01-20134. FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of public meeting.

SUMMARY:

There will be a 3-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA) Scientific Advisory Panel (SAP) review sets of issues being considered by the Agency pertaining to: Preliminary Cumulative Hazard and Dose-Response Assessment for Organophosphorus Pesticides: Determination of Relative Potency and Points of Departure for Cholinesterase Inhibition, and Common Mechanism of Action for Thiocarbamates and Dithiocarbamates. The meeting is open to the public. 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 appropriate arrangements can be made.

DATES:

The meeting will be held from September 5 through September 7, 2001, from 8:30 am to 5 p.m., as follows:

September 5 and 6, 2001—Session I-Preliminary Cumulative Hazard and Dose-Response Assessment for Organophosphorus Pesticides: Determination of Relative Potency and Points of Departure for Cholinesterase Inhibition.

September 7, 2001—Session II-Common Mechanism of Action for Thiocarbamates and Dithiocarbamates.

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-00733 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Paul Lewis or Larry Dorsey, Designated Federal Officials, Office of Science Coordination and Policy (7202), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail] or [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 is now available; EPA's primary background documents should be available by late August. 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-00733. 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 am to 4 pm, 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-00733 in the subject line on the first page of your request. Interested persons are permitted to file written statements before the meeting. To the extent that time permits, and upon advance written request to the person listed under FOR FURTHER INFORMATION CONTACT, interested persons may be permitted by the Chair of the FIFRA Scientific Advisory Panel to present oral statements at the meeting. 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, etc.). There is no limit on the extent of written comments for consideration by the Panel, but oral statements before the Panel are limited to approximately 5 minutes. The Agency also urges the public to submit written comments in lieu of oral presentations. Persons wishing to make oral and/or written statements at the meeting should contact the person listed under FOR FURTHER INFORMATION CONTACT and submit 30 copies of their presentation and/or remarks to the Panel. The Agency encourages that written statements be submitted before the meeting to provide Panel Members the time necessary to consider and review the comments.

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, 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-00733. You may also file a request online at many Federal Depository Libraries.

II. Background

A. Purpose of the Meeting

Session I—Preliminary Cumulative Hazard and Dose-Response Assessment for Organophosphorus Pesticides—Determination of Relative Potency and Points of Departure for Cholinesterase Inhibition

The Food Quality Protection Act (FQPA) of 1996 requires EPA to consider the cumulative effect to human health that can result from exposure to pesticides that have a common mechanism of toxicity. Over the last 2 years, the Office of Pesticide Programs (OPP) has presented to the FIFRA Scientific Advisory Panel (SAP) for comment proposed guidance, tools and methodologies for conducting cumulative risk assessments. In September 2000, a case study on 24 organophosphorus pesticides was presented to the SAP to demonstrate methods for determining the cumulative risk.

In order to accomplish the reassessment of 66% of pesticide tolerances by August 3, 2002, as required by the FQPA, the Agency needs to complete the tolerance reassessment for the organophosphorus pesticides by performing a cumulative risk assessment for this group. Therefore, the Agency intends to complete the Preliminary Cumulative Risk Assessment for the Organophosphorus Pesticides by December 2001. Toward this end, the Agency has considered the SAP written comments on the approach that was outlined in the September 27, 2000 SAP Report entitled “Endpoint Selection and Determination of Relative Potency in Cumulative Hazard and Dose-response Assessment: A Pilot Study of Organophosphorus Pesticide Chemicals” (This and related reports can be obtained at the SAP web site at http://www.epa.gov/​scipoly/​sap.). The current document has revised the relative potency factor analysis by incorporating the recommendations of the SAP.

The purpose of the current review is to seek comment from the SAP on whether the revised hazard and dose-response method on the organophosphorus pesticides has adequately addressed the September 2000 SAP comments.

Session II—Common Mechanism of Action for Thiocarbamates and Dithiocarbamates

At a public meeting held in September 1999, the SAP recommended that the Agency address effects of concern reported in studies conducted on thiocarbamates and dithiocarbamate pesticides. The Agency has since prepared two documents that describe: (1) The Agency's cumulative risk assessment of a common assessment group of thiocarbamates; and (2) The results of the Agency's evaluation of common effects induced by the dithiocarbamates by a common method of toxicity. The approach to assessment of thiocarbamates was to identify a common effect that might be attributable to a common mechanism and to conduct a screening level cumulative dietary (food) assessment to determine if grouping them based on the common effect and concurrent exposures to the group would reveal the potential for cumulative dietary risks. This assessment was conducted using the assumption that neuropathological effects induced by the thiocarbamates may be attributed to a common mechanism of toxicity. The screening approach also assumed 100% of crop treated with each thiocarbamate registered for use on crops and used tolerance levels for the exposure component of the assessment rather than a more refined estimate of actual residues.

The Agency's analysis of the dithiocarbamates indicated that they share a common metabolite that is associated with the induction of a common toxicity and that exposure to this group of chemicals will require an aggregation of the residue of that metabolite that may be formed following treatment of crops with these pesticides.

The purpose of this session is to seek the SAP's recommendations on the Agency work since the September 1999 SAP meeting.

B. Panel Report

The Agency anticipates that the Panel's report of their recommendations will be available approximately 60 days after the meeting. The Panel's 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: August 2, 2001.

Andy Privee, Jr.,

Acting Director, Office of Science Coordination and Policy.