Document ID: FDA-2008-D-0229-0001
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2008-04-25T04:00Z

[Federal Register: April 25, 2008 (Volume 73, Number 81)]
[Notices]               
[Page 22716-22717]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap08-158]                         

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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]

BILLING CODE 4160-01-S