Enviropig - Regulatory Requirements

Regulatory Requirements

On February 20, 2010 the Department of the Environment of the Canadian Government determined that Enviropig is in compliance with the Canadian Environmental Protection Act and can be produced outside of the research context in controlled facilities where they are segregated from other animals. Steven Liss, associate vice-president (research services) of the University of Guelph said in February 2010 that "Applications to other federal agencies to assess the safety of Enviropigs for human food and animal feed were currently under review both in the U.S. and Canada and there is no set date when or if these reviews will conclude."

United States Food and Drug Administration (FDA) has a Guidance Document that outlines types of data needed to assess food and environmental safety of a genetically engineered (GE) food animal:

1. Product identification/description.
2. Molecular characterization of the genetic construct introduced into animal.
3. Molecular characterization of the GE animal lineage.
4. Phenotypic (physiological) characterization of the GE animal.
5. Stability of the new inheritable trait through generations.
6. Food, feed and environmental safety.
7. Effectiveness of the new trait/claim validation.
8. Post-approval responsibilities.

The FDA guidance document is consistent with the United Nations Codex Alimentarius Commission regulatory guidance.

Regulatory approval of the Enviropig will be required in any country before commercialization of these pigs for human food consumption.