The latest attempt at updating the federal government’s coordinated biotechnology regulatory framework fails to adequately consider and address the importance of implementing strategies to avoid trade disruptions that result when biotech-enhanced products deregulated and approved for cultivation in the United States become present in shipments to important U.S. export markets where such traits have not yet been authorized for import.
That was the key message conveyed to the White House Office of Science and Technology Policy recently by the National Grain and Feed Association (NGFA) and four other grain-based agribusiness organizations. Joining the NGFA in submitting the statement on the Obama administration’s update to the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) were the Corn Refiners Association, National Oilseed Processors Association, North American Export Grain Association, and North American Millers’ Association.
Focus on marketability
The groups’ comments centered around the importance of marketability and the current absence of international regulatory coherence when it comes to the premarket regulatory review of grain and oilseed crops produced through agricultural biotechnology. Regrettably, the groups said, the proposed update to the Coordinated Framework essentially is silent on vital marketability-related issues, and focuses instead on merely clarifying the existing roles of the three agencies with principal premarket regulatory oversight of such biotech traits – the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA).
“By failing to address issues surrounding the marketability of U.S. crops produced through modern biotechnology, the updated Coordinated Framework continues to ignore the ‘elephant in the room,’” the grain-based groups stated. “Unfortunately, we believe this represents a significant missed opportunity. More importantly, it fails to recognize the underlying fact that nothing is gained if crops produced through modern biotechnology and other safe cropping technologies cannot be marketed. ... As our organizations have pointed out repeatedly, there are no shortages of documented cases in which access to U.S. crops has been disrupted or halted entirely – leading to significant downward pressure on U.S. farmgate prices, severe economic damage to U.S. exporters, and reduced economic value of U.S. agricultural production – as a result of commercialization of biotech-enhanced crops (in the United States) prior to commensurate approval by competent government authorities in significant U.S. export markets.”
The organizations also pointed out that the Coordinated Framework fails to address oversight of biotech-enhanced traits that have functionally different output characteristics than their conventional counterparts, such as corn containing alpha amylase to enhance ethanol production, which can affect the nutritional, compositional and other end-use properties, thereby making their presence in the food or feed system inappropriate above certain threshold levels.
New category of deregulation posed
As a way of potentially addressing these marketability-related issues, the groups promoted an idea developed by the NGFA and NAEGA that USDA’s Animal and Plant Health Inspection Service (APHIS) consider creating another category of deregulation, dubbed “conditional deregulation,” to apply to biotech-enhanced events that the agency has found do not present a plant pest or noxious weed risk, but which have not received approvals in significant U.S. export markets.
Under this concept, technology owners could be directed to implement sufficiently robust, trait-specific stewardship plans and retain responsibility to protect the value of U.S. crops until approvals are granted. The organizations said that if the U.S. government policy officials believe they lack the statutory authority to fill this and other “gaps” in their oversight of agricultural biotechnology, they should identify those within the newly updated Coordinated Framework and propose solutions.