Category: Biotechnology/Synthetic Biology

October 13, 2017

FDA Announces Meeting, Calls For Comments On FDA/USDA Agricultural Biotechnology Education And Outre

By Lauren M. Graham, Ph.D. On October 12, 2017, the U.S. Food and Drug Administration (FDA) announced two public meetings regarding its Agricultural Biotechnology Education and Outreach Initiative.  The meetings will be held in Charlotte, North Carolina, on November 7, 2017, from 8:00 a.m. to 1:00 p.m. (EST) and in San Francisco, California, on November 14, 2017, from 8:00 a.m. to 1:00 p.m. (PST).  FDA states the purpose of the public meetings is “to provide the public with...
October 10, 2017

FDA Releases Guidance Addressing FDA and EPA Jurisdiction over Mosquito-Related Products

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...
October 6, 2017

Inside EPA Quotes B&C Memorandum on EPA, FDA Jurisdiction for Mosquito Related Products

On October 6, 2017, Inside EPA quoted a recent Bergeson & Campbell, P.C. (B&C®) memorandum in the article “EPA wins power to oversee biotech mosquito controls.” EPA and the Food and Drug Administration (FDA) have issued new guidance clarifying that EPA has authority for regulating biotechnology (Bt) products such as genetically modified mosquitoes that are used to control the pests, a step that one industry law firm says will be helpful for navigating a federal...
October 5, 2017

FDA Guidance Addresses FDA and EPA Jurisdiction over Mosquito-Related Products

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...
September 8, 2017

Weekly Roundup of Other Biobased News

Platts, “New EU Biodiesel Greenhouse Gas Calculations Come Into Force” Biotechnology For Biofuels, “The Impact of Considering Land Intensification and Updated Data on Biofuels Land Use Change and Emissions Estimates” University of California, Irvine, “Markus Ribbe and Yilin Hu: Brewing Biofuel from Bacteria” United Kingdom Government, “Planes Fuelled by Waste Could Take Off from British Airports”
July 28, 2017

B&C And Sterne, Kessler, Goldstein & Fox P.L.L.C. Host Bioeconomy Leaders and Innovators Reception D

Scientists, executives, and investors gathered in Montreal, Canada on Tuesday evening for a fascinating and wide-ranging discussion on current issues facing bioeconomy leaders and innovators.  The reception, hosted by Bergeson & Campbell, P.C. (B&C®) and Sterne, Kessler, Goldstein & Fox P.L.L.C., included a brief question and answer (Q&A) session with Christine Lhulier, Corporate Counsel for DuPont Industrial Biosciences, Richard E. Engler, Ph.D., Senior Chemist with...
July 21, 2017

Don’t Miss The Bioeconomy Leaders And Innovators Reception At 2016 BIO World Congress

The BIO World Congress on Industrial Biotechnology will take place on July 23-26, 2017, at the Palais des congrès de Montréal.  Bergeson & Campbell, P.C. (B&C®) will co-host a Bioeconomy Leaders and Innovators Reception with Sterne, Kessler, Goldstein & Fox P.L.L.C. from 6:00-7:30 p.m. on July 25, 2017.  Enjoy cocktails and hors d’oeuvres while engaging with colleagues to exchange ideas and explore the prospect of establishing new partnerships. ...
July 19, 2017

Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the “Opportunities and Risks of Nanomaterials”

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64).  The editorial states that the Program’s primary goal was to investigate potential applications of existing nanomaterials in healthcare, the consumer industry, and in the environment, and to identify, characterize, and minimize the possible risks associated with their...
July 14, 2017

Do Not Miss The Bioeconomy Leaders And Innovators Reception At 2017 BIO World Congress

The BIO World Congress on Industrial Biotechnology takes place July 23-26, 2017, at the Palais des congrès de Montréal.  Bergeson & Campbell, P.C. (B&C®) will co-host a Bioeconomy Leaders and Innovators Reception with Sterne, Kessler, Goldstein & Fox P.L.L.C. from 6:00-7:30 p.m. on July 25, 2017.  Enjoy cocktails and hors d’oeuvres while engaging with colleagues to exchange ideas and explore the prospect of establishing new partnerships. ...
July 14, 2017

NAS Publishes Report On Preparing For Future Products Of Biotechnology

By Lauren M. Graham, Ph.D. On June 30, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) released the final version of its report Preparing for Future Products of Biotechnology, which is the result of a collaboration by a committee of experts convened by NAS.  The report provides an overview of the committee’s discussion on “the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies...
July 14, 2017

Bipartisan Renewable Chemicals Bill Introduced In The House

By Lauren M. Graham, Ph.D. On June 29, 2017, Representatives Bill Pascrell (D-NJ), Ryan Costello (R-PA), Brian Fitzpatrick (R-PA), and Linda Sánchez (D-CA) introduced the Renewable Chemicals Act of 2017 to the House.  If enacted, the legislation would create a targeted, short-term tax credit for the production of qualifying renewable chemicals from biomass and for investments in renewable chemical production facilities.  The tax credit would be provided based on job...
July 3, 2017

NAS Releases Final Report on Preparing for Future Products of Biotechnology

By Lynn L. Bergeson and Margaret R. Graham On June 30, 3017, the National Academies of Sciences, Engineering, and Medicine (NAS) released its final version of its report Preparing for Future Products of Biotechnology, which it states “analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making [and] … identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of...
June 30, 2017

Don’t Miss The Bioeconomy Leaders And Innovators Reception At 2017 BIO World Congress

The BIO World Congress on Industrial Biotechnology takes place July 23-26, 2017, at the Palais des congrès de Montréal, and features two new tracks on Flavors, Fragrances and Food Ingredients, and Agricultural Crop Technologies and Biomass Supply.  Bergeson & Campbell, P.C. (B&C®) will co-host a Bioeconomy Leaders and Innovators Reception on July 25, 2017, with Sterne, Kessler, Goldstein & Fox P.L.L.C.  More details to come.  Richard E. Engler, Ph.D.,...
June 23, 2017

BIO Announces 2017 Rosalind Franklin Award Winner

By Lauren M. Graham, Ph.D. On June 14, 2017, the Biotechnology Innovation Organization (BIO) announced that biotech industry veteran Vonnie Estes would receive the 4th annual Rosalind Franklin Award for Leadership in Industrial Biotechnology. Estes, an independent business consultant, will be presented the Rosalind Franklin Award for Leadership in Industrial Biotechnology during a lunch plenary session at the BIO World Congress on July 25, 2017.  Each year, the award celebrates a...
May 4, 2017

Lynn L. Bergeson and Richard E. Engler, Ph.D., Contribute to ABA SEER’s The Year in Review 2016

Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of The Year in Review 2016:  Environment, Energy, and Resources Law by the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER).  The Year in Review provides an annual summary of developments in environmental, energy, and resources law.  B&C Managing Partner Lynn L. Bergeson and Senior Chemist Richard E. Engler,...
March 24, 2017

Second Generation Ethanol More Cost-Effective In The Long Term

On March 14, 2017, researchers from the Brazilian Bioethanol Science and Technology Laboratory (CTBE) published a study focused on quantifying the economic and environmental impacts of second generation biofuels, based on current and future scenarios of sugarcane biorefineries that include consideration of improvements to the industrial process and biomass production systems.  Although costs were determined to be higher in the short term, the study demonstrates that second generation...
March 24, 2017

Nominations Open For Annual Rosalind Franklin Award

On March 8, 2017, the Biotechnology Industry Organization (BIO), a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced that nominations for the fourth annual Rosalind Franklin Award for Leadership in Industrial Biotechnology were being accepted.  The award, which recognizes an outstanding woman in the industrial biotechnology sector who has made significant contributions to the advancement of the biobased economy and biotechnology innovation, will be...
March 13, 2017

National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee). Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), was an external contributor to the Committee’s deliberations and presented...
March 10, 2017

NAS Issues Report on Preparing for Future Products of Biotechnology

By Lynn L. Bergeson and Margaret R. Graham On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report:  Preparing for Future Products of Biotechnology.  Pursuant to the White House Office of Science and Technology Policy's (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” NAS was tasked with looking into the future and describing the...
February 24, 2017

Weekly Roundup of Other Biobased News

Biotechnology Innovation Organization, “BIO Submits Comments on EPA Renewables Enhancement and Growth Support Rule”   ?  EPA, “Draft Inventory of U.S. Greenhouse Gas Emissions and Sinks: 1990-2015”   International Energy Agency, “New Bioenergy Roadmap Guide Released Jointly by IEA and FAO”