In response to a memorandum issued by the Executive Office of the President last July, representatives of the agencies that regulate the products of biotechnology in the United States–FDA, EPA and USDA–participated in a meeting at UC Davis today titled “Modernizing the Regulatory System for Biotechnology Products.”
The meeting was well attended, mostly by folks in the biotech industry. But there were a few of us who were more concerned with transparency and protecting health and the environment than with reducing regulatory burdens and inhibiting innovation. I count among the former Professor Albert C. Lin of the UC Davis School of Law.
Here is the text of the public comment I delivered at the meeting:
My name is Belinda Martineau. My Ph.D. is in plant molecular genetics and 25 years ago I spent 4 years interacting with FDA scientists as the agency was first learning 1) how crop genetic engineering worked, 2) what risks it might pose, and 3) how best to regulate these new food and feed products. These interactions were part of gaining regulatory approval of the first whole GE food to be commercialized, the Flavr SavrTM tomato, developed at Calgene where I was working at the time.
This tomato still serves as a good example for how to modernize the regulatory system for biotechnology products.
We knew from the get-go that the GE process could result in unintended, unexpected changes in GE plants via insertional mutations or somaclonal variation, and informed FDA accordingly. That’s why animal feeding studies are conducted with GE foods, and why FDA should require follow-up of the feeding studies carried out with NK603 corn.
We were still dialoging with FDA after the 1992 policy was published when FDA scientists asked us to make sure only the DNA we intended to insert in our tomatoes had been inserted. To our surprise we found that 20% of the time our entire minimally characterized “vector backbone” sequences had been inserted too. This is still a problem when using the agro-based method—although I learned recently of a GE developer who was not initially aware of this problem—and its a reason why regulation of GE products should be required by FDA.
We also didn’t understand exactly how the gene inserted into Flavr Savr tomatoes worked in 1994 when it was commercialized. It turned out to be RNA silencing, discovered years later.
We now know that alterations in endogenous versions of these small regulatory RNAs can be another source of unintended changes in GE crops, and even the new CRISPR-Cas9 process can have off-target effects.
Genetic engineers currently cannot prevent these unintended processes from occurring; but they can look afterward for unintended, unexpected changes in a GE crop, such as an unapproved food additive (as is mentioned in footnotes to many of [the hypothetical case studies that were reviewed during this meeting today]).
FDA should not just “strongly encourage” developers to voluntarily consult with the agency about these and other issues; because of the possibility of these unintended changes, the fact that a food or feed crop has undergone GE should trigger mandatory pre-market federal regulation.
As mentioned earlier, FDA regulated the antibiotic-resistance protein produced in Flavr SavrTM tomatoes as a Food Additive. Why hasn’t the FDA considered other foreign proteins expressed in other GE crops—insecticidal proteins, for example—as food additives as well?
Calgene voluntarily labeled the Flavr SavrTM tomato in 1994 and it sold like hot cakes. I am happy to see that more and more food companies are now, finally, doing the same. But for the Administration to attain its goal of ensuring public confidence in the regulatory system and improving its transparency, it should require mandatory labeling of all GE foods.
And here is the text of the part of my comment I could not fit into the 3 minutes allotted for each comment:
I also hope the federal agencies have learned from actual (as opposed to hypothetical) commercialized GE products that have been problematic during the last 20 years, like StarLink™ corn, Bt176 corn, and NK603 corn.
But if so, why wasn’t human allergenicity mentioned in the case studies after concern about StarLink corn led to monitoring US corn crops for 7 years after that product was removed from the market?
Will pollen from new Bt crops be tested for their toxicity to Monarch butterfly larvae prior to commercial release, in light of the toxicity of Bt176 pollen to those non-pest insects?
Is regulation of GE crops no longer based solely on “intended use” as a result of the case of avidin-producing corn?
And again, hopefully, FDA will require additional animal feeding studies with NK603 corn in an effort to provide conclusive evidence, one way or another, about the safety of that GE product.