Aqua Bounty Technologies

5 Myths About Federal Regulation of Transgenic Fish

MYTH 1: There are currently no federal laws that specifically govern the regulation of genetically engineered fish and marine organisms grown for human consumption.

FACT: Federal regulation of transgenic fish is governed by the Food, Drug and Cosmetics Act. As far back as 1986, the U.S. Food and Drug Administration asserted jurisdiction over transgenic animals and fish on the grounds that the transgene and any expressed proteins, affect the “structure and function” of the receiving animal analogous to the modalities of alternative veterinary drug formulations. FDA jurisdiction has been upheld by the federal courts.

MYTH 2: The 1986 federal “Coordinated Framework” was a political stratagem of the Reagan administration to exempt biotechnology from regulation.

FACT: The Coordinated Framework (51 Fed. Reg. 23303) asserts the scope of well-established statutory authorities to include, rather than exempt, products produced by modern biotechnology within traditional regulatory jurisdictions. Recognizing that individual products, and not the processes by which they are developed, are the ultimate source of risks and benefits and the focus of regulatory action, the Coordinated Framework clarified the existing authority of FDA, the Environmental Protection Agency and the Department of Agriculture to regulate biotech plants and animals under the established jurisdictions of the Food, Drug and Cosmetics Act (FDA), the Federal Insecticide, Fungicide and Rodenticide and the Toxic Substances Control Acts (EPA), and the Plant Pest Protection, the Plant Quarantine and the Virus, Serum and Toxin Acts (USDA).

FACT: The scientific rationale in support of the product-based focus of the Coordinated Framework has been endorsed in three separate reviews by the National Academies of Science, in 1989, 2000 and 2002.

FACT: The regulatory rationale in support of the Coordinated Framework was reviewed, evaluated and endorsed by the Clinton administration in 1999-2000.

MYTH 3: FDA does not evaluate the environmental impact of transgenic fish or limits any assessment to the molecular attributes, pharmaceutical effects or the impacts of any chemicals used in the engineering process. Any FDA environmental risk assessment does not extend to potential ecological impacts.

FACT: Environmental risk assessment at FDA is governed by the National Environmental Policy Act and the regulations implementing NEPA adopted by the Council on Environmental Quality (40 CFR Parts 1500 to 1508) and by FDA (21 CFR Part 25). The NEPA and CEQ obligations imposed on the agency are identical to those required of all agencies throughout the federal government, including the identical scope of environmental risk assessment.

FACT: The agency’s position on the scope of environmental risk assessment required to process new drug applications is detailed in its 1998 guidance: “FDA considers harm to the environment to include not only toxicity to environmental organisms but also environmental effects other than toxicity, such as lasting effects on ecological community dynamics.”

MYTH 4: FDA lacks the expertise in fisheries biology, ecology and environmental science to assess the environmental risks of transgenic fish.

FACT: The FDA staff includes specialists trained in biology, environmental science and risk assessment that have conducted hundreds of environmental impact assessments. Each assessment is based on the explicit assumption that the ultimate repository of agency-approved pharmaceuticals or food additives will be aquatic ecosystems following their production, use or disposal.

FACT: NEPA and CEQ require federal agencies to cooperate with other affected agencies in the assessment of the environmental impacts of agency actions. In the case of transgenic fish, FDA has engaged the cooperation of the U.S. Fish & Wildlife Service and the National Marine Fisheries Service in the design and evaluation of the environmental risk assessment. In the specific case of transgenic salmon, the two fisheries Services must also be consulted under ESA.

MYTH 5: Science-based risk assessment is inadequate for the evaluation of the environmental impacts of biotechnology. Only the Precautionary Principle can adequately address the uncertainties and unknown hazards of transgenic organisms.

FACT: Science-based risk assessment identifies potential hazards, quantifies the probabilities those hazards will occur and accounts for uncertainty with significant safety thresholds -- typically set at 1000 times the likely level that a risk will occur. This approach is wholly compatible with precaution.

FACT: The science-based process, according to a former undersecretary of Commerce in the Clinton administration, David Aaron, has "shown us that biotech foods developed and used in the U.S. present no safety risk beyond those of their 'natural' counterparts. Not a single ailment has been attributed to biotech foods. Not one. Not a sneeze, not a rash, not a headache." Similarly, environmental scares ranging from Monarch butterfly impacts to increased pesticide use to transgenic superweeds have all been disproved by adequate research or avoided by appropriate agricultural practice or regulatory standards.

FACT: The Precautionary Principle as adopted in the 1992 Rio Declaration calls only for “cost effective measures to prevent environmental degradation” when “threats of serious or irreversible damage” lack “full scientific certainty.” U.S. risk management practice meets this test.