Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Final Rule)
ICR 201507-2070-003 · OMB 2070-0012 · Historical Active
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Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances (Final Rule)
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.
US Code:
15 USC 2605
Name of Law: Toxic Substances Control Act
The burden changes analyzed in this ICR revision relate to both program changes and adjustments related to EPA's direct final rule. As explained in the supporting statement, a 258 hour burden adjustment increase is directly related to CDX registration activities that are already required under the e-PMN rule. The adjustment is related to the number of new and replacement employees of firms engaged in TSCA section 5 activities who need to register in CDX. In addition, EPA estimates a program change increase of 276 burden hours associated with respondents' familiarization with the requirements of the direct final rule, as well as a 522 burden hour program change reduction related to the electronic submission of bona fides as required by the direct final rule.
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