tion Act of 1906 (FMIA), USDA-FSIS
is responsible for the inspection of any
meat or meat food product intended
for human consumption and derived
from cattle, sheep, swine, goats, or fish
of the order Siluriformes (i.e., catfish).
USDA-FSIS also inspects poultry and
poultry products under the Poultry
Products Inspection Act of 1957 (PPIA).
Food products from animals not subject
to inspection under the FMIA or PPIA
(non-amenable species) are regulated by
the FDA under the Federal Food, Drug,
and Cosmetic Act of 1938 (FFDCA). It
follows then that food products derived
from cells of species not subject to
USDA jurisdiction fit solely under the
regulatory authority of FDA. However,
food products made from the cells of
species regulated by USDA under the
FMIA and PPIA will be regulated by
FDA during production (cell collection,
selection, and growth) and by USDA-FSIS during processing and labeling.
This arrangement resembles, in some
ways, the division of jurisdiction over
traditionally produced meat and poultry
products. Traditionally, FDA has food
safety authority over amenable livestock
and poultry during on-farm production,
and USDA-FSIS assumes food safety
authority when they are presented for
slaughter and processing. The agencies subsequently share authority over
amenable livestock and poultry, with
USDA-FSIS assuming primary responsibility for their regulation.
FDA has extensive experience regu-
lating various forms of cellular technol-
ogy, including substances produced
by cultured cells for both food and
therapeutic uses, cultured cells from
non-animal sources used as foods, ge-
netic engineering used to develop new
varieties of plants, and cultured cells
and USDA-FSIS are using their distinct statutory authorities and unique areas of
expertise to ensure that these new products are safe and truthfully labeled.
There has been much discussion on food safety oversight as well as debate over
what to call these products. You may have heard them referred to by other names.
To avoid confusion, we are going to refer to them as animal cell-culture food products. These food products begin with cells obtained from livestock, poultry, fish,
or other animals. Selected cells are prepared and stored for later use in a cell bank.
amounts of cells from the cell bank first multiply many times over and then, where
they differentiate into various cell types, including the muscle, fat, and connective
tissue cells that make up muscle tissue. Finally, the cells are collected and processed
into food products.
A Call to Action
With advances in technology and increased interest from many parties, the prospect of producing food products that incorporate cultured animal cells became a
hot topic of conversation in 2018. Many companies, both foreign and domestic,
are actively working on developing products using this technology. Some of these
products are being designed to have the same or similar smell, texture, taste, composition, and nutritional characteristics as traditional meat and poultry products.
As public discussion and press coverage of animal cell-culture technology increased,
questions about regulatory authority came to the forefront of conversations.
In February of 2018, the United States Cattlemen’s Association filed a petition
with USDA-FSIS regarding the labeling of cell-based products. Specifically, the petition requested that the definition of “beef” be limited to products from cattle born,
raised, and harvested in the traditional manner, and that the definition of “meat” be
limited to the tissue or flesh of animals that have been harvested in the traditional
manner. This petition was posted publicly and directed significant attention to cellular agriculture, including over 6,000 comments from industry trade associations,
consumer advocacy groups, businesses operating in the meat, poultry, and cell
culture-based food product markets, and consumers.
FDA and USDA-FSIS hosted a joint public meeting in Washington, DC, on October 23 and 24, 2018, to explore safety and labeling issues related to this new technology. The meeting allowed interested stakeholders to share their thoughts on potential hazards, oversight considerations, and labeling of cell-culture food products
derived from livestock and poultry. Meeting attendees included meat and poultry
packers, processors, and producers; firms intending to produce food cultured from
the cells of livestock, poultry, and seafood; consumer advocacy groups and consumers; and academia. FDA’s Science Board also met publicly to discuss potential hazards and nutritional considerations in the production of food derived from animal
cell-culture technologies on October 22, 2018.
So, Who Makes Sure It’s Safe?
The species of the animal from which the cells originate is the starting point for
determining which agency regulates these products. Under the Federal Meat Inspec-
“Animal cell-culture food technology is an emerging food production
technique involving the controlled growth of animal cells…, their
subsequent differentiation into various cell types, and their collection and
processing into food.”