Navigating the intricacies of the EPA’s CBI requirements for PMNs
Claiming chemical identity as confidential is becoming increasingly difficult, especially in this global market. In the EU, the rules are very stringent and require that all hazardous substances be declared on the safety data sheet (SDS), making it nearly impossible to keep chemical names confidential. In the US, for new chemical substances seeking listing on the Toxic Substances Control Act (TSCA) Inventory, the EPA requires that a detailed, written response to 14 standard questions is submitted along with your confidential business information (CBI) claim.
It is clear that industry is entering a new era, and corporate environmental, health and safety (EH&S), product stewardship and legal staff need to decide whether they proactively declassify substances or try to substantiate confidentiality claims.
In the following article, we will outline best practices for developing an effective CBI strategy that addresses the requirements outlined in TSCA Section 5 at 40 CFR Parts 720 – 725.
Optimising your TSCA PMN
Why do we have to detail trade secrets, the processes, and the means of our products? At high level, we detail this information in prior pre-manufacturing notice (PMN) submissions to provide the requisite information and subsequently protect CBI.
For TSCA Section 5, submitting firms are allowed to go through the PMN process providing generic names and uses and sanitising their documents provided in the submissions so that chemical identity, uses, volumes, processes, names of submitters and signatories, percentage concentration, test studies and results, customer names and toll manufacturers can all be held confidential.
On pages 1–13 of the PMN form, and on any and all supporting documentation, the regulations allow one to denote and redact much of the required data and information as CBI. The electronic documents that EPA CDX generates automatically include a sanitised version for placement in the public record. As best practice, PMN preparers and submitters are well advised to follow the guidance that the EPA provides for both nomenclature of generic names and uses.
On day 91, when the 90-day PMN review period is complete, you can start to manufacture or import your new substance. However, you can claim the right to confidentiality all over again by asserting the necessity and value to one’s business by answering a series of substantiation questions during the notice of commencement step (NOC) to the EPA that actually lists the PMN substance on the TSCA 8b Inventory.