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Background Analysis: Science Board to FDA to Hear CVM Response to National Antibiotic Resistance Monitoring System Review and Issues with Food from Animal Cell Culture Technologies – OCT 22, 2018 (SBFDA)


The Science Board to the US Food and Drug Administration (SBFDA) will meet on Monday, October 22, 2018. The SBFDA will hear a response from the Center for Veterinary Medicine (CVM) to the recommendations made by the Science Board’s 2017 review of CVM’s National Antibiotic Resistance Monitoring System (NARMS) program. The Science Board will also discuss potential hazards and nutritional considerations in the production of food derived from animal cell culture technologies.  


National Antibiotic Resistance Monitoring System Program

The National Antimicrobial Resistance Monitoring System (NARMS) is a national collaborative network of the FDA, the Centers for Disease Control and Prevention (CDC), the US Department of Agriculture (USDA), and State public health laboratories. NARMS was established in 1996 to track antibiotic resistance in foodborne bacteria from humans, retail meats, and food animals. The use of antimicrobial drugs enables antimicrobial resistant bacteria to increase in numbers, increasing the chance for individuals to become infected by resistant bacteria. When antimicrobial drugs are used in food-producing animals, they can increase the resistant strains that reach humans via the food supply.

The primary objectives of NARMS are to:

·       Monitor trends in antimicrobial resistance among foodborne bacteria from humans, meats, and animals;

·       Disseminate timely information on antimicrobial resistance to promote interventions that reduce resistance among foodborne bacteria;

·       Conduct research to better understand the emergence, persistence, and spread of antimicrobial resistance; and

·       Assist the FDA in making decisions on the approval of safe and effective antimicrobial drugs for animals.

In the June 26, 2017 meeting of the SBFDA, the Chair of the NARMS Review Committee (NRC) presented a summary of the NRC’s report to the SBFDA. The report provided a series of recommendations for the NARMS programs, including the review of current activities, expansion to other food types, and collaboration with other programs.  After the presentation, the SBFDA voted unanimously to accept the report and provide it to the FDA.

Food Derived from Animal Cell Culture Technologies

On July 11, 2018, the FDA held a public meeting to discuss the safety of innovative cultured food products (e.g., cultured meat). In that meeting and its related docket, the FDA requested comments on the safety of foods produced using animal cell cultures, specifically asking what considerations should be taken into account when evaluating foods produced by animal cell culture technology, how the technology could have an impact on food safety, how to evaluate the inputs used in this technology, and what how to assess hazards that may be unique to the production of foods using animal cell culture technology.

An overall consideration has been whether the FDA or United States Department of Agriculture (USDA) should have jurisdiction over products such as cultured meat. Related to this issue, on September 10, 2018, the US Secretary of Agriculture and the FDA Commissioner announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry. Note that this public meeting is scheduled for the two days after the October 22, 2018 date of the SBFDA meeting. The joint public meeting will focus on similar topics as listed for the SBFDA meeting; that is, the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry. The first day of the meeting will focus primarily on the potential hazards that need to be controlled for the safe production of animal cell cultured food products and oversight considerations by regulatory agencies. The second day of the meeting will focus on labeling considerations.

What’s Next? (With Subscription)

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: none Indication: none

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.