Archives

October 14, 2016

EPA Announces Public Meeting To Comment On Algae Guidance Documents

On October 12, 2016, the U.S. Environmental Protection Agency (EPA) announced a public meeting on the draft Algae Guidance for the Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions (Algae Guidance) in the Federal Register.  This meeting will receive public input and comments on the draft Algae Guidance that describes EPA’s data needs for supporting risk assessments of genetically engineered algae and cyanobacteria that are manufactured, imported, or...
October 7, 2016

Weekly Roundup of Other Biobased News

Amyris, "Amyris Expands In Global Nutraceuticals Market With New Collaboration and Partner Funding of $30 Million" Loyola, "Loyola Biology Professor Wins $50,000 National Science Foundation Grant to Create a Network to Prep Students for Careers in Biotechnology" Neste, "Henrik Erämetsä from Neste to Co-Chair EU Initiative for Advanced Biofuels in Aviation" National Science Foundation, "NSF Awards $94 Million to Create Four New Science and Technology...
September 30, 2016

Update To The Coordinated Framework For The Regulation Of Biotechnology Published In The Federal Reg

On September 22, 2016,  Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the  Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of...
September 23, 2016

Biotechnology: White House Releases Proposed Update To The Coordinated Framework And National Strat

On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology" and released two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared...
September 19, 2016

EPA, FDA, and USDA Release Updates to Coordinated Framework on Biotechnology

By Lynn L. Bergeson and Margaret R. Graham On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents that will update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) that was first rolled out by the White House Office of Science and Technology Policy (OSTP) in 1986 and updated in...
September 9, 2016

EPA Announces Public Meeting On Algae And TSCA

On September 1, 2016, the Algae Biomass Organization (ABO) announced that the U.S. Environmental Protection Agency (EPA) will be hosting an "Opportunity for Public Comment on Algae Guidance for The Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions." This meeting will receive public comments on EPA's algae guidance document, and will inform the development of EPA's "Algae Guidance for The Preparation of TSCA Biotechnology Submissions"...
September 9, 2016

Weekly Roundup of Other Biobased News

? Plastics Industry, "100 Percent Compostable Single Serve Coffee Pod Wins International Innovation Award" ? Market Wired, "Seventh Generation Develops EPA Safer Choice Certified Laundry Detergent Packs Mission-Led Household and Personal Care Products Company Introduces New Line Of Solid Laundry Detergent Packs Formulated With Plant-Based Ingredients" ? Synthetic Genomics, "Synthetic Genomics Team Engineers Vmax™, an Advantaged Next-Generation Host Organism for a...
September 9, 2016

Florida House Members Request Emergency Authorization to Combat Aedes aegypti Mosquitoes with Oxitec

On September 6, 2016, 61 members of the Florida House of Representatives issued a letter to the U.S. Department of Health and Human Services (HHS) and to the U.S. Food and Drug Administration (FDA) to urge them to:  (1) declare a public health emergency for the Zika virus; (2) grant Florida’s state and local governments access to Oxitec Ltd.’s (Oxitec) genetically engineered (GE) mosquitoes that can suppress the local Aedes aegypti mosquito population; and (3)...
August 19, 2016

Lynn L. Bergeson Presents “New TSCA’s Impact On Biotechnology” With The National Academies Of Scienc

On August 2, 2016, Lynn L. Bergeson, Managing Partner of B&C, presented the webinar "New TSCA's Impact on Biotechnology," with the National Academies of Sciences, Engineering, and Medicine (NAS). This webinar, available for free on the NAS website, includes an overview of TSCA updates resulting from the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Ms. Bergeson focused specifically on how these updates could impact the regulation of biotechnology,...
August 12, 2016

US Environmentalist And Organic Crop Farm Groups Want Overhaul Of Federal Biotechnology Strategy

On August 3, 2016, 24 farmer and public interest organizations wrote to the Obama Administration expressing their disappointment with the direction that the White House Office of Science and Technology Policy (OSTP) has taken with the proposed modernization of the Coordinated Framework for Regulation of Biotechnology (Coordinated Framework). The letter argues that an overly permissive regulatory framework for genetically engineered (GE) products has resulted in negative consequences, and that GE...
July 1, 2016

Agenda Of Biotechnology For Clean Vehicles Session Released; Includes Synthetic Biotechnology, Advan

On June 22, 2016, DOE released the detailed agenda for the Biotechnology for Clean Vehicles: Harnessing Synthetic Biology To Enable Next-Generation Biomaterials And Biofuels session at the Sustainable Transportation Summit. The session is hosted by DOE's Office of Energy Efficiency and Renewable Energy (EERE) and will focus on how novel biomaterials and renewable fuels can be used to improve vehicle efficiency and sustainability. The session will also discus the role of synthetic biology in...
May 20, 2016

National Academies Of Sciences, Engineering, And Medicine Holding Second Public Meeting On Future

The National Academies of Sciences, Engineering, and Medicine is hosting a second public meeting examining future biotechnology products on June 1-2, 2016. This two-day meeting will run from 9:00 a.m. – 5:30 p.m. both days, with a public comment period open to in-person attendees at the end of each day. The meeting will be held at the National Academy of Sciences Building in Washington D.C., and members of the public will have the opportunity to...
April 15, 2016

Don’t Miss The Upcoming 2016 BIO World Congress on Industrial Biotechnology

Bergeson & Campbell, P.C. (B&C®) is a proud sponsor of the 2016 BIO World Congress on Industrial Biotechnology. Make sure to visit our tabletop display to pick up content-driven articles about the current state of biotechnology regulations, with commentary by B&C and Biobased and Renewable Products Advocacy Group (BRAG®) professionals. Richard E. Engler, Ph.D., Senior Chemist with B&C, will be attending the conference and will be pleased to discuss questions attendees may...
April 15, 2016

Weekly Roundup of Other Biobased News

? DOE, "Harnessing Biotechnology to Accelerate Advanced Biofuels Production" ? Resource, "French Carrier Bag Ban to Boost Bio-Based Products" ? News Lodi, "Reverse Photosynthesis: Degradation of Biomass by Sunlight" ? Resource, "Bio-Based Material of the Year Announced" ? Center for Biological Diversity, "United Nations Urged to Withdraw Misleading Biofuels Report: Error-filled Document Touts Shuttered Plants, Bankrupt Company" ? Tennessee Today,...
April 7, 2016

NAS Releases Agenda for First Future Biotechnology Products and Regulatory System Committee Meeting

On April 5, 2016, the National Academies of Science, Engineering, and Medicine (NAS) posted the Agenda for the first open session of its committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.”  The Committee is beginning a study to provide an independent and objective examination of the future products of biotechnology, as commissioned pursuant to the White House Office of Science and Technology...
March 4, 2016

More Information Available On Upcoming “Modernizing The Regulatory System For Biotechnology Products

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the Regulatory System for Biotechnology Products." The memorandum, issued under the Executive Office of the President (EOP) and jointly by (OSTP), the Office of Management and Budget, the U.S. Trade Representative, and the Council on Environmental Quality, directs...
February 12, 2016

Nominations Open For Annual George Washington Carver Award And Rosalind Franklin Award

On February 1, 2016, the Biotechnology Innovation Organization (BIO) announced that nominations for the ninth annual George Washington Carver Award were being accepted. The award recognizes an individual who has contributed to building the biobased economy by creating sustainable, environmentally friendly products through industrial biotechnology. Previous recipients of the award include Ellen Kullman, CEO and Chair of the Board at DuPont and Dr. Jay Keasling, Hubbard Howe Jr. Distinguished...
February 5, 2016

Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Or

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to "prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms." The notice identifies...
February 5, 2016

Dates And Locations Of “Modernizing The Regulatory System For Biotechnology Products” Meetings Annou

On February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on October 30, 2015, and a record of the meeting is available on the U.S. Food and Drug Administration (FDA) website. The second of the three meetings will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office...
February 3, 2016

OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products.”  The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas.  The third public...