The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

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, patients, and U.S. trading partners. In his published statement, Dr. Gottlieb emphasizes FDA’s ongoing implementation of the Action Plan, particularly on intentional genomic alterations in animals. Using genetic engineering and genome editing technologies, these innovations are providing additional clarity about how FDA’s regulatory framework works and should continue to work. A key part of the Action Plan’s implementation involves FDA’s Center for Veterinary Medicine’s Innovation Program, which provides sponsors with innovative products based on genomic alterations in animals to benefit from early feedback and guidance.
 
In the released statement, Abram further highlights the impacts of intentional genomic alterations in animals on human health. DNA editing not only benefits animals by halting animal-to-animal transmission of diseases, but also has the potential to benefit humans. According to Abram, FDA has already evaluated and approved several intentional genomic alterations in animals that produce drugs used to treat human diseases, advance the studies of new drugs, as well as human organ and tissue transplants.  The Commissioners state that by ensuring safety of intentional genomic alterations to animals and animal-derived foods, FDA will continue to evaluate the effectivity of these alterations based on the totality of evidence provided rather than from any one particular assessment or result.
 
On April 25, 2019, FDA’s Center for Veterinary Medicine and the Center for Biologics Evaluation and Research will host a live webinar to discuss policy changes that may improve the Action Plan framework.


 

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 used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced food waste, or plants with reduced levels of harmful elements, amongst others).  To assist developers in this field, FDA has a voluntary premarket Plant Biotechnology Consultation Program, which provides developers with the opportunity to engage with FDA to help navigate the appropriate regulatory pathways.  The program includes individualized advice from FDA’s biotechnology and food safety experts prior to a plant-based product being permitted to enter the market and allows for biotechnology developers to consult with these FDA experts throughout the entire development, data collection, and evaluation process.


 

By Lynn L. Bergeson

On March 13, 2019, the European Commission (EC) published a fact sheet on the sustainability for biofuels specified.  EC adopted a delegated act that sets out the criteria for determining high low indirect land-use change (ILUC) risk feedstock for biofuels and the criteria for certifying ILUC-risk biofuels, bioliquids, and biomass fuels.  ILUC-risk fuels consist of fuels produced from food and feed crops that significantly expand globally into land with high carbon stock (high ILUC-risk fuels).  The consequences of creating high ILUC-risk fuels relate to the release of greenhouse gas (GHG) emissions, which negates the emissions savings from the use of biofuels rather than fossil fuels.  ILUC is addressed in the delegated act through two measures:   one measure sets national limits for the total contribution towards the renewable energy targets for biofuels, bioliquids, and biomass fuels from food or feed crops; and the other measure sets national limits as Member States’ 2019 level for the period 2021-2023.

Tags: EC, Biofuels, ILUC, GHG

 

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 economy by encouraging, promoting, stimulating, and supporting innovation and its transformation into new products, services and companies, leading to the creation and retention of quality jobs in Maine.” In support of the industrial biotechnology growth across the globe, MTI wishes to ensure that Maine is part of the bioeconomy. Eligible candidates must have submitted information to MTI’s request for information (RFI) in July 2018, and must submit RFP applications by January 25, 2019. MTI will award up to $1.5 million in grants for one or multiple projects. For further information on how to apply, please click here.


 

By Lynn L. Bergeson

On December 5, 2018, the United Kingdom (UK) published a policy paper titled “Growing the Bioeconomy, Improving Lives and Strengthening Our Economy: A National Bioeconomy Strategy to 2030.” As the UK strives to double its bioeconomy value by 2030, four main goals are outlined as part of the strategic plan:

  • Capitalize the research, development, and innovation base;
  • Maximize productivity and potential from existing bioeconomy assets;
  • Deliver real, measurable benefits for the UK economy; and
  • Create the right societal and market conditions to allow innovative biobased products and services to thrive.
Emphasizing the need for collaboration, the paper reports that the transformations necessary to achieve these goals will be led by regional and national government agencies, research councils, universities, and industrial leaders. The vision is that in 2030 the UK will be the global leader in developing, manufacturing, using, and exporting biobased solutions. The outlined strategy takes into account the global challenges facing the world right now and how the bioeconomy can play a critical role in addressing them. The intention is for a new government group to be created in support of the strategy and its related activities.
Tags: UK, Bioeconomy

 

By Lynn L. Bergeson

On November 28, 2018, the European Commission (EC) published a document called “A Clean Planet for all: A European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy.”  Due to EC’s expressed concerns about climate change, part of this new long-term vision includes new rulings that facilitate the production of bio-fertilizers, encourage the production of biogas from manure treatment, and increase biomass imports.  Emphasizing the crucial role of biomass in a world with a 30 percent higher population in 2050, the report states that “biomass can directly supply heat.  It can be transformed into biofuels and biogas and when cleaned can be transported through the gas grid substituting natural gas … And it can substitute for carbon intensive materials, particularly in the building sector but also through new and sustainable bio-based products such as biochemicals.”  The report also analyzes the economic and social impacts of these new rulings, and highlights the critical role of the European Union (EU) in leading a low-carbon transition at the global level.


 

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:

  1. Advancing public health by promoting innovation;
  2. Strengthening public outreach and communication; and
  3. Increasing engagement with domestic and international partners.

The statement includes an indication that FDA will be seeking public input in the coming year.  Once input is received, the first step in implementing the new action plan will be the adoption of “a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them.”  According to their statement, this policy framework will be modern and flexible, accompanied by two guidance documents in 2019.  The guidance documents are intended to provide greater clarity on how FDA will be applying regulatory oversight in evaluating risk profiles of various products.  In addition to these elements, the Action Plan also highlights FDA’s commitment to efforts with both national and international partners in fostering efficiency and cooperation.


 

By Lynn L. Bergeson

The European Commission (EC) announced on October 16, 2018, the launch of a new web-based tool called BioWatch. Developed by BIOWAYS, a project funded by the European Union (EU), this new tool expands BIOWAYS’ efforts in raising awareness of biobased products and their social, economic, and environmental benefits. BioWatch consists of “an interactive online platform that provides projects in the bioeconomy sector with a free service to position themselves alongside one another and provide direct access to industry, political stakeholders, the media, and the general public.” Essentially, this tool serves as an “e-library” for biobased research and projects for its members. BIOWAYS is currently recruiting biobased industry research projects to begin building its “e-library.” More information is available on its website.


 

 

By Lynn L. Bergeson

On October 11, 2018, the European Commission (EC) released a statement announcing its new action plan for a sustainable bioeconomy in Europe. The new action plan, originally announced by President Juncker and First Vice-President Timmermans in their letter of intent, aims to “improve and scale up the sustainable use of renewable sources to address global and local challenges such as climate change and sustainable development.” In his remarks, EC Vice-President for Jobs, Growth, Investment and Competitiveness, Jyrki Katainen, emphasized the need for systemic changes as key drivers of change for the bioeconomy sector. Renewable and sustainable solutions depend on collaborative efforts by governments and industry stakeholders. Based on this premise, EC’s new strategy focuses on three key objectives that include 14 measures to be taken as early as 2019.  The three objectives are to:

  1. Scale up and strengthen the biobased sectors;
  2. Rapidly deploy bioeconomies across Europe; and
  3. Protect the ecosystem and understand the ecological limitations of the bioeconomy.

​These long- and short-term objectives focus on modernizing the European biobased economy and call for systemic changes that will reduce the large underused biomass and waste potential. The action plan will be further discussed and outlined during a conference with stakeholders, hosted by the EC on October 22, 2018, in Brussels.


 
 1 2 3 >  Last ›