Document ID: EPA-HQ-OPPT-2021-0728-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Consolidation
of Certain Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)
Posted Date: 2022-03-08T05:00Z

[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Notices]
[Pages 12954-12956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04851]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0728; FRL-9155-01-OCSPP]

Agency Information Collection Activities; Proposed Renewal and 
Request for Comment; Consolidation of Certain Reporting and 
Recordkeeping Under Section 8 of the Toxic Substances Control Act 
(TSCA).

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit a request to renew 
and consolidate existing approved Information Collection Requests 
(ICRs) to the Office of Management and Budget (OMB). Before submitting 
the consolidated 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 consolidated ICR is entitled: 
``Reporting and Recordkeeping Under Section 8 of the Toxic Substances 
Control Act (TSCA)'' and is identified under EPA ICR No. 2703.01 and 
OMB Control No. 2070-[NEW]. EPA is consolidating several ICRs covering 
reporting and recordkeeping activities under TSCA Section 8 to 
streamline the presentation of the paperwork burden estimates for these 
various activities and eliminate any duplication, which will in turn is 
expected to reduce the administrative burden for both the public 
reviewers and the Agency. The ICR and accompanying materials are 
available in the docket for public review and comment.

DATES: Comments must be received on or before May 9, 2022.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2021-0728, through the Federal eRulemaking 
Portal at https://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 https://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Katherine Sleasman, Mission Support 
Division (7101M), Office of Program Support, Office of Chemical Safety 
and Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-1204; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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

[[Page 12955]]

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: Recordkeeping and Reporting Under Section 8 of the Toxic 
Substances Control Act (TSCA).
    ICR numbers: EPA ICR No. 2703.01; OMB Control No. 2070-[NEW].
    ICR status: This ICR reflects the consolidation of the following 
currently approved ICRs:
    1. ``Health and Safety Data Reporting, Submission of Lists and 
Copies of Health and Safety Studies'' (EPA ICR No. 0575.16, OMB Control 
No. 2070-0004), which is currently approved through November 30, 2022;
    2. ``Recordkeeping and Reporting Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment'' (EPA 
ICR No. 1031.12, OMB Control No. 2070-0017), currently approved and 
pending renewal (86 FR 58905, October 25, 2021) (FRL-9137-01-OMS);
    3. ``TSCA Section 8(a) Preliminary Assessment Information Rule 
(PAIR)'' (EPA ICR No. 0586.14, OMB Control No. 2070-0054), which is 
currently approved through December 31, 2022; and
    3. ``Chemical-Specific Rules, TSCA Section 8(a)'' (EPA ICR No. 
1198.10, OMB Control No. 2070-0067), which expired June 30, 2018, and 
is pending reinstatement.
    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: These ICRs all involve reporting and recordkeeping 
activities established under TSCA section 8 for specific chemical 
substances. Although imposed for a specific chemical substance, the 
activities are already established and only vary based on the specific 
authority under TSCA section 8 and the need for the information for 
that chemical. EPA is consolidating these ICRs to streamline the 
presentation of the paperwork burden estimates for these various 
activities, which will in turn facilitate and reduce the administrative 
burden for both the public reviewers and the Agency in terms of 
reviewing and updating the ICR every three years as required by the 
PRA, as well as to allow for a better assessment of the paperwork 
burden and costs associated with reporting and recordkeeping activities 
established under TSCA section 8 for specific chemical substances.
    This ICR covers reporting and recordkeeping requirements imposed 
under the authorities in TSCA section 8, for persons who manufacture 
(the term ``manufacture'' includes import under TSCA) or process 
chemical substances, mixtures, or categories, or distribute them in 
commerce. The purpose of the information collection activities is to 
collect data that will help the Agency evaluate the potential for human 
health and environmental risks that may be caused by the manufacture, 
processing, and distribution in commerce of chemical substances, 
mixtures, or categories.
    The TSCA section 8(a) Preliminary Assessment Information Rule 
(PAIR) requires manufacturers and importers of certain chemical 
substances to submit information about production, use, and/or 
exposure-related data. Under TSCA section 8(a), persons who 
manufacture, import, or process certain chemical substances or 
mixtures, or propose to manufacture, import, or process certain 
chemical substances or mixtures, are subject to chemical-specific rules 
promulgated under TSCA section 8(a). A chemical-specific ``8(a) rule'' 
requires more detailed and more types of information than is required 
by a PAIR rule. For example, a chemical-specific ``8(a) rule'' might 
require information that includes, but is not limited to, chemical 
names, categories of use, production volume, byproducts of chemical 
production, existing data on health and environmental effects, exposure 
data, and disposal information.
    Under TSCA section 8(c), persons who manufacture, import, process, 
or distribute in commerce any chemical substance or mixture must keep 
records of significant adverse reactions to health or the environment, 
as determined by the Administrator by rule, alleged to have been caused 
by the substance or mixture. TSCA section 8(c) requires that 
allegations of adverse reactions to the health of employees be kept for 
thirty years, and all other allegations be kept for five years. The 
rule also prescribes the conditions under which a firm must submit or 
make the records available to a duly designated representative of the 
Administrator.
    Finally, under TSCA section 8(d), persons, who manufacture, import, 
process, or distribute in commerce (or propose to manufacture, import, 
process, or distribute in commerce) certain chemical substances and 
mixtures, are required to submit to EPA lists and copies of health and 
safety studies in their possession which relate health and/or 
environmental effects of the chemical substances and mixtures. The 8(d) 
rules are codified in 40 CFR part 716. To comply, respondents must 
search their records to identify any health and safety studies in their 
possession, make copies of relevant studies, list studies that are 
currently in progress, and submit this information to EPA.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average one 
hour per response. The consolidated ICR, a copy of which is available 
in the docket, provides a detailed explanation of this estimate, which 
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 the North American Industrial Classification System 
(NAICS) Codes 325 and 324.
    Estimated total number of potential respondents: 13,294.
    Frequency of response: On occasion.
    Estimated average number of potential responses: 26,425.
    Estimated total annual burden hours: 26,226 hours.
    Estimated total annual costs: $5,109,515, which includes an 
estimated burden cost of $ 0 for non-burden hour paperwork costs, e.g., 
capital investment or maintenance and operational costs.

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

    This ICR will be submitted as a new ICR, which means that the total 
estimates for burden and costs provided in Unit IV. will be considered 
increases. However, since this ICR represents the consolidation and 
reinstatement of previously approved ICRs, the Agency compared the 
total estimates in this ICR to the estimated burden and costs 
previously approved. This identified an overall increase in the 
estimated total burden of 78 hours (26,226--26,148) and a corresponding 
increase in the estimated total burden cost of $ 297,119

[[Page 12956]]

[$5,109,515--$4,812,396]. This overall increase is due to the 
consolidation and reinstatement of the individual ICRs, and adjustments 
in EPA's estimates of the number of respondents, the activity burden, 
and updates to the wage rates and material costs to reflect 2021 
dollars. These changes are adjustments.

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

    EPA will consider the comments received and amend the consolidated 
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 for the 
public to submit additional comments for OMB consideration. Once this 
ICR is approved by OMB, it will replace the existing ICRs.
    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 2, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2022-04851 Filed 3-7-22; 8:45 am]
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