Genetically Engineered Salmon
ucsusa.org
The first transgenic animal could soon be served in a kitchen or restaurant near you. According to news reports, the U.S. Food and Drug Administration is currently reviewing an application to market gene-altered Atlantic salmon that grow far faster than normal.
If the FDA approves this engineered salmon, the transition from laboratory to sandwich could be rapid. The company seeking the approval, A/F Protein Inc., claims to have orders for upward of 15 million engineered salmon eggs.
Eyes Wide Shut
While the decision to approve or not approve this engineered salmon will set precedents for future regulation of transgenic fish and other animals, information about the regulatory process is sparse. Although the FDA's website acknowledges inquiries made about the salmon, it has not posted the application for the transgenic fish, nor does it even admit that an application has been received. What UCS has learned about the fish we have pieced together from newspapers, science magazines, and, to a limited degree, industry sources.
From what we know, the FDA is reviewing an engineered Atlantic salmon containing foreign genes that stimulate the fish to grow to market size in about half the time it takes normal salmon. Researchers accomplished this by inserting two genes into the fertilized eggs of the fish. The first gene, which produces growth hormones, is taken from the Atlantic salmon's cousin, the Chinook salmon. The second gene, from the ocean pout -- a more distant fish-relative -- is a "promoter" that activates the first gene. The pout promoter gene was used because this fish produces growth hormones year round. The new promoter disrupts the salmon's normal cycle, which produces growth hormones only during the warmer, summer months.
No Free Lunch
In aquatic biotechnology, a major goal is the improvement of growth rate and disease resistance. A/F Protein is touting its fish as the first of many newly enhanced animals that will supply abundant food at lower costs.
But not everyone in the salmon industry is convinced. Some have voiced strong opposition. The rapid growth of commercial fish farming over the past decade has led to sharp decreases in salmon prices. Once commercially available, transgenic salmon could flood the market, driving down the price of farmed salmon even further. Falling prices could put some farmers out of business while forcing others to accept the new technology -- willingly or unwillingly -- for fear of losing out economically.
The possible approval of the first transgenic fish raises many of the same fears and concerns as the registration of transgenic crops. Could these animals damage the environment? Are there health consequences from consuming transgenic animals?
Ecologists express great concern about engineered salmon. They fear that transgenic fish, if they are released -- or escape -- into the wild, may wreak havoc on native salmon populations. Concerns about escape are well founded. Farmed salmon are traditionally grown in ocean netpens and these cages are not escape-proof. Storms and hungry animals can damage netpens, releasing large numbers of fish. Once out, the animals are virtually impossible to recapture.
The release of transgenic fish into the wild could have many ramifications, from competition with wild populations to ecological disruptions due to changes in prey, food, or other resources. Perhaps even to extinction of native salmon, a possible result of the Trojan gene effect (see related links above). Although industry argues that transgenic fish do not pose great environmental risks, because it can produce fish that are sterile, critics note that the technology for producing sterile fish is not foolproof.
There are also questions about whether transgenic fish will be safe to eat. As with transgenic soybeans and corn, little scientific work has gone into protocols for testing the safety of transgenic foods.
Holes in the Regulatory Net
The FDA has not issued a formal policy statement on how it intends to regulate transgenic food animals, although a question-and-answer feature on its website provides some hints. It indicates that the FDA will not seek to regulate them as food. Instead, the agency will use the regulations that govern the substances the animals have been engineered to produce. If the new substance is considered a drug, the engineered animal will be regulated as a drug. If the substance is a food or color additive, or a vaccine, the FDA will regulate the engineered animal under the statutes appropriate to those substances. Because the growth hormone the transgenic salmon will produce is considered a drug, the salmon will be regulated under the FDA's veterinary drug statutes.
Why is the FDA using drug laws to regulate fish? Although the agency has provided no explanation, the answer probably has to do with the inadequacy of the regulatory framework that governs biotechnology. The current federal framework was initially put together in 1985 when the Reagan administration decided that it would not seek new legislative authority to regulate new biotechnology products. Instead, the government would rely on existing statutes and regulations. Under this policy, agencies must choose from among the statutes they administer those best suited to regulate the new products.
Although none of the statutes being applied to biotechnology products were enacted for that purpose, some of the existing laws fit better than others. The drug laws, for example, do a good job of regulating biotechnology drugs, such as human insulin. But some of the framework's most gaping holes come to light in relation to transgenic animals.
The FDA's decision to regulate fish as drugs (or vaccines or food additives) reflects the framework's weakness when applied to animals. For example, no existing food law requires that transgenic animal foods be reviewed for health and environmental risks before they go to market. Generally, food laws (except for the food-additive provisions) provide authority only for responding to risks that manifest themselves after foods are marketed. If the FDA wants to allow premarket review of the fish, then regulating fish under the drug laws makes sense. Those laws provide the FDA with the authority to examine the risks entailed by products before they go to market.
Although the FDA deserves credit for choosing the strongest of the laws it administers, the drug laws are not well suited for regulating transgenic animals. For one thing, some transgenic animals may not produce substances that qualify as drugs and, as a result, may slip through the regulatory net. In addition, the drug laws allow little public participation in product review, which is unacceptable in the case of genetically engineered food.
The weakness in the framework may also help explain another odd feature of the FDA's regulation of transgenic fish: the entry of an agency with little environmental expertise into the arena of environmental risk assessment. It seems likely that the FDA is moving to fill a vacuum, since no other federal agency has readily applicable statutes that would permit review of genetically engineered animals. While this boldness may be admirable, the result is strained. Besides having little experience, the FDA has few legal tools to oversee ocean aquaculture or to enforce any limitations it imposes. Even though, according to the Washington Post, the FDA is willing to accept input from federal agencies such as the Environmental Protection Agency, which has more experience with environmental assessments, it is still not the right agency for the job.
Coming Soon to a Supermarket Near You?
There is no official word yet on the timetable for the FDA's work. According to articles in the New York Times and Nature, the agency may take a year or more to finish its review of A/F Protein's application and decide what experiments it will require to assess the risks to human health and the environment.
Moreover, even if the FDA approves the engineered salmon for human consumption, fish farmers may need further approvals from the Fish and Wildlife Service and the National Marine Fisheries Service before they can place the animals in coastal waters. These may prove major hurdles, especially in light of the recent listing of the Atlantic salmon as an endangered species. Net pen farming of salmon on the East Coast is already a major threat to the survival of the remaining wild Atlantic salmon.
Behind the Floodgates
While a faster-growing salmon is the first transgenic animal the biotech industry is seeking to introduce to US markets, it will certainly not be the last. Scientists worldwide have altered the genes of at least 30 other aquatic species, including flounder, carp, lobster, and shrimp for both scientific study and commercial production. And on the farm, pigs that produce meat with less fat, chickens that resist bacterial infections, and cows that can grow faster on less feed are also said to be in the pipeline.
It's important that the decision to approve or not approve this first transgenic animal be done well. The FDA's bold, but inappropriate, approach to regulating the salmon should focus attention on the need for new legislation tailored to the animal food products of biotechnology, particularly fish and shellfish. UCS will monitor regulatory activities concerning transgenic animals as we have long done for engineered plants. We'll evaluate and publish the risks. And we'll work to ensure that you and other members of the public have the opportunity to make your voice heard as transgenic foods move through the regulatory process. |
