By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students...
Category: Biotechnology/Synthetic Biology
On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a new web portal that is available to the public to search for EPA guidance documents. The EPA Guidance Portal (Portal) was created under Executive Order 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents,” where agencies are to develop a central web portal for the public to review active guidance documents and the ability to request for modification or...
February 28, 2020
ASTM International Biotechnology Task Group Seeking Members
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new...
February 28, 2020
DOE ORNL Develops Method For Observing Biomaterials’ Nanostructure
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On February 25, 2020, DOE’s Oak Ridge National Laboratory (ORNL) announced that its scientists have developed a novel technique to closely observe the nanostructure of biomaterials without damaging the sample. Using a nonintrusive soft mechanical nanoablation (sMNA) technique can confirm structural features in starch, which is an important carbohydrate in the production of biofuels. ORNL’s chief scientist for systems biology and...
January 24, 2020
Penn State Offering IMPACT Seed Grants To Support Biotechnology R&D
By Lynn L. Bergeson Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals....
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a...
January 14, 2020
New Joint Website on Agricultural Biotechnology Products Launched by EPA, USDA, and FDA
On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products. This “one-stop-shop” website was created under the direction of Executive Order...
January 10, 2020
USDA, FDA, And EPA Announce Unified Website On Biotechnology
By Lynn L. Bergeson On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO)...
January 10, 2020
U.S. President Releases Message On Biotechnology Month
By Lynn L. Bergeson On January 1, 2020, U.S. President Donald Trump released a statement recognizing the beginning of National Biotechnology Month and the country’s “enormous potential” of biotechnology to improve lives in the United States and around the globe. Highlighting the benefits of biotechnology in different sectors, President Trump states that for every one job in biotechnology, nearly two other jobs are created in various sectors in the rural United States. In his...
Click here for a PDF brochure of the memorandum, and click here to listen to the special Forecast 2020 edition of the All Things Chemical podcast. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2020. In this detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our...
November 8, 2019
Biofuels Industry Supporters Come Together In Letter To Trump
By Lynn L. Bergeson On November 4, 2019, 60 organizations unified in an effort to urge U.S. President Donald Trump to reconsider EPA’s proposed amendments to the Renewable Fuel Standard (RFS) program. Signed by organizations such as the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, the letter to the President indicates flaws within the aforementioned proposal released on October 15, 2019. Arguing that the proposed...
August 9, 2019
Pace Environmental Law Review Issues Call for Papers
The Pace Environmental Law Review (PELR) will publish a themed issue this winter concerning issues in the development and regulation of nanotechnology and biotechnology. Articles or essays should discuss the intersection between nanotechnology and/or biotechnology and environmental issues. PELR encourages submitters to take an interdisciplinary approach to nanotechnology and/or biotechnology from legal and other perspectives, including technology, science, public health, economics, or...
July 26, 2019
Weekly Roundup of Other Biobased News
World Economic Forum, “Cheese Energy Could Power Hundreds of UK Homes” Iran Front Page, “Iran Ready to Tackle Biotechnology Sanctions: VP” Digital Journal, “Switching to Biobased Plastics: IDTechEx Research Asks Why So Slow?” The Yucatan Times, “Yucatan Cenotes to Be Sanitized with Biotechnology” World Economic Forum, “Your Next Pair of Sneakers Could Be Made from Coffee” CleanTechnica, “NextEra Energy Predicts 50% Renewable...
July 26, 2019
U.K. Announces Open Consultation Call For Evidence To Develop Standards For Compostable, And Biobase
By Lynn L. Bergeson On July 22, 2019, the United Kingdom (U.K.) Department for Business, Energy and Industrial Strategy and Department for Environment, Food and Rural Affairs announced an open consultation for the development of standards for biodegradable, compostable, and biobased plastics. The consultation welcomes views from any interested parties to identify gaps and provide expert advice on: The overall sustainability of biobased and biodegradable plastic products in comparison with other...
July 19, 2019
Bipartisan Patent Bill Introduced To House And Senate That Would Protect Biotechnology Innovation
By Lynn L. Bergeson On July 10, 2019, Senators Chris Coons (D-DE) and Tom Cotton (R-AR) and Representatives Steve Stivers (R-OH) and Bill Foster (D-IL) reintroduced the STRONGER (Support Technology & Research for Our Nation’s Growth and Economic Resilience) Patents Act of 2019. This legislation, an improvement on legislation introduced last year under the same name, would reform the inter partes post-grant review process, ensure all fees paid to the Patent and Trademark Office (PTO)...
July 12, 2019
Weekly Roundup of Other Biobased News
Youris.com, “Surfing on Bio-based Boards” Kemira, “Kemira to Participate in the Development of 100% Bio-based Chemicals for Paper and Cardboard Production as Part of an EU Funded Project” Green Car Congress, “Researchers in Netherlands Exploring Use of Lignin as Alternative Asphalt Binder” Asian Scientist, “Supercharging Bacterial Biofuel Production” The Express Tribune, “Biofuels Can Help Reduce Current Account Deficit” MediaPost,...
June 14, 2019
Weekly Roundup of Other Biobased News
Endpoints News, “Luck and Unicorns? Who Needs That? Sante Ventures’ New $250M Fund is Looking for Biotech Upstarts” Renewable Energy Magazine, “Neste and Air BP Deliver Sustainable Aviation Fuel to Swedavia Operated Airports” SportsMole, “F1 Eyes Carbon-Neutral Fuel for 2021” XinhuaNet, “Hong Kong Researchers Discover New Stem Cells Offering New Avenue for Biotechnology Study” Phys.org, “Study Identifies Most Promising Feedstocks for...
June 7, 2019
APHIS Proposes Revised Regulatory Framework Regarding the Movement of Certain Genetically Engineered Organisms
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk...
By Lynn L. Bergeson On May 8, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) announced the pilot launch of its new online permitting system: APHIS eFile. Launching on July 23, 2019, APHIS will be inviting, at the end of May, those who have been issued a BRS permit or notification in the past two years to apply for the pilot program. The plan is for BRS to transition fully to APHIS eFile in...
May 3, 2019
Weekly Roundup of Other Biobased News
nature, “Australian Gene-editing Rules Adopt ‘Middle Ground’” Reuters, “U.S. EPA Stalls Biofuel Waiver Transparency Plan after White House Blowback –Sources” Inhabitat, “Fueled by Chocolate: Ghana’s Newest Biofuel” ScienceDaily, “Sustainable Way to Increase Seed Oil Yield in Crops” The Pantagraph, “‘Better and Greener:’ ISU Project Focuses on Recycling, Sustainability” Forbes, “This Line of Bags...
April 26, 2019
Weekly Roundup of Other Biobased News
Boston Herald, “Massachusetts Researchers Find Way to Produce Biofuels ‘Greener’” Treehugger, “From Old Duvets to Corn Stalks, a Look at Bio-based Insulations” Virtual Strategy Magazine, “DuPont Nutrition & Biosciences Launches Biobased Enzymes for…” ScienceDaily, “Green Plastic Production Made Easy” Purdue University, “Free Networking Conference for Biotechnology, Pharmaceutical, Medical Research Fields Planned at...
April 5, 2019
Weekly Roundup of Other Biobased News
Science Daily, “Novel Role of Water in Production of Renewable Fuels” AgWeb, “Gene Editing Promise Stalled at FDA” World Economic Forum, “This Mexican Company is Making Biofuel from Cactus Plants” Feedstuffs, “Biofuel Groups Testify at EPA Hearing on Year-round E15” KFGO, “Aerion Designing Supersonic Jet to Run Completely on Biofuels: CEO” The Hill, “Ocasio-Cortez Says She Encouraged Senate Dems to Vote ‘Present’ on...
By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...
March 29, 2019
Weekly Roundup of Other Biobased News
Plastics News, “Sealed Air, Kuraray Join Forces for Plant-based Packaging” CNBC, “Starbucks Announces Trials for Recyclable and Compostable Cups” Baltimore Sun, “Maryland Senate Passes Renewable Energy Bill; House Outcome Uncertain” ScienceDaily, “First Evidence Bacterial-induced Apoptosis in Algae” Coatings World, “Clariant Launches First Bio-based Pigment Red 254” North Carolina Biotechnology Center, “bluebird bio Dedicates New...
March 29, 2019
FDA’s Premarket Voluntary Plant Biotechnology Consultation Program Provides Opportunity For Develope
By Lynn L. Bergeson In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards. Plant biotechnology consists of methods...
By Lynn L. Bergeson On March 19, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the delay of the spring release for BRS’ updated permitting system in APHIS eFile. The release is now expected to occur in mid-summer 2019, with periodic updates provided by APHIS BRS as the anticipated release approaches. In its announcement, APHIS BRS highlighted its commitment to bringing a permitting system that takes...
By Lynn L. Bergeson On, March 12, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) announced the publication of two draft documents related to the potential deregulation of a soybean variety GE for increased yield and resistance to the herbicide glufosinate. The draft documents are Draft Plant Pest Risk Assessment (PPRA) and Draft Environmental Assessment (dEA) for Petition to Deregulate GE Soybean for Increased Yield and Herbicide Resistance. The PPRA will examine any...
By Lynn L. Bergeson On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon. In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S. According to...
March 8, 2019
JRC Opens Calls for the Nanobiotechnology Laboratory
The European Commission’s (EC) Joint Research Center (JRC) opens its scientific laboratories and facilities, including its Nanobiotechnology Laboratory, to people working in academia and research organizations, industry, and small and medium enterprises (SME). JRC opened a call on February 1, 2019, for the Nanobiotechnology Laboratory for the following priority topics: Nanomaterial characterization, including their interactions with biological systems (culture media, proteins);...
March 8, 2019
Weekly Roundup of Other Biobased News
Biofuels International, “Coconut Biodiesel Increase Suggested by Lawmaker in Philippines” Chemical Engineering, “BP, Virent and Johnson Matthey Partner on Production of Bio-based Paraxylene” The Express Tribune, “Biotechnology Can Transform Pakistan’s Economy” Energy AgWired, “GROWMARK Offers Pre-blended E15 at More Terminals” Reuters, “U.S. EPA Gets 37 Bids for Small Refinery Waivers through Mid-February” PhysicsWorld,...
February 22, 2019
Weekly Roundup of Other Biobased News
Biofuels Digest, “Pilot Plant Pushes Forward Economic Research on Sugarcane Waste to Biofuels” Chemical Engineering Online, “Circa Group’s Commercial Demonstration Plant for ‘Green’ Solvent Comes Online” Biobased World News, “‘One-of-a-kind Peacock-inspired’ Bio-based Dress to Be Showcased at International Clothing Exhibition” Forbes, “Midwest Corn Farmers Put New Fertilizer Alternative to the Test” Labiotech.eu,...
February 22, 2019
University Of Manchester Is Awarded £10 Million For A Biomanufacturing Research Hub
By Lynn L. Bergeson On February 13, 2019, the University of Manchester was awarded £10 million by UK Research and Innovation (UKRI), an organization sponsored by the UK Department for Business, Energy and Industrial Strategy (BEIS) to foster research and innovation. These funds are to be used in the launching of a country-wide biomanufacturing research hub to lead the way in new medicines and sustainable energy solutions. To be led by Professor Niguel Scrutton, the Future...
The U.S. Environmental Protection Agency (EPA) released on February 19, 2019, an update of the Toxic Substances Control Act (TSCA) Chemical Inventory (TSCA Inventory), which lists chemicals that are “active” versus “inactive” in commerce in the U.S. EPA’s News Release states that a “key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce.”...
February 15, 2019
Weekly Roundup of Other Biobased News
POET, “POET’s Jive Improves, Rejuvenates Asphalt in Roads Across the US” Project Cargo Global, “Coalition Provides Sustainable Marine Biofuels Verification” Firstpost., “Govt Allows Export of Biofuels from Special Economic Zones and Export-oriented Units” Arab News, “Indonesia to Challenge ‘Discriminative’ EU Directive on Palm Oil” Biofuels Digest, “Biobased Smart Bombs for Pests: Two New Strategic Investments in...
January 25, 2019
Weekly Roundup of Other Biobased News
European Biotechnology Life Science and Industry Magazine, “VTT Turn Waste into Biofuels and Chemicals” EPPM, “Lund University Develops Promising Bioplastic Derived from ‘Poo Molecule’” Biofuels Digest, “Covestro Launches Biobased Polyurethane Film Formers for Cosmetic Industry” The Progressive Farmer, “Wheeler: E15 Rule Might Be Delayed” Euractiv, “Time is Running Out for Biofuels Sustainability Criteria” Renewable...
January 11, 2019
B&C Releases 2019 Forecast On U.S. Federal And International Chemical Regulatory Policy
On January 8, 2019, B&C and its consulting affiliate The Acta Group (Acta®) published the 2019 Forecast. The document details the legal, scientific, and regulatory trends in U.S. and global chemical law, providing informed judgment as to the shape of key developments we are likely to see in 2019. Sections on biobased products and biotechnology are included in the document. The full document can be accessed here.
Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2019. In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in the New Year. Our unique business platform and growing...
January 4, 2019
MTI Releases RFP For Innovation Challenge
By Lynn L. Bergeson The Maine Technology Institute (MTI) announced on December 14, 2018, a request for proposals (RFP) for Maine’s Forest Resources. Managed by Biobased Maine on behalf of MTI, the RFP for the Emerging Technology Challenge aims to deploy a forest industry technology in Maine, where forest biomass is used in the production of a value-added product for sale. MTI is a “publicly funded, nonprofit corporation with the core mission to diversify and grow Maine’s...
By Lynn L. Bergeson On December 21, 2018, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register that the Syracuse Research Corporation (SRC) will be assisting the EPA Office of Pollution Prevention and Toxics (OPPT) in the creation of a database that will cover key data from past biotechnology submissions, and the creation of a biotechnology literature database with documents provided or referenced in Toxic Substances Control Act (TSCA) biotechnology submissions. The...
December 7, 2018
Weekly Roundup of Other Biobased News
Chemical & Engineering News, “To Fulfill Biofuels’ Promise, Scientists Boost Plant Oils with Gene Editing” Ethanol Producer Magazine, “New Tax, Oversight Bill Aims to Extend Biofuel Tax Credits” MuscaDaily.com, “Omani Woman Scientist Wins UNESCO Fellowship for Research in Biofuels” The Times of India, “CSIR Working on Developing Biofuels on a Commercial Scale” Biofuels International, “Biodiesel By-product Has Potential as Clean...
November 30, 2018
Weekly Roundup of Other Biobased News
Biofuels International, “Biogas-to-Biofuel Technology Accepted for Testing” Biofuels International, “Prospects Raised for Large Scale Algae Biofuel Production” Reuters, “Biofuel Groups Ask Federal Judge to Freeze U.S. Refinery Waiver Program” Packaging Gateway, “Leaf Resources Extends Leafcoat License to Europe” Reuters, “Iowa Senator Says Expect Fewer Biofuel Waivers from Wheeler’s EPA” Fronteras, “Food Biotechnology Added...
November 16, 2018
Weekly Roundup of Other Biobased News
Phys.org, “New Method Enables Large-Scale Production of Bio-Based Plastic Bottles” Mercom India, “India Joins the Club for Collaboration on New and Alternate Fuels” Biofuels Digest, “University of Delaware Start-Up Creates Renewable Oil that Can Be Used from Cosmetics to Lubricants” Reuters, “Britain’s Renewable Electricity Capacity Overtakes Fossil Fuels -- Report” Renewable Energy Magazine, “APPA Claims Biofuel a Key Ingredient in...
November 9, 2018
Call For Candidate Chemicals For Equivalency Determinations
By Kathleen M. Roberts Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA). ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the...
November 2, 2018
FDA Releases Statement On A New Plant And Animal Biotechnology Innovation Action Plan
By Lynn L. Bergeson On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation. Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities: Advancing public health by promoting...
On October 10, 2018, EPA’s Office of Pesticide Programs (OPP) announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and that on
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By Lynn L. Bergeson On October 9, 2018, during a rally in Council Bluffs, Iowa, U.S. President Donald Trump announced that he will order the U.S. Environmental Protection Agency (EPA) to expand its sales of corn ethanol. This action, which farmers across the U.S. have been waiting for, will allow for year-round sales of 15 percent biofuels (E15) ethanol blends. Currently, E15 sales are restricted during the summer months in certain states, limiting the expansion of the market space for biofuels....
October 5, 2018
U.S. Government Funds Project On Biofuel Development
By Lynn L. Bergeson In late September 2018, Northwestern University announced a new bioengineering project funded by the U.S. Department of Energy (DOE) and the U.S. Department of Agriculture (USDA) under their joint program called the Biomass Research and Development Initiative (BRDI). Led by Michael Jewett, professor of chemical and biological engineering, the project aims to combine innovative bioengineering and biotechnology to develop biofuels and bioproducts. It is expected that through...
September 28, 2018
House Passes Pandemic And All-Hazards Preparedness And Advancing Innovation Act of 2018
By Lynn L. Bergeson On September 25, 2018, the U.S. House of Representatives passed without objection the Pandemic and All-Hazards Preparedness And Advancing Innovation Act of 2018. Introduced on July 16, 2018, by Congresswoman Susan W. Brooks (R-IN), this Act reauthorizes certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act, and amends the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Amongst these reauthorized programs are the federal...
September 21, 2018
Bergeson & Campbell’s Insight On TSCA
By Lynn L. Bergeson On September 11, 2018, Bloomberg Environment Insights published a three-part article series, written by Bergeson & Campbell, P.C. (B&C®), on the impact of the new Toxic Substances Control Act (TSCA) Section 5 and its implementation. Despite the U.S. Environmental Protection Agency’s (EPA) overall timely and balanced efforts in the implementation of TSCA, EPA’s approach to TSCA Section 5 implementation has proved itself less successful. With emphasis on...
September 14, 2018
5th Biotechnology World Congress Announced For 2019
By Lynn L. Bergeson The 5th Biotechnology World Congress has been scheduled to take place in Bangkok, Thailand, from February 13-15, 2019. The Welcome Letter states that the conference will “feature a variety of lectures in a number of key sessions in biotechnology, including a commercial exhibition and poster sessions” and the sessions given will include “strategic alliances in biotechnology, pharmaceutical biotechnology, medical biotechnology, plant and environmental...