Biotechnology Coordinated Framework update seen falling short in key areas

by Josh Sosland
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The groups seek a regulatory policy regarding the low-level presence of genetically engineered products in food, feed and seeds.

WASHINGTON — A proposed update of the Coordinated Framework for the Regulation of Biotechnology falls far short of changes needed with regard to ensuring the global marketability of bioengineered crops, according to leading U.S. grain groups.

Objections to the proposed changes are expressed in a November letter  to the Emerging Technologies Interagency Policy Coordination Committee signed by leaders of the North American Millers’ Association, the North American Export Grain Association, the National Grain and Feed Association and the Corn Refiners Association.

Because of a variety of challenges, including intermittent disruptions in global trade, the groups urge the inter-agency committee to consider the establishment of a “conditional deregulation” designation for biotechnology traits demonstrated to be safe but that have not yet received approvals in “significant U.S. export markets.”

The groups strongly support the importance of biotechnology in crop production.

“As we have expressed previously, the competence and objectivity of the science-based U.S. regulatory framework that ensures the safety of biotech-enhanced products for humans, animals and the environment is well proven,” the letter said.

Marrying this science with regulations that ensure the marketability of new grains is where federal oversight continues to fall short, the groups said.

“What is of overriding importance in our view are the serious issues related to the marketability and current lack of international regulatory coherence regarding the premarket regulatory review of crops produced through modern biotechnology, and the negative impact those factors have in facilitating access to U.S. crops,” the groups noted.

The Coordinated Framework was first issued in 1986, outlining a comprehensive federal regulatory policy for ensuring the safety of biotechnology products. The Framework was updated in 1992. Agencies responsible for the oversight of bioengineered agricultural products are the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture, the Food and Drug Administration and the Environmental Protection Agency.

Because of advances in technology that the White House said “have dramatically altered the biotechnology landscape since 1992,” the government has proposed an update to the Coordinated Framework.

In a summary of proposed changes, the White House said the revisions are intended to “clarify the current roles and responsibilities of the primary agencies involved in the regulation of biotechnology products.”

The grain groups described this narrow approach as 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,” the letter said.

The groups urged the government to explore specific issues and “gaps” that exist in the current U.S. approach and to “identify potential options for addressing them — including instances where new statutory authority may be needed.”

“We urge a redoubling of U.S. government efforts to fully engage and coordinate with competent regulatory authorities of key U.S. trading partners, and to explicitly highlight in the National Strategy the specific steps it plans to take to foster international regulatory coherence for products of modern biotechnology,” the letter said.

The National Strategy for Modernizing the Regulatory System for Biotechnology Products is a document that accompanies the updated Coordinated Framework. The National Strategy “identifies future steps to ensure the regulatory system addresses novel types of products developed through advances in science and technology appropriately,” the White House said.

A notable absence in the National Strategy is a role for the Office of the U.S. Trade Representative, the grain groups said.

“The newly updated Coordinated Framework continues to ignore the elephant in the room,” the letter said. “The U.S. regulatory system has never operated in a vacuum. And the marketability of crops matters — for U.S. producers and agribusinesses, the U.S. agricultural economy and ultimately to world food security.”

The concerns are not abstract worries about theoretical risks, the groups said.

“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 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 prior to commensurate approval by competent government authorities in significant U.S. export markets,” the letter said.

More broadly, they insist that a major global objective — the achievement of a sustainable supply of basic commodities — rests on the principle of fungibility — “that the supply of a given crop has a degree of substitutability and relatively comparable value, regardless of the geographic production area from which it originates.”

A specific concern of the groups regarding the updated Framework is failure to specially address bioengineered traits with functionally different output characteristics than conventional products, such as Enogen corn containing alpha amylase.

Such products “can affect nutritional, compositional or other end-use properties, thereby making their presence in the food or feed system inappropriate above certain threshold levels,” the groups said.

The establishment of the conditional deregulation category could be a helpful one, the letter said.

“We submit that the same ‘conditional deregulation’ approach should apply to biotech-enhanced events that have functionally different output traits whose presence in the fungible, commingled commodity system could disrupt domestic and international supply chains if they become present above specified threshold levels,” the groups said. “For biotechnology-enhanced events subject to ‘conditional deregulation,’ technology owners could be directed to implement sufficiently robust and appropriate trait-specific stewardship plans, in consultation with affected value-chain stakeholders, to protect the marketability and value of U.S. crops.

“This potential suggested approach would recognize and respect both the ‘sound-science’ requirement that solely should govern whether a biotech-enhanced event is determined to be a plant pest or noxious weed risk, while also recognizing the importance of addressing APHIS’s mission to protect the value and economic well-being of plant- and animal-based U.S. agriculture. Further, U.S.D.A.’s Agricultural Marketing Service could be looked to as a credible third-party auditor, through its ‘Process Verified Program,’ of sufficiently rigorous stewardship programs to prevent or minimize the presence of such traits in the commodity stream.”

The groups also are pressing the federal government to, through the Coordinated Framework and National Strategy, better address the challenge of achieving regulatory coherence and compatibility in the global market.

Specifically, in the letter they seek a regulatory policy regarding the low-level presence of genetically engineered products in food, feed and seeds, as well as consideration of compatibility with implicated U.S. laws.

Within the goals and objectives of the National Strategy, the groups urged an explicit recognition of marketability goals. In a goal around increasing predictability and efficiency, the groups urged the addition of the boldfaced words below:

“Identify changes to authorities, regulations, and policies that could improve agencies’ abilities to assess expeditiously the potential impacts and risks — including marketability-related risks — arising from future products of biotechnology and to ensure the transparency, predictability and efficiency of regulatory oversight for such products.”

Finally, the letter suggests in a fast-changing area like agricultural biotechnology, that waiting nearly 25 years between updates of the Coordinated Framework and the National Strategy is too long. The groups suggest a review “at least every five years, and more frequently if needed, to keep them current.”
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