How should the FDA regulate CRISPR gene-edited animals?

Screen Shot at PM

Gene editing is touted as a promising new way of altering the DNA of plants or animals to speed their growth, enhance flavor, extend shelf life or combat viruses. But those who see it as a key component of agriculture’s future want to make sure that the regulations written for it do not stifle its promise.

New methods such as CRISPR may allow plant breeders to avoid the regulatory bottlenecks.

All of the gene-edited products APHIS has reviewed thus far under its “Am I Regulated” process have received “no” answers – including a non-browning mushroom developed at Penn State using CRISPR/Cas9.

But that’s not the case for gene-edited animal products.

For now, the Food and Drug Administration (FDA) defines all intentionally altered genomic DNA as a new animal drug, irrespective of how or why they were changed. For example, firms that use gene editing to develop pigs with PRRS resistance, would have to go through FDA’s process for evaluating a drug.

“It’s a nonsensical position,” says Alison Van Eenennaam, a cooperative extension specialist in animal genomics and biotechnology at the University of California-Davis who has conducted extensive research on gene editing with cattle.

“Regulatory processes should be proportional to risk and consistent across products that have equivalent levels of risk,” she explained.

Read full, original post: Will new regulations stifle innovation in plant and animal breeding?

Outbreak
Outbreak Daily Digest
Biotech Facts & Fallacies
Talking Biotech
Genetics Unzipped
Video: Test everyone – Slovakia goes its own way to control COVID

Video: Test everyone – Slovakia goes its own way to control COVID

As Europe sees record coronavirus cases and deaths, Slovakia is testing its entire adult population. WSJ's Drew Hinshaw explains how ...
mag insects image superjumbo v

Disaster interrupted: Which farming system better preserves insect populations: Organic or conventional?

A three-year run of fragmentary Armageddon-like studies had primed the journalism pumps and settled the media framing about the future ...
dead bee desolate city

Are we facing an ‘Insect Apocalypse’ caused by ‘intensive, industrial’ farming and agricultural chemicals? The media say yes; Science says ‘no’

The media call it the “Insect Apocalypse”. In the past three years, the phrase has become an accepted truth of ...
globalmethanebudget globalcarbonproject cropped x

Infographic: Cows cause climate change? Agriculture scientist says ‘belching bovines’ get too much blame

A recent interview by Caroline Stocks, a UK journalist who writes about food, agriculture and the environment, of air quality ...
organic hillside sweet corn x

Organic v conventional using GMOs: Which is the more sustainable farming?

Many consumers spend more for organic food to avoid genetically modified products in part because they believe that “industrial agriculture” ...
benjamin franklin x

Are most GMO safety studies funded by industry?

The assertion that biotech companies do the research and the government just signs off on it is false ...
favicon

Environmental Working Group: EWG challenges safety of GMOs, food pesticide residues

Known by some as the "Environmental Worrying Group," EWG lobbies for tighter GMO legislation and famously puts out annual "dirty dozen" list of fruits and ...
m hansen

Michael Hansen: Architect of Consumers Union ongoing anti-GMO campaign

Michael K. Hansen (born 1956) is thought by critics to be the prime mover behind the ongoing campaign against agricultural biotechnology at Consumer Reports. He is an ...
News on human & agricultural genetics and biotechnology delivered to your inbox.
Optional. Mail on special occasions.
Send this to a friend