The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of products derived from cell lines of livestock and poultry. This agreement marks the next significant step in establishing the regulatory framework for these products and delineates the general roles that FSIS and FDA will play in regulating the developing of cell lines, culturing cells, harvesting cells, processing products from those cell cultures, labeling, and post-market enforcement. It builds on a November 2018 joint statement by USDA Secretary Perdue and FDA Commissioner Gottlieb last Fall, in which they announced that the agencies would establish a coordinated framework for regulating these products working within their existing statutory authorities. Although today’s formal agreement establishes a general regulatory framework, additional work remains, as both agencies will have to review and possibly update regulations, develop more specific regulatory guidance for these products, and resolve a number of important questions.

In general, the formal agreement adopts a “pre-harvest” and “post-harvest” approach, with FDA asserting oversight “through the time of harvest” and FSIS assuming jurisdiction over harvested cells that are intended for use in meat or poultry products. The agreement leaves jurisdiction at the point of “harvest” unresolved, with the agreement apparently contemplating both agencies having a role. The agreement calls for information sharing and coordination between FDA and FSIS, and the agencies have committed to a collaborative process for fleshing out the regulatory process moving forward.

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Photo of Gary Kushner Gary Kushner

Partner, Washington, DC

Gary Jay Kushner knows the food industry inside and out as he has been a part of it for almost 40 years. His clients are some of the largest food corporations in the world as well as their trade associations. Because of his extensive exposure to the industry at all levels, Gary approaches his clients’ challenges from the perspective of a food industry executive.
Gary has participated in the development of virtually every law and regulation affecting the food industry in the last four decades. Gary analyzes legislation considered by the U.S. Congress and state legislatures and regulations proposed by the U.S. Department of Agriculture, Food and Drug Administration, and other federal and state government agencies, and evaluates their impact on the food industry from farm to table. His insight allows him to anticipate how these initiatives might change the way his clients do business so they can plan most effectively.

Gary also helps companies address regulatory compliance issues, advising them on labeling, advertising, inspection, and representing them in enforcement proceedings before government agencies and the courts.

Previously, Gary served as vice president and general counsel for the American Meat Institute where he directed the organization’s legal, regulatory, and legislative activities. He began his food industry career as staff counsel for Scientific Affairs for the Grocery Manufacturers of America, and began his legal career as law clerk to the Honorable John R. Hess in the Superior Court for the District of Columbia.

Photo of Brian Eyink Brian Eyink

Counsel, Washington, DC

Drawing on experience throughout the supply chain — from animal production to food processing to distribution and retail sale — Brian Eyink brings vast and cross-cutting industry knowledge to help clients find practical solutions to regulatory problems. Brian is particularly sensitive to risk management issues as companies adapt to a regulatory and political environment increasingly focused on inspections, enforcement, and investigations.

Brian helps food and agriculture companies navigate increasingly complex and high-stakes federal and state regulatory issues. He draws on deep experience with the USDA, FDA, and FTC, as well as state, local, and self-regulatory bodies, litigation, and acquisitions to solve clients’ regulatory and business problems. Brian advises clients on the full scope of regulatory issues facing the food and agriculture sectors, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, legislative drafting, policy development, trade association governance, advertising disputes, and labeling issues.

Brian also represents food and agriculture trade associations, advising on issues including general counseling and governance, influencing policy and public perspective, and implementation of industry initiatives.

Before joining Hogan Lovells, Brian served as a judicial law clerk to the Honorable Gerald Bard Tjoflat of the United States Court of Appeals for the Eleventh Circuit. While in law school, he served as an executive editor of the Duke Law Journal.