Significant New Use Rules on Certain Chemical Substances (20-3.B), 15406-15412 [2020-05005]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Proposed Rules]
[Pages 15406-15412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05005]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 721 and 725

[EPA-HQ-OPPT-2020-0094; FRL-10005-76]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (20-3.B)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances which are 
the subject of premanufacture notices (PMNs) and a microorganism that 
was the subject of a Microbial Commercial Activity Notice (MCAN). This 
action would require 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 proposed rule. This action 
would further require that persons not commence manufacture or 
processing for the significant new use until they have submitted a 
Significant New Use Notice, and EPA has conducted a review of the 
notice, made an appropriate determination on the notice under TSCA, and 
has taken any risk management actions as are required as a result of 
that determination.

DATES: Comments must be received on or before April 17, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0094, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

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 proposed 
rule. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:

[[Page 15407]]

     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 proposed SNURs 
would need to certify their compliance with the SNUR requirements 
should these proposed rules be finalized. 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 proposed rule on or after April 17, 2020 are 
subject to the export notification provisions of TSCA section 12(b) (15 
U.S.C. 2611(b)) must comply with the export notification requirements 
in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

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

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 
chemical substances which were the subjects of MCAN J-19-1 and PMNs P-
18-391 and P-20-13. These proposed SNURs would 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.
    The record for the proposed SNURs on these chemicals was 
established as docket ID number EPA-HQ-OPPT-2020-0094. That record 
includes information considered by the Agency in developing these 
proposed SNURs.

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. In the case of a determination other than not 
likely to present unreasonable risk, the applicable review period must 
also expire before manufacturing or processing for the new use may 
commence.

C. Applicability of General Provisions

    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 use is not likely to present 
an unreasonable risk of injury under the conditions of use for the 
chemical substance or take such regulatory action as is associated with 
an alternative determination before the manufacture or processing for 
the significant new use can commence. If EPA determines that the use is 
not likely to present an unreasonable risk, EPA is required under TSCA 
section 5(g) to make public, and submit for publication in the Federal 
Register, a statement of EPA's findings.

III. Significant New Use Determination

    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 conditions of use of 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 proposing to designate those reasonably foreseen 
conditions of use as significant new uses.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for two chemical substances in 40 CFR part 721, subpart E and one 
chemical substance that is a microorganism in MCAN J-19-1 in 40 CFR 
part 725. In this unit, EPA provides the following information for each 
chemical substance:
     PMN or 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. This is information 
identified by EPA that would help characterize the potential health 
and/or environmental effects of the chemical substance in support of a 
request by the PMN submitter to modify the Order, or if a manufacturer 
or processor is considering submitting a

[[Page 15408]]

SNUN for a significant new use designated by the SNUR.
     CFR citation assigned in the regulatory text section of 
these proposed rules.
    The regulatory text section of these proposed rules specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits and other uses designated in the 
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed 
SNURs are undergoing 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 proposing to designate 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.
    The substances subject to these proposed rules are as follows:

PMN Number: P-18-391

    Chemical name: 1-Propanaminium, N-(carboxymethyl)-N, N-dimethyl-3-
[(3,5, 5-trimethyl-1-oxohexyl), amino]- inner salt.
    CAS number: 2169783-63-3.
    Basis for action: The PMN states that the use of the substance will 
be in liquid laundry detergent. Based on the physical/chemical 
properties of the PMN substance, test data on the PMN substance and SAR 
analysis of test data on analogous substances, EPA has identified 
concerns for lung effects (lung surfactancy), systemic (maternal) and 
developmental effects, and irritation to skin and eyes if the chemical 
substance is used in ways other than as intended by the PMN submitter. 
Other conditions of use of the PMN substance that EPA intends to assess 
before they occur include the following:
     It is a significant new use to manufacture, process, or 
use the substance for any use that results in inhalation exposures.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of specific target organ toxicity would help characterize the potential 
health effects of the PMN substance.
    CFR citation: 40 CFR 721. 11460.

PMN Number: P-20-13

    Chemical name: 2-Propenoic acid, 2-methyl-, (2-oxo-1,3-dioxolan-4-
yl)methyl ester.
    CAS number: 13818-44-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be in UV curable inks. Based on 
the physical/chemical properties of the PMN substance and SAR analysis 
of test data on analogous substances, EPA has identified concerns for 
respiratory sensitization, eye irritation, systemic toxicity, 
neurotoxicity, reproductive and developmental toxicity, immunotoxicity, 
liver and kidney effects if the chemical substance is used in ways 
other than as intended by the PMN submitter. Other conditions of use of 
the PMN substance that EPA intends to assess before they occur include 
the following:
     Annual manufacture (including import) volume greater than 
the confidential amount identified in the PMN;
     Use other than the confidential use described in the PMN; 
and
     Use in a consumer product.
    The proposed SNUR would designate as a ``significant new use'' 
these conditions of use.
    Potentially useful information: EPA has determined that certain 
information may be potentially useful to characterize the health 
effects of the PMN substance if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of respiratory sensitization, specific target organ toxicity, 
neurotoxicity, and reproductive toxicity (developmental effects) 
testing would help characterize the potential health effects of the PMN 
substance.
    CFR citation: 40 CFR 721. 11461.

MCAN Number: J-19-1

    Chemical name: Trichoderma reesei strain 3CH-3.
    CAS number: Not available.
    Basis for action: The MCAN states that the use of the substance 
will be to induce the production of biomass-degrading cellulases used 
for the manufacture of sugars or sugar-derived substances. EPA 
determined that certain fermentation conditions, other than the typical 
submerged standard industrial fermentation process for enzyme 
production, could result in increased exposures. Specifically, EPA is 
concerned that where growth on plant material or on solid substrates 
occurs, T. reesei has been shown to produce a secondary metabolite 
known as paracelsin, which is associated with a variety of toxic 
effects to mammalian and bacterial cells. The intended conditions of 
use of the MCAN microorganism described in the MCAN include the 
following protective measures:
     No manufacture, 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);
    (B) Any fermentation of solid plant material or insoluble 
substrate, to which Trichoderma reesei fermentation broth is added 
after the standard industrial fermentation is completed, is initiated 
only after the inactivation of the microorganism as delineated in 40 
CFR 725.422(d).
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that the results 
of the following studies would help characterize any potential human 
health and environmental effects of the MCAN substance if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR:
     Investigation of whether paracelsin will be produced, and 
at what levels if the genetically-modified T. reesei is grown on 
various plant biomass materials for different durations under various 
fermentation conditions in cellulosic biomass facilities.
     If paracelsin is produced, a study of whether paracelsin 
would be denatured/inactivated during production and processing.
     If paracelsin is released from the facility, a study of 
whether paracelsin would be degraded/inactivated during wastewater 
treatment.
     If released to the environment, studies on the 
persistence, stability, dissemination, accumulation, and the potential 
resulting biological activity of paracelsin with exposure to aquatic 
and

[[Page 15409]]

terrestrial organisms in the environment.
     Studies to determine the ability of the MCAN microorganism 
to survive in the environment relative to the survival of the 
unmodified parent or recipient strain, and to assess its 
competitiveness with other fungi in the environment. This study may 
require some supplementation with one or more carbon sources and the 
use of various soil types.
     A study to determine survival of the fungus during an 
anaerobic fermentation for production of ethanol by an ethanologen, and 
survival of the fungus during ethanol distillation or at the 
distillation temperature for ethanol.
    CFR citation: 40 CFR 725.1080.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject of these proposed SNURs and as further discussed 
in Unit IV, 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 proposing to designate 
these conditions of use as significant new uses to ensure that they are 
no longer reasonably foreseen to occur without first going through a 
separate, subsequent EPA review and determination process associated 
with a SNUN.

B. Objectives

    EPA is proposing 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.
     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 proposed 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.

VI. Applicability of the Proposed 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 proposed rule 
were undergoing premanufacture review at the time of signature of this 
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 proposed SNURs, EPA concludes 
that the proposed significant new uses are not ongoing.
    EPA designates March 4, 2020 as the cutoff date for determining 
whether the new use is ongoing. The objective of EPA's approach is to 
ensure that a person cannot defeat a SNUR by initiating a significant 
new use before the effective date of the final rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified on or after 
that date would have to cease any such activity upon the effective date 
of the final rule. To resume their activities, these persons would have 
to first comply with all applicable SNUR notification requirements and 
EPA would have to take action under TSCA section 5 allowing manufacture 
or processing to proceed. In developing this proposed rule, EPA has 
recognized that, given EPA's general practice of posting proposed rules 
on its website a week or more in advance of Federal Register 
publication, this objective could be thwarted even before Federal 
Register publication of the proposed rule.

VII. 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 40 
CFR 720.50 and 725.155). However, upon review of PMNs and SNUNs, the 
Agency has the authority to require appropriate testing. Unit IV. lists 
potentially useful information for all SNURs listed here. Descriptions 
are provided for informational purposes. The potentially useful 
information identified in Unit IV. 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. 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

[[Page 15410]]

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.

VIII. 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 or 
725.160. 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.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2020-0094.

X. 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 proposed rule would establish 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 Order 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 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.
    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 RFA, 5 U.S.C. 601 et seq., the 
Agency hereby certifies that promulgation of this proposed SNUR would 
not have a significant adverse economic impact on a substantial number 
of small entities. The requirement to submit a SNUN applies to any 
person (including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, it appears that no small or large entities presently 
engage in such activities. A SNUR requires that any person who intends 
to engage in such activity in the future must first notify EPA by 
submitting a SNUN. Although some small entities may decide to pursue a 
significant new use in the future, EPA cannot presently determine how 
many, if any, there may be. However, EPA's experience to date is that, 
in response to the promulgation of SNURs covering over 1,000 chemicals, 
the Agency receives only a small number of notices per year. For 
example, the number of SNUNs received was seven in Federal fiscal year 
(FY) 2013, 13 in FY2014, six in FY2015, 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 
proposed SNUR are not expected to be significant or adversely impact a 
substantial number of small entities. In a SNUR that published in the 
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that final SNURs are not expected 
to have a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

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 proposed 
rule. As such, EPA has determined that this proposed rule 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. 1531-1538 et seq.).

E. Executive Order 13132: Federalism

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

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

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor does it involve or impose 
any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175

[[Page 15411]]

(65 FR 67249, November 9, 2000), do not apply to this proposed rule.

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

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

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

List of Subjects in 40 CFR Parts 721 and 725

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

    Dated: February 28, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 is amended as 
follows:

PART 721--[AMENDED]

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

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

0
2. Add Sec. Sec.  721.11459 through 721.11461 to subpart E to read as 
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
721.11459 [Reserved]
721.11460 1-Propanaminium, N-(carboxymethyl)-N, N-dimethyl-3-[(3,5, 
5-trimethyl-1-oxohexyl), amino]- inner salt.
721.11461 2-Propenoic acid, 2-methyl-, (2-oxo-1,3-dioxolan-4-
yl)methyl ester.

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *


Sec.  721.11459  [Reserved]


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; CAS No. 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 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; CAS No. 
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--[AMENDED]

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

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

0
4. Add Sec.  725.1080 to subpart M to read as follows:

Subpart M--Significant New Uses for Specific Microorganisms

* * * * *


Sec.  725.1080  Trichoderma reesei (generic).

Subpart M--Significant New Uses for Specific Microorganisms

* * * * *


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);
    (B) any fermentation of solid plant material or insoluble substrate 
to which Trichoderma reesei fermentation broth is added after the 
standard industrial fermentation is completed is initiated only after 
the inactivation of the microorganism as delineated in 40 CFR 
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

[[Page 15412]]

Sec.  721.125(a) though (c) and (i) are applicable to manufacturers and 
processors of this microorganism.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2020-05005 Filed 3-17-20; 8:45 am]
BILLING CODE 6560-50-P