Revisions to Biotech Regulations
In 1986, the federal government instituted a risk-based regulatory system [policy announcement] to ensure that new agricultural biotechnology products are safe for the environment and human and animal health. The U.S. Government agencies responsible for the oversight of these products are USDA’s Animal and Plant Health Inspection Service [APHIS], the U.S. Environmental Protection Agency [EPA], and the Department of Health and Human Services’ Food and Drug Administration [FDA]. Click here for a summary explaining how the federal government regulates biotech plants.
Within USDA, APHIS is responsible for protecting agriculture production from pests and diseases. Under the auspices of the Plant Protection Act, it has regulatory oversight over products of modern biotechnology that could pose a risk. APHIS documents pertaining to this issue can be found here.
In May 2024, the USDA, EPA, and FDA issued a plan titled “The Coordinated Framework for Regulation of Biotechnology” to modernize the federal government’s regulatory system for the products of biotechnology. Important points contained in this plan that relate to plant agriculture follow.
• The above three government agencies have been directed to identify any regulatory ambiguities, gaps. or uncertainties in the framework document.
• The revised document is to provide plain-language information on the roles of each agency.
• The revised document is to provide a plan with processes and timelines to implement regulatory reform(s) where needed.
• The three agencies are issuing the above plan to implement regulatory reform that will include identifying regulations and other documents that can be updated and/or streamlined and/or clarified, and provide guidance on developing new regulations when and where needed.
• The regulatory plan will focus on the areas of biotechnology regulation for modified plants and microbes that affect crop agriculture.
• USDA will streamline its permitting process for new biotech innovations, and update its user guides for current innovations.
• USDA will clarify its exemption of modified plants containing plant-incorporated protectants [PIPs].
• The three agencies involved in the biotech regulatory process will work toward greater policy alignment that should reduce uncertainties and unnecessary redundancies for developers of biotech innovations.
According to information in the May 9, 2024 edition of eBean News from the American Soybean Association [ASA], highlights of the plan that can affect soybean production follow.
• The regulatory plan includes proposed changes for plant gene editing and genetically engineered microbes, which likely will affect the development of microbial seed treatments.
• USDA will be considering advancing a proposal for additional risk- and science-based exemptions from the department’s scope of regulation.
• EPA will identify ways to improve the process of approving PIPs that fall under their scope of regulation. This should clarify just which gene edited PIPs should be regulated since some have been indistinguishable from conventionally-bred PIPs in the past.
• The goal of ASA as a commodity group is to engage with the respective regulatory agencies to advance portions of the plan that will allow soybean farmers to have better access to forthcoming genetic innovations.
Of course, the ultimate goal of this plan is to protect the environment and consumer from any potential unintended negative consequences emanating from bioengineered crop plants and pesticides used on them. It is hoped that the implementation of this plan’s components will also consider that the U.S. soybean farmer is increasingly dependent on genetically engineered/biotech innovations to remain competitive in the world soybean market, and to produce the increased yields of a quality product that will be needed to ensure world food security.
And finally, it is imperative that government regulators recognize the importance of biotech innovations that will allow U.S. crop producers to continue to produce more of the quality products that will be needed to feed an increasing world population. Thus, the approval of worthwhile biotech innovations must be fast-forwarded so that producers can utilize forthcoming new products and developments as quickly as possible to improve their production capability.
Composed by Larry G. Heatherly, July 2024, larryh91746@gmail.com