By Bobby Frederick, Director of Legislative Affairs and Public Policy
The National Grain and Feed Association (NGFA) noted in comments submitted Nov. 1 that the White House’s latest proposal to update the government’s regulation of biotech products fails to adequately consider and address marketability- and trade-disruption issues posed by the commercialization of biotech-enhanced crops in the United States resulting from the lack of international coherence on how to provide pre-market regulatory review of such traits.
The NGFA submitted comments on the proposal from the White House Office of Science and Technology Policy to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). Joining the NGFA in submitting the statement were the Corn Refiners Association, National Oilseed Processors Association, North American Export Grain Association, and North American Millers’ Association.
The group’s comments centered around the importance of marketability and the current absence of international regulatory coherence when it comes to the premarket regulatory review of crops produced through biotechnology. Regrettably, the proposed update to the Coordinated Framework was essentially silent on vital marketability issues, and instead focused on merely clarifying the roles of the Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) in the regulation of biotechnology.
“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 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 U.S. export customers; 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.”
While acknowledging that a second document released by OSTP – the National Strategy for Modernizing the Regulatory System for Biotechnology Products (National Strategy) – did reference the importance of EPA, FDA and USDA “continu(ing) to provide leadership in international fora to promote…regulatory compatibility worldwide for biotechnology products,” the groups urged the U.S. government to redouble its efforts to engage and coordinate with competent regulatory authorities of our key trading partners.
The groups also noted that the updated Coordinated Framework document failed to address appropriate U.S. government oversight of biotech-enhanced traits that have functionally different output characteristics than their conventional counterparts – one example being Enogen® corn containing alpha amylase to enhance ethanol production – that can affect nutritional, compositional or 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) create 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 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.
Other recommendations made by the groups include achieving alignment with significant U.S. trading partners on science-based criteria for determining the appropriate level of pre-market regulatory review, if any, that should apply to new plant breeding innovation techniques, developing a U.S. regulatory policy for the low-level presence (LLP) of genetically engineered products, identify and propose strategies for addressing other shortcoming in the current Coordinated Framework that pertain to marketability and trade-disruption concerns, and voicing the need for two-way communication between federal agencies, value chain stakeholders and international trading partners.
To read the full comments click here.
Trivia answer for 10/19/2016 Newsletter: Candy Corn is the Halloween candy originally called “chicken feed” that featured a rooster on the candy box with the tagline “Something worth crowing for.”
Trivia winner: Craig Haugaard, vice president of grain at Sunrise Cooperative.
Election Day is next week.
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