Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Revision
ICR 201806-2070-001 · OMB 2070-0012 · Historical Active
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 2070-0012 can be found here:
Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Revision
Per 5 CFR 1320.5, the agency is reminded to display a valid OMB Control number. Per 5 CFR 1320.8, the agency is reminded to include a burden statement.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
11/30/2018
6 Months From Approved
11/30/2018
2,854
0
2,854
118,555
0
117,176
0
0
0
Section 5 of the Toxic Substances Control Act (TSCA) requires manufacturers and importers of new chemical substances to submit to EPA a notice of intent to manufacture or import a new chemical substance 90 days before manufacture or import begins. (Formerly accomplished via paper documents, but now done electronically!) EPA reviews the information contained in the notice to evaluate the health and environmental effects of the new chemical substance. On the basis of the review, EPA may take further regulatory action under TSCA, if warranted. If EPA takes no action within 90 days, the submitter is free to manufacture or import the new chemical substance without restriction.
TSCA section 5 also authorizes EPA to issue Significant New Use Rules (SNURs). EPA uses this authority to take follow-up action on new or existing chemicals that may present an unreasonable risk to human health or the environment if used in a manner that may result in different and/or higher exposures of a chemical to humans or the environment. Once a use is determined to be a significant new use, persons must submit a notice to EPA 90 days before beginning manufacture, processing or importation of a chemical substance for that use. Such a notice allows EPA to receive and review information on such a use and, if necessary, regulate the use before it occurs.
Finally, TSCA section 5 also permits applications for exemption from section 5 review under certain circumstances. An applicant must provide information sufficient for EPA to make a determination that the circumstances in question qualify for an exemption. In granting an exemption, EPA may impose appropriate restrictions. This information collection addresses the reporting and recordkeeping requirements associated with TSCA section 5.
EPA has determined that OMB's approval of this collection of information is needed prior to the expiration of the time periods established under the PRA. The issuance of this document and any associated collection of information is critical for the Agency to be able to make timely determinations on new chemical notifications as required under TSCA. The new requirements in TSCA related to new chemicals were effective immediately, and EPA continues to receive and review notices now. The regular process for ICRs under the PRA, which includes two comment periods with 60-day and 30-day timeframes, would disrupt the collection of information by preventing companies from accessing applicable and helpful EPA guidance with respect to PMNs and SNUNs submitted prior to OMB approval of the ICR and cause harm due to the ensuing delays in marketing new chemical substances because companies do not have access to the guidance. This would prolong the issues that submitters and EPA have experienced.
US Code:
15 USC 2605
Name of Law: Toxic Substances Control Act
This increase in burden results from EPA's Agency issuance of a new information document entitled "Points to Consider When Preparing TSCA New Chemical Notifications"(PtC). The PtC document will assist submitters of new chemical notices, to speed Agency review, and to reduce time consuming interactions among stakeholders of submissions.
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.
Pre-Manufacture Notifications