Document ID: EPA-HQ-OPP-2005-0227-0021
Agency: epa
Document Type: Notice
Title: Acetochlor; Tolerance Reassessment Decision
Posted Date: 2006-03-29T13:38:17Z

[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]               
[Page 15730-15731]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-76]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0227; FRL-7770-6]

 
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: (703) 305-7478; fax 
number: (703) 308-8005; e-mail address: fort.felicia@epa.gov.

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 (703) 305-5805.
    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

[[Page 15731]]

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. 
Sec. 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. Sec. 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.
[FR Doc. E6-4503 Filed 3-28-06; 8:45 am]

BILLING CODE 6560-50-S