Fixing a broken system

America is on the verge of a new industrial revolution powered by biology that is being killed by outdated policies.

By using recent advancements in genetic engineering, scientists are repurposing life in completely new ways. We are designing biosensors that monitor our ecosystems, sweeter strawberries with a longer shelf life and goats that produce stronger-than-steel spider silk. Such remarkable engineering is possible due to advancements like low-cost/high efficiency gene editing using CRISPR, low-cost genome sequencing and rapid improvements in gene synthesis.

But existing policies for gene-editing technology and its products are woefully outdated and create a regulatory environment that kills innovation. For starters, the regulatory process is undertaken in a cumbersome environment that splits oversight between the FDA, USDA and EPA. Next, products of genetic engineering are regulated with unfounded fears, and not data.

Take the example of hornless cattle. Farmers desire the hornless trait as horns are a danger to other cattle and farm workers. Hornless cattle bred for beef naturally exist due to a spontaneous mutation. However, dairy cows have horns and naturally breeding them to become hornless is completely impractical. Using gene-editing technology, scientists developed hornless dairy cows, but they never went commercial as they were killed by FDA regulations based on outdated fears rather than science and data.

The costs associated with this regulatory environment have been enormous. For instance, the regulatory compliance costs to take a new biotech crop to market between 2008 and 2012 was roughly $36 million. This burdensome, costly and inflexible regulatory environment has stifled market competition and innovation. We must unleash American innovation in biotech by fixing the regulatory system to account for recent advancements in genetic engineering.

I propose that Congress enacts new legislation for gene-editing biotechnology with the following framework: (a) stipulate that policies asses the outcomes of gene-editing rather than process itself, and (b) establish a new agency that oversees gene-editing technology.

New laws must be agnostic to the process of genetic engineering. Regulations should assess new functions that arise out of gene-editing, rather than process that led to it. Policies must be flexible to account for the differences within products and the extent of regulation necessary for each.

Enforcement of new policies and oversight of genetic engineering and its products should be conducted by a new federal agency. This agency would review applications for new products, assess the scope of necessary regulatory compliance, and coordinate with other federal agencies if necessary. This system would streamline the regulatory process for businesses, who would not have to coordinate independently with multiple federal agencies.

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