02-960. FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA) Scientific Advisory Panel (SAP) to review a set of issues being considered by the Agency pertaining to methods used to conduct a preliminary cumulative risk assessment for organophosphorous pesticides. Seating at the meeting will be on a first-come basis. Individuals requiring special accommodations at this meeting, including wheelchair access, should contact Paul Lewis at the address listed under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to the meeting so that appropriate arrangements can be made.

DATES:

The meeting will be held on February 5th-8th, 2002 from 8:30 a.m. to 5 p.m.

ADDRESSES:

The meeting will be held at the Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, VA 22202. The telephone number for the Sheraton Crystal City Hotel is [phone].

Requests to participate may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION: To ensure proper receipt by EPA, your request must identify docket control number OPP-00756 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Paul Lewis, Designated Federal Official, Office of Science Coordination and Policy, (7201M), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; 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. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), FIFRA and FQPA. Since other entities may also 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 Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. A meeting agenda and background documents relevant to this meeting are now available. The EPA's position paper and questions to the FIFRA SAP, and Panel composition (i.e. SAP members and consultants) will be available as soon as possible, but no later than mid January. In addition, the Agency may provide additional background documents as the material becomes available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, from the FIFRA SAP Internet Home Page at http://www.epa.gov/​scipoly/​sap. To access this document on the Home Page select Federal Register notice announcing this meeting. You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an administrative record for this meeting under docket control number OPP-00756. The administrative record consists of the documents specifically referenced in this notice, any public comments received during an applicable comment period, and other material information, including any information claimed as Confidential Business Information (CBI). This administrative record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. In addition, the Agency may provide additional background documents as the material becomes available. The public version of the administrative record, which includes printed, paper versions of any electronic comments that may be submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

C. How Can I Request to Participate in this Meeting?

You may submit a request to participate in this meeting through the mail, in person, or electronically. Do not submit any information in your request that is considered CBI. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00756 in the subject line on the first page of your request. Public statements presented at the meetings should not be repetitive of previously submitted oral or written statements.

Oral comments: Although requests for oral comments are accepted until the date of the meeting (unless otherwise stated), to the extent that time permits, interested persons may be permitted by the Chair of the FIFRA SAP to present oral statements at the meeting. Each individual or group wishing to make a brief oral presentation to the SAP is strongly advised to submit their request to the person listed under FOR FURTHER INFORMATION CONTACT no later than noon Eastern Standard Time, Thursday, January 31, 2002 in order to be included on the meeting agenda. The request should identify the name of the individual making the presentation, the organization (if any) the individual will represent, and any requirements for audiovisual equipment (e.g., overhead projector, 35 mm projector, chalkboard). Oral statements before the Panel are limited to approximately 5 minutes unless prior arrangements have been made. In addition, the speaker should bring to the meeting 30 copies of their comments and presentation slides for distribution to the Panel at the meeting.

Written comments: Although requests for written comment are accepted until the date of the meeting (unless otherwise stated), the Agency encourages that written statements be submitted no later than noon Eastern Standard Time, Thursday, January 31, 2002 to provide Panel members the time necessary to consider and review the comments. There is no limit on the extent of written comments for consideration by the Panel. Persons wishing to submit written comments at the meeting should contact the person listed under FOR FURTHER INFORMATION CONTACT and submit 30 copies.

1. By mail. You may submit a request to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your request electronically by e-mail to: [e-mail]. Do not submit any information electronically that you consider to be CBI. Use WordPerfect 6.1/8.0 or ASCII file format and avoid the use of special characters and any form of encryption. Be sure to identify by docket control number OPP-00756. You may also file a request online at many Federal Depository Libraries.

II. Background

A. Purpose of the Meeting

The Food Quality Protection Act of 1996 amended the FIFRA and the FFDCA. One of the major changes is the requirement that EPA consider risk posed by pesticides acting by common mechanism of toxicity. For such groups of pesticides, EPA's Office of Pesticide Programs (OPP) has treated cumulative risk, under FQPA, as the risk of a common toxic effect associated with concurrent exposure by all relevant pathways and routes.

Organophosphorous pesticides were assigned priority for tolerance reassessment early during the process of FQPA implementation. OPP considered whether this group of pesticides caused common toxic effects by a common mechanism of toxicity using EPA's “guidance for identifying pesticide chemicals and other substances that have a common mechanism of toxicity.” The inhibition of acetylcholinesterase was a focal point given that most organophosphorous pesticides cause this response as their critical and common effect. When acetylcholinesterase is inhibited, acetylcholine accumulates and cholinergic toxicity results due to continuous stimulation of cholinergic receptors throughout the central and peripheral nervous systems which innervate virtually every organ in the body. Cholinergic effects associated with exposures to OP pesticides have been found in both humans and animals.

OPP proceeded with the methodology and risk assessment development in a step by step process. The approach to the risk assessment was evaluated using a case study of 3 organophosphorous pesticides. That assessment was reviewed by the SAP (September and December, 1999), who recommended that OPP proceed with a more comprehensive case study. OPP developed the hazard, dose-response and exposure assessment for twenty four OP pesticides and brought it to the SAP for comment in September and December of 2000. Based on the comments, the hazard and dose-response assessment was revised and again reviewed by the SAP in September, 2001.

The exposure assessment of the OP pesticides presented here incorporates probabilistic approaches in all pathways considered: Food, drinking water, and residential/non-occupational. The methodology for conducting a preliminary cumulative risk assessment for the organophosphorous pesticides presented here is a first time that the Agency has assessed risk combining multiple sources of exposure for multiple chemicals acting via a common mechanism of toxicity. The general methodology and the specific approach have been under development for 5 years and have been subject to extensive peer review and public comment.

B. Panel Report

The Panel will prepare a report of its recommendations to the Agency in approximately 60 days. The report will be posted on the FIFRA SAP web site or may be obtained by contacting the Public Information and Records Integrity Branch at the address or telephone number listed in Unit I. of this document.

List of Subjects

• Environmental protection

Dated: January 8, 2002.

 Vanessa Vu,

Director, Office of Science Coordination and Policy