This article is taken from the National Grain and Feed Association's Feb. 10 newsletter.

Government agencies need to prioritize transparency in the commercialization of products produced through genetic engineering, noted NGFA in comments submitted to the White House Office of Science and Technology Policy (OSTP) on Feb. 3.

NGFA and seven other agriculture groups submitted comments in response to the OSTP’s request for information on the Coordinated Framework for Biotechnology Approval, which outlines regulatory policy for ensuring the safety of biotechnology products.

The Framework, last updated in 2017, clarifies the roles and responsibilities of the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA) and Food and Drug Administration (FDA).

The current system mandatorily protects plant health and the environment, but not human health.

“There is still an uncertainty on agency jurisdictions, lack of predictability on timeframe for approval and lack of transparency,” NGFA noted.

“Specifically, OSTP must carefully consider how to best protect those that use gene-edited products without adding unnecessary regulatory burdens and costs that would undermine the U.S. food chain resiliency and security and the industry’s ability to provide an abundant and affordable food supply to U.S. and world consumers.”

For example, the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule finalized in 2020 provides exemptions to regulatory review for products genetically engineered via gene editing.

This hinders transparency over what is being introduced into the marketplace for consumers, grain handlers, food manufacturers and retailers, NGFA noted.

NGFA’s full comments urged OSTP to consider the following “critical and necessary” changes and improvements to the Coordinated Framework:

1) Mandatory Notification and Transparency: FDA should require companies that are commercializing new biotechnology products to notify the FDA, NGFA stated, and this information should be made public.

“This is particularly important for commodity crops where there is known commingling in the supply chain,” the comments stated. (Under the current provisions of the SECURE Rule, the public is not mandatorily required to be notified by the FDA, EPA or USDA if any gene-editing company has formally submitted an application for a new product, even if it contains a food safety risk such as an allergen).

2) Reorganization of the FDA: FDA announced on Jan. 31 a proposal to unify its human foods program by combining the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and the relevant functions of the Office of Regulatory Affairs.

“A single leader who is empowered and accountable for the success of the foods program is central to its success,” NGFA concurred while encouraging OSTP to monitor how FDA’s restructuring may impact the agency’s food safety focus.

3) Additional Agency Involvement in the Coordinated Framework: The comments recommended adding a notification process to include the Agricultural Marketing Service, the Foreign Agricultural Service and/or the Office of the U.S. Trade Representative to enhance the marketability of new technologies.

“Each agency has an important role in maintaining access to domestic and foreign markets,” NGFA noted.

4) Outreach and Communication: NGFA encouraged federal agencies to develop and publish “clear and simple guidance” on the scope of biotechnology regulations and requirements.

“The details of the regulatory processes covered by the Coordinated Framework at FDA should be shared more broadly with stakeholders in the food and agriculture value chain to provide confidence in the processes as well as allow for clear communication around expectations for completing the processes.”

5) Periodic Review of the Coordinated Framework: The government should review the Coordinated Framework at least every five years, the comments noted.

Other groups that signed the comments include the American Frozen Food Institute, Corn Refiners Association, Institute of Shortening and Edible Oils, National Grocers Association, National Oilseed Processors Association, North American Export Grain Association, and North American Millers’ Association.


OSTP published the Request for Information; Identifying, Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology in the Dec. 20, 2022 issue of the Federal Register.