By CSPI Biotechnology Director Greg Jaffe
On March 9, 2017, the National Academy of Sciences (NAS) released its report titled Preparing for Future Products of Biotechnology. That study was requested in 2015 by the White House’s Office of Science and Technology Policy, the Food and Drug Administration (FDA), the US Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). The task of the study was to provide information on what biotechnology products to expect in the next five to ten years and determine whether federal regulators have the technical tools to address any risk issues that might arise from those products. The report made numerous recommendations, many of which will be dead upon arrival amid Washington, DC’s ongoing partisan debate about the federal government’s regulatory role. However, there are several recommendations that should receive bipartisan support from both Democrats and Republicans. If those recommendations are implemented, they would greatly improve the federal regulatory system for biotechnology products.
One recommendation that should garner universal support is that “to enable effective regulation, it would be beneficial to have a single point of entry into the regulatory system.” The current regulatory system for biotechnology products involves three different agencies—FDA, USDA, and EPA—and applies different statutes to different products. Some products, such as a corn plant engineered to produce a biological pesticide, require separate reviews by three agencies. Other products may require oversight from two, one, or even no agency. The current system is confusing and difficult for public and private developers to navigate. It is almost impossible to explain to our international trading partners and it does not convince many consumers that genetically engineered products are safe. Selecting one agency to receive an application, determine the scope of oversight by the different agencies, and coordinate the review process if several agencies are involved, would be more efficient and reduce redundancy.
A single-entry-point regulatory system could implement a second recommendation from the report that both Democrats and Republicans should support. The NAS report calls for a “proportionate” regulatory system, where the degree of oversight depends on the product’s complexity and novelty. For new biotechnology products that are simple and similar to existing products, federal oversight should be minimal or nonexistent. For products that are novel and/or complex, however, there should be closer scrutiny and a possible risk assessment by the federal government (at least until those products become familiar to us and are no longer novel). Such a science-based regulatory system would use scarce government resources effectively and reduce the time and cost for many products to get to market. No matter where you are on the political spectrum, we can all agree that a product developed by deleting a single DNA base pair clearly does not require the same degree of regulatory oversight as a product with 63 separate DNA changes involving multiple genes and metabolic pathway engineering.
With more biotechnology products expected in the next five to ten years than ever before, now is the time to make the necessary regulatory changes so that safe, new products can be marketed and their benefits can be realized by farmers, consumers, and the environment.
Two other recommendations from the report also should receive universal endorsement. The first is that the regulatory agencies “should increase their capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology.” An upfront investment to familiarize government regulators with new technologies and their products will prevent regulators from playing “catch up,” thereby saving time and money for taxpayers and developers. Secondly, the NAS report recommended government agencies that support scientific training should ensure that part of their funding educates scientists about applicable regulatory systems. If scientists are provided with knowledge about regulations, scientists can take those considerations into account to design safer products that need minimal or reduced regulation.
In the current anti-regulatory climate in Washington, DC, one hopes that this report will not gather dust on the shelves at FDA, EPA, and USDA. Instead, there are recommendations in everyone’s interest that should be implemented. With more biotechnology products expected in the next five to ten years than ever before, now is the time to make the necessary regulatory changes so that safe, new products can be marketed and their benefits can be realized by farmers, consumers, and the environment.