[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
Withdrawal of Guidance: Guidance for Industry on the FDA
Recommendations for Sampling and Testing Yellow Corn and Dry-Milled
Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein
Residues April 25, 2008