How should the FDA regulate CRISPR gene-edited animals?

, | | February 12, 2018
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This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

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?

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