Groups concerned that trade disruptions may occur when U.S. approved biotech products are exported to markets where the traits have not yet been approved.
In 1986, the White House Office of Science and Technology Policy issued the Coordinated Framework for the Regulation of Biotechnology, which outlined a comprehensive Federal regulatory policy for ensuring the safety of biotechnology products. The Framework was updated in 1992. Advances in science and technology have dramatically altered the biotechnology landscape since 1992. Due to the complexity of the array of regulations and guidance documents developed by the three primary U.S. federal agencies with jurisdiction over biotechnology products — the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) — an update to the Coordinated Framework was proposed by the U.S. government.
A unified statement was made against the update by the National Grain and Feed Association (NGFA), the Corn Refiners Association, the National Oilseed Processors Association, the North American Export Grain Association (NAEGA), and the North American Millers’ Association (NAMA). It 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. 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 by the EPA, the FDA and the 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 said 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 may affect the nutritional, compositional and other end-use properties, thereby making their presence in the food or feed system inappropriate above certain threshold levels.
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 may 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.
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