Category: Biotechnology/Synthetic Biology

February 17, 2023

EPA Announces Both EPA and FDA Seek Public Input on Modernizing Their Approach to Oversight of Certain Products

On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency’s...
January 11, 2023

Register Now for “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” Webinar

Registration is open for the “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” webinar on January 31, 2023, 11:00 a.m. - 12:00 p.m. (EST). This webinar offers our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2023. At a political level, the Republicans’ narrow control of the U.S. House of Representatives will almost certainly invite a greater degree of oversight of U.S. Environmental Protection...
January 11, 2023

Register Now for “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023”

Registration is now open for the “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” webinar on January 31, 2023, 11:00 a.m. - 12:00 p.m. (EST). This webinar offers our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2023. At a political level, the Republicans’ narrow control of the U.S. House of Representatives will almost certainly invite a greater degree of oversight of U.S. Environmental...
January 11, 2023

Register Now for “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023”

Registration is now open for the “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2023” webinar on January 31, 2023, 11:00 a.m. - 12:00 p.m. (EST). This webinar offers our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2023. At a political level, the Republicans’ narrow control of the U.S. House of Representatives will almost certainly invite a greater degree of oversight of U.S. Environmental...
January 9, 2023

APHIS Announces Final Regulatory Status Review Guide

The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using genetic engineering that APHIS has not...
January 9, 2023

APHIS Announces Final Regulatory Status Review Guide

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced on December 22, 2022, that it posted its final Regulatory Status Review (RSR) guide. The RSR guide details the information requirements and process for submitting an RSR request under the revised biotechnology regulations at 7 C.F.R. Part 340. Under the revised regulations, developers may request a permit and/or an RSR of a plant developed using...
January 5, 2023

Forecast for U.S. Federal and International Chemical Regulatory Policy 2023

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2023, our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year. We have worked hard to offer our best-informed judgment on the trends...
December 20, 2022

OSTP Publishes RFIs on Coordinated Framework for the Regulation of Biotechnology and National Biotec

By Lynn L. Bergeson and Carla N. Hutton   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 (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two...
December 5, 2022

USDA Scientists Produce Nanobodies in Plant Cells that Block Emerging Pathogens

 By Lynn L. Bergeson and Carla N. Hutton   On November 30, 2022, the U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) announced that its scientists have determined that plants could be used to produce nanobodies that quickly block emerging pathogens in human medicine and agriculture. The nanobodies are small antibody proteins naturally produced in specific animals like camels, alpacas, and llamas. ARS researchers evaluated nanobodies to prevent and...
December 2, 2022

EuropaBio Announces Biomanufacturing Platform

By Lynn L. Bergeson and Carla N. Hutton   EuropaBio announced on November 14, 2022, a new cross-sectoral Biomanufacturing Platform. EuropaBio states that the Platform has the mission to represent biomanufacturing at the highest policy levels in Europe and to ensure that it is visible and recognized within the industrial strategy and Europe’s green and digital transitions. The Platform will address the policy and wider frameworks through which biomanufacturing is delivered. EuropaBio...