[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Proposed Rules]
[Pages 53663-53670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21718]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0529; FRL-10000-60]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-6.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for seven chemical substances which
are the subject of premanufacture notices (PMNs). This action would
require persons to notify EPA at least 90 days before commencing
manufacture (defined by statute to include import) or processing of any
of these seven chemical substances for an activity that is designated
as a significant new use by this proposed rule. This action would
further require that persons not commence manufacture or processing for
the significant new use until they have submitted a Significant New Use
Notice, and EPA has conducted a review of the notice, made an
appropriate determination on the notice under TSCA and has taken any
risk management actions as are required as a result of that
determination.
DATES: Comments must be received on or before November 7, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0529, by one of the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-9232; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these proposed SNURs
would need to certify their compliance with the SNUR requirements
should these proposed rules be finalized. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20, any persons who export or intend
to export a chemical substance that is the subject of this proposed
rule on or after November 7, 2019 are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and
must comply with the export notification requirements in 40 CFR part
707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
[[Page 53664]]
II. Background
A. What action is the agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances which were the subjects of PMNs P-17-109, P-17-234,
P-17-400, P-18-92, P-18-105, P-18-295, and P-19-113. These proposed
SNURs would require persons who intend to manufacture or process any of
these chemical substances for an activity that is designated as a
significant new use to notify EPA at least 90 days before commencing
that activity.
The record for the proposed SNURs on these chemicals was
established as docket EPA-HQ-OPPT-2019-0529. That record includes
information considered by the Agency in developing these proposed
SNURs.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III. In the case of a determination other than not
likely to present unreasonable risk, the applicable review period must
also expire before manufacturing or processing for the new use may
commence. 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. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA must either determine that the use is not
likely to present an unreasonable risk of injury under the conditions
of use for the chemical substance or take such regulatory action as is
associated with an alternative determination before the manufacture or
processing for the significant new use can commence. If EPA determines
that the use is not likely to present an unreasonable risk, EPA is
required under TSCA section 5(g) to make public, and submit for
publication in the Federal Register, a statement of EPA's findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the conditions of use of the substances, in the context
of the four bulleted TSCA section 5(a)(2) factors listed in this unit.
During its review of these chemicals, EPA identified certain conditions
of use that are not intended by the submitters, but reasonably foreseen
to occur. EPA is proposing to designate those reasonably foreseen
conditions of use as significant new uses.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for seven 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 SNUR.
Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
This information may include testing not required to be conducted
but which would 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 VII. for more information.
CFR citation assigned in the regulatory text section of
these proposed rules.
The regulatory text section of these proposed rules specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
The chemical substances that are the subject of these proposed
SNURs are undergoing premanufacture review. In addition to those
conditions of use intended by the submitter, EPA has identified certain
other reasonably foreseen conditions of use. EPA has preliminarily
determined that the chemicals under their intended conditions of use
are not likely to present an unreasonable risk. However, EPA has not
assessed risks associated with the reasonably foreseen conditions of
use for these chemicals. EPA is proposing to designate these reasonably
foreseen and other potential conditions of use as significant new uses.
As a result, those conditions of use are no longer reasonably foreseen
to occur without first going through a separate, subsequent EPA review
and determination process associated with a SNUN.
The substances subject to these proposed rules are as follows:
[[Page 53665]]
PMN Number: P-17-109
Chemical name: Alkyldiamine, aminoalkyl dimethylaminoalkyl
dimethyl- (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will
be as an intermediate for a polyurethane catalyst and as a polyurethane
catalyst. Based on the physical/chemical properties of the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for acute
toxicity, irritation and corrosion to the eye, skin, respiratory tract
and mucous membranes, neurotoxicity, blood effects, systemic effects,
developmental effects, genotoxicity, and aquatic toxicity if the
chemical substance is used in ways other than as intended by the PMN
submitter. Other conditions of use of the PMN substance that EPA
intends to assess before they occur include the following:
1. Manufacture, processing or use of the PMN substance in a manner
that results in inhalation exposure.
2. Release of a manufacturing, processing, or use stream associated
with any use of the PMN substance into the waters of the United States
exceeding a surface water concentration of 660 ppb.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of acute toxicity, skin corrosion, eye damage, reproductive/
developmental toxicity, specific target organ toxicity, genetic
toxicity, and environmental toxicity testing would help characterize
the potential health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.11412.
PMN Number: P-17-234
Chemical name: Oxirane, 2-(chloromethyl)-, polymer with 2-
methyloxirane polymer with oxirane bis(2-aminopropyl) ether.
CAS number: 78390-60-0.
Basis for action: The PMN states that the use of the substance will
be as an adhesive intermediate. Based on the physical/chemical
properties of the PMN substance and Structure Activity Relationships
(SAR) analysis of test data on analogous substances, EPA has identified
concerns for sensitization, carcinogenicity, reproductive effects, lung
effects (surfactancy), and toxicity to aquatic organisms at surface
water concentrations exceeding 27 ppb, if the chemical substance is
used in ways other than as intended by the PMN submitter. Other
conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
1. Use of the PMN substance other than as a chemical intermediate.
2. Release of a manufacturing, processing, or use stream associated
with any use of the PMN substance into the waters of the United States
exceeding a surface water concentration of 27 ppb.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of skin sensitization, respiratory sensitization,
carcinogenicity, reproductive toxicity, specific target organ toxicity,
and aquatic toxicity testing would help characterize the potential
health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.11413.
PMN Number: P-17-400
Chemical name: Terpolymer of vinylidene fluoride,
tetrafluoroethylene and 2,3,3,3-tetrafluoropropene (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be in rubber products. Based on
the physical/chemical properties of the PMN substance and Structure
Activity Relationships (SAR) analysis of test data on analogous
substances, EPA has identified concerns for lung overload if the
chemical substance is used in ways other than as intended by the PMN
submitter. Other conditions of use of the PMN substance that EPA
intends to assess before they occur include the following:
1. Use of the PMN substance other than as described in the PMN; and
2. Manufacture, processing or use of the PMN substance in a manner
that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of pulmonary effects
testing would help characterize the potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.11414.
PMN Number: P-18-92
Chemical name: Phosphonium, tributylmethyl-, iodide (1:1).
CAS number: 1702-42-7.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst used in the
manufacture of monoethylene glycol. Based on the physical/chemical
properties of the PMN substance and Structure Activity Relationships
(SAR) analysis of test data on analogous substances, EPA has identified
concerns for liver effects and neurotoxicity if the chemical substance
is used in ways other than as intended by the PMN submitter. Other
conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
1. Manufacture, processing or use of the PMN substance in a manner
that results in inhalation exposure.
2. Release of a manufacturing, processing, or use stream associated
with any use of the PMN substance into the waters of the United States
exceeding a surface water concentration of 56 ppb.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of skin corrosion, eye damage, respiratory sensitization,
skin sensitization, pulmonary effects, developmental effects and
specific target organ toxicity
[[Page 53666]]
testing would help characterize the potential health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.11415.
PMN Number: P-18-105
Chemical name: Phosphorous acid, triisotridecyl ester.
CAS number: 77745-66-5.
Basis for action: The PMN states that the use of the substance will
be in rigid and flexible polyvinyl chloride (PVC) processing as a
booster of stabilizers. In addition, EPA has reviewed other known
conditions of use of the substance as a coatings additive. Based on the
physical/chemical properties of the PMN substance, available data for
the PMN substance, and Structure Activity Relationships (SAR) analysis
of test data on analogous substances, EPA has identified concerns for
irritation, sensitization, and systemic and reproductive effects if the
chemical substance is used in ways other than as intended by the PMN
submitter. Other conditions of use of the PMN substance that EPA
intends to assess before they occur include the following:
1. Use of the PMN substance other than as a booster of PVC
stabilizers or as a coatings additive.
2. Use of the PMN substance without a National Institute for
Occupational Safety and Health (NIOSH) certified respirator with an
assigned protection factor of at least 50 where there is a potential
for inhalation exposure, or at least 1000 where spray applied.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of skin irritation/
corrosion, eye damage, and skin sensitization testing would help
characterize the potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11416.
PMN Number: P-18-295.
Chemical name: 1,3-Butanediol, (3R)-.
CAS number: 6290-03-5.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient in the
manufacture of consumer cleaning products and as a monomer in the
manufacture of plastics products. Based on the physical/chemical
properties of the PMN substance and Structure Activity Relationships
(SAR) analysis of test data on analogous substances, EPA has identified
concerns for neurological, reproductive, and developmental effects if
the chemical substance is used in ways other than as intended by the
PMN submitter. Other conditions of use of the PMN substance that EPA
intends to assess before they occur include the following:
1. Use of the PMN substance for other than as a chemical
intermediate or other than as an ingredient in cleaning products; and
2. Manufacture within the United States (i.e., import only).
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that would be designated by this
proposed SNUR. EPA has determined that the results of neurotoxicity,
specific organ toxicity, developmental and reproductive toxicity
testing would help characterize the potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.11417.
PMN Number: P-19-113
Chemical name: Metal oxide-chloro (generic).
CAS number: Not available
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a flow cell additive.
Based on the physical/chemical properties of the PMN substance and
Structure Activity Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for acute toxicity,
systemic toxicity, reproductive toxicity, developmental toxicity,
neurotoxicity, immunotoxicity (asthma), lung cancer, irritation/
corrosion, serious eye damage, and toxicity to aquatic organisms at
surface water concentrations exceeding 13 ppb, if the chemical
substance is used in ways other than as intended by the PMN submitter.
Other conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
1. Use of the PMN substance other than as described in the PMN.
2. Manufacturing, processing, or use of the substance that results
in inhalation exposures.
3. Release of a manufacturing, processing, or use stream associated
with any use of the PMN substance into the waters of the United States
exceeding a surface water concentration of 13 ppb.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of skin irritation/corrosion, eye damage, acute toxicity,
specific target organ toxicity, pulmonary effects, reproductive/
developmental toxicity, neurotoxicity, carcinogenicity, and aquatic
toxicity testing would help characterize the potential health and
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.11419.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit IV., EPA identified certain other reasonably foreseen
conditions of use, in addition to those conditions of use intended by
the submitter. EPA has preliminarily determined that the chemical under
the intended conditions of use is not likely to present an unreasonable
risk. However, EPA has not assessed risks associated with the
reasonably foreseen conditions of use. EPA is proposing to designate
these conditions of use as significant new uses to ensure that they are
no longer reasonably foreseen to occur without first going through a
separate, subsequent EPA review and determination process associated
with a SNUN.
B. Objectives
EPA is proposing these SNURs because the Agency wants:
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under
[[Page 53667]]
TSCA section 5(a)(3)(C) that the significant new use is not likely to
present an unreasonable risk, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
by the Administrator under the conditions of use, or make a
determination under TSCA section 5(a)(3)(A) or (B) and take the
required regulatory action associated with the determination, before
manufacture or processing for the significant new use of the chemical
substance can occur.
To be able to complete its review and determination on
each of the PMN substances, while deferring analysis on the significant
new uses proposed in these rules unless and until the Agency receives a
SNUN.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Inventory.
Guidance on how to determine if a chemical substance is on the TSCA
Inventory is available on the internet at https://www.epa.gov/tsca-inventory.
VI. Applicability of the Proposed Rules to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
were undergoing premanufacture review at the time of signature of this
proposed rule and were not on the TSCA Inventory. In cases where EPA
has not received a notice of commencement (NOC) and the chemical
substance has not been added to the TSCA Inventory, no person may
commence such activities without first submitting a PMN. Therefore, for
the chemical substances subject to these proposed SNURs, EPA concludes
that the proposed significant new uses are not ongoing.
EPA designates October 2, 2019 (date of web posting) as the cutoff
date for determining whether the new use is ongoing. The objective of
EPA's approach is to ensure that a person cannot defeat a SNUR by
initiating a significant new use before the effective date of the final
rule.
Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified on or after
that date would have to cease any such activity upon the effective date
of the final rule. To resume their activities, these persons would have
to first comply with all applicable SNUR notification requirements and
EPA would have to take action under section 5 allowing manufacture or
processing to proceed. In developing this proposed rule, EPA has
recognized that, given EPA's general practice of posting proposed rules
on its website a week or more in advance of Federal Register
publication, this objective could be thwarted even before Federal
Register publication of the proposed rule.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known to or reasonably ascertainable by them (see 40
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit IV. lists potentially
useful information for all SNURs listed here. Descriptions are provided
for informational purposes. The potentially useful information
identified in Unit IV. will be useful to EPA's evaluation in the event
that someone submits a SNUN for the significant new use. Companies who
are considering submitting a SNUN are encouraged, but not required, to
develop the information on the substance, which may assist with EPA's
analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA sections 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0263.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This proposed rule would establish SNURs for seven new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
[[Page 53668]]
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this proposed SNUR would
not have a significant adverse economic impact on a substantial number
of small entities. The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was seven in Federal fiscal year
(FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and
11 in FY2018, only a fraction of these were from small businesses. In
addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this proposed
rule. As such, EPA has determined that this proposed rule does not
impose any enforceable duty, contain any unfunded mandate, or otherwise
have any effect on small governments subject to the requirements of
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1531-1538 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor does it involve or impose
any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175 (65 FR 67249, November 9, 2000),
do not apply to this proposed rule.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to
this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 30, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 is amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
[[Page 53669]]
0
2. Add Sec. Sec. 721.11412 through 721.11419 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
Sec. 721.11412 Alkyldiamine, aminoalkyl dimethylaminoalkyl
dimethyl- (generic).
Sec. 721.11413 Oxirane, 2-(chloromethyl)-, polymer with 2-
methyloxirane polymer with oxirane bis(2-aminopropyl) ether.
Sec. 721.11414 Terpolymer of vinylidene fluoride,
tetrafluoroethylene and 2,3,3,3-tetrafluoropropene (generic).
Sec. 721.11415 Phosphonium, tributylmethyl-, iodide (1:1)
Sec. 721.11416 Phosphorous acid, triisotridecyl ester.
Sec. 721.11417 1,3-Butanediol, (3R)-.
Sec. 721.11418 [Reserved].
Sec. 721.11419 Metal oxide-chloro (generic).
* * * * *
Sec. 721.11412 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkyldiamine,
aminoalkyl dimethylaminoalkyl dimethyl- (PMN P-17-109) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, processing or use of the PMN
substance in a manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 660.
(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), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11413 Oxirane, 2-(chloromethyl)-, polymer with 2-
methyloxirane polymer with oxirane bis(2-aminopropyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-
(chloromethyl)-, polymer with 2-methyloxirane polymer with oxirane
bis(2-aminopropyl) ether (PMN P-17-234, CAS No. 78390-60-0) 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(g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 27.
(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), (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11414 Terpolymer of vinylidene fluoride, tetrafluoroethylene
and 2,3,3,3-tetrafluoropropene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
terpolymer of vinylidene fluoride, tetrafluoroethylene and 2,3,3,3-
tetrafluoropropene (PMN P-17-400) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j). It is a significant new use to
manufacture, processing or use of the PMN substance in a manner that
results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11415 Phosphonium, tributylmethyl-, iodide (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonium,
tributylmethyl-, iodide (1:1) (PMN P-18-92, CAS No. 1702-42-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, processing or use of the PMN
substance in a manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 56.
(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), (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11416 Phosphorous acid, triisotridecyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphorous acid,
triisotridecyl ester (PMN P-18-105, CAS No. 77745-66-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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, (5)(respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor of at least 50, or at least 1,000 if spray applied,
(a)(6)(particulate), (b)(concentration set at 1.0%), and (c).
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the chemical substance for other than as a
booster of polyvinyl chloride (PVC) stabilizers, or other than as a
coatings additive.
(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), (d) and (i) are
[[Page 53670]]
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11417 1,3-Butanediol, (3R)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-butanediol,
(3R)- (PMN P-18-295, CAS No. 6290-03-5) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in 721.80(f) and (g). It is a significant new use to use
the chemical substance for other than as an ingredient in cleaning
products.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11418 [Reserved].
Sec. 721.11419 Metal oxide-chloro (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal
oxide-chloro (PMN P-19-113) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture, processing or use of the PMN substance in a manner that
results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 13.
(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), (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
[FR Doc. 2019-21718 Filed 10-7-19; 8:45 am]
BILLING CODE 6560-50-P