Report: More Biotech Regulations Needed, and Soon

(Makunin, Pixabay)

10 March 2017. A new report from the National Academies calls for a more robust and responsive regulatory system to handle an anticipated flood of biotechnology products. The report — published yesterday by a joint committee of the U.S. National Academies of Sciences, Engineering, and Medicine — focuses on the state of federal regulatory mechanisms to address risks posed by developments in biotechnology over the next 5 to 10 years in products involving plants and animals, but excluding drugs and medical devices for humans.

The study by a group of 4 committees made up largely of academic experts, but also representatives of private enterprise and national laboratories, sought to determine the directions in biotechnology for the next 10 years, and provide a road map for agencies tasked with regulating these developments. The work was funded by U.S. Department of Agriculture, Food and Drug Administration, and Environmental Protection Agency, but the study’s conclusions are expected to apply to other agencies involved in biotechnology.

The report, “Preparing for Future Products of Biotechnology,” indicates the biotech economy is growing quickly in both size and complexity, posing new kinds of risks for regulatory agencies to understand. The committees grouped new biotech developments into categories of open-release products, contained products, and platform technologies. Open-release products refers to genetically modified organisms like those found in new crop varieties, sterile insects, or mice engineered to find land mines. Contained products are organisms used to generate other products, such as genetically-engineered algae to produce chemicals or synthetic industrial enzymes. Platform technologies are methods and processes for developing biotech products, either wet-lab technologies like cloning kits, or dry-lab computerized tools, such as software. In some cases, platform technologies can combine wet- and dry-lab processes, such as organs-on-chips.

The committees concluded that the rate of change in biotechnology is accelerating at rate that threatens to leave current regulatory mechanisms behind. Not only is the quantity of new biotech discoveries increasing, the reach of these discoveries is extending into new types of organisms and biological processes, and in some cases, in disruptive ways. If agencies charged with regulating biotechnology expect to support innovation, protect public health, and reduce threats to the environment, says the report, they will need to gain the resources and expand their capabilities well beyond their current states.

The report cites as examples of new risks in biotechnology such as do-it-yourself bioengineering kits and genetically-modified organisms marketed directly to consumers. Tools for detecting and analyzing these risks may not yet be in place, nor in some cases are legal authorities clearly indicated. A new consumer biotech product, for example, may fall outside the jurisdiction of USDA, FDA, or EPA, and may need to be addressed by the Consumer Product Safety Commission.

At the same time, regulatory agencies still need to promote and not stifle innovation in biotechnology. Mechanisms for risk analysis need to be clear and straightforward for industry and make sense to consumers, if agencies expect to continue to have the confidence of their stakeholders.

The committees recommend increasing the qualitative capabilities of regulatory agencies to match the increasing speed and complexity of biotech developments, including new tools and expertise in the natural and social sciences, as well as regulatory processes. The report calls for the USDA, FDA, and EPA to conduct more pilot tests of ecological risk assessments to better understand novel and unfamiliar developments, and to prototype new approaches for assessing their risks.

In addition, the report calls on other government bodies that fund research in biotechnology to also increase their investments in regulatory research, as well as education for scientists and the public in biotechnology. The report specifically names National Science Foundation, Department of Defense, Department of Energy, and National Institute of Standards and Technology to take on these tasks.

“The rate at which biotechnology products are introduced – and the types of products — are expected to significantly increase in the next 5 to 10 years,” says joint committee chair Richard Murray,  a bioengineering professor at California Institute of Technology in a National Academies statement, “and federal agencies need to prepare for this growth. We hope this report will support agency efforts to effectively evaluate these future products in ways that ensure public safety, protect the environment, build public confidence, and support innovation.”

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