All Knowledge & Insights By Date

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....