Modification of Significant New Uses of Certain Chemical Substances, 18173-18179 [2020-06441]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Proposed Rules]
[Pages 18173-18179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06441]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2019-0614; FRL-10004-51]
RIN 2070-AB27


Modification of Significant New Uses of Certain Chemical 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to amend the significant new use rules 
(SNURs) for chemical substances, which were the subject of a 
premanufacture notice (PMN) and a significant new use notice (SNUN). 
This action would amend the SNURs to allow certain new uses reported in 
the SNUNs without additional notification requirements and modify the 
significant new use notification requirements based on the actions and 
determinations for the SNUN submissions. EPA is proposing this 
amendment based on review of new and existing data for the chemical 
substances.

DATES: Comments must be received on or before May 1, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0614, 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, Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-8974; 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:
     Manufacturers or processors of the chemical substance 
(NAICS codes 325 and 324110), e.g., chemical manufacturing and 
petroleum refineries.
    This proposed rule may 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 and must certify that the shipment of the chemical 
substance complies with all applicable rules and orders under TSCA. 
Importers of chemicals subject to a SNUR must certify their compliance 
with the SNUR requirements. Any person who exports or intends to export 
the chemical substance that is the subject of a final rule are subject 
to the export notification provisions of TSCA section 12(b) (15 U.S.C. 
2611(b)) (40 CFR 721.20), and 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 this information 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 amendments to the SNURs for chemical substances in 
40 CFR part 721, subpart E. A SNUR for a chemical substance designates 
certain activities as a significant new use. Persons who intend to 
manufacture or process the chemical substance for the significant new 
use must notify EPA at least 90 days before commencing that activity. 
The required notification would initiate EPA's evaluation of the 
intended use within the applicable review period. Manufacture and 
processing for the significant new use would be unable to commence 
until EPA conducted a review of the notice, made an appropriate 
determination on the notice, and took such actions as are required with 
that determination.

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

[[Page 18174]]

this determination by rule after considering all relevant factors and 
may issue or modify a TSCA section 5(e) Order and/or amend the SNUR 
promulgated under TSCA section 5(a)(2). Procedures and criteria for 
modifying or revoking SNUR requirements appear at 40 CFR 721.185.

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 whether and how to amend the significant new uses 
for the chemical substances that are the subject of these SNURs EPA 
considered relevant information about the toxicity of the chemical 
substance, likely human exposures and environmental releases associated 
with possible uses, and the four TSCA section 5(a)(2) factors listed in 
this unit.

IV. Substances Subject to This Proposed Significant New Use Rule 
Amendment and Proposed Changes

    EPA is proposing to amend the significant new use and recordkeeping 
requirements for chemical substances in 40 CFR part 721, subpart E. In 
this unit, EPA provides the following information for each chemical 
substance:
     PMN number and SNUN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) number (if assigned for 
non-confidential chemical identities).
     Federal Register publication date and reference for the 
final SNUR previously issued.
     Basis for the Proposed Amendment.
     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 TSCA Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated by the SNUR.
     CFR citation assigned in the regulatory text section of 
this proposed rule.

PMN P-95-169; SNUN S-08-7; SNUN S-14-1; and SNUN S-17-10

    Chemical name: 2-Propen-1-one, 1-(4- morpholinyl)-.
    CAS number: 5117-12-4.
    Federal Register publication date and reference: Jan. 5, 2000 (65 
FR 354) (FRL-6055-2), amended May 13, 2011 (76 FR 27910) (FRL-8871-5), 
and amended June 30, 2015, (80 FR 37165) (FRL-9928-93).
    Basis for the modified significant new use rule: P-95-169 is used 
as a diluent for ultraviolet and electron beam curable resins for 
coatings, inks, and curable adhesives, S-14-1 is used as a monomer in 
ultraviolet ink jet applications and S-08-7 is used in energy 
production. The proposed SNUR modification of April 9, 2015, (80 FR 
19037) (FRL-9924-10) contains the basis of the current SNUR codified at 
40 CFR 721.5185.
    On June 12, 2017, EPA received a SNUN (S-17-10) involving the 
chemical substance for use as a monomer for use in stereolithography. 
The 90-day review period for the SNUN expired on February 6, 2018 and a 
TSCA section 5(e) Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a determination that 
the use may present an unreasonable risk of injury to human health and 
the environment. EPA identified concerns, based on acute toxicity, 
neurotoxicity, eye irritation, sensitization, liver toxicity, and 
aquatic toxicity test data for the chemical substance. In addition to 
the dermal protection, hazard communication, use, and water release 
notification requirements under the SNUR, the TSCA section 5(e) Order 
for S-17-10 required respirators to prevent inhalation exposure during 
the use of the chemical substance as a monomer in stereolithography. 
The proposed amendment would remove the use described in the SNUN from 
the scope of the significant new use, except where that use does not 
include the protective measures described in the TSCA section 5(e) 
Order for S-17-10.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the health and environmental effects 
of the chemical substance in support of a request to modify the TSCA 
section 5(e) Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. The results of specific organ toxicity and aquatic 
toxicity testing would help characterize the potential health and 
environmental effects of the chemical substance
    CFR citation: 40 CFR 721.5185.

PMN P-10-136 and SNUN S-18-5

    Chemical names: (P-10-136, Chemical A) Butanoic acid, 3-mercapto-, 
1,1'-[2,2-bis[(substituted-1- oxoalkoxy)methyl]-1,3-propanediyl] ester 
(generic) and (P-10-136, Chemical B) Butanoic acid, 3-mercapto-,1,1'-
[2- (hydroxymethyl)-2-(substituted-1- oxoalkoxy)methyl)-1,3-
propanediyl] ester (generic).
    CAS numbers: Not Available.
    Federal Register publication date and reference: Apr. 27, 2012, (77 
FR 25236) (FRL- 9343-4).
    Basis for the modified significant new use rule: P-10-136 states 
that the chemical substances will be used as a monomer for acryl-based 
ultra-violet (UV)-curing coatings, inks, and adhesives. A SNUR was 
issued based on meeting the concern criteria at 40 CFR 721.170(b)(3)(i) 
and (b)(4)(i). EPA identified concerns for systemic toxicity, mutagenic 
effects, dermal sensitization and neurotoxicity, based on test data on 
the PMN substances. The SNUR required notification for domestic 
manufacture; for use other than as a monomer for acryl-based ultra-
violet (UV)-curing coatings, inks, and adhesives; and for 
manufacturing, processing or use resulting in releases to surface 
waters exceeding 2 ppb.
    On August 16, 2018, EPA received S-18-5 for the generic (non-
confidential) use as a monomer for industrial adhesives, coatings and 
inks. The 90-day review period expired on September 25, 2019. Based on 
the activities described in the SNUN, EPA determined under TSCA section 
5(a)(3)(C) that the use is not likely to present an unreasonable risk. 
The modified SNUR would retain the existing notification requirements 
and remove the new use described in S-18-5 from the scope of the 
significant new use.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the health and environmental effects 
of the chemical substances if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. The results of specific target organ 
toxicity and aquatic toxicity testing would help characterize the 
potential health and environmental effects of the chemical substances.
    CFR citations: 40 CFR 721.10371 and 40 CFR 721.10372.

[[Page 18175]]

PMN P-12-44; SNUN S-18-4; and SNUN S-19-5

    Chemical name: Functionalized multi-walled carbon nanotubes 
(generic).
    CAS number: None.
    Federal Register publication date and reference: May 9, 2013, (78 
FR 27056) (FRL-9384-8).
    Basis for the modified significant new use rule: The generic (non-
confidential) use for P-12-44 is an additive for rubber and batteries. 
The SNUR was issued based on meeting the concern criteria at 40 CFR 
721.170(b)(3)(ii) and (b)(4)(ii). EPA identified concerns for lung 
effects to workers exposed to the PMN substance and for sublethal 
effects in fish at levels at 100 ppb. The SNUR required notification if 
the chemical substance was used other than for the confidential use 
described in the PMN, for manufacturing, processing or use as a powder, 
and for manufacturing, processing or use resulting in releases to 
surface waters.
    On May 14, 2018, EPA received a SNUN, S-18-4 for the chemical 
substance for use as a chemical additive in epoxy compounds for 
transportation, marine and industrial coatings, paints and manufactured 
goods. The 90-day review period for the SNUN expired on February 22, 
2019. Based on the activities described in the SNUN, an Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on determinations under sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i) 
of TSCA that the use may present an unreasonable risk of injury to 
human health, and the information available to the Agency is 
insufficient to permit a reasoned evaluation of the environmental 
effects. EPA identified concerns for lung effects, carcinogenicity, 
immunotoxicity, and thymus toxicity.
    Due to potential worker exposures, the TSCA Order for S-18-4 allows 
the use of the chemical substance as a chemical additive for use in 
epoxy compounds for transportation, marine and industrial coatings, 
paints and manufactured goods and requires personal protective 
equipment including respirators to prevent dermal and inhalation 
exposure. The TSCA Order also retains the same requirements as the SNUR 
for no water release, for no manufacturing, processing or use as a 
powder, and allowing the confidential use described in PMN P-12-44.
    On May 20, 2019 EPA received a SNUN, S-19-5 for the chemical 
substance from the same submitter as S-18-4 for use in conductive ink. 
The 90-day review period for the SNUN expired on August 9, 2019. Based 
on the activities described in the SNUN, including the requirements of 
the TSCA Order for S-18-4, EPA determined under TSCA section 5(a)(3)(C) 
that the use is not likely to present an unreasonable risk. EPA 
modified the TSCA Order for S-18-4 to allow the use described in the 
SNUN.
    The proposed amendment would (1) remove the new uses described in 
SNUN S-19-5 from the scope of the significant new use and (2) remove 
the new uses described in SNUN S-18-4 from the scope of the significant 
new use except where that use does not include the protective measures 
described in the TSCA Order for S-18-4.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the health and environmental effects 
of the chemical substance in support of a request to modify the TSCA 
section 5(e) Order, or if a manufacturer or processor is considering 
submitting a SNUN. The results of particle size information, specific 
organ toxicity, carcinogenicity, and acute and chronic aquatic toxicity 
testing would help characterize the potential health and environmental 
effects of the chemical substance.
    CFR citation: 40 CFR 721.10663.

PMN P-12-0292; PMN P-17-217; and SNUN S-19-4

    Chemical name: Coke (coal), secondary pitch; a carbon-containing 
residue from the coking of air blown pitch coke oil and/or pitch 
distillate; composed primarily of isotropic carbon, it contains small 
amounts of sulfur and ash constituents.
    CAS number: 94113-91-4.
    Federal Register publication date and reference: November 17, 2016 
(81 FR 81264) (FRL-9953-41).
    Basis for the modified significant new use rule: P-12-292 states 
the generic (non-confidential) use of the chemical substance is in the 
carbon graphite industry. The SNUR issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), was based on the chemical 
substance may present an unreasonable risk of injury to human health. 
EPA identified concerns for lung effects and cancer to workers exposed 
to the substance via inhalation based on SAR analysis of test data on 
analogous respirable, poorly soluble particulates, in the carbon black. 
The SNUR required notification for use without the personal protective 
equipment, including a NIOSH-certified respirator with an APF of at 
least 50 or compliance with a New Chemicals Exposure Limit (NCEL) of 
0.0025 mg/m\3\; use without establishment and use of a hazard 
communication program; domestic manufacture; use other than the 
confidential use specified in the TSCA Order; and exceeding an 
aggregate confidential production volume limit.
    On January 19, 2017, EPA received PMN P-17-217 for the same 
chemical substance for use as an additive to increase the porosity in 
the manufacture of diesel particulate filters. The 90-day review period 
for the PMN expired on July 4, 2017. Based on the activities described 
in the PMN, an Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a determination that the chemical 
substance may present an unreasonable risk of injury to human health. 
In addition to the restrictions identified for the SNUR, the TSCA Order 
for P-17-217 did not allow processing or use of the chemical substance 
involving an application method that generates a dust, vapor, mist, or 
aerosol; permitted use as an additive for diesel particulate filters 
manufacture to increase the porosity of the filter material for export 
only (i.e., no use of the additive formulation within the United 
States); and required certain testing before exceeding an aggregate 
production volume limit of 2,500,000 kilograms.
    On June 4, 2019, EPA received a SNUN, S-19-4 for use of the 
chemical substance as a lubricating agent in the production of 
automotive disc brakes. The 90-day review period for the SNUN expired 
on September 13, 2019. Based on the activities described in the SNUN, 
EPA determined under TSCA section 5(a)(3)(C) that the use is not likely 
to present an unreasonable risk.
    The modified SNUR proposes to designate as a ``significant new 
use'' processing or use of the chemical substance involving an 
application method that generates a dust, vapor, mist, or aerosol, 
exceeding an aggregate production volume of 2,500,000 kilograms, and to 
allow the uses described in P-17-217 and S-19-4. It would also be a 
significant new use to use the substance in an additive formulation to 
produce diesel particulate filters within the United States.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the health effects of the chemical 
substance in support of a request to modify the TSCA section 5(e) 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this 
proposed SNUR. The results of pulmonary

[[Page 18176]]

toxicity and carcinogenicity testing would help characterize the 
potential health effects of the chemical substance.
    CFR citation: 40 CFR 721.10928.

V. Rationale for the Proposed Rule

    In those instances where EPA expanded the scope of the significant 
new use, the Agency identified concerns, as discussed in Unit IV., 
associated with certain uses that are not current. EPA determined that 
those uses could result in changes in the type or form of exposure to 
the chemical substance and/or increased exposures to the chemical 
substance and/or changes in the reasonably anticipated manner and 
methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substance, in addition to considering the 
factors discussed in Unit IV.

VI. Applicability of the Proposed Rule to Uses Occurring Before 
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. EPA solicits comments on whether any of the uses that 
are not currently a significant new use under the current rule, but 
which would be regulated as a ``significant new use'' if this proposed 
rule is finalized are ongoing. These specific new uses are processing 
or use involving an application method that generates a dust, vapor, 
mist, or aerosol or exceeding an aggregate production volume of 
2,500,000 kilograms for the SNUR for 40 CFR 721.10928, worker 
protection requirements for the SNUR for 40 CFR 721.10663, and the 
additional worker protection requirements for inhalation exposure for 
the SNUR for 40 CFR 721.5185. EPA designates April 1, 2020 as the 
cutoff date for determining whether the new use is ongoing. EPA has 
decided that the intent of TSCA section 5(a)(1)(B) is best served by 
designating a use as a significant new use as of the date of public 
release of the proposed SNUR rather than as of the effective date of 
the final rule. If uses begun after public release were considered 
ongoing rather than new, it would be difficult for EPA to establish 
SNUR notice requirements, because a person could defeat the SNUR by 
initiating the proposed significant new use before the rule became 
effective, and then argue that the use was ongoing as of the effective 
date of the final rule.
    Thus, any persons who begin commercial manufacture or processing 
activities with the chemical substance that are not currently a 
significant new use under the current rule but which would be regulated 
as a ``significant new use'' if this proposed rule is finalized, must 
cease any such activity as of the effective date of the rule if and 
when finalized. To resume their activities, these persons would have to 
comply with all applicable SNUR notice requirements and wait until the 
notice review period, including all extensions, expires.

VII. Development and Submission of Information

    TSCA section 5 generally does not require developing any particular 
new information (e.g., generating test data) before submission of a 
SNUN. There is an exception: If a person is required to submit 
information for a chemical substance pursuant to a rule, order or 
consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA 
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information 
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known or reasonably ascertainable (40 CFR 720.50). 
Unit IV. lists potentially useful information for all SNURs in this 
rule. Descriptions of this information 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. Furthermore, pursuant to TSCA section 4(h), 
which pertains to reduction of testing on vertebrate animals, EPA 
encourages dialog 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 listed in Unit IV. may not be 
the only means of providing information to evaluate the chemical 
substance. 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.

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. 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 721.25 and 40 CFR 720.40. E-PMN software is 
available electronically at https://www.epa.gov/opptintr/newchems.

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. The EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0614.

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 modify SNURs for chemical substances that 
were the subject of a PMN and a SNUN. The Office of Management and 
Budget (OMB) has exempted these types of actions from review under 
Executive Order 12866, entitled Regulatory Planning and Review (58 FR 
51735, October 4, 1993).

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

[[Page 18177]]

of the CFR, after appearing in the Federal Register, are listed in 40 
CFR part 9, and included on the related collection instrument or form, 
if applicable. EPA is amending the table in 40 CFR part 9 to list the 
OMB approval number for the information collection requirements 
contained in this rule. This listing of the OMB control numbers and 
their subsequent codification in the CFR satisfies the display 
requirements of PRA and OMB's implementing regulations at 5 CFR part 
1320. This Information Collection Request (ICR) was previously subject 
to public notice and comment prior to OMB approval, and given the 
technical nature of the table, EPA finds that further notice and 
comment to amend it is unnecessary. As a result, EPA finds that there 
is ``good cause'' under section 553(b)(3)(B) of the Administrative 
Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without 
further notice and comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review 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.), 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. EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemicals, the Agency 
receives only a small number of notices per year. For example, the 
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 
and only a fraction of these were from small businesses. In addition, 
the Agency currently offers relief to qualifying small businesses by 
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee 
reduces the total reporting and recordkeeping of cost of submitting a 
SNUN to about $10,116 for qualifying small firms. Therefore, the 
potential economic impacts of complying with this 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 final rule. 
As such, EPA has determined that this proposed rule would 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 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, entitled 
``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribe 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 would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this proposed rule.

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

    This proposed rule 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 proposed rule 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

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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


[[Page 18178]]


    Dated: March 10, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be 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. Amend Sec.  721.5185 by revising paragraphs (a)(1), (2)(i), and 
(2)(iii) to read as follows:


Sec.  721.5185  2-Propen-1-one, 1-(4-morpholinyl)-.

    (a) * * * (1) The chemical substance identified as 2-propen-1-one, 
1-(4-morpholinyl)- (PMN P-95-169; SNUN S-08-7; SNUN S-14-1; and SNUN S-
17-10 CAS No. 5117-12-4) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this rule do not apply to quantities of the 
chemical substance after it has been completely reacted (cured) because 
2-propen-1-one, 1-(4-morpholinyl)- will no longer exist.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(2)(iv), (a)(3)(i), (a)(3)(ii), (a)(4), 
(a)(6)(v), (b) (concentration set at 1.0 percent), and (c). Safety 4/4H 
EVOH/PE laminate, Ansell Edmont Neoprene number 865, and Solvex Nitrile 
Rubber number 275 gloves have been tested in accordance with the 
American Society for Testing Materials (ASTM) F739 method and found by 
EPA to satisfy the TSCA consent orders and Sec.  721.63(a)(2)(i) 
requirements for dermal protection to 100 percent PMN substance. Gloves 
and other dermal protection may not be used for a time period longer 
than they are actually tested and must be replaced at the end of each 
work shift. For additional dermal protection materials, a company must 
submit all test data to the Agency and must receive written Agency 
approval for each type of material tested prior to use of that material 
as worker dermal protection. However, for the purposes of determining 
the imperviousness of gloves, up to 1 year after the commencement of 
commercial manufacture or import, the employer may use the method 
described in Sec.  721.63(a)(3)(ii), thereafter, they must use the 
method described in Sec.  721.63(a)(3)(i). For use as a monomer for 
stereolithography: Requirements as specified in Sec.  721.63(a)(4), 
when determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(4), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible, (a)(5)(respirators must provide a National 
Institute for Occupational Safety and Health assigned protection factor 
of at least 50), (a)(6)(v), and (c).
    (ii) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(y)(1). It is a significant new use to use 
the chemical substance for any use other than as a monomer for use in 
ultraviolet ink jet applications or stereolithography, unless the 
chemical substance is processed and used in an enclosed process.
* * * * *
0
3. Amend Sec.  721.10371 by revising paragraphs (a)(1) and (2)(i) to 
read as follows:


Sec.  721.10371  Butanoic acid, 3-mercapto-,1,1'-[2-(hydroxymethyl)-2-
(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (generic).

    (a) * * * (1) The chemical substance identified generically as 
butanoic acid, 3-mercapto-,1,1'-[2-(hydroxymethyl)-2-(substituted-1-
oxoalkoxy)methyl)-1,3-propanediyl] ester (PMN P-10-136 and S-18-5, 
Chemical A) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives or the confidential use described 
in the significant new use notice S-18-5.
* * * * *
0
4. Amend Sec.  721.10372 by revising paragraphs (a)(1) and (2)(i) to 
read as follows:


Sec.  721.10372  Butanoic acid, 3-mercapto-,1,1'-[2,2-bis[(substituted-
1-oxoalkoxy)methyl]-1,3-propanediyl] ester (generic).

    (a) * * * (1) The chemical substance identified generically as 
butanoic acid, 3-mercapto-,1,1'-[2,2-bis[(substituted-1-
oxoalkoxy)methyl]-1,3-propanediyl] ester (PMN P-10-136 and SNUN S-18-5, 
Chemical B) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives, or the confidential use described 
in the SNUN S-18-5.
* * * * *
0
5. Amend Sec.  721.10663 by revising paragraphs (a)(1), (2)(i) and (ii) 
and (b)(1) to read as follows:


Sec.  721.10663  Functionalized multi-walled carbon nanotubes 
(generic).

    (a) * * * (1) The chemical substance identified generically as 
functionalized multi-walled carbon nanotubes (PMN P-12-44; SNUN S-18-4; 
and SNUN S-19-5) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), (4), when determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible, (a)(5)(respirators 
must provide a National Institute for Occupational Safety and Health 
(NIOSH) assigned protection factor of at least 50, (a)(6)(particulate), 
(b)(concentration set at 1.0%), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(v)(1), (w)(1), and (x)(1) It is a 
significant new use to use the substance other than as a chemical 
additive for use in epoxy compounds for transportation, marine and 
industrial coatings, paints and manufactured goods, for the 
confidential use described in PMN P-12-44, or for the confidential use 
described in SNUN S-19-5.
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (f), (i), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
* * * * *
0
 6. Amend Sec.  721.10928 by revising paragraphs (a)(1) and (2)(iii) to 
read as follows:

[[Page 18179]]

Sec.  721.10928  Coke (coal), secondary pitch; a carbon-containing 
residue from the coking of air blown pitch coke oil and/or pitch 
distillate; composed primarily of isotropic carbon, it contains small 
amounts of sulfur and ash constituents.

    (a) * * * (1) The chemical substance identified as coke (coal), 
secondary pitch. Definition: A carbon-containing residue from the 
coking of air blown pitch coke oil and/or pitch distillate; composed 
primarily of isotropic carbon, it contains small amounts of sulfur and 
ash constituents (PMN P-12-292, PMN P-17-217, and SNUN S-19-4; CAS No. 
94113-91-4) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (p)(2,500,000 kg), and (y)(1)(2). It 
is a significant new use to use the substance other than (I) for the 
confidential use permitted by the TSCA Order for P-12-292, (II) as a 
lubricating agent used in the production of automotive disc brakes, or 
(III) to process as an additive for the manufacture of diesel 
particulate filters to increase the porosity of the filter. It is a 
significant new use to use the substance in an additive formulation to 
produce diesel particulate filters within the United States.
* * * * *
[FR Doc. 2020-06441 Filed 3-31-20; 8:45 am]
 BILLING CODE 6560-50-P