The U.S. Food and Drug Administration held a public meeting to discuss foods produced using animal cell culture technology.
Title: Foods Produced Using Animal Cell Culture Technology
Date: July 12, 2018
Time: 8:30 a.m. until 3:00 p.m.
Location: 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. Experiences in evaluating and ensuring the safety of novel technologies in the food sector were shared at this upcoming public meeting, while also discussing these issues with, and gather relevant data and information from, stakeholders.
The public meeting gave interested parties and the public an opportunity to comment on these emerging food technologies. Specifically, the agency asked 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 was focused on food safety, FDA recognizes the importance of other issues related to foods produced through animal cell culture technology, such as labeling, and FDA welcomed 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 included introductory presentations and multiple opportunities for stakeholders and members of the public to express their opinions through oral presentations.
- Meeting Agenda (PDF: 170KB)
- Meeting Transcript (PDF: 1.08MB)
- Presentation by FDA: FDA’s Historical Experience with Food Safety Evaluation and Future Considerations (PPTX: 11.6MB)
- Presentation by FDA: Regulatory Framework for Food Safety at FDA (PPTX: 1.42MB)
- Presentation by External Participant: Overview of Animal Cell Culture Technology (PDF: 2.53MB)
- Presentation by External Participant: Memphis Meats Remarks (PDF: 2.77MB)
- Presentation by External Participant: New Harvest Remarks (PPTX: 447KB)
- Deadline to submit written/electronic comments September 25, 2018; submit electronic comments to docket folder FDA-2018-N-2155