Significant New Use Rules on Certain Chemical Substances (19-2.B), 22587-22593 [2020-07397]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 79 (Thursday, April 23, 2020)]
[Rules and Regulations]
[Pages 22587-22593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07397]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2019-0263; FRL-10005-57]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (19-2.B)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances which are 
the subject of premanufacture notices (PMNs). This action requires 
persons to notify EPA least 90 days before commencing manufacture 
(defined by statute to include import) or processing of any of these 
chemical substances for an activity that is designated as a significant 
new use by this rule. The required notification initiates EPA's 
evaluation of the intended use within the applicable review period. 
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 as a result of that determination.

DATES: This rule is effective on June 22, 2020. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
May 7, 2020.

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: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. 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

[[Page 22588]]

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 
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 rule on or after May 26, 2020 are 
subject to the export notification provisions of TSCA section 12(b) (15 
U.S.C. 2611(b)) (see Sec.  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 docket identification (ID) number EPA-HQ-OPPT-2019-0263, 
is available at https://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 https://www.epa.gov/dockets.

II. Background

A. What action is the agency taking?

    EPA is finalizing a SNUR under TSCA section 5(a)(2) for chemical 
substances which were the subject of PMNs P-16-425, P-18-125, P-18-228, 
P-18-234, P-18-270, P-18-322, P-19-4, and P-19-34. 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.
    Previously, in the Federal Register of June 11, 2019 (84 FR 27061) 
(FRL-9994-85), EPA proposed a SNUR for these chemical substances in 40 
CFR part 721 subpart E. More information on the specific chemical 
substances subject to this final rule can be found in the Federal 
Register documents proposing the SNUR. The record for the SNUR was 
established in the docket under docket ID number EPA-HQ-OPPT-2019-0263. 
That docket includes information considered by the Agency in developing 
the proposed and final rules, public comments submitted for the 
proposed rule, and EPA's responses to public comments received on the 
proposed rule.

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

    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. As described in Unit V. of the proposed 
SNUR, the general SNUR provisions are found at 40 CFR part 721, subpart 
A.

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 Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(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 significant new use 
is not likely to present an unreasonable risk of injury or take such 
regulatory action as is associated with an alternative determination 
before the manufacture or processing for the significant new use can 
commence. If EPA determines that the significant new 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

    Section 5(a)(2) of TSCA 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 addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors. 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, and 
potential human exposures and environmental releases that may be 
associated with the conditions of use of the substances, in the context 
of 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 two identifying entities on the 
proposed rule. The Agency's responses are described in a separate 
Response to Public Comments document contained in the public docket for 
this rule, EPA-HQ-OPPT-2019-0263.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for chemical substances in 40 CFR part 721, subpart E. In 
Unit IV. of the June 11, 2019 proposed SNUR (84 FR 27061) (FRL-9994-
85), EPA provided the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).

[[Page 22589]]

     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substances if a manufacturer or processor is considering submitting a 
SNUN for a significant new use designated by the SNUR.
    This information may include testing not required to be conducted 
but which would help characterize the potential health and/or 
environmental effects of the PMN substance. Any recommendation for 
information identified by EPA 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 chemical substance. Further, 
any such testing identified by 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. EPA also recognizes that 
whether testing/further information is needed will depend on the 
specific exposure and use scenario in the SNUN. EPA encourages all SNUN 
submitters to contact EPA to discuss any potential future testing. See 
Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of 
these rules.
    The regulatory text section of these rules specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits and other uses designated in the rules, may be 
claimed as CBI.
    The chemical substances that are the subject of these SNURs 
completed premanufacture review. In addition to those conditions of use 
intended by the submitter, EPA has identified certain other reasonably 
foreseen conditions of use. EPA has preliminarily determined that the 
chemicals under their intended conditions of use are not likely to 
present an unreasonable risk. However, EPA has not assessed risks 
associated with the reasonably foreseen conditions of use for these 
chemicals. EPA is designating these reasonably foreseen and other 
potential conditions of use as significant new uses. As a result, those 
conditions of use are no longer reasonably foreseen to occur without 
first going through a separate, subsequent EPA review and determination 
process associated with a SNUN.

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject of these SNURs and as further discussed in Unit IV 
of the June 11, 2019 proposed rule (84 FR 27061) (FRL-9994-85), EPA 
identified certain reasonably foreseen conditions of use and other 
circumstances different from the intended conditions of use identified 
in the PMNs and determined that those changes 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.

B. Objectives

    EPA is issuing these SNURs 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 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 obligated to make a determination under TSCA section 
5(a)(3) regarding the use described in the SNUN, under the conditions 
of use. The Agency will either determine under section 5(a)(3)(C) that 
the significant new use is not likely to present an unreasonable risk, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by the Administrator under the 
conditions of use, or make a determination under section 5(a)(3)(A) or 
(B) and take the required regulatory action associated with the 
determination, before manufacture or processing for the significant new 
use of the chemical substance can occur.
     To be able 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).
    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 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

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 an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    EPA designated June 6, 2019 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 June 6, 2019 that person will have to cease any such 
activity upon the effective date of the final rule. To resume their 
activities, that person 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.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of 
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 or reasonably ascertainable by them (see 
Sec.  720.50). However, upon review of PMNs and

[[Page 22590]]

SNUNs, the Agency has the authority to require appropriate testing. 
Unit IV. of the proposed SNUR lists potentially useful information for 
all SNURs listed here. Descriptions are provided for informational 
purposes. The potentially useful information identified in Unit IV. of 
the proposed SNUR will be useful to 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, which may assist with EPA's 
analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to 
consult with the Agency pertaining to protocol selection. Furthermore, 
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 
recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. of the 
proposed SNUR may not be the only means of providing information to 
evaluate the chemical substance associated with the significant new 
uses. However, submitting a SNUN without any test data 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. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at Sec.  
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 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 Sec.  
721.1725(b)(1) with that under Sec.  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 Sec.  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 Sec.  721.25. E-PMN software is 
available electronically at https://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-2019-0263.

XII. Statutory and Executive Order Reviews

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. 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 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. 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 requirements related to this action 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

[[Page 22591]]

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 
through 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.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this 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 11 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, 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, entitled 
``Federalism'' (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, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not 
apply to this action.

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

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (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, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (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, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (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: March 31, 2020.
Tala R. 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:


[[Page 22592]]


    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 Sec. Sec.  721.11258 through 721.11266 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
------------------------------------------------------------------------
 
                                * * * * *
Sec.   721.11258........................................       2070-0012
Sec.   721.11260........................................       2070-0012
Sec.   721.11261........................................       2070-0012
Sec.   721.11262........................................       2070-0012
Sec.   721.11263........................................       2070-0012
Sec.   721.11264........................................       2070-0012
Sec.   721.11265........................................       2070-0012
Sec.   721.11266........................................       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.  721.11258 through 721.11266 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11258 Amino-silane (generic).
721.11260 Acetic acid, 2-oxo-, sodium salt (1:1).
721.11261 Branched alkenyl acid, alkyl ester, homopolymer (generic).
721.11262 Alkenoic acid, reaction products with bis substituted 
alkane and ether polyol (generic).
721.11263 Ethanol, 2-butoxy-, 1,1'-ester (generic).
721.11264 Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- 
(generic).
721.11265 Aromatic dianhydride, polymer with aromatic diamine and 
heteroatom bridged aromatic diamine, reaction products with aromatic 
anhydride (generic).
721.11266 Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)- (generic).


Sec.  721.11258   Amino-silane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amino-
silane (PMN P-16-425) 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. Requirements 
as specified in Sec.  721.80(g).
    (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) though (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.  721.11260   Acetic acid, 2-oxo-, sodium salt (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as acetic acid, 2-oxo-
, sodium salt (1:1) (PMN P-18-125, CAS No. 2706-75-4) 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. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to 
manufacture, process, or use the substance in an application that 
generates a mist, spray, vapor, or aerosol.
    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  721.11261   Branched alkenyl acid, alkyl ester, homopolymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
branched alkenyl acid, alkyl ester, homopolymer (PMN P-18-228) 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. Requirements 
as specified in Sec.  721.80(j). It is a significant new use to 
manufacture, process or use the substance in any manner that results in 
inhalation exposures.
    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  721.11262   Alkenoic acid, reaction products with bis substituted 
alkane and ether polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, reaction products with bis substituted alkane and ether 
polyol (PMN P-18-234) 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 use the substance involving spray application 
that results in inhalation exposures.
    (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

[[Page 22593]]

provisions of Sec.  721.185 apply to this section.


Sec.  721.11263   Ethanol, 2-butoxy-, 1,1'-ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
ethanol, 2-butoxy-, 1,1'-ester (PMN P-18-270) 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. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to use the 
substance for other than an active co-solvent for solvent-based 
coatings; a coalescent for industrial water-based coatings; a coupling 
agent and solvent for industrial cleaners, rust removers, hard surface 
cleaners and disinfectants; and a primary solvent in solvent-based silk 
screen printing inks.
    (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.  721.11264   Heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteromonocycle, 4,6-dimethyl-2-(1-phenylethyl)- (PMN P-18-322) 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. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to process 
(formulate) the substance to a concentration of greater than 5% by 
weight.
    (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) and (b) (at concentrations of the substance greater than 5% 
by weight), Sec.  721.125(c) (at concentrations of the substance 
greater than 5% by weight), and Sec.  721.125(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.  721.11265   Aromatic dianhydride, polymer with aromatic diamine 
and heteroatom bridged aromatic diamine, reaction products with 
aromatic anhydride (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic dianhydride, polymer with aromatic diamine and heteroatom 
bridged aromatic diamine, reaction products with aromatic anhydride 
(PMN P-19-4) 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, process or use of the substance in 
any manner that results in inhalation exposures.
    (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.  721.11266   Metal, bis(2,4-pentanedionato-kO2,kO4)- (T-4)- 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as metal, 
bis(2,4-pentanedionato-kO2,kO4)- (T-4)- (PMN P-19-34) 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. Requirements 
as specified in Sec.  721.80(f) and (j). It is a significant new use to 
process or use the substance without the engineering controls described 
in the premanufacture notice.
    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

[FR Doc. 2020-07397 Filed 4-22-20; 8:45 am]
 BILLING CODE 6560-50-P