01-14905. FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a 2-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 an assessment of additional scientific information concerning StarLink^TM corn. Members of the public may submit written comments for consideration by the SAP. In addition, EPA will provide an opportunity during the public meeting for the public to make brief oral remarks to the SAP. The procedures governing submission of written comments and the presentation of oral comments are described below. 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 July 17 and July 18 from approximately 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-00724 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 (7202C), Environmental Protection Agency, 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) and FIFRA. 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 several background documents relevant to this meeting are now available. EPA's primary position, paper, and questions to the FIFRA SAP should be available as soon as possible, but no later than late June. In addition, the Agency expects to provide additional background documents as the material 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. 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 official record for this meeting under docket control number OPP-00724. 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 22202, 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-00724 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 SAP 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). 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 22202. 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-00724. You may also file a request online at many Federal Depository Libraries.

II. Background

A. Purpose of the Meeting

On November 28, 2000, the FIFRA SAP met to review the potential allergenicity, sensitization, and dietary exposure to StarLink^TM corn. The Panel concluded that based on the available information at that time, there was a medium likelihood that the Cry9C protein was a potential allergen. However, the Panel also concluded that “while not conclusive, the likely levels of the Cry9C protein in the U.S. diet provide sufficient evidence of a low probability of allergenicity in the exposed population.” The Panel recommended that certain additional information would be valuable to refining the risk assessment. The Panel recommended that the highest priority was for follow-up on those individuals who had claimed that they had suffered some type of allergic reaction after eating a corn product that might have contained StarLink^TM corn and to determine if there were antibodies for Cry9C in the blood serum of these individuals.

The SAP also recommended collecting additional information to improve the estimate of the levels of Cry9C protein in the food supply.

The SAP will be meeting to assess additional scientific information concerning StarLink^TM corn. The SAP will review EPA's paper on the possible presence of Cry9C protein in processed human foods from wet milling of corn, the work the United States Department of Agriculture and Aventis Crop Sciences have done to reduce the amount of StarLink^TM corn going into the food supply, the scientific data in Aventis Crop Sciences petition for a tolerance for Cry9C protein of 20 parts per billion in corn grain, validation of new detection methods for Cry9C protein in finished foods, and the Food and Drug Administration and Centers for Disease Control and Prevention's efforts to develop a test method for blood serum from individuals who reported having allergic type responses after eating foods containing corn.

B. Panel Report

The Panel will prepare a report of its recommendations to the Agency. The report will be posted on the FIFRA SAP web site or may be obtained by contacting the PIRIB at the address or telephone number listed in Unit I. of this document.

List of Subjects

• Environmental protection

Dated: June 4, 2001.

Vanessa Vu,

Director, Office of Science Coordination and Policy.