The Environmental Protection Agency (EPA) on August 11 published the final Toxic Substances Control Act (TSCA) Inventory Reset rule. The publication initiated a 180-day reporting period whereby manufacturers must notify EPA of active chemicals in U.S. commerce by February 7, 2018. Chemical processors can voluntarily notify EPA by October 5, 2018. The information will be used to distinguish active substances from inactive substances in the TSCA inventory list. EPA defines manufacturers as persons who import, produce, or manufactures a chemical substance including mixtures, byproducts, and impurities. Processors are defined as any person who processes a chemical substance or mixture after its manufacture, for distribution in commerce - either in the same or different form or physical state as it was when received from the manufacturer, or as part of a mixture or article containing the chemical substance.
Generally, the inventory reset rule outlines the EPA’s process for designating chemicals as active substances in U.S. commerce (versus inactive), while providing mechanisms to disclose information currently held as confidential via claims and substantiation. The rule establishes two types of reporting for industry manufacturers and processors: “retrospective” reporting (on Form A) and “forward-looking” reporting (on Form B).
“Retrospective” (Form A)
reporting requirements apply to companies that:
Domestically manufacture or import chemical substances listed on the TSCA inventory for a nonexempt commercial purpose
Engaged in manufacturing or importing during the ten-year period prior to June 21, 2016.
While processors can elect not to report at all, it is recommended that a company submit a notification to ensure that a substance is designated as “active” by EPA. If notices are not received on a specific substance, EPA will deem the substance as “inactive”.
After the period for “retrospective” reporting ends, the EPA will publish a draft inventory list with active and inactive designations. The anticipate date for release of the draft inventory is April 9, 2018.
“Forward-looking” (Form B)
notification requirements will take effect following publication of the TSCA inventory.
“Forward-looking” reporting requires manufacturers and processors to file Form B at least 90 days in advance of reintroducing a chemical which is listed as “inactive” into U.S. commerce.
Following a “forward-looking” notification, EPA will modify the listing of the substance with an “active” designation.
The inventory rule also requires EPA to automatically designate certain chemical substances as “active” without any prior notification from manufacturers or processors. Substances to be automatically listed as “active” in the interim inventory list
Substances in 2012 or 2016 Chemical Reporting Data (CDR); this relates only to a determination of “active” or “inactive” status. All Confidential Business Information (CBI) status claims for specific chemical identities must be reasserted or EPA will disclose the information.
Substances that were added to the Inventory during the ten-year “lookback period” ending on June 21, 2016, pursuant to a Notice of Commencement (NOC).
Any chemical substances added to the inventory after June 22, 2016
Additionally, there are several exemptions for the TSCA reporting rules:
1. Low releases and low exposures exemption
2. Low volume exemption
3. Polymer exemption
4. Research and development exemption
5. Test marketing exemption
6. Naturally occurring substances
Claiming and Substantiating CBI
Under the TSCA Inventory Reset Rule, all “retrospective” CBI claims other than specific chemical identities will need to be reasserted and substantiated by February 7, 2018 (for manufacturers), or EPA will disclose the information. Substantiation of the specific identity of a chemical substance is not required as part of the reset for these CBI claims, but companies that elect to do so will be exempt from the subsequent substantiation requirement to be imposed under a separate CBI review plan rule that is forthcoming.
Those submissions containing information claimed as CBI filed on or after March 21, 2017 must provide a substantiation for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA section 14(c)(2) at the time of submission. If a submitter’s claim is deemed to be inadequately substantiated, the Agency will provide the submitter with written notification, initiating a 30-day period whereby the CBI substantiation can be remedied. If the matter is not resolved by the submitter, EPA may publicly disclose information provided in the original CBI claim. The EPA must review all claims for chemical identity, and 25% of other CBI claims, within 90 days of receipt of the claim.
The opportunities to claim CBI for chemical substances with disclosed CAS Names and Numbers is limited. There are only three things that may be claimed:
Name of Authorized Official/Mailing address:
Company Name/Mailing Address:
Technical Contact/Telephone Number (in U.S.):
In the case of a confidential PMN there are additional opportunities for claiming CBI:
I am seeking to maintain an existing claim for the confidentiality of the chemical substance identity, as listed on the TSCA Inventory.
Or you can choose:
I am not seeking to maintain an existing claim for the confidentiality of the chemical substance identity, as listed on the TSCA Inventory.
A customer may file a joint submission and request support from the supplier as a method for maintaining CBI and gaining assurance that the substance has been covered.