B&C, BCCM Publish Article On Microbial TSCA Compliance
Industrial Biotechnology recently published a special issue to highlight the advances and challenges in algae-based products and applications. The article, written by B&C® Consortia Management, L.L.C. (BCCM) affiliate Bergeson & Campbell, P.C. (B&C®) Managing Partner, Lynn L. Bergeson; B&C Senior Chemist, Richard E. Engler, Ph.D.; and BCCM Manager, Lauren M. Graham, Ph.D., examines the complex regulatory domain and discusses the significance and implications of the Toxic Substances Control Act (TSCA) for industrialized microorganisms, such as algae. The article titled “TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses” provides an overview of the fundamentals of TSCA, the U.S. Environmental Protection Agency’s (EPA) review of new substances, the impact that chemical identity has on EPA’s regulation of new substances, and available reporting exemptions. In the article, the authors highlight the need for chemical product innovators “to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae); intermediates; and commercial products, and build TSCA compliance into business timelines and budgets.” While the products of industrial microbes have the potential to reduce toxicity, greenhouse gas (GHG) emissions, and dependence on non-renewable resources, companies must comply with TSCA and the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that such products successfully enter the market.
Senators Re-Introduce Bipartisan Bill To Extend MLP Benefits To Renewables
On October 25, 2017, bipartisan legislation aimed at leveling the playing field between renewable and fossil fuels was re-introduced in the Senate and House of Representatives. Senator Chris Coons (D-DE), along with eight bipartisan co-sponsors, introduced the Master Limited Partnerships Parity Act (S. 2005) in the Senate. Representative Ted Poe (R-TX), along with six co-sponsors, introduced similar legislation (H.R. 4118) in the House. The legislation would allow investors in a range of clean energy projects, including renewable fuels, access to a corporate structure whose tax advantage is currently available only to investors in fossil fuel-based energy projects. According to Senator Coons, “[u]pdating the tax code in this way will help increase parity and ensure that [clean] energy technologies can permanently benefit from the incentives that traditional energy sources have depended on to build infrastructure for more than 30 years.” The bills were previously introduced in the Senate and House on June 24, 2015.
DOE Workshop On Optimizing Bioenergy Production
The U.S. Department of Energy’s (DOE) Bioenergy Technology Office (BETO) is hosting an Advanced Development and Optimization (ADO) Workshop on December 12-13, 2017, in Golden, Colorado. At the workshop, BETO intends to discuss how the new ADO program area can best serve stakeholders in developing the bioenergy industry, and to raise awareness of existing assets from past investments and discuss future needs and opportunities for maximizing these assets’ value. The ADO program aims to remove the risk associated with bioenergy production technologies through validated proof of performance at the pilot, demonstration, and pioneer scales and to remove any additional barriers to commercialization. More information on the ADO program is available on the BETO website. Registration for the ADO Workshop will be available shortly.
DOE Awards $4.8 Million In Funding For BIRD Energy Projects
On November 1, 2017, DOE, along with Israel’s Ministry of Energy (MOE) and the Israel Innovation Authority, awarded $4.8 million in funding to five Binational Industrial Research and Development (BIRD) Energy projects. The five projects represent the ninth selection of BIRD Energy projects and span the fields of hydrogen storage, advanced biofuels, sustainable transportation, and energy efficiency. Despite the diversity among the topic areas, all BIRD Energy projects aim to promote energy innovation, economic security, and bilateral cooperation through a partnership between U.S. and Israeli researchers. Among the selected projects is a collaboration between CelDezyner Ltd. (Rehovot, Israel) and AdvanceBio LLC (Milford, Ohio) on the development of a process for production of ethanol from lignocellulosic feedstocks.
USDA Withdraws Proposed Rule On The Importation, Interstate Movement, And Environmental Release Of Certain GE Organisms
On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register announcing that it was withdrawing its proposed rule that would have revised the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms. The proposed rule, which was issued on January 19, 2017, aimed to “update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by [GE] organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks.” After reviewing public comments on the proposed rule, USDA decided to re-engage with stakeholders and explore alternative policy approaches. More specific comments from USDA and the reasons supporting its decision are set forth in the notice.
While it appears that some in industry may welcome the withdrawal, most would agree that all stakeholders should work collaboratively and quickly to develop a new framework to speed the process to market, and to ensure the regulatory landscape is more efficient and clearer than it currently is. USDA and pertinent others should immediately begin another process to enable the regrouping to begin.