All Articles, Books, & Other Publications

Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, "Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act," Industrial Biotechnology, October 2014.

Synthetic biology is delivering on its promise as an emerging scientific field in providing society with effective new sustainable products in diverse areas including renewable energy, contamination remediation, and medical applications, among others. As is the case with any rapidly evolving technology, the pace of technological innovation challenges regulators’ ability to identify and address adequately the substantial uncertainties they confront when discharging their legal obligations under controlling laws to ensure human and environmental safety. This article provides a brief description of synthetic biology, discusses the current domestic regulatory framework that governs the regulation of products of synthetic biology, and focuses narrowly on options and opportunities the US Environmental Protection Agency (EPA), innovators in the area of synthetic biology, and the Toxic Substances Control Act (TSCA)-regulated community at large may wish to consider to enhance TSCA’s core adaptive capacity to identify and address potential health and environmental risk implications posed by the commercialization of products of synthetic biology.

Pat Rizzuto, "Biobased Diesel Companies Petition EPA For Rules Comparable to Traditional Diesel," Bloomberg BNA Daily Environment Report, October 22, 2014.

On October 21, 2014, BRAG® submitted two petitions to the U.S. Environmental Protection Agency requesting that biodiesel fuel manufacturers be granted the same Chemical Data Reporting (CDR) exemptions that petroleum-based diesel manufacturers already receive.  Bloomberg BNA Daily Environment Report covered the petitions in this feature story.

Kathleen M. Roberts, "How to Make Friends and Win EPA Approvals: tips for biobased chemicals," Biofuels Digest, May 28, 2014.

In last week’s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to “avoid an afterthought approach to regulatory compliance.” As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive involved with biobased chemicals at a session titled “Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process.” This article highlights the top tips for gaining EPA regulatory approval shared by EPA’s Dr. Tracy Williamson and Dr. David Widawsky at the session.

Lynn L. Bergeson, Kathleen M. Roberts, "Promoting Renewable Chemicals," The Environmental Forum, January/February 2014.

Biofuels have gotten all the press. But biobased chemicals have equal environmental and health potential, and also the most exposure under the Toxic Substances Control Act. Implications range from irritating to crippling, depending upon a manufacturer’s response.

Lynn L. Bergeson, "The Regulation of Renewable Chemicals Under the Toxic Substance Control Act (TSCA)," Environmental Quality Management, Fall 2013.

The application of the Toxic Substances Control Act (TSCA) to biobased chemicals is sometimes overlooked, given the enthusiasm supporting the commercialization of biobased products. This “Washington Watch” article explains TSCA’s application to these products and outlines strategies to ensure the successful marketing of biobased chemical products.

American Bar Association, "Special Green Chemistry Issue," ABA Section of Environment, Energy, and Resources Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, November 2013.

Green chemistry is a hot topic in the 2013–2014 Pesticide, Chemical Regulation, and Right-to-Know (PCRRTK) Committee Action Plan. According to the U.S. Environmental Protection Agency (EPA) (http://www2.epa.gov/green-chemistry), green chemistry is “the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances.” The momentum that green chemistry has taken on is so notable that we are taking the unusual step of devoting a special issue of the PCRRTK Newsletter to this exciting and groundbreaking topic.

Lynn L. Bergeson, Kathleen M. Roberts, Heidi B. Lewis, "Why BRAG Before You Go to Market? The Biobased and Renewable Products Advocacy Group (BRAG) Helps," Industrial Biotechnology, August, 2013.

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.

 

Lynn L. Bergeson, Charles M. Auer, and R. David Peveler, "TSCA and the Regulation of Renewable Chemicals," Industrial Biotechnology, October 2012.

Lynn L. Bergeson, Charles M. Auer, and R. David Peveler published an article appearing in the October 2012 issue of Industrial Biotechnology. The article discusses how the Toxic Substances Control Act (TSCA) applies to biobased chemicals, and suggests strategies for industrial stakeholders to ensure the successful introduction and marketing of biobased chemical products.

Welle, Whitehouse, Sturdevant, Mann, "Minnesota Roadmap: Recommendations for BioIndustrial Processing," , 2012.

Published by The BioBusiness Alliance of Minnesota, LifeScience Alley, and The Great Plains Institute.

Chapter 2 addresses downstream market development of biobased chemicals and Chapter 6 covers policy development for BioIndustrial Processing.

, "The National Bioeconomy Blueprint," , April, 2012.

Issued by the White House Office of Science and Technology.

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