Wednesday, January 13, 2021
Key Takeaways
What Happened: USDA is seeking comment on its intent to transfer portions of the regulatory framework governing agricultural animals modified or produced by genetic engineering from USDA to FDA.
Who’s Impacted: Companies who produce, distribute, and/or sell animal biotechnology products.
What Should They Consider Doing in Response: Review the ANPRM document—in in particular, the “Contemplated Regulatory Framework” section—to assess how their products might be regulated under the approaches discussed and determine whether to submit comments. USDA indicated that stakeholders and any other members of the public will have a 60-day opportunity to submit comments, ending on February 26, 2021.