EPA Rule for Chemical Manufacturing
Monday, January 30, 2017 @ 04:01 PM gHale
The much-anticipated proposed reset to the Toxic Substances Control Act (TSCA) Chemical Substance Inventory published in the Federal Register.
The new TSCA amendments require the Environmental Protection Agency (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 manufactured in or imported into the U.S. for non-exempt business purposes between June 21, 2006 and June 21, 2016.
Properly notified substances would end up designated by EPA as active. Substances on the inventory that do not receive a valid notice will end up designated as inactive. A manufacturer cannot make, import, or process inactive substances 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 under TSCA section 8(b) must keep a current list of chemical substances manufactured or processed in the United States.
This list is the TSCA Chemical Substance Inventory (TSCA Inventory). EPA maintains the TSCA inventory as the authoritative list of all chemicals manufactured or processed for nonexempt commercial purposes since 1975. There are over 85,000 chemicals in EPA’s Inventory, many of which are no longer produced.
On June 22 last year, TSCA ended up amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The amendments require the 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 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 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, 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 already 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 end up submitted more than 30 days before the actual date of manufacturing.
Under the proposed rule, NOA Form B would end up 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.
Companies that make or rely on a chemical that has been on the inventory for 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 can end up made, imported, distributed, sold or used in the U.S.
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