Docket Management
Docket: 00N-1396 - Premarket Notice Concerning Bioengineered Foods
Comment Number: EC -102

Accepted - Volume 23

Comment Record
Commentor Ms. Barbara Parcells Date/Time 2001-02-28 23:20:09
Organization Ms. Barbara Parcells
Category Individual

Comments for FDA General
1. General Comments The proposed rules for Premarket Notice of Bioengineered Foods look pretty good. I have the following comments, as well as proposals for additions/modifications: - - - - - Imports-- YES, these should meet the same requirments. Good call. - - - - - FDA should require sufficient notification that it is at least aware of the existence of all bioengineered foods; even if said foods contain only substances already GRAS in existing foods. - - - - - Requirements regarding food plants which are being transformed to include non-GRAS substances anywhere within the plant tissue should be more stringent. As mentioned in the document, such plants fall under EPA's reporting requirements, of which I wholeheartedly approve. - - - - - Non-Food transforms of former food plant types-- Due to the possibility of mistaken introduction into the food supply, developers of non-food uses of food species plants (such as corn containing cosmetics ingredients) should be held to the same requirements of 120 day notification as proposed in this rule. ... Again, FDA should be at least aware that these plants exist. ... FDA should suggest to such producers that they also introduce traits which would make the food easily distinguishable at a food processing plant-- such as unusually colored or textured seed skins. It would be pretty disastrous (except for late night comedians) if corn which had been engineered to be high in vinyl chloride (a building block of plastics) were to make it into the nation's taco shell supply. - - - - - (page 4721 or 22 of summary of the proposed rule)-- Regarding modified plant species which could pose a hazard to or be unsuitable for humans or animals (depending on the normal application of the bioengineered plant)... I think FDA should indeed require that producers detail how their product could be detected at the processor, and make it as easily detectable as possible. This should go for both plants which are intended for use as food or feed, and especially for those which are non-food transforms as mentioned above. - - - - - I don't think that nonhazardous bioengineered foods, intended as food, need to be made, say, odd colors which can be seen in finished food products. However (as I commented on a separate proposed rule), I do think labeling should be required for such products, to be included in the nutrition label. - - - - - Record of transforms and techniques used-- this is a good idea, as it will enable FDA to keep a record of what was done to each plant line to generate its new characteristics. If unexpected results, either harmful or beneficial, should arise later from a plant line, this information would be helpful both to policymakers and to producers hoping to reproduce/avoid the unexpected effect, as well as to epidemiologists studying it. - - - - - The redacted-copy policy described on page 4715 (16?)-- Sounds like a good way to cover producers' trade secrets. It would be wise, however for them to keep records at their facility of the details of the techniques used for, say 20 years. If adverse effects arise from their product, the producer can be required to produce the details of the transformation techniques used, to allow epidemiologists et al. to determine what went wrong and enable other producers to avoid repeating the error. I believe drug producers are held to a similar requirement. - - - - - Producer must explain why they want to keep confidential-- I agree, and they must show a) compelling business reason, and b) firm evidence that such confidentiality will not harm the public (such as by introducing a product unexpectedly that has the potential to cause allergic reactions or worse). - - - - - When a PBN is withdrawn, will the producer still have to provide another one more than 120 days before introducing the bioengineered food to market? - - - - - The proposed PBN format looks pretty good to me: ... Page 4723, paragraph labeled 2. Status of the Bioengineered Food at EPA-- I agree, this sounds like a very good policy. It sounds like the existence of rDNA food plants with pesticidal additives, would be discoverable by the public through the PBN system. ... Public Disclosure-- Put the PBN's on the Web, definitely. This what I think of when I hear the term electronic reading room. ... FDA should be very strict about requiring justification for exempting an entire PBN from public disclosure. ... The rest of section X, Public Disclosure, looks good. - - - - - XI Animal Feed-- Attention should also be paid to the possibility of a bioengineered ingredient in feed remaining resident in the animal's tissues, when the animal will be used for food by humans. (ex: chickens, cattle) Similar phenomena have been seen in the past (birds of prey accumulating pesticides in their tissues from contaminated fish). - - - - - Paperwork Reduction-- Perhaps a Web-based form of PBN submission is possible in the future. This method would require means of verifying the submitter's identity, credentials, etc.

EC -102