GE Fish Threaten Human Health The human health impacts of eating these GE fish are completely unknown. While data on human health impacts of GE fish is sparse, some recent studies have provided cause for serious concern. For example, the routine use of antibiotics to control diseases often found in farm-raised fish may already be impacting human health. Some research has suggested that transgenic fish may be susceptible to more diseases than fish currently grown in aquaculture facilities.7 Consequently, the amount of antibiotics given to transgenic fish may be higher than the amount currently given to farmed fish; farmed salmon are already given more antibiotics than any other livestock by weight. By eating farmed fish treated with antibiotics, humans will be ingesting antibiotics that may be harmful. Indeed, some antibiotics are toxic and can even cause fatal allergic reactions.8 The use of antibiotics in aquaculture further exacerbates the significant problem of antibiotic resistant bacteria. The potential human health concerns connected with the use of antibiotics in aquaculture, including the unique role transgenic fish may play in escalating these concerns, must be fully assessed by FDA. FDA reviews noted that increased prevalence of focal inflammation in various tissues in the salmon is most likely due to the presence of the AquAdvantage genetic engineering. These findings suggest that the AquAdvantage salmon may require more antibiotics. The importance of thorough human health and environmental studies cannot be overstated because the AquaBounty transgenic salmon is the first-ever GE animal intended for human consumption. This animal should not be approved for human consumption until and unless further study indicates that they are safe for consumers, native salmon populations and the environment. No Federal Laws Specifically Govern The Regulation Of GE Animals Unfortunately, there are no U.S. laws specifically governing the regulation of GE animals. Instead, FDA has decided to “regulate” GE fish and any other future GE animals as “new animal drugs.” To receive FDA approval to commercialize a GE fish, producers must complete a New Animal Drug Application (NADA) and demonstrate the efficacy of the fish and genetic construct. There are numerous major weaknesses in such an approach, including lack of transparency, improper scope of review, lack of appropriate agency expertise, and lack of public participation. To date, the Center has taken a number of steps to attempt to address this regulatory disparity. • As far back as 2001, the Center for Food Safety, on behalf of a coalition of over 60 organizational partners, filed legal petitions with the FDA and other regulatory agencies demanding a moratorium on the domestic marketing and importation of GE fish until and unless FDA adequately addresses impacts to the environment, native fish populations, and threats to food safety, and requires labeling of any GE fish in the marketplace. • In 2011, the Center, Earthjustice, Ocean Conservancy, Friends of the Earth, Food & Water Watch, Center for International Environmental Law, and Greenpeace filed a legal petition demanding FDA complete a thorough environmental impact statement assessing the full range of potential environmental and ecological risks associated with the AquaBounty GE salmon, and calling on the agency to fix the flaws in its regulatory process for GE animals.9 • Later in 2011 Center for Food Safety filed a legal petition with FDA to require the labeling of all GE foods, including any GE fish. So far over 1 million of you have written to FDA in support of that petition. FDA’s decision to go ahead with this approval process is misguided and dangerous. We all know there is a great appetite for salmon, but the solution is not to factory farm genetically engineered salmon; the solution is to work to bring our wild salmon populations—and the ecosystems they depend upon—back to sustainability. Instead, the approval of these dangerous transgenic fish will only exacerbate the problems facing our ocean ecosystems. The Center for Food Safety strongly opposes the commercialization of genetically engineered fish and is urging FDA not to approve AquaBounty’s GE salmon. Should FDA decide to approve the AquAdvantage GE salmon despite our opposition, clear, mandatory labeling is an absolute must to allow consumers to make informed purchasing decisions. What You Can Do: Get Involved! Visit our campaign website, www.ge-fish.org, to get involved! Individuals can send comments to FDA, download campaign materials, or send a letter to Congress.