The Toxic Substances Control Act
(TSCA), as amended by the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, required EPA to designate chemical substances
on the TSCA Chemical Substance Inventory as either “active” or
“inactive” in U.S. commerce. To accomplish that, EPA finalized a
rule, the TSCA Inventory Notification (Active-Inactive)
Requirements Rule (“2017 Active-Inactive Rule”), requiring industry
reporting of chemicals manufactured (including imported) or
processed in the U.S. over the past 10 years, ending on June 21,
2016. This retrospective reporting was used to identify which
chemical substances on the TSCA Inventory are active in U.S.
commerce and will help inform the prioritization of chemicals for
risk evaluation. The retrospective reporting period for
manufacturers (includes importers) ended on February 7, 2018, and
the retrospective reporting period for processors ended on October
5, 2018. 82 FR 37520 (8/11/17)
https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0426-0070.
Included in the 2017 Active-Inactive Rule were provisions for the
submission of confidential business information (CBI) and requests
to maintain existing CBI claims for the specific chemical
identities of chemical substances. Submitters were required to
substantiate all CBI claims made in that collection except for
specific chemical identity CBI claims asserted during retrospective
reporting—which they had an option to voluntarily substantiate at
the time of filing their report. This regulatory action, the
Procedures for Review of CBI Claims for the Identity of Chemicals
on the TSCA Inventory (RIN 2070-AK21), is a companion rule to the
2017 Active-Inactive Rule. TSCA section 8(b)(4)(C) requires that
“[n]ot later than 1 year after the date on which the Administrator
compiles the initial list of active substances [pursuant to the
2017 Active-Inactive Rule], the Administrator shall promulgate a
rule that establishes a plan to review all claims to protect the
specific chemical identities of chemical substances on the
confidential portion of the list” that were asserted during
retrospective reporting under the 2017 Active-Inactive Rule. The
statute at section 8(b)(4)(D) prescribes the requirements of the
plan. TSCA section 8(b)(4)(E) provides the timeframe for the
reviews of CBI claims for specific chemical identities, extension
possibilities and process, and requirements for providing updates
on the Agency’s progress. The data elements covered under the rule
are chemical substance identities claimed as CBI in commercial
activity notices, or Notices of Activity (NOAs), submitted as part
of the 2017 Active-Inactive Rule collection. In many instances the
CBI claims for specific chemical identities were voluntarily
substantiated through the 2017 Active-Inactive Rule collection.
This ICR covers the burden for those who submitted NOAs Form A
(retrospective commercial activity notice) and requested to
maintain an existing CBI claim for a specific chemical identity for
the 2017 Active-Inactive Rule. Additional burden from this
regulatory action that is related to NOAs Form B submissions
(forward-looking commercial activity notices), which occur on an
annual ongoing basis, are addressed in a separate ICR for the 2017
Active-Inactive Rule.
US Code:
15
USC 2607 Name of Law: Toxic Substances Control Act (TSCA)
US Code: 15 USC 2607 Name of Law: TSCA, as
amended by the Frank R. Lautenberg Chemical Safety for the 21st
Century Act
This is a new data collection
activity resulting from the Frank R. Lautenberg Chemical Safety for
the 21st Century Act, which requires additional responsibilities of
EPA in maintaining the TSCA Inventory and imposes reporting
requirements on regulated entities wishing to maintain claims of
confidentiality for chemical substance identity. As such, the
change being implemented in this ICR period is the addition of new
burden and cost for these activities.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form NOA Form A Substantiation of TSCA CBI claims for Specific Chemical Identities
2594ss03.docx
Substantiation of TSCA CBI claims for Specific Chemical Identities