Chemical Identity CBI Claims for Active Chemicals on the Toxic Substances Control Act Inventory

23 April, 2019

Questions remain as to when the 10-year ‟clock” starts, e.g. id relying on substantiation made for the 2016 CDR Rule is the date of that submission the initiating event, or when the information to establish the exemption is submitted?  Also, if another legal entity provided upfront substanstaion with their NOA Form A and you submit substantation now for the same substance, when does the ‟clock” start?

 

In instances where a CBI claim is denied, the Agency would notify the submitter, in writing, of its intent to disclose the specific chemical identity and the reasons for denying the claim.  Disclosure of the specific chemical identity would not occur until 30 days after the date on which the submitter receives the denial notice.  Submitters can challenge the denial by commencing an action to prevent disclosure in an appropriate Federal district court.

 When the official version of the proposed rule is published in the Federal Register there will be time to submit comments via the on-line docket.

How Could it Impact Me?

This proposed plan affects A-I Rule reporters who did not provide upfront (voluntary) substantiation at that time of Form A submission.  A potential exemption is available to those able to reference certain substantiations for chemical identity CBI claims in another submission that was made to USEPA less than five years before the substantiation deadline, such as those made for the 2016 Chemical Data Reporting (CDR) rule.  For an exemption based upon any other recently-submitted substantiation (e.g., a Notice of Commencement, Significant New Use Notice, etc.) the following information will be required:

  • Submission date
  • Submission type and case number
  • Transaction ID, or equivalent identifier that uniquely identifies the previous submission that includes the substantiation (e.g., TS number)

Otherwise, substantiation must include:

  • The answers to the questions identified in Unit III.C.1 of NOA Form A
  • A signed and dated certification statement identified in Unit III.C.2 by an authorized official of the company claiming CBI protection

All submissions must be made via the Central Data Exchange (CDX).

 USEPA is proposing to require that all substantiations and submissions to establish exemption eligibility be filed not later than 90 days after the effective date of the final rule.  If this deadline is not met the Agency could make the information public without further notice.  Since the updated TSCA Inventory was released on February 19, 2019, the deadline for issuing a final rule is no later than February 19, 2020.

Bottom Line:

The Agency is required to review substantiations to determine if the claim qualifies for protection from disclosure, and must approve or deny each claim.  In instances where a CBI claim is approved, the Agency would inform the submitter, and the chemical substance will be identified in subsequent publications of the TSCA Inventory by a new unique identifier in addition to the existing accession number, generic name, and, if applicable, premanufacture notice case number.

The Agency must protect the information from disclosure for a period of 10 years (except as otherwise provided in TSCA sections 8 and 14), unless:

  • The claim is withdrawn, or
  • The Agency becomes aware that the information does not qualify for protection from disclosure, in which case the Agency must notify the claimant of the intent to disclose the information

Questions remain as to when the 10-year ‟clock” starts, e.g. id relying on substantiation made for the 2016 CDR Rule is the date of that submission the initiating event, or when the information to establish the exemption is submitted?  Also, if another legal entity provided upfront substanstaion with their NOA Form A and you submit substantation now for the same substance, when does the ‟clock” start?

In instances where a CBI claim is denied, the Agency would notify the submitter, in writing, of its intent to disclose the specific chemical identity and the reasons for denying the claim.  Disclosure of the specific chemical identity would not occur until 30 days after the date on which the submitter receives the denial notice.  Submitters can challenge the denial by commencing an action to prevent disclosure in an appropriate Federal district court.

When the official version of the proposed rule is published in the Federal Register there will be time to submit comments via the on-line docket.

Contact Us:

knoell USA, LLC  will continue to follow TSCA developments and can provide your company with periodic TSCA updates to assist you in addressing  future regulatory requirements.  knoell USA can also provide representatives of your company with a free consultation to talk through the ongoing issues and how they could affect your business.

 

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Elizabeth Dederick, Ph.D. Vice President, Industrial Chemicals and Biocides
+1 610 558 3001 Ext. 102 +1 610 558 6025 send mail