Biobased and Renewable Products Update
November 8, 2018
Call For Candidate Chemicals For Equivalency Determinations
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 Ligia Duarte Botelho if your company is interested in submitting a nomination.
FDA Submits A Collection Of Information Proposal To OMB
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.
Neste Partners With Clariant In A Joint Effort To Develop Biobased Solutions
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.”
Canada National Energy Board Releases Report On Energy Future
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.
|ABOUT THE FIRM
The Biobased and Renewable Products Advocacy Group (BRAG®) helps members develop and bring to market their innovative biobased 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.
|Biobased and Renewable
Products Advocacy Group
2200 Pennsylvania Ave., N.W.
Washington, D.C. 20037