Archives

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...
May 3, 2023

APHIS Releases New Strategic Plan for 2023-2027, Includes Biotechnology Objectives

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to: Protect agriculture from...
May 1, 2023

OMB Seeks Input on Bioeconomy-Related Industries and Products

By Lynn L. Bergeson and Carla N. Hutton   The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a...
April 5, 2023

DOD Publishes Biomanufacturing Strategy and RFI on Biomanufactured Products and Process Capabilities

By Lynn L. Bergeson and Carla N. Hutton   As part of the National Biotechnology and Biomanufacturing Initiative, the U.S. Department of Defense (DOD) announced in September 2022 an investment of $1.2 billion in bioindustrial domestic manufacturing infrastructure to catalyze the establishment of a domestic bioindustrial manufacturing base accessible to U.S. innovators. As reported in our March 30, 2023, blog item, on March 22, 2023, DOD released its Biomanufacturing Strategy to guide these...
April 3, 2023

White House OSTP Outlines Goals for U.S. Biotechnology and Manufacturing

By Lynn L. Bergeson and Carla N. Hutton As reported in our March 30, 2023, blog item, on March 22, 2023, the White House Office of Science and Technology Policy (OSTP) released a new report, Bold Goals for U.S. Biotechnology and Biomanufacturing: Harnessing Research and Development to Further Societal Goals. The report includes five sections, each presenting goals that highlight what could be possible with the power of biology. The goals set ambitious national targets...
March 30, 2023

Biden Administration Announces New Goals and Priorities to Advance Biotechnology and Biomanufacturin

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, President Joseph Biden signed an Executive Order (EO) on September 12, 2022, creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On March 22, 2023, the White House Office of Science and Technology Policy (OSTP) published a fact sheet announcing “new...
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...
October 24, 2022

APHIS Issues RSR Responses under Revised Biotechnology Regulations for Modified Corn and Potato Plan

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 October 21, 2022, that it recently reviewed a corn plant and a potato plant that were modified using genetic engineering to determine whether they present an increased pest risk as compared to unmodified plants. APHIS has posted its Regulatory Status Review (RSR) responses on its website, as required under 7 C.F.R....
October 14, 2022

NIFA Will Hold RFA Technical Assistance Webinar on Biotechnology Risk Assessment Research Grants

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Biotechnology Risk Assessment Research Grants (BRAG) program supports the generation of new information that will assist federal regulatory agencies in making science-based decisions about the environmental effects of introducing genetically engineered organisms. In an October 27, 2022, technical assistance webinar, staff will provide an overview of the program, which is jointly administered by...
October 7, 2022

APHIS BRS Will Hold Annual Stakeholder Meeting on December 8, 2022

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) will hold its annual Stakeholder Meeting on December 8, 2022. BRS will offer in-person, at the USDA Center at Riverside, 4700 River Road, Riverdale, Maryland 20737, and virtual options for attendance. Attendees will hear updates about BRS’s implementation of the revised biotechnology regulations,...
October 5, 2022

Federal Agencies Announce Investments and Resources to Advance National Biotechnology and Biomanufac

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 (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact...
September 13, 2022

President Biden Launches National Biotechnology and Biomanufacturing Initiative

By Lynn L. Bergeson and Carla N. Hutton   On September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments...
September 1, 2022

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS...
September 1, 2022

USDA’s APHIS Announces New Microbes Q&A and Updated Confirmation Request Guidance

 On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340: These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS...