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Agency Information Collection Activities; Submission of EPA ICR No. 0574.11 to OMB

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Environmental Protection Agency (EPA).

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Notice of submission to OMB.


In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that the Information Collection Request (ICR) entitled: “Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances” (EPA ICR No. 0574.11; OMB Control No. 2070-0012) has been forwarded to the Office of Management and Budget (OMB) for review and approval pursuant to the OMB procedures in 5 CFR 1320.12. The ICR, which is abstracted below, describes the nature of the information collection and its estimated cost and burden. The Agency is requesting that OMB renew for 3 years the existing approval for this ICR, which is scheduled to expire on May 31, 2000. A Federal Register notice announcing the Agency's intent to seek the renewal of this ICR and the 60-day public comment opportunity, requesting comments on the request and the contents of the ICR, was issued on September 13, 1999 (64 FR 49484). EPA received no comments on this ICR during the comment period.


Additional comments may be submitted on or before June 22, 2000.

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Sandy Farmer at EPA by phone on (202) 260-2740, by e-mail: “,” or download off the Internet at​icr/​icr.htm and refer to EPA ICR No. 0574.11.

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Send comments, referencing EPA ICR No. 0574.11 and OMB Control No. 2070-0012, to the following addresses:

(1) Ms. Sandy Farmer, U.S. Environmental Protection Agency, Collection Strategies Division (Mail Code: 2822), 1200 Pennsylvania Avenue, N.W., Washington, DC 20460; and

(2) Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W., Washington, DC 20503.

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Review Requested: This is a request to renew a currently approved information collection pursuant to 5 CFR 1320.12.

ICR Numbers: EPA ICR No. 0574.11; OMB Control No. 2070-00012.

Title: Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for New Chemical Substances.

Abstract: Section 5 of the Toxic Substances Control Act (TSCA) requires manufacturers and importers of new chemical substances to submit to EPA notice of intent to manufacture or import a new chemical substance 90 days before manufacture or import begins. 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.

Responses to the collection of information are mandatory (see 40 CFR parts 700, 720, 721, 723 and 725). Respondents may claim all or part of a document confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.

Burden Statement: The annual public reporting burden for this collection of information is estimated to average 105.5 hours per response for an estimated 443 respondents making one or more submissions of information annually. These estimates include the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. No person is required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for these regulations are displayed in 40 CFR part 9.

Respondents/Affected Entities: Entities potentially affected by this action are companies that manufacture or import new chemical substances, as defined by TSCA, or manufacture, process or import a chemical substance for a use that has been determined to be a significant new use, as defined by TSCA.

Estimated Number of Respondents: 443.

Estimated Total Annual Burden on Respondents: 184,608 hours.

Frequency of Collection: On occasion.

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Dated: May 16, 2000.

Oscar Morales,

Director, Collection Strategies Division.

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[FR Doc. 00-12956 Filed 5-22-00; 8:45 am]