Significant New Use Rules on Certain Chemical Substances (20-5.B), 29907-29914 [2020-10086]
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Federal Register / Vol. 85, No. 97 / Tuesday, May 19, 2020 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2020–0222; FRL–10009–
17]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (20–5.B)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for
chemical substances which are the
subject of premanufacture notices
(PMNs). This action would require
persons to notify EPA at least 90 days
before commencing manufacture
(defined by statute to include import) or
processing of any of these chemical
substances for an activity that is
designated as a significant new use by
this proposed rule. This action would
further require that persons not
commence manufacture or processing
for the significant new use until they
have submitted a Significant New Use
Notice, and EPA has conducted a review
of the notice, made an appropriate
determination on the notice under
TSCA, and has taken any risk
management actions as are required as
a result of that determination.
DATES: Comments must be received on
or before June 18, 2020.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0222, 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:
SUMMARY:
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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: moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
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 the Toxic Substances
Control Act (TSCA) (15 U.S.C. 2601 et
seq.). Chemical importers are subject to
the TSCA section 13 (15 U.S.C. 2612)
import provisions. This action may also
affect certain entities through preexisting import certification and export
notification rules under TSCA, which
would include 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 June 18,
2020 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–
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ROM that you mail to EPA, mark the
outside of the disk or CD–ROM as CBI
and then identify electronically within
the disk or CD–ROM the specific
information that is claimed as CBI. In
addition to one complete version of the
comment that includes information
claimed as CBI, a copy of the comment
that does not contain the information
claimed as CBI must be submitted for
inclusion in the public docket.
Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) for chemical substances
which are the subjects of PMNs P–17–
86, P–17–294, P–18–262, P–19–136, P–
19–174, P–20–41, and P–20–52. 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–2020–0222.
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.
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). In
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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
several chemical substances in 40 CFR
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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 nonconfidential chemical identities).
• Basis for the SNUR.
• Potentially Useful 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:
PMN Number: P–17–86
Chemical names: Cycloalkyl,
bis(ethoxyalkyl)-, cis- (generic) (P–17–
86, chemical A) and Cycloalkyl,
bis(ethoxyalkyl)-, trans- (generic) (P–17–
86, chemical B).
CAS numbers: Not available (P–17–
86, chemical A) and Not available (P–
17–86, chemical B).
Basis for action: The PMN states that
the generic (non-confidential) use of the
substances will be as a fragrance
chemical. 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 reproductive
toxicity, skin irritation, and specific
target organ toxicity if the chemicals are
not used following the limitations
noted. The conditions of use of the PMN
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substances as described in the PMN
include the following protective
measures:
• Processing the PMN substances to a
concentration greater than 1.5% (by
weight) in the final consumer product.
• Manufacturing and processing
release of the PMN substances resulting
in surface water concentrations that
exceed 330 parts per billion (ppb).
Processors receiving the PMN
substances from fragrance compounding
processors at concentrations below 10%
(by weight) are exempt from the water
release provisions.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the exposure to the PMN
substances may be potentially useful to
characterize the health effects of the
PMN substances 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 environmental exposure
monitoring would help characterize the
potential health effects of the PMN
substances.
CFR citations: 40 CFR 721.11490 (P–
17–86, chemical A); 40 CFR 721.11491
(P–17–86, chemical B).
PMN Number: P–17–294
Chemical name: 2-Butanone, 3methyl-, peroxide.
CAS number: 182893–11–4.
Basis for action: The PMN states that
the use of the substance will be as an
organic peroxide polymerization
initiator for unsaturated acrylic,
unsaturated polyester, and vinyl ester
resins used in traditional acrylic
systems such as acrylic solid surface,
acrylic adhesives, acrylic castings and
acrylic coatings. Based on the physical/
chemical properties of the PMN
substance and submitted test data, EPA
has identified concerns for respiratory
sensitization, serious eye damage, skin
corrosion, skin sensitization, and
specific target organ toxicity if the
chemical is not used following the
limitations noted. The conditions of use
of the PMN substance as described in
the PMN include the following
protective measures:
• Use without personal protective
equipment where there is a potential for
dermal exposure.
• Use without a National Institute for
Occupational Safety and Health
(NIOSH)-certified air purifying, tightfitting full-face respirator with an
Assigned Protection Factor (APF) of at
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least 50 where there is a potential for
inhalation exposures.
• Use other than as an organic
peroxide polymerization initiator.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the exposure to the PMN
substance may be potentially useful to
characterize the 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
workplace exposure monitoring would
help characterize the potential effects of
the PMN substance.
CFR citation: 40 CFR 721.11492 (P–
17–294).
PMN Number: P–18–262.
Chemical name: 2-Propenoic acid, 2methyl-, dodecyl ester, polymer with
ammonium 2-methyl-2-[(1-oxo-2propen-1-yl)amino]-1-propanesulfonate
(1:1), N,N-dimethyl-2-propenamide and
.alpha.-(2-methyl-1-oxo-2-propen-1-yl).omega.-(dodecyloxy)poly(oxy-1,2ethanediyl).
CAS number: 1190091–71–4.
Basis for action: The PMN states that
the use of the substance will be as a
suspension stabilizer for detergents,
consistent with the manufacturing,
processing, use, distribution, and
disposal information described in the
PMN. Based on the physical/chemical
properties of the PMN substance and
SAR analysis of test data on analogous
substances, EPA has identified concerns
for developmental, eye irritation, gene
cell mutagenicity, hematotoxicity,
neurotoxicity, skin irritation, and
specific target organ toxicity if the
chemical is not used following the
limitations noted. The conditions of use
of the PMN substance as described in
the PMN include the following
protective measures:
• Use other than for the confidential
uses specified in the PMN.
• Processing of the PMN substance
above the confidential percentage in
formulation specified in the PMN for
use in consumer products.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the 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
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designated by this proposed SNUR. EPA
has determined that the results of eye
irritation/corrosion, genetic toxicity,
neurotoxicity, skin irritation/corrosion,
and specific target organ toxicity would
help characterize the potential health
effects of the PMN substance.
CFR citation: 40 CFR 721.11493 (P–
18–262).
PMN Number: P–19–136
Chemical name: Iso-alkylamine, Nisoalkyl-N-methyl (generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance will be as
intermediate. Based on the physical/
chemical properties of the PMN
substance and SAR analysis of test data
on analogous substances, EPA has
identified concerns for eye irritation,
skin irritation, and specific target organ
toxicity if the chemical is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measure:
• Use other than as a chemical
intermediate.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
about the 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 eye
irritation/corrosion, skin irritation/
corrosion, and specific target organ
toxicity would help characterize the
potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.11494 (P–
19–136).
PMN Number: P–19–174
Chemical name: Octadecanoic acid,
(alkylphosphinyl), polyol ester
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a phosphorus antiwear compound. Based on the physical/
chemical properties of the PMN
substance and SAR analysis of test data
on analogous substances, EPA has
identified concerns for eye irritation,
reproductive toxicity, skin irritation,
and specific target organ toxicity if the
chemical is not used following the
limitations noted. The conditions of use
of the PMN substance as described in
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the PMN include the following
protective measures:
• Manufacture, process, or use the
PMN substance in any manner that
results in inhalation exposure.
• Process the PMN substance above
the confidential percentage in
formulation specified in the PMN for
use in consumer products.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the 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
developmental toxicity, eye damage,
reproductive toxicity, skin irritation,
and specific target organ toxicity would
help characterize the potential health
effects of the PMN substance.
CFR citation: 40 CFR 721.11495 (P–
19–174).
PMN Number: P–20–41
Chemical name: 1,3Benzenedicarboxylic acid, polymer with
3-methyl-1,5-pentanediol.
CAS number: 76962–70–4.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a chemical
intermediate for coatings. Based on the
physical/chemical properties of the
PMN substance and SAR analysis of test
data on analogous substances, EPA has
identified concerns for acute oral
toxicity, developmental effects, eye
irritation, systemic effects, and aquatic
toxicity if the chemical is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measures:
• Use other than for the confidential
uses specified in the PMN.
• Release of the PMN substance
resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the 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 eye irritation and aquatic
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toxicity testing would help characterize
the potential health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.11496 (P–
20–41).
PMN Number: P–20–52
Chemical name: Oxirane, 2-methyl-,
polymer with oxirane, mono(3,5,5trimethylhexanoate).
CAS number: 148263–50–7.
Basis for action: The PMN states that
the use of the substance will be as a
liquid shrinkage reducing admixture for
concrete. Based on the physical/
chemical properties of the PMN
substance and SAR analysis of test data
on analogous substances, EPA has
identified concerns for aquatic toxicity,
eye irritation, kidney and liver effects,
and developmental toxicity, lung
irritation and lung effects, skin
irritation, and specific target organ
toxicity if the chemical is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measures:
• No use of the PMN substance in a
consumer product.
• No use other than as a liquid
shrinkage reducing admixture for
concrete.
• No changes in manufacture,
processing or use of the PMN substance
resulting in inhalation exposures.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the toxicity of the PMN substance
may be potentially useful to characterize
the environmental and 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 aquatic toxicity,
developmental toxicity, pulmonary
effects, and specific target organ toxicity
would help characterize the potential
environmental and health effects of the
PMN substance.
CFR citation: 40 CFR 721.11497 (P–
20–52).
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
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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
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
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/tscainventory.
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
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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 May 4, 2020 (date of
web posting of this proposed rule) 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
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useful information identified in Unit IV.
will be useful to EPA’s evaluation in the
event that someone submits a SNUN for
the significant new use. Companies who
are considering submitting a SNUN are
encouraged, but not required, to develop
the information on the substance, which
may assist with EPA’s analysis of the
SNUN.
EPA strongly encourages persons,
before performing any testing, to consult
with the Agency pertaining to protocol
selection. Furthermore, pursuant to
TSCA section 4(h), which pertains to
reduction of testing in vertebrate
animals, EPA encourages consultation
with the Agency on the use of
alternative test methods and strategies
(also called New Approach
Methodologies, or NAMs), if available,
to generate the recommended test data.
EPA encourages dialog with Agency
representatives to help determine how
best the submitter can meet both the
data needs and the objective of TSCA
section 4(h).
The potentially useful information
described in Unit IV. may not be the
only means of providing information to
evaluate the chemical substance
associated with the significant new
uses. However, submitting a SNUN
without any test data may increase the
likelihood that EPA will take action
under TSCA section 5(e) or 5(f). EPA
recommends that potential SNUN
submitters contact EPA early enough so
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-chemicalsunder-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
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potential manufacturers and processors
of the chemical substances subject to
this proposed rule. EPA’s complete
economic analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2020–0222.
X. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations-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 8 new chemical substances
that were the subject of PMNs. The
Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Order 12866 (58 FR 51735, October 4,
1993) and 13563 (76 FR 3821, January
21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501
et seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Regulatory
Support Division, Office of Mission
Support (2822T), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
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29911
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
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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 action would not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This action 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 action.
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 action 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.
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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: April 29, 2020.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, it is proposed that 40 CFR
part 721 is amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add §§ 721.11490 through
721.11497 to subpart E to read as
follows:
■
Subpart E —Significant New Uses for
Specific Chemical Substances
Sec.
*
*
*
*
*
721.11490 Cycloalkyl, bis(ethoxyalkyl)-,
trans- (generic) (P–17–86, chemical A).
721.11491 Cycloalkyl, bis(ethoxyalkyl)-,
cis- (generic) (P–17–86, chemical B).
721.11492 2-Butanone, 3-methyl-, peroxide.
721.11493 2-Propenoic acid, 2-methyl-,
dodecyl ester, polymer with ammonium
2-methyl-2-[(1-oxo-2-propen-1yl)amino]-1-propanesulfonate (1:1), N,Ndimethyl-2-propenamide and .alpha.-(2methyl-1-oxo-2-propen-1-yl)-.omega.(dodecyloxy)poly(oxy-1,2-ethanediyl).
721.11494 Iso-alkylamine, N-isoalkyl-Nmethyl (generic).
721.11495 Octadecanoic acid,
(alkylphosphinyl), polyol ester (generic).
721.11496 1,3-Benzenedicarboxylic acid,
polymer with 3-methyl-1,5-pentanediol.
721.11497 Oxirane, 2-methyl-, polymer
with oxirane, mono(3,5,5trimethylhexanoate).
*
*
*
*
*
§ 721.11490 Cycloalkyl, bis(ethoxyalkyl)-,
cis- (generic) (P–17–86, chemical A).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as cycloalkyl,
bis(ethoxyalkyl)-, cis- (PMN P–17–86,
chemical A) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
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(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to process the PMN substance
greater than 1.5% (by weight) for use in
consumer products.
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4) and (b)(4),
where N=330. Processors receiving the
substance from fragrance compounding
processors at concentrations below 10%
(by weight) are exempt from the water
release provisions.
(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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11491 Cycloalkyl, bis(ethoxyalkyl)-,
trans- (generic) (P–17–86, chemical B).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as cycloalkyl,
bis(ethoxyalkyl)-, trans- (PMN P–17–86,
chemical B) 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 process the PMN substance
greater than 1.5% (by weight) for use in
consumer products.
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4) and (b)(4),
where N = 330. Processors receiving the
substance from fragrance compounding
processors at concentrations below 10%
(by weight) are exempt from the water
release provisions.
(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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11492
peroxide.
2-Butanone, 3-methyl-,
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance identified as
2-butanone, 3-methyl-, peroxide (PMN
P–17–294, CAS No. 182893–11–4) 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
§ 721.63(a)(1), (2)(i), (3) through (6).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible, and
(c). For purposes of § 721.63(a)(5),
respirators must provide a National
Institute for Occupational Safety and
Health (NIOSH) assigned protection
factor (APF) of at least 50. For purposes
of § 721.63(a)(6), the applicable airborne
form of the substance is particulate
(including solids or liquid droplets).
(ii) Industrial, commercial, and
consumer activities. It is a significant
new use to use the substance for other
than as an organic peroxide
polymerization initiator.
(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
§ 721.125(a) through (e), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11493 2-Propenoic acid, 2-methyl-,
dodecyl ester, polymer with ammonium 2methyl-2-[(1-oxo-2-propen-1-yl)amino]-1propanesulfonate (1:1), N,N-dimethyl-2propenamide and .alpha.-(2-methyl-1-oxo-2propen-1-yl)-.omega.-(dodecyloxy)poly(oxy1,2-ethanediyl).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 2-methyl-, dodecyl
ester, polymer with ammonium 2methyl-2-[(1-oxo-2-propen-1-yl)amino]1-propanesulfonate (1:1), N,N-dimethyl2-propenamide and .alpha.-(2-methyl-1oxo-2-propen-1-yl)-.omega.(dodecyloxy)poly(oxy-1,2-ethanediyl)
(PMN P–18–262, CAS No. 1190091–71–
4) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
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(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j). It is a significant
new use to process the PMN substance
above the confidential percentage in
formulation specified in the PMN for
use in consumer 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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11494 Iso-alkylamine, N-isoalkyl-Nmethyl (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as iso-alkylamine, Nisoalkyl-N-methyl (PMN P–19–136) 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(g).
(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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11495 Octadecanoic acid,
(alkylphosphinyl), polyol ester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as octadecanoic acid,
(alkylphosphinyl), polyol ester (PMN P–
19–174) 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
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29913
new use to manufacture, process, or use
the PMN substance in a manner that
results in inhalation exposure. It is a
significant new use to process the PMN
substance above the confidential
percentage in formulation specified in
the PMN for use in consumer 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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11496 1,3-Benzenedicarboxylic acid,
polymer with 3-methyl-1,5-pentanediol.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,3-benzenedicarboxylic acid, polymer
with 3-methyl-1,5-pentanediol (PMN P–
20–41, CAS No. 76962–70–4) 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(j).
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4), where N = 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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11497 Oxirane, 2-methyl-, polymer
with oxirane, mono(3,5,5trimethylhexanoate).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-methyl-, polymer with
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oxirane, mono(3,5,5trimethylhexanoate) (PMN P–20–52,
CAS No. 148263–50–7) 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. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process or use the substance in a
manner that results in inhalation
exposures. It is a significant new use to
use the substance for other than as a
liquid shrinkage reducing admixture for
concrete.
(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 § 721.125
(a) through (c), and (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2020–10086 Filed 5–18–20; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 0, 1, and 63
[IB Docket No. 16–155; DA 20–452; FRS
16720]
Process Reform for Executive Branch
Review of Certain FCC Applications
and Petitions Involving Foreign
Ownership
Federal Communications
Commission.
ACTION: Proposed record of proceeding.
AGENCY:
In this document, the
International Bureau (IB) refreshes the
record in Executive Branch Review
Process Proceeding, IB Docket 16–155,
by adding Executive Order 13913 into
the record of the proceeding and seeking
comment.
DATES: Comments are due on or before
June 18, 2020, and reply comments are
due on or before July 2, 2020.
ADDRESSES: Pursuant to §§ 1.415 and
1.419 of the Commission’s rules, 47 CFR
1.415, 1.419, interested parties may file
comments and reply comments on or
before the dates indicated in this
document. Comments may be filed
using the Commission’s Electronic
SUMMARY:
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17:43 May 18, 2020
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Comment Filing System (ECFS). See
Electronic Filing of Documents in
Rulemaking Proceedings, 63 FR 24121
(1998).
• Electronic Filers. Comments may be
filed electronically using the internet by
accessing the ECFS: https://
www.fcc.gov/ecfs.
• Paper Filers. Parties who choose to
file by paper must file an original and
one copy of each filing. If more than one
docket or rulemaking number appears in
the caption of this proceeding, filers
must submit two additional copies for
each additional docket or rulemaking
number.
Filings can be sent by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
Æ Commercial overnight mail (other
than U.S. Postal Service Express Mail
and Priority Mail) must be sent to 9050
Junction Drive, Annapolis Junction, MD
20701. U.S. Postal Service first-class,
Express, and Priority mail must be
addressed to 445 12th Street SW,
Washington, DC 20554.
• Effective March 19, 2020, and until
further notice, the Commission no
longer accepts any hand or messenger
delivered filings. This is a temporary
measure taken to help protect the health
and safety of individuals, and to
mitigate the transmission of COVID–19.
See FCC Announces Closure of FCC
Headquarters Open Window and
Change in Hand-Delivery Policy, Public
Notice, DA 20–304 (March 19, 2020).
https://www.fcc.gov/document/fcccloses-headquarters-open-window-andchanges-hand-delivery-policy.
• People with Disabilities: To request
materials in accessible formats for
people with disabilities (braille, large
print, electronic files, audio format),
send an email to fcc504@fcc.gov or call
the Consumer & Governmental Affairs
Bureau at 202–418–0530 (voice) or 202–
418–0432 (TTY).
In addition, filers may provide one
copy of each filing to each of the
following: (1) Arthur Lechtman,
Attorney, Telecommunications and
Analysis Division, International Bureau,
at Arthur.Lechtman@fcc.gov, and (2)
David Krech, Associate Division Chief,
Telecommunications and Analysis
Division, International Bureau, at
David.Krech@fcc.gov.
FOR FURTHER INFORMATION CONTACT: For
further information, please contact
Arthur Lechtman, Telecommunications
and Analysis Division, International
Bureau, at Arthur.Lechtman@fcc.gov or
(202) 418–1465.
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The
Commission refers certain applications
to Executive Branch agencies when
there is reportable foreign ownership in
the applicant. Specifically, where an
applicant has a 10% or greater direct or
indirect owner that is not a U.S. citizen,
Commission practice has been to refer
an application for: (1) International
section 214 authority; (2) assignment or
transfer of control of domestic or
international section 214 authority; (3) a
submarine cable landing license; and (4)
assignment or transfer of control of a
submarine cable landing license. The
Commission also refers petitions
seeking authority to exceed the foreign
ownership limits in section 310(b) of the
Communications Act of 1934, as
amended, 47 U.S.C. 310(b), for
broadcast and common carrier wireless
licensees, including common carrier
satellite earth stations.
On June 24, 2016, the Commission
adopted a Notice of Proposed
Rulemaking (NPRM) to improve the
timeliness and transparency of the
process involving referral of certain
applications with reportable foreign
ownership to Executive Branch
agencies, including the Team Telecom
agencies, for feedback on any national
security, law enforcement, foreign
policy, or trade policy concerns. Process
Reform for Executive Branch Review of
Certain FCC Applications and Petitions
Involving Foreign Ownership, 81 FR
46870 (2016) (Executive Branch Review
Process NPRM). Specifically, the
Commission sought comment on: (1)
The types of applications to be referred
to the Executive Branch; (2) the
information that should be provided by
an applicant with reportable foreign
ownership in order to facilitate
Executive Branch review; (3)
certifications to be made by an applicant
that it will comply with several
mitigation measures; and (4) time
frames for Executive Branch review of
the applications. The Commission
proposed a 90-day review period for
applications referred to the Executive
Branch, with a one-time additional 90day extension for circumstances where
the Executive Branch required
additional review time beyond the
initial period.
On April 4, 2020, the President signed
Executive Order 13913, Establishing the
Committee for the Assessment of
Foreign Participation in the United
States Telecommunications Services
Sector, 85 FR 19643 (April 8, 2020).
Importantly, among other things, the
Executive Order sets out procedures and
timeframes for the Committee’s review
of applications referred by the
Commission.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19MYP1.SGM
19MYP1
]]>Agencies
[Federal Register Volume 85, Number 97 (Tuesday, May 19, 2020)]
[Proposed Rules]
[Pages 29907-29914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10086]
[[Page 29907]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2020-0222; FRL-10009-17]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (20-5.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 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
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 June 18, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0222, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-9232; email address:
[email protected]
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
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 the Toxic
Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.). Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions. This action may also affect certain entities through pre-
existing import certification and export notification rules under TSCA,
which would include 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 June 18, 2020 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 https://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) for chemical substances which are the subjects of PMNs P-
17-86, P-17-294, P-18-262, P-19-136, P-19-174, P-20-41, and P-20-52.
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-2020-0222. 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.
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). In
[[Page 29908]]
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 several 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.
Potentially Useful 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:
PMN Number: P-17-86
Chemical names: Cycloalkyl, bis(ethoxyalkyl)-, cis- (generic) (P-
17-86, chemical A) and Cycloalkyl, bis(ethoxyalkyl)-, trans- (generic)
(P-17-86, chemical B).
CAS numbers: Not available (P-17-86, chemical A) and Not available
(P-17-86, chemical B).
Basis for action: The PMN states that the generic (non-
confidential) use of the substances will be as a fragrance chemical.
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 reproductive
toxicity, skin irritation, and specific target organ toxicity if the
chemicals are not used following the limitations noted. The conditions
of use of the PMN substances as described in the PMN include the
following protective measures:
Processing the PMN substances to a concentration greater
than 1.5% (by weight) in the final consumer product.
Manufacturing and processing release of the PMN substances
resulting in surface water concentrations that exceed 330 parts per
billion (ppb). Processors receiving the PMN substances from fragrance
compounding processors at concentrations below 10% (by weight) are
exempt from the water release provisions.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the exposure to the PMN substances may be potentially
useful to characterize the health effects of the PMN substances 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 environmental exposure monitoring
would help characterize the potential health effects of the PMN
substances.
CFR citations: 40 CFR 721.11490 (P-17-86, chemical A); 40 CFR
721.11491 (P-17-86, chemical B).
PMN Number: P-17-294
Chemical name: 2-Butanone, 3-methyl-, peroxide.
CAS number: 182893-11-4.
Basis for action: The PMN states that the use of the substance will
be as an organic peroxide polymerization initiator for unsaturated
acrylic, unsaturated polyester, and vinyl ester resins used in
traditional acrylic systems such as acrylic solid surface, acrylic
adhesives, acrylic castings and acrylic coatings. Based on the
physical/chemical properties of the PMN substance and submitted test
data, EPA has identified concerns for respiratory sensitization,
serious eye damage, skin corrosion, skin sensitization, and specific
target organ toxicity if the chemical is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measures:
Use without personal protective equipment where there is a
potential for dermal exposure.
Use without a National Institute for Occupational Safety
and Health (NIOSH)-certified air purifying, tight-fitting full-face
respirator with an Assigned Protection Factor (APF) of at
[[Page 29909]]
least 50 where there is a potential for inhalation exposures.
Use other than as an organic peroxide polymerization
initiator.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the exposure to the PMN substance may be potentially
useful to characterize the 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 workplace exposure monitoring would
help characterize the potential effects of the PMN substance.
CFR citation: 40 CFR 721.11492 (P-17-294).
PMN Number: P-18-262.
Chemical name: 2-Propenoic acid, 2-methyl-, dodecyl ester, polymer
with ammonium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonate (1:1), N,N-dimethyl-2-propenamide and .alpha.-(2-
methyl-1-oxo-2-propen-1-yl)-.omega.-(dodecyloxy)poly(oxy-1,2-
ethanediyl).
CAS number: 1190091-71-4.
Basis for action: The PMN states that the use of the substance will
be as a suspension stabilizer for detergents, consistent with the
manufacturing, processing, use, distribution, and disposal information
described in the PMN. Based on the physical/chemical properties of the
PMN substance and SAR analysis of test data on analogous substances,
EPA has identified concerns for developmental, eye irritation, gene
cell mutagenicity, hematotoxicity, neurotoxicity, skin irritation, and
specific target organ toxicity if the chemical is not used following
the limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measures:
Use other than for the confidential uses specified in the
PMN.
Processing of the PMN substance above the confidential
percentage in formulation specified in the PMN for use in consumer
products.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the 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 eye irritation/corrosion, genetic
toxicity, neurotoxicity, skin irritation/corrosion, and specific target
organ toxicity would help characterize the potential health effects of
the PMN substance.
CFR citation: 40 CFR 721.11493 (P-18-262).
PMN Number: P-19-136
Chemical name: Iso-alkylamine, N-isoalkyl-N-methyl (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will
be as intermediate. Based on the physical/chemical properties of the
PMN substance and SAR analysis of test data on analogous substances,
EPA has identified concerns for eye irritation, skin irritation, and
specific target organ toxicity if the chemical is not used following
the limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
Use other than as a chemical intermediate.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information about the 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 eye irritation/corrosion, skin
irritation/corrosion, and specific target organ toxicity would help
characterize the potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11494 (P-19-136).
PMN Number: P-19-174
Chemical name: Octadecanoic acid, (alkylphosphinyl), polyol ester
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a phosphorus anti-wear
compound. Based on the physical/chemical properties of the PMN
substance and SAR analysis of test data on analogous substances, EPA
has identified concerns for eye irritation, reproductive toxicity, skin
irritation, and specific target organ toxicity if the chemical is not
used following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measures:
Manufacture, process, or use the PMN substance in any
manner that results in inhalation exposure.
Process the PMN substance above the confidential
percentage in formulation specified in the PMN for use in consumer
products.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the 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 developmental toxicity, eye damage,
reproductive toxicity, skin irritation, and specific target organ
toxicity would help characterize the potential health effects of the
PMN substance.
CFR citation: 40 CFR 721.11495 (P-19-174).
PMN Number: P-20-41
Chemical name: 1,3-Benzenedicarboxylic acid, polymer with 3-methyl-
1,5-pentanediol.
CAS number: 76962-70-4.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate
for coatings. Based on the physical/chemical properties of the PMN
substance and SAR analysis of test data on analogous substances, EPA
has identified concerns for acute oral toxicity, developmental effects,
eye irritation, systemic effects, and aquatic toxicity if the chemical
is not used following the limitations noted. The conditions of use of
the PMN substance as described in the PMN include the following
protective measures:
Use other than for the confidential uses specified in the
PMN.
Release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the 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 eye irritation
and aquatic
[[Page 29910]]
toxicity testing would help characterize the potential health and
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.11496 (P-20-41).
PMN Number: P-20-52
Chemical name: Oxirane, 2-methyl-, polymer with oxirane,
mono(3,5,5-trimethylhexanoate).
CAS number: 148263-50-7.
Basis for action: The PMN states that the use of the substance will
be as a liquid shrinkage reducing admixture for concrete. Based on the
physical/chemical properties of the PMN substance and SAR analysis of
test data on analogous substances, EPA has identified concerns for
aquatic toxicity, eye irritation, kidney and liver effects, and
developmental toxicity, lung irritation and lung effects, skin
irritation, and specific target organ toxicity if the chemical is not
used following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measures:
No use of the PMN substance in a consumer product.
No use other than as a liquid shrinkage reducing admixture
for concrete.
No changes in manufacture, processing or use of the PMN
substance resulting in inhalation exposures.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the environmental and 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 aquatic toxicity,
developmental toxicity, pulmonary effects, and specific target organ
toxicity would help characterize the potential environmental and health
effects of the PMN substance.
CFR citation: 40 CFR 721.11497 (P-20-52).
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 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 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 May 4, 2020 (date of web posting of this proposed
rule) 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
[[Page 29911]]
useful information identified in Unit IV. will be useful to EPA's
evaluation in the event that someone submits a SNUN for the significant
new use. Companies who are considering submitting a SNUN are
encouraged, but not required, to develop the information on the
substance, which may assist with EPA's analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA section 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so 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-
2020-0222.
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 8 new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., the
Agency hereby certifies that promulgation of this proposed SNUR would
not have a significant adverse economic impact on a substantial number
of small entities. The requirement to submit a SNUN applies to any
person (including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was seven in Federal fiscal year
(FY) 2013, 13 in FY2014, six in FY2015, 12 in FY2016, 13 in FY2017, and
11 in FY2018, only a fraction of these were from small businesses. In
addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to
[[Page 29912]]
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 action would not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action 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 action.
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 action 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: April 29, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 is amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11490 through 721.11497 to subpart E to read as
follows:
Subpart E --Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11490 Cycloalkyl, bis(ethoxyalkyl)-, trans- (generic) (P-17-86,
chemical A).
721.11491 Cycloalkyl, bis(ethoxyalkyl)-, cis- (generic) (P-17-86,
chemical B).
721.11492 2-Butanone, 3-methyl-, peroxide.
721.11493 2-Propenoic acid, 2-methyl-, dodecyl ester, polymer with
ammonium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate
(1:1), N,N-dimethyl-2-propenamide and .alpha.-(2-methyl-1-oxo-2-
propen-1-yl)-.omega.-(dodecyloxy)poly(oxy-1,2-ethanediyl).
721.11494 Iso-alkylamine, N-isoalkyl-N-methyl (generic).
721.11495 Octadecanoic acid, (alkylphosphinyl), polyol ester
(generic).
721.11496 1,3-Benzenedicarboxylic acid, polymer with 3-methyl-1,5-
pentanediol.
721.11497 Oxirane, 2-methyl-, polymer with oxirane, mono(3,5,5-
trimethylhexanoate).
* * * * *
Sec. 721.11490 Cycloalkyl, bis(ethoxyalkyl)-, cis- (generic) (P-17-
86, chemical A).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
cycloalkyl, bis(ethoxyalkyl)-, cis- (PMN P-17-86, chemical A) 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 process the PMN substance greater than 1.5% (by
weight) for use in consumer products.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4) and (b)(4), where N=330. Processors receiving the substance from
fragrance compounding processors at concentrations below 10% (by
weight) are exempt from the water release provisions.
(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
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11491 Cycloalkyl, bis(ethoxyalkyl)-, trans- (generic) (P-17-
86, chemical B).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cycloalkyl, bis(ethoxyalkyl)-, trans- (PMN P-17-86, chemical B) 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 process the PMN substance greater than 1.5% (by
weight) for use in consumer products.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4) and (b)(4), where N = 330. Processors receiving the substance
from fragrance compounding processors at concentrations below 10% (by
weight) are exempt from the water release provisions.
(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
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11492 2-Butanone, 3-methyl-, peroxide.
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 29913]]
(1) The chemical substance identified as 2-butanone, 3-methyl-,
peroxide (PMN P-17-294, CAS No. 182893-11-4) 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), (2)(i), (3) through (6). When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (4), engineering control measures (e.g., enclosure or confinement
of the operation, general and local ventilation) or administrative
control measures (e.g., workplace policies and procedures) shall be
considered and implemented to prevent exposure, where feasible, and
(c). For purposes of Sec. 721.63(a)(5), respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50. For purposes of Sec.
721.63(a)(6), the applicable airborne form of the substance is
particulate (including solids or liquid droplets).
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance for other than as an organic
peroxide polymerization initiator.
(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), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11493 2-Propenoic acid, 2-methyl-, dodecyl ester, polymer
with ammonium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonate (1:1), N,N-dimethyl-2-propenamide and .alpha.-(2-
methyl-1-oxo-2-propen-1-yl)-.omega.-(dodecyloxy)poly(oxy-1,2-
ethanediyl).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, dodecyl ester, polymer with ammonium 2-methyl-2-[(1-oxo-2-
propen-1-yl)amino]-1-propanesulfonate (1:1), N,N-dimethyl-2-propenamide
and .alpha.-(2-methyl-1-oxo-2-propen-1-yl)-.omega.-
(dodecyloxy)poly(oxy-1,2-ethanediyl) (PMN P-18-262, CAS No. 1190091-71-
4) 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 process
the PMN substance above the confidential percentage in formulation
specified in the PMN for use in consumer 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 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. 721.11494 Iso-alkylamine, N-isoalkyl-N-methyl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as iso-
alkylamine, N-isoalkyl-N-methyl (PMN P-19-136) 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) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11495 Octadecanoic acid, (alkylphosphinyl), polyol ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
octadecanoic acid, (alkylphosphinyl), polyol ester (PMN P-19-174) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in a manner that results in inhalation exposure. It is a significant
new use to process the PMN substance above the confidential percentage
in formulation specified in the PMN for use in consumer 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 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. 721.11496 1,3-Benzenedicarboxylic acid, polymer with 3-methyl-
1,5-pentanediol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-
benzenedicarboxylic acid, polymer with 3-methyl-1,5-pentanediol (PMN P-
20-41, CAS No. 76962-70-4) 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).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N = 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 (c), (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)(i) of
this section.
Sec. 721.11497 Oxirane, 2-methyl-, polymer with oxirane, mono(3,5,5-
trimethylhexanoate).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with
[[Page 29914]]
oxirane, mono(3,5,5-trimethylhexanoate) (PMN P-20-52, CAS No. 148263-
50-7) 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. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process or use the substance in a manner that results in
inhalation exposures. It is a significant new use to use the substance
for other than as a liquid shrinkage reducing admixture for concrete.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2020-10086 Filed 5-18-20; 8:45 am]
BILLING CODE 6560-50-P
