[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Notices]
[Page 58980]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc07-140]
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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 http://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 http://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