[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Notices]
[Pages 6627-6628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing 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 that was introduced into the StarLink<SUP>TM</SUP> 
variety of yellow corn using recombinant deoxyribonucleic acid (DNA) 
techniques to make the corn more resistant to certain types of insects. 
StarLink<SUP>TM</SUP> corn is lawful only for use in animal feed, not 
human food. However, some Cry9C-containing corn was commingled with 
yellow corn intended for human use. This document outlines the approach 
that FDA recommends to manufacturers of corn products for human food 
use for sampling and testing yellow corn (and milled yellow corn in 
certain situations) in order to minimize the production of human food 
products with corn containing the Cry9C protein.

DATES: Submit written comments concerning this guidance to the Dockets 
Management Branch (address below) by March 23, 2001. After March 23, 
2001, submit written comments to the contact person (address below).

ADDRESSES: Submit written comments concerning this guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written requests 
for single copies of the guidance to Lauren M. Posnick, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5321. Send one self-
adhesive address label to assist that office in processing your 
request. Comments and requests for copies should be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the guidance and comments received by March 23, 2001, are available 
for public

[[Page 6628]]

examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Lauren M. Posnick, Center for Food 
Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5321, FAX 202-205-4422, e-
mail: <a href="/cdn-cgi/l/email-protection#7519051a061b1c161e35161306141b5b1311145b121a03"><span class="__cf_email__" data-cfemail="92fee2fde1fcfbf1f9d2f1f4e1f3fcbcf4f6f3bcf5fde4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing guidance for industry on sampling and testing for 
the presence of Cry9C protein residues in yellow corn (and milled 
yellow corn in certain situations) intended for human food use. Cry9C 
is a pesticidal protein that was introduced into the StarLink<SUP>TM</SUP> 
variety of yellow corn to make the corn more resistant to certain types 
of insects. The Environmental Protection Agency (EPA) authorized 
StarLink<SUP>TM</SUP> corn only for use in animal feed, not human food. 
EPA has not authorized the use of StarLink<SUP>TM</SUP> corn in human 
food because there is an unresolved question about the allergenic 
potential of the Cry9C protein.
    Although restricted to animal food use, some StarLink<SUP>TM</SUP> 
corn was commingled with yellow corn intended for human use. In 
addition, in certain limited cases, the Cry9C protein has also been 
detected in corn seeds of a non-StarLink<SUP>TM</SUP> variety of corn 
or in corn from such seeds. Aventis S.A., the developer of 
StarLink<SUP>TM</SUP>, in cooperation with the U.S. Department of 
Agriculture, has been buying back harvested StarLink<SUP>TM</SUP> corn 
from the year 2000 crop to prevent its introduction into the human food 
supply. Because some Cry9C-containing corn may have been missed in the 
buy-back program and because some StarLink<SUP>TM</SUP> corn from the 
1999 crop may still be in some grain elevators, FDA is urging corn dry-
milling and masa operations to screen yellow corn (and milled yellow 
corn in certain situations) to minimize the production of human food 
products with corn containing the Cry9C protein. Because corn 
containing the Cry9C pesticide is adulterated if intended for human 
food use (21 U.S.C. 342(a)(2)(B)), manufacturers who detect Cry9C-
containing corn in any lot should divert the lot to animal feed or 
industrial use.
    The guidance document contains FDA's recommendations to dry milling 
and masa operations for sampling and testing yellow corn shipments; the 
guidance recommends appropriate tests, representative sampling 
procedures, appropriate analytical procedures, and appropriate 
personnel training. FDA believes these recommendations will help 
manufacturers to identify those lots of corn that contain the 
StarLink<SUP>TM</SUP> variety commingled with other yellow corn and 
avoid the use of such corn in human food products.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (65 FR 56468, September 19, 2000). The 
guidance represents the agency's current thinking on sampling and 
testing yellow corn for residues of the Cry9C protein. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations. To the extent that use of this guidance helps millers and 
food manufacturers avoid the production of human food containing Cry9C 
residues, the guidance will help prevent human exposure to a potential 
food allergen and will otherwise help prevent adulteration of the food 
supply. Due to the urgent need to convey the sampling and testing 
recommendations to members of the food industry to help prevent the 
further introduction of Cry9C-containing corn into the human food 
supply, FDA conveyed the substance of this guidance to affected millers 
and food manufacturers in a letter dated December 27, 2000 (Ref. 1). 
Similarly, FDA is making this guidance document effective immediately 
because public participation prior to its implementation is not 
appropriate in these circumstances (21 CFR 10.115(g)(2); 65 FR 56478). 
However, in its letter of December 27, 2000, FDA recognized that some 
dry milling and masa operations may have inventories of stored grain or 
meal that have not been tested or have not been tested as described in 
the guidance document. Consistent with that advice, the agency is 
recommending that manufacturers that choose to follow this sampling 
guidance phase it in over a period of no more than 30 days dating from 
December 27, 2000.
    Although the guidance document announced in this notice is being 
implemented immediately, FDA is requesting comments on the guidance. 
FDA will review all comments received, revise the guidance in response 
to the comments as appropriate, and publish a notice of availability of 
the revised guidance, if it is revised.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this immediately-in-effect 
guidance by March 23, 2001. After March 23, 2001, submit written 
comments regarding this guidance to the contact person (address above). 
FDA will consider such comments when determining whether to revise the 
current guidance. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. A copy of the guidance document and comments received by 
March 23, 2001, may be seen in the Dockets Management Branch between 9 
a.m. and 4 p.m., Monday through Friday. An electronic version of this 
guidance is available on the Internet at www.cfsan.fda.gov.

III. References

    The following references have been placed on display at the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday
    1. Letter and recommendations, dated December 27, 2000.
    2. ``Sampling and testing plan, scientific basis,'' January, 2000.

    Dated: January 12, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-1609 Filed 1-19-01; 8:45 am]
BILLING CODE 4160-01-S


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