Industry, NGO Disagree on TSCA Approach to Confidential Chemical Identities

Chemical industry groups are backing a company-specific approach for assigning a "unique identifier" to confidential chemical identities under the new TSCA, but an NGO is advocating a stricter interpretation of the law.

The US EPA consulted earlier this year on how it will apply this identifier to substances with identities protected as confidential. This new provision is intended to allow the public to locate other filings related to that substance without disclosing its identity.

At the time, it proposed two alternative approaches "to meaningfully inform the public without compromising trade secrets".

The first called for the EPA to ensure that any submission related to a confidential chemical, including non-CBI information, contains only the unique identifier and not the substance’s name. But the agency warned that masking information not claimed as CBI "might be viewed as inconsistent with policy", while screening non-confidential submissions against a list of confidential substances "carries considerable risk of error", and "may be such a burden on EPA resources as to be impracticable".

The second option proposed assigning a unique identifier for all information on a protected chemical submitted by the same person or company, but applying another for submissions on that same substance from other entities. Such an approach would allow the public to "link some submissions on the same chemical, but not necessarily all", said the EPA.

Unique identifier
TSCA allows companies to ask that a substance’s identity be kept confidential. If the EPA grants this, the substance is listed in the public portion of the TSCA inventory by an accession number and a generic chemical name that masks the specific substance identity.

Under section 14 of the new TSCA, the EPA must:

develop a system to assign a unique identifier to each specific chemical identity for which it has approved a confidentiality request;
apply that identifier consistently to all information relevant to the applicable substance;
annually publish a list of confidential substances with their unique identifiers, including the expiration date for the claim;
ensure that any non-confidential information received identifies the substance using the unique identifier; and
for any expired confidentiality claim, link the chemical identity back to its unique identifier.
But in a May Federal Register notice, the agency said that two requirements – to apply the unique identifier to all non-confidential information related to the substance, while ensuring the identity is protected from disclosure – "do not appear to be completely reconciled in the statute". And it cited several examples where universally applying such an identifier to every information submission could result in CBI, including the chemical identity, being revealed.

Industry backs second alternative
In a May stakeholder hearing and in submitted public comments, a plurality of industry groups lent their support to the EPA’s second option.

Speciality chemicals group Socma said in comments that it offers "the only feasible approach that will protect chemical identity CBI claims adequately".

The American Chemistry Council agreed that it was the most workable solution. The trade group supports the public’s right-to-know "up to the line where to do so would disclose protected CBI", it said, but it believes the statute is clear that "EPA is legally bound to protect CBI from improper (including inadvertent) disclosure and that obligation outweighs the public interest of access to information."

It also cautioned that any system "should not enable competitors or members of the public to go on a fishing expedition for protected CBI and cause a cascade of CBI disclosures in the absence of compelling need."

EDF demurs
The Environmental Defense Fund, however, says the chemical industry’s preferred option "directly violates" section 14(g)(4) of TSCA, and that a court would not uphold the interpretation.

Both of the agency’s proposed approaches "would have the perverse effect of denying the public the right to know even more information than would otherwise be the case".

The NGO argues that the EPA has found "an apparent conflict that does not exist in the law and overstates a problem that it has successfully navigated in the past". The agency, it says, has "no statutory basis" for refusing to apply the unique identifier to all information relevant to a substance.

In its comments to the consultation, the EDF cited "significant precedent" under TSCA for limited disclosure of CBI. These include when a company submits a bona fide notice for a substance subject to a significant new use rule (Snur), or the assignment of the same accession number to multiple reports on the same protected chemical identity under the chemical data reporting (CDR) rule.

And it said that when companies craft CBI requests they should be mindful of the unique identifier provisions to mitigate any concerns around inadvertent release of confidential information.

But the ACC said that the reporting rule and bona fide examples are "very limited in scope… [and] do not establish a precedent for broader disclosures to the public of information protected from disclosure by statute".

And Socma added that if the EPA adopts a system that could allow a chemical identity to be unwittingly revealed by a competitor or academic’s filing of information on it, the original submitter "is going to claim everything CBI".

Indeed, a "simplistic interpretation" would "likely restore the status quo pre-[Lautenberg Act], with rampant overclaiming of CBI" – which is exactly what NGOs and others were seeking to end through the new law, said Socma.

EPA plans to finalise the unique identifier system by December.