The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would amend the Class E airspace at Missoula International Airport, Missoula, MT to support instrument flight rules (IFR) operations at the airport.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2019-0761; Airspace Docket No. 19-ANM-18”. The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.

This document proposes to amend FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E4 airspace at Missoula International Airport extending upward from the surface within 1.2 miles each side of the 310° bearing extending from the 4.4-mile radius to 10.8 miles northwest of the airport, and within 1.3 miles each side of the 295° bearing extending from the 4.4-mile radius to 5.6 miles northwest of the airport, and within 0.7 miles each side of the 142° bearing extending from the 4.4-mile radius to 5.6 miles southeast of the airport, and within 1.5 miles each side of the 171° bearing extending from the 4.4-mile radius to 10.6 miles south of the Missoula International Airport. This airspace is designed to contain IFR aircraft descending below 1,000 feet above the surface.

This action also proposes to amend Class E5 airspace extending upward from 700 feet above the surface within 3.5 miles each side of the 311° bearing extending from the 4.4-mile radius to 22.3 miles northwest of the airport, and 1.6 miles west and 4.3 miles east of the 179° bearing extending from the 4.4-mile radius to 15.2 miles south of the Missoula International Airport. This airspace is designed to contain IFR aircraft descending below 1,500 feet above the surface. Further, this action proposes to amend Class E5 airspace extending upward from 1,200 feet above the surface within a 35-mile radius of the Missoula International Airport. This action also proposes an administrative update to remove the Missoula VORTAC from the legal description, this will allow the airspace to be described from a single point, enhancing the simplicity of airspace description.

Further, this action proposes to remove the Missoula VORTAC from the Class E5 legal description. The VORTAC is not needed to define the airspace and removing reference to it allows for a simpler description of the airspace from the airport.

Lastly, this action proposes an administrative update to the Class D and Class E2 legal descriptions to replace Airport/Facilities Directory with Chart Supplement.

Class D, E2, E4 and E5 airspace designations are published in paragraphs 5000, 6002, 6004 and 6005, respectively, of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The Commission is proposing to amend 17 CFR 242.608 (Rule 608 of Regulation NMS) under the Exchange Act to rescind paragraph (b)(3)(i) of Rule 608 and thereby eliminate the effective-upon-filing exception for proposed NMS plan amendments to establish or change a fee or other charge collected on behalf of all the plan participants in connection with access to, or use of, any facility contemplated by the plan or amendment (including changes in any provision with respect to distribution of any net proceeds from such fees or other charges to the participants) (“Proposed Fee Changes”).

Section 11A(a) of the Exchange Act directs the Commission to facilitate the creation of a national market system for qualified securities. 1 To help implement the national market system, the Commission has required the self-regulatory organizations (“SROs”) to act jointly through NMS plans to, among other things, establish certain facilities. Some NMS plans govern the facilities through which registered securities information processors (“SIPs”) collect, consolidate, and distribute real-time market information (also known as core data) that is essential to investors and others who wish to participate in the U.S. markets for exchange-listed equities and options. The SRO participants, through these NMS plans, charge fees for core data, and the total revenues generated by these fees totaled more than $500 million in 2017. 2 Core data fees are paid by a wide range of market participants, including investors, broker-dealers, data vendors, and others. The NMS plan governing the consolidated audit trail (“CAT”) also contemplates fees would be paid by SRO participants and collected from SRO members.

Rule 608(b) of Regulation NMS sets forth the procedure and requirements for amending an NMS plan. Specifically, pursuant to Rule 608(b)(1), the Commission shall publish notice of any proposed NMS plan amendments, together with the terms of substance of the filing or a description of the subjects and issues involved, and provide interested persons an opportunity to submit written comments. These filings and related comments assist the Commission in determining whether to approve the proposed amendment. Pursuant to Rule 608(b)(2), the Commission shall approve a proposed NMS plan amendment, with such changes or subject to such conditions as the Commission may deem necessary or appropriate, if it finds that such plan amendment is necessary or appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanisms of, a national market system, or otherwise in furtherance of the purposes of the Exchange Act. 3 Pursuant to Rule 608(b)(1) and (2), the Commission publishes public notice of a proposed NMS plan amendment and provides an opportunity for public comment before the amendment can go into effect. In addition, the rule provides that a proposed amendment cannot become effective until it is approved by the Commission. 4

Paragraph (b)(3)(i) of Rule 608, however, provides an exception to the standard procedure for Proposed Fee Changes (“Fee Exception”). Under the Fee Exception, a Proposed Fee Change may be put into effect upon filing with the Commission, and an NMS plan may begin charging the new fee prior to an opportunity for public comment and without Commission action.

Rule 608(b)(3)(iii) also provides that the Commission may summarily abrogate a Proposed Fee Change within 60 days after filing and require it to be refiled in accordance with the standard procedure if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanisms of, a national market system, or otherwise in furtherance of the purposes of the Exchange Act. The substance of a Proposed Fee Change filed under the Fee Exception is required to be the same as the substance of a Proposed Fee Change (or any other proposed NMS plan amendment) filed under the standard procedure. 5

Given the substantial amount and broad effect of NMS plan fees, as well as the need of many market participants to obtain core data and the potential conflicts of interest in setting fees discussed below, 6 the Commission preliminarily believes that a Proposed Fee Change should not become effective (and SROs should not be able to charge new or altered fees to investors, broker-dealers, and others) until after the public has had an opportunity to comment and the Commission has approved the Proposed Fee Change. Accordingly, the Commission is proposing to eliminate the Fee Exception by rescinding subparagraph (b)(3)(i) of Rule 608.

The Fee Exception is available for NMS plans that currently charge or intend to charge fees and for which the SRO participants, through these NMS plans, must file Proposed Fee Changes with the Commission. Currently, these NMS plans are the core data plans and the CAT plan. 7 The participants in these plans are all SROs.

For each NMS security, 8 the NMS plans generally define consolidated market information (or “core data”) as consisting of: (1) The price, size, and exchange of the last sale; (2) each exchange's current highest bid and lowest offer, and the shares available at those prices; and (3) the national best bid and offer ( i.e., the highest bid and lowest offer currently available on any exchange). 9 Pursuant to NMS plans, this core data is collected, consolidated, processed, and disseminated by the SIPs. 10 In addition, the SIPs collect, calculate, and disseminate certain regulatory data, including information required by the National Market System Plan to Address Extraordinary Market Volatility (“LULD Plan”), 11 information relating to regulatory halts and market-wide circuit breakers (“MWCBs”), 12 and information regarding short sale circuit breakers pursuant to Rule 201, 13 as well as collect and disseminate other NMS stock data and disseminate certain administrative messages.

Multiple NMS plans currently govern the collection, consolidation, processing, and dissemination of core data for NMS stocks. Specifically, these plans govern three networks (“Networks”) that disseminate core data based on primary listing market: (1) Network A for NYSE-listed stocks; (2) Network B for stocks listed on exchanges other than the NYSE or Nasdaq; and (3) Network C for stocks listed on Nasdaq. Networks A and B are operated pursuant to the Consolidated Tape Association (“CTA”) Plan, which governs the collection and distribution of transaction information, and the Consolidated Quotation (“CQ”) Plan, which governs the collection and distribution of quotation information. Transaction and quotation information for Network C stocks is collected and distributed pursuant to the Joint Self-Regulatory Organization Plan Governing the Collection, Consolidation, and Dissemination of Quotation and Transaction Information for Nasdaq-Listed Securities Traded on Exchanges on an Unlisted Trading Privilege Basis (“Nasdaq/UTP”).

In addition, one NMS plan governs the collection, consolidation, processing, and dissemination of last sale and quotation information for listed options, namely, the plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information (“OPRA”).

The NMS plan governing the CAT was approved by the Commission on November 15, 2016. 14 The purpose of the CAT plan is to provide for the creation, implementation, and maintenance of a comprehensive audit trail for the U.S. securities markets. 15 This consolidated audit trail is designed to “capture customer and order event information for orders in NMS securities, across all markets, from the time of order inception through routing, cancellation, modification, or execution in a single, consolidated data source.”  16

The CAT plan approved by the Commission allows the operating committee of CAT NMS, LLC (the entity charged with the creation, implementation, and maintenance of CAT), to establish funding for CAT NMS, LLC, including establishing an allocation of its related costs among SRO participants and SRO members that is consistent with the Exchange Act. 17 The CAT plan thus contemplates that fees would be paid by the SRO plan participants, as well as collected from SRO members, which are the “Industry Members” under the plan. 18

Each of the NMS plans is governed by an operating committee composed of one voting representative from each SRO participant. 19 Through their participation in the plan operating committees and votes to approve plan amendments, the SRO plan participants approve new fee proposals for each plan and, in the case of the core data plans (CTA/CQ, Nasdaq/UTP and OPRA), new proposed allocations of fee revenues. 20 Under the CAT plan, the operating committee has discretion to establish fees, which the SRO participants will implement, for both SRO participants and Industry Members. 21 Once a fee or revenue allocation proposal has been approved by the SRO plan participants, the proposal must be filed with the Commission pursuant to Rule 608 of Regulation NMS in order to become effective.

Rule 608 of Regulation NMS sets forth requirements for filing and amendment of NMS plans. Rule 608(a) provides that any two or more SROs, acting jointly, may file a new proposed NMS plan or a proposed amendment to an existing NMS plan by submitting to the Commission the text of the plan or amendment along with extensive supporting information. Rule 608(b) addresses the effectiveness of proposed NMS plans and plan amendments. It sets forth the standard procedure, along with exceptions for certain types of proposals. Specifically, paragraphs (b)(1) and (b)(2) of Rule 608 generally require that proposed plan changes must be filed with the Commission, published for comment, and approved by Commission order before they can become effective and implemented. 22 Paragraph (b)(3) of Rule 608, however, provides an exception to this procedure in three contexts: (i) To establish or change fees or charges (including the allocation of resulting revenues among the participating SROs) ( i.e., the Fee Exception), (ii) solely plan administration matters, and (iii) solely technical or ministerial matters. Proposed NMS plan amendments fitting one of these contexts may (but are not required to) be filed pursuant paragraph (b)(3) of Rule 608 and thereby avoid the standard procedure of paragraphs (b)(1) and (2).

A proposed NMS plan amendment that is filed pursuant to paragraph (b)(3) of Rule 608 is deemed effective upon filing, prior to an opportunity for public comment and without Commission action. Paragraph (b)(3)(iii), however, provides that the Commission, at any time within 60 days of the filing of an immediately effective amendment, may summarily abrogate the amendment and require that the amendment be re-filed pursuant to the standard procedure of paragraphs (b)(1) and (2). Consequently, while Rule 608(b)(3) provides an opportunity for public comment and for the Commission to abrogate a Proposed Fee Change, the effective-upon-filing provision means that market participants can be charged a new or altered fee before comments can be submitted and before the Commission can evaluate whether to abrogate a Proposed Fee Change.

The Commission originally adopted the Fee Exception in 1981 in Rule 11Aa3-2, the predecessor to Rule 608. Rule 11Aa3-2 was adopted pursuant to Section 11A(a)(3)(B) of the Exchange Act, which broadly authorizes the Commission to require SROs to act jointly with respect to matters relating to the national market system or facilities thereof, including NMS plans. 23 Separate from the context of NMS plans and the SROs' roles as participants in those plans, SROs also charge fees individually pursuant to a different section of the Exchange Act. In contrast to Section 11A(a)(3)(B), which governs Rule 608 and NMS plan fees, Section 19(b) of the Exchange Act governs the fees that a SRO charges individually. 24 Unlike Section 11A(a)(3)(B), which does not statutorily mandate an effective-upon-filing procedure for Proposed Fee Changes, Section 19(b)(3)(A) specifically mandates by statute an effective-upon-filing procedure for all fee changes that SROs individually propose, regardless of whether the fee is charged to persons other than members of the SRO. 25 Congress added this mandate to Section 19(b)(3)(A) of the Exchange Act in the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (“Dodd-Frank Act”). 26 The legislative history of the Dodd-Frank Act indicates that Congress was responding to a concern expressed by several exchanges that the Section 19(b) SRO rule filing process creates a significant competitive advantage for less regulated competitors that do not have to seek regulatory approval before changing their rules. 27

NMS plan fees, in contrast, are not subject to Section 19(b) of the Exchange Act and, as discussed above, Congress, in amending Section 19(b)(3)(A), was responding to concerns about competitive disparities in the context of individual SRO fees. Indeed, the Commission previously has noted that Congress did not intend to treat NMS plan amendments the same as individual SRO rule changes. For example, when the Commission adopted Rule 11Aa3-2 (the prior designation of Rule 608), the Commission stated that it did “not believe that it was the intent of Congress to treat NMS Plans as analogous to SRO rules” and rejected the argument of some commenters that the procedures for NMS plan amendments under Section 11A should incorporate the same procedures specified in Section 19 for rule changes by individual SROs. 28

Although the Commission did not believe that Congress mandated Section 19 procedures for NMS plan amendments, Rule 11Aa3-2, as adopted in 1981, included all three of the effective-upon-filing exceptions that currently are in Rule 608 and that were similar to the effective-upon-filing exceptions in Section 19. 29 At that time, the Commission stated that the Fee Exception was added in response to concerns expressed by exchanges that they should be able to change NMS plan fees without prior Commission approval to avoid administrative delay. 30

When Regulation NMS was adopted in 2005, Rule 11Aa3-2 was redesignated as Rule 608 (and will hereinafter be referred to as Rule 608). 31 Several commenters on the proposal of Regulation NMS in 2004 advocated eliminating the effective-upon-filing procedure; they argued that it gave excessive power to self-interested parties and did not facilitate informed and meaningful public and industry participation and comment. 32 When adopted however, Regulation NMS did not change the effective-upon-filing procedure. Rather, the Commission stated that issues relating to the level of core data fees would be most appropriately addressed in the broader context of its separate review of SRO structure, governance, and transparency, which included a 2004 proposal on SRO transparency and a 2004 concept release on SRO structure. 33 The Commission ultimately did not take further action on the proposal or concept release.

Some market participants questioned the Fee Exception more recently. Two petitions for rulemaking were submitted to the Commission in 2017 and 2018 requesting, among other things, that the Fee Exception be rescinded. 34 One of the petitions was submitted by 24 firms representing a broad cross section of market participants, including institutional investors, broker-dealers, and data vendors. 35 In connection with and during the Roundtable on Market Data and Market Access (“Roundtable”) that was hosted by SEC staff in October 2018, commenters and panelists urged the Commission to rescind the Fee Exception to allow for more public and Commission scrutiny of Proposed Fee Changes for core data before they are effective. 36 These commenters and petitioners believe that market participants do not have an opportunity to meaningfully comment on Proposed Fee Changes for core data before the market participants are subject to the new fees. 37

The Commission is proposing to rescind Rule 608(b)(3)(i) and thereby eliminate the effective-upon-filing procedure for Proposed Fee Changes. As a result, the standard procedure, which requires public notice, an opportunity for public comment, and Commission approval by order before a proposed plan amendment can become effective, would apply to any Proposed Fee Change.

The proposed rescission of the Fee Exception would not change any requirements regarding the substantive information that must be set forth in Proposed Fee Changes. The information required by paragraph (a) of Rule 608 and the relevant provisions of the Exchange Act apply whether a proposed fee change filing is submitted under the Fee Exception or the standard procedure.

The Commission preliminarily believes that eliminating the Fee Exception and instead requiring the standard procedure for Proposed Fee Changes would help ensure that fees are fair and reasonable before they go into effect. NMS plan fee changes can significantly affect the interests of investors and market participants. By changing the timing of effectiveness, the proposed rescission of the Fee Exception would give commenters an opportunity to provide their views about a Proposed Fee Change prior to the time they are charged a new or altered fee. Moreover, while the Commission can abrogate an immediately effective NMS plan amendment, the input of commenters is an important part of the Commission's review of Proposed Fee Changes, and the Commission generally has not abrogated a Proposed Fee Change prior to reviewing the comments. Rather than allow an NMS plan to charge new or altered fees during this review process, with the potential that investors and market participants may not have adequate notice or time to plan for a fee change before it goes into effect, the Commission preliminarily believes, for the reasons discussed throughout, that the effectiveness and implementation of new or altered fees should occur only after the comment and review process is complete.

Non-SRO market participants, including investors, broker-dealers, data vendors, and others, are required to pay the fees charged by the NMS plans to obtain access to core data. 38 Retail investors that access core data through their broker-dealers (and not directly) can still be affected by core data fees in that such fees paid by their broker-dealers can affect their ready access through their broker-dealer to full NBBO market information. 39 The Commission has previously stated that investors must have core data to participate in the U.S. equity markets. 40 And many market participants, including all broker-dealers, must have access to core data to meet their regulatory obligations. Broker-dealer panelists at the Roundtable noted that they are compelled to purchase core data for various reasons, including to receive Limit Up/Limit Down (“LULD”) plan price bands, to perform checks required by Rule 15c3-5 under the Exchange Act (the “market access” rule), 41 and for redundancy purposes. 42 Moreover, some broker-dealers use core data to comply with the requirements of Rule 611 of Regulation NMS to prevent trade-throughs and to meet their duty of best execution for customer orders. Also, pursuant to Rule 603(c) of Regulation NMS, 43 known as the “Vendor Display Rule,” if a broker-dealer displays any information with respect to quotations for or transactions in an NMS stock in certain contexts, it must also provide a consolidated display for such stock. 44 Broker-dealers typically meet this regulatory requirement by using core data, for which fees must be paid. 45

Similarly, pursuant to the CAT plan, the SRO participants may set fees that Industry Members must pay for the costs of the CAT system. 46 As discussed above, the CAT plan allows the SRO plan participants, through the operating committee of CAT, to establish an allocation of costs among SRO participants and Industry Members, and collect fees from Industry Members. 47 SRO participants, in setting the allocation of costs among themselves and Industry Members, are beset by similar conflicts that exist when setting fees for core data. 48

Moreover, the total revenues derived from NMS plan fees are substantial. For example, the total revenues generated by fees for core data totaled more than $500 million in 2017. 49 Similarly, with respect to the CAT plan, the fees related to the costs of creation and maintenance of the CAT systems are and will continue to be substantial. 50 The substantial fees charged by NMS plans to a wide range of market participants heightens the need for full review of Proposed Fee Changes prior to the time that a new or altered fee is charged to market participants.

As noted above, 51 the Commission added the Fee Exception to Rule 608 in 1981 in response to concerns expressed by exchanges about the administrative burdens and delays that could occur if fees could not be changed without prior Commission approval. 52 A potential concern about administrative delay could arise in circumstances where an SRO's competitive position might be harmed by the inability to change its fee quickly. However, the Commission previously has noted that where plans responsible for providing core data are monopolistic providers of such data, there is no market competition that can be relied upon to set competitive prices. 53 For example, the core data plans provide critical market information that is not available from other sources, such as LULD plan price bands and administrative messages. 54

Moreover, SRO structures and the nature of SRO relations with their members have changed substantially since the Fee Exception was adopted in 1981. Then, exchange SROs were structured as mutual organizations that were owned, for the most part, by SRO members that were registered broker-dealers. 55 Today, in contrast, nearly all exchange SROs are part of publicly-traded exchange groups that are not owned by the SRO members, and there is less opportunity for members to influence a Proposed Fee Change before it is filed with the Commission. As a result, the Commission preliminarily believes that it is more important today than it was prior to the demutualization of the exchange SROs for members and other interested parties to have an opportunity, via the standard procedure, to express their views on a Proposed Fee Change after it is filed with the Commission but before it is effective and can be charged to market participants. This opportunity is not available under the Fee Exception because, even if a Proposed Fee Change is subsequently abrogated, the fee is effective immediately upon filing, remains effective for the period between filing and abrogation, and market participants can be charged the fee during the entire period between filing and abrogation.

The Commission recognizes that eliminating the Fee Exception and subjecting Proposed Fee Changes to the standard procedure may extend the timeframe in which NMS plan participants can put into effect new or amended fees. But the Commission preliminarily believes that changes in the costs of operating NMS plans generally can be reasonably forecasted and that NMS plan participants should be able to account for the longer time periods of the standard procedure in planning new or amended fees. Moreover, as discussed below, few Proposed Fee Changes are filed each year under Rule 608, and we estimate based on past practice that the median time it would take the Commission to make a decision to approve or disapprove proposed NMS plan amendments would be 70.5 days from the time of filing. 56 In the Commission's preliminary view, this delay should not disrupt the ability of NMS plan participants to implement new or amended fees as necessary to perform their plan responsibilities. On balance, therefore, the Commission preliminarily believes that subjecting Proposed Fee Changes to the standard procedure should not impose significant costs, and that any such costs are justified by the benefit of requiring public notice, an opportunity for public comment, and Commission approval by order before a Proposed Fee Change can become effective and market participants are charged a new or altered fee.

The Commission therefore is proposing that all Proposed Fee Changes be subject to the standard procedure set forth in Rule 608(b)(1) and (2).

Requests for Comment:

The Commission requests comment on all aspects of this proposal as well as, in particular, on the following:

1. Do commenters agree that the Commission should rescind the Fee Exception? Why or why not?

2. Are there positive or negative implications, in addition to those discussed above, of the Commission's proposal to rescind the Fee Exception?

3. Is the procedure for notice, comment, and Commission approval or disapproval under existing Rule 608(b)(1) and (2) appropriate for Proposed Fee Changes? Should there be an opportunity for public comment before Proposed Fee Changes can become effective? Should Commission approval be required before Proposed Fee Changes can become effective? Should the time periods set forth in Rule 608(b)(2) be longer or shorter if applied to Proposed Fee Changes? Should any other aspects of paragraphs (b)(1) or (b)(2) of Rule 608 be altered in their application to Proposed Fee Changes?

4. Does the current effective-upon-filing procedure detract from the willingness of commenters to submit their views on Proposed Fee Changes, given that the proposed fee is already in effect when commenters may submit their views? Would market participants be more likely to comment on Proposed Fee Changes if they knew that the fees at issue were not yet effective and could not become effective without Commission action after consideration of comments? If so, do commenters believe that the proposed approach would lead to a more diverse and rich comment process and thereby promote a more informed evaluation of Proposed Fee Changes than is currently provided by the Fee Exception? If commenters do not believe the change would promote a more informed evaluation, why not?

5. Instead of rescinding the Fee Exception altogether, should the Commission modify the abrogation procedure in Rule 608(b)(3)(iii) such that Proposed Fee Changes are not effective immediately upon filing, but become automatically effective some time period ( e.g., 60 or 90 days) after filing if the Commission does not abrogate the filing? This alternative would assure that commenters had an opportunity to comment prior to being charged a new or altered fee, as well as provide the Commission an opportunity to review the comments in deciding whether to abrogate the filing. If this new period between the date of filing and automatic effectiveness expired without Commission abrogation, the Proposed Fee Change would become effective without Commission action. Do commenters believe this alternative is preferable to the proposed rescission of the Fee Exception? What, if any, additional aspects of this potential alternative should be considered?

6. Are there other alternative approaches that the Commission could adopt for achieving the goal of providing an opportunity for public comment on and Commission review of Proposed Fee Changes prior to the time they become effective and new or altered fees are charged to market participants?

7. Do commenters believe that the fact that nearly all exchange SROs are public companies that have demutualized raises concerns about immediate effectiveness of Proposed Fee Changes? Do commenters believe that, currently, investors and other market participants that are not plan participants do not have a meaningful opportunity to influence Proposed Fee Changes before they become effective under the Fee Exception? Do commenters believe that such an opportunity is provided under the Rule 608(b)(1) and (2) procedures?

8. What issues or improvements relating to Rule 608 procedures would you recommend the Commission address or undertake to ensure Proposed Fee Changes are not unduly delayed if the immediate effectiveness procedure were eliminated?

9. Do commenters believe that additional guidance on the content of Proposed Fee Changes would help improve the process for handling such filings?

10. Does the availability of proprietary data products sold by some SROs mitigate the Commission's preliminary concerns about subjecting market participants to new fees prior to any review by the Commission or opportunity for comment? Do those proprietary data products represent viable, competitively-priced alternatives to the core data distributed by the NMS plan processors?

The Commission believes that the proposed rescission of the Fee Exception would not impose any new, or revise any existing, collection of information requirement as defined by the Paperwork Reduction Act of 1995, as amended (“PRA”). 57 Accordingly, the Commission is not submitting this proposal to the Office of Management and Budget for review under the PRA. 58 The Commission requests comment on whether the proposed rescission of the Fee Exception would create any new, or revise any existing, collection of information pursuant to the PRA.

Section 3(f) of the Exchange Act requires the Commission, whenever it engages in rulemaking and is required to consider or determine whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action would promote efficiency, competition, and capital formation. 59 In addition, Section 23(a)(2) of the Exchange Act requires the Commission, when making rules under the Exchange Act, to consider the impact such rules would have on competition. 60 Exchange Act Section 23(a)(2) prohibits the Commission from adopting any rule that would impose a burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act.

Wherever possible, the Commission has quantified the likely economic effects of the proposed amendments. However, most of the costs, benefits, and other economic effects discussed are inherently difficult to quantify. Therefore, much of our discussion is qualitative in nature. Our inability to quantify certain costs, benefits, and effects does not imply that such costs, benefits, or effects are less significant. We request that commenters provide relevant data and information to assist us in analyzing the economic consequences of the proposed amendments.

The Commission has assessed the likely economic effects of the proposed amendments, including benefits, costs, and effects on efficiency, competition, and capital formation, against a baseline that consists of the existing regulatory process for NMS plan fee filings in practice, the structure of the market for core data and aggregated market data products, and the structure of the market for trading services in NMS securities.

There are currently a total of five NMS plans that either charge fees or could charge fees and have filed Proposed Fee Changes under the Fee Exception. These consist of the CAT Plan along with four NMS plans that govern the collection and dissemination of core data: The CTA Plan, the CQ Plan, the Nasdaq/UTP Plan, and the OPRA Plan. 61

The SROs approve all Proposed Fee Changes. 62 This can create potential conflicts of interest for the SROs because their duties administering NMS plans that either charge or could charge fees could potentially come into conflict with other products the SROs sell or costs they incur as part of their businesses. 63 For example, some of the SROs sell proprietary data products that can, in some situations, be used as substitutes for core data. 64 This can create a conflict of interest with respect to the four NMS plans that set fees for core data because the SROs vote to set SIPs' fees and also own and control the dissemination of all equity and option market data and set the prices of some of the proprietary data products SIPs may compete against. 65 Another conflict potentially exists because both SRO participants and Industry Members are responsible for paying fees related to the CAT plan; however, the CAT operating committee decides how these fees should be split. 66 The Commission comment process is one of the only ways market participants have to express their views on these Proposed Fee Changes. 67 However, under the current process, market participants do not have the opportunity to comment before the Proposed Fee Changes become effective. 68

Because Proposed Fee Changes are effective upon filing, fees in connection with an NMS plan can be charged immediately upon filing with the Commission. 69 In some cases, SRO members or subscribers to core data plans may not be given adequate time to plan for a new or altered fee before it is implemented. 70 For example, if subscribers to SIP core data are not given enough warning before a SIP changes fees, some subscribers, such as market data vendors, might not have enough time to adjust to the fee changes.

Table 1 shows information on the number of Proposed Fee Changes filed under Rule 608(b)(3)(i) since 2010 for each of the NMS plans that either charge fees or could charge fees. Since 2010, an average of 4.2 Proposed Fee Changes have been filed each year. The median time it takes the Commission to notice a Proposed Fee Change on its website is 25.5 days from the time it is filed. 71 The median time it takes an NMS plan to begin charging new fees pursuant to Proposed Fee Changes is 62.5 days after filing with the Commission. 72 Table 1 also contains information on how many of the fee filings were abrogated by the Commission or withdrawn by the NMS plan after receiving comments from market participants. For cases in which the Commission abrogates a NMS plan fee filing, the median time the fee filing is effective before the Commission abrogates the filing is 57 days. 73 No Proposed Fee Changes that have been abrogated by the Commission have been refiled under the standard procedure. 74 For cases in which an NMS plan withdraws a fee filing, the median time that the fee filing is effective before the NMS plan withdraws the filing is 46.5 days. 75 The median time it takes the Commission to notice fee filings that have been withdrawn is 34 days. 76 When an NMS plan refiles a withdrawn Proposed Fee Change, it is refiled on an immediately effective basis. The median time it takes an NMS plan to refile a withdrawn Proposed Fee Change is 174 days from the time the initial Proposed Fee Change was withdrawn. 77 The median time it takes the Commission to determine whether to approve an NMS plan amendment filed under the standard procedure is 45 days from the time it was noticed. 78

Invitation to Comment: We invite you to submit comments regarding these proposed regulations. To ensure that your comments have maximum effect in developing the final regulations, we urge you to identify clearly the specific section or sections of the proposed regulations that each of your comments addresses and to arrange your comments in the same order as the proposed regulations.

We invite you to assist us in complying with the specific requirements of Executive Orders 12866, 13563, and 13771 and their overall requirement of reducing regulatory burden that might result from these proposed regulations. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the Department's programs and activities.

During and after the comment period, you may inspect all public comments about these proposed regulations by accessing Regulations.gov . You may also inspect the comments in person at 400 Maryland Avenue SW, Washington, DC, between 8:30 a.m. and 4:00 p.m., Eastern Time, Monday through Friday of each week except Federal holidays. To schedule a time to inspect comments, please contact one of the persons listed under FOR FURTHER INFORMATION CONTACT .

Assistance to Individuals with Disabilities in Reviewing the Rulemaking Record: On request we will provide an appropriate accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these proposed regulations. If you want to schedule an appointment for this type of accommodation or auxiliary aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

The Secretary proposes to revise the regulations in 34 CFR part 263 that govern the Professional Development program to clarify certain statutory changes made to section 6122 of the ESEA by the ESSA and to better enable the Department and grantees to meet the objectives of the program. We also propose changes that are technical only and therefore will not be addressed in the preamble. For example, we will replace the term “Indian institution of higher education” with “Tribal College or University (TCU)” throughout in order to align with the reauthorized statute.

The primary statutory change that we are addressing in this notice of proposed rulemaking (NPRM) is the requirement that, after completing their training as teachers or administrators, program participants must work in local educational agencies (LEAs) that serve a high proportion of Indian students. We propose a definition of “LEA that serves a high proportion of Indian students” to provide clarity to applicants, participants, and prospective employers.

We also propose adding new priorities that would allow work by administrators in Tribal educational agencies (TEAs), or in entities starting a new school to serve Indian students, to serve as qualifying employment. We also propose to revise priorities and definitions to allow projects to support Native American language certification for teachers in States that offer this option. These changes would allow for greater flexibility for grantees to recruit and retain Indian teachers and administrators to serve in settings desired by Tribes while meeting the statutory requirements.

The Department held a blended in-person and virtual Tribal Consultation on November 15, 2018, to solicit input on the future direction of the Professional Development program, and continued to solicit Tribal comment through December 31, 2018, via its tribalconsultation@ed.gov mailbox. The Department also solicited Tribal input by issuing several email messages to Tribal leaders from each of the federally recognized Indian Tribes, all TCU presidents, current grantees under ESEA Title VI formula and discretionary grant programs, and external stakeholders. The topics on which we sought input included how we should define “LEA that serves a high proportion of Indian students”; whether we should establish a priority for training Indian administrators to start new Indian-serving charter schools; and ways to encourage opportunities for administrators to work with, and in, TEAs. Most respondents were in favor of the Department defining the term “LEA that serves a high proportion of Indian students” in order to allow as many LEAs as possible to serve as a qualifying job placement for successful participants, and the Department concurs and proposes to do so in these regulations. The Department had asked for specific input on using Indian student population percentage thresholds to define “high proportion” ( e.g. LEAs with 50 percent Indian student population); Tribal consultation participants were generally opposed to using any specific percentages in the definition. Several participants and subsequent submitted written comments to the Department stated that the options proposed by the Department would result in only schools on reservations qualifying for the program, and would be a disadvantage to urban or off-reservation schools that serve a large number but not a high percentage of Indian students relative to the districtwide student population. Many Tribal consultation participants expressed support for administrator opportunities to work in an entity starting a new charter school or transitioning a school to Tribally controlled, and to work for TEAs under this program.

We group major issues according to subject, with the appropriate sections of the proposed regulations referenced in parentheses. We discuss other substantive issues under the sections of the proposed regulations to which they pertain.

Statute: Section 6122(e)(2) of the ESEA requires applicants to describe how they will use grant funds to train teachers or principals to work in LEAs that serve a high proportion of Indian students. Similarly, the participant service payback requirement described in section 6122(h) requires work that benefits Indian students in an LEA that serves a high proportion of Indian students. The statute does not define the phrase “LEA that serves a high proportion of Indian students.”

Current Regulations: In § 263.5(b)(1)(ii), the priority for pre-service teacher training requires grantees to provide induction services in schools with a “significant” Indian student population. The selection criterion in § 263.6(d)(1) addresses the likelihood that the proposed project will prepare students for successful teaching and/or administration in schools with significant Indian populations.

The selection criteria in § 263.6(a), (c), and (d) (“need for project,” “quality of project design,” and “quality of project services”) do not reference the type of schools that can qualify for service payback. Under § 263.8(b), work in a school with a significant Indian student population satisfies the requirement that work-related payback benefits Indian people. The current regulations do not define the phrase “schools with a significant Indian student population.” The current regulations also make multiple references (§§ 263.4, 263.5 and 263.11) to the terms “qualifying job[s]” and “qualifying employment” but do not define these terms.

Proposed Regulations: We propose to establish a definition of “LEA that serves a high proportion of Indian students” in § 263.3 as an LEA with either (1) a high proportion of Indian students in the LEA as compared to other LEAs in the State; or (2) a high proportion of Indian students in the school in which the participant works, even if the LEA as a whole does not have a high proportion of Indian students. The definition would make clear that “LEA” includes a BIE-funded school for this purpose.

We propose to establish a definition of “qualifying employment” as employment in an LEA that serves a high proportion of Indian students. We also propose revising the definition of “induction services” to require that such services be provided in an LEA that serves a high proportion of Indian students; and revising the priorities in renumbered § 263.6(b)(1) and (2) to specify that induction services are to be provided to participants completing work-related payback in an LEA that serves a high proportion of Indian students.

We propose adding an application requirement in new 263.5 stating that applicants must submit one or more letters of support from LEAs that serve a high proportion of Indian students.

In the selection criterion renumbered 263.7(a), “Need for project,” we propose adding a selection factor that would ask applicants to describe the extent to which employment opportunities exist in LEAs that serve a high proportion of Indian students in the project service area. We also incorporate the new defined term “LEAs that serve a high proportion of Indian students” in the selection factor for “quality of project design” in renumbered 263.7(c)(3).

Finally, in renumbered § 263.12(c)(1) we propose adding an element to the required payback agreement that participants must sign, clarifying that in order to qualify for the work payback requirement, the job must be in an LEA “that serves a high proportion of Indian students.”

Reasons: First, we propose to define “LEA that serves a high proportion of Indian students” broadly in order to maximize the number of LEAs that would qualify under this definition. This proposed definition, informed by Tribal Consultation feedback, would allow us to consider whether an LEA's student body population has a high proportion relative to the Indian population in the grantee's State, as opposed to a nationwide comparison using a strict percentage. It would also permit a comparison of whether the school in which the participant works has a high percentage of Indian students compared to other LEAs in the State. This approach would mitigate the potential for perceived “competition” between urban and rural areas, address the need for serving Indian students in States where few to no schools have high percentages of Indian student populations, and would still adhere to the intent of this requirement.

In addition, we propose to add a definition of “qualifying employment” because the current regulations use different terms, such as “qualifying employment” and “qualifying jobs,” but do not define either. Defining this term with reference to the new statutory requirement of working in an LEA with a high proportion of Indian students would provide clarity for grantees, participants, and employers regarding which jobs will qualify for the work payback requirement. For example, under 263.12(d) (as proposed to be renumbered in this NPRM), grantees continue to have an obligation to assist participants in obtaining qualifying employment (consistent with the definition); but the definition would remove any ambiguity as to which job placements meet the definition of “LEA that serves a high proportion of Indian students.”

The proposed revision to the definition of “induction services,” which would require that such services be provided in an LEA that serves a high proportion of Indian students, would align that definition to the statutory requirement that applicants describe how they will support the preparation and professional development of teachers or principals in LEAs that serve a high proportion of Indian students. We propose revising the priorities in renumbered § 263.6(b)(1) and (2) to replace the current language concerning induction services for participants “in schools with significant Indian populations” with the new statutory “high proportion” language.

We propose adding the application requirement in § 263.5 for letters of support from LEAs that serve a high proportion of Indian students to help ensure that participants have actual opportunities for jobs following their training, at schools that will qualify for the work payback obligation. The letters of support would need to include evidence, such as a school, district and State report card that includes demographic information, that the LEA meets the definition of “LEA that serves a high proportion of Indian students.” We invite comment on what type of evidence the Department should accept, and what type of evidence is available to LEAs.

The proposed new element in the payback agreement (in proposed § 263.12(c)) would clarify in writing for participants that to satisfy the work payback requirement, they must work in an “LEA that serves a high proportion of Indian students.” This will increase the potential for participants to successfully meet the service payback requirement.

Statute: The ESEA, both prior to and after the ESSA amendments, does not specify whether an applicant IHE for this program must be a degree-granting institution. Although section 6122 of the ESEA does not define the phrase “institution of higher education,” section 8101 of the ESEA, which is also applicable to this program, contains a definition of “institution of higher education.” The statute does not define the term “full-time student.”

Current Regulations: Under § 263.2(c), eligibility of an applicant requiring a consortium with any IHE, including a TCU, requires that the IHE be accredited to provide the coursework and level of degree required by the project. In § 263.3, the current definition of “full-time student” requires that a student be a candidate for a baccalaureate or graduate degree. The definition of “institution of higher education” requires that the institution be accredited to award a baccalaureate degree or higher. “Pre-service training” is defined as training that results in licensing or certification in a field requiring at least a baccalaureate degree. In the priority for pre-service teacher training in § 263.5(b)(1), the training must be in a subject area that requires a degree.

Proposed Regulations: The proposed regulations in § 263.2(c), regarding eligibility of an applicant requiring a consortium with any IHE, would be broadened to include IHEs that are accredited to provide the coursework and level of degree or Native American language certificate required by the project.

In the definition of “full-time student” in § 263.3, the proposed regulations would add the option that students who are candidates for a Native American language certificate can also qualify as “full-time students,” for an applicant proposing a program that awards a certificate of Native American language instruction rather than a baccalaureate degree. For the definition of “institution of higher education,” the proposed regulations would use the statutory definition from ESEA section 8101. For consistency with that definition, the list of eligible entities in § 263.2(a)(1) would be revised to use the word “or” between the phrase “institution of higher education” and the phrase “TCU,” rather than the existing word “including.” Conforming changes would be made to add “or TCU” following the phrase “institution of higher education” in paragraphs (a)(2) through (a)(4) of § 263.2, and in the definition of “Indian organization” in § 263.3.

The proposed regulations would add to the definition of “pre-service training” the option that the training could be either in a field that requires at least a baccalaureate degree, or certification in Native American language instruction.

The proposed regulations would also revise the priority for pre-service teacher training in § 263.6(b)(1)(i), as renumbered, to add the option of training in the field of Native American language instruction. Finally, the proposed regulations would add definitions of the terms “Native American” and “Native American language.”

Reasons: The Department has learned, both from current grantees and through Tribal consultation, that there is interest in providing training for teachers of Native American languages, and that there is a shortage of qualified teachers in this field. We understand that a number of States now have a certificate or license for teaching Native American languages, and that such certificates generally do not require a bachelor's degree. This enables non-traditional students such as Tribal elders to obtain the needed qualifications to teach Native American languages in the public schools. These proposed changes to the regulations would provide more flexibility to grantees, better recognize Tribal sovereignty, and help fulfill the Department's obligation under the Native American Languages Act (NALA) to support efforts to preserve, protect, and promote the rights and freedom of Native Americans to use, practice, and develop Native American languages.

The proposed regulations contain several changes to facilitate this flexibility in the Professional Development program. First, the proposed regulations would change the definition of “IHE” to the general definition in title VIII of the ESEA, which in turn uses the definition in section 101(a) of the Higher Education Act of 1965 (HEA). This proposed definition would eliminate the prior requirement in the regulatory definition for this program that the institution must award a baccalaureate degree or higher. The proposed definition would enable an IHE that meets the HEA definition but does not award a baccalaureate degree, such as a community college that has a Native American language certificate or licensing program, to be eligible for this program. For consistency with that definition, the list of eligible entities in section 263.2(a) would be revised to use the word “or” between the phrase “IHE” and the phrase “TCU,” because a TCU is generally not included under the ESEA definition of IHE, which requires State authorization of the entity. We understand that TCUs are generally authorized by the Tribe and not the State.

Next, the proposed regulations would revise the definitions of “full-time student” and “pre-service training” to add the option of a Native American language certificate that does not require a baccalaureate degree. The proposed definition of “Native American language” is taken from section 8101 of the ESEA, which references section 103 of NALA (25 U.S.C. 2902). We have used the language from NALA in the definition for user convenience. The proposed definition of “Native American” is also from section 8101 of the ESEA, which references section 103 of NALA (25 U.S.C. 2902), which defines “Native American” as an “Indian, Native Hawaiian, or Native American Pacific Islander.” The NALA definition of “Indian” further references the ESEA title VI definition of that term (ESEA section 6151). We propose a definition that is a user-friendly compilation of these three discrete sources; the proposed definition is also the same definition used in the ESEA Title I regulations in 34 CFR 200.6(k).

Finally, the priority for pre-service teacher training in section 263.6(b)(1)(i), as renumbered, would add the option of training in the field of Native American language instruction.

Statute: Under section 6122 of the ESEA, the Secretary requires applicants to describe how they will recruit qualified Indian individuals, such as students who may not be of traditional college age, to become teachers, principals, or school leaders; use funds made available under the grant to support the recruitment, preparation, and professional development of Indian teachers or principals in LEAs that serve a high proportion of Indian students; and assist participants in meeting the payback obligation requirement.

Current Regulations: The current regulations do not include a specific section that describes application requirements. However, under the current section 263.5 there is a priority for applicants that include a letter of support from an LEA or BIE-funded school that agrees to consider program graduates for qualifying employment.

Proposed Regulations: We plan to include this list of statutory requirements under a new section 263.5. In addition, we propose that the current priority for applicants that include a letter of support now be made an application requirement.

Reasons: First, adding a new section that describes the application requirements provides applicants with one place to reference multiple requirements. Second, we are proposing adding to the statutorily-mandated requirements a requirement that applicants include a letter of support from prospective LEAs, including BIE-funded schools, that meet the qualifying employment definition, in order to increase applicants' understanding, at the outset, of their statutory obligation to support participants' placement in qualifying employment, should they receive a grant. One reason we are proposing this change is that, when we included a competitive preference priority for letters of support in each of the last two grant competition cycles in Fiscal Years (FYs) 2016 and 2018, the competitive preference priority points did not help to discern which applications were of the highest quality. Second, in the past, applicants have provided letters from LEAs that may no longer be considered locations for qualifying employment under the new definition of “LEAs that serve a high proportion of Indian students.” Requiring, rather than providing an incentive for, applicants to provide letters of support from LEAs that serve a high proportion of Indian students would help to ensure that participants will find qualifying employment.

Statute: Section 6122(d) of the ESEA permits grant funds to be used for teacher induction services during the first three years of teachers' employment.

Current Regulations: The definition of “induction services” in current section 263.3 includes only services provided during the first year of teaching. The priorities for pre-service teacher training and pre-service administrator training in current 263.5(b)(1)(ii) and (b)(2)(ii) also require one year of induction services.

Proposed Regulations: The proposed definition of “induction services” would include services provided during a teacher's first one to three years of qualifying employment; the Department would announce the number of years of required induction services in the applicable notice inviting applications. The allowable costs provision in proposed § 263.4(c)(4) would include the new statutory language concerning induction services but would indicate that induction services can be provided for up to the first three years of a teacher's employment. Similarly, the priorities for pre-service teacher training and pre-service administrator training in 263.6(b)(1)(ii) and (b)(2)(ii), as renumbered, would include language stating that induction services are to be provided for the period of time stated in the applicable notice inviting applications.

Reasons: The proposed change would provide flexibility in tailoring the length of induction services to the total grant period. Prior to the ESSA amendments, the Department had awarded four-year grants, and grantees were required to provide induction services to graduated and employed participants during the fourth year of the grant. In the latest competition, for FY 2018, the Department awarded five-year grants because the statute now authorizes grants for an initial period of up to three years, with possible renewal for up to two years for grantees that are achieving the objectives of the grant. In the FY 2018 competition, the Department required three years of training and two years of induction services, assuming the grantee makes substantial progress towards the objectives. A longer period of induction services should provide more support to new teachers and lead to fewer participants leaving the teaching profession.

Statute: The Secretary has the authority to establish regulatory priorities for the Indian Education Professional Development Program under 20 U.S.C. 1221e-3 and 3474.

Current Regulations: The current regulations in section 263.5 contain one priority required by statute, and three regulatory priorities. There is no priority for administrator training for work in TEAs. Section 263.3 does not include a definition of TEA. Current § 263.8(b) provides the requirements for work-related payback but does not address TEAs.

Proposed Regulations: The proposed regulations in section 263.6(b), as renumbered, would include a priority for training administrators to work for TEAs. Under this priority, grantees would be required to provide opportunities for participants to work with or for TEAs during the training period, and to make efforts to place participants in administrator jobs in TEAs following program completion.

The proposed regulations would also add a definition of TEA to the definitions in § 263.3. In addition, the proposed regulations would include a note following § 263.9(b), as renumbered, regarding work-related payback, stating that for grants that provide administrator training, if a graduate works for a TEA that provides administrative control or direction of public schools ( e.g., BIE-funded schools or charter schools), such employment would satisfy the requirements for work payback.

Reasons: We understand from Tribal consultation that many Tribes have established or are seeking greater control over education. In some cases, TEAs are in control of BIE-funded schools or Tribally funded schools. Under the current regulations, it has been unclear to grantees whether graduates are permitted to work in a TEA to satisfy the work payback obligation, or whether they must obtain employment in a State-funded LEA. The proposed change would provide clarity on this issue, increase flexibility for applicants interested in administrator training, and better recognize Tribal sovereignty.

The proposed definition of TEA in § 263.3 is taken from the definition in ESEA section 6132. The proposed note following § 263.9(b), as renumbered, would clarify that graduates who work for a TEA would satisfy the work payback obligation, if the TEA has administrative control or direction of schools. This clarification is needed due to the statutory requirement that work payback take place in an LEA; the note would explain that the work payback requirement is satisfied if the graduate is employed by a TEA that satisfies the requirements in the statutory definition of LEA in ESEA section 8101.

Statute: The Secretary has the authority to establish regulatory priorities for the Indian Education Professional Development Program under 20 U.S.C. 1221e-3 and 3474.

Current Regulations: The current regulations in section 263.5 contain one priority required by statute, and three regulatory priorities. There is no priority for administrator training for school start-ups.

Proposed Regulations: The proposed regulations in section 263.6(b), as renumbered, would include a priority for training administrators to start new schools that serve Indian students, such as charter schools or schools transitioning from BIE-operated to Tribally controlled. Grantees would be required to make efforts to place participants in administrator jobs working for an entity planning to start a school to serve Indian students or transitioning an existing school to one under Tribal control.

Reasons: We heard through Tribal consultation that Tribes are interested in opportunities to train administrators in ways to expand choice in Indian country, including specifically how to establish new charter schools, or how to change a BIE-funded school that is currently BIE-operated to one that is Tribally operated. A priority for such training would enable the Department to provide a competitive advantage to projects that include this focus. Because of the statutory requirement for work payback, a project doing such training would need to ensure that its graduates obtain jobs in which they would be administering schools, as opposed to merely planning for future administration. Thus, if the graduate worked for an entity such as a TEA that is planning to open a new school, that person would also need to be in a position that involves current school administration duties. The proposed change would provide more flexibility to applicants interested in administrator training and would better recognize Tribal sovereignty.

Statute: The Secretary has the authority to establish regulatory selection criteria for the Indian Education Professional Development program under 20 U.S.C. 1221e-3 and 3474.

Current Regulations: Under the current section 263.6 there are five criteria, each with corresponding factors specific to the Professional Development program, including need for the project, significance, quality of the project design, quality of project services, and quality of project personnel.

Proposed Regulations: The proposed regulations would add under the selection criterion (d), “Quality of Project Design,” a selection factor regarding the extent to which the proposed project has a plan for recruiting and selecting participants, including students who may not be of traditional college age, that ensures that program participants are likely to complete the program. The proposed regulations in § 263.7(d), as renumbered, would also include a sixth factor to address the extent to which the applicant will assist participants in meeting the service obligation requirements.

Reasons: One of the statutory changes made by ESSA is to add the requirement that applicants describe how they will recruit and select participants. Adding this as a selection criterion will help ensure that projects include participants who are likely to complete the program. Another statutory change requires applicants to describe how they will assist participants in meeting the work payback obligation. By including this as a selection factor, we can encourage applicants to increase their focus on placement in qualifying employment. Our review of current and past projects shows that participants' ability to meet the service obligation can be better supported when grantees give more time and attention to planning for how they will support participants' placement in jobs that meet the service obligation requirements.

Statute: Section 6122 of the ESEA includes Bureau-funded schools, as defined in section 1146 of the Educational Amendments of 1978, among eligible entities of the Professional Development program.

Current Regulations: Section 263.3 defines Bureau-funded school as a Bureau of Indian Education school, a contract or grant school, or a school that receives support under the Tribally Controlled Schools Act of 1988. Section 263.2 also uses the term in the list of eligible entities. However, the priority described in § 263.5(b)(3) makes reference to a BIE-funded school.

Proposed Regulation: The proposed regulations would change the term from Bureau-funded school to BIE-funded school throughout the regulations and would change the term to BIE-funded school in the definitions in § 263.3, but the content of the definition would remain unchanged.

Reasons: Using the term BIE-funded school throughout the regulations would ensure consistency. And although the statute refers to Bureau-funded school, the term “BIE-funded school” is a term more commonly used and more familiar to grantees, participants and other stakeholders.

Statute: The Secretary has the authority to establish regulatory selection criteria for the Indian Education Professional Development program under 20 U.S.C. 1221e-3 and 3474.

Current Regulations: Section 263.6(e)(3) is a selection factor that considers the qualifications of subcontractors and consultants who may be included in the proposed project.

Proposed Regulations: The proposed regulations would eliminate this selection factor.

Reasons: Most applicants do not identify subcontractors and consultants who are not already in the role of project director or key personnel. Consequently, any applicant whose proposed project does not include subcontractors or consultants cannot receive peer review points because they lack this non-required element. Eliminating this evaluation factor would eliminate this negative impact on such projects.

Statute: The Secretary has the authority to regulate post-award requirements that apply to the Professional Development program under 20 U.S.C. 1221e-3 and 3474.

Current Regulations: Current § 263.11(c)(1) requires that grantees obtain a signed payback agreement from each participant and submit it to the Department within seven days of signing.

Proposed Regulations: The proposed regulations would extend the timeframe for grantees to submit the signed payback agreement to the Department to 30 days.

Reasons: Based on current grantee feedback, participant orientation and related administrative processes generally take more than seven days due to grantees holding related activities. Addressing all related administrative duties for a part-time staff has proven challenging. Based on Department analysis of submission times over the last four years, 30 days is more reasonable and is adequate for the time period needed for grantees to adhere to this requirement.

The ESSA amendments to Title VII of the ESEA also necessitate multiple technical changes to the current program regulations. As a result, this NPRM includes the following technical changes:

(1) In § 263.1, we add language regarding the purposes of the program as stated in ESEA section 6122(a)(2).

(2) In §§ 263.2(a), 263.3, and 263.6, we reflect changes to the eligible entities listed in ESEA section 6122(b)(1). We remove references to “Indian institution of higher education” and replace them with “TCU” throughout. In section 263.2(a) we also add the statutory language requiring BIE-funded schools to apply in consortium with at least one TCU, where feasible.

(3) We revise the definition of induction services in § 263.3, and we add to section 263.4 new paragraphs (c)(4) and (c)(5), to reflect authorized activities described in ESEA section 6122(d)(1)(B).

(4) We add new § 263.5 to reflect application requirements described in ESEA section 6122(e). We also revise the selection criteria in redesignated § 263.7 to add the element regarding recruiting participants, from ESEA section 6122(e)(1), to redesignated § 263.7(c)(2) and (d)(5), and we add the element regarding helping participants with payback, from ESEA section 6122(e)(3), to redesignated § 263.7(d)(6).

(5) We revise §§ 263.1-263.3, and redesignated §§ 263.6, 263.7, 263.9, 263.11, and 263.12 to reflect the service obligation described in ESEA section 6122(h)(1)(A)(ii), which requires that work must benefit Indian students in an LEA that serves a high proportion of Indian students.

Under Executive Order 12866, it must be determined whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

Under Executive Order 13771, for each new regulation that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866 and that imposes total costs greater than zero, it must identify two deregulatory actions. For Fiscal Year 2020, any new incremental costs associated with a new regulation must be fully offset by the elimination of existing costs through deregulatory actions. The proposed regulations are not a significant regulatory action. Therefore, the requirements of Executive Order 13771 do not apply.

We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing these proposed regulations only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that these proposed regulations are consistent with the principles in Executive Order 13563.

We have also determined that this regulatory action would not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

Discussion of Costs and Benefits: The potential costs associated with the proposed regulatory changes would be minimal, while there would be greater potential benefits.

For Professional Development grants, applicants may anticipate minimal additional costs in developing their applications due to the new required letter of support that the applicant must obtain from an LEA in proposed section 263.5, estimated at two hours of additional work. We anticipate no additional time spent reporting participant payback information in the Professional Development Program Data Collection System (PDPDCS) and the costs of carrying out these activities would continue to be paid for with program funds.

The benefits include enhancing project design and quality of services to better meet the objectives of the programs with the result being more participants successfully completing their programs of study and obtaining employment as teachers and administrators. Elsewhere in this section under Paperwork Reduction Act of 1995, we identify and explain burdens specifically associated with information collection requirements.

Executive Order 12866 and the Presidential memorandum “Plain Language in Government Writing” require each agency to write regulations that are easy to understand.

The Secretary invites comments on how to make these proposed regulations easier to understand, including answers to questions such as the following:

• Are the requirements in the proposed regulations clearly stated?

• Do the proposed regulations contain technical terms or other wording that interferes with their clarity?

• Does the format of the proposed regulations (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity?

• Would the proposed regulations be easier to understand if we divided them into more (but shorter) sections? (A “section” is preceded by the symbol “§ ” and a numbered heading; for example, § 263.3 What definitions apply to the Professional Development program?)

• Could the description of the proposed regulations in the SUPPLEMENTARY INFORMATION section of this preamble be more helpful in making the proposed regulations easier to understand? If so, how?

• What else could we do to make the proposed regulations easier to understand?

To send any comments that concern how the Department could make these proposed regulations easier to understand, see the instructions in the ADDRESSES section.

The Secretary certifies that these proposed regulations would not have a substantial economic impact on a substantial number of small entities. The U.S. Small Business Administration Size Standards define proprietary institutions as small businesses if they are independently owned and operated, are not dominant in their field of operation, and have total annual revenue below $7,000,000. Nonprofit institutions are defined as small entities if they are independently owned and operated and not dominant in their field of operation. Public institutions are defined as small organizations if they are operated by a government overseeing a population below 50,000.

The small entities that would be affected by these proposed regulations are LEAs, institutions of higher education, TCUs, tribes, and tribally operated schools receiving Federal funds under this program. The proposed regulations would not have a significant economic impact on the small entities affected because the regulations do not impose excessive regulatory burdens or require unnecessary Federal supervision. The proposed regulations would impose minimal requirements to ensure the proper expenditure of program funds, including reporting of participant payback information. We note that grantees that would be subject to the minimal requirements that these proposed regulations would impose would be able to meet the costs of compliance using Federal funds provided through the Indian Education Discretionary Grant programs.

However, the Secretary specifically invites comments on the effects of the proposed regulations on small entities, and on whether there may be further opportunities to reduce any potential adverse impact or increase potential benefits resulting from these proposed regulations without impeding the effective and efficient administration of Indian Education Discretionary Grant programs. Commenters are requested to describe the nature of any effect and provide empirical data and other factual support for their views to the extent possible.

As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps ensure that: the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.

Proposed §§ 263.5, 263.6, and 263.7, as renumbered, contain information collection requirements for the program application package, and proposed §§ 263.12 and 263.13 contain information collection requirements renewed by OMB on August 12, 2019. Table A-1 illustrates the status of both the current and proposed collections associated with this program:

As a result of the proposed revisions to §§ 263.5, 263.6, and 263.7, we would transfer the grant application package information collection burden from 1810-0580 to 1894-0006, resulting in discontinuation of 1810-0580.

Proposed § 263.12 contains information collection requirements that will continue in order to:

• Fulfill six Government Performance and Results Act (GPRA) performance measures and reporting requirements;

• Ensure that participants fulfill the statutory payback requirements; and

• Collect budget and project-specific performance information from grantees for project monitoring.

This information collection was recently renewed by OMB. We expect that the proposed amendments will slightly change, but not increase, the current OMB approved data collection burden. Because the changes impact only information collection requirements for post-award induction activities that would not occur prior to FY 2022, and in order to mitigate revisions due to any possible changes to the proposed regulations, we plan to submit the revised information collection for OMB approval once final regulations are published.

If your comments relate to the ICR for these proposed regulations, please specify the Docket ID number and indicate “Information Collection Comments” on the top of your comments.

Written requests for information or comments submitted by postal mail or delivery related to the information collection requirements should be addressed to the Director of the Information Collection Clearance Program, U.S. Department of Education, 550 12th Street SW, room 9086, Washington, DC 20202.

Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

Executive Order 13132 requires us to ensure meaningful and timely input by State and local elected officials in the development of regulatory policies that have federalism implications. “Federalism implications” means substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. These proposed regulations may have federalism implications. We encourage State and local elected officials to review and provide comments on these proposed regulations.

In accordance with section 411 of the General Education Provisions Act, 20 U.S.C. 1221e-4, the Secretary particularly requests comments on whether these proposed regulations would require transmission of information that any other agency or authority of the United States gathers or makes available.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format ( e.g., braille, large print, audiotape, or compact disc) on request to the person listed under FOR FURTHER INFORMATION CONTACT .

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

For the reasons discussed in the preamble, the Secretary of Education proposes to amend part 263 of title 34 of the Code of the Federal Regulations as follows:

The revisions and addition read as follows:

The revisions read as follows:

The additions and revisions read as follows:

The additions read as follows:

The addition and revisions read as follows:

The additions and revisions read as follows:

The addition reads as follows:

The addition reads as follows:

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to final SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after November 12, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

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

EPA is proposing these SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks and, if appropriate, to regulate the significant new use before it may occur. Additional background regarding SNURs is more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376) (FRL-3658-5). Consult that preamble for further general information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III.

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the proposed rule, recordkeeping requirements, and exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.

• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.

• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.

• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining significant new uses for the 31 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with the substances, in addition to the factors in TSCA section 5(a)(2). Consistent with TSCA section 5(f)(4), for the eight chemical substances subject to an order under TSCA section 5(e), EPA is proposing to identify any use not conforming to the restrictions of the order as a significant new use. For the 23 chemical substances that EPA has determined “not likely” to present an unreasonable risk under the conditions of use, EPA is proposing to identify other circumstances that, while not reasonably foreseen, would warrant further EPA review before manufacture or processing for such a use is commenced.

EPA is proposing significant new use and recordkeeping requirements for 31 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Basis for the SNUR or basis for the TSCA section 5(e) Order.

• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.

• CFR citation assigned in the regulatory text section of the proposed rule. The regulatory text section of each proposed rule specifies the activities that would be designated as significant new uses. Certain new uses, including exceedance of production volume limits ( i.e., limits on manufacture volume) and other uses designated in this proposed rule, may be claimed as CBI.

These proposed rules include 8 PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA section 5(e) Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA section 5(e) Orders, consistent with TSCA section 5(f)(4).

These proposed rules also include 23 PMN substances that received “not likely to present an unreasonable risk” determination in TSCA section 5(a)(3)(c). However, during the course of these reviews, EPA identified concerns for certain health and/or environmental risks if the chemicals were not used following the limitations identified by the submitters in the notices. EPA did not deem such uses as reasonably foreseen in the TSCA section 5(a)(3)(C) determinations. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to those same limitations.

The chemicals subject to these proposed SNURs are as follows:

Chemical names: Perfluoropolyether halide (generic) (P-16-151), Perfluoropolyether aryl (generic) (P-16-152), Substituted aryl-perfluoropolyether (generic) (P-16-153), Sulfonated perfluoropolyether aromatic transition metal salt (generic) (P-16-154), and Sulfonated perfluoropolyether aryl alkali metal salt (generic) (P-16-155).

CAS numbers: Not available.

Effective date of TSCA section 5(e) Order: April 30, 2019.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances P-16-151 and P-16-152 will be as intermediates and P-16-153, P-16-154, P-16-155 will be as lubricant additives. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on results of testing on analogous small fluorinated polyether substances, EPA has identified concerns for the possible degradation products of the PMN substances for liver toxicity, kidney effects, hematology and clinical chemistry changes, pancreatic and testicular cell tumor formation, and reproductive and developmental effects. Based on estimated ecotoxicity values for the possible degradation products, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 153 parts per billion (ppb). The TSCA section 5(e) Order was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the human health and environmental effects of the PMN substances. The TSCA section 5(e) Order was also issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA section 5(e) Order requires:

1. Submission to EPA of certain fate testing within one year after the Notice of Commencement of the PMN P-16-155;

2. Establishment and use of a hazard communication program, including environmental hazard precautionary statements on each label and in the Safety Data Sheet (SDS);

3. Dispose of the PMN substances only with Hazardous Waste, High Temperature Incineration with a control efficiency of 99.99% efficiency or greater;

4. No release of the PMN substances to surface waters;

5. Manufacture the PMN substances only for the confidential uses specified in the PMNs; and

6. No manufacture beyond the annual production volumes specified in the TSCA section 5(e) Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. The submitter has agreed not to manufacture (including import) the P-16-155 substance beyond one year after the Notice of Commencement without performing an indirect photolysis screening test (OCSPP Test Guideline 835.5270). EPA has also determined that the results of hydrolysis testing, photodegradation in soil, chronic aquatic toxicity, and reproductive toxicity testing would help EPA determine the potential human and environmental effects of the PMN substances. Although the TSCA section 5(e) Order does not require these tests, the TSCA section 5(e) Order's restrictions remain in effect until the TSCA section 5(e) Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citations: 40 CFR 721.11346 (P-16-151); 40 CFR 721.11347 (P-16-152); 40 CFR 721.11348 (P-16-153); 40 CFR 721.11349 (P-16-154) and 40 CFR 721.11350 (P-16-155).

Chemical names: Cyclohexanol, 4-ethylidene-2-propoxy- (P-16-225, chemical A) and Cyclohexanol, 5-ethylidene-2-propoxy- (P-16-225, chemical B).

CAS numbers: 1631145-48-6 (P-16-225, chemical A) and 1631145-49-7 (P-16-225, chemical B).

Basis for action: The PMN states that the use of the substance will be as a fragrance ingredient, being blended (mixed) with other fragrance ingredients to make fragrance oils that will be sold to industrial and commercial customers for their incorporation into soaps, detergents, cleaners, air fresheners, candles and other similar industrial, household and consumer products. Based on the physical/chemical properties of the PMN substances, test data on the PMN substances, and Structure Analysis Relationships (SAR) analysis of test data on analogous substances, EPA has identified concerns for systemic toxicity, and aquatic toxicity at surface water concentrations exceeding 300 ppb, if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substances as described in the PMN include the following protective measures:

1. No domestic manufacture of the PMN substances ( i.e., import only);

2. No import of the PMN substances at more than 10,000 kg annual production volume;

3. No use of the PMN substances other than for the fragrance use stated in the PMN submission; and

4. No processing of the PMN substances to greater than 10% in compounded fragrance oil formulation.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substances in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of absorption testing and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances.

CFR citation: 40 CFR 721.11351 (P-16-225, chemical A) and 40 CFR 721.11352 (P-16-225, chemical B).

Chemical Name: Ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)-.

CAS Number: 1370699-98-1.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as part of a fragrance formula. Based on test data on the new chemical substance, the estimated physical/chemical properties of the PMN, and SAR analysis on analogous neutral organics, EPA has identified concerns for liver toxicity for the intact new chemical substance, oncogenicity for the ketone/aldehyde hydrolysis product(s) that may be formed under the acidic conditions in the stomach, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No domestic manufacture of the PMN substance ( i.e., import only);

2. Less than 10% of the PMN substance in any formulation from processing; and

3. No manufacture (including import) beyond an annual production volume of 10,000 kilograms per year.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of absorption testing and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11353.

Chemical Name: Endcapped polysiloxane (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a universal tint paste resin having high solids. Based on the estimated physical/chemical properties of the PMN substance, structural information, and information on analogous alkoxysilanes, EPA has identified lung effects and irritation to the eye, skin, lung, and mucous membranes if the chemical substance is not used following the limitation noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• Use of the PMN substance only for the confidential use specified in the PMN.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects and skin irritation testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11354.

Chemical Name: 2,7-Nonadien-4-ol, 4,8-dimethyl-.

CAS Number: 103983-77-3.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as part of a fragrance formula. Based on the estimated physical/chemical properties of the PMN substance and available data on the new chemical substance, EPA has identified concerns for skin irritation, eye irritation, liver and thyroid toxicity, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No release of the PMN substance from manufacturing or processing resulting in surface water concentrations that exceed 113 ppb;

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of specific organ toxicity and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11355.

Chemical Name: Carbonodithioic acid, O-[2-[(dithiocarboxy)amino]-2-methylpropyl] ester, sodium salt (1:2).

CAS Number: 1947332-67-3.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be for use in ore processing. Based on the estimated physical/chemical properties of the PMN substance, available PMN data, comparison with structurally analogous chemical substances, and SAR analysis of test data on analogous dithiocarbamates, EPA has identified concerns for irritation and corrosion to all tissues, developmental and neurological effects, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No release of the PMN substance resulting in surface water concentrations exceeding 2 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of reproductive/developmental toxicity, neurotoxicity, skin irritation/ corrosion, and toxicokinetics and chronic aquatic ecotoxicity testing would help characterize the potential health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11356.

Chemical Name: Oxirane, 2-methyl-, polymer with oxirane, methyl 2-(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be to enhance formulation solubilization properties. Based on its estimated physical/chemical properties, data on analogous chemicals, and other structural information, EPA has identified concerns for lung effects and irritation if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measures:

• No processing of the substance to a concentration greater than 5% by weight in the final formulated product, for any use; and

• No consumer use.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11357.

Chemical Name: Vegetable oil, polymers with diethylene glycol- and polyol- and polyethylene glycol-depolymd. poly(ethylene terephthalate) waste plastics and arylcarboxylic acid anhydride (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a chemical intermediate (polyol) for use in the manufacture of polyurethane polymers. Based on the estimated physical/chemical properties of the PMN substance, comparison with structurally analogous chemical substances, test data on analogous substances, and SAR analysis on esters, EPA has identified concerns for lung effects, irritation to eye, mucous membranes and lung, anesthetization of the eye, developmental, renal and bladder toxicity, kidney toxicity, and renal cancer if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• No modification of manufacture, processing or use if it results in inhalation exposures to vapors, particulate, mist or aerosols.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of in vitro skin irritation and eye damage testing using human derived cells would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11358.

Chemical Name: 1H-Pyrrole-2,5-dione, 1,1′-C36-alkylenebis-.

CAS Number: 1911605-95-2.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an adhesive component. Based on the available data for the new chemical substance, estimated physical/chemical properties of the PMN substance, and comparison with structurally analogous chemical substances, EPA has identified concerns for developmental toxicity and sensitization if the chemical substance is not used following the limitation noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• No manufacturing, processing, or use of the substance that results in inhalation exposures.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of developmental toxicity and sensitization testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11359.

Chemical name: Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.

CAS number: 107737-97-3.

Effective date of TSCA section 5(e) Order: April 30, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate used for chemical production. Based on test data on the PMN substance and analogue data, EPA has identified concerns for sensitization and developmental toxicity. In addition, based on SAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations greater than 99 ppb. The TSCA section 5(e) Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA section 5(e) Order requires:

• No manufacture (including import) of the PMN substance beyond the confidential annual production volume specified in the TSCA section 5(e) Order.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of biodegradability, chronic aquatic toxicity, and reproductive toxicity testing would help EPA determine the potential human and environmental effects of the PMN substance. Although the TSCA section 5(e) Order does not require this information, the TSCA section 5(e) Order's restrictions remain in effect until the TSCA section 5(e) Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11360.

Chemical name: Multiwalled carbon nanotubes (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) Order: May 3, 2019.

Basis for TSCA section 5(e) Order: The PMN states that substance will be used in heat transfer, heat storage, thermal emission, and general temperature management in heat-generating systems such as electronics, to improve mechanical properties or electrical conductivities of other materials or products, and for light absorption properties. EPA has identified concerns for pulmonary toxicity based on carbon nanotube analogues. EPA has also identified concerns for aquatic toxicity when the substance is at low concentrations and in the presence of natural organic matter. The TSCA section 5(e) Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA section 5(e) Order requires:

1. Use of personal protective equipment by workers to prevent dermal exposure where there is potential dermal exposure;

2. Use of a National Institute of Occupational Safety and Health (NIOSH) certified respirators with an Assigned Protection Factor (APF) of at least 50 workers to prevent inhalation exposure where there is potential inhalation exposure;

3. Refrain from using the PMN in applications that generates a dust, vapor, mist, or aerosol, unless such application method occurs in an enclosed process;

4. Process and use of the PMN substance only as described in the PMN;

5. No release of the PMN substance to surface waters; and

6. Disposal only by incineration or landfill.

The proposed SNUR designates as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the human health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of pulmonary toxicity and chronic aquatic toxicity testing would help EPA determine the potential human and environmental effects of the PMN substance. Although the TSCA section 5(e) Order does not require this information, the TSCA section 5(e) Order's restrictions remain in effect until the TSCA section 5(e) Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11361.

Chemical Name: Polyolefin ester (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a fuel additive. Based on the estimated physical/chemical properties of the PMN substance and comparison with structurally analogous substances, EPA has identified concerns for lung surfactancy and irritation to the eye and skin if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No use involving an application method that generates a vapor, mist, or aerosol; and

2. No manufacture (including import) of the substance at less than the confidential average molecular weight identified in the PMN.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of absorption, distribution, metabolism, and excretion (ADME)/toxicokinetic and lung toxicity testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11362.

Chemical Names: Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,.alpha.′-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-propanol-blocked (generic) (P-18-247); Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol-blocked (generic) (P-18-248); Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked (generic) (P-18-249); Isocyanic acid, polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (generic) (P-18-250); Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (generic) (P-18-251); Isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked (generic) (P-18-252).

CAS Number s: Not available.

Basis for action: The PMNs state that the use of the PMN substances will be as crosslinkers for automotive electrocoats. Based on the physical/chemical properties, chemical structure of the substances, submitted data on the substances, and comparison to structurally analogous substances, EPA has identified concerns for lung effects, skin sensitization, and aquatic toxicity if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measures:

1. No manufacture, processing, or use in a manner that results in inhalation exposure; and

2. No release of the PMN substance to surface waters exceeding 200 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health and environmental effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of chronic ecotoxicity testing and lung effects tiered testing for surfactants would help characterize the potential health and environmental effects of the PMN substances.

CFR citations: 40 CFR 721.11363 (P-18-247); 40 CFR 721.11364 (P-18-248); 40 CFR 721.11365 (P-18-249); 40 CFR 721.11366 (P-18-250); 40 CFR 721.11367 (P-18-251); and 40 CFR 721.11368 (P-18-252).

Chemical Name: Fatty acid ester, polyether, diisocyanate polymer (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an adhesive. Based on the estimated physical/chemical properties of the PMN substance, test data on an analogue of the residual isocyanate, and comparison with structurally analogous chemical substances, EPA has identified concerns for irritation/sensitization for the skin, eyes, mucous membrane, and lungs, and respiratory effects if the chemical substance is not used following the limitation noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• No manufacturing, processing, or use of the PMN substance containing greater than the confidential percentage of residual isocyanate identified in the PMN.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin irritation, eye damage, skin sensitization, and pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11369.

Chemical Name: Alkenoic acid, alkyl-, alkyl ester, polymer with alkyl alkenoate, substituted heteromonocycle, substituted carbomonocycle, substituted alkanediol and alkenoic acid, alkali metal salt (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component of ink. Based on the estimated physical/chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified lung effects if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• No manufacturing, processing, or use of the substance that results in inhalation exposures.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11370.

Chemical Name: Alkyl heteromonocycle with heteroatom substituted alkyl cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-blocked homopolymer (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as an immobilizing agent for the microbial promoter of nitrogen decomposition. Based on the estimated physical/chemical properties of the PMN substance and comparison with structurally analogous chemical substances, EPA has identified lung effects if the chemical substance is not used following the limitations noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• No manufacture, processing, or use that results in inhalation exposures.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of specific target organ toxicity including pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11371.

Chemical Name: Phenol-formaldehyde epoxy, polymer with an alkyl polyether polysulfide (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: March 29, 2019.

Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as an adhesive for automotive parts. EPA identified concerns for reproductive/developmental toxicity, mutagenicity, and carcinogenicity for the low molecular weight components based on the epoxides chemical category and submitted test data. EPA also identified concerns for skin and lung sensitization and systematic toxicity based on the epoxide moieties. In addition, based on analysis of test data on the PMN substance and SAR analysis on analogous thiols/mercaptans, polyepoxides, and monoepoxides, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations greater than 1 ppb. The TSCA section 5(e) Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the TSCA section 5(e) Order requires:

1. Use of personal protective equipment where there is a potential for dermal exposure;

2. Refraining from manufacture, processing or use of the PMN substance in a manner that would result in inhalation exposure;

3. No release of the PMN substance to surface waters exceeding 1 ppb; and

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The SNUR designates as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA section 5(e) Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has also determined that specific ecological hazard, reproductive/developmental toxicity, sensitization, and carcinogenicity effects testing of the PMN substance would be useful in determining the health and environmental effects of the PMN substance. Although the TSCA section 5(e) Order does not require these tests, the TSCA section 5(e) Order's restrictions remain in effect until the TSCA section 5(e) Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11372.

Chemical Name: Alkylphenol, reaction products with carbon dioxide, distn. residues from manuf. of alkylphenol derivs. and calcium alkylphenol derivs. (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a lubricating additive. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation, sensitization, blood and liver toxicity, lung toxicity, and developmental toxicity if the chemical substance is not used following the limitation noted. The condition of use of the PMN substance as described in the PMN includes the following protective measure:

• No use of the PMN substance involving an application method that generates a vapor, mist, or aerosol.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of sensitization, irritation, target organ toxicity/pulmonary effects, and reproduction/developmental effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11373.

Chemical Name: Acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)-.

CAS Number: 1374760-95-8.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a fragrance. Based on the estimated physical/chemical properties of the PMN substance, available test data on the new chemical substance, and SAR analysis on analogous thiophenes, EPA has identified concerns for severe eye irritation, sensitization, lung effects, histopathological effects on the nasal passages, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

1. No domestic manufacture of the PMN substance; and

2. No release of the PMN substance to surface waters exceeding 15 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of pulmonary effects testing would help characterize the potential health effects of the PMN substance.

CFR Citation: 40 CFR 721.11374.

Chemical Names: Polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (generic) (P-19-54, chemical A) and Polyamines, reaction products with succinic anhydride polyalkenyl derivs., metal salts (generic) (P-19-54, chemical B).

CAS Numbers: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substances will be as an automotive lubricant additive. Based on the available data for the new chemical substance, estimated physical/chemical properties of the PMN substances, comparison with structurally analogous chemical substances and other structural information, EPA has identified irritation to all tissues if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substances as described in the PMN include the following protective measure:

• Exceeding the concentration of the PMN substances in a formulated lubricant fluid for consumer use greater than the confidential percentage identified in the PMN.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information may be potentially useful to characterize the health effects of the PMN substances if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of skin and eye irritation testing would help characterize the potential health effects of the PMN substances.

CFR Citation: 40 CFR 721.11381 (P-19-54, chemical A) and 40 CFR 721.11382 (P-19-54, chemical B).

During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for 8 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

During review of the other 23 chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified certain circumstances different from the intended conditions of use that raised potential risk concerns. EPA determined that deviations from the protective measures identified in the submissions could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances, and therefore warranted SNURs. The SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the protective measures in the submission.

EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants:

• To receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.

• To review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for 8 of the 31 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which would be designated as significant new uses. The identities of 25 of the 31 chemical substances subject to this proposed rule have been claimed as confidential (per 40 CFR 720.85) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

Therefore, EPA designates October 11, 2019 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

EPA recognizes that TSCA section 5 does not require developing any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: Development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).

In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information identified by EPA that would help characterize the potential health and/or environmental effects of the PMN/SNUN substance for all the listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have led to modifications in our approach to testing requirements, including an increased consideration of alternatives to vertebrate testing. Descriptions of tests/information needs are provided for informational purposes only and EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the potentially useful information. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

The potentially useful information listed in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket identified for this rulemaking under ADDRESSES .

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

This proposed rule would establish SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

According to 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 that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection requirements related to this proposed rule have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to section 605(b) of the RFA (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of this proposed SNUR would not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

This action would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This action would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use.

In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

Therefore, it is proposed that 40 CFR chapter I be amended as follows: