August 19, 2019

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The Miraculous Mushroom: How BioTech Regulations Influence Innovation

20 years or five months? On March 8, 2019, nearly 20 years after AquaBounty Technology discovered a novel approach to increase the growth of Atlantic salmon, the U.S. Food and Drug Administration (FDA) finally “deactivated” the import alert that effectively kept AquAdvantage salmon from the U.S. market. Yet, the U.S. Department of Agriculture took only five months to decide “not” to regulate a genetically modified mushroom. How long it takes your bioengineered innovation to receive approval depends not only on what you are doing but how you are doing it. Innovators and investors who focus their resources on products and techniques that have an easier path to market, larger potential market, and less risk stand to reap the largest reward.

Bioengineering agriculture is a relatively new, and a rapidly evolving field. The first bioengineered crop—tobacco—was developed in 1982. To grapple with this emerging field of law, the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) developed the first Coordinated Framework for Regulation of Biotechnology in 1986 (“Coordinated Framework”). The Coordinated Framework describes the federal system for evaluating products developed using modern biotechnology under the web of laws they may interact with.

Generally speaking, the USDA and EPA regulate bioengineered products through the permitting and labeling process. The USDA’s Animal and Plant Health Inspection Service (APHIS) regulates, through its permitting or notification procedures, the introduction of certain bioengineered organisms. The goal for innovators is to establish that the innovation poses no more of a risk than an equivalent non-genetically-engineered organism and that the APHIS does not need to regulate their innovation. If the APHIS declines to regulate, the innovator does not need to get a permit or notify APHIS in order to market the product, and the product may be introduced into the U.S. market without any further APHIS regulatory oversight.

Currently, there are 10 bioengineered crops available in the U.S. However, new tools and technologies such as CRISPR, a powerful genome-editing technique, and techniques for rapid and inexpensive sequencing have opened the field to new innovators who are developing an ever-expanding range of products. These new innovators face significant regulatory hurdles, but the magnitude of these regulatory hurdles can depend on how the new bioengineered trait works. At first glance, this is counter to the guiding principle underlying the Coordinated Framework, which is based upon existing laws designed to protect public health and the environment.

For instance, take products that have disabled the “browning” gene. There are at least three ways to disable the “browning” trait. The first to market was the RNA interference (RNAi) technique, a biological process wherein RNA molecules inhibit gene expression or translation. In the bioengineered “Innate Potato” and “Artic Apple”, inserted DNA was utilized to disable the browning gene. Both these products underwent a lengthy review process before the USDA allowed the producer to market the product free of restrictions. The approval process for the Artic apple took years and involved a lengthy and expensive public comment period.

A second approach is to use the CRISPR technique to remove the DNA responsible for browning. On October 30, 2015, scientists from the Pennsylvania State University approached the USDA to see if it would regulate an anti-browning mushroom, developed by the group using the CRISPR technique. On April 13, 2016, the USDA confirmed that it does not consider the anti-browning mushroom “regulated.” This review took less than five months to complete.

A third way to disable the browning gene is the so-called “spray-on” RNAi technique. RNAi, in theory, can be accomplished through the application of a genetic or non-genetic compound onto or into the plant or animal. Although the “spray-on” RNAi technique shows promise, no RNAi pesticide sprays have been approved yet for use in the U.S. While the spray-on RNAi technique may face stiffer regulatory scrutiny than “gene deletion” through CRISPR, it is likely to have an easier path to approval when trying to add traits to a plant because the sprays appear to be targeted, will not persist in the environment and do not leave a significant pesticide residue.

The RNAi technique appears to be most promising when trying to add a new beneficial trait. For example, the EPA regulates crops containing both plant-incorporated protectants (PIP) as well as conventional pesticides. Both PIPs and conventional pesticides must be registered and labeled under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Both require an EPA “approved” label because EPA must approve any product claimed to have pesticidal qualities. The EPA also takes into consideration a wide range of factors, including the pesticide residue and potential spread of the crop or trait before approving a PIP or pesticide. Only a limited number of crops with PIPs have been approved thus far and the review process takes a significant amount of time and energy.

Unfortunately, there are other instances where the regulatory hurdles continue to impede progress. This is true when it comes to bioengineered livestock, where the regulatory uncertainty associated with bioengineered animals is driving many innovators to relocate or simply not invest in companies who could make raising livestock cheaper, safer, and more humane through modern genetic techniques. But, with the FDA’s recent move to allow AquAdvantage salmon into the U.S. market, there is a renewed hope for other genetically engineered animals to reach consumers. While it may be too soon to tell whether this move was a trend or an aberration, it underscores the need to monitor how the regulatory framework, and the regulators themselves, are changing over time.

In conclusion, understanding the regulatory framework early in the process and using it to inform the decision process will help everyone—from innovators to investors—to maximize their investment in the emerging world of biotechnology.

© Polsinelli PC, Polsinelli LLP in California

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Bill develops creative and practical solutions to help companies identify and manage risks, regulatory burdens, and potential liabilities throughout strategic planning and litigation.  
 
Bill’s practice focuses on two areas.  
 
First, he represents companies who may assume liability due to the potential use, sale, release, or disposal of potentially dangerous material or products in mass tort cases, class actions, environmental litigation, accident investigations, and for related insurance coverage issues.   
 
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