With little fanfare, 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 could have significant implications for innovators in the biotechnology and synthetic biology commercial space.
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.
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.
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.
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.
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.
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.
It is official. California’s Office of Administrative Law (OAL) approved the California Department of Toxic Substances Control (DTSC) Safer Consumer Products regulations, and the program went into effect on October 1, 2013. The regulations mark the much-anticipated regulatory implementation of California’s Green Chemistry Initiative. The regulations and final statement of reasons are available at http://www.dtsc.ca.gov/SCPRegulations.cfm. This new program is a true game-changer, and it will have profound national and international business, regulatory, and commercial implications for consumer product manufacturers and others for the reasons noted in this Washington Watch article.
On January 29, 2014, the U.S. Environmental Protection Agency (EPA) released two final Alternatives Assessment Reports for the flame retardant decabromodiphenyl ether (DecaBDE) and bisphenol A (BPA) in thermal paper. The EPA’s Design for the Environment (DfE) program developed the assessments, which profile the environmental and human health hazards for DecaBDE, BPA, and their alternatives. This article explains why these assessments are important.
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.