By Randy Gordon, President
A new study finds that the profusion and diversity of new biotechnology products expected to be introduced during the next five to 10 years could “overwhelm” the U.S. regulatory system.
The 177-page report, issued March 9 by the National Academies of Sciences, Engineering and Medicine (NAS), found that the U.S. Environmental Protection Agency, Food and Drug Administration, U.S. Department of Agriculture and other agencies involved in regulating biotechnology products should increase their scientific capabilities, tools and expertise in key areas of expected growth in biotechnology.
The report states that the “profusion” of new biotech products “will in many cases be very different in terms of their type, scope and complexity, and the number of actors who will be able to contribute to biotechnology will be even more diverse as engineering biology becomes accessible to a broader range of actors.”
The report cites cosmetics, toys, pets and office supplies as among the “broad array” of new types of biotechnology products that may emerge.
“The safe use of new biotechnology products requires rigorous, predictable and transparent risk-analysis processes whose comprehensiveness, depth and throughput mirror the scope, scale, complexity and temp of future biotechnology applications,” the report states.
The U.S. biotechnology economy is growing rapidly, the report states, with the scale, scope, and complexity of products increasing. More types of organisms likely will be bioengineered, the report notes, and the kinds of traits introduced with biotechnology also will increase. Some future biotechnology products likely will use genome-editing techniques, such as CRISPR, for familiar applications, such as modifying agricultural crops. The report says other future products are expected to be entirely new – citing as examples plants that can serve as sentinels of environmental contamination and collections of microorganisms that can produce chemical compounds efficiently. Engineered microbes, plants and insects designed to live in the environment with little or no human management also likely will become more common. With few exceptions, products such as these have not yet been evaluated under the current U.S. government regulatory system, the report warns.
Current staffing levels, expertise, and resources available at EPA, FDA, USDA and other federal agencies may not be sufficient to address the expected scope and scale of future biotechnology products, the report says. It notes that it will be critical that the agencies involved in biotech regulation develop and maintain scientific capabilities, tools and expertise in key evolving areas. It cites such examples as understanding relationships between intended genetic changes and an organism’s observable traits, the unintended effects of genetic changes on target and non-target organisms, predicting and monitoring ecosystem responses, and quantifying the economic and social costs and benefits of various biotechnologies.
To respond to the expected increase and diversity of products, the NAS report urges federal agencies to develop risk-analysis approaches tailored to the familiarity of products and the complexity of their uses. For biotechnology products that are similar to products already in use, the report states, established risk-analysis methods can be applied or modified and a more expedited review process used. For products that have less-familiar characteristics or more complex risk pathways, the report states, new risk-analysis methods may need to be developed. Regulatory agencies should “build their capacity” to rapidly determine the type of risk-analysis approaches most appropriate for new products entering the regulatory system, the report says.
The NAS study recommends that EPA, FDA and USDA identify products that could serve as pilot projects to develop new approaches to assess risks and benefits, and to inform regulatory decisions. It advises that such pilot projects also could be used by the agencies to evaluate future products as they move from laboratory scale, to field- or prototype-scale, to full-scale operation.
One challenge regulators will face is finding jurisdiction under existing statutes to regulate the diverse range of anticipated biotech products, the report says. Even when statutes do allow agencies to regulate products, the current laws may not equip regulators adequately with the tools to regulate the products effectively, the report says. For example, existing laws may not empower regulators to require product sponsors to share in the burden of generating information about product safety, thereby placing the burden of proof on regulators to demonstrate that a product is unsafe before they can take action. This finding, the report says, implies that adequate federal support for research will be crucial to protect consumer and occupational safety, as well as the environment.
The U.S. regulatory system will need to achieve a balance among competing interests, risks, and benefits when considering how to manage development and use of new biotech products, the report notes. In addition, it says more research may be needed to develop methods for governance systems that integrate ethical, cultural, and social implications into risk assessments in meaningful ways. The report states this may not be feasible nor justified for all new biotechnology products – such as those with which there is already familiarity or products that will not be released into the environment.
The report concludes that the federal government should develop a strategy that “scans the horizon for new biotechnology products, identifying and prioritizing those products that are less familiar or that present a need for more complex risk analysis.” The federal government also should work to establish appropriate federal funding levels for sustained, multiyear research to develop the necessary advances in regulatory science.