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Biological Chemistry

White House attempts to clarify, but not change, genetic engineering regulations

First update in decades draws both praise and scorn, but is mostly marked as a missed opportunity

by Ryan Cross
January 9, 2017

A scientist examines plants in a greenhouse.
Credit: Shutterstock
The biotechnology industry is expected to grow, and perhaps overwhelm regulators, with new gene-editing methods such as CRISPR.

The Obama Administration’s update of a decades-old policy for reviewing U.S. biotechnology products, including genetically modified foods, is perhaps most notable for what it leaves out: a call for new regulations or mention of new gene-editing technologies such as CRISPR.

Released last week, the revision for the first time sets down in a single document the roles and responsibilities of the three agencies involved in regulating products of biotechnology, says Robbie Barbero, assistant director for biological innovation at the White House Office of Science and Technology Policy (OSTP).

The Environmental Protection Agency regulates crop plants engineered to produce their own pesticides. The Agriculture Department has jurisdiction over crops produced with genetic parts of plant pests—a formerly common but now aging method of genetic engineering. And the Food & Drug Administration regulates animals that contain recombinant DNA as if the animals were drugs.

The agencies’ division of labor was first spelled out in 1986, when the Reagan Administration addressed the stream of new genetically manipulated products through the Coordinated Framework for the Regulation of Biotechnology. Instead of creating new laws explicitly regulating genetically modified products, the framework specifies which laws authorize the agencies to review such products. It was last updated in 1992.

Barbero of OSTP said the update to the framework “was really meant to be ground truth for how the system functions now.”

Absent in the new document is mention of CRISPR gene editing, a method for tweaking DNA that makes older methods look cumbersome and costly by comparison. The fast and affordable CRISPR method is anticipated to open doors for smaller biotech companies to compete in a market currently dominated by a few large players.

CRISPR-edited foods are already cropping up. Last year, USDA said it would not regulate a mushroom that was edited with CRISPR because it didn’t use plant pest parts—the regulatory hook for USDA review of engineered crops.

“In some instances, the agencies are hamstrung and unable to adapt to these rapidly changing technologies. And that can only get fixed by actually changing the regulation,” says Todd Kuiken of the Genetic Engineering & Society Center at North Carolina State University. “We will continue to see these problems emerge. It is CRISPR today, but tomorrow it will be something else.”

Doug Gurian-Sherman of the Center for Food Safety, an environmental advocacy organization, says that without calling for new regulations, the revised framework “is really just kicking the can down the road.”

“It’s been clear from the last several years in particular that this system is really antiquated and really needs some serious updates,” he says.

The Biotechnology Innovation Organization, an industry group, says it is reviewing the updated framework. It offered no detailed comment except that it supports efforts to modernize the regulatory system for biotechnology products.

Because of regulatory loopholes, there are more than 30 known instances of genetically engineered crops hitting the U.S. market without USDA oversight (Nature 2016, DOI: 10.1038/531165a).


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