EPA Issues Final TSCA Inventory Notification Rule
By Lynn L. Bergeson
On June 22, 2017, the U.S. Environmental Protection Agency (EPA) issued the final inventory notification rule under the amended Toxic Substances Control Act (TSCA). The rule establishes an electronic notification of chemical substances listed on the TSCA Inventory that were manufactured/imported for nonexempt commercial purposes during the 10-year time period ending on June 21, 2016, with provision to also allow processor notification. These notifications will be used to distinguish “active” from “inactive” substances. A summary of this rule follows.
The TSCA Inventory is the listing of chemical substances manufactured or imported in the U.S. for commercial purposes. TSCA experts have long claimed the inventory overstates chemicals in commerce as it lists more than 85,000 chemicals, many of which are no longer in commercial use. A key goal in amending TSCA was to ╥reset╙ the inventory and distinguish between active and inactive substances. The final rule is intended to achieve that goal.
EPA states that it will include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the inventory. The final rule also establishes procedures for forward-looking electronic notification of chemical substances listed on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for nonexempt commercial purposes is expected to resume. On receiving forward-looking notification, EPA will change the designation of the pertinent chemical substance listed on the TSCA Inventory from inactive to active. The rule establishes the procedures regarding the manner in which such retrospective and forward-looking activity notifications must be submitted, the details of the notification requirements, exemptions, and procedures for handling confidentiality claims.
Reportable Chemical Substances and Activities
The retrospective reporting requirements apply to chemicals listed on the inventory that were manufactured for nonexempt commercial purposes during the 10-year period ending on June 21, 2016. The forward-looking reporting requirements apply to substances listed as inactive on the inventory that are to be reintroduced into U.S. commerce for nonexempt purposes.
The final rule establishes an exemption from the retrospective reporting requirement for circumstances in which EPA has already received equivalent notice that a chemical substance was manufactured during the look-back period: chemical substances that are on the interim list of active substances described in new TSCA Section 8(b)(6); chemical substances added to the inventory during the 10-year time period ending on June 21, 2016, pursuant to a Notice of Commencement received by EPA between June 21, 2006, and June 21, 2016; and particular chemical substances, if the manufacturer has evidence in the form of a Central Data Exchange (CDX) receipt, documenting EPA╒s receipt of a Notice of Activity (NOA) Form A from another manufacturer. Chemical substances added to the inventory on or after June 22, 2016, will be designated as active, and such substances are not subject to reporting under the rule.
Timing of Reporting
Manufacturers must report to EPA no later than 180 days after the final rule is published in the Federal Register. EPA will include the active designations, determined by the notices received, on a draft of the Inventory. EPA will publish the draft inventory with the active designations following the close of the submission period. The draft inventory will not have the legal effect of designating any chemical substance as inactive. EPA does not construe it as the list with ╥designations of active substances and inactive substances╙ from which forward-looking reporting commences. Processors may report to EPA not later than 420 days after the final rule is published in the Federal Register.
The forward-looking reporting period begins on the effective date of EPA╒s final active/inactive substance designations. Manufacturers and processors intending to reintroduce into U.S. commerce for a nonexempt commercial purpose a chemical substance designated as inactive on the inventory must report to EPA not more than 90 days before the anticipated date of manufacturing or processing.
Information That Will Be Reported
Manufacturers reporting for retrospective reporting must provide chemical identity information and indicate whether they seek to maintain an existing claim for confidential business information (CBI) protection. Persons are required to report information to the extent it is known to or reasonably ascertainable by them. EPA is not establishing a formal corrections provision in the regulation, but will allow a manufacturer or processor to withdraw an NOA Form A, provided that the withdrawn notice is submitted prior to the end of the submission period for processors, i.e., not later than 420 days after the final rule is published in the Federal Register. The manufacturer may effect a correction by filing a new NOA Form A following withdrawal, so long as the new Form A is filed within the time provided in the rule for the initial filing (i.e., no later than 180 days after the final rule is published).
Processors that report for the retrospective reporting period will be required to provide chemical identity information and whether they seek to maintain an existing claim for protection against disclosure of a CBI chemical identity, if applicable. EPA is not establishing a formal corrections provision in the regulation for an NOA Form A, but will allow a processer to withdraw an NOA Form A, provided that the withdrawn notice is submitted not later than 420 days after the final rule is published. As with manufacturers, EPA notes that processors can effectuate a correction by filing a new Form A within the time provided in the rule for the initial filing (i.e., no later than 420 days after the final rule is published).
The rule requires that persons who intend to manufacture or process an inactive substance for nonexempt commercial purpose provide chemical identity information, the anticipated date of manufacturing or processing for nonexempt commercial purpose, and whether they seek to maintain an existing claim for protection against disclosure of a CBI chemical identity, if applicable.
The NOA Form A will be used by manufacturers for the retrospective reporting period. It will also be used by processors who choose to report for the retrospective reporting period. The NOA Form B will be used by manufacturers and processors for forward-looking reporting, which includes reporting chemical substances reintroduced into U.S. commerce during the transitional period.
Submission of Information to EPA
The rule requires electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA. Submitters will use EPA╒s CDX and Chemical Information Submission System (CISS) for all reporting. Notices may contain two different types of CBI assertions: claims for protection of information other than specific chemical identity, and requests to maintain existing claims for protection of specific chemical identity.
This is an important rule and complying with it will take time. Stakeholders are urged to begin now to assess the impact of the rule on their operations, and be prepared to satisfy the timing and notification requirements.
Lynn L. Bergeson is Managing Partner of Bergeson & Campbell, P.C. (B&C¿), a Washington, D.C. law firm focusing on conventional, nanoscale, and biobased industrial, agricultural, and specialty chemical product regulation and approval matters, environmental health and safety law, chemical product litigation, and associated business counseling and litigation issues. She is President of The Acta Group, with offices in Washington, D.C., Manchester, UK, and Beijing, China, and President of B&C¿ Consortia Management, L.L.C. (BCCM), with offices in Washington, D.C. More information is available at www.lawbc.com.