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Agency Information Collection Activities; Submission of EPA ICR No. 1031.07 (OMB No. 2070-0017) to OMB for Review and Approval; Comment Request

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Environmental Protection Agency (EPA).




In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that the following Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval: Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment (TSCA Section 8(c)) (EPA ICR No. 1031.07; OMB Control No. 2070-0017). The ICR, which is abstracted below, describes the nature of the information collection and its estimated cost and burden. On April 16, 2002 (67 FR 18604), with a correction on May 15, 2002 (67 FR 34705), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA has addressed the single comment it received.


Additional comments may be submitted on or before September 30, 2002.


Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section.

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Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, Mailcode: 7408, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-554-1404; e-mail address:

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EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. EPA has established a public docket for this ICR under Docket ID No. OPPT-2002-0002, which is available for public viewing at the TSCA Non-confidential Information Center (NCIC), North East Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC, from 12 noon to 4 p.m., Monday through Friday, excluding legal holidays (202-260-7099) until August 14, and afterwards at the OPPT Docket in the EPA Docket Center, EPA West Building Basement Room B102, 1301 Constitution Ave., NW., Washington, DC. The Center is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets (EDOCKET) at​edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

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Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions:

(1) Submit your comments to EPA online using EDOCKET (our preferred method), by e-mail to, or by mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, Mailcode: 7407M, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No. OPPT-2002-0002, and

(2) Mail a copy of your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET.

Title: Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment (EPA ICR No. 1031.07; OMB Control No. 2070-0017). This is a request to renew an existing approved collection that is scheduled to expire on August 31, 2002. Under the PRA regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Abstract: TSCA section 8(c) requires companies that manufacture, process, or distribute chemicals to maintain records of significant adverse reactions to health or the environment alleged to have been caused by such chemicals. Since section 8(c) includes no automatic reporting provision, EPA can obtain and use the information contained in company files only by inspecting those files or requiring reporting of records that relate to specific substances of concern. Therefore, under certain conditions, and using the provisions found in 40 CFR part 717, EPA may require companies to report such allegations to the Agency.

EPA uses such information on a case-specific basis to corroborate suspected adverse health or environmental effects of chemicals already under review by EPA. The information is also useful to identify trends of adverse effects across the industry that may not be apparent to any one chemical company.

Responses to the collection of information are mandatory (see 40 CFR part 717). Respondents may claim all or part of a notice 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.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/or instrument, if applicable.

Burden Statement: The annual public reporting burden for this collection of information is estimated to range between 0.25 hours and 8.0 hours per response, depending upon the category of respondent. Burden means the total time, effort or financial resources expended by persons to generate, maintain, retain or disclose or provide information to or for a Federal agency. This includes 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 Start Printed Page 55836able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Manufacturers, processors, importers, or distributers in commerce of chemical substances or mixtures.

Frequency of Collection: On occasion.

Estimated No. of Respondents: 7,397.

Estimated Total Annual Burden on Respondents: 29,939 hours.

Estimated Total Annual Costs: $2,613,486.

Changes in Burden Estimates: There is a decrease of 340 hours in the total estimated burden compared with that identified in the information collection request most recently approved by OMB. This decrease reflects minor downward re-estimates in the number of small and large businesses and the average number of employees at those businesses (adjustment). The decrease in the estimates of number of employees in turn decreases the number of estimated allegations. Because allegations trigger response by industry, this results in a decrease in the estimated burden hours and costs.

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Dated: August 21, 2002.

Oscar Morales,

Director, Collection Strategies Division.

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[FR Doc. 02-22233 Filed 8-29-02; 8:45 am]