USDA reopens comment period on animal biotechnology as new administration comes in and evaluates previous comments made.
The U.S. Department of Agriculture is reopening the public review and comment period for an Advance Notice of Proposed Rulemaking (ANPR) regarding whether to establish regulations for the movement of certain animals modified or developed using genetic engineering.
in consultation with FDA, USDA is contemplating regulations that would establish a flexible, risk- and science-based regulatory framework for the regulation of certain animals modified or developed using genetic engineering that are intended for agricultural purposes. In the final days of the Trump administration, USDA and Health and Human Services announced a memorandum of understanding to allow for USDA to have jurisdiction over the regulation of these animals. However, the FDA continued to oppose transferring oversight.
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At the outset of the Biden Administration it is clear that there will be a sharp pivot in the Federal Government’s approach to many environmental regulatory policies. One area that will be interesting to keep track of regulation of agricultural biotechnology (ag biotech). As previously discussed, efforts to modernize the U.S. regulatory system applicable to ag biotech was one of the few areas of environmental regulation and policy that saw a consistent approach between the Obama and Trump Administrations. In fact, Executive Order 13874, Modernizing the Regulatory Framework for Agricultural Biotechnology, could be viewed as a direct outgrowth of the Update to the Coordinated Framework that was issued by President Obama’s Administration in January 2017.
TSCA/FIFRA/TRI
EPA Seeks Comments On Draft Compliance Guide Addressing Surface Coatings Under PFAS SNUR: On December 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval. 85 Fed. Reg. 81466. The draft guide provides additional clarity on what is meant by a “surface coating,” identifies which entities are regulated, describes the activities that are required or prohibited, and summarizes the notification requirements of the final SNUR. More information on the draft compliance guide is available in our December 14, 2020, memorandum, “EPA Publishes Draft Compliance Guide Addressing Surface Coatings under PFAS SNUR.” Comments on the draft g
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.