A cumbersome and time-consuming federal regulatory process is stifling commercial investment in the development of genetically engineered animals for food and has serious long-term implications for agriculture and food security in the United States, reports a task force of experts led by a UC Davis animal scientist.

“Although humans and animals have been consuming genetically engineered food from plants for years, images of genetically engineered animals open new and often contentious debates about the issue,” said Alison Van Eenennaam, the report’s lead author and a UC Davis Cooperative Extension specialist in animal genomics and biotechnology.

“Some of the controversy regarding GE animals stems from issues of regulatory oversight of research, development, and post-approval marketing,” she said.

In the report, various stakeholders point out strengths and weaknesses in the U.S. Food and Drug Administration’s regulatory approach. The task force members address:

• thoroughness of the premarket product review process for safety and efficacy;
• potential for withdrawing FDA endorsement after a product has been approved;
• need for public transparency in the review process;
• the FDA’s lack of authority to consider ethics and other social concerns;
• reliance on data produced by the corporation seeking approval; and
• lack of provision for environmental review.

The task force also determined that the issues are clouded by the potential for opposition groups to delay or obstruct approval by co-opting regulations and concerns about labeling requirements. At this time, the FDA cannot require that food labels include information about production methods, such as genetic engineering, unless that process results in a material difference in the product.

The report, published by the Council for Agricultural Science and Technology, examines a proposal by the private firm AquaBounty to raise and sell genetically engineered salmon as a test case. The “AquaAdvantage” salmon carry a Chinook salmon gene, which enables them to grow to market size in half the time of conventional salmon.

The report, The Science and Regulation of Food from Genetically Engineered Animals, is available free of charge on the council’s website at http://www.cast-science.org.

The U.S.-based Council for Agricultural Science and Technology is an international consortium of scientific and professional societies, companies and nonprofit organizations that interprets and communicates credible science-based information regionally, nationally and internationally to legislators, regulators, policymakers, the media, the private sector and the public.