
[Federal Register: April 25, 2008 (Volume 73, Number 81)]
[Notices]               
[Page 22715-22716]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap08-157]                         


[[Page 22715]]

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Part V





Environmental Protection Agency





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Department of Health and Human Services





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Food and Drug Administration



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EPA White Paper Regarding StarLink[reg] Corn Dietary 
Exposure and Risk; Availability; Notice



Guidance for Industry on FDA Recommendations for Sampling and Testing 
Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Use 
for Cry9C Protein Residues; Withdrawal of Guidance; Notice


[[Page 22716]]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0832; FRL-8358-7]

 
EPA White Paper Regarding StarLink[reg] Corn Dietary 
Exposure and Risk; Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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[reg] 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: (703) 308-8715; fax 
number: (703) 308-7026; e-mail address: mendelsohn.mike@epa.gov.

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 (703) 305-5805.
    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[reg] 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.

[FR Doc. E8-9003 Filed 4-24-08; 8:45 am]

BILLING CODE 6560-50-S
