2018-25774. Agency Information Collection Activities; Renewal 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 (Renewal)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (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. 0575.16 and OMB Control No. 2070-0004. The ICR, which is available in the docket, is only briefly summarized in this document. This is a request to renew the approval of an existing ICR, which is currently approved through November 30, 2018. EPA previously provided a 60-day public review opportunity via the Federal Register on July 25, 2018. With this submission, EPA is providing an additional 30-days for public review.

DATES:

Comments must be received on or before December 27, 2018.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number [EPA-HQ-OPP-2017-0646, to: (1) EPA online using http://www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460 and (2) OMB via email to [e-mail]. Address comments to OMB Desk Officer for EPA.

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.

FOR FURTHER INFORMATION CONTACT:

 

For technical information contact: Andrea Mojica, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone: [phone]; email address: [e-mail].

For general information contact: TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

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 http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. For additional information, visit http://www.epa.gov/​dockets.

ICR status: This is a request to renew the approval of an existing ICR, which is currently approved through November 30, 2018. EPA received one comment in response to the previously provided 60-day public review opportunity (83 FR 35271, July 25, 2018), and has addressed that comment in the ICR submitted to OMB. Under the 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: This ICR covers the information collection activities that implement the statutory mandates in section 8(d) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607(d). Specifically, TSCA section 8(d) authorizes EPA to promulgate rules requiring certain persons who manufacture, process or distribute in commerce (or propose to manufacture, process or distribute in commerce) chemical substances and mixtures, to submit to EPA lists and copies of health and safety studies in their possession with respect to such chemical substances and mixtures. These rules, which are codified in 40 CFR part 716, require the manufacturers and processors of the chemical substances and mixtures subject to a TSCA section 8(d) rulemaking to submit lists and copies of health and safety studies relating to the health and/or environmental effects of the chemical substances and mixtures. To comply, 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. The collection schedule under this ICR is chemical-specific in nature and occurs once in an established timeframe between 60 days and 2 years. Reporting of information is only required when the subject matter information (i.e., the lists of studies and final study reports) is available. Availability of study reports on the list may occur after the established reporting period for the list and must still be submitted when they become available. Studies previously submitted to EPA are exempt.

EPA uses this information to construct a complete picture of the known effects of the chemical substance in question, leading to determinations by EPA of whether additional testing of the chemical substance should be required. The information enables EPA to base its testing decisions on the most complete information available and to avoid requiring testing that may be duplicative. EPA will use information obtained via this collection to support its investigation of the risks posed by the chemical substance and, in particular, to support its decisions on whether to require additional test data be submitted under TSCA section 4. Respondents may claim all or part of a response 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.

Form numbers: None.

Respondents/affected entities: Persons who manufacture, or process chemical substances or mixtures, or who propose to do so.

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

Frequency of response: On occasion.

Estimated total number of respondents: 21.

Estimated total burden: 302 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Estimated total cost: $24,435 (per year), includes $0 annualized capital or operation and maintenance costs.

Changes in the estimates: There is a decrease of 1,303 hours in the total estimated respondent burden compared with that currently approved by OMB. This adjustment reflects the realization that the methodology used in the previous ICR overestimated the burden resulting from the addition of chemicals to the TSCA section 8(d) rule.

Courtney Kerwin,

Director, Collection Strategies Division.