Attachment 13- Consultation

Subject: ICR for Recordkeeping and Reporting Under Section 8 of TSCA

Hello All:
On March 8, 2022, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal
Register 87 FR 12954 announcing that EPA intends to submit an Information Collection Request (ICR)
to Office of Management and Budget (OMB). In compliance with the Paperwork Reduction Act
(PRA), this document announces the availability of and solicits public comment on the ICR entitled
“Recordkeeping and Reporting Under Section 8 of the Toxic Substances Control Act (TSCA)” and
identified by EPA ICR No. 2703.01 and OMB Control No. 2070-NEW. This is a new ICR that
consolidates the information collection activities currently covered by several ICRs previously
approved by OMB under the separate OMB control numbers. Those ICRs all involved reporting and
recordkeeping activities established under TSCA section 8 for chemical substances and Subpart B of
40 CFR part 766 which was previously consolidated within the OMB-approved ICR for the TSCA
Section 8(a) Preliminary Assessment Information Rule (PAIR). Although imposed for a specific
chemical substance, the activities are already established and only vary based on the specific
authority under TSCA section 8 and 40 CFR 766 and the need for the information for that chemical.
EPA is consolidating these ICRs to streamline the presentation of the paperwork burden estimates
for these various activities, which will in turn facilitate and reduce the administrative burden for both

the public reviewers and the Agency in terms of reviewing and updating the ICR every three (3) years
as required by the PRA, 44 U.S.C. 3501 et seq., as well as allow for a better assessment of the
paperwork burden and costs associated with reporting and recordkeeping activities established
under TSCA section 8 for specific chemical substances. This ICR addresses the following four (4)
types of information collections (ICs) required by TSCA section 8 and identifies the persons required
to keep records and report such information, which include: TSCA Section 8(a) Preliminary
Assessment Information Rule (PAIR), Chemical-Specific Rules, TSCA Section 8(a), Recordkeeping and
Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the
Environment, and Health and Safety Data Reporting, Submission of Lists and Copies of Health and
Safety Studies.
In addition to the public comment requested by the notice in the Federal Register, OMB regulations
at 5 CFR 1320.8(d)(1) require agencies to consult with potential respondents and data users about
specific aspects of an ICR. As part of this required consultation, I am contacting you to solicit your
input through the attached questionnaire.
If you have any comments in response to the above questions, or with respect to any other part of
this ICR, please respond by return e-mail by COB on May 9, 2022 or submit your comment to the
docket EPA-HQ-OPPT-20121-0728 via ww.regulations.gov. EPA will consider those responses, as well
as any public comment received in response to the Federal Register notice identified above, in
preparing a final document for OMB review.
Thank you,

Consultation Questions for ICR Renewals
EPA Questions asked in Consultation
(1)

(2)

Publicly Available Data
$

Is the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?

$

If yes, where can you find the data? (Does your answer indicate a true
duplication, or does the input indicate that certain data elements are available, but
that they don=t meet our data needs very well?)

Frequency of Collection
$

(3)

(4)

Can the Agency collect the information less frequently and still produce the same
outcome?

Clarity of Instructions
$

The ICR is intended to require that respondents provide certain data so that the
Agency can utilize them.

$

Based on the instructions (regulations, PR Notices, etc.), is it clear what you are
required to do and how to submit such data? If not, what suggestions do you have
to clarify the instructions?

$

Do you understand that you are required to maintain records?

$

Considering that there is no required submission format, is it difficult to submit
information in ways that are clear, logical and easy to complete?

$

Are there forms associated with this process? Do you use them? Are they clear,
logical, and easy to complete?

Electronic Reporting and Record keeping
The Government Paperwork Elimination Act requires agencies make available to the
public electronic reporting alternatives to paper-based submissions by 2003.
$

(5)

Are you keeping your records electronically? If yes, in what format?

Burden and Costs
$
$
$

Are the labor rates accurate?
The Agency assumes there is no capital cost associated with this activity. Is that
correct?
Bearing in mind that the burden and cost estimates include only burden hours and
costs associated with the paperwork involved with this ICR, e.g., the ICR does not
1

$

include estimated burden hours and costs for conducting studies, are the estimated
burden hours and labor rates accurate? If you provide burden and cost estimates
that are substantially different from EPA’s, please provide an explanation of how
you arrived at your estimates.
Are there other costs that should be accounted for that may have been missed?

2