Category: Biotechnology/Synthetic Biology

January 3, 2022

Forecast for U.S. Federal and International Chemical Regulatory Policy 2022

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its 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 2022. The extraordinary diversity and complexity of global industrial, agricultural, and biocidal chemical initiatives in which our clients engage are reflected in the detailed summary that follows, prepared by the legal,...
November 11, 2021

B&C Launches FIFRA Tutor™ Online, On-Demand Regulatory Training

Bergeson & Campbell, P.C. (B&C®) is pleased to announce that FIFRA Tutor™ regulatory training courses are now available at www.FIFRAtutor.com. Professionals can preview and enroll in on-demand classes to complete at their own pace and timing. FIFRA Tutor joins B&C’s existing TSCA Tutor® training courses in offering efficient and essential training for chemical regulatory professionals, and a third training program, HazCom GHS Tutor, is planned...
August 31, 2021

APHIS Announces Draft Regulatory Status Review Guide Available for Public Comment

On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. Developers of certain genetically modified organisms may use the RSR process to determine the regulatory status of the organisms. The draft guide is open for public comment for 60 days. APHIS also will host a webinar to...
May 6, 2021

EC To Hold Webinar On Biotechnology IP

By Lynn L. Bergeson On May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions.  The 60-minute webinar will provide an overview of: Relevant IP rights; Product development IP context; IP specifics in biotechnology; IP portfolio development; and IP portfolio management. The webinar is free of charge, but registration is required.  Additional information...
March 17, 2021

Lynn L. Bergeson, “The importance of regulatory diligence in funding,” Financier Worldwide, April 2021.

Lawyers counselling companies in the biotechnology, biopesticide and related crop protection and industrial biotechnology areas appreciate the critically important role federal agencies play in ensuring the success of start-up businesses. Federal agencies, including the US Environmental Protection Agency (EPA) and the US Food and Drug Administration (FDA), among others, wield enormous power over businesses that require premarket product approval. While we product approval practitioners know...
January 21, 2021

Registration Opens for NNI Webinar on “What We Know about NanoEHS: How It All Began”

Registration is now open for the U.S. National Nanotechnology Initiative’s (NNI) February 9, 2021, webinar, “What We Know about NanoEHS:  How It All Began.”  NNI states that its 2021 NanoEHS webinar series will focus on sharing what it now knows about the environmental, health, and safety aspects of engineered nanomaterials (nanoEHS).  According to NNI, throughout the series, “experts will share the big take-home EHS messages with the broader nanotechnology...
December 22, 2020

BRAG Celebrates Gains In Regulatory Parity For Biobased Products

Having created an impressive legacy of regulatory and policy success for biobased and renewable chemicals and chemical products, the Biobased and Renewable Products Advocacy Group (BRAG®) will sunset at the end of 2020. BRAG was formed in 2013 to give biobased chemical stakeholders the expertise and collective voice necessary to educate legislative and administrative decision-makers during the negotiations occurring at that time regarding reform of the Toxic Substances Control Act...
August 24, 2020

USDA Hosts Stakeholder Forum for Discussion and Feedback on AIA

The U.S. Department of Agriculture (USDA) held a forum on its Agriculture Innovation Agenda (AIA) on August 16, 2020. The forum focused on science-informed policies and programs from government agencies with the shared aim of supporting environmentalism and enhanced productivity. AIA seeks to spur developments in biotechnology and support accessibility in response to modern industry challenges. Stakeholders were given a chance to hear from representatives and participate in a question and answer...
August 6, 2020

U.S. Senators Vote Against Deputy Secretary Of Energy Nominee and other Biobased Developments

Federal U.S. Senators Vote Against Deputy Secretary Of Energy Nominee On August 4, 2020, U.S. Senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) voted against Mark Menezes, who is nominated to become Deputy Secretary of Energy. In a statement, both Senators said that “[g]iven the uncertainty with the ‘gap year’ small refinery waivers, the wasted time and resources to score the waivers again, the lack of transparency in the entire process, and most importantly, the toll this has...
July 24, 2020

NASEM Seeks Nominations for Experts for Committee on Anticipatory Research for EPA’s ORD to Inform Future Environmental Protection

The National Academies of Sciences, Engineering, and Medicine (NASEM) are now assembling an ad hoc committee to identify emerging scientific and technological advances from across a broad range of disciplines that the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) should consider in its research planning to support EPA’s mission for protecting human health and the environment.  In addition, according to NASEM, the committee will...