Makers of genetically engineered (GE) products have long been on the lookout for changes in U.S. regulations. The system that divvies up the safety review of these products between the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) is in the middle of a years-long overhaul, in part to accommodate modern gene-editing technologies such as CRISPR. And a set of new proposals released last week offers hints about what those agencies still hope to change.
Products made through genetic engineering have often faced an inconsistent and counterintuitive path to market. Some have worried that potentially risky products could fall through the regulatory cracks and avoid proper review. (USDA’s decision last April not to regulate a CRISPR-edited nonbrowning mushroom, for example, shocked some genetically modified [GM] organism opponents.) Meanwhile, developers of these products have argued that new, precise techniques to edit a few letters of genetic code shouldn’t be held to the same strict standards as older approaches that make less predictable or more widespread genetic changes.
Earlier this month, the White House released an update to the overarching system of biotech regulation, known as the Coordinated Framework for Regulation of Biotechnology. But it’s still up to individual agencies to clarify how they intend to classify and evaluate various GE products. In an apparent effort to get plans on the table before a change of administration, USDA and FDA put out draft proposals on 18 January addressing several categories of GE products. Reactions from the companies behind those products have been mixed: