NASEM releases report on future of biotechnology products, regulations

On March 9, the National Academies of Sciences, Engineering and Medicine (NASEM) released a two-year study, titled, Preparing for the Future of Biotechnology, and Bruce Darling, NASEM executive officer, noted that advances in technology have led to an explosion in biotechnology.

“While some see the promise to address social or environmental issues through biotechnology, others have expressed the concerns about safety and ethics of biotech products,” Darling said. “Over the next decade, the U.S. regulatory system will need to anticipate these advances and develop an approach to the benefits and risks to manage biotechnology products and their use.”

The results of the study were presented on March 9 during a webinar that laid out the priorities of the study.

Reasons for study

Study Chair Richard Murray of the California Institute of Technology explained that the impetus of a study was a memorandum from the White House issued in July 2015.

The memorandum asked for modernization of biotechnology regulatory systems, said Murray, and they were asked to update the coordinated framework for regulating biotechnology products while also clarifying the roles and responsibilities of the agencies that regulate those products.

“The second aspect was to formulate a long-term strategy for the biotechnology regulatory system to efficiently address the risks associated with the future of products of biotechnology and to support innovation,” Murray added. “The third aspect was to commission an external independent analysis of the future landscape of biotechnology products.”

They started by looking at the future of biotechnology over the next five to 10 years, then described the existing systems. Next, they looked at the potential products and risks relative to those. Finally, the committee looked at scientific capabilities that might to be useful.

Defining biotech

When getting started, Murray noted that the committee began by first defining biotechnology products as, “products developed through genetic engineering or genome engineering or the targeted, in vitro manipulation of genetic information of organisms, including plants, animals and microbes.”

Within that category, he said that there are three categories of biotechnology products, including open release products, contained use products and platforms.

“Open release products are things that are out in the open,” Murray said. “Genetically engineered crops are the most familiar example, but other products like genetically engineered mosquitos exist, as well.”

Contained use products are not open or affecting the environment, such as those products used in research labs.

Finally, platforms are those biotech products used to produce other products. They are currently primarily used in the research sphere.

Themes

“As we talked about the products, there were a couple of cross-cutting things that came up over and over again,” Murray said.

The ideas of expanding regulatory mechanisms, as well as the increase in the number of biotechnology products, were among the overarching themes.

“As Bruce mentioned, there are a lot of people who see the promise of biotechnology products, but there are those who are concerned,” he continued. “Those two sides need to be balanced as we move forward in thinking about risk assessment and regulation.”

He also noted that making sure to maintain innovation while also protecting both human health and environment are protected is important.

“A balanced approach that considers all these points of view will be necessary in making regulatory decisions regarding biotechnology,” Murray commented.

He added, “A second theme that came up over and over was the potential profusion of biotechnology products and the rapid scale, scope, complexity and tempo that is happening. That has the potential to overwhelm the U.S. regulatory system.”

The increase in production will create challenges for regulators, and risk analysis processes must be rigorous, predictable and transparent in such a way that mirrors biotechnology development.

Future development

Many products are likely to come in the next five to 10 years, Murray said, and it’s likely they will fall along a spectrum that provides a variety of levels of risk, complexity and innovation.

As products grow in complexity and novelty, it is important to look at all the possible interactions that might happen within an ecosystem and to analyze and understand those through risk assessments that are likely to be both challenging and complex, he described.

“Our likelihood of predicting the advances in biotechnology is low,” Murray said. “We have to know what properties in general we will see.”

Murray and the committee also looked at the current regulatory framework, noting that the process offers flexibility to cover a wide range of products, but the jurisdiction of the agencies involved may leave gaps.

“The conclusion that we had was the regulatory system is quite complex and fragmented, and that complexity may cause uncertainty and lack of predictability,” he commented. “It could also have the potential for a lack of public confidence.”

The committee recommended perhaps persuing a system with a single point of entry for biotechnology products into a regulatory structure.

“One of the conclusions we reached in this study is that, to enable effective regulation, it might be beneficial to have a single point of entry into the regulatory system,” Murray said.

Recommendations

The committee made two recommendations, noting that agencies involved in regulation of biotechnology products – including the Environmental Protection Agency, Food and Drug Administration, USDA and others – should increase their scientific capabilities and expertise to address biotechnology advancements in natural, regulatory and social sciences.

“In an area that expects growth, we need to advance scientific tools, capabilities and expertise in the natural, regulatory and social sciences,” Murray explained.

“The second recommendation is that the agencies should increase their use of pilot projects and prototypes,” he added. “The agencies are going to need to keep up, and we think this is one way to do it.”

Finally, the committee recommended that research-funding organizations should continue to fund biotechnology developments.

“We have a number of more detailed recommendations in our report,” Murray said, “and we hope that people take the chance to look at those to look at the future of biotechnology.”

Saige Albert is managing editor of the Wyoming Livestock Roundup and can be reached at saige@wylr.net.