OMB files this
comment in accordance with 5 CFR 1320.11(c). This OMB action is not
an approval to conduct or sponsor an information collection under
the Paperwork Reduction Act of 1995. If OMB has assigned this ICR a
new OMB Control Number, the OMB Control Number will not appear in
the active inventory. For future submissions of this information
collection, reference the OMB Control Number provided. OMB is
withholding approval at this time. Prior to publication of the
final rule, the agency should provide a summary of any comments
related to the information collection and their response, including
any changes made to the ICR as a result of comments. In addition,
the agency must enter the correct burden estimates. This action has
no effect on any current approvals.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
0
0
0
0
0
0
0
0
0
EPA is proposing to require electronic
reporting for information that must be submitted under Toxic
Substances Control Act (TSCA) section 4 (pursuant to test rules and
enforceable consent agreements (ECAs)), TSCA section 8(a)
Preliminary Assessment Information Rule (PAIR), and TSCA section
8(d) Health and Safety Data Reporting rules. Additionally, EPA is
proposing amendments to certain TSCA section 5 reporting
regulations that would extend electronic reporting requirements to
Notices of Commencement of Manufacture or Import (NOCs) and support
documents (e.g., correspondence, amendment, and test data) relating
to TSCA section 5 notices submitted to EPA before April 6, 2010.
This proposed rule would require the use of EPA's Central Data
Exchange (CDX) and the Chemical Information Submission System
(CISS) web-based reporting tool for the submission of forms,
reports, and other documents except for TSCA section 5 submissions,
which would use existing e-PMN software. This action is intended to
streamline the reporting process and reduce the administrative
costs associated with information submission and recordkeeping.
This rule-related Information Collection Request (ICR) addresses
the incremental paperwork activities related to submitting sections
4, 5, 8(a) PAIR, and 8(d) data, reports, and other documents to EPA
electronically and describes the changes that will ultimately be
incorporated into the ICRs upon their renewal date that are
currently approved under OMB Control No. 2070-0033, No. 2070-0012,
No. 2070-0054, No. 2070-0004, and 2070-0012. (EPA ICR No. 1139.08
TSCA Section 4 Test Rules, Consent Orders, Test Rule Exemptions,
and Voluntary Data Submission; EPA ICR No. 0574 Premanufacture
Review Reporting and Exemption Requirements for New Chemical
Substances and Significant New Use Reporting Requirements for
Chemical Substances; EPA ICR No. 0586.11, TSCA 8(a) Preliminary
Assessment Information Rule (PAIR); EPA ICR No. 0575.12 Health and
Safety Data Reporting, Submission of Lists and Copies of Health and
Safety Studies; and EPA ICR No. 0574.15 Pre-Manufacture Review
Reporting and Exemption Requirements for New Chemical Substances
and Significant New Use Reporting Requirements for Chemical
Substances, respectively). In addition, OPPT initiated a voluntary
pilot program to accept certain health and safety data submissions
in an electronic format. The voluntary use of a cover sheet
facilitates the submission of information by displaying certain
basic data elements, permitting EPA more easily to identify, log,
track, distribute, review and index submissions, and makes
information publicly available to the mutual benefit of both
industry and EPA. The specific reporting form used by this
information collection is known as the TSCA Health & Safety
Study Cover Sheet (EPA Form No. 7710-58). This rule-related ICR
incorporates the data elements captured in the voluntary form and
addresses the incremental paperwork activities related to
submitting the form electronically and describes the changes that
will be incorporated into the existing ICR approved under OMB
Control No. 2070-0156 (EPA ICR No. 1780.05 Voluntary Cover Sheet
for TSCA Submissions).
The burden increase would
result from EPA's implementation of a rulemaking to require that
various submissions under sections 4 and 8 of TSCA be signed and
submitted electronically via EPA's Central Data Exchange (CDX).
Respondents would need to submit information to register their
respective company's authorized submitters with EPA's Central Data
Exchange and obtain CDX electronic signatures. In addition,
respondents would need to provide certain metadata in the CDX
interface about each submission to assist with EPA's information
processing and data management.
$333,424
No
No
No
No
No
Uncollected
Angela Hofmann
No
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.
CDX_Registration_Guide_v0_02.pdf
CDX_Screen Shots_Section 8(d) HaSD_2012-01-25.doc
2412-01-icr.docx
New CDX Activities - TSCA Section 8(d) Health and Safety Data Submissions