How to Make Friends and Win EPA Approvals: tips for biobased chemicals

By Kathleen Roberts,
Executive Director, Biobased and Renewable Products Advocacy Group

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,” presented by Bergeson & Campbell, P.C. and the Biobased and Renewable Products Advocacy Group (BRAG), a D.C.-based industry consortium focusing on making the commercialization of biobased and renewable chemicals a reality by anticipating and minimizing the challenges federal and state regulatory systems can pose.

The speakers gave a high-level overview of one of the most significant regulatory requirements for new biobased chemical products — new chemical review under Toxic Substances Control Act Section 5. TSCA is a bit of a misnomer to many in this commercial space. After all, biobased chemicals are not “toxic.” TSCA, however, regulates all chemical substances in commerce, regardless of toxicity unless exempt.

Dr. Tracy Williamson, Chief of the Industrial Chemistry Branch, Office of Pollution Prevention and Toxics, EPA, noted that EPA encourages the development of safer and greener new chemicals. It also serves as pre-market gatekeeper for new chemicals and must ensure no chemical poses an unreasonable risk to health or the environment.

By law, the review process is to occur in 90 days. This timeframe can be extended and the process can take much longer as it often does if a Premanufacture Notification (PMN) is not carefully prepared. Delay can invite catastrophic consequences, particularly for a small company with its commercial hopes and dreams hinged on the successful commercialization of its new chemical product.

Dr. Tracy Williamson’s Tips for Preparing Successful PMNs

1. Schedule a pre-notification meeting with EPA. A pre-notification meeting is a terrific opportunity to meet EPA scientists, familiarize them with your company and its products, and to establish a positive relationship with an important “client” — the federal government! It also allows a newcomer to the TSCA world a chance to ask questions about the review process and the required elements on the form. This tip was echoed by Dr. Frank Pacholec of Stepan Company, another of the panelists.

2. Pay attention to the “naming” of the chemical substance. This is relevant to biobased chemical producers, and requires the services of a chemist familiar with the sometimes arcane rules of chemical nomenclature.

Hot slides from Dr. Williamson’s presentation

Dr. David Widawsky, an economist and Director of the Economics, Exposure, and Technology Division in OPPT, emphasized EPA’s interest in finding opportunities to bridge market sectors to find value in green chemistries. Dr. Widawsky also manages EPA’s Presidential Green Chemistry Awards, which have been awarded in the past to Digest “Hot 30” companies like Elevance, Genomatica, BioAmber, LS9, and Virent.

Dr. David Widawsky’s Top Tips

1. Use the Pollution Prevention (P2) page of the PMN form.

2. Tout the new chemical’s sustainability, lower hazard profile, and/or other green factors that fit within EPA’s goals of safer chemicals.

3. Do not just state it, quantify it.

Hot Slides from EPA’s Dr. Widawsky

Hot Slides from Stepan Company’s Dr. Pacholec

As biobased chemicals grow in significance, the need for precision increases. Navigating the regulatory minefield is tricky, but manageable. Successful companies will:

• Review guidance documents and EPA Frequently Asked Questions.

• Take advantage of the EPA-sponsored TSCA hotline (202-554-1404).

• Visit the BRAG website for updates on regulatory developments.

Kathleen M. Roberts is Executive Director of the Biobased and Renewable Products Advocacy Group (BRAG) and Vice President of B&C Consortia Management. Contact her here.