Placeholder Banner

BIO Statement on USDA Withdrawal of 340 Biotech Rules

November 6, 2017

“BIO supports the USDA’s course correction as the appropriate next step in considering improvements to its regulatory system.

“We applaud USDA for its efforts to update its regulatory system to reflect both its twenty-plus-year experience reviewing these products and recent advances made in plant breeding innovation, and its work to use the best available science to make regulatory oversight more proportional to actual risk. The proposal issued by USDA on January 18, 2017 took positive steps in that regard.

“We support USDA’s science-based exclusion of some classes of gene editing, and the recognition of the safety of familiar crop-trait combinations with which they have years of experience. We strongly encourage continued USDA support for U.S. agricultural innovation. USDA’s ongoing coordination with other agencies, such as the Food and Drug Administration and the Environmental Protection Agency, will hopefully result in a consistent approach for advances such as gene editing, both domestically and internationally, so the United States can continue to be a leader in the regulation of products of agricultural biotechnology.

“However, the proposed rule also had significant flaws that would have rendered the proposed system difficult to implement and created greater uncertainty for developers. Going forward, the Department could benefit from a robust discussion with stakeholder groups in order to understand how it can meet its important regulatory mission in ways that do not unnecessarily impact bringing innovative products to market. 

“BIO looks forward to working with regulators and others in the stakeholder community toward policies that will foster innovation, encourage the adoption of new technologies and promote continued growth in our bioeconomy.” 

Discover More
Biotechnology Innovation Organization (BIO) Chief Scientific Officer, E. Cartier Esham issued the following statement on the release of the Prescription Drug User Fee Act (PDUFA) VII performance goals letter: “The Prescription Drug User Fee…
President Joe Biden today announced a slew of drug pricing reforms, including changes that would radically alter the widely successful Medicare program for seniors and people with disabilities. Rich Masters, BIO’s Chief Public Affairs and Advocacy…
Annual competition takes place during BIO’s International Convention