The quest for artificial meat inches
forward—the company Memphis Meats announced
today it has developed chicken and duck meat from cultured
cells of each bird, producing “clean poultry.” The firm provided few
details, although participants at a tasting reportedly said the chicken tasted
like, well, chicken. Below is a repost of a story originally published 23
August 2016 on some of the regulatory challenges and questions facing
Memphis Meats and other companies pursuing artificial meats.
The first hamburger cooked with labmade meat didn’t
get rave reviews for taste. But the test
tube burger, rolled out to the press in 2013, has helped put a spotlight on the
question of how the U.S. government will regulate the emerging field of
cellular agriculture, which uses biotechnology instead of animals to make
products such as meat, milk, and egg whites.
So far, none of these synthetic foods has reached the
marketplace. But a handful of startup companies in the United States and
elsewhere are trying to scale up production. In the San Francisco Bay area in
California, entrepreneurs at Memphis Meats hope to have their
cell-cultured meatballs, hot dogs, and sausages on store shelves in about 5
years, and those at Perfect Day are targeting the end of 2017
to distribute cow-free dairy products. It’s not clear, however, which
government agencies would oversee this potential new food supply.
Historically, the U.S. Department of
Agriculture (USDA) regulates meat, poultry, and eggs, whereas the Food and Drug
Administration (FDA) oversees safety and security for food additives. FDA also
approves so-called biologics, which include products made from human tissues,
blood, and cells, and gene therapy techniques. But emerging biotechnologies may
blur those lines of oversight, because some of the new foods don’t fit neatly
into existing regulatory definitions. “Cellular culture raises a lot of
questions,” says Isha Datar, CEO of New Harvest, a New York City–based
nonprofit founded to support this nascent industry.
To help provide answers, the White House last
year launched an initiative to review and overhaul how U.S. agencies
regulate agricultural biotechnology. And
the National Academies of Sciences, Engineering,
and Medicine in Washington, D.C., is working on a broader study of future biotechnology developments and
regulation, with a report slated for
release at the end of this year. (Editor's Note: The report was released on
March 9, 2017)
In the meantime, industry leaders are thinking
about how their potential lab-based foods might be handled by regulators. One
approach, they tell ScienceInsider, is to show that their product is similar to an existing
product that testing has already shown to pose no hazards. “Most food
regulation is about aligning new products with something that’s already
recognized as safe,” Datar notes.
That’s the approach already taken by companies
that use microbes and other biotechnologies to produce enzymes and proteins
that are added to foods, notes Vincent Sewalt, senior director, product
stewardship and regulatory, for DuPont Industrial Biosciences, based in Palo
Alto, California. For example, yeast can be used to produce specific amylases,
which are enzymes added to baked goods to prolong freshness. Such additives
require premarket approval from FDA “unless you can demonstrate they are
substances generally recognized as safe,” Sewalt says. To meet that
standard—known in the industry as GRAS—companies start by selecting microbial
strains that are known to be nontoxigenic and nonpathogenic, then use those
strains to produce their products. “And that can be safely done as long as
you’ve selected a safe strain and demonstrated that safety through repeated
toxicology studies,” Sewalt says.
That strategy might also work for companies
experimenting with using engineered yeast to produce single proteins to create
egg whites, without cracking open a chicken's egg. In this case, egg white
proteins are already considered to be a GRAS ingredient.
The same scenario might also work for Perfect
Day, the startup that’s using yeast to make milk proteins, and then adding
other ingredients to create a cow-free “milk.” Those milk proteins, caseins and
whey, are already recognized as safe because they’re identical to the milk proteins
we get from cows, says Datar, also a founder of the company.
The product can’t legally be called milk,
however, because FDA has standards of identity that specifically define milk as
lacteal secretions from a cow. “That definition completely leaves out any kind
of beverage produced by fermentation or other tools of molecular biology,” says
Phillip Tong, former director of the Dairy Products Technology Center and
professor emeritus at California Polytechnic State University, San Luis Obispo.
“When these definitions were promulgated, nobody ever thought we’d be able to
do something like this,” he adds.
Meaty complications
The regulatory situation gets more complicated
with cell-cultured meat, in which cells taken from animal muscle are grown on
special scaffolds until they form enough tissue strands (about 20,000) to make
a meatball or hamburger. It is not quite animal, not exactly a food
additive—yet intended as food.
“It’s uncharted territory,” says Nicole
Negowetti, policy director for the Good Food Institute, a Washington, D.C.,
nonprofit that supports cultured and plant-based food alternatives. For
example, “from my understanding, the USDA regulations are based on food from
animal slaughter, so [they don’t] make sense for these products,” she says.
Although cellular agriculture advocates tend
to dwell on the process—because they say it could lead to safer, more humane,
and more sustainable food production—FDA looks only at the final product. So,
whether the end product is genetically modified corn, soybean, or maybe meat,
Negowetti says the product should be regulated by FDA if it is meant to be a
food.
But meat from cell cultures could also fall
under FDA oversight for drug manufacturing, she notes. Because FDA defines a
drug as something that includes human cells, tissues, and tissue-based
products, it might not be so much of a stretch to say animal tissue could be
included in that definition, too, she adds.
There also could be arguments made for
regulating cell-cultured meat under FDA’s New Animal Drug Application process.
Under this scheme, the agency regulates drugs given to animals or added to
their food. So if companies manipulate meat cultures to improve the flavor, fat
content, or other qualities, that could be considered the same as giving a drug
to an animal.
Safety advantages?
Although biotechnology may make it harder to
define new food products, it could also facilitate more precise safety
measures, DuPont’s Sewalt says. For instance, he says that as genome sequencing
becomes faster, so could the process of figuring out whether gene insertions or
deletions in new organisms pose health risks or other concerns. There’s also
the possibility of explicitly designing in safety, such as by engineering egg
white proteins so they don’t trigger allergic reactions. And, in the future,
the potential to insert barcodes in genes and the development of in-line ID
kits, that recognize specific strains of cell lines, could make it easier to
verify new organisms and their protein products, and track products through
supply chains.
For the moment, however, which government
agencies will oversee these changes remains unclear. As biotech creates more
overlap among regulatory systems, Datar suggests it would be ideal to create a
single regulatory agency. “Right now,” she says, “our system is set up in a way
that promotes imitation as opposed to innovation.”
FROM THE DESK OF ANIMAL RIGHTS WRITERS
ASSOCIATION OF NIGERIA.
http://www.sciencemag.org/news/2017/03/artificial-chicken-grown-cells-gets-taste-test-who-will-regulate-it
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