Attachment C- Consultation

From:
To:
Cc:
Subject:
Date:
Attachments:

Dear

Samek, Karen
Alwood, Jim; Sleasman, Katherine
Information Collection Request (ICR) Consultation
Monday, February 5, 2024 8:55:00 AM
ICR_Consultation Questions Nano.docx

,

I am contacting you to solicit your input on the renewal of the Information Collection Request
(ICR). Enclosed, please find a list of several questions we hope you might consider during
your review. (see attached questions). The existing ICR expires on September 30, 2024, for
requirements pursuant to TSCA section 8(a) titled, “Chemical-Specific Rules under the Toxic
Substances Control Act (TSCA) Section 8(a); Certain Nanoscale Materials,” it is identified by
OMB Control No. 2070-0194. OMB requires federal agencies to consult with nine or fewer
potential respondents prior to submitting the ICR renewal to OMB for review and approval.
This consultation requirement is in addition to providing the public with 60 days to comment
on the proposed collection activity. The meaningful and timely comments the Agency receives
from you will help us during the development of this renewal ICR. The notice announcing the
ICR renewal and solicitation of comments was published in the Federal Register on February
1, 2024, (89 FR 6520) See http://www.regulations.gov/, docket ID EPA-HQ-OPPT-20100572, and the ICR supporting statement for this renewal located is in that docket for additional
information.
The Paperwork Reduction Act (PRA) requires that agencies receive Office of Management
and Budget (OMB) clearance before requesting most types of information from the public. In
order to receive OMB clearance, federal agencies prepare draft ICRs providing an overview of
the information collection and estimates of the cost and time for the public to respond. The
agencies consult with potential respondents and the public about the ICR and, where
appropriate, incorporate comments received. The draft ICR is then sent to OMB for its review
and approval. These ICRs are periodically renewed. This ICR renewal covers reporting and
recordkeeping requirements for persons who manufacture or process chemical substances as
nanoscale materials under the authority of section 8(a) of the Toxic Substances Control Act
(TSCA) and implementing regulations in 40 CFR part 704.20.
Please note that, if you take this opportunity to provide input, your name, affiliation, and
phone number and any information you provide (e.g., copies of emails) will be incorporated
and attached to the ICR supporting statement which will be a public document. In addition,
you may be contacted by the OMB Desk Examiner for the ICR to verify the accuracy of any
comments as reported in the ICR by EPA.
Your response will be greatly appreciated. If you have any comments in response to the
attached questions, or with respect to any other part of the information collection, please
respond by return e-mail by April 1, 2024. 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 for your assistance.
Sincerely yours,

Karen Samek
\
Karen Samek, Program Manger
Environmental Protection Agency
Office of Pollution Prevention and Toxics
New Chemicals Division; RMB 1
(202) 564-4968
[email protected]

EPA ICR No. 2517.04

OMB CONTROL NO. 2070-0194

Consultation Questions for the Information Collection Request (ICR) for ChemicalSpecific Rules under the Toxic Substances Control Act (TSCA) Section 8(a); Certain
Nanoscale Materials
(1) Publicly Available Data
A. Is the data that the Agency seeks available from any public source, or already collected
by another office at EPA or by another agency?

B. 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 do not meet our data needs very well?)

(2) Clarity of Instructions
The ICR covers the requirement under the PBT rule for respondents to maintain records.
A. Based on the instructions (regulations, FR Notices, etc.), is it clear what you are required
to do? If not, what suggestions do you have to clarify the instructions?

B. Do you understand that you are required to maintain records?

(3) 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, unless there is a strong
reason for not doing so. One such reason is that, at the present time, the Agency is unable to
ensure the security of CBI that might be transmitted over the Internet.
A. What do you think about electronic alternatives to paper-based records and data
submissions? Would you be interested in pursuing keeping records electronically?

1

EPA ICR No. 2517.04

OMB CONTROL NO. 2070-0194

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

(4) Burden and Costs
A. Are the labor rates accurate?

B. The Agency assumes there is no capital cost associated with this activity. Is that correct?

C. 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 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.

D. Are there other costs that should be accounted for that may have been missed?

2