Agency Information Collection Activities; Proposed Renewal of an Existing Collection and Request for Comment; Expanded Access to the Toxic Substances Control Act (TSCA) Confidential Business Information

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (PRA), this document announces the availability of and solicits public comment on an Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB). The ICR, entitled: “Expanded Access to TSCA Confidential Business Information” and identified by EPA ICR No. 2570.02 and OMB Control No. 2070-0209, represents the renewal of an existing ICR that is scheduled to expire on March 31, 2022. Before submitting the ICR to OMB for review and approval under the PRA, EPA is soliciting comments on specific aspects of the 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 October 12, 2021.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0625, online 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.

Please note that 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 and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Jessica Barkas, PMOD (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 250-8880; email address: barkas.jessica@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 the Paperwork Reduction Act (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: Expanded Access to TSCA Confidential Business Information.

ICR number: EPA ICR No. 2570.02.

OMB control number: OMB Control No. 2070-0209.

ICR status: This ICR is currently scheduled to expire on March 31, 2022. 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: The 2016 amendments to the Toxic Substances Control Act (TSCA) in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, expanded the categories of people to whom EPA may disclose TSCA confidential business information (CBI). The amendments authorize EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. Three guidance documents have been developed, corresponding to the new authorities in TSCA section 14(d)(4), (5), and (6).

The conditions for access vary under each of the new provisions, but generally include the following: Requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and except in emergency situations EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA.

In accordance with the requirements of TSCA section 14(c)(4)(B), the guidance documents cover the content and form of the agreements and statements required under each provision, and include information on where and how to submit requests to EPA.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to annual average 14.8 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 mainly government employees (federal, state, local, tribal), as well as medical professionals, such as doctors and nurses. The NAICS code for health care and social assistance is 62.

Respondent's obligation to respond: Voluntary.

Estimated total number of potential respondents: 3.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: 2.

Estimated total annual burden hours: 89 hours.

Estimated total annual costs: $5,873.98. This includes an estimated burden cost of $5,873.98 and an estimated cost of $0 for capital investment or maintenance and operational costs.

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

There is no change in the estimated total annual burden compared with that identified in the ICR currently approved by OMB, but there is an increase in the estimated burden costs and a decrease in the estimated number of total respondents. The change in estimated cost was caused by an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead), and the change in the estimated number of respondents is based on EPA experience. This change is an adjustment.

In addition, this ICR reflects a change in format. 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. The Agency does not believe that this change in format resulted 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 person listed under FOR FURTHER INFORMATION CONTACT.

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