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Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies

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In compliance with the Paperwork Reduction Act, 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: Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies. The ICR, which is abstracted below, describes the nature of the information collection activity and its expected burden and costs.


Additional comments may be submitted on or before August 17, 2012.


Submit your comments, referencing docket ID Number EPA-HQ-OPPT-2011-0777 to (1) EPA online using (our preferred method), by email to or by mail to: Document Control Office (DCO), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, Mail Code: 7407T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) 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.


Pamela Myrick, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, Mail code: 7408-M, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-554-1404; email address:


EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On January 25, 2012 (77 FR 3766), EPA sought comments on this renewal pursuant to 5 CFR 1320.8(d). EPA received no comments during the comment period. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice.

EPA has established a public docket for this ICR under Docket ID No. EPA EPA-HQ-OPPT-2011-0777, which is available for online viewing at, or in person inspection at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202-566-1744, and the telephone number for the Pollution Prevention and Toxics Docket is 202-566-0280. Use 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.

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (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 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 For further information about the electronic docket, go to

Title: Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies.

ICR Status: This is a request to renew an existing approved collection. This ICR is scheduled to expire on October 31, 2012. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Abstract: Section 8(d) of the Toxic Substances Control Act (TSCA) and 40 CFR part 716 require manufacturers and processors of chemicals to submit lists and copies of health and safety studies relating to the health and/or environmental effects of certain chemical substances and mixtures. In order to comply with the reporting requirements of section 8(d), respondents must search their records to identify any health and safety studies in their possession, copy and process relevant studies, list studies that are currently in progress, and submit this information to EPA.

EPA uses this information to construct a complete picture of the known effects of the chemicals in question, leading to determinations by EPA of whether additional testing of the chemicals is required. The information enables EPA to base its testing decisions on the most complete information available and to avoid demands for testing that may be duplicative. EPA uses information obtained via this collection to support its investigation of the risks posed by chemicals and, in particular, to support its decisions on whether to require industry to test chemicals under section 4 of TSCA.

Responses to the collection of information are mandatory (see 40 CFR part 716). Respondents may claim all or part of a notice as CBI. EPA will disclose information that is covered by a CBI claim only to the extent permitted by, and in accordance with, the procedures in 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 in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average about 9.7 hours per response. Burden is defined in 5 CFR 1320.3(b).

Respondents/Affected Entities: Entities potentially affected by this action are companies that manufacture, process, import, or distribute in commerce chemical substances or mixtures.

Frequency of Collection: On occasion.

Estimated average number of responses for each respondent: 1.2.

Estimated No. of Respondents: 119.

Estimated Total Annual Burden on Respondents: 1,364 hours.

Estimated Total Annual Costs: $88,588.

Changes in Burden Estimates: This request reflects an increase of 908 hours (from 456 hours to 1,364 hours) in the total estimated respondent burden from that currently in the OMB inventory. This increase reflects EPA's revised estimate for the rate of chemical additions (from 20 to 70 chemicals per year) and to the episodic nature of rulemakings that add chemicals to the TSCA section 8(d) list. The Supporting Statement provides details about the change in burden estimate. The change is an adjustment.

John Moses,

Director, Collection Strategies Division.

[FR Doc. 2012-17468 Filed 7-17-12; 8:45 am]