02-13522. FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 (FIFRA SAP) to consider and review two topics. The first topic is to update the FIFRA SAP on the status of preliminary results from cumulative risk estimates for organophosphate pesticides (OP) using alternative models (Calendex^TM, LifeLine^TM, and CARES^TM) and similar input data and parameters. The second topic is review of cumulative risk assessments for OPs: Susceptibility and age dependent sensitivity.

DATES:

The meeting will be held from June 25-27, 2002, from 8:30 a.m. to 5 p.m, eastern standard time.

For dates on requests to present oral comments, submission of written comments, or requests for special seating arrangements, see Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES:

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

Requests to present oral comments, submission of written comments, or requests for special seating arrangements 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 ID number OPP-2002-0083 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Olga Odiott, Designated Federal Official (DFO), for topic 1 or Paul Lewis, DFO, for topic 2, Office of Science Coordination and Policy (7202M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail addresses: [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 one of the DFOs listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

A meeting agenda and background documents relevant to this meeting are now available. EPA's position paper, questions to the FIFRA SAP, and the FIFRA SAP composition (i.e., members and consultants) will be available as soon as possible, but no later than mid-June. In addition, the Agency may provide additional background documents as the materials become 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.

2. In person. The Agency has established an official record for this meeting under docket ID number OPP-2002-0083. The official 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 official 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 official 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 May I Participate in this Meeting?

You may submit requests to present oral comments, written comments, or requests for special seating arrangements 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 ID number OPP-2002-0083 in the subject line on the first page of your request.

1. Oral comments. Oral comments presented at the meetings should not be repetitive of previously submitted oral or written comments.

Although requests to present 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 comments at the meeting. Each individual or group wishing to make brief oral comments to the FIFRA SAP is strongly advised to submit their request to one of the DFOs listed under FOR FURTHER INFORMATION CONTACT no later than noon, eastern standard time, Thursday, June 20, 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 comments before the FIFRA SAP are limited to approximately 5 minutes unless prior arrangements have been made. In addition, the speaker should bring to the meeting 30 copies of the oral comments and presentation slides for distribution to the FIFRA SAP at the meeting.

2. Written comments. Although submission of written comments are accepted until the date of the meeting (unless otherwise stated), the Agency encourages that written comments be submitted no later than noon, eastern standard time, Thursday, June 20, 2002, to provide the FIFRA SAP the time necessary to consider and review the written comments. There is no limit on the extent of written comments for consideration by the FIFRA SAP. Persons wishing to submit written comments at the meeting should contact one of the DFOs listed under FOR FURTHER INFORMATION CONTACT and submit 30 copies.

3. Seating at the meeting. Seating at the meeting will be on a first-come basis. Individuals requiring special accommodations at this meeting, including wheelchair access, should contact the DFOs at least 5 business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT so that appropriate arrangements can be made. Contact DFO, Olga Odiott, for topic 1 and DFO, Paul Lewis for topic 2.

4. Submission of requests and written comments—a. By mail. Submit your request or written comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Pennsylvania Ave., NW., Washington, DC 20460.

b. In person or by courier. Deliver your request or written comments to: 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].

c. Electronically. You may submit your request or written comments electronically by e-mail to: [e-mail]. Do not submit any information electronically that you consider to be CBI. Use WordPerfect 9.0 or ASCII file format and avoid the use of special characters and any form of encryption. Be sure to identify by docket ID number OPP-2002-0083. You may also file a request online at many Federal Depository Libraries.

II. Background

A. Purpose of the Meeting

The FIFRA SAP will meet to review two topics:

1. Update the FIFRA SAP on the status of preliminary results from cumulative risk estimates for organophosphate pesticides (OP) using alternative models (Calendex^TM, LifeLine^TM, and CARES^TM) and similar input data and parameters.

Cumulative risk estimates for OPs derived by EPA using the Calendex^TM model (Novigen Sciences, Inc.) will be compared to preliminary results derived by The LifeLine Group using the LifeLine^TM model and the Sound Science Policy Alliance (SSPA) using the CARES^TM model. The LifeLine^TM assessments were conducted under contract to EPA. CARES^TM assessments were conducted by a group of OP registrants and their consultants (SSPA). These preliminary results will be presented to the FIFRA SAP by EPA for informational purposes only. The FIFRA SAP will not be asked to formally review and comment on these preliminary results.

2. Cumulative risk assessments for organophosphate pesticides: Susceptibility and age dependent sensitivity. The FQPA instructs EPA, in making its “reasonable certainty of no harm” finding, that in “the case of threshold effects,...an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential prenatal and postnatal toxicity and completeness of data with respect to exposure and toxicity to infants and children.” In implementing the FQPA safety factor provision in the context of assessing cumulative risk, the Agency has evaluated pertinent data concerning the potential for prenatal and postnatal effects associated with the common mechanism of toxicity for OP pesticides (namely, inhibition of acetylcholinesterase), the completeness of the hazard data with respect to common mechanism of toxicity to infants and children, and the completeness of the exposure database. The Agency seeks the FIFRA SAP's review on the interpretation of the available laboratory studies on cholinesterase activity in fetal, neonatal and juvenile rats. In addition, the FIFRA SAP is asked to consider the mechanistic basis underlying the age dependent sensitivity of young to cholinesterase inhibition caused by OP pesticides.

B. The FIFRA SAP Report

The FIFRA SAP 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 the SUPPLEMENTARY INFORMATION.

List of Subjects

• Environmental protection
• Organophosphate pesticides
• Pesticides and pests

Dated: May 22, 2002.

Sherell A. Sterling,

Director, Office of Science Coordination and Policy.