SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

This action provides information that is directed to the public in general.

B. What is the Agency's authority for taking this action?

EPA is publishing this document in the Federal Register as required by sections 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., and corresponding EPA regulations.

Under TSCA, a chemical substance may be either an “existing” chemical substance or a “new” chemical substance, see https://www.epa.gov/​chemicals-under-tsca. Any chemical substance that is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is classified as a “new chemical substance,” while a chemical substance that is listed on the TSCA Inventory is classified as an “existing chemical substance.” See TSCA section 3(2) and (11). For more information about the TSCA Inventory, see https://www.epa.gov/​inventory.

Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the new chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).

TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture a new chemical substance, or manufacture or process a chemical ( printed page 34234) substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical substances will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing exemption, or TME.

Premanufacture notification procedures for review of certain new microbial products of biotechnology are established in 40 CFR part 725. These pertain to MCANs and biotechnology exemptions, including TSCA experimental release applications (TERAs), TMEs for microorganisms, and Tier I and Tier II exemptions.

C. What action is the Agency taking?

This document provides notice of receipt and status reports for the covered period and certain submissions under TSCA section 5 and provides an opportunity to comment on this information. The Agency is providing information about the receipt of PMNs, SNUNs, MCANs, and amendments to a previously submitted notice; test information; biotechnology exemption applications under 40 CFR part 725; TME applications; NOCs for new chemical substances; and a periodic status report on chemical substances that are currently under EPA review or have recently concluded review.

D. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the instructions at https://www.epa.gov/​dockets/​commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. In addition to one complete version of the comment that includes CBI, a copy of the comment without CBI must be submitted for inclusion in the public docket. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/​dockets/​commenting-epa-dockets.

II. Background

A. What information is being provided in this document?

The tables in this document provide the following information on the TSCA section 5 submissions and amendments received by EPA during this period and determined to be completely consistent with 40 CFR 720.70(a).

• Case number. The EPA number assigned to the TSCA section 5 submissions. Please note that a case number may be listed more than once in the table when the submission involves a subsequent amendment.
• Chemical substance. Name of the chemical substance, or generic name if the specific name is claimed as CBI.
• Manufacturer. Name of the submitting manufacturer, to the extent that such information is not subject to a CBI claim. The term “manufacturer” is defined by statute to include importer.
• Use(s). Potential uses identified by the manufacturer.
• Received. Date the submission was received by EPA.
• Commencement. Date of commencement provided by the submitter in the NOC.
• Test information. For test information received, the type of test information submitted to EPA is based on the attachment type and subtype data selected by the submitter.

B. What do the acronyms mean that are used in the tables?

As used in each of the tables, the following explanations apply:

• (S) Indicates that the information in the table is the specific information provided by the submitter.
• (G) Indicates that the information in the table is generic information because the specific information provided by the submitter was claimed as CBI.

C. How can I access other information about TSCA section 5 submissions?

EPA provides information on its website about cases reviewed under TSCA section 5, including the PMNs, SNUNs, MCANs, and exemption applications received; the date of receipt; the final EPA determination on the submission; and the effective date of EPA's determination. https://www.epa.gov/​new-chemicals-under-toxic-substances-control-act-tsca/​status-pre-manufacture-notices. In addition, information EPA receives about chemical substances under TSCA, including non-CBI new chemical submissions, can be accessed in ChemView at https://chemview.epa.gov/​chemview.

III. Receipt Reports

Table 1 provides non-CBI information for the PMNs, SNUNs and MCANs received by EPA that have passed an initial screening and determined to be complete consistent with 40 CFR 720.70(a) during this period.

In Table II of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs that have passed an initial screening by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, and chemical substance identity.

Table 2 provides non-CBI information on the NOCs received by EPA that have passed an initial screening during this period.

Table 3 provides non-CBI information on the test information that has been received by EPA that has passed an initial screening during this period.

IV. Status Reports

Information about the TSCA section 5 PMNs, SNUNs, MCANs, and exemption applications received, including the date of receipt, the status of EPA's review, the final EPA determination, and the effective date of EPA's determination, is available online at: https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca/​status-pre-manufacture-notices.

Authority:15 U.S.C. 2601 et seq.

91 FR 34233