On February 26, 2016, the U.S. Department of Energy (DOE) announced the upcoming Agile Biomanufacturing Industry Listening Workshop that is being held by nine national laboratories to increase understanding of industry needs around synthetic biology. The national laboratories are working to create an agile biomanufacturing platform using synthetic biology tools to quickly engineer biofuels and biochemical in response to industry demands. A successful platform will help organizations to develop biological processes to create biobased products, while reducing associated risks. The workshop is occurring on March 15, 2016, in Berkeley, California from 8:00 a.m. to 6:30 p.m. Those wishing to attend should register online by March 4, 2016.
On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs to ask and answer when it receives a Microbial Commercial Activity Notice (MCAN) for GE algae. Dr. Morris discussed how this workshop will contribute to EPA's broader effort to update the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms document that relates to other GE microorganisms, as well as the update to the federal Coordinated Framework on the Regulation of Products of Biotechnology. While updating the framework will assist EPA in handling risk assessments for GE algae, regulation will continue to be risk-based and determined on a case-by-case basis.
Members of EPA's biotech review team discussed aspects of MCAN review and pointed out particular areas where EPA seeks input, in particular:
- Taxonomy of algae;
- Propensity to transfer genetic material to other species;
- Ability to produce toxins or allergenic effects;
- How the growth rate and forms (unicellular or filamentous) might relate to exposure;
- Survivability of GE algae in the wild; and
- Propensity to out-compete wild populations of algae, and organismal control mechanisms.
The panel, as well as stakeholders, commented on how algae are different than traditional industrial microbes in some significant ways:
- The organisms are not as well studied, largely because, unlike bacteria and fungi, they have only recently been used for industrial production.
- Inactivation methods are quite different because of the protective cell walls that algae have, that most microbes lack.
Dr. Morris also made it clear that this meeting is just the beginning of the conversation. EPA continues to seek input from stakeholders on algae, in particular, and other GE organisms as part of EPA's effort to update the regulatory framework for GE organisms. Draft Charge questions are available on the workshop website, speaker presentations can be accessed through the meeting agenda webpage, and the deadline for written comments is October 31, 2015. More information on EPA's development and use of biotechnology is available in B&C's memorandum EPA Posts Information on Biotechnology Algae Project.
The Expert Workshop focusing on technical questions for the U.S. Environmental Protection Agency's (EPA) development of a biotechnology algae considerations document is drawing near. The workshop will be open to the public and is scheduled for September 30, 2015, from 8:00 a.m. to noon. More details, including instructions on how to register for the workshop, will be made available in a Federal Register notice. More information regarding the biotechnology algae project is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum EPA Posts Information on Biotechnology Algae Project.
BETO is hosting a workshop on November 5, 2014, in Arlington, Virginia, to address challenges in converting waste food products to energy. The workshop will gather experts in the field to identify technical barriers to the commercial development of liquid transportation fuels from waste feedstocks, which will ultimately help develop a roadmap that highlights the key pathways and metrics to reaching commercialization. Registration is free, but space is limited. More information is available online.
The U.S. Environmental Protection Agency (EPA) has announced that, as part of its work to improve the safety of existing chemicals under the Toxic Substances Control Act (TSCA), the Agency will hold a public workshop to hear from experts on the use of trichloroethylene (TCE) as a degreaser, availability and efficacy of safer alternatives, and possible risk reduction approaches. The workshop is scheduled to be held on July 29, 2014, from 9:00 a.m. to 5:00 p.m., and on July 30, 2014, from 9:00 a.m. to 12:00 p.m. It will be located at EPA Headquarters, East William Jefferson Clinton Building, Room 4225, 1201 Constitution Avenue N.W., Washington, D.C. 20460-0001.
More information on the workshop, including how to participate, is available online.
The BIO World Congress on Industrial Biotechnology, being held May 12-15, 2014, in Philadelphia, Pennsylvania, is the world's largest industrial biotechnology event for business leaders, investors, and policy makers in biofuels, biobased products, and renewable chemicals. BRAG and B&C will present a practical workshop to fully inform, equip, and assist renewable chemical producers in finding the path of least resistance on the road to commercialization.
"Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process"
Tuesday, May 13, 2014, 2:30 p.m. - 4:00 p.m.
Moderator: Lynn Bergeson, B&C
David Widawsky, Director - Economics, Exposure, and Technology Division, Office of Pollution Prevention and Toxics (OPPT), EPA, Manager of the Presidential Green Chemistry Challenge Awards
Tracy Williamson, Chief, Industrial Chemistry Branch, OPPT, EPA
Frank Pacholec, VP R&D/Corporate Sustainability Officer, Stepan Company
Nancy Clark, DuPont Industrial Biosciences
* Overview of the 90-day EPA new chemical notification review process
* Filling out the premanufacture notification (PMN) form -- Top Ten Mistakes and How to Avoid Them
* Challenges posed by chemical identity/nomenclature under U.S. and European Union (EU) law
* Leveraging successfully pollution prevention benefits
For information and to register click here.
The Department of Energy's (DOE) Bioenergy Technologies Office will host the second of two workshops on algae biofuels strategy on March 26-27, 2014, in Charleston, South Carolina. A copy of the agenda is available online.
The workshop will focus on the research and development still needed to achieve affordable, scalable, and sustainable algae-based biofuels. It will cover topics including barriers to commercialization for algae biofuels and appropriate metrics for success. It comes five years after DOE organized the National Algal Biofuels Technology Roadmap workshop. The workshop is intended to help DOE in its strategic development, evaluating the National Algal Biofuels Technology Roadmap, and planning a breakout session at the Office's annual Bioenergy Conference in 2014.
Participants may register online.
Attendees at the Society for the Commercial Development of Industrial Biotechnology's (SCD-iBIO) 2nd Annual "Commercializing Global Green" forum in Philadelphia this week participated in a practical, in-depth three-hour workshop presented by the Biobased and Renewable Products Advocacy Group (BRAG™) on the critical policy, legislative, and regulatory issues impacting the commercialization of renewable chemicals. Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®) and Of Counsel with BRAG, shared the latest developments from Capitol Hill on the Chemical Safety Improvement Act of 2013 (CSIA) (S. 1009), in what she referred to as a "groundbreaking legislation" with bi-partisan support. Ms. Bergeson cautioned that "many difficulties remain and the likelihood of success is unclear." Ms. Bergeson also emphasized the need for the biochemical industry to engage with the U.S. Environmental Protection Agency (EPA) and identified strategies for companies to move successfully new chemicals through the regulatory process with EPA under the current version of the Toxic Substances Control Act (TSCA).
Kathleen M. Roberts, Executive Director of BRAG, updated workshop attendees on BRAG's efforts to petition for partial reporting exemptions under the TSCA Chemical Data Reporting (CDR) rule, and other efforts BRAG is making to level the regulatory playing field for biobased chemical manufacturers. Attendees learned about the complexities surrounding byproduct reporting under the CDR. They also learned that a number of listed chemicals, mainly derivative of the petroleum process stream, are exempted from Part III reporting, but those from renewable feedstocks are not, so the renewable chemicals may face higher regulatory hurdles than manufacturers anticipate. BRAG will be petitioning EPA early in 2014 for exemptions using a list of Chemical Abstract Service (CAS) numbers provided by members, and Ms. Roberts urged renewable chemical manufacturers to contact her to be included on this list.
Copies of BRAG's workshop presentations are available by contacting Chad Howlin at Tags: TSCA, workshop