Rubber stampWe’re about to enter a brave new world in which transgenic, or genetically engineered (GE, as they are more commonly known), food animals may soon be appearing on our plates. An FDA special committee is meeting right now to determine whether a GE fish — AquAdvantage salmon, genetically engineered by AquaBounty Technologies to reach mature size more quickly, thanks to genes from the Chinook salmon and from the eel-like ocean pout — is safe for human consumption. The approval process for the GE salmon will set a precedent for all future GE animals; if the FDA does not set the bar high for solid science, it will mean a lack of scrutiny for other, perhaps less safe, GE animals in the future.

Unfortunately, the FDA appears poised to rubber-stamp the AquAdvantage salmon. After working with AquaBounty since the mid-1990’s on the application for the GE salmon, the FDA has only just recently released 255 pages of technical information — and then allowed a mere 14 days for the public to comment on it. And there is something decidedly fishy about the makeup of the committee chosen to weigh the scientific risk assessments. One might say that the scales are heavily weighted in favor of pro-biotech interests.

The FDA is regulating the GE salmon as a “New Animal Drug,” in agency terminology, and it is thus being evaluated by a special Veterinary Medicine Advisory Committee (VMAC) meeting today and yesterday. Consumers Union, the nonprofit watchdog group and publisher of Consumer Reports, has written a letter to the FDA and formally submitted comments protesting aspects of this approval process, from the shortened time frame, committee makeup, and data rigor (or lack of it). In the latest twist, the GE salmon data was taken from a small sample of fish raised in a facility in Prince Edward Island, whereas AquaBounty actually plans to raise the fish in Panama; thus, approving the fish based on the current data actually represents a violation of the law.

So, given the significance of the GE salmon’s approval process to the future of the U.S. food supply, why is the FDA all of a sudden in such a rush to approve the salmon that the public can only have 14 days to submit comments? A more standard public comment period would be 60 or 90 days. As Consumers Union points out, the GE salmon is not a life-saving medical technology that is urgently needed on the market. The only harm that could come from allowing the public 60 days to weigh in on the GE salmon is that AquaBounty will wait a few extra months to cash in. And perhaps independent scientists could raise difficult questions about the GE salmon’s safety that would make it harder to ram through its approval.

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Is there a fish vet(eran) in the house?

Among the ten current members of the VMAC, eight are vets. The other two are Jodi Ann Lapidus and Alan G. Mathew. Lapidus is an assistant professor in the department of public health and preventative medicine in the division of biostatistics at Oregon Health & Science University; Mathew heads the department of animal science at the University of Tennessee, Knoxville. Mathew also owns a 40-head cow-calf beef operation. He previously owned a 200-sow “farrow to finish” hog operation and a 720-acre grain farm.

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Given the committee’s lack of expertise on genetic engineering and fish, the FDA added four “temporary voting members” for the GE salmon meeting.

Let’s take a closer look at these experts charged with objectively evaluating the risk to the public.

  • Alison L. Van Eenennaam: A former Monsanto employee, Van Eenennaam works as a cooperative extension specialist in animal biotechnology and genomics at University of California-Davis. She also serves on the USDA’s heavily pro-genetic engineering Advisory Committee on Biotechnology and 21st Century Agriculture (AC21). Van Eenennaam has been vocal about her support for genetically engineering animals. She recently produced a YouTube video called “Animal Biotechnology” that compares genetic engineering and cloning to traditional animal breeding, artificial insemination, and in vitro insemination, as if they were all equally benign “biotechnologies.” The video oversimplifies genetic engineering, suggesting that scientists simply cut some DNA from one genome and paste it into another (almost as if it were as simple as using the Cut and Paste functions on your computer). But genetic engineering is highly imprecise. It takes many tries to successfully “paste” the genes into the DNA of the target species, and scientists have little control over where in the DNA the genes land. GE animals tend to have far higher rates of deformities than nature does. In the case of the GE salmon, AquaBounty Technologies successfully implanted its packet of genes into two separate locations in the Atlantic salmon’s DNA, and they had a different outcome from each. The genes pasted into one location resulted in faster-growing fish; the same genes pasted into a different location in the same DNA did not.

    Van Eenennaam’s primary work is not fish, but she has some background on GE fish. In publications, she has stated that genetically engineered fish will provide many benefits, such as increased feed-conversion efficiency, providing “economic and potential environmental benefits such as reduced feed waste and effluent from fish farms.” Her primary concern with GE fish is the difficulty in containing them, as farmed fish can escape, survive in wild ecosystems, and breed with wild populations.

  • Kevin G. Wells: Also a genetic engineering expert, Wells has directly performed genetic engineering, working on the creation of a mastitis-resistant GE cow while he worked at the USDA in its Gene Evaluation and Mapping Laboratory. Like Van Eenennaam, he is more familiar with cows than fish. In his role at USDA, he worked on “communication of embryo and genome manipulation technologies to the public.”

    Today, Wells is an assistant professor at the University of Missouri, Columbia, in the division of animal sciences. He is also the senior scientist, project manager, and department head of embryology and cell biology at Revivicor Inc. (formerly PPL Therapeutics), a Virginia-based spinout company from the UK company that created the cloned sheep Dolly. Revivicor works on genetically engineering pigs for use in human medicine. In other words, Wells has a bit of a professional and financial stake in the approval process for the GE salmon, as his employer, Revivicor Inc., will need the government to also approve its genetically engineered animals.

  • Gary Thorgaard: The lone fish expert on the entire committee. However, his specialization is in polyploidy, fish with extra complete sets of chromosomes. This is important in the GE salmon hearing, as the GE salmon are all female triploids (fish with three complete sets of chromosomes instead of two). Obviously, there is an importance in the committee understanding triploidy, as any differences observed in a GE triploid salmon (compared to a non-GE diploid) may be attributable to either the genetic engineering, triploidy, or both. Furthermore, the containment of the genetically engineered salmon will be an important issue in the hearing, and t
    riploidy is the method used to ensure that most (but not all) of the fish will be sterile. But the hearing will cover much more ground than triploidy.

  • Gregory Jaffe: Last and perhaps most concerning, the committee’s supposed consumer advocate is a lawyer (not a scientist) representing the Center for Science in the Public Interest, an organization that favors the use of agricultural biotechnology. Like Van Eeenennaam, he has served on AC21, from 2004 to 2008. His views can be seen in a paper he wrote called “Creating the Proper Environment for Acceptance of Agricultural Biotechnology.” In it he states CSPI’s unequivocal support for agricultural biology and his belief that genetically engineered crops have increased productivity and farmer income while reducing pesticide use, and that GE crops are safe for humans and the environment. Each of these conclusions is controversial, and credible evidence abounds disproving each, give or take the claim on farmer income.

    Jaffe completes the paper by tackling what he sees as the true threat of biotechnology — public acceptance of GE foods. He calls for “a strong, but not stifling, regulatory system.” He also calls for the regulatory system to be “transparent and participatory” with “independent risk assessment research that informs the public and regulators.” Sounds good, but a full reading of the paper makes it apparent that perhaps his interest in regulation is intended more as a public show to convince the public to eat GE foods, than a true review of the safety of GE products. In a more recent article, “Questions About Genetically Engineered Animals,” Jaffe expresses optimism that genetically engineered animals, including the AquAdvantage salmon, will provide environmental or health benefits.

Looking at this stacked committee, Consumers Union in its letter recommends adding “three fish ecologists, four food safety experts (including specialists in food allergies and in the effects of hormones on human health), and scientists from the consumer and environmental community … to the Committee, to provide appropriate balance and expertise.”

Ana-filet-actic shock

Consumers Union also has many concerns about the safety of the fish, specifically increased allergenicity:

Because FDA’s assessment is inadequate, we are particularly concerned that this salmon may pose an increased risk of [severe], even life-threatening allergic reactions to sensitive individuals.  Instead of approving this product, FDA should be requiring studies with data from many more engineered fish, not the tiny sample of six fish [emphasis added] on which it currently bases its conclusions.

Consumers Union is also concerned about the lack of data on fish raised at the Panama facility where the GE salmon, if approved, will be raised. The data used in the FDA assessment of the GE salmon’s safety was all taken from fish raised at a facility in Prince Edward Island. The FDA itself acknowledges that “the culture (e.g., water temperature, pH, alkalinity, etc.) were likely to be significantly different from the facility at PEI as a result of differences in, among others, water surface, facility design, and environmental factors due to geographic location. . . .  the effect of the difference between the PEI and Panama facilities, especially temperature, on the resulting AquAdvantage phenotype is unknown.”

Consumers Union notes that this is a legal violation, based on the law the FDA is using to regulate the GE salmon:

FDA is regulating the GE salmon as a New Animal Drug, with the NAD being the genetic (e.g. rDNA) construct itself. Thus, the husbandry and rearing conditions of GE fish into which the genetic construct has been inserted would constitute the production process. Under the NAD provisions of the Federal Food Drug and Cosmetics Act (FFDCA), a NAD is granted for a specific production process; if a company changes the production process for a NAD, the company must submit data to the FDA to show that such a change does not have an effect on the safety or efficacy of the NAD, i.e. the FDA does not assume that drugs made with different production processes are equivalent and requires data to show they are equivalent.  Since the husbandry/rearing conditions differ between Panama and PEI — the former being in the tropics, the latter in the temperate zone — this means that the production process (e.g. husbandry/rearing conditions) differs as well, and FDA should require Aqua Bounty to submit data showing that it does not impact the safety of the NAD. FDA should insist, for example, that the rearing conditions in Panama do not increase the levels or potency of allergenic proteins in the salmon.

Requiring new data would, of course, slow down what has all of a sudden become a mad rush to approve an entirely new product.

Why is the FDA accepting such sloppy science, flouting its own regulations, giving the public nearly no time to weigh in, and packing its committee full of biotech hacks who will not ask the tough questions necessary to ensure the AquAdvantage salmon is safe before it winds up (unlabeled, the Washington Post reports) on our plates?

Who knows. But one thing’s for sure: AquaBounty, which only spent $30,000 on lobbying between the end of 2009 and the first half of 2010, is getting more than its money’s worth.