Congress should improve FDA's ability to regulate GE animals

If adopted on a large scale, the company claims that the salmon would reduce producers’ costs and benefit the environment by reducing the feed that fish-farming operations use, the waste produced, and the transportation costs to get the fish to market by growing them at local inland farms.

The AquAdvantage salmon is not the first, nor will it be the last, GE animal. Already, pet owners can purchase “glowfish,” fish with an inserted gene that makes them glow in the dark. Medical patients with a rare clotting disorder are treated today with Atryn, manufactured by goats engineered with a human gene whose biologically-active molecule is expressed in their milk. GE animals on the horizon include a pig that produces environmentally friendlier waste and cattle resistant to mad cow disease.

The federal government regulates GE animals using FDA’s “new animal drugs” process. Adding genes to an animal fits the legal definition of an “animal drug” even if the public and developers find this legal fiction confusing. The upside of that approach is the FDA’s strong mandatory pre-market approval authority, which requires a company to demonstrate that any food from the animal is safe to eat and that the genetic changes don’t harm the animal.

The downside is that drug applications and the approval process are shrouded in secrecy, with limited opportunity for public participation. (FDA and AquaBounty have been in discussions for over 10 years but the public got its first look at some safety data and FDA’s analysis at the eleventh hour of the decision process.) Sen. Mark Begich (D-Alaska) and 10 of his colleagues sent FDA Commissioner Hamburg a letter on Sept. 28, identifying numerous problems with FDA’s regulatory process, including the lack of transparency and participation.

While FDA has the expertise to address food-safety questions, it has less expertise to analyze environmental concerns presented by GE animals. The Environmental Protection Agency, the Fish and Wildlife Service, and other federal agencies with expertise and experience with environmental assessments (and fish in particular) have been surprisingly silent about any role they might have in regulating GE animals (and none were formally present at FDA’s hearing).

Congress should step in and provide FDA with adequate authority to analyze and address the full range of environmental concerns that GE animals might pose, including the power to “recall” those animals if problems arise after commercialization. Congress should eliminate the confidentiality requirements so safety data and FDA’s analysis could be reviewed by outside experts before granting any approvals. And FDA should be directed to consult with other agencies with expertise in assessing environmental risks of animals. Sen. Richard Durbin’s Genetically Engineered Foods Act, introduced in 2004, would do all that, and Congress should take it up again next year.

In the meantime, the public should take comfort that if FDA goes forward and approves the AquAdvantage salmon, the data and analysis released last month indicate that the filets are just as safe to eat as filets from any other salmon. The proposed conditions for rearing those fish – in two facilities in Canada and Panama with multiple layers of physical, biological, and geographical containment – also make it extremely unlikely that the salmon would escape the facilities, reproduce, and impact other salmon or the environment.

The FDA is unlikely to require mandatory labeling of AquAdvantage filets because they don’t differ from other Atlantic salmon in any “material” way that impacts consumers. FDA should work with food industry representatives, however, to implement voluntary labeling. Going to the store and finding a labeling identifying the salmon as “AquAdvantage salmon” or “fast-growing environmentally friendly salmon” (assuming those benefits can be verified) could go a long way toward satisfying consumers who are interested in knowing if they are purchasing GE salmon (without scaring other consumers by using the words “genetically engineered”). Also, FDA needs to allow “absence” labeling that is truthful and not misleading if supermarkets want to label salmon they can verify is not engineered.

GE animals, like GE crops (which encompass over 80 percent of U.S. corn, soybeans, cotton, and sugar beets), may become a significant part of American agriculture. But without regulatory procedures that are thorough and transparent, consumers will question the safety of GE animals, handicapping a technology that potentially has beneficial applications for farmers, consumers, and the environment. Before the government becomes too invested in the currently flawed regulatory process, Congress should pass legislation that allows safe, beneficial products to reach the marketplace while protecting consumers and the environment.

Gregory Jaffe is the director of the Biotechnology Project at the Center for Science in the Public Interest.