“The Food and Drug Administration [FDA] is seriously considering whether to approve the first genetically engineered [GE] animal that people would eat—salmon that can grow at twice the normal rate,” reports New York Times biotechnology correspondent Andrew Pollack in this article about the decade-long regulatory process. Pollack identifies the petitioner as a Waltham, Massachusetts, company named AquaBounty Technologies, which has now submitted “most or all of the data the [FDA] needs to analyze whether the salmon are safe to eat, nutritionally equivalent to other salmon and safe for the environment.”

The fish under review is an Atlantic salmon that contains “a growth hormone gene from Chinook salmon as well as a genetic on-switch from ocean pout.” As AquaBounty Chief Executive Ronald Stotish explained to Pollack, the accelerated maturation would not result in “salmon the size of the Hindenburg,” but would help bring fish to market in one half the usual timeframe. “Our fish is identical in every measurable way to the traditional food Atlantic salmon,” confirmed Stotish, who indicated that his product is indistinguishable from the non-engineered version “in terms of taste, color, vitamins, minerals, fatty acids, proteins and other nutrients.”

Nevertheless, FDA Principal Deputy Commissioner Joshua Sharfstein has purportedly suggested that mandatory or voluntary labeling is still a possibility for GE animals brought to market. Such a move, according to Pollack, would break from past FDA policies that required labeling only if a product differed in nutritional properties or other characteristics. “It’s going to be a P.R. issue,” one anonymous government official was quoted as saying.

Noting that pushback is likely from some consumer and environmental groups, Pollack claims that FDA could hold a public meeting on the issue “as early as this fall.” In particular, groups like the Union of Concerned Scientists (UCS) have expressed concern that the agency treats and evaluates GE animals in a confidential manner reserved for veterinary drugs. “There is no opportunity for anyone from the outside to see the data or criticize it,” opined one UCS spokesperson.

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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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