The New TSCA Regulation

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The law to update the US EPA (Environmental Protection Agency), Toxic Substances Control Act (TSCA) was established by the Frank R. Lautenberg Chemical Safety Act for the 21st Century (also known as the TSCA Reform Act), which was signed into law on 22 June 2016.

One of the first tasks was the notification of all non-exempt chemical substances manufactured, processed or imported for commercial purposes during a 10 year look period ending on 21 June 2016, and currently on the TSCA Inventory. These substances had to be electronically (re)notified via the EPA Central Data Exchange (CDX) System to be considered “active” chemical substances and TSCA compliant. Substances that are not re-notified will eventually be deemed “inactive” and no longer permitted for commercial use without further registration action.

The deadline for notification of 07 February 2018 has now passed. However, there is further opportunity for companies intending to manufacture, import or process a substance designated “inactive”, providing the intention is reported electronically to EPA not more than 90 days before the anticipated date of manufacturing or processing, termed “Forward-looking” reporting. 

Legislators intend to make substance evaluation less complex and more efficient under revised TSCA legislation. EPA will establish a risk-based process to identify “high” priority chemicals for safety assessment and risk evaluation. Substances deemed to pose unreasonable risk will be subject to risk management action, which could result in phase-out, or a ban from commercial activity. EPA will concentrate initial efforts on the substances identified as commercially active under the TSCA Inventory “Re-set” Rule.

Retrospective reporting for chemicals where the Agency already has equivalent notice of active status is not required. This means that notification is not required for non-confidential chemicals reported in accordance with the 2012 or 2016 Chemical Data Reporting (CDR) requirement, or for confidentially notified chemicals, if the manufacturer or importer no longer claims chemical identity as confidential business information (CBI). New chemicals added to the Inventory on or after June 22, 2016 are also exempt from the notification requirement.

There are several other exemptions to the re-set rule including R&D and test marketing substances, substances in “articles” that are processed or imported, by-products and impurities, labelled export-only substances (unless a 12(a)(2) finding is made), and “naturally occurring” substances (unless produced synthetically).

Under what is being called a “one-and-done” approach, a Notice of Activity (NOA) is not required, if a central data exchange (CDX) receipt of a NOA, submitted via the required Form A has been obtained from another manufacturer. 

Page published 26 April 2018