Document ID: EPA-HQ-OPPT-2018-0777-0245
Agency: epa
Document Type: Rule
Title: Significant New Use Rules: Certain Chemical Substances (19-1.F)
Posted Date: 2021-05-06T04:00Z

[Federal Register Volume 86, Number 86 (Thursday, May 6, 2021)]
[Rules and Regulations]
[Pages 24328-24336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08840]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 721, and 725

[EPA-HQ-OPPT-2018-0777; FRL-10023-11]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (19-1.F)

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 were 
the subject of premanufacture notices (PMNs) and a microorganism that 
was the subject of a Microbial Commercial Activity Notice (MCAN). This 
action requires persons to notify EPA at 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. This action further 
requires that persons not commence manufacture or processing for the 
significant new use until they have submitted a Significant New Use 
Notice (SNUN), and EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and has taken any risk 
management

[[Page 24329]]

actions as are required as a result of that determination.

DATES: This rule is effective on July 6, 2021. For purposes of judicial 
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 20, 
2021.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: William Wysong, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4163; email address: 
wysong.william@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 
provisions. This action may also affect certain entities through pre-
existing import certification and export notification rules under TSCA, 
which would include the SNUR requirements. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, pursuant to 40 CFR 721.20 (or 40 CFR 725.920 for the MCAN 
substance), any persons who export or intend to export a chemical 
substance that is the subject of this rule are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), 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-2018-0777, 
is available at https://www.regulations.gov and 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.
    Due to the public health emergency, the EPA Docket Center (EPA/DC) 
and Reading Room is closed to visitors with limited exceptions. The 
staff continues to provide remote customer service via email, phone, 
and webform. For the latest status information on EPA/DC services and 
docket access, visit https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical 
substances which were the subject of PMNs P-17-382, P-18-41, P-18-70, 
P-18-100, P-18-102, P-18-116, P-18-136, P-18-137, P-18-219, P-18-224, 
P-18-225, P-18-233, P-18-279, and of MCAN J-18-41. 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 July 31, 2019 (84 FR 37199) 
(FRL-9994-62), EPA proposed SNURs for these chemical substances. EPA 
will address the other proposed SNURs in a subsequent Federal Register 
document. More information on the specific chemical substances subject 
to this final rule can be found in the Federal Register document 
proposing the SNURs. The docket includes information considered by the 
Agency in developing the proposed and final rules, including the public 
comments received on the proposed rules that are described in Unit IV.

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.A.

C. Do the SNUR general provisions apply?

    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. Pursuant 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 
PMNs under TSCA section 5(a)(1)(A). In particular, 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), 
5(h)(2), 5(h)(3), and 5(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 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

A. Determination Factors

    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

[[Page 24330]]

substances that are the subject of these SNURs, EPA considered relevant 
information about the toxicity of the chemical substances and potential 
human exposures and environmental releases that may be associated with 
the substances, in the context of the four bulleted TSCA section 
5(a)(2) factors listed in this unit.
    During its review of the chemical substances that are the subjects 
of these SNURs and as further discussed in Unit VI., EPA identified 
potential risk concerns associated with other circumstances of use 
that, while not intended or reasonably foreseen, may occur in the 
future. EPA is designating those other circumstances of use as 
significant new uses.

B. Procedures for Significant New Uses Claimed as Confidential Business 
Information (CBI)

    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 40 CFR 
721.1725(b)(1) and has referenced it to apply to other SNURs.
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a specific 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 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.

IV. Public Comments

    EPA received public comments from two identifying entities on the 
proposed rule. The Agency's responses are presented in the Response to 
Public Comments document that is available in the docket for this rule. 
EPA did not make changes to any of the proposed rules as a result of 
these comments. Separately, EPA made changes to the SNUR proposed at 40 
CFR 725.1079 for the microorganism which was the subject of MCAN J-18-
41. This SNUR, as proposed, included references to 40 CFR part 721. 
These have been changed to refer instead to the equivalent provisions 
in 40 CFR part 725, concerning reporting requirements and review 
processes for microorganisms. The effect of the SNUR has not been 
altered by these changes.

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, for 
several chemicals that were the subject of PMNs, and in 40 CFR part 725 
for one chemical substance that is a microorganism (MCAN J-18-41). In 
Unit IV. of the proposed SNUR, EPA provided the following information 
for each chemical substance:
     PMN or MCAN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Potentially useful information.
     CFR citation proposed to be assigned in the regulatory 
text section. This final rule makes the final assignment to set the CFR 
citation for the chemical.
    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.

VI. Rationale and Objectives of the Rule

A. Rationale

    The chemical substances that are the subjects of these SNURs 
received ``not likely to present an unreasonable risk'' determinations 
under TSCA section 5(a)(3)(C) based on EPA's review of the intended, 
known, and reasonably foreseen conditions of use. However, EPA has 
identified other circumstances that, should they occur in the future, 
even if not reasonably foreseen, may present risk concerns. 
Specifically, EPA has determined that deviations from the protective 
measures identified in the PMN submissions could result in changes in 
the type or form of exposure to the chemical substances, 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. 
These SNURs identify as a significant new use manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the protective measures identified in the submissions. As a 
result, those significant new uses cannot occur without first going 
through a separate, subsequent EPA review and determination process 
associated with a SNUN.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     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 TSCA 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 TSCA 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.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Inventory. Guidance on how 
to determine if a chemical substance is on

[[Page 24331]]

the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory.

VII. Applicability of the Rules to Uses Occurring Before the Effective 
Date of the Final Rule

    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.
    When the 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, the identities of many of the chemical 
substances subject to this rule have been claimed as confidential (per 
40 CFR 720.85). 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.
    EPA designated July 31, 2019 (the date of FR publication of the 
proposed rule) as the cutoff date for determining whether the new use 
is ongoing. The objective of EPA's approach is to ensure that a person 
cannot defeat a SNUR by initiating a significant new use before the 
effective date of the final rule.
    Persons who began commercial manufacture or processing of the 
chemical substances for a significant new use identified on or after 
that date will have to cease any such activity upon the effective date 
of the final rule. To resume their activities, these persons would have 
to first comply with all applicable SNUR notification requirements and 
EPA would have to take action under section 5 allowing manufacture or 
processing to proceed.

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, then TSCA section 5(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 40 
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV. of the proposed rule 
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 rule 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 election. 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). For more 
information on alternative test methods and strategies to reduce 
vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    The potentially useful information described in Unit IV. of the 
proposed rule 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 sections 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.

IX. 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. According to 40 CFR 725.900, persons 
submitting an MCAN for a significant new use of a microorganism must 
comply with the same notification requirements and EPA regulatory 
procedures as persons submitting an MCAN for a new microorganism, 
including submission of test data on health and environmental effects 
as described in 40 CFR 725.160. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

X. 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 for this rulemaking.

XI. 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 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 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 PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control

[[Page 24332]]

numbers for EPA's regulations in title 40 of the CFR, after appearing 
in the Federal Register, are listed in 40 CFR part 9, and included on 
the related collection instrument or form, if applicable.
    The information collection requirements related to this 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 instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    The listing of the OMB control numbers of the collection 
instruments and their subsequent codification in the table in 40 CFR 
9.1 satisfies the display requirements of the PRA and OMB's 
implementing regulations at 5 CFR part 1320. Since this ICR was 
previously subject to public notice and comment prior to OMB approval, 
and given the technical nature of the table in 40 CFR part 9, 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 in 40 CFR 9.1 without further notice 
and comment.

C. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b), 5 U.S.C. 601 et seq., I hereby 
certify that promulgation of this SNUR does 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, 12 in FY2016, 13 in FY2017, and 11 in FY2018. 
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 does not have federalism implications because it is not 
expected to 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 will not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes, 
significantly or uniquely affect the communities of Indian Tribal 
governments, and does not 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 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 a significant regulatory 
action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    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).

K. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA 
will submit a rule report containing this rule and other required 
information to each House of the Congress and to the Comptroller 
General of the United States. 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 Parts 721 and 725

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

    Dated: April 22, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is amended as follows:

[[Page 24333]]

PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT

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, 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, amend the table by adding entries for Sec. Sec.  
721.11278, 721.11282, 721.11283, 721.11285 through 721.11287, 721.11289 
through 721.11294, and 721.11603 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.............
 
                                * * * * *
721.11278...............................................       2070-0012
721.11282...............................................       2070-0012
721.11283...............................................       2070-0012
721.11285...............................................       2070-0012
721.11286...............................................       2070-0012
721.11287...............................................       2070-0012
721.11289...............................................       2070-0012
721.11290...............................................       2070-0012
721.11291...............................................       2070-0012
721.11292...............................................       2070-0012
721.11293...............................................       2070-0012
721.11294...............................................       2070-0012
 
                                * * * * *
721.11603...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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.  721.11278, 721.11282, 721.11283, 721.11285 through 
721.11287, 721.11289 through 721.11294, and 721.11603 to subpart E to 
read as follows:

Subpart E --Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
721.11278 Amides, tallow, N,N-bis(2-hydroxypropyl).
721.11282 2,5-Furandione, polymer with 2-ethyl-2-(hydroxymethyl)-
1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5(or 
6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate.
721.11283 Waste plastics, polyester, depolymd. with glycols, 
polymers with dicarboxylic acids (generic).
721.11285 Substituted alkanoic acid, polymer with alkylcarbonate, 
alkanediols and isocyanate substituted carbomonocycles, sodium salt, 
alkenoic acid substituted polyol reaction products-blocked 
(generic).
721.11286 Alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-
substituted alkanediol], polymer with alkylcarbonate, alkanediols, 
substituted alkanoic acid and isocyanate and alkyl substituted 
carbomonocycle, sodium salt (generic).
721.11287 Castor oil, reaction products with soybean oil.
721.11289 1-Butanaminium,N,N,N-tributyl-,2(or 5)- 
[[benzoyldihydrodioxo [(sulfophenyl) amino]heteropolycycle]oxy]-5(or 
2)-(1,1-dimethylpropyl)benzenesulfonate (2:1) (generic).
721.11290 Alkylsilsesquioxane, ethoxy-terminated (generic).
721.11291 Polythioether, short chain diol polymer terminated with 
aliphatic diisocyanate (generic).
721.11292 Alkenoic acid, polymer with alkenylcarbomonocycle, 
[alkanediylbis (substituted alkylene)] bis[heteromonocycle] and 
(alkylalkenyl) aromatic, salt (generic).
721.11293 Alkenoic acid, polymer with substituted alkyloxirane, 
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and 
(alkylalkenyl) aromatic, salt (generic).
721.11294 Alkyl alkenoic acid, alkyl ester, telomer with alkylthiol, 
substituted carbomonocycle, substituted alkyl alkyl alkenoate and 
hydroxyalkyl alkenoate, tertbutyl alkyl peroxoate-initiated 
(generic).
* * * * *
721.11603 Substituted heteromonocycle, polymer with substituted 
alkanediol and diisocyanate substituted carbomonocyle, alkylene 
glycol acrylate-blocked (generic).
* * * * *

Sec.  721.11278  Amides, tallow, N,N-bis(2-hydroxypropyl).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as amides, tallow, 
N,N-bis(2-hydroxypropyl) (PMN P-17-382; CAS No. 1454803-04-3) 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 the substance in 
any manner that results in inhalation exposures. It is a significant 
new use to process the substance resulting in an end use product 
containing greater than 3% by weight of the substance.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=11.
    (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), (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11282  2,5-Furandione, polymer with 2-ethyl-2-
(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-hexahydro-4,7-methano-
1H-inden-5(or 6)-yl ester, ester with 2,3-dihydroxypropyl neodecanoate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2,5-Furandione, 
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3a,4,5,6,7,7a-
hexahydro-4,7-methano-1H-inden-5(or 6)-yl ester, ester with 2,3-
dihydroxypropyl neodecanoate (PMN P-18-41) 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). It is a significant new use to 
manufacture (including import) the substance with the number average 
molecular weight of less than 1000 daltons.
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 24334]]

Sec.  721.11283  Waste plastics, polyester, depolymd. with glycols, 
polymers with dicarboxylic acids (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as waste 
plastics, polyester, depolymd. with glycols, polymers with dicarboxylic 
acids (PMN P-18-70) 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).
    (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) Limitation 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.  721.11285  Substituted alkanoic acid, polymer with 
alkylcarbonate, alkanediols and isocyanate substituted carbomonocycles, 
sodium salt, alkenoic acid substituted polyol reaction products-blocked 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted alkanoic acid, polymer with alkylcarbonate, alkanediols and 
isocyanate substituted carbomonocycles, sodium salt, alkenoic acid 
substituted polyol reaction products-blocked (PMN P-18-100) 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), (j), and (o).
    (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) Limitation 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.  721.11286  Alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-
substituted alkanediol], polymer with alkylcarbonate, alkanediols, 
substituted alkanoic acid and isocyanate and alkyl substituted 
carbomonocycle, sodium salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, ester with [oxybis(alkylene)]bis[alkyl-substituted 
alkanediol], polymer with alkylcarbonate, alkanediols, substituted 
alkanoic acid and isocyanate and alkyl substituted carbomonocycle, 
sodium salt (PMN P-18-102) 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), (j), and (o).
    (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) Limitation 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.  721.11287  Castor oil, reaction products with soybean oil.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as castor oil, 
reaction products with soybean oil (PMN P-18-116) 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 in any manner that generates an aerosol or 
mist. It is a significant new use to exceed the confidential annual 
production volume stated in the PMN.
    (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) Limitation 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.  721.11289  1-Butanaminium,N,N,N-tributyl-,2(or 5)- 
[[benzoyldihydrodioxo [(sulfophenyl) amino]heteropolycycle]oxy]-5(or 
2)-(1,1-dimethylpropyl)benzenesulfonate (2:1) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 1-
butanaminium,N,N,N-tributyl-,2(or 5)- [[benzoyldihydrodioxo 
[(sulfophenyl) amino]heteropolycycle]oxy]-5(or 2)-(1,1-
dimethylpropyl)benzenesulfonate (2:1) (PMN P-18-136) 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 the substance in 
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=19.
    (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), (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11290  Alkylsilsesquioxane, ethoxy-terminated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylsilsesquioxane, ethoxy-terminated (PMN P-18-137) 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:

[[Page 24335]]

    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=58.
    (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), (i), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11291  Polythioether, short chain diol polymer terminated 
with aliphatic diisocyanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polythioether, short chain diol polymer terminated with aliphatic 
diisocyanate (PMN P-18-219) 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 PMN substance with molecular 
weight greater than 10,000 daltons. It is a significant new use to 
manufacture the PMN substance with free isocyanate residuals greater 
than 0.01% 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) though (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11292  Alkenoic acid, polymer with alkenylcarbomonocycle, 
[alkanediylbis (substituted alkylene)] bis[heteromonocycle] and 
(alkylalkenyl) aromatic, salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, polymer with alkenylcarbomonocycle, [alkanediylbis 
(substituted alkylene)] bis[heteromonocycle] and (alkylalkenyl) 
aromatic, salt (PMN P-18-224) 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 the substance in 
any manner that results in inhalation exposure. It is a significant new 
use to manufacture the substance to contain an acid content greater 
than 20% 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) though (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11293  Alkenoic acid, polymer with substituted alkyloxirane, 
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and 
(alkylalkenyl) aromatic, salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, polymer with substituted alkyloxirane, 
alkenylcarbomonocycle, alkyl substituted alkyl alkanediol and 
(alkylalkenyl) aromatic, salt (PMN P-18-225) 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 the substance in 
any manner that results in inhalation exposure. It is a significant new 
use to manufacture the substance to contain an acid content greater 
than 20% 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) though (c) and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11294  Alkyl alkenoic acid, alkyl ester, telomer with 
alkylthiol, substituted carbomonocycle, substituted alkyl alkyl 
alkenoate and hydroxyalkyl alkenoate, tertbutyl alkyl peroxoate-
initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
alkenoic acid, alkyl ester, telomer with alkylthiol, substituted 
carbomonocycle, substituted alkyl alkyl alkenoate and hydroxyalkyl 
alkenoate, tertbutyl alkyl peroxoate-initiated (PMN P-18-233) 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(w)(2).
    (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) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
* * * * *

Sec.  721.11603  Substituted heteromonocycle, polymer with substituted 
alkanediol and diisocyanate substituted carbomonocyle, alkylene glycol 
acrylate-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted heteromonocycle, polymer with substituted alkanediol and 
diisocyanate substituted carbomonocyle, alkylene glycol acrylate-
blocked (PMN P-18-279) 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), (4), and (5). For purposes of Sec.  721.63(a)(4), only 
persons subject to inhalation exposure from spray application of the 
chemical substance are subject to these requirements. 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

[[Page 24336]]

exposure, where feasible. For purposes of Sec.  721.63(a)(5) 
respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 1000.
    (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 (d) are applicable to manufacturers and processors of 
this substance.
    (2) Limitation or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR 
MICROORGANISMS

0
5. The authority citation for part 725 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

0
6. Add Sec.  725.1079 to read as follows:

Sec.  725.1079  Arsenic detecting strain of E. coli with extra-
chromosomal elements, including an intergeneric screening marker 
(generic).

    (a) Microorganism and significant new uses subject to reporting. 
(1) The genetically-modified microorganism identified generically as 
arsenic detecting strain of E. coli with extra-chromosomal elements, 
including an intergeneric screening marker (MCAN J-18-41) 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) It is a significant new use to manufacture (excluding import) 
the microorganism in the United States for any use.
    (ii) It is a significant new use to use the microorganism other 
than to detect arsenic in small water samples.
    (b) Specific requirements. The provisions of subpart L of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
725.950(b)(2) through (4) are applicable to manufacturers and 
processors of this microorganism.
    (2) Modification or revocation of certain notification 
requirements. The provisions of Sec.  725.984 apply to this section.

[FR Doc. 2021-08840 Filed 5-5-21; 8:45 am]
BILLING CODE 6560-50-P