[Federal Register Volume 86, Number 82 (Friday, April 30, 2021)]
[Rules and Regulations]
[Pages 22870-22875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08880]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 721, and 725

[EPA-HQ-OPPT-2020-0094; FRL-10016-30]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (20-3.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 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 actions as are required as a result of that determination.

DATES: This rule is effective on June 29, 2021. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
May 14, 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:

[[Page 22871]]

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 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-2020-0094, 
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.
    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 MCAN J-19-1 and PMNs P-18-391 and 
P-20-13. 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.

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.

C. Do the SNUR general provisions apply?

    General provisions for SNURs appear in 40 CFR part 721, subpart A, 
and (for microorganisms) 40 CFR part 725, subpart L. 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) (15 U.S.C. 2604(a)(1)(A)). In particular, these 
requirements include the information submission requirements of TSCA 
sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and 2604(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 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 
these chemicals, EPA identified certain conditions of use that are not 
intended by the submitters, but reasonably foreseen to occur. EPA is 
designating those reasonably foreseen conditions of use as well as 
certain 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

[[Page 22872]]

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 on the proposed rule (85 FR 15406, 
March 18, 2020) from four identifying entities. The Agency's responses 
are presented in the Response to Public Comments document that is 
available in the docket for this rule. EPA has made changes to the 
final rule as described in these comments.

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, and 
in 40 CFR part 725 for one chemical substance that is a microorganism 
(MCAN J-19-1). 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 assigned in the regulatory text section of 
this final rule.
    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

    During review of the PMNs and MCAN submitted for the chemical 
substances that are the subject of these SNURs and as further discussed 
in Unit IV. of the proposed rule, EPA identified certain other 
reasonably foreseen conditions of use in addition to those conditions 
of use intended by the submitter. EPA has preliminarily determined that 
the chemical under the intended conditions of use is not likely to 
present an unreasonable risk. However, EPA has not assessed risks 
associated with the reasonably foreseen conditions of use. EPA is 
designating these conditions of use as well as certain other 
circumstances of use as significant new uses. As a result, those 
significant new uses cannot occur without 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 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.
     To be able to complete its review and determination on 
each of the PMN or MCAN substances, while deferring analysis on the 
significant new uses proposed in these rules unless and until the 
Agency receives a SNUN.
    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 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 were 
undergoing premanufacture review at the time of signature of the 
proposed rule and were not on the TSCA inventory. 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 
the chemical substances subject to these SNURs EPA concluded at the 
time of signature of the proposed rule that the designated significant 
new uses were not ongoing.
    EPA designated March 4, 2020 (the date of web posting 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

[[Page 22873]]

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).
    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 and 721.25 (or 40 CFR 725.25 and 725.27 for 
an MCAN). 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 PRA, 44 U.S.C. 3501 et seq., an agency may not conduct 
or sponsor, and a person is not required to respond to a collection of 
information that requires OMB approval under PRA, unless it has been 
approved by OMB and displays a currently valid OMB control number. The 
OMB control numbers for EPA's regulations in title 40 of the CFR, after 
appearing in the Federal Register, are listed in 40 CFR part 9, and 
included on the related collection instrument or form, if applicable.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 0574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
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 RFA section 605(b), 5 U.S.C. 601 et seq., I hereby 
certify 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, 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

[[Page 22874]]

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 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)

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

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

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

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 Part 721

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

40 CFR Part 725

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

    Dated: January 14, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Editorial Note: This document was received for publication by 
the Office of the Federal Register on April 23, 2021.

    Therefore, for the reasons set forth in the preamble, EPA amends 40 
CFR parts 9, 721, and 725 as follows:

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.  
721.11460 and 721.11461 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.

* * * * *

------------------------------------------------------------------------
                    40 CFR citation                      OMB control No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11460.............................................         2070-0012
721.11461.............................................         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.  721.11460 and 721.11461 to read as follows:


Sec.  721.11460  1-Propanaminium, N-(carboxymethyl)-N,N-dimethyl-3-
[(3,5,5-trimethyl-1-oxohexyl)amino]-, inner salt.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-Propanaminium, N-
(carboxymethyl)-N,N-dimethyl-3-[(3,5,5-trimethyl-1-oxohexyl)amino]-, 
inner salt. (PMN P-18-391; CASRN 2169783-63-3) 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 for 
any use 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

[[Page 22875]]

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.  721.11461  2-Propenoic acid, 2-methyl-, (2-oxo-1,3-dioxolan-4-
yl)methyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 
2-methyl-, (2-oxo-1,3-dioxolan-4-yl)methyl ester (PMN P-20-13; CASRN 
13818-44-5) 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) and (o). It is a significant new use to 
manufacture or import greater than the confidential annual production 
volume identified 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) 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.

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.  725.1080 to read as follows:


Sec.  725.1080  Trichoderma reesei (generic).

    (a) Microorganism and significant new uses subject to reporting. 
(1) The genetically modified microorganism identified as Trichoderma 
reesei strain 3CH-3 (MCAN J-19-1) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2)(i) The significant new use is any manufacturing, processing, or 
use of the microorganism other than in a fermentation system that meets 
all of the following conditions:
    (A) Enzyme production occurs by submerged fermentation (i.e., for 
enzyme production, growth of the microorganism occurs beneath the 
surface of the liquid growth medium); and
    (B) Any further fermentation, such as saccharification (i.e., 
addition of Trichoderma reesei fermentation broth to solid plant 
material or insoluble substrate after the standard industrial 
fermentation is completed), is initiated only after the inactivation of 
the microorganism as delineated in Sec.  725.422(d).
    (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) of this chapter, are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 of this chapter apply to this section.

[FR Doc. 2021-08880 Filed 4-29-21; 8:45 am]
BILLING CODE 6560-50-P


