Significant New Use Rules on Certain Chemical Substances, 50838-50849 [2018-21871]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 83, Number 196 (Wednesday, October 10, 2018)]
[Rules and Regulations]
[Pages 50838-50849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21871]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0649; FRL-9984-65]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 28 chemical substances 
which were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to Orders issued by EPA pursuant to section 5(e) 
of TSCA. This action requires persons who intend to manufacture 
(defined by statute to include import) or process any of these 28 
chemical substances for an activity that is designated as a significant 
new use by this rule to notify EPA at least 90 days before commencing 
that activity. The required notification initiates EPA's evaluation of 
the intended use within the applicable review period. Persons may not 
commence manufacture or processing for the significant new use until 
EPA has conducted a review of the notice, made an appropriate 
determination on the notice, and has taken such actions as are required 
with that determination.

DATES: This rule is effective on December 10, 2018. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
October 24, 2018.
    Written adverse comments on one or more of these SNURs must be 
received on or before November 9, 2018 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments, 
on one or more of these SNURs before November 9, 2018, EPA will 
withdraw the relevant sections of this direct final rule before its 
effective date.
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0649, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-9232; email address: 
[email protected].
    For general information contact: The TSCA--Hotline, ABVI-Goodwill, 
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected]

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification

[[Page 50839]]

requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 
127.28. Chemical importers must certify that the shipment of the 
chemical substance complies with all applicable rules and orders under 
TSCA. Importers of chemicals subject to these SNURs must certify their 
compliance with the SNUR requirements. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after November 9, 2018 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)) (see Sec.  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 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?

    1. Direct Final Rule. EPA is promulgating these SNURs using direct 
final rule procedures. These SNURs will require persons to notify EPA 
at least 90 days before commencing the manufacture or processing of a 
chemical substance for any activity designated by these SNURs as a 
significant new use. Receipt of such notices obligates EPA to assess 
risks that may be associated with the significant new uses under the 
conditions of use and, if appropriate, to regulate the proposed uses 
before they occur.
    2. Proposed Rule. In addition to this Direct Final Rule, elsewhere 
in this issue of the Federal Register, EPA is issuing a Notice of 
Proposed Rulemaking for this rule. If EPA receives no adverse comment, 
the Agency will not take further action on the proposed rule and the 
direct final rule will become effective as provided in this action. If 
EPA receives adverse comment on one or more of SNURs in this action by 
October 25, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the 
Agency will publish in the Federal Register a timely withdrawal of the 
specific SNURs that the adverse comments pertain to, informing the 
public that the actions will not take effect. EPA would then address 
all adverse public comments in a response to comments document in a 
subsequent final rule, based on the proposed rule.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in 
Unit V., the general SNUR provisions are found at 40 CFR part 721, 
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 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

    Section 5(a)(2) of TSCA 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 addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 28 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 28 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     Information identified by EPA that would help characterize 
the potential

[[Page 50840]]

health and/or environmental effects of the chemical substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated by the SNUR.
    This information may include testing required in a TSCA section 
5(e) Order to be conducted by the PMN submitter, as well as testing not 
required to be conducted but which would also help characterize the 
potential health and/or environmental effects of the PMN substance. Any 
recommendation for information identified by EPA was made based on 
EPA's consideration of available screening-level data, if any, as well 
as other available information on appropriate testing for the chemical 
substance. Further, any such testing identified by EPA that includes 
testing on vertebrates was made after consideration of available 
toxicity information, computational toxicology and bioinformatics, and 
high-throughput screening methods and their prediction models. EPA also 
recognizes that whether testing/further information is needed will 
depend on the specific exposure and use scenario in the SNUN. EPA 
encourages all SNUN submitters to contact EPA to discuss any potential 
future testing. See Unit VIII. for more information.
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of these rules specifies the activities 
designated as significant new uses. Certain new uses, including 
exceedance of production volume limits (i.e., limits on manufacture 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    These rules include 28 PMN substances that are subject to Orders 
under TSCA section 5(e)(1)(A). Each Order is based on one or more of 
the findings in TSCA section 5(a)(3)(B): there is insufficient 
information to permit a reasoned evaluation; in the absence of 
sufficient information to permit a reasoned evaluation, the activities 
associated with the PMN substances may present unreasonable risk to 
human health or the environment; the substance is or will be produced 
in substantial quantities, and enters or may reasonably be anticipated 
to enter the environment in substantial quantities or there is or may 
be significant (substantial) human exposure to the substance. Those 
Orders require protective measures to limit exposures or otherwise 
mitigate the potential unreasonable risk. The SNURs identify as 
significant new uses any manufacturing, processing, use, distribution 
in commerce, or disposal that does not conform to the restrictions 
imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) Order required, among other things, 
that potentially exposed employees wear specified respirators unless 
actual measurements of the workplace air show that air-borne 
concentrations of the PMN substance are below a New Chemical Exposure 
Limit (NCEL) that is established by EPA to provide adequate protection 
to human health. In addition to the actual NCEL concentration, the 
comprehensive NCELs provisions in TSCA section 5(e) Orders, which are 
modeled after Occupational Safety and Health Administration (OSHA) 
Permissible Exposure Limits (PELs) provisions, include requirements 
addressing performance criteria for sampling and analytical methods, 
periodic monitoring, respiratory protection, and recordkeeping. 
However, no comparable NCEL provisions currently exist in 40 CFR part 
721, subpart B, for SNURs. Therefore, for these cases, the individual 
SNURs in 40 CFR part 721, subpart E, will state that persons subject to 
the SNUR who wish to pursue NCELs as an alternative to the Sec.  721.63 
respirator requirements may request to do so under Sec.  721.30. EPA 
expects that persons whose Sec.  721.30 requests to use the NCELs 
approach for SNURs that are approved by EPA will be required to comply 
with NCELs provisions that are comparable to those contained in the 
corresponding TSCA section 5(e) Order for the same chemical substance.
    PMN Numbers: P-15-442, P-15-443, P-15-444, P-15-445, P-15-446, P-
15-447, P-15-525, P-15-526, P-15-527, and P-15-528.
    Chemical names: Rare earth doped zirconium oxide (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: January 25, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as catalysts. EPA 
identified concern for lung toxicity and oncogenicity based on analogy 
to respirable poorly soluble particulates and the crystalline structure 
of the substances. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substances may present an unreasonable risk of injury to human health 
and the environment. The order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substances will be produced in substantial quantities and that the 
substances either enter or may reasonably be anticipated to enter the 
environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substances. To 
protect against these risks, the Order requires:
    1. Submit to EPA certain toxicity testing for both P-15-443 and P-
15-445 within the 18 and 60-month time limits specified on the Order.
    2. Use of a National Institute of Occupational Safety and Health 
(NIOSH)-certified respirator with an assigned protection factor (APF) 
of at least 1,000 where there is a potential for inhalation exposure or 
compliance with a NCEL of 0.07 mg/m\3\ as an 8-hour time-weighted 
average to prevent inhalation exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the safety data sheet (SDS).
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substances may be 
potentially useful to characterize the effects of the PMN substances in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. The 
submitter has agreed not to exceed the time limits in the Order without 
performing specific pulmonary toxicity testing and carcinogenicity 
testing on PMN substances P-15-443 and P-15-445.
    CFR citation: 40 CFR 721.11173.
    PMN Numbers: P-16-194, P-16-195, P-16-196, P-16-197, P-16-198, P-
16-199, P-16-460, P-16-461, P-16-462, P-16-463, and P-16-464.
    Chemical names: Silane-treated aluminosilicate (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) Order: January 22, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substances will be as process aids. Based 
on analysis of test data on the PMN substances, EPA identified human 
health concerns for cancer and non-cancer chronic toxicity effects 
associated with the metal

[[Page 50841]]

impurities found in the PMN substances. Environmental effects were 
identified for the metal constituents in the PMN substances. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substances may present an 
unreasonable risk of injury to human health and the environment. To 
protect against these risks, the Order requires:
    1. Submit to EPA metals content analysis of the material used to 
manufacture the PMN substances.
    2. Provide personal protective equipment to its workers to prevent 
dermal exposure where there is potential for dermal exposure.
    3. Use of a NIOSH-certified respirator with an APF of at least 50 
where there is a potential for inhalation exposures.
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    5. Not manufacture or process the PMN substances other than at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    6. Not use the PMN substances other than as described in the PMN.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substances may be 
potentially useful to characterize the effects of the PMN substances in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. The 
submitter has agreed not to exceed the time limits in the Order without 
sampling and analyzing the immediate precursor used to manufacture the 
PMN substances via EPA Method 6010B for the following elements: 
arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, lead, 
manganese, mercury, nickel, selenium, silver, vanadium, and zinc.
    CFR citations: 40 CFR 721.11174.
    PMN Number: P-16-307
    Chemical Name: Heteropolycycliccarboxylic acid, 1,3-dihydro-
disubstituted-, polymer with 1,1'-methylenebis, reaction products with 
silica (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: January 5, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be an open, non-dispersive 
use. Based on physical/chemical properties of the PMN substance and 
structure activity relationship (SAR) analysis of test data on 
analogous poorly, soluble respirable particles and isocyanates, EPA 
identified concerns for lung effects and dermal and respiratory 
sensitization. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health. To protect against these risks, the Order requires:
    1. Manufacture of the PMN substance to contain no more than 0.1% 
residual of free isocyanate by weight;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. No manufacturing, processing, or use of the PMN substance in any 
manner that generates a vapor, dust, mist, or aerosol;
    4. Refraining from manufacture, processing or use for consumer use 
or in commercial use where there is use in a consumer setting;
    5. Manufacture, process, or use the PMN substance only in liquid 
formulation; and
    6. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. EPA has also 
determined that the results of acute toxicity testing and specific 
target organ toxicity testing would help characterize the potential 
human effects of the PMN substance. Although the Order does not require 
these tests, the Order's restrictions remain in effect until the Order 
is modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citation: 40 CFR 721.11175.
    PMN Number: P-17-176
    Chemical name: Carbonic acid, alkyl carbomonocyclic ester 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: February 21, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substance will be as a battery 
ingredient. Based on toxicology data from an analogue, EPA has 
identified possible human health concerns for developmental toxicity 
and effects on the ovaries, adrenals and liver. The Order was issued 
under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health. To protect against these risk, the Order 
requires:
    1. Submit to EPA certain toxicity testing within 3 years of the 
notice of commencement of manufacturing (including import) of the PMN 
substance;
    2. Use of personal protective equipment to its workers to prevent 
dermal exposure where there is a potential for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    4. Refraining from domestic manufacture in the United States (i.e., 
import only); and
    5. No release of the PMN substance into waters of the United States 
exceeding 45 parts per billion.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this SNUR. 
The submitter has agreed not to manufacture the PMN substance without 
performing specific reproductive/developmental toxicity testing 3 years 
from the notice of commencement. EPA has also determined that the 
results of specific chronic aquatic toxicity testing would help 
characterize the potential environmental effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11176.
    PMN Number: P-17-183.

[[Page 50842]]

    Chemical name: 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer 
with 2-(chloromethyl)oxirane, reaction products with polyethylene-
polypropylene glycol 2-aminopropyl Me ether.
    CAS number: 1627528-04-4.
    Effective date of TSCA section 5(e) Order: February 28, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the substance will be as a pigment wetting 
and dispersing additive. Based on the surfactant potential of the PMN 
compound, EPA has identified concerns for lung effects to workers if 
respirable particulates or droplets are inhaled. The Order was issued 
under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding 
that the available information is insufficient to permit a reasoned 
evaluation of the human health effects of the PMN substance. To protect 
against these risks, the Order requires:
    1. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    2. Refraining from domestic manufacture in the United States (i.e., 
import only);
    3. No manufacturing, processing, or using the PMN substance in any 
manner that results in inhalation exposure to vapors, mists, aerosols 
or dusts;
    4. No use of the PMN substance other than the confidential uses 
allowed by the Order; and
    5. No use of the PMN substance in consumer products.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. EPA has 
determined that the results of specific physical-chemical properties 
and acute and chronic pulmonary toxicity testing would help 
characterize the potential health effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11177.
    PMN Number: P-17-232.
    Chemical name: Copolyamide of an aromatic dicarboxylic acid and a 
mixture of diamines (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: March 5, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance is as an engineering 
thermoplastic. Based on SAR analysis on structurally similar poorly 
soluble particles, EPA identified concerns for lung effects to workers 
if respirable particles are present. The Order was issued under TSCA 
section 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health. To protect against these risk, the Order requires:
    Manufacture the PMN substance with a particle size of greater than 
10 microns.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. EPA has also 
determined that the results of pulmonary toxicity testing would help 
characterize the potential human effects of the PMN substance. Although 
the Order does not require this testing, the Order's restrictions 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or relevant information.
    CFR citation: 40 CFR 721.11178.
    PMN Number: P-17-257.
    Chemical name: Single-walled carbon nanotubes.
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: January 17, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an additive in 
composite materials for mechanical, thermal, and conductivity 
improvements. Based on analysis of analogous carbon nanotubes, EPA 
identified concerns for pulmonary toxicity. Based on analogous carbon 
nanotubes, EPA also identified potential toxicity to aquatic organisms 
if the PMN substance is released to water. The order was issued under 
TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the PMN substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
    1. Submit to EPA certain toxicity testing before manufacturing 
(including import) by the times specified in the Order.
    2. Provide personal protective equipment to its workers to prevent 
dermal exposure where there is a potential for dermal exposure.
    3. Provide NIOSH certified respirators with an APF of at least 50 
to its workers to prevent inhalation exposure.
    4. No use of the PMN substance in application methods that generate 
a dust, vapor, mist or aerosol.
    5. Use the PMN substance for industrial uses only.
    6. Use the PMN substance only for the confidential uses allowed in 
the Order.
    7. No release of the PMN substance to water.
    8. Disposal of the PMN substance only via landfill or incineration.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this SNUR. 
The submitter has agreed not to manufacture the PMN substance without 
performing specific physical property and pulmonary toxicity testing. 
EPA has also determined that the results of specific chronic aquatic 
toxicity testing would help characterize the potential environmental 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citation: 40 CFR 721.11179.
    PMN Number: P-17-283.
    Chemical name: Arenesulfonic acid, alkyl derivatives, metal salts 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: February 6, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a lubricating oil 
additive for automotive engine oils. Based on

[[Page 50843]]

analysis of test data on the PMN substance, EPA identified concern for 
corrosion to skin, eyes, mucous membranes, and lungs. There is also 
concern for surfactant effects on the lung based on surfactant 
properties of the compounds. There is also concern for acute toxicity, 
mutagenicity, irritation, and sensitization based on submitted analogue 
test data. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation, the substance 
may present an unreasonable risk of injury to human health and the 
environment. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance is or will be produced in substantial quantities and that the 
substance wither enters or may reasonably be anticipated to enter the 
environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the Order requires:
    1. Submit to EPA certain toxicity testing within six months of 
filing a notice of commencement (NOC) to EPA;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    4. Refrain from manufacturing, processing, or using the PMN 
substance in any manner that produces vapor, mist, spray or aerosol.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this SNUR. The 
submitter has agreed not to manufacture the PMN substance without 
performing sensitization testing. EPA has also determined that the 
results of specific physical-chemical properties and acute and chronic 
pulmonary toxicity testing would help characterize the potential health 
effects of the PMN substance. Although the Order does not require these 
tests, the Order's restrictions remain in effect until the Order is 
modified or revoked by EPA based on submission of this or relevant 
information.
    CFR citation: 40 CFR 721.11180.
    PMN Number: P-17-353.
    Chemical name: Heteromonocycle, 2-[(bicarbomonocycle-2-
substituted)alkyl]- (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: February 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an additive in resin 
manufacture. Based on information on analogous substances, EPA has 
identified concerns for irritation to the eye, lung, and mucous 
membranes, skin and lung sensitization, oncogenicity, developmental 
toxicity, male reproductive toxicity, liver toxicity, and kidney 
toxicity. Ecotoxicity hazard concerns were high based on EcoSAR 
analysis of analogous chemical. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the PMN substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Use of the PMN substance only for the confidential use allowed 
in the Order;
    3. No processing and use of the PMN substance using methods that 
may generate a spray, mist or aerosol.
    4. Use of personal protective equipment where there is a potential 
for dermal exposure.
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    6. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this SNUR. 
EPA has also determined that the results of specific acute and chronic 
aquatic toxicity testing, skin sensitization testing, carcinogenicity 
testing, and specific target organ testing would help characterize the 
potential human effects of the PMN substance. Although the Order does 
not require these tests, the Order's restrictions remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or relevant information.
    CFR citation: 40 CFR 721.11181.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for all 28 chemical 
substances, regulation was warranted under TSCA section 5(e), pending 
the development of information sufficient to make reasoned evaluations 
of the health or environmental effects of the chemical substances. The 
basis for such findings is outlined in Unit IV. Based on these 
findings, TSCA section 5(e) Orders requiring the use of appropriate 
exposure controls were negotiated with the PMN submitters.
    The SNURs identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying Orders, 
consistent with TSCA section 5(f)(4).

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA will be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     EPA will identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, use, or 
disposal that does not conform to the restrictions imposed by the 
underlying Orders, consistent with TSCA section 5(f)(4).

[[Page 50844]]

    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule. The effective 
date of this rule is December 10, 2018without further notice, unless 
EPA receives written adverse comments before November 9, 2018.
    If EPA receives written adverse comments on one or more of these 
SNURs before November 9, 2018, EPA will withdraw the relevant sections 
of this direct final rule before its effective date.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse comments must identify the chemical 
substance and the new use to which it applies. EPA will not withdraw a 
SNUR for a chemical substance not identified in the comment.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received an 
NOC and the chemical substance has not been added to the TSCA 
Inventory, no person may commence such activities without first 
submitting a PMN. Therefore, for chemical substances for which an NOC 
has not been submitted EPA concludes that the designated significant 
new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) Orders have been issued 
for all of the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) Orders from undertaking activities 
which will be designated as significant new uses. The identities of 26 
of the 28 chemical substances subject to this rule have been claimed as 
confidential and EPA has received no post-PMN bona fide submissions 
(per Sec. Sec.  720.25 and 721.11) for a chemical substance covered by 
this action. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this rule are ongoing.
    Therefore, EPA designates October 10, 2018 as the cutoff date for 
determining whether the new use is ongoing. The objective of EPA's 
approach has been to ensure that a person could not defeat a SNUR by 
initiating a significant new use before the effective date of the 
direct final rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of that 
date will have to cease any such activity upon the effective date of 
the final rule. To resume their activities, these persons will have to 
first comply with all applicable SNUR notification requirements and 
wait until EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and has taken such actions as 
are required with that determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: Development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. Unit IV. lists potentially useful information for 
all of the listed SNURs. Descriptions of the information are provided 
for informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. Furthermore, pursuant to TSCA section 4(h), which 
pertains to reduction of testing in vertebrate animals, EPA encourages 
consultation with the Agency on the use of alternative test methods and 
strategies (also called New Approach Methodologies, or NAMs), if 
available, to generate the recommended test data. EPA encourages dialog 
with Agency representatives to help determine how best the submitter 
can meet both the data needs and the objective of TSCA section 4(h).
    In certain of the TSCA section 5(e) Orders for the chemical 
substances regulated under this rule, EPA has established production 
volume or time limits in view of the lack of data on the potential 
health and environmental risks that may be posed by the significant new 
uses or increased exposure to the chemical substances. These limits 
cannot be exceeded unless the PMN submitter first submits the results 
of toxicity tests that would permit a reasoned evaluation of the 
potential risks posed by these chemical substances. Listings of the 
information required in the TSCA section 5(e) Orders are included in 
Unit IV. The SNURs contain the same production volume limits as the 
TSCA section 5(e) Orders. Exceeding these production limits is defined 
as a significant new use. Persons who intend to exceed the production 
limit must notify the Agency by submitting a SNUN at least 90 days in 
advance of commencement of non-exempt commercial manufacture or 
processing.
    Any request by EPA for the triggered and pended testing described 
in the Orders was made based on EPA's consideration of available 
screening-level data, if any, as well as other available information on 
appropriate testing for the PMN substances. Further, any such testing 
request on the part of EPA that includes testing on vertebrates was 
made after consideration of available toxicity information, 
computational toxicology and bioinformatics, and high-throughput 
screening methods and their prediction models.
    Potentially useful information identified in Unit IV. may not be 
the only means of addressing the potential risks of the chemical 
substance. However, submitting a SNUN without any test data may 
increase the likelihood that EPA will take action under TSCA section 
5(e), particularly if satisfactory test results have not been obtained 
from a prior PMN or SNUN submitter. 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.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

[[Page 50845]]

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at Sec.  
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in Sec.  
721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 
electronically at https://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2018-0649.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances 
that were the subject of PMNs, or TSCA section 5(e) Orders. 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 PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this action. 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, 
Collection Strategies Division, Office of Environmental Information 
(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)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300. A copy of that certification is 
available in the docket for this action.
    This action is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not have a 
significant economic impact on a substantial number of small entities.

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

[[Page 50846]]

believe that any State, local, or Tribal government will be impacted by 
this action. As such, EPA has determined that this action does not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect on small governments subject to the requirements of 
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action will 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

    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 does 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.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (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

    This action is not subject to Executive Order 13211, entitled 
``Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use'' (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

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: October 1, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.

0
2. In Sec.  9.1, add the following sections in numerical order under 
the undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:


Sec.  9.1   OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11173...............................................       2070-0012
721.11174...............................................       2070-0012
721.11175...............................................       2070-0012
721.11176...............................................       2070-0012
721.11177...............................................       2070-0012
721.11178...............................................       2070-0012
721.11179...............................................       2070-0012
721.11180...............................................       2070-0012
721.11181...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  721.11173 to subpart E to read as follows:


Sec.  721.11173   Rare earth doped zirconium oxide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as rare 
earth doped zirconium oxide (P-15-442, P-15-443, P-15-444, P-15-445, P-
15-446, P-15-447, P-15-525, P-15-526, P-15-527, and P-15-528) are 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. 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 (NIOSH) assigned 
protection factor of at least 1000), (a)(6) (particulate), (b) 
(concentration set at 1.0%), and (c).

[[Page 50847]]

    (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) Order for this substance. The NCEL is 0.07 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 are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), (iii), (iv)(use respiratory protection or maintain 
workplace airborne concentrations at or below an 8-hour time-weighted 
average of 0.07 mg/m\3\), and (g)(5). 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. Requirements 
as specified in Sec.  721.80(p) (18 months).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) through (i) are applicable to 
manufacturers and processors of the substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.11174 to subpart E to read as follows:


Sec.  721.11174  Silane-treated aluminosilicate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
silane-treated aluminosilicate (PMNs P-16-194, P-16-195, P-16-196, P-
16-197, P-16-198, P-16-199, P-16-460, P-16-461, P-16-462, P-16-463, and 
P-16-464) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substances after they have been completely incorporated into a polymer 
matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. 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 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) (particulate), (b) (concentration set at 0.1%), 
and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(ii), 
(iii), (iv), (v), (vi), (vii), (viii), (ix), (g)(2)(i), (ii), (iii), 
(iv), (v), and (g)(5). 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. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the substances without sampling and analyzing the immediate 
precursor used to manufacture the substances according to the terms 
specified in the 5(e) Order for the following elements: Arsenic, 
barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, 
mercury, nickel, selenium, silver, vanadium, and zinc. It is a 
significant new use to manufacture the substances at facilities other 
than those equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency. It is a 
significant new use to process the substances other than in an enclosed 
system that does not allow for the release of particulates or at 
facilities equipped with pollution controls, such as a bag house, that 
remove particulates from the air at 99% or greater efficiency.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d), (f), (g), (h), and (i) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
6. Add Sec.  721.11175 to subpart E to read as follows:


Sec.  721.11175  Heteropolycycliccarboxylic acid, 1,3-dihydro-
disubstituted-, polymer with 1,1'-methylenebis, reaction products with 
silica (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
heteropolycycliccarboxylic acid, 1,3-dihydro-disubstituted-, polymer 
with 1,1'-methylenebis, reaction products with silica (P-16-307) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), (a)(6) (particulate), 
(when determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1), 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 
exposures, where feasible), (b) (concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (g)(2)(i), (ii), (iii), (v), and (g)(5). 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. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture, process, or use the substance for consumer use or for 
commercial uses that could introduce the substance into a consumer 
setting. It is a significant new use to manufacture, process, or use 
the substance other than in a liquid formulation. It is a significant 
new use to manufacture the PMN substance to contain more than 0.1% 
residual isocyanate by weight. It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in generation of a vapor, dust, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) are applicable to manufacturers, importers, and 
processors of this substance.

[[Page 50848]]

    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  721.11176 to subpart E to read as follows:


Sec.  721.11176   Carbonic acid, alkyl carbomonocyclic ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carbonic acid, alkyl carbomonocyclic ester (PMN P-17-176) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2), (a)(2)(i), (iv), (a)(3), (a)(6) (particulate), 
(a)(6)(v), (vi), (when determining which persons are reasonable likely 
to be exposed as required for Sec.  721.63(a)(1), 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 
exposures, where feasible), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(iv), (v), 
(vi), (ix), (g)(2)(i), (v), (g)(3)(i), (ii), (g)(4) (do not release to 
water above 45 parts per billion), and (g)(5). 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. Requirements 
as specified in Sec.  721.80(f) and (p)(3 years).
    (iv) Release to water. Release to water requirements as specified 
in Sec.  721.90(a)(4), (b)(4), and (c)(4) where N = 45 ppb.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i), (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  721.11177 to subpart E to read as follows:


Sec.  721.11177   1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-, polymer 
with 2-(chloromethyl)oxirane, reaction products with polyethylene-
polypropylene glycol 2-aminopropyl Me ether.

    (a) Chemical substance and significant new used subject to 
reporting. (1) The chemical substance identified as 1,3-propanediol, 2-
ethyl-2-(hydroxymethyl)-, polymer with 2-(chloromethyl)oxirane, 
reaction products with polyethylene-polypropylene glycol 2-aminopropyl 
Me ether (PMN P-17-183, CAS No 1627528-04-4) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), (o). It is a significant new use 
to process or use the substance in any manner way that results in 
generation of a vapor, dust, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (f) through (i) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  721.11178 to subpart E to read as follows:


Sec.  721.11178  Copolyamide of an aromatic dicarboxylic acid and a 
mixture of diamines (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
copolyamide of an aromatic dicarboxylic acid and a mixture of diamines 
(PMN P-17-232) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture the substance with a particle size less than 10 microns.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c) and (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  721.11179 to subpart E to read as follows:


Sec.  721.11179  Single-walled carbon nanotubes.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as single-walled 
carbon nanotubes (PMN P-17-257) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section do not apply to 
quantities of the substances that have been:
    (i) Embedded or incorporated into a polymer matrix that itself has 
been reacted (cured);
    (ii) Embedded in a permanent solid polymer form that is not 
intended to undergo further processing, except mechanical processing; 
or
    (iii) Incorporated into an article as defined at 40 CFR 720.3(c).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (when determining which 
persons are reasonable likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measure (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) (particulate), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), (p) (6 months), (y)(1), and 
(y)(2). (It is a significant new use to process or use the substance 
for non-industrial use except for the confidential non-industrial use 
described in the 5(e) Order).

[[Page 50849]]

    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), (c)(2).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (j), and (k) are applicable to manufacturers 
and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.

0
11. Add Sec.  721.11180 to subpart E to read as follows:


Sec.  721.11180  Arenesulfonic acid, alkyl derivatives, metal salts 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
arenesulfonic acid, alkyl derivatives, metal salts (PMN P-17-283) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (a)(3), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g. enclosure or confinement of 
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), (b) 
(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(skin 
sensitization), (eye irritation), (lung effects), (skin corrosion), 
(g)(2)(i), (iii), (v), and (g)(5). 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. Requirements 
as specified in Sec.  721.80(p) (6 months). It is a significant new use 
to manufacture, process or use the substance in any manner way that 
results in generation of a vapor, mist, spray, or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provision of Sec.  721.185 apply to this section.

0
12. Add Sec.  721.11181 to subpart E to read as follows:


Sec.  721.11181  Heteromonocycle, 2-[(bicarbomonocycle-2-
substituted)alkyl]- (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteromonocycle, 2-[(bicarbomonocycle-2-substituted)alkyl]- (PMN P-17-
353) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section. The requirements of 
this section do not apply to quantities of the substance after they 
have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (ii), (iii), (iv), (a)(3), (when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), 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), (b) (concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1), 
(g)(1)(iv), (vi), (vii), (ix), (mutagenicity), (eye, skin, lung, and 
mucous membrane irritation), (skin and lung sensitization), (g)(2)(i), 
(ii), (iii), (v), (avoid workplace airborne concentrations), (g)(3)(i), 
(ii), (g)(4)(iii), and (g)(5). 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: Requirements 
as specified in Sec.  721.80(f) and (k). It is a significant new use to 
process or use the substance in any manner that generates a vapor, 
spray, mist, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.
[FR Doc. 2018-21871 Filed 10-9-18; 8:45 am]
 BILLING CODE 6560-50-P