Guidance for Industry on FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues; Comments on Possible Withdrawal, 58980 [E7-20379]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 72, Number 200 (Wednesday, October 17, 2007)]
[Notices]
[Page 58980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0025 (formerly Docket No. 01D-0025)]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is 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.'' FDA is considering withdrawing its guidance in response to 
the release by the Environmental Protection Agency (EPA) of a draft 
``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: Submit written or electronic comments by December 17, 2007.

ADDRESSES: Submit written comments on this notice to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments.

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:

I. Background

    In the Federal Register of January 22, 2001 (66 FR 6627), FDA 
issued final guidance for industry 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 United States 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.
    EPA has developed a draft ``White Paper Concerning Dietary Exposure 
to Cry9C Protein Produced by STARLINK Corn and the Potential Risks 
Associated with Such Exposure'' (draft White Paper), which it is making 
available for comment elsewhere in this issue of the Federal Register. 
In the draft White Paper, EPA 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 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 recommends 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.
    FDA is now 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.''

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this document. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at https://www.cfsan.fda.gov/guidance.html.

    Dated: September 6, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20379 Filed 10-16-07; 8:45 am]
BILLING CODE 4160-01-S