now, the better we will be able to design
regulatory processes that work with each
technology, preventing regulatory delays
down the road.
We expect that many characteristics
of the products that can be produced
by these processes and technologies will
vary, such as the composition, nutritional content, shelf life, and functionality.
We believe that many of these characteristics will need to be reflected through
the labeling of these products, which
may require careful evaluation and an
iterative, data-driven dialogue with industry. Given these considerations, we
also believe that these discussions with
industry should begin soon to prevent
unnecessary delays once companies are
ready to bring products to market. n
Matthew Michael is the Director of the Issuances
Staff at USDA-FSIS. Jeremiah Fasano, Ph.D., is a
senior policy advisor in the Office of Food Additive
Safety's Division of Science and Technology at the
Center for Food Safety and Applied Nutrition, FDA.
FDA, and FMIA and PPIA for USDA-FSIS). Both agencies have agreed to work together to identify and work through any changes needed to statutory and regulatory
authorities. However, at this time, neither agency anticipates that additional legislation will be necessary for this food production technology. USDA-FSIS has publicly
stated that it is interested in developing new labeling requirements for meat and
poultry products produced using this process. USDA-FSIS is committed to a public
process for developing these requirements, which likely will involve rulemaking.
The joint FDA and USDA-FSIS public meeting also served to identify key areas
where coordination between both agencies will be necessary to inform future decision making; three FDA and USDA-FSIS work groups have been formed as a result.
The first work group established, led by FDA, is a pre-market food safety assessment
group tasked with developing the overall pre-market consultation process. The second work group concerns transfer of jurisdiction and will develop the procedures for
transferring inspection from FDA to USDA-FSIS at the cell harvest stage; FDA and
USDA-FSIS are co-leads for this work group. The final work group is the labeling
group, led by USDA-FSIS, which will develop coordinated principles for product
labeling and claims to ensure consistency and transparency.
Bringing the Production Process into Focus
Although animal cell-culture food technology products are in various phases of
development, both FDA and USDA-FSIS are engaging with industry to learn about
the specific processes and technologies that companies are using to develop products.
The agencies recognize that some details of this technology might be considered proprietary, but we encourage industry to share information with regulators sooner rather
than later. The more we know about the finer points of the processes and technologies
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