BIO Letter to OMB on Animal Biotech and the Need to Allow Draft Guidance

The Biotechnology Innovation Organization (BIO) writes this letter to urge the Biden Administration to take specific and immediate steps towards modernizing U.S. oversight of animals derived from biotechnology, especially those intended for agricultural use. Specifically, we ask that the Office of Management and Budget (OMB) allow the Food and Drug Administration (FDA) to promptly publish a draft guidance document for stakeholder notice and comment on proposed changes to FDA’s regulatory framework for animal biotechnology.

BIO strongly believes that an effective regulatory framework for the oversight of biotech animals intended for agricultural use should be based upon the following principles:

1. Oversight must protect animal health and welfare, ensure the safety of food and feed derived from the animals, and consider the possible impacts of the animals on the environment.
2. Implementation of oversight must be clear, transparent, efficient, predictable, timely, and based upon the best available science.
3. Risk assessment must be proportionate to the actual risk posed by the specific species/trait combination. Lower-risk, more-familiar traits, including traits that impart health benefits to humans and animals, should be given a more expedited review than traits for which there is less familiarity or greater uncertainty.
4. Once all appropriate safety reviews are completed, the approved animals should be allowed to be treated as any other farm animal in production and commerce. Ongoing post-market regulatory requirements imposed on such animals, even after they have been determined to be as safe as conventional animals, strongly disincentivizes development and commercialization of farm animals with improved traits.