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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 green bio industry, and realize...

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....

Download transcript. Download “Considerations for the Environmental Risk Assessment of the Application of Sprayed or Externally Applied dsRNA-Based Pesticides." This week, listeners are in for a real treat as I sit down with Dr. Meibao Zhuang, Senior Scientist/Regulatory Consultant with B&C and our consulting affiliate, The Acta Group, to discuss double-stranded ribonucleic acid interference, better known as ds RNAi. Ds RNAi is a technology that allows scientists to silence (or interfere...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) “advis[ed] the public” on December 1, 2023, of its determination that DP23211 maize (corn) that has been developed using genetic engineering for insect resistance to western corn rootworm and contains the gene that codes for the phosphinothricin acetyltransferase protein responsible for tolerance to glufosinate-ammonium herbicides, as well as the gene that encodes for the phosphomannose isomerase...

The U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on November 29, 2023, updating the National Bioengineered Food Disclosure Standard’s (the Standard) List of Bioengineered (BE) Foods (the List) by adding “sugarcane (Bt insect-resistant varieties)” and amending “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).” 88 Fed. Reg. 83305. AMS states that in updating the List, “this final rule...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) proposed on November 15, 2023, five new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering because such modifications could otherwise be achieved through conventional breeding methods. 88 Fed. Reg. 78285. According to APHIS’s November 14, 2023, press release, the proposed exemptions...

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: Report on Stakeholder Outreach Related to Ambiguities, Gaps, Uncertainties in Regulation of Biotechnology Under the Coordinated Framework (Report on Stakeholder Outreach) (Mar. 11, 2023); and The Coordinated Framework for the Regulation of Biotechnology:...

On October 23, 2023, the Biden Administration announced the designation of 31 communities across the United States as Regional Innovation and Technology Hubs (Tech Hubs) through the U.S. Department of Commerce Economic Development Administration. According to the fact sheet, the Tech Hubs focus on developing and growing innovative industries in regions across the country, bringing together private industry, state and local governments, institutions of higher education, labor unions, Tribal...

On October 13, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of a revised draft of the Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering under 7 CFR Part 340 and a Response to Comments on the first draft of the Guide, published on March 23, 2023. APHIS’s Biotechnology Regulatory Services (BRS) received comments on a range of issues and grouped the comments and its...

On September 7, 2023, the Congressional Research Service (CRS) published a report entitled Gene-Edited Plants: Regulation and Issues for Congress. The report notes that the U.S. regulation and oversight of gene editing in plants is facilitated by the Coordinated Framework for Regulation of Biotechnology, which involves the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA). Established in 1986 by the White House...

On September 19, 2023, the Congressional Research Service (CRS) published a report providing an overview of cell-cultivated meat. The report provides an overview of the science of cell-cultivated meat, the industry, the regulatory framework for cell-cultivated meat products, congressional interests, and potential policy considerations. CRS states that cell-cultivated meat is developed in a lab, grown from a sample of animal cells that does not require the slaughter of animals. Developing...

The U.S. Environmental Protection Agency (EPA) announced on September 8, 2023, that it is now accepting nominations for the 2024 Green Chemistry Challenge Awards from companies or institutions that have developed a new green chemistry process or product that helps protect human health and the environment. EPA states that its “efforts to speed the adoption of this revolutionary and diverse discipline have led to significant environmental benefits, innovation, and a strengthened economy.” The...

By Lynn L. Bergeson and Carla N. Hutton   On July 27, 2023, the Organization for Economic Cooperation and Development (OECD) published a new document in its Series on Harmonization of Regulatory Oversight in Biotechnology, Safety Assessment of Transgenic Organisms in the Environment, Volume 10: OECD Consensus Document on Environmental Considerations for the Release of Transgenic Plants. The document addresses environmental risk/safety assessment at a broader level than previous consensus...

By Lynn L. Bergeson and Carla N. Hutton   On July 12, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the release of its 2022 impact report. The 2022 impact report lists the following biotechnology activities: Fully implemented USDA’s revised biotechnology regulations, which allow APHIS to focus oversight on products that may pose a risk and reduce regulatory burden for developers of organisms that are unlikely to...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on June 27, 2023, that it recently reviewed soybean, tomato, and potato plants modified using genetic engineering. APHIS reviewed the plants to determine whether they presented an increased plant pest risk compared to similar cultivated soybean, tomato, and potato plants: InnerPlant modified two soybean plants and one tomato plant to...

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...

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...

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...

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) issued a final rule that exempts 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. EPA states that the final rule includes exemptions as described in its October...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce that additional FIFRA Tutor® regulatory training courses are now available at www.FIFRAtutor.com. The one-hour F105 -- Due Diligence and Transferring FIFRA Registrations and/or Data module and two-hour F208 -- Data Citation, Data Compensation, and Data Sharing module join six existing FIFRA Tutor courses providing expert, essential Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) training....