Regulatory Agencies Need Better Preparation for Next-Generation Biotechnologies

A profusion of biotechnology products is expected over the next five to 10 years, and the number and diversity of new products has the potential to overwhelm the U.S. regulatory system, says a new report from the National Academies of Sciences, Engineering, and Medicine.

Some future biotechnology products are likely to use genome-editing techniques such as CRISPR for familiar applications, such as modifying agricultural crops. Other future products are expected to be entirely new — plants that can serve as sentinels of environmental contamination, for example, 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 are likely to be more common.  With few exceptions, products such as these have not yet been evaluated by the current regulatory system.

Regulators will face difficult challenges as they grapple with a broad array of new types of biotechnology products—for example, cosmetics, toys, pets, and office supplies—that go beyond contained industrial uses and traditional environmental release (e.g., Bt or herbicide-resistant crops).

Current staffing levels, expertise, and resources available at the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) and other agencies may not be sufficient to address the expected scope and scale of future biotechnology products, the report says.

It is critical that the agencies involved in regulation develop and maintain scientific capabilities, tools, and expertise in key evolving areas. Examples of such areas include 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 biotechnologies.

To respond to the expected increase and diversity of products, the agencies should develop risk-analysis approaches tailored to the familiarity of products and the complexity of their uses, the report says. For biotechnology products that are similar to products already in use, established risk-analysis methods can be applied or modified, and a more expedited process could be used. For products that have less-familiar characteristics or more complex risk pathways, 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.

EPA, FDA, and USDA should identify products that could serve as pilot projects to develop new approaches to assess risks and benefits and to inform regulatory decisions, the report says.  Pilot projects could also 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. The current collection of statutes and regulations that provide the basis for agencies’ oversight, known as the Coordinated Framework for Regulation of Biotechnology, appears to have considerable flexibility to cover a wide range of biotechnology products, but in some cases the agencies’ jurisdiction has been defined in ways that could leave gaps or overlaps in regulatory oversight.  At times, FDA, EPA, and USDA may need to make use of the flexibility under their statutes to minimize gaps in jurisdiction.

There are also potential regulatory gaps and redundancies. For example, it was not clear to the committee how state regulatory authorities issue national pollutant discharge elimination system permits for potential release of biotechnology products to publicly owned treatment works or to receiving bodies. To what extent would EPA coordinate activities across TSCA, the Clean Water Act, the Resource Conservation and Recovery Act, and the activities of the states (which are, in part, delegated implementation of water and solid waste laws) to minimize redundancy and maximize efficiency in any post-market monitoring? How would potential effects on the environment be monitored, regardless of who has the responsibility to do it?

This lack of clarity does not necessarily suggest that there is a risk of concern or that new risks of concern may arise with future biotechnology products; however, the extent to which any adverse effects may be expected by intentional or accidental releases to U.S. waters is not clear.

Even when statutes do allow agencies to regulate products, the current statutes may not adequately equip regulators with the tools to regulate the products effectively, the committee said. For example, the statutes may not empower regulators to require product sponsors to share in the burden of generating information about product safety, and may place the burden of proof on regulators to demonstrate that a product is unsafe before they can take action to protect the public.  This implies that adequate federal support for research will be crucial to protect consumer and occupational safety and the environment.

Biotechnology products on the horizon are likely to generate substantial public debate, the report notes. Many members of society have concerns over the safety and ethics of various biotechnologies, while others see prospects for biotechnology addressing social or environmental problems. 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.

Read the full National Academies’ report: Preparing for Future Products of Biotechnology.

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