The U.S. government is hoping an expert panel will be the next best thing to a crystal ball in helping predict what the future of biotechnology holds. The National Academies of Sciences, Engineering, and Medicine (NAS) in Washington, D.C., yesterday held the first public meeting of a new committee of academic and industry researchers, tasked with forecasting what biotechnologies will emerge in the next 5 to 10 years, and what new types of risk they might pose to the environment or human health.
The effort comes as U.S. regulatory agencies prepare to update the legal framework for evaluating biotechnology products.
The White House announced last July that it would revise the nearly 24-year-old framework for how companies should clear agricultural biotech products, such as genetically modified (GM) crops and animals, with the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). New gene-editing technologies such as CRISPR have sped the development of new crop varieties and animals, but products based on engineered organisms sometimes face a web of complex and overlapping regulations before they can reach the market.
“We certainly are aware … that science is rapidly advancing,” Consumer Safety Officer Carrie McMahon of FDA’s Center for Food Safety and Applied Nutrition in College Park, Maryland, told the panel yesterday. “It’s happening so fast that the committee here can do a great service to the agencies by looking to see what’s going on.”
The panel won’t release its predictions until December, but EPA, USDA, and FDA regulators who presented to the committee at yesterday’s meeting shared some of the emerging technologies they’re most concerned about. For Chris Wozniak of EPA’s Office of Pesticide Programs in Washington, D.C., the uncharted territory is RNA interference—a process of exposing weeds or insects to engineered, double-stranded RNA molecules that silence key genes by disrupting a cell’s ability to translate them into proteins. No companies have yet asked the agency to evaluate such a product, he says, but many are interested. “I’ve been to some meetings where it’s just one person after another. They all want to know the same thing: Who’s going to regulate it and how?”
When committee member Jennifer Kuzma, a policy analyst at North Carolina State University in Raleigh, asked what exactly represents a “different type of risk” from existing products, several regulators invoked another nascent technology, known as gene drive. That technology could quickly change the genetic makeup of an entire population of animals by introducing a gene that prevents them from spreading disease, or wipes out a pest population altogether. A separate NAS committee is in the process of evaluating gene-drive technology, which still faces both scientific and regulatory roadblocks. But the prospect of such large-scale changes to a population is “something that we have never looked at before, and we may not have an adequate risk assessment paradigm,” said Neil Hoffman, a science adviser to USDA’s Animal and Plant Health Inspection Service in Washington, D.C.
Mark Segal with EPA’s Office of Pollution Prevention and Toxics in Washington, D.C., meanwhile, wants the panel’s thoughts on a more immediate concern—the growing interest in genetic engineering based on totally lab-designed genes, not genes extracted from another organism. “[For] many of the sources of genetic material that people are thinking about … the organism itself has never been seen—never been cultivated,” he says. He wonders whether that approach makes it inherently more risky to release the resulting GM organism—such as a microbe designed to break down pollutants.
Ever in the background of the meeting was CRISPR, the highly precise and efficient gene-editing method generating a slew of new products. This week, USDA announced that it will not regulate CRISPR-edited mushrooms designed to resist browning, or a strain of high-yield waxy corn created by DuPont Pioneer using CRISPR. Like an earlier generation of gene-edited crops already in commercial use, those two products don’t fall in USDA’s purview because their genomes contain no foreign DNA from species considered to be plant pests.