E8-9003. EPA White Paper Regarding StarLink®

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is making available a final White Paper that reviews data on the level in the human food supply of Cry9C protein from StarLink^® corn grain. It concludes that the protein has been sufficiently removed from the human food supply to render the level of risk low enough that continued testing for the protein in yellow corn at dry mills and masa production facilities provides no added public heath protection. The White Paper therefore recommends that the Food and Drug Administration (FDA) withdraw its guidance recommending testing yellow corn grain for Cry9C at dry mills and masa production facilities. Concurrent with this notice, FDA is publishing a notice in the Federal Register withdrawing their guidance.

FOR FURTHER INFORMATION CONTACT:

Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511P), 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?

You may be potentially affected by this action if you are an agricultural producer or food manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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 Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0832. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr.

II. Background

EPA is making available a final White Paper that reviews data on the level in the human food supply of Cry9C protein from StarLink^® corn grain.

The Agency notified the public regarding the availability of a draft version of the White Paper in the October 17, 2007 Federal Register (72 FR 58978) (FRL-8145-7), with a docket identification number of EPA-HQ-OPP-2007-0832. The open comment period from October 17, 2007 to December 3, 2007, was held to allow members of the general public to submit letters and/or documents to the Agency on this White Paper. The Agency received comment from the North American Export Grain Association, Inc., the Corn Refiners Association, the Biotechnology Industry Association (BIO), the National Grain and Feed Association, the U. S. Grains Council, the North American Millers' Association, the Food Corn Industry Coalition, the National Corn Growers, and two unsigned comments. These comments are addressed in the final White Paper.

The final White Paper concludes that the Cry9C protein has been sufficiently removed from the human food supply to render the level of risk low enough that continued testing for the protein in yellow corn at dry mills and masa production facilities provides no added public heath protection. The final White Paper therefore recommends that FDA withdraw its guidance recommending testing yellow corn grain at dry mills and masa production facilities. A full copy of the final EPA White Paper is available in docket EPA-HQ-OPP-2007-0832.

List of Subjects

• Environmental protection
• Agricultural commodities
• Pesticides and pests

Dated: April 21, 2008.

James B. Gulliford,

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.