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05.02.2018 |

REGULATORY OUTLOOK: Political climate may be favorable for GE crop reform

The latest from the Trump administration suggests USDA may be ready to once again try and overhaul its regulations for genetically engineered crops.

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GE animals in the cold

Although the administration has shown interest in the GE crop rules, it has yet to signal its intent with regard to FDA's oversight of GE animals.

The Obama administration in January 2017 released draft revisions to FDA's guidance on GE animals. The proposal calls for the agency to continue regulating GE animals as new animal drugs and to expand its oversight – currently FDA considers the presence of an rDNA construct from another species as its trigger for regulation.

But the draft guidance moves far beyond that in a bid to bring in new gene editing technologies, such as CRISPR and TALENs, and to subject any animal with intentionally altered genomes to FDA's new animal drug review and regulations.

The draft guidance drew sweeping criticism from ag and biotech interests, including the American Farm Bureau Federation, BIO, the National Pork Producers Association, the National Milk Producers Federation, North American Meat Institute and NASDA.

Critics worry the proposed revisions will expand the agency's authority and undermine efforts to develop and commercialize biotech innovations that could help producers control diseases, improve food safety, enhance animal welfare and decrease the environmental impacts of animal agriculture.

The vocal opposition, however, has not yet convinced FDA to change course.

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