June 15, 2018
The U.S. Food and Drug Administration announced today a public meeting to discuss foods produced using animal cell culture technology. The public meeting will be held on July 12, 2018 from 8:30 a.m. until 3:00 p.m. at the Harvey W. Wiley Federal Building, 5001 Campus Drive, Auditorium (first floor), College Park, MD 20740.
Cell culture technologies that have been increasingly used to produce cells and tissues for human therapeutic use are now being used by the food sector to create innovative products that resemble conventional meat, poultry, and seafood. The FDA has multiple authorities and programs that can support efforts to safely bring products with new ingredients to the market. Food safety is at the core of the agency’s mission to protect and promote public health for our nation’s consumers.
The FDA has extensive experience applying its existing authority flexibly and effectively to rapidly evolving areas of technological innovation such as plant biotechnology. We look forward to sharing our experiences in evaluating and ensuring the safety of novel technologies in the food sector at this upcoming public meeting, while we also discuss these issues with, and gather relevant data and information from, stakeholders.
The public meeting will give interested parties and the public an opportunity to comment on these emerging food technologies. Specifically, the agency is asking for input, relevant data and information on the following questions:
- What considerations specific to animal cell culture technology would be appropriate to include in evaluation of food produced by this method of manufacture?
- What kinds of variations in manufacturing methods would be relevant to safety for foods produced by animal cell culture technology?
- What kinds of substances would be used in the manufacture of foods produced using animal cell culture technology and what considerations would be appropriate in evaluating the safety of these uses?
- Are the potential hazards associated with production of foods using animal cell culture technology different from those associated with traditional food production/processing? Is there a need for unique control measures to address potential hazards associated with production of foods using animal cell culture technology?
While the primary subject of the meeting will focus on food safety, FDA recognizes the importance of other issues related to foods produced through animal cell culture technology, such as labeling, and FDA welcomes comment on these other issues and expects that they will be the focus of future engagement with stakeholders and the public. We intend to share our initial thinking for how we intend to appropriately apply our existing regulatory tools and policies to this novel area of technology. In addition, we plan to leverage the expertise of the FDA Science Board during their regular scheduled meeting in October to further inform our efforts.
As this field continues to advance, it will be important for FDA to provide timely information to both consumers and industry given the Agency’s expertise and role in advancing food safety. The agency is committed to working with stakeholders to foster innovation while ensuring the safety of our Nation’s food supply.
The meeting format will include introductory presentations and multiple opportunities for stakeholders and members of the public to express their opinions through oral presentations. Parties who are unable to participate in person will be able to join the meeting via live webcast.
Public meeting attendees are encouraged to register online to attend the meeting in person or by live webcast. Registration is free, and early registration is strongly recommended because seating is limited. For questions regarding registration, contact Cindy Nachman-Senders, CNS Consulting Group, 7826 Whiterim Terrace, Potomac, MD, 20854, phone: 301-648-4466, email: firstname.lastname@example.org.
For general questions about the meeting or to request special accommodations due to a disability, contact Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, phone: 240-402-1731, email: Juanita.Yates@fda.hhs.gov.
Important Dates to Remember:
- Request special accommodations due to disability June 28, 2018
- Request to make an oral presentation June 28, 2018
- Advance Registration July 5, 2018
- Public Meeting July 12, 2018, 8:30 a.m. to 3:00 p.m.
- Deadline to submit written/electronic comments September 25, 2018
For Additional Information: