesticide Analytical Manual Volume II (PAM II) of the Food and Drug Administration (FDA) includes suitable analytical methods for the determination of hexythiazox and metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (AMR-985-87) in pome fruits, citrus, and livestock tissue.

B. International Residue Limits

Codex maximum residues limits (MRLs) for apple, pear, and citrus are established for residues of hexythiazox per se. The Agency has previously determined that the residues of concern for application of hexythiazox to fruit crops are hexythiazox and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as parent). Since the Codex and EPA tolerance expression differ, harmonization is not possible.

V. Conclusion

Therefore, 40 CFR 180.448 is amended by revising the established tolerances for combined residues of hexythiazox, trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide and its metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety (expressed as parent), in or on citrus dried pulp to 0.60 ppm; citrus oil to 24 ppm; pome fruit, crop group 11 to 0.25 ppm; wet apple pomace to 0.40 ppm; and meat byproducts of cattle, goat, horse, and sheep at 0.02 ppm.

VI. Statutory and Executive Order Reviews

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, 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) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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).

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).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

Dated: August 26, 2008.

Donald R. Stubbs,

Acting 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. Section 180.448 is amended in paragraph (a), in the table by revising the entries for the following commodities to read as follows:

§180.448

Hexythiazox; tolerances for residues.

(a) * * *

Commodity	Parts per million
*    *    *      *     *
Apple, wet pomace	0.40
*    *    *      *     *
Cattle, meat byproducts	0.02
Citrus, dried pulp	0.60
Citrus, oil	24
*    *    *      *     *
Fruit, pome, group 11	0.25
*    *    *      *     *
Goat, meat byproducts	0.02
*    *    *      *     *
Horse, meat byproducts	0.02
*    *    *      *     *
Sheep, meat byproducts	0.02
*    *    *      *     *