Regulatory Developments

FDA Approves First Genetically Engineered Animal

November 23, 2015 PRINT

On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies' application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has approved a GE animal. FDA regulates GE animals under the new animal drug requirements through the Center for Veterinary Medicine in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA).

FDA states in the news release that it "thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that [AquaBounty Technologies] met the regulatory requirements for approval, including that food from the fish is safe to eat." The AquAdvantage Salmon have an introduced genetic trait that makes them grow faster, thereby allowing them to reach the market more quickly than traditional salmon. FDA in its review "determined that food from AquAdvantage Salmon is as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon." FDA also determined in its environmental assessment that there would be no significant effects on the environment in the United States. The AquAdvantage Salmon are intended for consumption in the United States but are to be raised in specifically controlled locations outside the United States (i.e., Canada and Panama). FDA, along with the Canadian and Panamanian governments, will maintain regulatory oversight on these production facilities.

In addition to the approval of the GE Salmon, FDA published two guidance documents on voluntary labeling of food from GE sources. The two guidance documents are "Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon" and "Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants." In both guidance documents, FDA offers detailed examples, explanations, and specific terminology for the voluntary labeling of GE foods and foods derived from GE sources as well as foods that are not GE.

FDA states that while the term "Genetically Modified Organism" or "GMO" may be used in voluntary labeling, it is viewed by FDA as a technically inaccurate term to describe GE or bioengineered food or food sources. FDA explains, "the term 'genetic modification' encompasses a broad range of methods that can be used to alter the genetic composition of a plant [or Atlantic salmon]. FDA's longstanding position has been that the term has traditionally been used broadly to signify the alternation of the genotype of a plant using any technique, new or traditional." FDA also states "GMO free," "GE free," "does not contain GMOs," "non-GMO," and similar claims convey "zero or total absence" of genetic modification and provides additional guidance to industry to address "[t]he potential challenges of substantiating a 'free' claim."

Furthermore, FDA is clear that the guidance is voluntary for labeling if food contains or does not contain GE plants or animals (Atlantic salmon). Any labeling that indicates a non-GE plant or animal is significantly different than a GE one in terms of nutritional value or additional safety would be viewed as misleading and would be considered "misbranded" in accordance with FFDCA Section 403(a)(1) (21 U.S.C. § 343(a)(1)).

Commentary

FDA's approval of AquaAdvantage Salmon represents five years of effort and a triumph for AquaBounty Technologies and FDA. FDA's comprehensive analysis of the evidence and rigorous approval process yielded a result that many believe will pave the way for other innovations with perhaps less time-consuming review times. Notwithstanding the decision, it may be some time before GE salmon reach U.S. markets. The application approved only two facilities, neither of which is located in the United States. The approval of additional facilities will require separate assessments of potential environmental impacts.

Pioneering work is hard, and, not surprisingly, not everyone is pleased with the decision. Products of GE will continue to invite debate, but for the moment, the regulatory process has worked as intended. AquaAdvantage Salmon is the first, but certainly not the last, GE animal that will be considered for approval.


 
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