After more than 20 years since the last update, the Coordinated Framework for the Regulation of Biotechnology undergoes a formal review and update.
Last July, the White House issued a memorandum directing the Environmental Protection Agency, the Food and Drug Administration and the Department of Agriculture — the three agencies with jurisdiction over biotechnology products — to update the federal regulatory policy for ensuring the safety of biotech products. The focus of these efforts is on plants, animals and microbes but not human drugs and medical devices.
In general, the FDA regulates the use of biotechnology products as food or food additives; EPA regulates the use of biotechnology products as pesticides or plant incorporated protectants; and USDA regulates the release into the environment plants, seeds and other regulated articles altered or produced through genetic engineering that are deemed to be a plant pest.
As part of the memorandum, the three agencies have been asked to: update the Coordinated Framework for the Regulation of Biotechnology; develop a long-term strategy to ensure that the system is prepared for future biotechnology products; and commission an expert analysis of the future landscape of biotechnology products to support this effort.
“While the current regulatory system for biotechnology products effectively protects health and the environment, advances in science and technology since 1992 [when the framework was last updated] have been altering the product landscape,” writes John Holdren, director of the White House Office of Science and Technology Policy. “In addition, the complexity of the array of regulations and guidance documents developed by the three federal agencies with jurisdiction over biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.”
Industry Welcomes Review
The Biotechnology Industry Organization, commonly known as BIO, welcomed the White House memorandum. “BIO commends the White House for recognizing that coordination between the agencies that oversee the approval of biotech products … must be a priority to encourage innovation by improving transparency, timeliness and predictability of the regulatory system,” says Matt O’Mara, acting vice president of BIO’s Food and Agriculture Section.
According to BIO, the coordinated framework has come under criticism in recent years for impeding the timely approval of much-needed and long-reviewed biotech products. However, the organization reports that USDA has since implemented new processes to address the issue, and similar efforts across all three agencies would prove increasingly beneficial.
“BIO supports a regulatory system that is timely, predictable, based upon the best available science, and incorporates 20-plus years of experience with the technology,” O’Mara says. “We look forward to reviewing the proposal in more detail and working with the administration moving forward.”
Holdren says the goal of this effort is to “ensure public confidence in the regulatory system and improve transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system.”
Under the Radar GE Crops
In 2014, Alan Bennett, director of the Public Intellectual Property Resource for Agriculture at the University of California, Davis, and colleagues submitted information to the editor of Nature Biotechnology, highlighting technologies that did not require full assessment under the existing Coordinated Framework and calling for its reconsideration.
In the correspondence “Genetically engineered crops that fly under the U.S. regulatory radar,” Bennett cited that in recent years, products emerging from the technology development pipeline are increasingly falling outside the scope of USDA’s Animal and Plant Health Inspection Service regulations. The analysis highlights the incongruity of regulation that is based on process, rather than product.
The authors analyzed the 26 inquires that were made to USDA-APHIS during the past 20 years seeking a determination on regulatory status. They divided the inquiries into five categories based on the final plant product, transformation processes or the use of recently developed technologies. These categories were null segregants, classic gene delivery systems, cisgenics/intragenics, site-directed nucleases and miscellaneous. Of these 26 inquires, only four were determined to be regulated.
In their correspondence, the authors wrote: “The fact that the U.S. Coordinated Framework is on the one hand failing to oversee these new product types and on the other overregulating GE crops and technologies with proven track records of safety should be a cause for concern. … The United States remains the only country with a case history of challenges and determinations on the regulatory status of crops modified using modern technologies and genetic elements.”
The authors argue that a rational, science-based regulatory system should not regulate products based on null segregants because they contain no genetic modification.
Similarly, they say products generated by site-directed nucleases should not be regulated because they use the natural DNA repair and replication enzymes found in living organisms and result in changes that could be a result of conventional breeding.
“It is time to … build a system of oversight that is product- and science-based,” the authors wrote. “This system should have enough flexibility to evolve with accumulating scientific knowledge and new technologies, and, importantly, allow the participation of small companies and public sector institutions to fulfill the range of innovation needed to sustainably meet the next decades’ agricultural needs.”
While the end product is yet to be seen and much work has to be done, this gives industry an opportunity to educate others about the new breeding techniques being used today and expand the Coordinated Framework with input being gathered from stakeholders and the public. As part of the process to update the Coordinated Framework, three public engagement sessions have been held.
What Should You Expect from the Coordinated Framework Review?
First, the administration has asked the National Academies of Sciences, Engineering and Medicine to conduct an outside, independent analysis of the future landscape of the products of biotechnology. Due to the rapidly changing landscape, the memorandum calls for an external analysis at least every five years.
Second, after gathering public input, the administration will update the Coordinated Framework to include clearly defined roles and responsibilities of the Environmental Protection Agency, Department of Agriculture and Food and Drug Administration in the process. This update is suppose to help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
Third, to ensure that the federal regulatory system is well-equipped to assess any risks associated with the future products of biotechnology, the administration will develop a long-term strategy. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system and create user-friendly digital tools for presenting the agencies’ authorities, practices and basis for decision-making.
