A wave of TSCA chemical identity confidentiality claims is set to expire in October, linked to chemical data reporting (CDR) submissions filed during the 2016 reporting cycle, a US EPA official has said.
The news, shared during an agency webinar on the TSCA CBI sunset programme earlier this month, adds a second significant deadline to the compliance calendar that so far has been focused on an initial tranche of claims expiring between 22 June and 31 July.
Unlike the first wave, which spans a range of submission types, the October deadline will involve a higher proportion of chemical identity claims, a type of CBI claim with a more nuanced renewal timeline.
The CBI sunset programme, ushered in by the 2016 Lautenberg amendments, requires companies to resubstantiate existing CBI claims every ten years to maintain confidentiality protection for such information.
Most claims expire ten years from the date of the original filing. Chemical identity claims, however, run on a ten-year period that begins from the date the first submitter asserted a CBI claim for a given substance.
As a result of that timing, a large number of chemical identity claims based on 2016 CDR submissions are due to expire in October, according to Ryan Wallace, a senior official in the TSCA CBI policy implementation branch at the EPA.
In addition, a company that filed a chemical identity claim after another submitter had already done so for the same substance may face an expiration date earlier than ten years after its own submission, which could lead to unexpected renewal requirements arriving this autumn.
Higher substantiation standards
In addition to noting the expiring claims, the EPA used the webinar to warn companies about the quality of information the agency will expect when reviewing extension requests. Substantiations from the early post-Lautenberg period may not clear today’s bar, the agency said.
Nick Lillo, an EPA official in the TSCA CBI policy implementation branch who led the webinar presentation, said many substantiations filed in 2016 and the years immediately following "were not quite at the calibre of the substantiations we see now".
"A lot of the substantiations that we received in 2018 and earlier were very basic; they would just say, ‘This information is confidential because it’s confidential’," he said.
The agency has since pushed companies to engage specifically with the substantiation questions and to explain why the information continues to warrant protection a decade on, Lillo said.
Companies considering relying on their original filings for renewals should review them before doing so, he said.
According to Wallace, companies need to provide thorough substantiation upfront because TSCA does not give a "second bite at the apple" to resubstantiate a claim once denied.
"Put your best foot forward, and we’ll be evaluating that," said Wallace. "There’s not going to be a chance just to add additional substantiation if we reject the extension request."
New lists and revised claims
The 6 May webinar coincided with a series of updates to the EPA’s CBI claim expiration webpage that expanded the public resources available to companies trying to determine whether they have claims approaching expiration.
Alongside the submissions spreadsheet, the agency first published in April, the EPA posted two additional lists on 6 May – one covering chemical identities with expiring claims, and another listing company names associated with submissions or chemical identities due to expire by the end of July.
Wallace said the company list deliberately stops short of linking company names to specific submissions, so as not to risk divulging CBI.
The agency also published a revised version of its original submissions spreadsheet as part of the same update.
Of the 294 cases included in the April version, the EPA crossed out 83 that it determined are not subject to expiration. The reasons for the modifications include:
- all CBI claims in the submission were subsequently withdrawn;
- the submission contains only exempt claims;
- the filing predates the Lautenberg Act; or
- all claims were previously denied.
The remaining 211 cases are due to expire in the June-July timeframe if not appropriately resubstantiated.