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 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 Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” requiring EPA to conduct new chemical assessments.  If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments.  Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology.  These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals -- restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
 
POTENTIAL SOLUTION:  To address these issues, the Biobased and Renewable Products Advocacy Group (BRAG®) has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted. 
 
REQUEST:  BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests.  Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent.  If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
 
BRAG and Bergeson & Campbell, P.C. (B&C®) are committed to this project.  As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
 
Please contact .(JavaScript must be enabled to view this email address) if your company is interested in submitting a nomination.

Tags: BRAG, Biobased

 

By Lynn L. Bergeson

On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition of Section 351(k). The BPCI Act also amended the Federal Food, Drug, and Cosmetic Act to include Section 351(k) under human drug applications for prescription drug user fees provisions. The Program is meant to “create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. This allows a company to apply for licensure of a biosimilar or interchangeable biological product.” In 2012, the Biosimilar User Fee Act (BsUFA) allowed FDA to assess and collect user fees for activities connected with biosimilar biological product development (BPD). Some of these activities include the submission and review of forms, as well as an annual survey of all BsUFA participants.
 
The information collection proposal estimates an annual reporting burden of 57 hours, based on the number of respondents, the number of responses per respondent, the total annual responses, and the average burden per response. OMB will be accepting comments on FDA’s collection of information proposal until December 5, 2018.

Tags: FDA, OMB

 

By Lynn L. Bergeson

On November 6, 2018, Neste, a BRAG member, announced its partnership with Clariant to develop new sustainable material solutions. While Clariant concentrates on specialty chemicals, Neste consists of one of the leading companies providing renewable diesel and drop-in chemical solutions. In the announcement, Neste outlined the phases of the partnership, as follows:
 
Phase 1: The companies will start to replace fossil-fuel based ethylene and propylene with monomers from renewable feedstock.
 
Phase 2: The companies will develop alternative sustainable solutions from renewable raw materials for plastics and coatings.
 
The two phases are designed to allow the two companies to increase their biobased products, while reducing dependency on crude oil and climate emissions. Neste’s President and Chief Executive Officer (CEO), Peter Vanacker, stated that the “[c]ollaboration marks an essential step forward in Neste’s quest to become a preferred partner as a provider of sustainable chemicals solutions for forerunner brands.”


 

By Lynn L. Bergeson

On October 31, 2018, the Canadian National Energy Board released its 2018 report on energy supply and demand projections to 2040: “Canada’s Energy Future 2018: An Energy Market Assessment.” Based on a set of assumptions about technology, energy, climate, human behaviors, and the structure of the economy, the assessment identifies five key findings as follows:

  1. Canada’s energy demand growth is slowing, while the sources to meet these demands are becoming less carbon intensive;
  2. With greater adoption of new energy technologies, Canadians use over 15 percent less total energy and 30 percent less fossil fuels by 2040;
  3. Energy use and economic growth continue to decouple;
  4. Canada’s energy mix continues to become more diverse, adding more renewables; and
  5. Canadian oil and natural gas production increases, with price and technology changes influencing production in the future.

The report predicts that energy generation from renewable sources will increase in 2040 to represent 12 percent of all electricity generation. It concludes, that given the higher demand in reducing carbon emissions and the increase in biofuel blending rates, the costs of renewables will likely drop.


 

 

By Lynn L. Bergeson

On October 30, 2018, Earthjustice and the Clean Air Task Force submitted to the U.S. Environmental Protection Agency (EPA) a petition “to amend its ‘aggregate compliance’ approach to the definition of biomass under the Renewable Fuel Standard (RFS) … to prevent the conversion of native grasslands.”  The petition was filed on behalf of 11 organizations, including the National Wildlife Federation and the Sierra Club, and urges EPA’s Administrator Andrew Wheeler to amend regulations related to land permissibility for renewable biomass production.  Under the 2007 Energy Independence and Security Act’s (EISA) RFS, land conversion for the production of renewable fuel sources is restricted to agricultural land cultivated prior to the enactment of the ruling that is nonforested or uncultivated.  Meant to ensure that growing renewable fuel sources would not significantly increase greenhouse gas emissions, the petition claims that these requirements are not being implemented by EPA due to an aggregate compliance system for measuring land use.  Instead, green groups are requesting that EPA use an individualized compliance approach in evaluating biofuel producers to assure compliance with EISA’s land use restrictions.  The petition also requests that EPA require additional “proof that only EISA-compliant land is used to grow crops displaced by renewable biomass production.”


 

By Lynn L. Bergeson

On October 30, 2018, the U.S. Department of Energy (DOE) announced the topics for 2019 funding opportunities.  Amongst the program offices that are participating in this solicitation, is the Office of Energy Efficiency and Renewable Energy, who will be hosting an informational webinar on November 6, 2018, at 2:00 p.m. (EST) as an opportunity to ask the DOE Program Managers any questions about DOE funding opportunities.  The 90-minute webinar requires registration and allows for the submission of questions prior to the event.  Important upcoming dates regarding the submission funding applications include:

  • Funding Opportunity Announcement:  November 26, 2018;
  • Letter of Intent Due Date:  December 17, 2018;
  • Non-response Letter of Intent Feedback Provision:  January 7, 2019;
  • Application Due Date:  February 4, 2019;
  • Award Notification Date:  April 29, 2019; and
  • Start of Grant Budget Period:  June 10, 2019.

‚ÄčBoth the award notification and the start of the grant budget period dates are subject to change.


 

By Lynn L. Bergeson

In October 2018, DOE’s Bioenergy Technologies Office (BETO) published a report called “Cell-Free Synthetic Biology and Biocatalysis:  Prototyping and Conversion Platforms.”  The report consists of a summary from discussions held on a listening day by BETO in Denver, Colorado, in 2017.  The public meeting was intended to discuss research and development opportunities related to cell-free synthetic biology and biocatalysis, and how these techniques could be leveraged in the production of biofuels and bioproducts. Attendees of the meeting included representatives from academia, DOE national laboratories, industry, and other federal agencies.


 

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.


 
 < 1 2 3 4 5 >  Last ›