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Approvals by FDA of NADAs related to transgenic animals are limited to a very specific set of conditions. FDA approvals for articles regulated under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may be for a specific set of conditions with the transgenic animal remaining under regulatory oversight as long as it is produced and marketed and where such conditions are proposed in the drug sponsor’s NADA, or are required by FDA to mitigate potential risks, and are explicitly set forth in the conditions of approval. FDA has determined that for the proposed action, conditions of use should include appropriate and redundant mitigation measures such as use of physical, biological, and geographical/ geophysical forms of containment.
Major and moderate changes require the filing and review of a supplemental NADA. Approvals of such supplemental applications would constitute agency actions and trigger environmental analyses under NEPA.
Any other uses are not approved, and the sponsor must notify FDA about each proposed change in each condition established in an approved application and obtain FDA approval of a supplemental application for the change where necessary.
FDA has determined that this application for AquAdvantage Salmon should include appropriate and redundant mitigation measures such as use of physical, biological, and geographical/ geophysical forms of containment.
The proposed specific limitations on the production and use (grow-out) of AquAdvantage Salmon, including the production of triploid (effectively sterile), all-female fish populations, are designed to mitigate potential adverse environmental impacts.
