Regulatory Landscape Brightens For Ag Biotechs

Last month, President Trump signed an Executive Order to streamline the complex maze of rules and policies that regulate agricultural biotech products. For those who lament the lack of bipartisanship in Washington, it may provide some comfort to note that the order itself references the importance of the Obama Administration’s national biotech strategy in clarifying federal regulatory roles and responsibilities. To be sure, that reference underscores the history of this issue, which dates back decades, spanning the Clinton and both Bush administrations. 

This most recent move was hailed by farmers, agtech companies and the financial world as an important step in the right direction, but what, really, will this new order accomplish? First, it is important to consider that the executive order establishes an internal process among the federal agencies within the Executive Branch. Unfortunately, or fortunately, depending on one’s point of view, it does not come with congressionally appropriated funding to put new processes in place.

"Unfortunately, executive orders often don't come with any funds attached," said Mark Trostle, vice president of global regulatory affairs for Concentric Ag Corporation, who has logged more than 47 years working with federal, state and international crop input regulators. (Full disclosure: I am the CEO of Concentric Ag Corporation.) "I think that will be the challenge for ag biotech companies. The other challenge I see is that we have three separate agencies headed by two different directors and one cabinet-level secretary. All have to answer back to Congress and to the Office of Budget and Finance."

What this Executive Order does provide is a much-needed coordinating framework for the three key agencies involved in regulating biotechnology to review their own regulations, as well as a way to work on crosscutting issues with each other. Those agencies are the U.S. Department of Agriculture, the U.S. Environmental Protection Agency and the Food and Drug Administration. This action is a nudge to break down some of the bureaucratic silos that can build up around regulatory jurisdictions, as well as reconcile the fact that the fast-paced evolution of the industry itself has in many ways outstripped its regulatory oversight.

The order also addresses the global regulatory situation. Significantly, it lays out a process for those three agencies to work with the United States Trade Representative, our chief trade negotiating agency, to develop a strategy “to remove unjustified trade barriers and expand markets for products of agricultural biotechnology.” 

The trade aspect is an important part of this new approach to regulation, according to Andy LaVigne, President and CEO of the American Seed Trade Association (ASTA), which devotes considerable resources to regulatory matters on behalf of the 700 seed producers, distributors and scientists that comprise its membership. Agriculture is a global industry, and there are biotech-related trade difficulties that are long overdue to be resolved. 

“A lot of various issues probably should have been handled under the WTO (World Trade Organization) mantle years ago as things evolved, and they've just been pushed off to the side," said LaVigne. “Our (trade) partners need to come back around the table to rework their nontransparent, non-science-based regulatory barriers.”

A global trading system built on science-based regulations is critical to promoting future innovation and competitiveness for the U.S. biotech industry, especially in a fast-paced and dynamic global market. This is especially true as the biotechnology regulatory frontier evolves beyond Washington. According to LaVigne, “For the first time in a long time, you've got a core group of European countries pushing the European Union to deal with the Biotech Directive so that they don't get left behind with respect to gene editing.”

LaVigne also sees another explicit objective of the executive order as crucial: Tasking the agencies to develop a “domestic engagement strategy” that builds “public confidence in, and acceptance of, the use of safe biotechnology in agriculture and the food system.” As he notes, “We can have the best policies in the world, but if the public does not accept them, we are no further along at all.”

The bottom line is this: The impact of this executive order, with its potential to increase productivity for farmers and spur innovation from large and small agricultural businesses, as well as our public research institutions, will come from its ability to successfully create a transparent, timely and science-based system that both fosters public confidence and avoids undue regulatory burdens.

Source: Forbes.com

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