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Friday,

April 25, 2008

Part V

Environmental
Protection Agency
Department of
Health and Human
Services
Food and Drug Administration

EPA White Paper Regarding StarLink


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
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Human Use for Cry9C Protein Residues;


Withdrawal of Guidance; Notice

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22716 Federal Register / Vol. 73, No. 81 / Friday, April 25, 2008 / Notices

ENVIRONMENTAL PROTECTION certain entities. If you have any Paper therefore recommends that FDA
AGENCY questions regarding the applicability of withdraw its guidance recommending
this action to a particular entity, consult testing yellow corn grain at dry mills
[EPA–HQ–OPP–2007–0832; FRL–8358–7]
the person listed under FOR FURTHER and masa production facilities. A full
INFORMATION CONTACT. copy of the final EPA White Paper is
EPA White Paper Regarding StarLink
Corn Dietary Exposure and Risk; B. How Can I Get Copies of this available in docket EPA–HQ–OPP–
Availability Document and Other Related 2007–0832.
Information? List of Subjects
AGENCY: Environmental Protection
Agency (EPA). 1. Docket. EPA has established a Environmental protection,
ACTION: Notice. docket for this action under docket Agricultural commodities, Pesticides
identification (ID) number EPA–HQ– and pests.
SUMMARY: EPA is making available a OPP–2007–0832. Publicly available
final White Paper that reviews data on docket materials are available either in Dated: April 21, 2008.
the level in the human food supply of the electronic docket at http:// James B. Gulliford,
Cry9C protein from StarLink corn www.regulations.gov, or, if only Assistant Administrator, Office of Prevention,
grain. It concludes that the protein has available in hard copy, at the Office of Pesticides and Toxic Substances.
been sufficiently removed from the Pesticide Programs (OPP) Regulatory
[FR Doc. E8–9003 Filed 4–24–08; 8:45 am]
human food supply to render the level Public Docket in Rm. S–4400, One
BILLING CODE 6560–50–S
of risk low enough that continued Potomac Yard (South Bldg.), 2777 S.
testing for the protein in yellow corn at Crystal Dr., Arlington, VA. The hours of
dry mills and masa production facilities operation of this Docket Facility are DEPARTMENT OF HEALTH AND
provides no added public heath from 8:30 a.m. to 4 p.m., Monday HUMAN SERVICES
protection. The White Paper therefore through Friday, excluding legal
recommends that the Food and Drug holidays. The Docket Facility telephone Food and Drug Administration
Administration (FDA) withdraw its number is (703) 305–5805.
guidance recommending testing yellow 2. Electronic access. You may access
[Docket No. FDA–2008–D–0229 (formerly
corn grain for Cry9C at dry mills and this Federal Register document Docket No. 2001D–0025)]
masa production facilities. Concurrent electronically through the EPA Internet
with this notice, FDA is publishing a under the ‘‘Federal Register’’ listings at Guidance for Industry on the Food and
notice in the Federal Register http://www.epa.gov/fedrgstr. Drug Administration
withdrawing their guidance. II. Background Recommendations for Sampling and
FOR FURTHER INFORMATION CONTACT: Testing Yellow Corn and Dry-Milled
EPA is making available a final White Yellow Corn Shipments Intended for
Mike Mendelsohn, Biopesticides and
Paper that reviews data on the level in Human Food Use for Cry9C Protein
Pollution Prevention Division (7511P),
the human food supply of Cry9C protein Residues; Withdrawal of Guidance
Office of Pesticide Programs,
from StarLink corn grain.
Environmental Protection Agency, 1200
The Agency notified the public AGENCY: Food and Drug Administration,
Pennsylvania Ave., NW., Washington,
regarding the availability of a draft HHS.
DC 20460–0001; telephone number:
version of the White Paper in the ACTION: Notice; withdrawal.
(703) 308-8715; fax number: (703) 308-
October 17, 2007 Federal Register (72
7026; e-mail address:
FR 58978) (FRL–8145–7), with a docket SUMMARY: The Food and Drug
mendelsohn.mike@epa.gov.
identification number of EPA–HQ– Administration (FDA) is announcing the
SUPPLEMENTARY INFORMATION: OPP–2007–0832. The open comment withdrawal of a guidance document
I. General Information period from October 17, 2007 to entitled ‘‘FDA Recommendations for
December 3, 2007, was held to allow Sampling and Testing Yellow Corn and
A. Does this Action Apply to Me? members of the general public to submit Dry-Milled Yellow Corn Shipments
You may be potentially affected by letters and/or documents to the Agency Intended for Human Food Use for Cry9C
this action if you are an agricultural on this White Paper. The Agency Protein Residues.’’ FDA is withdrawing
producer or food manufacturer. received comment from the North its guidance in response to the release
Potentially affected entities may American Export Grain Association, by the Environmental Protection Agency
include, but are not limited to: Inc., the Corn Refiners Association, the (EPA) of its final ‘‘White Paper
• Crop production (NAICS code 111). Biotechnology Industry Association Concerning Dietary Exposure to Cry9C
• Animal production (NAICS code (BIO), the National Grain and Feed Protein Produced by STARLINK Corn
112). Association, the U. S. Grains Council, and the Potential Risks Associated With
• Food manufacturing (NAICS code the North American Millers’ Such Exposure,’’ the availability of
311). Association, the Food Corn Industry which is announced elsewhere in this
• Pesticide manufacturing (NAICS Coalition, the National Corn Growers, issue of the Federal Register.
code 32532). and two unsigned comments. These DATES: April 25, 2008.
This listing is not intended to be comments are addressed in the final
FOR FURTHER INFORMATION CONTACT:
exhaustive, but rather provides a guide White Paper.
for readers regarding entities likely to be The final White Paper concludes that Lauren Posnick Robin or Samir Assar,
affected by this action. Other types of the Cry9C protein has been sufficiently Center for Food Safety and Applied
entities not listed in this unit could also removed from the human food supply to Nutrition (HFS–300), Food and Drug
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be affected. The North American render the level of risk low enough that Administration, 5100 Paint Branch
Industrial Classification System continued testing for the protein in Pkwy., College Park, MD 20740, 301–
(NAICS) codes have been provided to yellow corn at dry mills and masa 436–1639 or 301–436–1636,
assist you and others in determining production facilities provides no added respectively.
whether this action might apply to public heath protection. The final White SUPPLEMENTARY INFORMATION:

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