Substantiation and review of CBI claims for chemical identity on the TSCA Inventory

24 February, 2020

On February 19, 2020, EPA provided a prepublication copy of the final rule on the procedures for companies to substantiate Confidential Business Information (CBI) claims for the specific chemical identities of substances on the TSCA inventory, as well as EPA plans for claim review (details). This summary will focus on the substantiation requirements.  The final rule is a follow-on to the 2017 Inventory ‘reset’ (TSCA Inventory Notification (Active-Inactive) Rule. It amends certain substantiation provisions and describes the procedures and deadlines for substantiating these CBI claims, including provisions for supplementing previously filed substantiations.

What’s different?

The major change involves the addition of two questions regarding a chemical’s susceptibility to reverse engineering that manufacturers and processors would be required to answer to substantiate CBI claims in Notice of Activity (NOA) Forms A or B. The questions more directly address whether the specific chemical identity can be readily discovered by analysis of the substance using existing technologies and any associated costs, difficulties, or limitations.

Also, the Agency has revised other substantiation questions to provide more clarity. For instance, EPA divided the substantiation regarding the appearance of the CBI in any public document into three sub-categories:

  • patents and patent applications
  • state, local, or Federal agency files
  • any document required to be publicly disclosed under any other Federal law

Finally, EPA revised the proposed substantiation question pertaining to substantial competitive harm to make clear that responses should include an explanation of 1) how a competitor could use the information and 2) the causal relationship between the disclosure and the harmful effects.

Does this rule apply to me?

Persons who filed a retrospective NOA Form A and claimed the specific chemical identity as confidential will have 180 days from the effective date of the CBI rule (the effective date being 60 days after publication of the final rule in the Federal Register) to amend voluntary substantiations or file new ones consistent with the requirements of the final CBI rule. Persons who have already filed a forward-looking NOA Form B will have 30 days from the effective date to update their substantiations.

Exemptions

A) Those who previously completed the substantiation in a NOA Form A may rely on the previously submitted substantiation for the first six substantiation questions in this rule, but are required to submit answers to the two new questions regarding reverse engineering.

B) Those who previously substantiated CBI claims in submissions other than NOA forms made less than five years before the substantiation deadline set forth in this rule, as long as that prior substantiation contains the answers to all questions required by that submission, e.g.,
- Chemical Data Reporting (CDR) in accordance with 40 CFR 711.30(b)(1)
- Notices of Commencement (NOCs) in accordance with 40 CFR 720.85(b)(3)(iv)

To establish eligibility for this exemption and to ensure that EPA can locate and match the prior substantiation with the proper NOA form filer, persons who seek to rely on this exemption must report to EPA the

  • submission date
  • submission type
  • case number and/or transaction ID
  • or equivalent identifier

for the previous submission by the deadline specified in this rule.

Those eligible for the second exemption may choose to take advantage of the reduced reporting afforded by the exemption or submit a new full substantiation in accordance with all requirements of this rule.

Failure to Comply

The final rule provides that when a person who asserted a CBI claim for a specific chemical identity in an NOA Form A failed to timely submit a substantiation or notice of prior substantiation, the CBI claim will be denied, but the submitter will be provided notice and an opportunity to seek judicial review of the final confidentiality determination.

New forward-looking activity notice filers claiming specific chemical identity as confidential will be required to address all substantiation questions after the effective date of the final CBI rule.

Conclusion

Due to the risk of CBI protection loss it is essential to review all of the forms sent in response to the TSCA Inventory Notification (Active-Inactive) Rule and to update or resubmit where required. This information is based on a prepublication copy of the final rule.  It is not the official version of the document; the final rule will not be promulgated until it is published in the Federal Register.

 

Business Units: