In the U.S., there is no single law or federal agency that oversees the products of biotechnology. Instead, the government oversees GE products under a mosaic of existing laws that were never intended for that function. This unfortunate approach has raised numerous “square peg, round hole” problems, and GE animal oversight is a good example.
In 2009, FDA issued a guidance determining that it would be the agency to oversee GE animals, and it would do so pursuant to the animal veterinary drug provisions of the Federal Food Drug and Cosmetic Act. FDA’s authority is based on the fact that the GE animal’s transgenic construct meets the definition of a “drug,” which included “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”[i] As a drug, FDA bases its review on the “drug’s” safety and efficacy. Yet transgenic animals are plainly very different than veterinary animal drugs. For example, environmental impacts are nowhere contemplated under FDA’s statutory process.
Neither is food safety prioritized; the review is really an assessment of whether an applicant has a legitimate “claim” of safe and effective use (i.e., whether AquaBounty’s genetic engineering will generate faster-growing fish). Further problems with the oversight framework include: lack of relevant agency expertise (why is FDA analyzing fisheries biology?); lack of transparency and public participation (as a drug approval, the process has strict confidentiality); and an improper scope of review (failing to analyze broader environmental, health, and socioeconomic effects).
As far back as in 2001, CFS filed several groundbreaking legal petitions with the federal agencies including FDA demanding rigorous agency oversight and overlapping jurisdiction by agencies with relevant expertise. More recently, CFS has filed several legal petitions on improving FDA oversight and requiring labeling. These actions have thus far fallen on deaf agency ears. The U.S. approach stands in stark contrast to that of other countries, such as those of the European Union, that have one law specifically for all GE organisms, and over 60 countries that require GE labeling.
[i] 21 U.S.C. § 321(g)(1)(C).