On August 25, 2015, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing a Public Meeting and Opportunity for Public Comment on Considerations for Risk Assessment of Genetically Engineered Algae. The public meeting, entitled "Workshop for Public Input on Considerations for Risk Assessment of Genetically Engineered Algae," is intended to receive public input and comments on the data needs of EPA to support risk assessments of biotechnology products using genetically engineered algae and cyanobacteria under the Toxic Substances Control Act (TSCA). Feedback from the workshop will also be used to update the EPA guidance document "Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms."
The public workshop will be held on September 30, 2015, from 8:00 a.m. to noon (EDT) in Washington D.C., and will also be available online for registered participants. Advance registration will close on September 25, 2015, and written comments are due by October 31, 2015. More information regarding the workshop is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum EPA Schedules Workshop on Considerations for Risk Assessment of Biotechnology Algae.
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.
On August 12, 2015, the U.S. Environmental Protection Agency (EPA) announced three webinars to review the new features of the updated online Premanufacture Notifications (PMN) Submission System. The new web-based submission system for the Toxic Substances Control Act (TSCA) Section 5 submissions is replacing the ePMN reporting software that is currently in use. The first webinar is on August 26, 2015, from 1:00 p.m. - 4:00 p.m., and will cover the process of registering with the Central Data Exchange (CDX) and user roles. The second webinar is on September 16, 2015, from 1:00 p.m. - 4:00 p.m., and will review the PMN form, support form, and joint submissions. The final webinar will occur on September 30, 2015, from 1:00 p.m. - 4:00 p.m., and will include a discussion of Notice of Commencement (NOC), biotech, "bona fide," and Significant New Use Rules (SNUR) Alternate Control Measures electronic submissions.
The inclusion of biotechnology algae in the third and final webinars was previously mentioned in the announcement of the "US Environmental Protection Agency Biotechnology Algae Project." The biotechnology algae project will result in the development of a stand-alone document that will assist innovators who are developing new microbial technology applications under TSCA. EPA will develop the algae guidance in conjunction with the update of the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider) document. The webinar will allow the public to submit questions on both technical issues relating to the development of a biotechnology algae considerations document, as well as on the societal implications of the development of biotechnology algae. This invitation for stakeholder input is a key opportunity to explain the steps that are being taken to ensure responsible development and use of biotechnology, and to provide comment on how EPA can improve and update the Points to Consider document. 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.
With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum directs the federal agencies to develop a long-term strategy to ensure that the regulatory system for biotechnology products is prepared for future products, and commissions an expert analysis of the future landscape of biotechnology products. A July 2, 2015, OSTP blog item entitled "Improving Transparency and Ensuring Continued Safety in Biotechnology" notes that the complexity of the array of regulations and guidance documents developed by EPA, FDA, and USDA "can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies." The memorandum states that the objectives "are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment."
The Coordinated Framework describes the federal regulatory policy intended to ensure the safety of biotechnology products. The 1992 update to the Coordinated Framework "sets forth a risk-based, scientifically sound basis for the oversight of activities that introduce biotechnology products into the environment." According to the memorandum, the update affirmed that federal oversight should focus on the characteristics of the product and the environment into which it is being introduced, rather than the process by which the product is created.
The memorandum states that federal agencies regulating biotechnology products "should continually strive to improve predictability, increase efficiency, and reduce uncertainty in their regulatory processes and requirements." Improvements must:
- Maintain high standards that are based on the best available science and that deliver appropriate health and environmental protection;
- Establish transparent, coordinated, predictable, and efficient regulatory practices across agencies with overlapping jurisdiction; and
- Promote public confidence in the oversight of the products of biotechnology through clear and transparent public engagement.
BRAG affiliate Bergeson & Campbell, P.C.'s (B&C®) full memorandum, "Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology," is available online.
ACS Green Chemistry & Engineering Conference, July 14-16, 2015, North Bethesda, Maryland
The longest running green chemistry conference in the United States, American Chemical Society Green Chemistry & Engineering (GC&E) Conference invites scientists, decision-makers, students, and advocates to come together, compare findings, and discuss the science of the future. BRAG is a proud sponsor. Richard E. Engler, Ph.D., will present a session on July 16, 2015, regarding how the Toxic Substances Control Act (TSCA) applies to biorenewable feedstocks.
BIO World Congress On Industrial Biotechnology, July 19-22, 2015, Montreal, Canada
The BIO World Congress on Industrial Biotechnology is the world's largest industrial biotechnology event for business leaders, investors, and policy makers in biofuels, biobased products, and renewable chemicals. BRAG advisor Lynn L. Bergeson will offer opening remarks at the Women in Industrial Biotechnology Reception, sponsored by BRAG, at 4:00 p.m. on July 19, 2015, and will open the Renewable Chemicals and Biobased Materials track, sponsored by BRAG affiliate Bergeson & Campbell, P.C. (B&C®), at 8:30 a.m. on July 20, 2015. Richard E. Engler, Ph.D., will present "TSCA and the Regulation of Biofuels" at 8:30 a.m. on July 20, 2015, and "Leveraging 'Green' for Visibility" at 10:30 a.m. on July 20, 2015.
2015 BIO Rosalind Franklin Award Recipient Announced
On May 8, 2015, BIO announced that Dr. Jennifer Holgrem, CEO of LanzaTech, will receive the 2015 BIO Rosalind Franklin Award, honoring an outstanding woman in the field of industrial biotechnology. Dr. Holgrem has led LanzaTech to develop the first alternative jet fuel made from industrial waste gases and has defined the genetic blueprint of gas fermenting organisms and demonstrated that they can be engineered to produce novel, commercially viable molecules. "To be honored in this way is incredibly humbling for me," stated Dr. Holmgren. "Throughout my career, I've been surrounded by teams, partners and investors who believe we can challenge the status quo and create an energy future that isn't at odds with society or the environment. It is through that shared vision and collective wisdom that we are able to use industrial biotechnology to move forward on a path to the sustainable and equitable energy future our planet deserves."
The Biobased and Renewable Products Advocacy Group (BRAG®) is proud to once again be sponsoring the Women in Industrial Biotechnology Reception at the 12th Annual BIO World Congress 2015, July 19-22, 2015, in Montreal, Canada. The reception is open to all BIO registrants, but RSVP is required. B&C, BRAG's affiliate, is sponsor of the Renewable Chemical and Biobased Materials track of programs at the conference.
On March 13, 2015, the National Academies issued Industrialization
Of Biology: A Roadmap To Accelerate The Advanced Manufacturing Of Chemicals,
a 143-page report prepared in response to a request from the U.S. Department of
Energy (DOE) and the National Science Foundation (NSF) to "develop a
roadmap of necessary advances in basic science and engineering capabilities,
including knowledge, tools and skills" to accelerate the advanced
manufacturing of chemicals using biological systems. Thirteen committee members
with expertise in synthetic biology, metabolic engineering, molecular biology,
microbiology, systems biology, synthetic chemistry, chemical engineering,
bioinformatics, systems integration, metrology, chemical manufacturing, and law
and bioethics worked together with researchers to create a technical roadmap
for the future of the biochemicals industry. The report, with chapters
including "Industrial Biotechnology: Past and Present," "Vision
of the Future: What New Chemicals Could Be Made?," and "How Do We Get
There?," examines the regulatory and societal factors limiting the
adoption of bioprocessing in the chemical industry today and makes
recommendations for EPA, the U.S. Department of Agriculture (USDA), the U.S.
Food and Drug Administration (FDA), and other agencies responsible for
governance of existing and emerging biobased chemicals. A prepublication
version of the report is available now, with a final publication date to be
Bergeson & Campbell, P.C. (B&C®) and the
Biobased and Renewable Products Advocacy Group (BRAG®) were honored
to sponsor the Women in Industrial Biotechnology Networking Reception, which
took place on December 7, 2014, at the 2014 BIO Pacific Rim Summit on
Industrial Biotechnology and Bioenergy in San Diego, California. The awardee
this year of the BIO Rosalind Franklin Award for Leadership in Industrial
Biotechnology was Dr. Debbie Yaver. During the reception, attendees dialogued
on the critical challenges and opportunities for today's women working within
the bioeconomy, as well as the need to ensure the best and brightest women
continue to pursue the biobased industry in the future.
As stakeholders eagerly await the impending official release of the U.S. Environmental Protection Agency's (EPA) proposed 2014 Renewable Fuel Standard (RFS) rule, strong advocacy from all sides continues on the issue in Washington. The Office of Management and Budget (OMB) has been reviewing the proposed rule since August 30, 2013. Recently, a draft of it was leaked (the leaked draft proposal). In the leaked draft proposal, for the first time, EPA would lower the RFS target volumes not only for cellulosic biofuels, but for conventional ethanol and advanced biofuels as well.
On October 23, 2014, biofuels advocates, including representatives from the Biotechnology Industry Organization (BIO), Advanced Ethanol Council (AEC), DuPont, Novozymes, and Abengoa, met with officials from OMB and the White House. Reportedly, they urged the Administration to reconsider the leaked draft proposal. They argued that the oil and gas industry's concerns about the blendwall -- the point at which no additional E10 may be blended into the fuel supply -- are unfounded and result not from the inability to blend greater amounts of ethanol into the fuel supply, but instead from the industry's refusal to do so. On October 29, 2013, BIO and AEC sent a letter signed by over 30 biofuels companies to President Obama again urging the Administration to reconsider the leaked draft proposal and stressing the importance of consistent RFS implementation to promoting investment in biofuels, including next generation biofuels.
This week, AAA and Sportsmen have come out in support of the oil and gas industry's position that EPA should lower the RFS volume requirements for ethanol to no more than 9.7 percent of the U.S. fuel supply. AAA echoes the industry's argument that such reduction is needed due to the E10 blend wall and concern that E15 could damage car engines. The Congressional Sportsmen's Foundation held a briefing this week during which it suggested that the ethanol volume requirements under the RFS have caused hunting and fishing areas to be converted to cropland, and have degraded water quality in the Mississippi River watershed, among other changes.
On October 1, 2013, U.S.-based INVISTA and UK-based industrial biotechnology company Ingenza Ltd. announced they are partnering on the development of new technologies to enable bio-derived processes for the production of industrial chemicals. A copy of INVISTA's press release is available online.