E6-4505. Chloroacetanilide Cumulative Risk Assessment; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's cumulative risk assessment for the chloroacetanilide group of pesticides and opens a public comment period on these documents. As required by the Food Quality Protection Act (FQPA), a cumulative risk assessment, which evaluates exposures based on a common mechanism of toxicity, was conducted to evaluate the risk from food, drinking water, and non-occupational exposure resulting from all registered uses of chloroacetanilide pesticides. The chloroacetanilides group includes the pesticides acetochlor, alachlor and butachlor; however, butachlor was not incorporated into the cumulative assessment because there are no U.S. registrations or established tolerances. The Agency is also releasing the Report on FQPA Tolerance Reassessment Progress and Risk Management Decision (TRED) for Acetochlor concurrent with the release of the chloroacetanilide cumulative assessment. See EPA-HQ-OPP-2005-0227 in the Notice section of this issue of the Federal Register.

DATES:

Comments must be received on or before May 30, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0202, 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-2006-0202. 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 number EPA -HQ-OPP-2006-0202. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at http://www.regulations.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 captured automatically 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/​docket.htm/​.

Docket. All documents in the docket are listed in the regulation.gov index. Although listed in the index, some information is not publicly available, i.e., 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 at 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. 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].

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. 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 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.

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.

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

A. What Action is the Agency Taking?

EPA is making available the completed cumulative risk assessment for the chloroacetanilide pesticides. The chloroacetanilides group includes the pesticides, acetochlor, alachlor and butachlor; however, butachlor was not incorporated into the cumulative assessment because there are no U.S. registrations or established tolerances. The Agency developed this risk assessment as part of its public process for making pesticide reregistration eligibility and tolerance reassessment decisions. Through these programs, EPA is ensuring that pesticides meet current standards under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by FQPA.

-A chloroacetanilide cumulative risk assessment was conducted for acetochlor and alachlor exposures based on a common mechanism of toxicity, their ability to cause nasal turbinate tumors. This determination can be found in the chloroacetanilides decision document published in 2001 entitled “The Grouping of a Series of Chloroacetanilide Pesticides Based on a Common Mechanism of Toxicity” (http://www.epa.gov/​oppfod01/​cb/​csb_​page/​updates/​commechs.htm). The Agency has concluded that the cumulative risk associated with chloroacetanilide pesticides is below the Agency's level of concern.

EPA is providing an opportunity, through this notice, for interested parties to provide comments and input on the Agency's completed cumulative risk assessment for the chloracetanilides. Such comments and input could address the Agency's risk assessment methodologies and assumptions as applied to this cumulative assessment.

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to chloroacetanilide pesticides, compared to the general population.

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.

Comments should be limited to issues raised within the risk assessment and associated documents. Failure to comment on any such issues as part of this opportunity will not limit a commenter's opportunity to participate in any later notice and comment processes on this matter. All comments should be submitted using the methods in ADDRESSES, and must be received by EPA on or before the closing date. Comments will become part of the Agency Docket for the chloroacetanilide cumulative risk assessment. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

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

Section 4(g)(2)(A) of 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)) * * *”

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).

List of Subjects

• Environmental protection
• Pesticides and pests

Dated: March 21, 2006.

Debra Edwards,

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