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House subcommittee discusses the future of biotech

The use of biotechnology to grow food and manufacture products is rapidly expanding, fueled by recent advances in gene sequencing and editing. But federal regulations and support have not kept pace. What rules should govern how biotech products move from the lab to the marketplace? How can the United States remain competitive?

The House Subcommittee on Research and Technology examined these questions in a hearing December 8 that emphasized non-health biotech applications: agriculture, energy, and manufacturing. A set of guidelines called the Coordinated Framework for the Regulation of Biotechnology currently governs bio-based products in these sectors. These rules were established in 1986 and last updated in 1992 — well before the development of cheap DNA sequencing and modern editing techniques such as CRISPR.

All five expert witnesses in the hearing — including representatives of academia, national labs, and industry — called for an update of the Coordinated Framework to bring it in line with modern biotech practice. Without this, companies will have trouble gaining approval for new products.

Zach Serber, co-founder of biotech company Zymergen, told the committee that regulatory systems based on this old framework "have not kept up with changes in the technology, creating business-sapping confusion, delays, and inefficiencies."

Steve Evans, of Dow AgroSciences, underlined the urgency for quick federal action by describing the scale of the food security problem over the next 35 years. "Agriculture will need to produce more food in this timeframe than the sum total of what it has produced in the last 10,000 years," he said. The typical timeframe to develop a marketable biotech agricultural product is a decade, he noted, and industry is reluctant to make research and development investments without a predictable regulatory framework in place.

Texas A&M professor Martin Dickman expanded on this point, and said that only a new, biotech-enabled Green Revolution, as we had in the early 20th century, can address the world's food needs given the challenges of drought, climate change, and urbanization.

In addition to updated rules for product development, the federal government and universities should focus on making sure that scientists and engineers have the right training since the technology requires a multidisciplinary skillset. "Our most valuable employees are rare individuals with expertise in multiple relevant domains, able to bridge the gaps between, for example, genome editing and software engineering," Serber said. "Federally supported educational and training programs are critical to fulfill our potential."

Serber has been in talks with UC Berkeley on a new Masters program, and the national labs have become involved. "We've launched a workforce initiative to collaborate with community colleges and national organizations to incorporate biological engineering biomanufacturing into curricula and programs," said Mary Maxon, the deputy for biosciences at Lawrence Berkeley National Laboratory. She noted that students are often trained for academia, but usually don't spend their careers there.

The Office of Science and Technology Policy has taken the first steps toward a federal approach to biotech, issuing a memo last July that directs the EPA, FDA, and USDA to work together on the Coordinated Framework update and other projects.

Maxon is optimistic that the agencies will be able to make rapid progress, enabling the United States to remain ahead of international competitors such as the United Kingdom and China.

"A focused and coordinated national engineering biology initiative would help drive U.S. leadership in biomanufacturing, enable new fundamental discoveries, provide solutions to national challenges, and fuel the bioeconomy," she said.

More information on the hearing, including an archived video feed, is available on the committee website.

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Chris Spitzer

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