Agency Information Collection Activities; Proposed Revision to an Existing Collection, Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions From Testing Requirements; Comment Request

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB): “Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirements),” and identified by EPA ICR No. 1139.25 and approved under OMB Control No. 2070-0033. This ICR incorporates the activities and burdens recently approved under a separate ICR entitled “User Guide for submitting TSCA Section 4 Test Order Information,” and identified by EPA ICR No. 2697.01 and approved under OMB Control No. 2070-0215, which is scheduled to expire on April 30, 2022. Merging these ICRs before that expiration is appropriate because the activities are integrated components of the same information collection program. Before submitting the ICR to OMB for review and approval under the PRA, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.

DATES:

Comments must be received on or before January 3, 2022.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2015-0436, through the Federal eRulemaking Portal at http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) is by appointment only. For the latest status information on EPA/DC and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

David Turk (7410M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-1527; email address: turk.david@epa.gov .

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

Pursuant to PRA section 3506(c)(2)(A), 44 U.S.C. 3506(c)(2)(A), EPA specifically solicits comments and information to enable it to:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply to?

Title: Generic Clearance for TSCA Section 4 Test Rules, Test Orders, Enforceable Consent Agreements (ECAs), Voluntary Data Submissions, and Exemptions from Testing Requirements (Revision).

EPA ICR number: 1139.25.

OMB control number: 2070-0033.

ICR status: This ICR Revision incorporates the activities and burdens currently contained in another ICR that is scheduled to expire on April 30, 2022. The existing ICR that is being revised is currently scheduled to expire on December 31, 2023. 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 Code of Federal Regulations (CFR), after appearing in the Federal Register when approved, are listed in 40 CFR part 9, 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 generic ICR covers the information collection activities associated with the submission of information to EPA pursuant to TSCA section 4 regulatory actions. (15 U.S.C. 2603). Under TSCA, EPA has the authority to issue regulatory actions designed to gather or develop health and safety information and exposure information on chemical substances and mixtures, and to control unreasonable risks associated with new and existing chemical substances. TSCA section 4 authorities allow EPA to require the development of information related to chemicals and the use of prescribed “protocols and methodologies” in order to inform EPA and other federal agencies about chemical risks, which in turn will inform decision makers for purposes of prioritization for risk evaluation, risk evaluation and risk management of those chemicals as necessary.

This revision incorporates the activities and burdens associated with the guidance documents and outreach to stakeholders about submitting Test Orders to the Agency that were recently approved under a separate ICR entitled “User Guide for submitting TSCA Section 4 Test Order Information,” and identified by EPA ICR No. 2697.01 and approved under OMB Control No. 2070-0215, which is scheduled to expire on April 30, 2022. Merging these ICRs is appropriate because the activities are integrated components of the same information collection program. Upon approval of this revised Generic ICR, EPA will be able to discontinue that ICR because the activities and burden will be covered by this revised ICR.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to annual average 137 hours per response. Burden is defined in 5 CFR 1320.3(b).

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 here:

Respondents/Affected Entities: Entities potentially affected by this ICR are manufacturers (including imports) or processors of chemical substances of mixtures, which are mostly chemical companies classified under NAICS Code 325 and 324.

Respondent's obligation to respond: Mandatory, 15 U.S.C 2603.

Estimated total number of potential respondents: 175.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: 1.5.

Estimated total annual burden hours: 32,435 hours.

Estimated total annual costs: $8,072,601, includes $5,447,620 annualized capital or operation and maintenance costs.

III. Are there changes in the estimates from the last approval?

There is an overall increase of 288 hours in the total respondent burden that is currently approved by OMB for this ICR. This increase reflects the incorporation of the activities and burdens associated with the addition of guidance documents and pre-issuance outreach for Test Orders recipients.

IV. What is the next step in the process for this ICR?

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

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