Letter to Hon. Thomas J. Vilsak, Secretary of Agriculture, and Hon. Janet Woodcock, M.D., Acting Commissioner of the FDA - Baird, Plaskett Lead Letter to Administration Urging Progress on USDA Regulatory Clarity for Animal Biotechnology

Letter

Dear Secretary Vilsack and Acting Commissioner Woodcock,

As you know, several challenges facing the agriculture industry and our communities have
emerged or intensified in recent years. Zoonotic disease, climate change, and a growing global
population require us to consider new solutions to protect our food supply and sustainably meet
demand. Ongoing research and existing innovations in animal genetics show great promise in
addressing these challenges. However, an efficient, risk and science-based regulatory system
that can create a safe, predictable path to market is imperative to capitalizing on these solutions.
We believe the existing U.S. regulatory process for the review of animals developed or improved
through biotechnology requires significant improvement to meet that standard, and we encourage
the U.S. Department of Agriculture (USDA) and Food & Drug Administration (FDA) to
continue working with each other and with other relevant federal partners to appropriately
modernize this important process.

For thousands of years, genetic improvements have been a hallmark of agriculture. Over the last
century, organized research and formal plant and animal breeding programs have rapidly
advanced the success and sustainability of agricultural production. Since the 1950s, milk
production in the United States has nearly doubled while using half the number of cows,
reducing both the environmental footprint and costs of production. However, many of the
challenges we face today will not afford us another 70 years to make similar incremental
improvements. Zoonotic disease risks like SARS-CoV-2 or recent avian influenza spread to
humans in Asia, could be greatly mitigated by disease-resistant livestock. Animals improved to
reduce methane emissions or improve heat tolerance could play an important role in our efforts
to address climate change and achieve more resilient supply chains.

Unfortunately, the existing regulatory system is not conducive to the timely adoption of these
sorts of innovations. In the past 25 years, only two animals intended for agricultural purposes
have been approved for use domestically by FDA. One of these innovations is primarily intended
for biomedical applications, and both took decades to achieve regulatory approval. A costly,
protracted regulatory system will continue to stifle important agricultural innovations.

Efforts to modernize the regulatory environment for products of biotechnology have transcended
administrations and party lines--a tradition we hope to see continued. In 2015, President
Obama's Executive Office of the President (EOP) issued a memo initiating a process to
modernize the Federal regulatory system for products of biotechnology with the objective of
ensuring public confidence, preventing unnecessary barriers to future innovation, and continuing
to protect health and the environment. These are sound objectives, and we support efforts to
continue exploring improvements in our regulatory system, such as USDA's publication of an
Advance Notice of Proposed Rulemaking (ANPR) regarding whether to establish regulations for
the movement of certain animals modified or developed using genetic engineering. We were
heartened by the decision to extend the ANPR's comment period to ensure ample opportunity for
thoughtful input from the public.

With the ANPR comment period now closed--and as the Administration decides how to best
navigate this vital modernization effort--we encourage USDA and FDA to carefully consider the
feedback provided by stakeholders. The challenges facing our food supply and society demand
an improved regulatory approach, and we are hopeful that this Administration will rise to the
occasion and empower agriculture with the tools necessary to be a part of the solution.

Sincerely,

Members of Congress

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