2021-05778. Agency Information Collection Activities; Proposed Renewal of an Existing Collection and Request for Comment; User Fees for the Administration of the Toxic Substances Control Act (TSCA)

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 an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: “User Fees for the Administration of the Toxic Substances Control Act (TSCA)” and identified by EPA ICR No. 2569.02 and OMB Control No. 2070-0208, represents the renewal of an existing ICR that is scheduled to expire on October 31, 2021. Before submitting the ICR to OMB for review and approval, 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 May 18, 2021.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0616, by using 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.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Marc Edmonds, 7407M, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

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

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: User Fees for the Administration of the Toxic Substances Control Act (TSCA).

ICR number: EPA ICR No. 2569.02.

OMB control number: OMB Control No. 2070-0208.

ICR status: This ICR is currently scheduled to expire on October 31, 2021. 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 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: The Frank R. Lautenberg Chemical Safety for the 21st Century Act of 2016 made transformative changes to the TSCA, including an amendment that provides EPA with authority to collect fees to defray 25% of the costs associated with administering sections 4, 5, and 6 of TSCA, as well as the costs of collecting, processing, reviewing and providing access to and protecting CBI from disclosure as appropriate under TSCA section 14. The payment from manufactures (defined by statute to include importers) of a chemical substance who: are required to submit information to EPA under TSCA section 4, who submit certain notices and exemption requests to EPA under TSCA section 5, who manufacture a chemical substance that is subject to a risk evaluation under TSCA section 6(b)(4), and who process a chemical substance that is the subject of a Significant New Use Notice (SNUN) or Test Market Exemption (TME) under TSCA section 5 and who are required to submit information to EPA under TSCA section 4 related to a SNUN submission. These fees are intended to achieve the goals articulated by Congress to provide a sustainable source of funds for EPA to fulfill its legal obligations to conduct the activities required under TSCA sections 4, 5 and 6 (such as risk-based screenings, designation of applicable substances as High- and Low-Priority, conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, requiring testing of chemical substances and mixtures, and evaluating and reviewing manufacturing and processing notices), as well as the activities under TSCA section 14 (i.e., collecting, processing, reviewing, and providing access to and protecting information about chemical substances from disclosure as appropriate.

As amended in 2016, TSCA section 26(b) provides EPA with authority to establish fees to defray 25% the costs associated with administering TSCA sections 4, 5, 6 and of collecting, processing, reviewing, and providing access to and protecting information about chemical substances from disclosure as appropriate under TSCA section 14. Fee payments from chemical manufactures (including importers) who make submissions under TSCA section 5, are required to submit information under TSCA section 4 or are subject to a risk evaluation under TSCA section 6. EPA is not collecting a fee for submissions of Confidential Business Information (CBI) submitted under TSCA section 14.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 3 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 may include the following entities (identified by North American Industrial Classification System (NAICS) codes):

• Petroleum and Coal Products (NAICS code 324);
• Chemical Manufacturing (NAICS code 325); and
• Chemical, Petroleum and Merchant Wholesalers (NAICS code 424).

Estimated total number of potential respondents: 1,348.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: 0.833

Estimated total annual burden hours: 581 hours.

Estimated total annual costs: $ 273,388. This includes an estimated burden cost of $230,607 it is estimated that there are no capital investment or maintenance and operational costs.

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

There is an increase in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB due to the increase in the number of entities potentially affected by this ICR and an increase in the number of information collection activities. The change in potentially affected entities reflects the number of submissions received under TSCA sections 5 and 6. EPA's burden estimates for this collection based upon historical information on the number of chemicals per premanufacture notices (PMNs), significant new use notifications (SNUNs), microbial commercial activity notices (MCANs), and exemption notices and applications including low-volume exemptions (LVEs), test-marketing exemptions (TMEs), low exposure/low release exemptions (LoREXs), TSCA experimental release applications (TERAs), certain new microorganism (Tier II) exemptions, and film article exemptions., and actions under TSCA section 6. This change is an adjustment.

In addition, OMB has requested that EPA move towards using the 18-question format for ICR Supporting Statements used by other federal agencies and departments and is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. EPA intends to update this Supporting Statement during the comment period to reflect the 18-question format, and has included the questions in an attachment to this Supporting Statement. In doing so, the Agency does not expect the change in format to result in substantive changes to the information collection activities or related estimated burden and costs.

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 technical person listed under FOR FURTHER INFORMATION CONTACT.

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

Dated: March 15, 2021.

Michal Freedhoff,

Acting Assistant Administrator, Office of Chemical Safety and Pollution Prevention.