The Food and Drug Administration (FDA) has recently drawn criticism over
the delayed release of documents evaluating the environmental impact
of genetically engineered (GE) salmon. Created by Massachusetts-based
AquaBounty Technologies, the GE salmon in question evidently contain genes
from Chinook salmon as well as ocean pout that allow the company to bring
the fish to market in half the normal time. After a publicly contentious review
process, FDA released the May 4, 2012, draft assessment and a preliminary
finding of no significant impact in late December, raising questions among
groups such as the Genetic Literacy Project (GLP) about whether the agency
froze the application to avoid political turmoil during the election season.

“The delay, sources within the government say, came after meeting with the
White House, which was debating the political implications of approving the
[GE] salmon, a move likely to infuriate a portion of its base,” GLP Executive
Director Jon Entine wrote in a December 19, 2012, article published by Slate.
com. In 2010, FDA found that AquAdvantage salmon were safe for human
consumption and the environment, needing only to decide whether the fish
pose any threat to wild salmon under the Endangered Species Act. According
to GLP, the agency should have published its finding of “no effect” in the
Federal Register as soon as it reached this conclusion, the final step in an
approval process that began in 1995.

“This shouldn’t be happening,” agreed Center for Science in the Public Interest
Director of Biotechnology Gregory Jaffe despite the consumer group’s qualms
about GE foods. “AquaBounty deserves regulatory due process. We need
science-based decisions made in a timely fashion. The public deserves this,
and there are questions whether that is what’s going on in this case.”

Meanwhile, GLP has pointed to several factors blamed for the delay, among
them the White House’s alleged interest in the effects of the application’s
approval and reports circulated by environmental groups about a salmon
virus found in AquaBounty’s testing facilities. “The FDA, apparently caught in
the political crossfire, appears to be in violation of its own scientific integrity
guidelines, adopted last February,” claimed Entine. “Scientists and staffers
involved in the process say they have been instructed not to discuss the
application. Key provisions of the guidelines require the agency to shield its
staff from ‘political influence’ and to allow the ‘FDA staff to communicate their
personal scientific or policy views to the public, even when those views differ
from official Agency opinions.’”

Meanwhile, the agency has reportedly attributed the delay to bureaucratic oversight. “Yes there was a delay,” a spokesperson told the press. “As you are aware, we’ve been working on this for a while, and it was oversight in our [quality control] process. We are working to address it now.” The agency has requested comments on the draft environmental assessment and its preliminary finding of no significant impact by February 25, 2013. But with final approval for GE salmon now looming, consumer groups have already stepped up efforts to block the product or at least require special labeling. “[I]t’s [] outrageous that FDA would take AquaBounty’s word over that of dozens of legislators and scientists, including the National Oceanic and Atmospheric Administration (NOAA) and the U.S. Fish and Wildlife Service, not to mention hundreds of thousands of concerned consumers,” opines a Food & Water Watch campaign asking its followers to submit comments. “We have until February 25 to submit comments to the FDA asking them to stop their mad dash to put GE salmon in our grocery stores and to reject this frankenfish!” See Los Angeles Times, December 26, 2012.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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