Source: Julie Larson Bricher, MEATINGPLACE, 10/23/18

USDA Secretary of Agriculture Sonny Perdue and FDA Commissioner  Scott Gottlieb welcomed a packed room of attendees to the agencies' joint public meeting on the use of cell culture technology to develop products derived from livestock and poultry this morning.

The public stakeholder meeting, which is being held in the USDA's South Building in Washington, DC, Oct. 23-24, 2018, is focused on gathering input that will be used to establish a policy, regulatory and labeling framework for meat and poultry products grown in a lab.

"It's a new technology and it is always good to have stakeholders interested in new technologies as we being to talk about this because it helps inform our agencies as we go forward,” said Perdue in his opening remarks.  

"We have a room filled today with individuals who have an interest in ensuring that the food on America's tables remain safe, wholesome and accurately labeled," Perdue continued. "These are challenges as new technologies that have never been before... come to fruition [making it] very important that we have a framework that encourages innovation and new technology while we provide a responsibility for safe, wholesome and nutritious food supply."

In a media briefing following opening remarks, the two officials stressed that the USDA and FDA would work quickly to determine a policy framework and the oversight role of each agency.

"There are obviously new types of biology and technology [in which] FDA has experience and USDA has experience in testing commercialization in processing," Perdue told reporters, "so we hope to define very clear lines of demarcation regarding the responsibilities of both agencies going forward.

"Dr. Gottlieb and I agreed this morning [that this stakeholder meeting] is not just episodic. It's the beginning of a process of collaboration where we get our teams together and we'll more clearly define those areas of demarcation and regulatory authority in this area," added Perdue. "So, that's what we'll be doing posthaste after this meeting and bring to the public transparent comments as soon as possible."

Gottlieb agreed, noting, "The science and the technology we understand, so I think that the question is going to be defining the policy framework for the proper regulation and the proper oversight of the technology so that we can ensure that this can be done safely and that we're providing consumers confidence in the products that are being developed.

"We have a very collaborative process underway at USDA and FDA, there's been many cases where we've shared jurisdiction with different products and I think this is going to be one of those cases where we share jurisdiction," he added.

Perdue said comments from an FDA meeting this past summer and those gathered over the next two days will be analyzed and shared with an eye toward "get[ing] this done in 2019."

Gottlieb was also optimistic about FDA-USDA collaboration resulting in a speedier pathway for regulatory guidance and innovation, telling reporters, "We're often in the position at FDA of trying to come up with an appropriate policy or regulatory scheme after a technology has taken root and products are being developed, and sometimes being put on the market. We've seen that with multiple product areas within the FDA regulatory portfolio.

"This is one of those unique examples where we're contemplating all these things really early in the process, really in advance of the products even being available and I think that's going to help the innovation really take root and provide clear guidance to the manufacturers and I think it should accelerate the innovation," he said.

Approximately 600 people have registered to attend the two-day public meeting, either in-person or via webcast, according to USDA's public affairs officers. Oral public comments are being taken throughout the meeting.

Meat industry weighs in
The North American Meat Institute argued that the USDA Food Safety and Inspection Service (FSIS) should have primary jurisdiction for regulating new cell-based meat products.

In his oral comments, North American Meat Institute Senior Vice President of Regulatory and Scientific Affairs Mark Dopp said,

"That the inspection system FSIS administers is more rigorous than the one administered by FDA is undeniable. Administration officials have said as much. But I am baffled why those who advocate that FDA should have primary jurisdiction over cell-based meat products want to deny those companies the benefits of FSIS inspection,” Dopp said.

National Cattlemen's Beef Assocation President-Elect Jennifer Houston in prepared remarks said that USDA is well-positioned to apply current food safety processes to "lab-grown fake meat products", noting that two-thirds of the facilities already overseen by USDA are “processing-only” facilities where harvesting of animals does not take place.   

“Ensuring lab-grown fake meat products are subject to strong, daily inspection by USDA’s trained professionals is essential,” she said. “The health of consumers is on the line, and USDA is far better suited to ensure the safety of lab-grown products.”

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