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February 24, 2010

EPA Publishes Final Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes

The ACTA Group

Today the U.S. Environmental Protection Agency (EPA) published its final clarification under which certain activated phosphors that are not on the Toxic Substances Control Act (TSCA) Section 8(b) Chemical Substance Inventory (TSCA Inventory) will be considered to be “new” chemical substances under TSCA Section 5, and thus will be subject to applicable notification requirements under TSCA Section 5. According to EPA, the clarification is necessary because EPA’s statements in this area have not been consistent. EPA states that, in certain letters and other statements issued by EPA from 1978 to 2003, EPA erroneously indicated that activated phosphors constitute mixtures of phosphors and dopants for purposes of the TSCA Inventory, and thus were not separately reportable as chemical substances under TSCA Section 5(a) new chemical notification requirements. The final clarification is effective August 24, 2011.

Entities not directly engaged in activated phosphors are urged to take note of EPA’s actions on this issue. We understand that EPA’s regulatory response may be instructive to others in that it may be a reliable indication of EPA’s plans for addressing other instances in which regulatory guidance has been inconsistent, such as reliance on statutory mixture classifications for listing on the TSCA Inventory.

Why Chemical Identity Clarification Is Necessary

According to the notice, because EPA does not view activated phosphors as mixtures, some previous EPA statements that such materials may not need to be reviewed through the new chemicals process were incorrect. As a result of certain past EPA statements, some manufacturers of activated phosphors have not submitted new chemical notices under TSCA Section 5 because EPA’s statements incorrectly indicated that activated phosphors were covered for TSCA purposes if the phosphors and activators were already on the TSCA Inventory. Other manufacturers have submitted new chemical notices for similar materials, and they have generally been given TSCA Inventory listings. Several industry representatives asked EPA to clarify its chemical identity policy for activated phosphors. EPA states that it “now agrees that it is necessary to add listings to the TSCA Inventory for activated phosphors which have been manufactured but not listed.” On August 24, 2011, activated phosphors that are not on the TSCA Inventory will be considered new chemical substances under TSCA Section 5. Because some of the statements provided by the Agency prior to 2003 led some manufacturers to believe that the products they manufactured were already on the TSCA Inventory if the phosphors and activators were on the TSCA Inventory, some manufacturers of activated phosphor products have not submitted new chemical notices under TSCA Section 5. According to EPA, this chemical identification problem is similar to one involving monomer acid and its derivatives, which was resolved through EPA-industry dialog and a period for submission of new chemical notices. EPA is addressing the activated phosphor situation in a similar manner.

Nature and Scope of the Clarification

In the Federal Register notice, EPA states that it “does not believe that activated phosphors are mixtures rather than chemical substances in their own right,” and, as a result, listing on the TSCA Inventory “may be required for these chemical substances.” The clarification will affect anyone who manufactures, or who plans to manufacture, an activated phosphor not currently listed on the TSCA Inventory and for a TSCA-covered use.

Key Dates and Provisions of the Clarification

After August 24, 2011, any person manufacturing an activated phosphor for a non-exempt commercial purpose and who has not met the new chemical substances requirements of TSCA Section 5 will not be considered in compliance with TSCA. By that date, companies required to submit premanufacture notification (PMN) or exemption notices must have done so at least 90 days (for PMNs, less for exemption notices) before the effective date. As discussed below, however, such “last minute” submissions may result in commercial disruption and earlier submission is strongly encouraged to ensure that EPA review is completed before the clarification takes effect. EPA states that new chemical notice review may entail suspension of the notice review period (either by EPA or at the request of the submitter). If a new chemical notice seeking an exemption is rejected, a PMN would need to be filed to avoid commercial disruption. Because manufacture may not continue after the 18-month period provided in the notice, EPA advises companies “to submit any required new chemical notices well before the effective date to ensure that all issues are resolved in a timely fashion.” EPA intends to work closely with manufacturers to resolve chemical identity issues for any specific material that the manufacturer believes should be viewed as a mixture.

To facilitate the new chemical notice process for activated phosphors currently being manufactured but which are not listed on the TSCA Inventory as distinct chemical substances, EPA states that it will allow an exception to its TSCA New Chemicals Program policy limit of six chemical substances per consolidation notice for these chemical substances. EPA “encourages persons intending to manufacture activated phosphors to file new chemical notices using the proper chemical identity immediately instead of delaying their submissions to near the effective date” of the clarification notice. New chemical notices must include all information normally included with a new chemical notice submission, such as toxicity data on the chemical substance that are in the possession or control of the notice submitter, or known to or reasonably ascertainable by the notice submitter.