EPA to grapple with TSCA 'unique identifier' CBI requirement

The US EPA has asked for feedback on implementing a provision of the new TSCA regarding the application of a 'unique identifier' for substances protected as confidential business information (CBI).

As amended by the Lautenberg Act, section 14 of the new TSCA requires the EPA to assign a so-called unique identifier when it approves a CBI claim that protects a substance's chemical identity.

This identifier is distinct from currently used accession numbers. It is intended "to provide a specific reference identifier that protects the confidentiality claim to the specific chemical identity for the duration of the claim, while providing a way for the public to identify other filings pertaining to that substance."

More specifically, the identifier must be applied "consistently to all information relevant to" the protected chemical, including to non-confidential information.

For any confidentiality claim that subsequently expires, is withdrawn, or is denied by the agency, the EPA must "clearly link" the specific chemical to its unique identifier on any information that has been made public.

But in a Federal Register notice, the EPA has outlined issues with the new law's requirements that "do not appear to be completely reconciled in the statute".

These include the fact that having a single unique identifier publicly applied to all information about a specific chemical may cause the release of CBI information to other parties. For example, if two manufacturers are producing the same confidential chemical and submit documents to the EPA that it then labels with the same unique identifier, each company may be able to tell that a competitor is also making the substance.

The agency has outlined two possible approaches to "meaningfully inform the public without compromising trade secrets". It is also accepting feedback on additional approaches.

The EPA has convened a public meeting in Washington, DC, on 24 May to discuss the issue and hear oral testimony. It will accept written comments until 7 July.