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 Lauren M. Graham, Ph.D.

On April 4, 2017, Members of the European Parliament (MEP) approved a resolution calling on the European Commission (EC) to phase out the use of palm oil as a component of biofuels and advocating for a single certification scheme for palm oil entering the European Union (EU).  The resolution states that biofuels production accounts for 46 percent of the palm oil imported by the EU and requires about one million hectares of tropical soils.  To limit the deforestation and habitat degradation that comes from unsustainable palm oil production, the EU aims to phase out the use of vegetable oils that drive deforestation as a component of biofuels by 2020.  Additionally, the resolution encourages the use of a single certification scheme with specific sustainability criteria for palm oil to ensure that only sustainably produced palm oil and products enter the EU market.  MEP also called on EC to improve the traceability of imported palm oil. 
 
Following the approval of the resolution, Neste, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), announced an update to the Crude Palm Oil Dashboard on its website.  The dashboard provides information on Neste’s crude palm oil suppliers across the supply chain in an effort to improve supply chain transparency.  Neste states that all of its crude palm oil has been fully traceable to the plantation level since 2007 and has been 100 percent certified since 2013.


 

By Lauren M. Graham, Ph.D. 

On March 24, 2017, the California Energy Commission (CEC) published a notice on the proposed recipients of up to $23 million in Electric Program Investment Charge (EPIC) funding for applied research and development (AR&D) and technology demonstration and development (TD&D) activities focused on advancing bioenergy electricity generation.  The funding opportunity is focused on three main bioenergy applications, including:

 
■  Efficient, Sustainable and Lower-Cost Bioenergy: Innovations to Improve Woody Biomass-to-Electricity Systems ($5,000,000);
 
■   Demonstration and Evaluation of Environmentally and Economically Sustainable Woody Biomass-to-Electricity Systems ($10,000,000); and
 
■  Demonstration and Evaluation of Environmentally and Economically Sustainable Food Waste Biomass-to-Electricity Systems ($8,000,000).
 
Of the 57 abstracts submitted, 28 passed Phase 1 screening.  All of the 23 proposals received during Phase 2 passed the administrative screening process.  CEC published the recommended funding and score for each of the 23 proposed projects.  The funding recommendations will be approved during the Energy Commission Business meeting, at which time the Energy Commission can add, remove, or shift funding to make additional awards and negotiate with applicants to modify the project scope, schedule, or funding level.

 

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 possible future products of biotechnology that will arise over the next five to ten years, as well as providing some insights that can help shape the capabilities within the agencies as they move forward.  More information regarding the July 2015 memorandum is available on our website under the key phrase Biobased Products, Biotechnology.

Via an ad hoc committee, the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, NAS developed this report through several months of gathering and synthesizing information from several sources, including:  74 speakers over the course of three in-person meetings and eight webinars, including one presented by Lynn L. Bergeson; responses to its request for information from a dozen federal agencies; statements solicited from members of the public at its in-person meetings; written comments through the duration of the study; and recent NAS studies related to future products of biotechnology.

The report presents conclusions concerning the future biotechnology products themselves, as well the challenges that federal agencies will face in regulating them, which include:

  • The bioeconomy is growing rapidly and the U.S. regulatory system needs to provide a balanced approach for consideration of the many competing interests in the face of this expansion;
  • The profusion of biotechnology products over the next five to ten years has the potential to overwhelm the U.S. regulatory system, which may be exacerbated by a disconnect between research in regulatory science and expected uses of future biotechnology products;
  • Regulators will face difficult challenges as they grapple with a broad array of new types of bio-technology products -- for example, cosmetics, toys, pets, and office supplies -- that go beyond contained industrial uses and traditional environmental release;
  • The safe use of new biotechnology products requires rigorous, predictable, and transparent risk-analysis processes whose comprehensiveness, depth, and throughput mirror the scope, scale, complexity, and tempo of future biotechnology applications.

The report provides three recommendations for federal agencies in responding to these challenges, which it states should be taken to “enhance the ability of the biotechnology regulatory system to oversee the consumer safety and environmental protection required for future biotechnology products”:

  1. The U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and other agencies involved in regulation of future bio-technology products should increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural, regulatory, and social sciences. 
  2. EPA, FDA, and USDA should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex and to prototype new approaches for iterative risk analyses that incorporate external peer review and public participation. 
  3. The National Science Foundation, the Department of Defense, the Department of Energy, the National Institute of Standards and Technology, and other agencies that fund bio-technology research with the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory-science activities.  

Commentary

The report is well-written and contains an impressive amount of new, relevant, and important information.  The Committee participants are to be commended for an important new piece of scholarship in this area.

The report’s conclusions are also significant, but not entirely unexpected.  For those of us working in this space, we have recognized for years the lack of clarity regarding jurisdictional boundaries, the paucity of government resources, and the urgent need for regulatory clarity and significantly enhanced funding.  Unfortunately, given current Trump Administration efforts to diminish government funding for EPA, FDA, and elsewhere, the well-crafted and spot-on recommendations may tragically fall on deaf ears.  Shareholders should carefully review the report and work hard to ensure the recommendations are implemented.  The consequences of failing to “increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural regulatory, and social sciences” -- the number one recommendation in the report -- are too great to ignore.


 

 

Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Charles M. Auer, Senior Regulatory and Policy Advisor with B&C, have published “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” in Industrial Biotechnology. This article discusses how the “New [Toxic Substances Control Act (TSCA)] fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years.  The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.”


 

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.


 

By Lynn L. Bergeson and Carla N. Hutton

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.”  Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.”  To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.”  EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities.  In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products.  When completed, the agencies will consider the study’s findings, as well as the comments.  More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.


 

On November 30, 2016, Neste, a member of the Biobased and Renewable Products Advocacy Group (BRAG®), released a statement in response to the publication of the European Commission’s (EC) proposal on the revised Renewable Energy Directive (Directive) for 2021 to 2030.  The aim of the Directive is to raise renewable energy usage in Europe to 27 percent by 2030.  In the revised Directive, the EC introduced a mandate requiring fuel suppliers to include a minimum share of advanced biofuels in their offering, which will increase steadily between 2021 and 2030.  Neste highlighted the fact that for the first time renewable solutions from the aviation and marine sectors are included in the biofuels blending mandate.  Neste stated the proposal would support biofuels use and development in Europe, and provide predictability that would allow companies to plan their long-term operations and investments.  The proposal requires approval from the European Council and the European Parliament before it becomes official.


 

On November 3, 2016, the European Commission announced that 144 new green and low-carbon projects from 23 Member States will be funded by a €222.7 million investment from the European Union (EU) budget, which will be combined with €175.9 from additional investments.  The funding comes from the LIFE programme, the EU’s funding body for the environment and climate action, with the goal of progressing Europe towards a more sustainable future.
 
The selected projects align with the EU’s objective to reduce GHG emissions and transition to a more circular economy.  Examples of 2015 projects include:  

 

Implementation of Biodolomer®, a fossil-free biomaterial, in place of plastic packaging for four commercial reference products;

 

Production of biopolymers for the tanning industry using recycled biomass from the tanning process; and

 

Incorporation of cultivated banana organic waste fibers as an additive to create bioplastic covers to protect banana treats from UV radiation.

 
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