Docket Management
Docket: 00D-1598 - Voluntary Labeling Indicating Whether Foods Have Been Developed Using Bioengineering
Comment Number: EC -256

Accepted - Volume 78

Comment Record
Commentor Dr. Keith Redenbaugh Date/Time 2001-03-16 20:18:30
Organization Seminis Vegetable Seeds
Category Company

Comments for FDA General
Questions
1. General Comments March 16, 2001 Margaret Dotzel Associate Commissioner for Policy Attn: Dockets Management Branch U.S. Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Ref: Comments on draft “Guidance for Industry Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering” [Docket No: 00D-1598] Dear Dr. Dotzel: Seminis Vegetable Seeds, a company headquartered in Oxnard, California, wishes to provide the following comments on FDA’s draft Guidance for Industry Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering. In general, Seminis strongly supports the Guidance for Industry, which provide consumers, industry, universities, non-governmental agencies, and others with clear guidance on acceptable labeling for products which have either been modified using modern biotechnology or have not been so modified. FDA has done a very admirable job in examining the confusing terminology surrounding biotechnology and in providing guidance. For example, despite the usage of “genetically modified organism” and “GMOs,” FDA has clearly seen that such terms are misleading and are equally appropriate for products which have not been modified using modern biotechnology. Seminis supports FDA’s choice of “bioengineered” and “biotechnology” for labeling this technology. Because of the many different terms used for products of modern biotechnology, Seminis encourages FDA to provide specific language to use on products which do not contain bioengineered ingredients or have not been modified using biotechnology. FDA has done this in the past with BST and provided language for an acceptable label: “milk from cows not treated with rBST.” Similarly, FDA should consider providing consistent and uniform language for biotechnology, for example, “tomatoes from plants not developed using biotechnology.” Enforcing such uniform language would provide consumers with clear information and would minimize the use of false or misleading language in labeling about the absence of the use of bioengineering in the production of a food or its ingredients. Seminis agrees with the FDA and supports its position that there is no evidence or reason to modify the 1992 Statement of Policy: Foods Derived From New Plant Varieties. To date, there has been no information generated which would suggest that biotechnology, in general, leads to material changes in plants or products derived from them. As such, there is no support for general labeling requirements. Seminis is aware of at least one example bioengineered product which had a material change and for which a new common or usual name was required: Laurate canola. This is evidence that the FDA’s labeling regulations are working and that industry is in full compliance. It is important for FDA to continue to be cautious about usage of the term “free” in making claims for absence of bioengineering. There are certainly many opportunities where inadvertent mixing between products developed using bioengineering and those without can occur. Some of these opportunities are under human control and some are natural. Examples are mixing of seed during milling and pollen flow, respectively. Because pollen flow is a completely natural and uncontrolled process in agricultural production fields, there should be no stigma or issue should such pollen movement occur between fields of plants developed using bioengineering and those without. Pollen flow, a natural process, is inherently different from human-directed activities, such as herbicide applications and the potential issues associated with herbicide drift. Thank you for this opportunity to provide comments. Sincerely, Dr. Keith Redenbaugh Associate Director Regulatory Affairs Seminis Vegetable Seeds




EC -256