b"StimulatingInnovationHOW THE U.S. IS REVISING ITS BIOTECH REGULATIONS. BY: MARCEL BRUINSWHY IT MATTERS I ts been quite a while since the U.S. first draftedforIn combination, the 2016 National Strategy its Coordinated Framework that articulatesModernizing the Regulatory System for Products ofhow the products of biotechnology are reg- Biotechnology Products (Strategy) and subse-biotechnologyulated in the United States. More than 30 yearsquent June 2019 Executive Order on Modernizing in the U.S. arehave passed since the three federal agencies thatthe Regulatory Framework for Agricultural regulated by threedeal with agricultural products of biotechnologyBiotechnology Products (EO) requested USDA different federal USDA APHIS, EPA and the FDAsat togetherAPHIS, EPA, and FDA to examine and revise rel-agencies: APHIS,and decided what they thought was the best wayevant agricultural biotechnology regulations and EPA and FDA. Theto protect public health and the environment.guidance to ensure that they are risk proportionate, original regulatoryBut a lot has changed on the technical side, so itavoid arbitrary or unjustifiable distinctions across framework stemswas time for revisions. We sat down with Fan-Lilike products developed through different tech-from 1986 and APHISChou, Biotechnology Coordinator advising thenologies, ensure public confidence, and promote regulation is currentlySecretary's Office at USDA for her take on thefuture innovation. Each agency is currently work-under revision. Timebackground of the revision of the USDA regula- ing through implementing the directives of the EO. for European Seed tions, and an outlook on some of the proposals. to get an inside look at the proposal. EUROPEAN SEED (ES): IN A NUTSHELL, HOW DOES THE U.S. REGULATE BIOTECH? We need all the tools FAN-LI CHOU (FLC):Since 1986, three fed- available in the plant eral agencies, the United States Department of Agricultures Animal and Plant Inspection Servicebreeders toolbox to meet (USDA APHIS), the U.S. Environmental Protectionthe challenges of global Agency (EPA), and the U.S. Food and Drug Administration (FDA), have provided oversight offood security; sustainable products of biotechnology under the Coordinated Framework for Regulation of Biotechnology. Theand resilient agriculture.Coordinated Framework is based upon existing laws designed to protect public health and the environment. The three agencies wrote regula-tions, policies, and guidance to apply the applica-ble laws to particular products of biotechnology,For USDA APHIS, we published a proposed to ensure that they are safe for use on farms, saferule on June 5, 2019, titled Movement of Certain to consume as food or feed, and safe for the envi- Genetically Engineered Organisms. The proposed ronment. rule is intended to revise the regulation to enable USDA APHIS to focus its regulation on those bio-ES: WHY WAS IT NECESSARY TOtech organisms that are likely to pose plant pest MODERNIZE THESE CURRENTrisks in a manner that balances oversight and risk, REGULATIONS? is based on the best available science, and aligns FLC:Originally drafted in 1986, the Coordinatedwith the EO, which calls for, among other things, Framework outlined a policy approach for a reg- regulatory streamlining in order to bring products ulatory framework to ensure health and environ- of agricultural biotechnology to the market effi-mental safety and maintain sufficient regulatoryciently, consistently and safely. flexibility to avoid impeding innovation. The Coordinated Framework anticipated that futureES: WHICH ARE THE KEY ISSUES AND scientific developments would lead to further reg- CHALLENGES YOURE FACING?ulatory refinements in response to the experienceFLC:We believe that improved international reg-gained by the industry, the scientific communityulatory compatibility is needed for agricultural and the regulatory agencies. The Coordinatedproducts of biotechnology, including products of Framework was updated in 1992, and moreprecision breeding innovations (such as genome recently in 2017. editing). Compatibility is needed both in approach 16IEUROPEAN SEEDIEUROPEAN-SEED.COM"