Federal agencies join efforts for electronic home for biotech regs

The U.S. Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency Thursday launched a unified website for biotechnology regulation. The agencies timed the rollout to coincide with January 2020’s observance of National Biotechnology Month.

New forms of biotechnology allow for the modification of living organisms, such as plants or animals, in order to produce a new product, such as a novel pharmaceutical, new food variety or disease-resistant crop, according to then FDA’s Plant and Animal Biotechnology Innovation Action Plan announced in 2018.

The new joint website announced yesterday streamlines information from the three regulatory agencies charged with overseeing agricultural biotechnology products and is part of President Trump’s “Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

“Agricultural biotechnology has been and will continue to be an essential tool in helping America’s farmers and ranchers feed, fuel, and clothe the world,” said U.S. Secretary of Agriculture Sonny Perdue in the announcement.

“From producers to consumers, all Americans deserve a government that delivers science-based, common-sense regulations that foster innovation, conserve resources, and protect public health — especially when it comes to the food supply. The launch of this unified biotechnology regulation website is proof of President Trump’s commitment to providing the American people with sensible regulations in a clear and transparent manner.”

EPA Administrator Andrew Wheeler said the website would provide clarity for consumers.

“EPA is pleased to be working with our partners at USDA, FDA, and across the federal government to implement President Trump’s Executive Order and launch this new, coordinated website,” Wheeler said in the announcement. “This new website will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and breakdown barriers for these biotechnology products in the marketplace.”

The FDA commissioner touted the agency’s commitment to science-based standards.

“This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace,” said FDA Commissioner Stephen Hahn. “At the FDA, we are committed to fostering flexible, risk-based approaches in this field while upholding our mission of protecting and promoting both human and animal health and animal well-being, for example by reducing their susceptibility to diseases like novel influenzas and resistance to zoonotic or foreign animal diseases. Our approach balances our internationally respected, science-based review standards with our ongoing risk-based regulatory approaches to ensure the safety of our food supply.”

Background
The unified website for biotechnology regulation describes the federal review process for certain biotechnology products and allows users to submit questions to the three agencies. The goals of the website, as stated in the announcement, are to provide enhanced customer service to innovators and developers while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology innovations.

The White House Office of Science and Technology Policy (OSTP) first published the U.S. Coordinated Framework for the Regulation of Biotechnology in 1986, describing the comprehensive federal regulatory policy for ensuring the safety of biotechnology products. The framework sought to protect health and the environment without impeding innovation.

In 1992, OSTP issued an update to the framework that set forth a risk-based, scientifically sound basis for the oversight of biotechnology products introduced into the environment or used for human or animal food. The update affirmed that federal oversight should focus on the characteristics of the product and the environment into which it is being introduced, not the process by which the product is created. The most recent update was released in 2017

Each of the three federal regulatory agencies — USDA, FDA and EPA — implements its authority under existing laws, resulting in the federal regulatory system assessing and managing the health and environmental risks of biotechnology products.

Regulation under the coordinated framework
Under the framework, the three agencies aim to cover the full range of plants, animals, and microorganisms derived from biotechnology in an integrated and coordinated manner. Each agency has regulatory programs to achieve the health and environmental protection goals derived from its own statutory authorities.

The framework is based on laws governing the regulation of products and their uses. In providing oversight, the agencies employ a rational, scientific evaluation of products. Each agency has developed its own agency-specific regulations or policy documents to establish its regulatory approach to biotechnology products.

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