Document ID: EPA-HQ-OPPT-2017-0646-0006
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies
Posted Date: 2018-11-27T05:00Z

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60853-60854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25774]

[[Page 60853]]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2017-0646; FRL-9986-84-OEI]

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.

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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 
[email protected]. 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: (202) 564-0599; email address: 
[email protected].
    For general information contact: TSCA-Hotline, ABVI-Goodwill, 422 
South Clinton Ave., Rochester, NY 14620; telephone: (202) 554-1404; 
email address: [email protected].

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

[[Page 60854]]

previous ICR overestimated the burden resulting from the addition of 
chemicals to the TSCA section 8(d) rule.

Courtney Kerwin,
Director, Collection Strategies Division.
[FR Doc. 2018-25774 Filed 11-26-18; 8:45 am]
 BILLING CODE 6560-50-P