Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Charles M. Auer, Senior Regulatory and Policy Advisor with B&C, have published “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” in Industrial Biotechnology. This article discusses how the “New [Toxic Substances Control Act (TSCA)] fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years. The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.”
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.
Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. The renewable chemicals’ market is estimated to reach $83.4 billion by 2018 in applications ranging from transportation and agriculture to textiles and cosmetics. In addition to all the elements great companies need to succeed -- a great product, a great brand, inspiring leadership, and vision -- biobased product companies need to understand how the U.S. Environmental Protection Agency (EPA) occupies a virtual seat at their management table, whether or not they know it.
An article by BRAG in the August 2013 issue of Industrial Biotechnology, available online, lays out the regulatory challenges the Toxic Substances Control Act (TSCA) presents to biobased and renewable chemical products and the rationale behind the formation of BRAG. Through strategic insight into regulatory and legislative issues, collective advocacy on Capitol Hill and before EPA, education and training opportunities, and hands-on guidance from a deep bench of TSCA legal and scientific policy experts, BRAG is removing obstacles to commercialization for its members.