From: Mary Needham [mneedham@iamerica.net] Sent: Thursday, February 08, 2001 4:09 PM To: fdadockets@oc.fda.gov Subject: Re: dockets OON-1396 and OOD 1598 - GEF FDA Commissioner Dockets Management Branch (HFA 305) Food and Drug Administration 5630 Fisher's Lane, Room. 1061 Rockville MD 20852 Dear FDA Commissioner: I am one of thousands of ordinary consumers very upset about the proposed relaxation of labeling requirements for genetically engineered foods. One of the freedoms of choice should be that we are entitiled to know what we are eating. I would choose NOT to consume GE foods. Many large companies obviously are pressuring you to make it possible for them to disguise GE foods in what the rest of us buy unknowingly. Labeling GE foods would protect the public from potential hazardous health effects such as food allergies and toxicity that can only be traced if GE foods can be identified. By refusing to require both labeling and mandatory pre-market safety testing of foods, the FDA puts consumer's health at risk, ignores possible environmental hazards, and fails to satisfy the overwhelming desire of American consumers to exercise freedom of choice in the marketplace. It is not enough to require that firms simply notify you of their intent to market a food produced with genetic engineering; this is no substitute for thorough pre-market safety testing. The proposed "voluntary labeling" guidelines will do nothing to inform consumers of the presence of genetically engineered ingredients in their food, because biotech companies and food manufacturers have vehemently opposed labeling in the past and will not voluntarily label their foods in the future. Therefore, I urge you to keep all genetically engineered ingredients and crops off the market unless or until: 1) They are labeled to ensure consumers¹ right-to-know; 2) The biotechnology corporations that produce them are held responsible for any harm they may cause. 3) Independent safety testing demonstrates they have no harmful effects on human health or the environment after about 20 years of use! . Voluntary labeling unfairly reverses the financial burden onto producers who do not use GEFs. Mandatory labeling is essential for the traceability of GEF products throughout the food supply for health professionals. Mandatory labeling also protects overseas markets for farmers. FDA must require MANDATORY labeling of GEFs. FDA's proposed rule is unlikely to provide the public with adequate information on GEFs for independent review. The FDA notes that producers of GEFs may claim that any such information, including the premarket notification, is trade secret or confidential business information subject to exemption from public disclosure requirements. FDA must require full disclosure. I will not think anything less than mandatory safety testing, labeling, pre-market environmental review, and full disclosure are appropriate. All GEFs should be taken off supermarket shelves until these are established. I do not want to eat them, and I don't want them camouflaged in things I do choose to eat. -- Mary Needham President Reserve Technology Inst. 2610A Dunlavy Houston, TX 77006 Tel: 713-521-7979 Fax: 713-521-3607 Websites: rti-hou.com fpso-subsea.com Email: mneedham@iamerica.net