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.”
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Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.
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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 announced. 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. |
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