b"STIMULATING INNOVATIONHow the United States is revising its biotech regulations. Marcel Bruins mbruins@issuesink.comITS BEEN QUITEa while since the United States firstbiotech organisms that are likely to pose plant pest risks in a drafted its Coordinated Framework that articulates how themanner that balances oversight and risk, is based on the best products of biotechnology are regulated in the United States.available science, and aligns with the EO, which calls for, among More than 30 years have passed since the three federal agen- other things, regulatory streamlining in order to bring products cies that deal with agricultural products of biotechnologyU.S.of agricultural biotechnology to the market efficiently, consist-Department of Agriculture Animal and Plant Health Inspectionently and safely. Service (USDA APHIS), U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA)satES: Which are the key issues and challenges youre together and decided what they thought was the best way tofacing?protect public health and the environment. Our sister publica- FLC: We believe that improved international regulatory com-tion European Seed sat down with Fan-Li Chou, Biotechnologypatibility is needed for agricultural products of biotechnology, Coordinator advising the Secretary's Office at USDA for her takeincluding products of precision breeding innovations (such as on the background of the revision of the USDA regulations, andgenome editing). Compatibility is needed both in approach an outlook on some of the proposals. and timing of decisions to avoid trade disruption and to foster agricultural innovation. We encourage countries to implement European Seed (ES): Why was it necessary to modernizepolicies that are risk-proportionate, that encourage scientific these current regulations? innovation without creating unnecessary barriers or unjustifiably Fan-Li Chou (FLC): Originally drafted in 1986, the Coordinatedstigmatizing products of new technologies.Framework outlined a policy approach for a regulatory frame- In November 2018, the United States joined with 12 other work to ensure health and environmental safety and maintainnations to support the International Statement on Agricultural sufficient regulatory flexibility to avoid impeding innovation.Applications of Precision Biotechnology which was intro-The Coordinated Framework anticipated that future scientificduced by Argentina at the World Trade Organization (WTO) developments would lead to further regulatory refinements inCommittee on the Application of Sanitary and Phytosanitary response to the experience gained by the industry, the scien- Measures. We need all the tools available in the toolbox to meet tific community and the regulatory agencies. The Coordinatedthe challenges of global food security; sustainable and resilient Framework was updated in 1992, and more recently in 2017. agriculture. Science-based advances in biotechnology have In combination, the 2016 National Strategy for Modernizinggreat promise to enhance rural prosperity and improve the qual-the Regulatory System for Biotechnology Products (Strategy)ity of life across America and around the globe.and subsequent June 2019 Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology ProductsES: How does the USDA go about ensuring sufficient (EO) requested USDA APHIS, EPA, and FDA to examine andstakeholder input?revise relevant agricultural biotechnology regulations and guid- FLC: In advance of drafting and publishing the proposed rule, ance to ensure that they are risk proportionate, avoid arbitrary orUSDA APHIS met with more than 80 organizations to seek their unjustifiable distinctions across like products developed throughviews and input. USDA APHIS also sought input from the public different technologies, ensure public confidence, and promoteby conducting three public hearings across the United States future innovation. Each agency is currently working throughand by publishing a Notice of Intent for public comment. Finally, implementing the directives of the EO.the proposed rule was open for public comment for 60 days. For USDA APHIS, we published a proposed rule on JuneInternationally, USDA shared rationales, experience and infor-5, 2019, titled Movement of Certain Genetically Engineeredmation for potential regulatory changes with U.S. trading partners, Organisms. The proposed rule is intended to revise the regu- like-minded countries and other countries, to garner understand-lation to enable USDA APHIS to focus its regulation on thoseing and support for the proposed updated approach. The WTO 116/ SEEDWORLD.COMDECEMBER 2019"