Chemicals

Confidential Business Information under TSCA

The EPA has floated several approaches to assigning unique identifiers (UIDs) to chemical substances to protect information claimed as confidential by the manufacturers of the substances.

In the latest development, the Agency is requesting public comment on an approach that ensures that the approved confidential business information (CBI) is not disclosed even if it is linked to information about the chemical substances that is not CBI. The approach also considers situations where the same substance is claimed as CBI by one company while another company has not asked for CBI protection.

When a chemical identity on the Toxic Substances Control Act (TSCA) Inventory is claimed as CBI, the chemical substance is maintained on the confidential portion of the Inventory. Conversely, a specific chemical identity that appears on the public portion of the Inventory, and is therefore known to be (or to have been) manufactured for commercial purposes in the United States, is generally not eligible for confidential protection.

TSCA’s Unique Identifier Requirement

The 2016 amendments to TSCA direct the EPA to “assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure.” The EPA must also assign the same UID “consistently to all information relevant to the applicable chemical substance,” including “any non-confidential information received by the Administrator with respect to a chemical substance … while the specific chemical identity of the chemical substance is protected from disclosure.” Application of the UID to non-CBI results in a linkage that can reveal the identity of the chemical substance and thereby undermine the approved CBI claim.

“The basic criterion for application of the UID to submissions made by different submitters is that the Agency’s act of applying the UID must not disclose to the public the confidential specific chemical identity that the UID was assigned to protect,” the EPA states.

Nonconfidential Information

Under the approach for which the EPA is requesting public comment, the Agency says it would assign one UID per chemical substance, and “in most cases” would apply the UID to all confidential information concerning the same chemical substance, from any company. However, in a small number of cases, the Agency would not apply the UID to some nonconfidential documents to preserve approved CBI claims for specific chemical identity where the nonconfidential document itself does not undermine the CBI claim, but EPA’s application of the UID to that document would result in a linkage that does undermine the CBI claim.

Two Submitters, Same Substance

The approach is similar in cases wherein two companies manufacture the same substance. Specifically, the EPA says that before applying a UID to public versions of documents concerning the same substance, which were filed by different submitters, those documents would be reviewed for presence of the specific chemical identity. If the specific chemical identity (e.g.,Chemical Abstracts Service [CAS] name or CAS number) appears in any of the documents, the EPA would revisit the CBI claim in the remaining document(s) to ensure that the claim is unexpired and otherwise still valid. If the CBI claim remains valid, the Agency would not apply the UID to the document that reveals the specific chemical identity to preserve the CBI claim in the other document(s). All documents would be available to the public, and the specific chemical identity would be revealed in the document where it was not claimed as CBI—the document revealing the specific chemical identity would simply not be connected by the UID to the other document(s) where the specific chemical identity is CBI.

The EPA says it expects that exceptions to application of the UID will be fairly rare. For example, in reviewing all nonconfidential TSCA Section 8(e) submissions submitted over the past 5 years that included a CAS number (such that Inventory status can be readily checked), the Agency found that fewer than 4 percent of these submissions mentioned substances that are currently on the confidential portion of the TSCA Inventory.

Notice of the CBI approach was published in the February 8, 2018, FR.

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