Stop Frankenfish!

FDA Considering First Genetically Engineered Animal- -Salmon– for Human Consumption!

On August 25, 2010, U.S. Food and Drug Administration (FDA) officials announced their process for making a decision on an application relating to the first genetically engineered (GE) animal intended for human consumption — the AquAdvantage Salmon (AA Salmon) produced by Aqua Bounty Technologies.

The genetically engineered Atlantic salmon being considered was developed by artificially combining growth hormone genes from an unrelated Pacific salmon, (Oncorhynchus tshawytscha) with DNA from the anti-freeze genes of an eelpout (Zoarces americanus).  This modification causes production of growth-hormone year-round, creating a fish the company claims grows at twice the normal rate, allowing factory fish farms to crowd fish into pens and still get high production rates.

The FDA’s announcement regarding its process is the first of its kind for any GE food animal.  Similarly, the decision whether to label any such GE animal if approved will be a first.  The FDA  recognizes that whether or not to approve the first GE animal for use as food will be a critical and precedent-setting decision.

House Passes Amendment that Prohibits FDA from Approving GE Salmon in 2012

In November 2010 CFA sent letters to members of U.S. Congress asking them to halt the Food and Drug Administration’s (FDA) approval of the first GE organism for human consumption. CFA is concerned that a GE seafood product could have significant adverse impacts to wild fish stocks, the environment, coastal communities, and human health.

On June 15, 2011 the US House of Representatives passed an amendment offered by Reps. Don Young (R-AK) and Lynn Woolsey (D-CA) to prohibit the use of FDA funds to approve any application for approval of genetically engineered salmon. The full appropriations bill is entitled, “The Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act (H.R. 2112)” and it passed by a 217-203 vote.

In a statement, Rep. Young said, “Frankenfish is uncertain and unnecessary. Should it receive approval as an animal drug, it clears the path to introduce it into the food supply. My amendment cuts them off before they can get that far. Any approval of genetically modified salmon could seriously threaten wild salmon populations as they grow twice as fast and require much more food.”

After passing the House, the appropriations bill and amendment now goes to the Senate. If the Senate passes the amendment, then the FDA will not be allowed to use it’s funds for Fiscal Year 2012 to approve GE salmon for human consumption.

In February 2011, Sen. Mark Begich (D-Alaska) and Rep. Don Young (R-Alaska) introduced complimentary legislation (S. 229, S. 230 and H.B. 520, H.B. 521) that would ban genetically engineered (GE) fish and require mandatory labeling if approved.  The bill was initiated, in part, by CFA board member Dale Kelley of Alaska Trollers Association, who has worked with state and federal legislators on the issue for many years.Besides the Commercial Fishermen of America, the two pieces of legislation were endorsed by other commercial, recreational and subsistence fisheries associations, food businesses and retailers, along with consumer, worker, religious and environmental groups.  CFA member groups the Alaska Trollers Association and Pacific Coast Federation of Fishermen’s Association also signed on in support of the legislation.

In California, a legislative effort began this year to require that all genetically engineered fish sold in California contain clear and prominent labeling.  Alaska passed a labeling law in 2005 with the help of CFA board member Dale Kelley, and is in the process of re-affirming its support for labeling and opposition to GE salmon through three unique pieces of legislation (HB 99 / HB 100 / HJR 8).  Kelley works with other fishing, environmental, and food safety organizations, such as the Center for Food Safety, in support of the CA and AK bills.  AB 88, sponsored by CA Assemblyman Jared Huffman, passed the Assembly Health Committee, but unfortunately was held over until 2012, when it will need to go through the California legislative committee process again. The Alaska legislation will also be reviewed again in 2012. For more up to date information on the GE fish debate visit: http://ge-fish.org/

October 27, 2010 UPDATE: FDA Declined to Disclose that  Fisheries Agencies Prohibit the Growing of Genetically Engineered Salmon In Open-water Net Pens Under The Endangered Species Act

Adding a new twist to the controversy over genetically engineered (GE) salmon, it was discovered that during the recent hearings on transgenic fish that the (FDA) knowingly withheld a Federal Biological Opinion by the U.S. Fish and Wildlife Service (FWS) and National Oceanic and Atmospheric Administration (NOAA) prohibiting the use of transgenic salmon in open-water net pens pursuant to the U.S. Endangered Species Act (ESA).

The Biological Opinion issued by FWS and NOAA’s National Marine Fisheries Service (NMFS) to the U.S. Army Corps of Engineers in 2003 expresses concerns that transgenic salmon would threaten and adversely affect wild Atlantic salmon, currently on the Endangered Species List.  Federal agencies are required by Section 7 of the ESA to consult with the expert fisheries agencies when any action may impact a protected species.  As part of the consultation, the expert agencies draft a Biological Opinion explaining under what circumstance the proposed activity would not endanger the survival of the protected species.  The Biological Opinion here analyzed the authorization of net pen salmon aquaculture and required:

“The prohibition on the use of transgenic salmonids at existing marine sites off the coast of Maine” in order to “eliminate the potentially adverse disease and ecological risks posed by the use of transgenic salmonids in aquaculture.”

In a similar Biological Opinion issued by FWS and NMFS to the U.S. Environmental Protection Agency in 2001, also included in the material released by CFS today, the agencies noted:

“It is reasonable to assume that genetically-modified salmonids, possessing a greatly accelerated growth potential and occupying the same habitat as wild fish, would have a greater displacement impact on wild fish than non-transgenic domestic strains.”

Conversations between NOAA and FWS staff in 2009 highlight a Swedish study that found that in simulated escapes, transgenic fish have a “considerably greater effect on the natural environment than hatchery-reared, non-transgenic fish when they escape.” The study further noted that genetically modified fish survive better when there is a shortage of food, benefit more than non-transgenic fish from increasing water temperatures, and can be more resistant to environmental toxins that may ultimately end up in consumers.

Continued Food Safety and Environmental Data Gaps

The data FDA provided to the public on food safety is deficient in light of the fact that the FDA has had 10 years to review the product. A clearly biased company, AquaBounty, compiled the Environmental Assessment (EA). Their incomplete review is inherently flawed and does not take into account the full and broad range of impacts which approval of GE salmon would have on the environment. The study on morphology of the new GE salmon involved only 12 fish and included a limited study on possible allergic reactions involving only six fertile GE fish. These small sample sizes are inadequate for a full review of the health and safety of these fish which are expected to be raised in a commercial operation.

The VMAC voiced similar concerns with regard to the study’s small sample sizes, incomplete data, and poor scientific assessments, pointing out the complexity and numerous uncertainties that remain. Regarding potential allergenicty, one Committee member noted “I don’t have adequate evidence to determine if it’s safe.”  This was followed by his colleague who said “the short answer as a professor is I don’t know.”

In light of the numerous unknowns raised throughout the Sep. 19-20 meeting, FDA officials announced that any approval will require post-market review and data requirements.  The VMAC expressed its concerns with this plan, as post-market review and labeling are not adequate substitutions for proper regulation and thorough safety assessments.

The FDA announced at these VMAC meetings that the EA provided to the public and the VMAC was merely a draft and said it plans to publish a final environmental assessment (EA) as well as a notice in the Federal Register establishing a 30-day public comment period.  By most accounts, the existing EA is considered to be very narrow in focus.

If the FDA approves a supplemental application, transgenic salmon will be among the millions of salmon that currently escape each year, possibly delivering the final blow to wild salmon stocks — and to the thousands of men and women who depend on salmon fishing for their livelihoods. Salmon are a species that travels between instream and ocean waters, so  “inland water” containment will present novel threats to our nation’s lakes, rivers, and estuaries, many of which are already under attack by invasive fish species like the Asian carp and Northern snakehead.  Approving genetically engineered salmon is a sharp contradiction to the agreements the United States has signed at the meetings of the North Atlantic Salmon Conservation Organization (NASCO), where transgenic salmonids are considered a serious threat to wild salmon.

Escaped GE salmon would pose another significant threat – genetic pollution resulting from what scientists call the “Trojan gene” effect.” Research published in the Proceedings of the National Academy of Sciences notes that a release of just sixty GE salmon into a wild population of 60,000 would lead to the extinction of the wild population in less than 40 generations.  While the company claims it will produce only sterile fish, FDA materials show that up to 5% of the fish will be fertile and able to reproduce.  In 2002, the National Academy of Sciences issued a report saying that GE fish could cause significant environmental and food safety problems. More recently, a 2009 study commissioned by the European Union revealed that fish engineered to grow faster have a resultant high tolerance to environmental toxins. The study’s authors expressed grave concerns that both toxins and growth hormones had a high potential to end up in consumers’ bodies, calling for further tests to determine safety. Dr. Gary Thorgaard, the only member of the VMAC with expertise on fisheries, called on the FDA to conduct an Environmental Impact Statement, a sentiment echoed by other members of the Committee during the public meeting.

On September 29, 2010, Members of Congress  (Led by Reps. DeFazio, Kucinich, and Thompson in the U.S. House and by Sen. Begich in the U.S. Senate) wrote to the FDA asserting that it used the wrong process to evaluate the fish, treating it as a new veterinary drug and not as a new animal that humans eat. Additionally, 53 commercial and recreational fisheries associations, food businesses and retailers, consumer and environmental groups signed a letter supporting the Congressional sign-on letters. So far, the FDA has not responded to this Congressional inquiry.

Get Involved!

Urge Congress to take a Stand Against GE Fish!

If you would like your fishing group to sign onto upcoming letters opposing GE salmon, please contact: Sara Randall, srandall@ifrfish.org , 415-561-FISh x 222.