The Biotechnology Innovation Organization (BIO) submits these comments in response to the U.S. Department of Agriculture’s (USDA’s) advance notice of proposed rulemaking and request for public comment on a proposed framework for oversight of certain animals modified or developed through genetic engineering. In particular, USDA proposes a new regulatory framework for amenable species intended for agricultural use, to be administered jointly by USDA’s Animal and Plant Health Inspection Service (APHIS) and the Food Safety Inspection Service (FSIS). The use of biotechnology to improve the genetics of animals used in agriculture has the potential to address a broad array of important societal issues—improvements in animal health and welfare; improved human health and nutrition; responding effectively to zoonotic disease; adaptation to climate change; and increasing the sustainability of animal agricultural production. The success of these innovations is critically dependent on regulatory systems that ensure animal health and welfare, food safety, and protection of the environment, but does so in a way that does not disincentivize development and commercialization of innovation. Without an efficient and effective system for oversight of animal biotechnology, the U.S. risks its leadership role in utilizing important, cutting-edge tools to address these critical societal challenges. The U.S. Food and Drug Administration (FDA) currently regulates the safety of animals containing “intentional genomic alterations” utilizing the new animal drug authority of the Federal Food, Drug, and Cosmetics Act (FFDCA), as described in draft “Guidance for Industry #187” (GFI 187).2 For reasons discussed in more detail below, BIO has long expressed concern over FDA’s approach to oversight of animal biotechnology, the implementation of which is having real and immediate impacts on our members and the U.S.’s ability to remain the leader in animal biotechnology. We appreciate…

Equality of opportunity is a key pillar of our great democracy—one that allows all people to pursue their American Dream—and part of what makes our nation exceptional. Our industries, representing and employing tens of millions of Americans, understand this basic fact and have been at the forefront of efforts to combat discrimination based on sexual orientation and gender identity in the workplace.

The Biotechnology Innovation Organization is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture hearing entitled, "Climate Change and the U.S. Agriculture and Forestry Sectors." BIO applauds the Committee for putting its immediate focus on the climate crisis. As we outline in our attached "100 Days of Innovation" Blueprint, our nation is at a critical juncture. The start of the new administration and new Congress presents a unique opportunity to come together to galvanize our nation's scientific and entrepreneurial capacity, to mobilize new waves of homegrown innovation and American ingenuity to tackle the climate crisis, end the pandemic, and get more Americans back to work. BIO is committed to working with the Committee, Congress, and the Administration to address the climate crisis. We urge you to support policy that advances pioneering technology breakthroughs. With science, we can return our Nation and the world to health and prosperity by taking bold and drastic action to address the climate crisis.