Document ID: EPA-HQ-OPPT-2018-0649-0097
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances (18-2)
Posted Date: 2019-12-05T05:00Z

[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Rules and Regulations]
[Pages 66591-66599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26225]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0649; FRL-10001-47]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (18-2)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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[[Page 66592]]

SUMMARY: EPA is issuing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances that are 
the subject of premanufacture notices (PMNs), and Orders issued by EPA 
under TSCA. The SNURs require persons who intend to manufacture 
(defined by statute to include import) or process any of these chemical 
substances for an activity that is designated as a significant new use 
by this rule to notify EPA at least 90 days before commencing that 
activity. Persons may not commence manufacture or processing for the 
significant new use until EPA has conducted a review of the notice, 
made an appropriate determination on the notice, and has taken such 
actions as are required by that determination.

DATES: This rule is effective on February 3, 2020. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
December 19, 2019.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-9232; email address: 
moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this 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 these SNURs must certify 
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 rule on or after January 6, 2020 
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.

B. How can I access the docket?

    The docket includes information considered by the Agency in 
developing the proposed and final rules. The docket for this action, 
identified by the docket identification (ID) number listed at the top 
of this document, is available at http://www.regulations.gov or at the 
Office of Pollution Prevention and Toxics Docket (OPPT Docket), 
Environmental Protection Agency Docket Center (EPA/DC), West William 
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, 
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPPT Docket is (202) 566-0280. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 28 
substances which were the subject of PMNs. These SNURs require persons 
who intend to manufacture or process any of these chemical substances 
for an activity that is designated as a significant new use to notify 
EPA at least 90 days before commencing that activity.
    EPA is not finalizing one proposed SNUR at 40 CFR 721.11173 for the 
chemical substances P-15-442, P-15-443, P-15-444, P-15-445, P-15-446, 
P-15-447, P-15-525, P-15-526, P-15-527, and P-15-528, because the 
Agency is currently reviewing data submitted in support of a request to 
modify the underlying TSCA section 5(e) Order that forms the basis for 
the proposed SNUR. EPA will finalize that proposed SNUR after the data 
has been reviewed and any changes to the Order and/or SNUR have been 
considered and identified. In addition, the Agency has modified the 
underlying Order for the SNUR at 40 CFR 721.11174 to add the substances 
described in PMNs P-18-193, P-18-194, P-18-195, P-18-196, P-19-124, P-
19-125, P-19-126, P-19-127, P-19-128, and P-19-129. All terms of the 
Order and proposed SNUR remain the same.
    In the Federal Register of October 10, 2018 (83 FR 50872) (FRL-
9984-67), EPA proposed a SNUR for 28 chemical substances to be added to 
40 CFR part 721 subpart E. The comment period closed on November 9, 
2018. More information on the specific chemical substances subject to 
this final rule can be found in the Federal Register documents for the 
direct final SNUR of October 10, 2018 (83 FR 50838) (FRL-9984-65). This 
direct final SNUR was withdrawn on December 7, 2018 (83 FR 63066) (FRL-
9987-43) due to adverse public comments related to SNURs identified in 
the document. The record for the SNUR was established in the docket 
under docket ID number EPA-HQ-OPPT-2018-0649. That docket includes 
information considered by the Agency in developing the proposed and 
final rules, public comments submitted for the rule, and EPA's 
responses to public comments received on the proposed rule.

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

    TSCA section 5(a)(2) (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 TSCA section 5(a)(2) factors 
listed in Unit III. Once EPA determines that a use of a chemical 
substance is a significant new use, TSCA section 5(a)(1)(B) requires 
persons to submit a significant new use notice (SNUN) to EPA at least 
90 days before they manufacture or process the chemical substance for 
that use (15 U.S.C. 2604(a)(1)(B)(i)).

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, 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. According 
to 40 CFR 721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of

[[Page 66593]]

PMNs under TSCA section 5(a)(1)(A). These requirements include the 
information submission requirements of TSCA sections 5(b) and 5(d)(1), 
the exemptions authorized by TSCA sections 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.

III. Significant New Use Determination

    When the Agency issues an Order under TSCA section 5(e), section 
5(f)(4) requires that the Agency consider whether to promulgate a SNUR 
for any use not conforming to the restrictions of the Order or publish 
a statement describing the reasons for not initiating the rulemaking. 
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 what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from three entities on the proposed 
rule. The Agency's responses are described in a separate Response to 
Public Comments document that is available in the docket for this rule. 
As described in the Response to Public Comments document, EPA made a 
minor change to the final rule to be consistent with the requirements 
of the TSCA Section 5(e) Order for P-17-257 (40 CFR 721.11179).

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 28 chemical substances in 40 CFR part 721, subpart E. 
In Unit IV. of the original direct final SNUR of October 10, 2018 (83 
FR 50838), 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 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 
this rule.
    The regulatory text section of each rule specifies the activities 
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 rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    These final rules include 28 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 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 Orders, consistent with TSCA section 5(f)(4).

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that 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. of the original direct final SNUR of 
October 10, 2018 (83 FR 50838). 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.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     To 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 Orders, 
consistent with TSCA section 5(f)(4).
     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 have an opportunity 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 be able 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.

[[Page 66594]]

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this 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 a NOC has not been submitted, EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this 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 all the chemical substances, and the PMN submitters are prohibited 
by the TSCA section 5(e) Orders from undertaking activities which will 
be designated as significant new uses. The identities of 27 chemical 
substances subject to this rule have been claimed as confidential 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 rule are ongoing.
    Furthermore, EPA designated October 10, 2018 (the date of public 
release of the proposed and direct final rules) as the cutoff date for 
determining whether the new use is ongoing. The objective of EPA's 
approach has been to ensure that a person could not defeat a SNUR by 
initiating a significant new use before the effective date of the final 
rule.
    In the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of October 10, 2018, that person will have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, these persons will 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.

VIII. Development and Submission of Information

    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: If a person is required to 
submit information for a chemical substance pursuant to a rule, Order 
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA 
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information 
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, Order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known to them or reasonably ascertainable (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing under 40 CFR part 721, subpart 
E. Unit IV. of the original direct final SNUR (83 FR 50838) lists 
potentially useful information for all SNURs listed here. Descriptions 
of this information is provided for informational purposes. The 
potentially useful information identified in Unit IV. of the original 
direct final rule will inform EPA's evaluation in the event that 
someone submits a SNUN for the significant new use. Companies who are 
considering submitting a SNUN are encouraged, but not required, to 
develop the information on the substance. EPA strongly encourages 
persons, before performing any testing, to consult with the Agency. 
Furthermore, pursuant to TSCA section 4(h), which pertains to reduction 
of testing on 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 recommended test data. 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).
    In some of the TSCA section 5(e) Orders for the chemical substances 
regulated under this rule, EPA has established production volume limits 
in view of the lack of data on the potential health and environmental 
risks that may be posed by the significant new uses or increased 
exposure to the chemical substances. These limits cannot be exceeded 
unless the PMN submitter first submits the results of specified tests 
that would permit a reasoned evaluation of the potential risks posed by 
these chemical substances. The SNURs contain the same production volume 
limits as the TSCA section 5(e) Orders. Exceeding these production 
limits is defined as a significant new use. Persons who intend to 
exceed the production limit must notify the Agency by submitting a SNUN 
at least 90 days in advance of commencement of non-exempt commercial 
manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    The potentially useful information identified in Unit IV. of the 
original direct final SNUR of October 10, 2018 (83 FR 50838) may not be 
the only means of addressing the potential risks of the chemical 
substance. However, submitting a SNUN without any test data or other 
information may increase the likelihood that EPA will take action under 
TSCA section 5(e) or 5(f). 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.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. The EPA procedure to deal with the situation 
where a specific significant new use is CBI is in 721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to

[[Page 66595]]

manufacture or process the chemical substance. If EPA concludes that 
the person has shown a bona fide intent to manufacture or process the 
chemical substance, EPA will tell the person whether the use identified 
in the bona fide submission would be a significant new use under the 
rule. Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in 40 CFR 
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    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.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2018-0649.

XII. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action establishes 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).

B. Paperwork Reduction Act (PRA)

    According to the PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under the 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. EPA is amending the table in 40 CFR part 9 to list 
the OMB approval number for the information collection requirements 
contained in this action. This listing of the OMB control numbers and 
their subsequent codification in the CFR satisfies the display 
requirements of PRA and OMB's implementing regulations at 5 CFR part 
1320. This Information Collection Request (ICR) was previously subject 
to public notice and comment prior to OMB approval, and given the 
technical nature of the table, EPA finds that further notice and 
comment to amend it is unnecessary. As a result, EPA finds that there 
is ``good cause'' under section 553(b)(3)(B) of the Administrative 
Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without 
further notice and comment.
    The information collection activities in this action have already 
been approved by OMB pursuant to the 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 using 
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.

C. Regulatory Flexibility Act (RFA)

    Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency 
hereby certifies that promulgation of this SNUR will 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. 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 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.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State,

[[Page 66596]]

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 action does 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.).

E. Executive Order 13132: Federalism

    This action will 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).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action does not significantly nor uniquely affect the communities of 
Indian Tribal governments, nor does 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.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    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.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this action is not expected to affect energy 
supply, distribution, or use and because this action is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

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

XIII. Congressional Review Act (CRA)

    Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication of the rule in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: November 13, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 
7542, 9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add entries for Sec. Sec.  721.11174 through 721.11181 
in numerical order under the undesignated center heading ``Significant 
New Uses of Chemical Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
721.11174...............................................       2070-0012
721.11175...............................................       2070-0012
721.11176...............................................       2070-0012
721.11177...............................................       2070-0012
721.11178...............................................       2070-0012
721.11179...............................................       2070-0012
721.11180...............................................       2070-0012
721.11181...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec. Sec.  721.11174 through 721.11181 to subpart E to read as 
follows:

Subpart E--Significant New Uses For Specific Chemical Substances

Sec.
* * * * *
721.11174 Silane-treated aluminosilicate (generic).
721.11175 Heteropolycycliccarboxylic acid, 1,3-dihydro-
disubstituted-, polymer with 1,1'-methylenebis[4-isocyanatobenzene], 
reaction products with silica (generic).
721.11176 Carbonic acid, alkyl carbomonocyclic ester (generic).
721.11177 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer with 
2-(chloromethyl)oxirane, reaction products with polyethylene-
polypropylene glycol 2-aminopropyl Me ether.
721.11178 Copolyamide of an aromatic dicarboxylic acid and a mixture 
of diamines (generic).
721.11179 Single-walled carbon nanotubes (generic).
721.11180 Arenesulfonic acid, alkyl derivatives, metal salts 
(generic).
721.11181 Heteromonocycle, 2-[(bicarbomonocycle-2-
substituted)alkyl]- (generic).
* * * * *

Sec.  721.11174  Silane-treated aluminosilicate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
silane-treated aluminosilicate (PMNs P-16-194, P-16-195, P-16-196, P-
16-197, P-16-198, P-16-199, P-16-460, P-16-461, P-16-

[[Page 66597]]

462, P-16-463, P-16-464, P-18-193, P-18-194, P-18-195, P-18-196, P-19-
124, P-19-125, P-19-126, P-19-127, P-19-128, and P-19-129) are subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section. The requirements of this section 
do not apply to quantities of the substances after they have been 
completely incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (5) (respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor of at least 
50) and (6) (particulate), (b) (concentration set at 0.1%), and (c). 
When determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(4), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(ii) 
through (ix), (2)(i) through (v), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substances without sampling and 
analyzing the immediate precursor used to manufacture the substances 
according to the terms specified in the TSCA section 5(e) Order for the 
following elements: Arsenic, barium, beryllium, cadmium, chromium, 
cobalt, copper, lead, manganese, mercury, nickel, selenium, silver, 
vanadium, and zinc. It is a significant new use to manufacture the 
substances at facilities other than those equipped with pollution 
controls, such as a bag house, that remove particulates from the air at 
99% or greater efficiency. It is a significant new use to process the 
substances other than in an enclosed system that does not allow for the 
release of particulates or at facilities equipped with pollution 
controls, such as a bag house, that remove particulates from the air at 
99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11175  Heteropolycycliccarboxylic acid, 1,3-dihydro-
disubstituted-, polymer with 1,1'-methylenebis[4-isocyanatobenzene], 
reaction products with silica (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteropolycycliccarboxylic acid, 1,3-dihydro-disubstituted-, polymer 
with 1,1'-methylenebis[4-isocyanatobenzene], reaction products with 
silica (PMN P-16-307) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) through (iii), (3) and (6) (particulate), (b) 
(concentration set at 1.0%), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i) and 
(ii), (2)(i) through (iii) and (v), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance for 
consumer use or for commercial uses that could introduce the substance 
into a consumer setting. It is a significant new use to manufacture, 
process, or use the substance other than in a liquid formulation. It is 
a significant new use to manufacture the PMN substance to contain more 
than 0.1% residual isocyanate by weight. It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in generation of a vapor, dust, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11176  Carbonic acid, alkyl carbomonocyclic ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbonic acid, alkyl carbomonocyclic ester (PMN P-17-176) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iv), (3), (6)(v) and(vi), (particulate), (b) 
(concentration set at 1.0%), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv), 
(v), (vi) and (ix), (2)(i) and (v), (3)(i) and (ii), (4) (do not 
release to water above 45 parts per billion), and (5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to 
manufacture the chemical substance more than 3 years.
    (iv) Release to water. Release to water requirements as specified 
in Sec.  721.90(a)(4), (b)(4), and (c)(4) where N = 45.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).

[[Page 66598]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11177  1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer 
with 2-(chloromethyl)oxirane, reaction products with polyethylene-
polypropylene glycol 2-aminopropyl Me ether.

    (a) Chemical substance and significant new used subject to 
reporting. (1) The chemical substance identified as 1,3-propanediol, 2-
ethyl-2-(hydroxymethyl)-, polymer with 2-(chloromethyl)oxirane, 
reaction products with polyethylene-polypropylene glycol 2-aminopropyl 
Me ether (PMN P-17-183, CAS No 1627528-04-4) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), 
(2)(ii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (o). It is a significant new 
use to process or use the substance in any manner way that results in 
generation of a vapor, dust, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (f) through (i) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11178  Copolyamide of an aromatic dicarboxylic acid and a 
mixture of diamines (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
copolyamide of an aromatic dicarboxylic acid and a mixture of diamines 
(PMN P-17-232) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance with a particle size 
less than 10 microns.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11179  Single-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as single-
walled carbon nanotubes (PMN P-17-257) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance that have been embedded or incorporated 
into a polymer matrix that itself has been reacted (cured); embedded in 
a permanent solid polymer form that is not intended to undergo further 
processing, except mechanical processing; or incorporated into an 
article as defined at 40 CFR 720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (3), (4), (5) (respirators must provide a 
National Institute for Occupational Safety and Health assigned 
protection factor of at least 50), and (6)(particulate), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
manufacture the chemical substance more than 6 months. It is a 
significant new use to process or use the substance for non-industrial 
use except for the confidential non-industrial use described in the 
TSCA section 5(e) Order. It is a significant new use to use an 
application method that generates a vapor, dust, mist or aerosol unless 
the application method occurs in an enclosed process.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(2), (b)(1) and (2), and (c)(1) and (2).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e) and (j) through (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

Sec.  721.11180  Arenesulfonic acid, alkyl derivatives, metal salts 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
arenesulfonic acid, alkyl derivatives, metal salts (PMN P-17-283) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii) and (3), (b)(concentration set at 1.0%), 
and (c). When determining which persons are reasonably likely to be 
exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1) ((skin 
sensitization), (eye irritation), (lung effects), (skin corrosion)), 
(2)(i), (iii) and (v), and (5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.

[[Page 66599]]

    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the chemical substance more than 6 
months. It is a significant new use to manufacture, process or use the 
substance in any manner way that results in generation of a vapor, 
mist, spray, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provision of Sec.  721.185 apply to this section.

Sec.  721.11181  Heteromonocycle, 2-[(bicarbomonocycle-2-
substituted)alkyl]- (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteromonocycle, 2-[(bicarbomonocycle-2-substituted)alkyl]- (PMN P-17-
353) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section. The requirements of 
this section do not apply to quantities of the substance after they 
have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) through (iv) and (3), (b) (concentration set at 
0.1%), and (c). When determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1), (vi), 
(vii), and (ix) ((mutagenicity) (eye, skin, lung, and mucous membrane 
irritation) (skin and lung sensitization)), (2)(i) through (iii) and 
(v) (avoid workplace airborne concentrations), (3)(i) and (ii), 
(4)(iii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities: Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
process or use the substance in any manner that generates a vapor, 
spray, mist, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

[FR Doc. 2019-26225 Filed 12-4-19; 8:45 am]
 BILLING CODE 6560-50-P