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Agency Information Collection Activities; Information Collection Request Submitted 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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Environmental Protection Agency (EPA).




EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): “Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies” and identified by EPA ICR No. 0575.15 and OMB Control No. 2070-0004. The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. EPA did not receive any comments in response to the previously provided public review opportunity issued in the Federal Register on March 30, 2015 (80 FR 16672). With this submission, EPA is providing an additional 30 days for public review.


Comments must be received on or before November 9, 2015.


Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0734, to both EPA and OMB as follows:

  • To EPA online using (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
  • To OMB via email to Address comments to OMB Desk Officer for EPA.Start Printed Page 61209

EPA's policy is that all comments received will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

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Colby Lintner, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; email address:

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Docket: Supporting documents, including the ICR that explains in detail the information collection activities and the related burden and cost estimates that are summarized in this document, are available in the docket for this ICR. The docket can be viewed online at or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA's public docket, visit​dockets.

ICR status: This ICR is currently scheduled to expire on November 30, 2015. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB.

Under PRA, 44 U.S.C. 3501 et seq., 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 are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

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 TSCA 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 will use 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. This information collection request addresses the reporting requirements found in TSCA section 8(d).

Respondents/Affected Entities: Persons who manufacture, process, or distribute in commerce chemical substances or mixtures, or who propose to do so.

Respondent's obligation to respond: Mandatory. (see 40 CFR part 716).

Estimated total number of potential respondents: 119.

Frequency of response: On occasion.

Estimated total burden: 1,605 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Estimated total costs: $116,551 (per year), includes no annualized capital investment or maintenance and operational costs.

Changes in the estimates: There is a net decrease of 6,778 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This decrease reflects in particular EPA's withdrawal of a cadmium reporting rule, the burden for which is included in the currently approved ICR. In addition there was a smaller burden increase resulting from the one-time requirement for respondents to register with EPA's CDX reporting system and to establish electronic signature agreements, plus correcting the estimated number of robust summaries submitted each year. This change is both a program change (in the case of the burden decrease due to the withdrawal of the cadmium rule) and an adjustment (for all other burden changes).

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Authority: 44 U.S.C. 3501 et seq.

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Courtney Kerwin,

Acting Director, Collection Strategies Division.

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[FR Doc. 2015-25753 Filed 10-8-15; 8:45 am]