TSCA

Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182, significantly amends the Toxic Substances Control Act (TSCA). The Act was signed into law by President Obama on June 22, 2016. The date of signature is both the date of enactment and of entry into force of amended TSCA. New 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.

Richard E. Engler, Ph.D., "The Impact of Toxic Substances Control Act Nomenclature on the Commercialization of Biobased Chemicals," AOCS Inform, July/August, 2015.

Imagine receiving a certified letter from the US Environmental Protection Agency (EPA) announcing that it plans to conduct an audit of your company’s facility in two weeks. The audit will focus on your company’s compliance obligations as a chemical manufacturer under the Toxic Substances Control Act (TSCA). Would you be prepared or are you unsure of what TSCA is and whether it applies to you? This article explains how TSCA applies to biobased chemicals and how nomenclature and chemical identity can impact commercialization.

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 3, Call to Action," Biofuels Digest, May 18, 2015.

In the second installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products across a manufacturing process, from feedstock to product. In this last installment, I present options for updating TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered in as part of the original TSCA Inventory.

The key is to find a way to level the field without compromising the U. S. Environmental Protection Agency’s (EPA) mission and authority to protect human health and the environment.

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," Biofuels Digest, May 1, 2015.

In the first installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products. In this article, we will look across a manufacturing process.

TSCA applies to chemical substances that are used for purposes other than food, food additives, animal feed, cosmetics, drugs, tobacco and tobacco products, pesticides, munitions, and nuclear source materials. Biobased chemicals, that is, chemicals made from lignocellulose or other biomass, are finding markets in food and cosmetic markets, but much of the recent innovation focuses on biobased fuels and commodity chemicals. For these final products, TSCA applies. Chemical products must be listed on the TSCA Inventory of Chemical Substances (the Inventory) or be eligible for an exemption. If the product is not listed on the Inventory, the manufacturer must file a premanufacture notification 90 days before manufacturing (or importing) that substance or qualify for an appropriate exemption.

Richard E. Enlger, Ph.D., "The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," Biofuels Digest, April 26, 2015.

Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable Fuel Standard, fuel additive registration, or other CAA submissions. TSCA also applies to bioproducts used in industrial, commercial, and most consumer products, including fuels. TSCA reporting requirements are in addition to, and separate from, CAA reporting.

Kevin Adler, "TSCA Nomenclature May Be Barrier for Advanced Biofuels," OPIS Ethanol & Biodiesel Information Service Newsletter, April 7, 2015.

The Oil Price Information Network (OPIS) spoke with BRAG's  Richard E. Engler, Ph.D. , Senior Policy Advisor with Bergeson & Campbell, P.C., regarding the application of the Toxic Substances Control Act (TSCA) to oils made from algae feedstocks and other non-traditional bio-materials.  The resulting article in the OPIS Ethanol & Biodiesel Newsletter is reprinted here with permission from OPIS. 

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.

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.

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.


 
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