Page 42 - Breeding Edge ebook

New methods such as CRISPR may allow plant breeders to avoid the regulatory bottlenecks. Harry
Klee, a colleague of Folta’s at the University of Florida who is working to improve the taste of tomatoes,
says he’s using CRISPR instead of “traditional genetic engineering” that uses foreign DNA.

“We are hopeful that a clean gene-edited mutation
with no foreign DNA that is equivalent to a natural
mutation will be free and clear of regulations,” he said
in an email. “Being able to take such a mutation
and introduce it widely into many elite breeding
lines without the need for extensive backcrossing is
a potential game changer in breeding programs.”

So far, the odds are good that Klee will get his wish.
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. For now, “GE animal regulatory burdens are disproportional
high and associated with unaccountable delays and considerable uncertainty. These regulatory burdens
are not justified by scientific evidence or experience," she adds. And they require elaborate and costly
studies, not to mention time delays.

So, for many industry stakeholders, there is
still a great deal of regulatory uncertainty.
And it's not clear how the regulations might
change in the future.

Mike Firko, deputy administrator for APHIS'
Biotechnology Regulatory Services, said at
BRS’s recent annual stakeholders meeting
that the track record so far isn’t necessarily
predictive of the future.

“We decided that those particular products
that were put before us would not be regulated,” he said. “CRISPR is a very powerful tool. It may very
well be possible that we will soon see a product produced with CRISPR technology where we would

40 www.Agri-Pulse.com