Posted Sept. 14, 2011
Members of Congress are pushing the Food and Drug Administration in opposite directions over whether the agency should finish investigating an application to allow the use of a genetic construct in growing salmon intended for human consumption.
The FDA has been considering whether the genetic modification in Atlantic salmon produced by AquaBounty Technologies should be approved as an animal drug, which is needed before the fish can be sold as food. AquaBounty claims that its AquAdvantage salmon can grow to market weight in half the time needed for naturally spawned fish because of an rDNA construct that contains gene-coding sequences from ocean pout and Chinook salmon.
An AquAdvantage salmon (Barrett & Mackay Photography Inc.)
In a letter sent in July, eight senators urged FDA Commissioner Margaret A. Hamburg, MD, to stop her agency from further considering approving the construct. The letter expresses concerns about potential threats to public and environmental health and economic harm for wild salmon producers. It also argues that the genetic manipulation in the AquAdvantage fish is not a veterinary drug, the approval process lacks transparency, and approval could set a precedent.
The letter also indicates that the Senate could concur with a measure passed by the House of Representatives that would ban the agency from approving the drug application. In approving the Agriculture Appropriations Bill for Fiscal Year 2012, the House of Representatives passed in a voice vote an amendment that would prohibit appropriation of FDA money to approve use of the genetic modification.
The letter was signed by Sens. Daniel Akaka of Hawaii, Mark Begich of Alaska, Maria Cantwell of Washington, Jeff Merkley of Oregon, Barbara Mikulski of Maryland, Lisa Murkowski of Alaska, Patty Murray of Washington, and Jon Tester of Montana.
In August, three Massachusetts representatives wrote to Commissioner Hamburg to urge her to let the FDA continue its scientific investigation. In the letter, Reps. Barney Frank, Edward J. Markey, and James P. McGovern indicated they were not taking a position on the merits of AquaBounty's application but were encouraging the agency to complete its evaluation.
The representatives' letter states that the FDA has spent 15 years working with AquaBounty to collect health, safety, and environmental data; sought consultation and expertise from other federal agencies; and evaluated the safety and effectiveness of the genetic modification. The letter indicates the FDA found that food from the salmon is safe.
"We believe that fair consideration should be given to this new technology and encourage you to proceed with the science-based evaluation and review of AquaBounty's application," the representatives' letter states.
The FDA is considering the rDNA construct as a drug because it is intended to alter the structure or function of the AquAdvantage salmon. In fall 2010, members of the FDA Veterinary Medicine Advisory Committee considered the AquaBounty drug application and the FDA accepted comments from the public. The FDA has not set a deadline for determining whether the construct will be approved.
The company has indicated it plans to breed and grow the fish in landlocked facilities on Prince Edward Island in Canada and in Panama.
A pair of bills, H.R. 521 and S. 230, introduced early this year would define the genetically engineered fish as unsafe, preventing approval. Both bills were referred to committees, and no actions have been taken on the Senate version since January or on the House version since February. The AVMA has taken a position of nonsupport of the bills.
A transcript of House of Representatives proceedings indicates Alaska Rep. Don Young, in proposing the amendment to the Agriculture Appropriations Bill, said the genetically modified salmon are unnatural and their production could create competition for his state's fishing industry. California Rep. Sam Farr said that, in the absence of long-term studies on the safety of the genetically modified salmon, the salmon pose unknown risks for human health.
Georgia Rep. Jack Kingston argued that the FDA was using a sound scientific process for evaluating the fish and the risks to human health, and the fish could help feed more people. But California Rep. Lynn Woolsey argued in favor of the amendment, citing public opposition to the sale of such fish, recent losses by salmon fishing industries, and the risks of escape.
In the Animal Agriculture Coalition's Aug. 2 letter to congressional leaders, 38 organizations, including the AVMA, expressed concern about the amendment, which they indicated could disrupt the FDA's congressional mandate to base assessments on science and diminish the agency's credibility domestically and internationally.
Ronald L. Stotish, PhD, AquaBounty's president and CEO, announced after the House of Representatives amendment was approved that the "outrageous" action was "wrong on the facts, wrong on the process, and wrong on the policy."
"A handful of representatives have chosen to subvert the FDA's rigorous 15-year- plus process," he said. "It completely ignores the results of a rigorous scientific review. This sort of political gamesmanship undermines the science-based system that protects the nation's health and safety."
The announcement indicates AquaBounty's fish are safe, global demand for fish protein is increasing, and the U.S. already imports most of its Atlantic salmon.
In response to the senators' letter, Dr. Stotish said actions based on "a handful of legislators' misinformed paranoia" would set a dangerous precedent.
"The real waste of taxpayer dollars would be to abandon the important American principle of science-based regulation, responding instead to economic protectionist fears or subjective and emotional arguments," Dr. Stotish said.