Regulatory Awareness and Relief
Industrial chemicals and fuels are subject to extensive federal regulation. These regulatory controls are primarily premised on risk assessment and risk management paradigms developed for petroleum-derived feedstocks, and often do not apply readily to biobased products. The application of these models and systems are creating impediments that can delay the regulatory approval status of biobased products requiring premarket approval and, in some cases, prevent their commercialization. Through our consortium, we address this obstacle, and provide policy awareness and work to gain regulatory relief in key compliance areas.
A crucial first point is helping consortium members understand that Toxic Substances Control Act (TSCA) requirements apply to biobased chemicals and therefore regulatory compliance requirements must be satisfied. In fact, biobased chemicals used for commercial purposes under TSCA's jurisdiction (i.e., used other than as drugs, pesticides, food, or related applications that are subject to other authorities) are required either to be listed on the TSCA Inventory or to be submitted for review by the U.S. Environmental Protection Agency (EPA) as a new chemical. The answer to this question is one that needs to be known well in advance of any plans for commercial activities such as manufacture, import, or processing of an individual chemical, including each member of a series of chemicals used as intermediates to make a final commercial substance.
If TSCA's Chemical Inventory listing for the chemical(s) can be established, the premanufacture notification (PMN) hurdle as a new chemical can be avoided entirely. If, on the other hand, one or more of the chemicals is subject to TSCA's new chemical notification, this point needs to be recognized and addressed early as part of a company's business development plan for the product or the process. Although most new chemicals submitted for EPA review are not ultimately regulated, when EPA targets a chemical for regulation, this will at a minimum result in unplanned delays, potentially lasting for months to years, as the regulatory process proceeds and under the worst case could result in a regulatory barrier to commercialization.
A corollary is that once EPA targets a new chemical for regulatory controls, there is a great likelihood that other new chemicals that are similar in chemical structure and in their uses/exposures will encounter a similar fate. A bottom line is that, given the potential scale of biobased chemical introductions over the coming years, new chemical notification requirements can represent a significant and continuing regulatory challenge and impediment to commercial development.
Legislative Policies and Politics
Farm Bill, BCAP, and Renewable Fuel Standard
Government policies regarding renewable energy and advanced biofuels production are inextricably linked to those of the emerging biobased products industry. Relevant policies include the Renewable Fuel Standard, as well as tax credits, loan guarantees, and other funding to support research and development (R&D), processing plant construction, as well as programs supporting the production and processing of non-food biomass sources to ethanol and other biofeedstocks. We are actively engaged with Capitol Hill and senior officials in key agencies, and are aware of the nuances of the politics that will determine the future of these programs. The consortium tracks developments in the Farm Bill, the Biomass Crop Assistance Program (BCAP), and advocates for provisions favorable to the biobased products industry.
USDA and DOE Programs
Also facing reauthorization challenges from fiscal conservatives and others are programs of the U.S. Department of Agriculture (USDA) and the U.S. Department of Energy (DOE) that have provided loan guarantees and other financial support for R&D and construction of biomass conversion facilities. The reauthorization of policies promoting bioenergy, biofuels, biomass, and bioproducts must compete for attention and support with annual appropriations legislation, deficit reduction, and many other major topics. Consortium members will have a "ring-side seat" in this ongoing process and the political status of programs critical to them. They also will have opportunities to advocate before Congress and federal agencies on topics critical to the success of their business.
More information is available regarding the biobased products practice areas of BRAG affiliates Bergeson & Campbell, P.C., and international consulting firm The Acta Group. Click on the links below: