Our Issues

TSCA and the Regulation of Renewable Chemicals

While the U.S. Environmental Protection Agency (EPA) remains committed to promoting cleaner technologies, the legal requirements of the Toxic Substances Control Act (TSCA) require EPA to conduct new product notifications in ways that do not necessarily optimize the promise of the technology.

Although they may have been developed as potential substitutes for existing petroleum-derived chemicals, some new biobased chemicals are not listed on the TSCA Inventory and thus are subject to "new chemical" review and evaluation processes by EPA scientists. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of renewable chemicals, restrictions that may not apply to older petroleum chemistries even though they may be functionally identical. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter operating conditions.  To complicate matters further, TSCA was amended in June 2016, and the implementing regulations and policies adopted by EPA for amended TSCA have resulted in some cases in even more obstacles and longer timelines for commercialization of innovative new chemicals. (For more about TSCA and renewable chemicals, see our articles: "Proposal for a Toxic Substances Control Act (TSCA) Inventory Representation and Equivalency Determinations for Renewable and Sustainable Bio-based Chemicals," BRAG/BIO White Paper, April 2018; "TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses," Industrial Biotechnology, October 2017; and "Practitioner Insights: Enhancing TSCA Reform Implementation," BNA Daily Environment Report, August 2, 2017.)

Individually, biobased companies may not have the resources to advocate for change. That is where the Biobased and Renewable Product Advocacy Group (BRAG^®) comes in. Working together within BRAG provides strength in numbers, which allows the industry to achieve reasonable, equitable regulations now and in the future through:

• Direct engagement with EPA staff;
   
• Inclusion in petitions for appropriate exemptions;
   
• Education to assist members in navigating successfully the existing regulatory framework;
   
• Advocacy focused on the implementation of new TSCA; and
   
• Tailored monitoring and analysis of Congressional activity.

As the leader in TSCA compliance issues for the biobased chemical industry, BRAG will be engaged in:

• Identifying additional opportunities for partial reporting exemptions under the TSCA Chemical Data Reporting (CDR) rule for its members' biobased products.
   
  BRAG will build off the success of its 2015 petition for six biodiesel chemicals, which EPA approved in a final rulemaking dated January 27, 2015.  The reporting exemption, published ahead of the 2016 CDR reporting schedule, resulted in industry saving significant time, energy, and resources.
   
• Conferring with EPA and other stakeholder groups to address gaps in current chemical nomenclature rules that may not properly cover complex biobased chemicals.
   
  Due to existing nomenclature rules, some complex biobased chemical products that are designed to be equivalent to existing chemical products may, in fact, be considered new chemicals, which are subject to obtaining a new chemical name, and undergoing new chemical notification. As a further complication, the new chemical name of the biobased chemical can carry over into downstream products, which places a TSCA reporting burden on downstream customers. BRAG will lead industry efforts to identify and execute an effective solution to this commercialization obstacle.
   
• Engaging in dialogue as to how the unique biobased feedstocks are regulated under TSCA and reducing associated industry reporting burdens.
   
  Under existing EPA policy, if a material that is typically considered "waste" is used in the manufacture of a commercially available chemical, that "waste" is considered a chemical feedstock and could be subject to TSCA regulations. Given the ever-expanding growth of technology to utilize non-food feedstock, BRAG work with other industry stakeholders and EPA to develop a regulatory strategy to address potential gaps between existing policy and manufacturing reality.
   
• Developing key issues and principles that BRAG members wish to see reflected in new TSCA implementation.
  
  BRAG appreciates that it is critical for biobased chemical companies to engage in the implementation of new TSCA to ensure their unique sector is appropriately addressed in final regulatory language, including rulemakings on the processes for TSCA risk evaluation and prioritization.