Archives

May 16, 2024

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take,...
April 1, 2024

APHIS Seeks Comment on Draft EIS for Deregulation of Maize Developed Using Genetic Engineering

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 22, 2024, that it has prepared a draft environmental impact statement (EIS) and draft plant pest risk assessment (PPRA) evaluating the potential environmental impacts and plant pest risk that may result from the approval of a petition for nonregulated status for maize developed using genetic engineering for dicamba, glufosinate, quizalofop, and 2,4-dichlorophenoxyacetic acid...
March 29, 2024

CRS Publishes Report on Regulation of Gene-Edited Plants and Issues for Congress

The Congressional Research Service (CRS) published a report on March 22, 2024, on “Gene-Edited Plants: Regulation and Issues for Congress.” Gene-edited plants are regulated under the U.S. Coordinated Framework for Regulation of Biotechnology, which coordinates how the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) regulate biotechnology products to ensure their safety. Over time, the agencies have been...
February 28, 2024

Library of Congress Publishes Article on South Korea’s Act on Promoting the Green Bio Industry

On February 7, 2024, the Library of Congress posted an article entitled “South Korea: Act to Promote Green Bio Industry Published.” According to the article, South Korea published the Act on Promoting the Green Bio Industry (Green Bio Act) on January 2, 2024. The Green Bio Act, which will enter into force on January 3, 2025, “aims to promote the application of biotechnology to agricultural bioresources and increase the added value of agriculture, develop the...
January 16, 2024

Law Library of Congress Publishes Report on Selected Issues in Biotechnology Regulation

The Law Library of Congress published a November 2023 report entitled Selected Issues in Biotechnology Regulation: Australia, Belgium, Brazil, Canada, China, England, European Union, Germany, India, Japan, Mexico, New Zealand, Singapore, South Africa, South Korea, Taiwan that provides an overview of the main statutes and policies governing selected issues on the development of biotechnology products, particularly those derived from genetically modified organisms (GMO) and genetic engineering....
November 14, 2023

USDA, EPA, and FDA Post Report on Stakeholder Comments on Coordinated Framework for the Regulation of Biotechnology and Plain-Language Regulatory Information

On November 13, 2023, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) posted the following documents on the Unified Website for Biotechnology Regulation: As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative to accelerate biotechnology innovation and grow America’s...
October 11, 2023

EC Recommends Carrying Out Risk Assessment on Biotechnologies

The European Commission (EC) announced on October 3, 2023, that it adopted a Recommendation on critical technology areas for the European Union’s (EU) economic security, for further risk assessment with EU member states. According to the EC, the Recommendation relates to the assessment of technology risk and technology leakage. The EC states that the risk assessment “will be objective in character, and neither its results nor any follow-up measures can be anticipated at this stage.”...
July 5, 2023

OECD Working Party on the Harmonization of Regulatory Oversight in Biotechnology Met in April 2023

By Lynn L. Bergeson and Carla N. Hutton   The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of...
July 3, 2023

OSTP Announces New Action Plan to Bolster, Expand, and Diversify the Biotechnology and Biomanufactur

By Lynn L. Bergeson and Carla N. Hutton   On June 27, 2023, the Office of Science and Technology Policy (OSTP) announced the release of a new action plan intended to “rapidly and equitably expand biotechnology and biomanufacturing education and job training programs in the United States.” According to OSTP, biomanufacturing “is a critical aspect of advanced manufacturing that can drive new, sustainable alternatives across industries” and “can unlock new...
June 6, 2023

EPA Issues Final Rule to Accelerate Use of Plant-Incorporated Biotechnologies

By Lisa R. Burchi, James V. Aidala, and Heather F. Collins, M.S. On May 31, 2023, the U.S. Environmental Protection Agency (EPA) released a final rule exempting a class of plant-incorporated protectants (PIP) created using genetic engineering, from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. PIPs are pesticidal...