Meat+Poultry - September 2021 - 54

ALTERNATIVE PROTEINS
cell-based regulation, Venkataraman said. An
important development came in 2019, when the
US Department of Agriculture and the Food and
Drug Administration released an agreement to
create a joint regulatory framework for cellbased
meat product approval.
" I think that
the United
States could
very well be
one of the next
countries to
grant approval,
especially for
seafood "
- HARINI VENKATARAMAN
Under the joint regulatory framework, the
USDA and FDA will co-regulate all cell-based
products except for seafood, which will fall
solely under the FDA's jurisdiction.
" I think that the United States could
very well be one of the next countries to
grant approval, especially for seafood, "
Venkataraman said. " Because it falls solely
under the FDA, and because we've seen some
developments from companies like BlueNalu
in terms of getting cell-based seafood to the
market, I imagine seafood regulation may be
faster than beef and some of the other types of
products we're looking at. "
Singapore was the first
country to approve
the sale of cell-based
meat products.
For products beyond seafood, the FDA will
oversee cell collecting and cell culturing and
will be responsible for conducting premarket
consultations on production processes. The
USDA's Food Safety and Inspection Service will
oversee processing, packaging and labeling of
food products from the harvested cells.
" If you think about procuring the cell lines
and other raw materials, the FDA will have
more visibility into that, " Venkataraman said.
" The USDA will be looking at the finished
products as well as getting the latter part of the
value chain into place. "
The two agencies created several groups
to tackle specific co-regulation challenges. A
transfer of jurisdiction group is developing
procedures to guide the transfer of inspection
at harvest, while a premarket assessment
group led by the FDA is working to clarify
the processes for premarket reviews of cellbased
meat.
A labeling group led by the USDA currently
is developing joint principles for product
labeling claims.
" I think the industry consensus now is
either to use 'cell-based meat' or 'cultivated
meat,' because you're cultivating it from a
bioreactor, " Venkataraman said. " We've moved
away from other terms like lab-grown, clean
meat and in-vitro meat. "
Other questions exist, including what
the guidelines will be for cell-based meat
makers looking to get production facilities up
and running.
In the European Union, cell-based meat
will be regulated as part of the EU's Novel
Food Regulation published in 2018. While
this streamlined process allows for EU-wide
approval, it requires at least 18 to 24 months.
In Japan, the Center for Rule-making
Strategies, a think tank, launched the
Association for Cellular Agriculture to advise
on regulations to commercialize cell-based
meat in the Japanese market.
Cell-based meat remains a nascent industry
in China, but industry players have recognized
the importance of novel food production
methods to meet the region's looming food
insecurity challenge. In June 2020, a Chinese
official called for urgent measures to execute
a regulatory framework for cell-based meat,
including the possibility of regulating it under
China's existing novel food regulation.
Israel is widely viewed as having a
favorable regulatory landscape, given the
government's support and involvement,
according to Lux. Tel Aviv-based startup
SuperMeat last year opened a test restaurant
in Israel that serves cultured chicken, though
cell-based meat products are not currently
regulated in the country.
" Although countries like Singapore and
Israel have favorable regulatory landscapes,
these small markets will not be enough
for widespread adoption and market
penetration, " Venkataraman said. " Larger
nations will need to remove regulatory
barriers to unlock a mass market. "
54 MEAT+POULTRY | 09.21 | www.meatpoultry.com
Eat Just Inc.
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Meat+Poultry - September 2021

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