E6-4503. Acetochlor; Tolerance Reassessment Decision

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's Report on Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for the chloroacetanilide pesticide acetochlor. The Agency's risk assessments and other related supporting documents also are available in the acetochlor docket. Through the tolerance reassessment program, EPA is ensuring that all pesticides meet current health and food safety standards. This decision is being released concurrent with the Notice of Availability of the cumulative risk assessment for the chloroacetanilide pesticides which include acetochlor and alachlor. See EPA-HQ-OPP-2006-0202 in the Notice section of this issue of the Federal Register.

FOR FURTHER INFORMATION CONTACT:

Felicia Fort, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

-This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. 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 Get Copies of this Document and Other Related Information?

-1. Docket. EPA has established a docket for this action under Docket identification number (ID) [EPA-HQ-OPP-2005-0227; FRL-7770-6]. Publicly available docket materials are available either electronically at http://www.regulations.gov or in hard copy at the Public Information and Records Integrity Branch (PIRIB), 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].

-2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

II. Background

A. What Action is the Agency Taking?

-EPA has assessed risks associated with use of the chloroacetanilide pesticide acetochlor, and reached a tolerance reassessment and risk management decision reassessing 12 existing tolerances or legal residue limits for acetochlor. Acetochlor, 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide, is a preemergence herbicide used for the control of weeds and is registered for use on field corn and popcorn. Corn fields treated with acetochlor may later be rotated to grain sorghum (milo), soybeans, wheat, and tobacco, according to the currently registered use pattern. Corn and the rotational crops listed above were considered in the risk assessment supporting the acetochlor TRED. There are no risks of concern associated with the use of acetochlor. The Agency is now issuing a Report on Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision for acetochlor, known as a TRED, as well as related technical support documents.

-EPA must review tolerances and tolerance exemptions that were in effect when FQPA was enacted in August 1996, to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard established by the new law. Tolerances are considered reassessed once the safety finding has been made or a revocation occurs. EPA has reviewed and made the requisite safety finding for the acetochlor tolerances included in this notice.

-The acetochlor TRED presents the Agency's tolerance reassessment conclusions for acetochlor alone; however, section 408(b)(2)(D)(v) of the Federal Food, Drug and Cosmetic Act (FFDCA) directs the Agency also to consider available information on the cumulative risk from substances sharing a common mechanism of toxicity. Because the chloroacetanilides pesticides share a common mechanism of toxicity, due to their ability to cause nasal turbinate tumors, the Agency evaluated the cumulative risk posed by this group before making its final tolerance reassessment decision on the chloroacetanilide pesticide, acetochlor. EPA has determined that the cumulative risk associated with chloroacetanilide pesticides, which include acetochlor and alachlor, is below the Agency's level of concern. Therefore, the 12 tolerances established for residues of acetochlor in/on raw agricultural commodities are now considered reassessed as safe under section 408(q) of FFDCA, as amended by FQPA.

-EPA is applying the principles of public participation to all pesticides undergoing reregistration and tolerance reassessment. The Agency's Pesticide Tolerance Reassessment and Reregistration; Public Participation Process, published in the Federal Register on May 14, 2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these programs, EPA is tailoring its public participation process to be commensurate with the level of risk, extent of use, complexity of issues, and degree of public concern associated with each pesticide. Due to its uses, risks, and other factors, acetochlor was reviewed through the modified 4-Phase public participation process. Through this process, EPA worked extensively with stakeholders and the public to reach the regulatory decisions for acetochlor.

-The tolerance reassessment program is being conducted under Congressionally mandated time frames, and EPA recognizes the need both to make timely decisions and to involve the public. Few substantive comments were received during the earlier comment period for this pesticide, and all issues related to this pesticide were resolved through consultations with stakeholders. The Agency therefore is issuing the acetochlor TRED without a comment period. However, the Agency is concurrently issuing the cumulative risk assessment for the chloroacetanilide group of pesticides, which includes acetochlor and alachlor, for public comment (see EPA-HQ-OPP-2006-0202 in the Notice section of this issue of the Federal Register).

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

-Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for pesticide residues in effect as of August 2, 1996, to determine whether the tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review is to be completed by August 3, 2006. A tolerance or exemption meets the requirements of section 408(b)(2) or (c)(2), respectively, if “the Administrator determines the pesticide chemical residue is safe”, i.e., “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.” 21 U.S.C. §346a(b)(2)(A),(c)(2)(A). In making this safety finding, FFDCA requires the Administrator to consider, among other factors, “available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity . . . .” 21 U.S.C. §346a(b)(2)(D)(v), (c)(2)(B).

-Section 4(g)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as amended, requires the Administrator to make “a determination as to the eligibility for reregistration (i) for all active ingredients subject to reregistration under this section for which tolerances or exemptions from tolerances are required under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), not later than the last date for tolerance reassessment established under section 408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C))....”

List of Subjects

• -Environmental protection
• Pesticides and pests

Dated: March 21, 2006.

Debra Edwards,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.