Final TSCA Inventory Notification Rule Eases Reporting Burden

Changes reflected in the US EPA’s final rule on notifying substances as active or inactive on the TSCA inventory will ease reporting obligations for affected companies, say legal experts.

The so-called inventory reset rule requires manufacturers and importers to submit to the agency – within 180 days of the final rule’s publishing in the Federal Register – the substances they have used in the ten-year ‘lookback period’ ending 21 June 2016. Processors (downstream users) will be able to subsequently report to fill any gaps.

The EPA intends to use the data to determine the substances active in commerce, to better focus its existing chemicals programme under section 6 of TSCA, and to ensure confidential business information (CBI) claims are current.

But throughout the rule’s consultation, industry groups have pressed the EPA to adopt efficiencies that remove "duplicative and unnecessary" reporting requirements.

And according to Judah Prero, an attorney with law firm Sidley Austin, it is clear the team at the EPA "actually did listen to comments that they received".

"All the way around, it’s streamlined," agreed Michael Boucher, partner at Dentons. "Overall, the changes will make reporting easier."

'Streamlining'

Consistent with requests from industry groups, the EPA adopted a number of changes in its final inventory reset rule. These included increased reporting exemptions; less information on notifications; and delayed deadlines.

The agency expanded the pool of substances that will be included on an "interim active substances list" – for which notification will not be required – to include substances reported as confidential under the 2012/2016 chemical data reporting (CDR) rule as well as those for which it has received a Notice of Commencement (NOC) during the lookback period.

Substances manufactured solely for export, as well as those used only for testing and marketing purposes, are similarly exempted.

The agency is also allowing manufacturers not to have to report a substance for which it can produce a Central Data Exchange (CDX) receipt, documenting EPA’s receipt of a notification from another company. This runs contrary to comments made by some NGOs, which said the statute does not allow for only a subset of manufacturers to report a substance's use.

In response to comments on the burden of information required, the EPA has removed the need to report commercial activity type and date range. And it has clarified that persons must only report information "known to or reasonably ascertainable by them".

The EPA has also added a 90-day transitional period after it publishes the final active/inactive list, before an inactive designation takes effect. This will allow companies to submit a forward-looking notification before the designation kicks in, thus preventing a scenario where processing would need to be halted overnight on a substance that was erroneously not notified.

And it has extended the optional reporting period for processors – during which they can notify any substances not reported by upstream suppliers – by an additional 180 days. Downstream users had requested a longer period to ensure they had sufficient time to review the list of active substances reported by manufacturers and identify any that were missing.

'Huge amount of work'

The agency however, did not agree to requests to adopt a ‘one-and-done’ approach, calling such a system "unfeasible". As proposed by industry, this would have had the EPA maintain a list of substances that have already been reported as active and for which further notifications would not be required.

And despite expanded exemptions, substances excluded from CDR reporting – including polymers and those that qualify for low-volume exemptions – will not be similarly exempted from inventory notification.

Notwithstanding reporting exemptions, if a company wishes to maintain an existing confidentiality claim, it must submit a notification stating so.

Speaking on a recent Keller & Heckman webinar, firm partner Herb Estreicher said that despite the changes to the rule, there is "a huge amount of work for companies to do within the next six months".

The workload, he added, would be on par with pre-registration for REACH in 2008. And unlike with the EU regime, a company cannot broadly pre-register all substances. Rather, the TSCA process requires that a substance be active in commerce during the prescribed ten-year period.

"Even though the proposed rule was streamlined in some respects, it’s still a remarkably complicated rule," said Dr Estreicher.

Tom Berger, a fellow partner at K&H, recommended that companies that have not already done so begin determining which substances they have used during the lookback period. And those with foreign suppliers, he said, should begin requesting accession numbers or coordinating a joint submission with those parties.

Finally, companies should determine which substances they will seek to maintain confidentiality claims for, especially if they plan to rely on reporting exemptions.