Modification of Significant New Uses of Certain Chemical Substances (20-2.M), 73439-73446 [2020-25032]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Proposed Rules]
[Pages 73439-73446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25032]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2020-0302; FRL-10013-54]
RIN 2070-AB27


Modification of Significant New Uses of Certain Chemical 
Substances (20-2.M)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend significant new use rules (SNURs) 
issued under the Toxic Substances Control Act (TSCA) for certain 
chemical substances, which were the subject of a premanufacture notice 
(PMN) and a significant new use notice (SNUN). EPA is proposing these 
amendments following review of SNUNs for the chemical substances and 
based on review of new and existing data. Specifically, this action 
proposes to 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.

DATES: Comments must be received on or before December 18, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2020-0302, using the Federal eRulemaking Portal 
at 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.
    Due to the public health concerns related to COVID-19, 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.

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: [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)) and 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/commenting-epa-dockets.

II. Background

A. What action is the Agency taking?

    EPA is proposing amendments to the SNURs for certain 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 (i.e., a SNUN) 
initiates EPA's evaluation of the intended use within the applicable 
review period. Manufacture and processing for the significant new use 
may not commence until EPA has conducted a review of the notice, made 
an appropriate determination on the notice, and taken 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 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.

[[Page 73440]]

C. How do the SNUR general provisions apply to this action?

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the final rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the rule to uses occurring before the effective date 
of the final rule. Provisions relating to user fees appear at 40 CFR 
part 700. According to 40 CFR 721.1(c), persons subject to these SNURs 
must comply with the same notice requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In 
particular, these requirements include the information submission 
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions 
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and 
the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must 
either determine that the significant new use is not likely to present 
an unreasonable risk of injury or take such regulatory action as is 
associated with an alternative determination before the manufacture or 
processing for the significant new use can commence. If EPA determines 
that the significant new use is not likely to present an unreasonable 
risk, EPA is required under TSCA section 5(g) to make public, and 
submit for publication in the Federal Register, a statement of EPA's 
findings.

III. Significant New Use Determination

    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 modify the significant new uses 
for the chemical substances that are the subject of these SNURs, and as 
described in the preamble to the proposed rule, 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 Proposed Significant New Use Rule Amendments 
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).
     Citation for the final SNUR. This is the citation to the 
final rule that established the SNUR that EPA is proposing to amend.
     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 5(e) order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated as such by the SNUR.
     CFR citation. This is the citation for the codified SNUR 
that EPA is proposing to amend.

PMN P-99-1202 and SNUN S-15-6

    Chemical name: Sulfonyl azide intermediate (generic).
    CAS number: Not Available.
    Citation for the final SNUR: December 17, 2003 (68 FR 70174) (FRL-
7307-3).
    Basis for the modified significant new use rule: P-99-1202 and S-
15-6 state that the generic (non-confidential) use of the substance is 
as a reactive additive for polymers. Based on submitted test data, EPA 
identified concerns for blood, kidney and lung toxicity from inhalation 
exposure to the PMN substance. Based on analogue data, EPA identified 
concerns for aquatic toxicity. The original SNUR was issued based on 
EPA's determination that the chemical substance met the concern 
criteria at 40 CFR 721.170(b)(3)(i) and (b)(4)(ii) and requires 
notification if the substance is released to water, manufactured 
domestically, or processed or used as a powder.
    On March 6, 2015, EPA received a SNUN (S-15-6) for the significant 
new use of importing the chemical substance as a powder. The applicable 
review period for the SNUN expired on June 18, 2015. Based on submitted 
test data, EPA identified concerns for blood, kidney and lung toxicity 
from inhalation exposure to the PMN substance. EPA did not find that 
import of the granular form of the SNUN substance would cause an 
unreasonable risk to human health because it contained particles that 
are greater than 200 microns and would not result in inhalation 
exposures. The proposed amendment to the SNUR would modify the 
significant new use notification requirement to require notification if 
the chemical substance as a powder contains greater than 1% of 
particles by weight less than 200 microns.
    This proposed amendment is based on 721.185, EPA's review of a 
significant new use notice. After reviewing the notice, EPA concluded 
that there is no need to require additional notice from persons who 
propose to engage in identical or similar activities.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the health and environmental effects 
of the chemical substance in support of 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 721.983.

PMN P-90-226; SNUNs P-96-1408, S-08-6, S-09-4, S-13-49, S-16-5, and S-
17-6.

    Chemical name: Titanate [Ti6O13 (2-)], dipotassium.
    CAS number: 12056-51-8.
    Citation for the final SNUR: November 13, 2015 (80 FR 70171) (FRL-
9935-43).
    Basis for the modified significant new use rule: The generic use of 
the chemical substance is as a friction material. An order for P-90-226 
was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) 
based on a finding that the chemical substance may present an 
unreasonable risk of injury to human health. Based on test data for the 
substance, EPA identified concerns for lung effects. The final SNUR 
issued on November 13, 2015 required notification for domestic 
manufacture, non-industrial use, manufacture other than by the methods 
described in premanufacture notice P-90-226 and significant new use 
notices P-96-1408, S-08-6, S-09-4, and S-13-49, and manufacture 
producing respirable, acicular fibers with an average aspect ratio of 
greater than 5. The average

[[Page 73441]]

aspect ratio is defined as the ratio of average length to average 
diameter.
    On June 22, 2016, EPA received S-16-5 for the generic (non-
confidential) use of abrasion resistant applications. The applicable 
review period expired on February 8, 2019. Based on test data for the 
substance, EPA identified concerns for lung effects. 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 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 section 5(e) order for S-16-5 
required that the substance be manufactured as described in the SNUN.
    On February 14, 2017, EPA received S-17-6 for the generic (non-
confidential) use of physical characteristics modifier for industrial 
use in certain solid composite articles. The applicable review period 
expired on June 14, 2018. Based on test data for the substance, EPA 
identified concerns for lung effects. 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 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 
section 5(e) order for S-17-6 required that the substance be 
manufactured as described in the SNUN including the resulting particle 
size distribution. The order also required respiratory protection for 
workers exposed by inhalation and included a new chemical exposure 
limit of 0.8 mg/m\3\.
    The proposed amendment to the SNUR would retain the existing 
significant new use notification requirements but would remove the 
manufacturing processes described in S-16-5 and S-17-6 from the scope 
of the significant new use. It would also add worker inhalation 
protection requirements for workers who are exposed by inhalation to S-
17-6, along with related recordkeeping requirements.
    This proposed amendment is based on 721.185, EPA's review of a 
significant new use notice. After reviewing the notice, EPA concluded 
that there is no need to require additional notice from persons who 
propose to engage in identical or similar activities.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the health effects of the chemical 
substances if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated as such by this 
proposed SNUR. The results of pulmonary effects testing would help 
characterize the potential health effects of the chemical substance.
    CFR citations: 40 CFR 721.9675.

PMN P-11-316

    Chemical name: Cyclohexane, oxidized, by-products from, distn. 
residues.
    CAS number: 1014979-92-0.
    Citation for the final SNUR: April 4, 2012 (77 FR 20296) (FRL-9333-
3).
    Basis for the modified significant new use rule: P-11-316 
identified the generic (non-confidential) uses for the substance as an 
industrial solvent in closed and open systems, and as an accelerant in 
permitted industrial explosives. The SNUR was issued based on EPA's 
determination that the chemical substance met the concern criteria at 
40 CFR 721.170(b)(4)(ii). Based on test data on analogous esters, EPA 
predicted toxicity to aquatic organisms may occur at concentrations 
that exceed 4 parts per billion (ppb) of the PMN substance in surface 
waters. The SNUR required notification for manufacturing, processing or 
use resulting in releases to surface waters that exceed 4 ppb.
    On July 22, 2017, the PMN submitter sent four acute ecotoxicity 
studies to address the environmental toxicity concerns identified for 
the SNUR. EPA evaluated the studies and determined that toxicity to 
aquatic organisms may occur at concentrations that exceed 470 ppb. 
Because there is still potential for water releases that exceed 470 
ppb, the proposed amendment to the SNUR would modify the significant 
new use notification requirement to require notification for 
manufacturing, processing, or use resulting in releases in surface 
waters that exceed 470 ppb.
    This proposed amendment is based on EPA's determination under 40 
CFR 721.185(a)(1) that the test data sent to EPA provide a reasonable 
basis for concluding that activities designated as significant new uses 
of the substance will not present an unreasonable risk of injury to 
human health or the environment.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the environmental effects of the 
chemical substance if a manufacturer or processor is considering 
submitting a SNUN. The results of chronic aquatic toxicity testing 
would help characterize the potential environmental effects of the 
chemical substance.
    CFR citation: 40 CFR 721.10288.

PMN P-98-1028; and SNUNs S-14-9, S-17-12, and S-17-15

    Chemical name: 1,2,4,5,7,8-hexoxonane, 3,6,9-triethyl-3,6,9-
trimethyl-.
    CAS number: 24748-23-0.
    Citation for the final SNUR: September 21, 2012 (77 FR 58666) (FRL-
9357-2).
    Basis for the modified significant new use rule: P-98-1028 states 
that the use of the chemical substance is as a viscosity modifier in 
the manufacture of polypropylene manufactured and supplied as a 
solution in at least 40 percent mineral spirits. The SNUR was issued 
based on EPA's determination that the chemical substance met the 
concern criteria at 40 CFR 721.170(b)(4)(ii). Based on test data on 
analogous peroxides, EPA predicted toxicity to aquatic organisms. The 
SNUR required notification for use of the chemical substance other than 
as a viscosity modifier in the manufacture of polypropylene 
manufactured and supplied as a solution in at least 40 percent mineral 
spirits.
    On March 21, 2014, EPA received S-14-9 for the generic (non-
confidential) use of a polymerization initiator. The applicable review 
period for the SNUN expired on June 18, 2014. Based on test data on 
analogous peroxides, EPA identified concerns for toxicity to aquatic 
organisms at a concentration as low as 1 ppb. Based on information 
contained in the SNUN, EPA did not find that use of the substance as a 
polymerization initiator would cause an unreasonable risk to human 
health or the environment.
    On March 22, 2017, EPA received S-17-12 for the generic (non-
confidential) use of a polymerization initiator. The applicable review 
period expired on March 18, 2019. Based on test data for the substance, 
EPA identified concerns for lung, liver, kidney, and blood effects, 
reproductive/developmental toxicity, dermal sensitization, and aquatic 
toxicity. 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 a determination that the chemical substance may present an 
unreasonable risk of injury to human health and the environment. The 
TSCA section 5(e) order for S-17-12 required dermal and respiratory 
protection for exposed workers, hazard communication requirements, no 
application method that generates a mist, vapor or aerosol, and no 
releases

[[Page 73442]]

to surface waters that exceed 56 ppb (a change from the assessment of 1 
ppb for S-14-9).
    On August 31, 2017, EPA received S-17-15 for the generic (non-
confidential) use of a polymerization initiator. The applicable review 
period expired on March 18, 2019. Based on test data for the substance, 
EPA identified concerns for lung, liver, kidney, and blood effects, 
reproductive/developmental toxicity, dermal sensitization, and aquatic 
toxicity. 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 a determination that the chemical substance may present an 
unreasonable risk of injury to human health and the environment. The 
TSCA section 5(e) order for S-17-15 required dermal and respiratory 
protection for exposed workers, hazard communication requirements, no 
application method that generates a mist, vapor or aerosol, and no 
releases to surface waters that exceed 56 ppb.
    The proposed amendment to the SNUR would remove use of the chemical 
substance other than as a viscosity modifier in the manufacture of 
polypropylene manufactured and supplied as a solution in at least 40 
percent mineral spirits from the scope of the significant new use. It 
would also add notification requirements for worker protection, hazard 
communication, releases to surface waters exceeding 56 ppb, and 
application methods that generate a mist, vapor, or aerosol based on 
the TSCA 5(e) orders issued for S-17-12 and S-17-15, along with related 
recordkeeping requirements.
    This proposed amendment is based on 721.185, EPA's review of a 
significant new use notice. After reviewing the notice, EPA concluded 
that there is no need to require additional notice from persons who 
propose to engage in identical or similar activities.
    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 as 
such by this proposed SNUR. The results of a toxicokinetics and chronic 
aquatic toxicity testing would help characterize the potential health 
and environmental effects of the chemical substance.
    CFR citation: 40 CFR 721.10432.

PMN P-15-326 and SNUN S-17-11

    Chemical name: Polyfluorohydrocarbon.
    CAS number: Not Available.
    Citation for the final SNUR: May 16, 2016 (81 FR 30452) (FRL-9944-
77).
    Basis for the modified significant new use rule: P-15-326 states 
that the generic (non-confidential) use of the chemical substance is as 
a specialty gas and transfer fluid. The SNUR was issued based on EPA's 
determination that the chemical substance met the concern criteria at 
Sec.  721.170(b)(3)(i) and (b)(3)(ii). Based on test data on the 
chemical substance and structure-activity relationship (SAR) analysis 
of test data on analogous substances, EPA identified concerns for 
neurotoxicity, developmental toxicity, and cardiac sensitization. The 
SNUR requires notification for any use of the substance other than the 
confidential uses listed in the PMN or any use in a consumer product.
    On January 19, 2017, EPA received SNUN S-17-11 for the significant 
new use generically described as a foam additive. The applicable review 
period for the SNUN expired on January 22, 2020. Based on submitted 
tests for the chemical substance, EPA identified concerns for 
neurotoxicity, systemic toxicity, and developmental toxicity. Based on 
the activities described in the SNUN, EPA determined under TSCA section 
5(a)(3)(C) that the significant new use is not likely to present an 
unreasonable risk.
    The proposed amendment to the SNUR would remove the confidential 
use described in S-17-11 from the scope of the significant new use. It 
would also designate as a significant new use any use other than the 
confidential uses described in P-15-326 and S-17-11.
    This proposed amendment is based on 721.185, EPA's review of a 
significant new use notice. After reviewing the notice, EPA concluded 
that there is no need to require additional notice from persons who 
propose to engage in identical or similar activities.
    Potentially Useful Information: Certain information may be 
potentially useful to characterize the health effects of the chemical 
substance if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated as such by this 
proposed SNUR. The results of specific target organ toxicity testing 
would help characterize the potential health effects of the chemical 
substance.
    CFR citation: 40 CFR 721.10907.

PMN P-15-607 and S-17-13

    Chemical name: 1,2,4,5,7,8-hexoxonane, 3,6,9-trimethyl-, 3,6,9-
tris(alkyl) derivs.
    CAS number: Not Available.
    Citation for the final SNUR: May 16, 2016 (81 FR 30542) (FRL-9944-
77).
    Basis for the modified significant new use rule: P-15-607 states 
that the generic (non-confidential) use of the chemical substance is as 
a polymerization initiator. The SNUR was issued based on EPA's 
determination that the chemical substance met the concern criteria at 
40 CFR 721.170(b)(4)(i) and (ii). Based on test data on the substance 
and on analogous peroxides, EPA predicted toxicity to aquatic organisms 
at concentrations in surface waters that exceed 55 ppb. The SNUR 
required notification for any use other than the confidential use 
specified in the PMN.
    On March 22, 2017, EPA received S-17-13 for the generic (non-
confidential) use of a polymerization initiator. The applicable review 
period expired on March 18, 2019. Based on test data for an analogous 
peroxide chemical, EPA identified concerns for lung, liver, kidney, and 
blood effects, reproductive/developmental toxicity, dermal 
sensitization, and aquatic toxicity. 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 a determination that the chemical 
substance may present an unreasonable risk of injury to human health 
and the environment. The TSCA section 5(e) order for S-17-13 required 
dermal and respiratory protection for exposed workers, hazard 
communication requirements, no application method that generates a 
mist, vapor or aerosol, and no releases to surface waters that exceed 
56 ppb.
    The proposed amendment to the SNUR would remove uses other than the 
confidential use described in P-15-607 from the scope of the 
significant new use. It would also add notification requirements for 
worker protection, hazard communication, releases to water exceeding 56 
ppb, and application methods that generate a mist, vapor, or aerosol 
based on the TSCA 5(e) order issued for S-17-13, along with related 
recordkeeping requirements.
    This proposed amendment is based on 721.185, EPA's review of a 
significant new use notice. After reviewing the notice, EPA concluded 
that there is no need to require additional notice from persons who 
propose to engage in identical or similar activities.

[[Page 73443]]

    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 as 
such by this proposed SNUR. The results of a toxicokinetics and chronic 
aquatic toxicity testing would help characterize the potential health 
and environmental effects of the chemical substance.
    CFR citation: 40 CFR 721.10922.

V. Rationale for the Proposed Rule

    In those instances where EPA expanded the scope of or added a 
significant new use, as discussed in Unit IV., the Agency identified 
concerns associated with certain uses. In those instances where EPA 
eliminated significant new uses, the Agency no longer identified 
concerns with those new uses. In addition to considering the factors 
discussed in Unit IV., EPA determined that those uses could result in 
changes in the type or form of exposure to the chemical substance, 
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.

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 SNURs addressed in 
this proposed rule, but which would be regulated as a ``significant new 
use'' if this proposed rule is finalized, are ongoing. These specific 
new uses are use without certain worker protection for the SNUR at 40 
CFR 721.9675, and processing or use involving an application method 
that generates a dust, vapor, mist, or aerosol, worker protection, 
hazard communication, and water release requirements for the SNURs at 
40 CFR 721.10432 and 10922. EPA designates November 18, 2020 as the 
cutoff date for determining whether the 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, then TSCA section 5(b)(1)(A) 
requires such information to be submitted to EPA at the time of 
submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known or reasonably ascertainable (40 CFR 720.50). 
Unit IV. lists potentially useful information for all SNURs addressed 
in this proposed 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 of a chemical 
substance in the event that someone submits a SNUN for a significant 
new use pursuant to the SNURs address in this proposed rule. Companies 
who are considering submitting a SNUN are encouraged, but are not 
required, to develop the potentially useful 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 dialogue 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 dialogue 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; and information on 
risks posed by the chemical substances compared to risks posed by 
potential substitutes.

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 under 40 CFR part 720, 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/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. The EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2020-0302.

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

[[Page 73444]]

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. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is not subject to Executive Order 13771 (82 FR 9339, 
February 3, 2017), because this action is not a significant regulatory 
action under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
under the PRA (44 U.S.C. 3501 et seq.). Burden is defined in 5 CFR 
1320.3(b). The information collection activities associated with new 
chemical SNURs have already been approved under OMB control number 
2070-0012 (EPA ICR No. 0574). This action does not impose any burden 
requiring additional OMB approval.
    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. 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.
    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. 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.

D. 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 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 this SNUR 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.

E. 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.).

F. 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).

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribe Governments

    This action does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action does not significantly nor uniquely affect the communities of 
Indian Tribal governments, nor 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 action.

H. 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. EPA interprets Executive Order 
13045 as applying only to those regulatory actions that concern 
environmental health or safety risks that EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order.

I. 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,

[[Page 73445]]

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.

J. National Technology Transfer and Advancement Act (NTTAA)

    This action does not involve any technical standards and is 
therefore not subject to considerations under NTTAA section 12(d) (15 
U.S.C. 272 note).

K. 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 Part 721

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

    Dated: November 3, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, 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.  721.983 by revising paragraphs (a)(1) and (2)(ii) to 
read as follows:


Sec.  721.983   Sulfonyl azide intermediate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
sulfonyl azide intermediate (PMN P-99-1202 and SNUN S-15-6) is subject 
to reporting under this section for the significant new use described 
in paragraph (a)(1) of this section.
    (2) * * *
    (i) * * *
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import, 
process, or use this chemical substance as a powder unless less than 1% 
of particles by weight are less than 200 microns.
* * * * *
0
3. Amend Sec.  721.9675 by revising paragraphs (a)(1), (2)(i) and (ii), 
and (b)(1) to read as follows:


Sec.  721.9675   Titanate [Ti6O13 (2-)], dipotassium.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as titanate [Ti6O13 
(2-)], dipotassium (PMN P-90-226; SNUNs P-96-1408, S-08-6, S-09-4, S-
13-49, S-16-5, and S-17-6; CAS No. 12056-51-8)) 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. For manufacturing, processing, and 
use of SN-17-6: Requirements as specified in Sec.  721.63(a)(4) through 
(6), and (c). 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. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 10. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include 
particulate including solid or liquid droplets.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) consent order for this substance. The NCEL is 0.8 mg/
m\3\ as an 8-hour time weighted average. Persons who wish to pursue 
NCELs as an alternative to Sec.  721.63 respirator requirements may 
request to do so under Sec.  721.30. Persons whose Sec.  721.30 
requests to use the NCELs approach that are approved by EPA, will be 
required to follow NCELs provisions comparable to those contained in 
the corresponding TSCA section 5(e) consent order.
    (B) [Reserved]
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (l). In addition, a significant new 
use of the substance is importation of the chemical substance if: (A) 
Manufactured by other than the method described in premanufacture 
notice P-90-226 and significant new use notices P-96-1408, S-08-6, S-
09-4, S-13-49, S-16-5, and S-17-6.
    (B) Manufactured producing respirable, acicular fibers with an 
average aspect ratio of greater than 5. The average aspect ratio is 
defined as the ratio of average length to average diameter. For 
manufacture of S-17-6: Manufacture with a particle size distribution 
containing greater than 30% of particles less than 10 microns.
    (b) * * *
    (1) Recordkeeping. The following recordkeeping requirements are 
applicable to manufacturers and processors of this substance as 
specified in Sec.  721.125 (a) through (d) and (i).
* * * * *
0
4. Amend Sec.  721.10288 by revising paragraphs (a)(1) and (2)(i) to 
read as follows:


Sec.  721.10288   Cyclohexane, oxidized, by-products from, distn. 
residues.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cyclohexane, 
oxidized, by-products from, distn. residues (PMN P-11-316; CAS No. 
1014979-92-0) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4) where N = 470 ppb.
* * * * *
0
5. Amend Sec.  721.10432 by revising paragraphs (a)(1), (2)(i) through 
(iv) and (b)(2) to read as follows:


Sec.  721.10432   1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-
trimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2,4,5,7,8-
hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl- (PMN P-98-1028 and SNUNs S-
14-9, S-17-12, and S-17-15; CAS No. 24748-23-0) 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) through (5) and (6)(v), and (b), and (c). 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. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 50. For purposes of 
Sec.  721.63(b) the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a)

[[Page 73446]]

through (f), and (g)(1)(iv) and (vi), (2)(v), (3), (4)(i) and (5). For 
purposes of Sec.  721.72(e), the concentration is set at 1.0%. For 
purposes of Sec.  721.72(g)(1), required human health hazard statements 
include allergic skin reaction. For purposes of Sec.  721.72(g)(2), 
required human health precautionary statements include where 
engineering controls are not determined to be adequate, use respiratory 
protection. For purposes of Sec.  721.72(g)(3), required environmental 
hazard statements include this substance may cause long lasting harmful 
effects to aquatic life. Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial commercial, and consumer activities. It is a 
significant new use to process or use the substance with an application 
method that generates a mist, vapor, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4) where N = 56 ppb.
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers and processors 
of this substance.
* * * * *
0
6. Amend Sec.  721.10907 by revising paragraphs (a)(1) and (2)(i) to 
read as follows:


Sec.  721.10907   Polyfluorohydrocarbon (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyfluorohydrocarbon (PMN P-15-326 and SNUN S-17-11) 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(o). It is a significant new use to use the 
substance other than for the confidential uses described in PMN P-15-
326 and SNUN S-17-11.
* * * * *
0
7. Amend Sec.  721.10922 by:
0
a. Revising paragraphs (a)(1) through (2)(ii);
0
b. Adding paragraphs (a)(2)(iii) and (iv);
0
c. Revising paragraph (b)(1); and
0
d. Removing paragraph (b)(3).
    The revisions and additions read as follows:


Sec.  721.10922   1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-
tris(alkyl) derivs. (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
1,2,4,5,7,8-hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs. 
(PMN P-15-607 and SNUN S-17-13) 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) through (5) and (6)(v), and (b) and (c). 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. For purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 50. For purposes of 
Sec.  721.63(b) the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1)(iv) and (vi), (2)(v), (3), (4)(i) and 
(5). For purposes of Sec.  721.72(e), the concentration is set at 1.0%. 
For purposes of Sec.  721.72(g)(1), required human health hazard 
statements include allergic skin reaction. For purposes of Sec.  
721.72(g)(2), required human health precautionary statements include 
where engineering controls are not determined to be adequate, use 
respiratory protection. For purposes of Sec.  721.72(g)(3), required 
environmental hazard statements include this substance may cause long 
lasting harmful effects to aquatic life. Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial commercial, and consumer activities. It is a 
significant new use to process or use the substance with an application 
method that generates a mist, vapor, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4) where N = 56 ppb.
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
* * * * *
[FR Doc. 2020-25032 Filed 11-17-20; 8:45 am]
BILLING CODE 6560-50-P