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say, ‘Oh, yes, that falls within our regulatory authority, under our current regulation.’ So, I want to make
it clear that our decisions haven't been about all products produced with CRISPR technology – only
those that we've seen so far.”

It may be some time before there are clear answers on where the federal agencies responsible for
regulating genetically engineered products draw the line. Given the fractured nature of the current
regulatory framework, that will take a lot of meetings, talk and compromise.

There are also major trade concerns to address: Exporters of grains, oilseeds and other commodities
have raised concerns about an overhaul of U.S. regulations, saying that any changes need to be
coordinated with importing countries to make sure that shipments of gene edited products will be
accepted. Many countries, from the nations of Europe to Japan and New Zealand, are in various stages
of assessing how they will regulate products of various gene-editing techniques.

As for the effort to modernize U.S. regulations, Nicholas Jordan, University of Minnesota
“My feeling is it’s pretty stalemated,” says
Nicholas Jordan, a professor at the University
of Minnesota who has studied and written
about biotech regulation. “There are such
divergent ideas about what the future
regulatory system should look like.”

That’s not just because of rapidly advancing
technology, which makes it difficult – if not
impossible – for regulators to keep up. It’s also
because of the three-legged approach used to
regulate biotech in the U.S.

Currently, the USDA’s Animal and Plant Health
Inspection Service regulates genetically
engineered plants if they are deemed to pose a
plant pest risk. APHIS also reviews petitions to
determine whether new genetically engineered
products pose enough of a safety risk to even
warrant regulation.

Also in the regulatory mix: The Food and Drug Administration, which regulates plant and animal food

products derived from conventional breeding techniques or genetic engineering. Finally, the
Environmental Protection Agency regulates plant-incorporated protectants – “plants that have been
genetically altered to produce proteins that are harmful to certain insect pests,” EPA explains, citing as

examples Bt corn and Bt cotton, engineered to resist pests such as corn rootworm and cotton bollworm.

Despite their best efforts to coordinate oversight of gene edited products, the arrangement has
occasionally led to confusion, as with Oxitec’s attempt to release male mosquitos with a “self-limiting”

gene that causes offspring to die before reaching adulthood. Initially, FDA performed an environmental
assessment on the mosquitos based on its conclusion that they were “animal drugs,” but later it kicked
the regulatory responsibility to EPA after both agencies concluded that “articles or categories of articles
that control the population of mosquitoes are most appropriately regulated as pesticides.”

www.Agri-Pulse.com 41