[Federal Register Volume 73, Number 81 (Friday, April 25, 2008)]
[Notices]
[Pages 22716-22717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8805]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0229 (formerly Docket No. 2001D-0025)]
Guidance for Industry on the Food and Drug Administration
Recommendations for Sampling and Testing Yellow Corn and Dry-Milled
Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein
Residues; Withdrawal of Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of a guidance document entitled ``FDA Recommendations for
Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments
Intended for Human Food Use for Cry9C Protein Residues.'' FDA is
withdrawing its guidance in response to the release by the
Environmental Protection Agency (EPA) of its final ``White Paper
Concerning Dietary Exposure to Cry9C Protein Produced by STARLINK Corn
and the Potential Risks Associated With Such Exposure,'' the
availability of which is announced elsewhere in this issue of the
Federal Register.
DATES: April 25, 2008.
FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin or Samir Assar,
Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1639 or 301-436-1636, respectively.
SUPPLEMENTARY INFORMATION:
[[Page 22717]]
I. Background
In the Federal Register of January 22, 2001 (66 FR 6627), FDA
announced the availability of a guidance document entitled ``FDA
Recommendations for Sampling and Testing Yellow Corn and Dry-Milled
Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein
Residues.'' Cry9C is a pesticidal protein in the STARLINK variety of
yellow corn that makes the corn more resistant to certain types of
insects. EPA authorized STARLINK corn only for use in animal feed. EPA
did not authorize the use of STARLINK corn in human food because of
unresolved questions about the allergenic potential of the Cry9C
protein. Although restricted to animal food use, some STARLINK corn was
commingled with yellow corn intended for human use. In addition, in
certain limited cases, the Cry9C protein was also detected in corn
seeds of a non-STARLINK variety of corn or in corn from such seeds. In
response to these findings, Aventis S.A. (the developer of STARLINK
corn), EPA, FDA, the U.S. Department of Agriculture, and the food
industry undertook efforts starting in 2000 to remove all STARLINK corn
from the food supply. Among other measures, FDA issued guidance
recommending that corn dry milling and masa operations screen yellow
corn (and milled yellow corn in certain situations) to minimize the
production of human food products with corn containing the Cry9C
protein. Corn containing the Cry9C pesticide is adulterated under
section 402(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 342(a)(2)(B)) if such corn is for human food use
because there is no tolerance or exemption from the need for a
tolerance under section 408 of the act (21 U.S.C. 346a). Therefore, FDA
recommended that manufacturers who detected Cry9C-containing corn in
any lot should divert the lot to animal feed or industrial use.
In the Federal Register of October 17, 2007 (72 FR 58978), EPA
announced the availability of its draft ``White Paper Concerning
Dietary Exposure to Cry9C Protein Produced by STARLINK Corn and the
Potential Risks Associated with Such Exposure'' (draft White Paper), in
which it concluded 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 additional human health protection.
EPA reached that conclusion based on information including results from
more than 4 million tests for Cry9C at corn handling operations over
the past 7 years and an exposure assessment by Exponent, Inc., of the
levels of Cry9C still present in the U.S. food supply. Based on its
analysis, EPA recommended in its draft White Paper that FDA withdraw
its guidance on the sampling and testing of yellow corn grain for Cry9C
at dry mills and masa production facilities.
In response to the EPA recommendation that FDA withdraw its
guidance on the sampling and testing of yellow corn grain for Cry9C at
dry mills and masa production facilities (72 FR 58978), FDA announced
that it was seeking comment on whether to withdraw its guidance
document entitled ``FDA Recommendations for Sampling and Testing Yellow
Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use
for Cry9C Protein Residues'' (72 FR 58980, October 17, 2007). FDA
received five comments, all from trade associations, that supported
withdrawal of the guidance document.
In its final ``White Paper Concerning Dietary Exposure to Cry9C
Protein Produced by STARLINK Corn and the Potential Risks Associated
With Such Exposure,'' EPA continues to recommend, as reflected
elsewhere in this issue of the Federal Register, that FDA withdraw its
guidance. Based on EPA's recommendation, the comments that FDA received
that support withdrawal of the guidance, and its own evaluation of
these circumstances, FDA is withdrawing its guidance document entitled
``FDA Recommendations for Sampling and Testing Yellow Corn and Dry-
Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C
Protein Residues.''
Dated: April 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8805 Filed 4-24-08; 8:45 am]
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