On January 13, 2017, the U.S. Environmental Protection Agency (EPA) published its much anticipated proposed reset to the Toxic Substances Control Act (TSCA) Chemical Substance Inventory in the Federal Register. The new TSCA amendments require EPA to subdivide the existing inventory into lists of active and inactive substances. The proposed rule sets out reporting and procedural requirements for chemical manufacturers and processors to notify the Agency which chemicals should be considered active.
The proposal requires “retrospective” notification for substances listed on the TSCA Inventory that were manufactured in or imported into the US for non-exempt business purposes between June 21, 2006 and June 21, 2016. Properly notified substances would be designated by EPA as active. Substances on the inventory that do not receive a valid notice will be designated as inactive. Inactive substances may not be manufactured, imported, or processed for a non-exempt commercial purpose under TSCA. EPA is also proposing “forward-looking” procedures for converting inactive substances to active substances in the event a company intends to resume manufacture, import, or processing of an inactive substance.
EPA is required under TSCA section 8(b) to keep a current list of chemical substances manufactured or processed in the United States. This list is known as the TSCA Chemical Substance Inventory (TSCA Inventory). EPA maintains the TSCA inventory as the authoritative list of all chemicals that have been manufactured or processed for nonexempt commercial purposes since 1975. There are currently over 85,000 chemicals in EPA’s Inventory, many of which are no longer actively produced.
On June 22, 2016, TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The amendments require EPA to designate substances on the TSCA Inventory as active or inactive. New TSCA section 8(b)(4)(A) requires EPA to promulgate a rule that requires manufacturers and importers to notify the EPA of substances manufactured or imported during the ten years preceding June 21, 2016. New section 8(b)(5)(B) requires persons that intend to manufacture, import, or process a substance for a non-exempt purpose that is designated by EPA as inactive to notify EPA in advance of those activities.
Under the amended TSCA, manufacturers have 180 days to notify the EPA about substances on the current inventory that they have manufactured or imported during the ten-year reporting period. EPA has developed Notice of Activity (NOA) Form A for manufacturers, importers, and processors to use for retrospective reporting. The proposed form is largely based on TSCA’s Notice of Commencement form. It requires manufacturers to report (1) the chemical’s identity, (2) type of commercial activity, (3) date range of manufacture, import, or processing, and (4) whether they seek to maintain an existing claim for protection against disclosure of a confidential chemical identity, if applicable. EPA intends to use CDX, the agency’s electronic reporting portal, and EPA’s Chemical Information Submission System (CISS), a web-based reporting tool to collect this information.
Processors may voluntarily report during the retrospective reporting period. The proposed rule gives processors an optional 360-day reporting period, which is intended to allow processors to submit notifications for substances not already reported after reviewing a draft active inventory prepared by EPA at the close of the manufacturer’s reporting period.
The reporting requirements apply to chemical substances already listed on the TSCA Inventory. EPA is also proposing an exception for substances that have already been reported under the Chemical Data Reporting rules.
The rule also proposes a process by which chemical manufacturers can move a substance from the inactive inventory to the active one. Under the amended TSCA, any person who intends to manufacture, import, or process an inactive substance for a non-exempt commercial purpose must first notify EPA. EPA is also proposing that notifications not be submitted more than 30 days before the actual date of manufacturing.
Under the proposed rule, NOA Form B would be used for forward-looking reporting. This form asks for substantially similar information, and also includes the actual date by which the inactive substance is to be domestically manufactured, imported, or processed.
What This Means to You
Companies that make or rely on a chemical that has been on the inventory for many years need to be aware of the importance that chemical’s inventory status plays in their day-to-day operations. Under the amended TSCA, only active chemicals may be made, imported, distributed, sold or used in the U.S.
Chemical manufacturers and processors should begin preparing now for compliance with the new standards. Chemical regulation has strong bipartisan support. Scott Pruitt, President Trump’s pick to run the EPA, testified in his nomination hearing that implementing the amended TSCA framework regulations, including the inventory reset rule, would be an absolute priority. EPA must finalize these requirements by June 22, 2017. Once the final rule is published in the Federal Register, the retrospective notification period will begin.
Comments on the proposed rule are due March 14, 2017.