[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Proposed Rules]
[Pages 38158-38177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16539]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0359; FRL-9996-62]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-2.F)
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 31 chemical substances which
were the subject of premanufacture notices. 7 of these chemical
substances are subject to Orders issued by EPA pursuant to TSCA section
5(e). This action would require persons who intend to manufacture
(defined by statute to include import) or process any of these 31
chemical substances for an activity that is proposed as a significant
new use to notify EPA at least 90 days before commencing that activity.
The required notification initiates EPA's evaluation of the use, under
the conditions of use for that chemical substance, within the
applicable review period. Persons may not commence manufacture or
processing for the significant new use until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and has
taken such actions as are required by that determination.
DATES: Comments must be received on or before September 5, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0359, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-9232; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to final SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after
September 5, 2019 are subject to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must
comply with the export notification requirements in 40 CFR part 707,
subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or
[[Page 38159]]
CD-ROM the specific information that is claimed as CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances that were the subject of PMNs and an MCAN. These
proposed SNURs would require persons to notify EPA at least 90 days
before commencing the manufacture or processing of a chemical substance
for any activity proposed as a significant new use. Receipt of such
notices would allow EPA to assess risks and, if appropriate, to
regulate the significant new use before it may occur. Additional
background regarding SNURs is more fully set out in the preamble to
EPA's first direct final SNUR published in the Federal Register issue
of April 24, 1990 (55 FR 17376). Consult that preamble for further
general information on the objectives, rationale, and procedures for
SNURs and on the basis for significant new use designations, including
provisions for developing test data.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore
prohibits such manufacturing or processing from commencing until EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and taken such actions as are required in association
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)).
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the proposed rule,
recordkeeping requirements, and 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 Sec. 721.1(c), persons subject to SNURs must
comply with the same SNUN requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C.
2604(a)(1)(A)). In particular, these requirements include the
information submission requirements of TSCA sections 5(b) and 5(d)(1)
(15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA
sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40
CFR part 720. Once EPA receives a SNUN, EPA must either determine that
the 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. In the case of a determination other than not likely to
present unreasonable risk, the applicable review period must also
expire before manufacturing or processing for the new use may commence.
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 significant new use for the 31 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 for the substances, in addition to the factors in
TSCA section 5(a)(2). Note that when the Agency issues an order under
TSCA section 5(e), TSCA section 5(f)(4) requires that the Agency
consider whether to promulgate a SNUR for any use not conforming to the
restrictions of the order or publish a statement describing the reasons
for not initiating the rulemaking.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 31 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 or basis for the TSCA 5(e) Order.
Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substance in support of a request by the PMN submitter to modify the
Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR. This information
may include testing required in a TSCA section 5(e) Order to be
conducted by the PMN submitter, as well as testing not required to be
conducted but which would also help characterize the potential health
and/or environmental effects of the PMN substance. Any recommendation
for information identified by EPA was made based on EPA's consideration
of available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models. EPA also recognizes that
whether testing/further information is needed will depend on the
specific
[[Page 38160]]
exposure and use scenario in the SNUN. EPA encourages all SNUN
submitters to contact EPA to discuss any potential future testing. See
Unit VII. for more information.
CFR citation assigned in the regulatory text section of
the proposed rule. The regulatory text section of each proposed rule
specifies the activities that would be designated as significant new
uses. Certain new uses, including exceedance of production volume
limits (i.e., limits on manufacture volume) and other uses designated
in this proposed rule, may be claimed as CBI.
These proposed rules include 7 PMN substances that are subject to
Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). Those Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The proposed SNURs would identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) Order usually requires, among other
things, that potentially exposed employees wear specified respirators
unless actual measurements of the workplace air show that air-borne
concentrations of the PMN substance are below a New Chemical Exposure
Limit (NCEL) that is established by EPA to provide adequate protection
to human health. In addition to the actual NCEL concentration, the
comprehensive NCELs provisions in TSCA section 5(e) Orders, which are
modeled after Occupational Safety and Health Administration (OSHA)
Permissible Exposure Limits (PELs) provisions, include requirements
addressing performance criteria for sampling and analytical methods,
periodic monitoring, respiratory protection, and recordkeeping.
However, no comparable NCEL provisions currently exist in 40 CFR part
721, subpart B, for SNURs. Therefore, for these cases, the individual
SNURs in 40 CFR part 721, subpart E, will state that persons subject to
the SNUR who wish to pursue NCELs as an alternative to the 40 CFR
721.63 respirator requirements may request to do so under 40 CFR
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use
the NCELs approach for SNURs that are approved by EPA will be required
to comply with NCELs provisions that are comparable to those contained
in the corresponding TSCA section 5(e) Order for the same chemical
substance.
These proposed rules also include 24 PMN substances that received
``not likely to present an unreasonable risk'' determination in TSCA
section 5(a)(3)(c). However, during the course of these reviews, EPA
identified concerns for certain health and/or environmental risks if
the chemicals were not used following the limitations identified by the
submitters in the notices but the TSCA section 5(a)(3)(C)
determinations did not deem those uses as reasonably foreseen. The
proposed SNURs would identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to those same protection measures.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-16-400
Chemical Name: Alkanes, C11-16-branched and linear.
CAS Number: 1809170-78-2.
Basis for action: The PMN states that the use of the PMN substance
will be as a chemical intermediate, in cured coatings, cleaning fluids,
metalworking fluids/rolling oils, and in agrochemicals. Based on the
estimated physical chemical properties of the PMN substance and analogy
to structurally similar substances, EPA has identified concerns for
lung effects and dermal irritation if the chemical substance 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:
1. No manufacture, processing, or use of the PMN substance other
than for the uses stated in the PMN; and
2. No manufacture, processing, or use of the PMN substance for
consumer use.
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 human health effects of the PMN substance may be
potentially useful 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 irritation
and pulmonary effects testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11300.
PMN Number: P-17-119
Chemical Name: Alkyl alkenoic acid, alkoxyalkyl ester, polymer with
alkyl alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl
alkenoate (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of
industrial coatings. Based on the estimated physical chemical
properties of the PMN substance and test data on the PMN substance, EPA
has identified concerns for lung effects and irritation to the eyes,
skins, lung, and mucous membranes if the chemical substance 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:
1. No domestic manufacture of the PMN substance; and
2. No manufacture, processing, or use of the PMN substance that
results 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 human health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of pulmonary
effects testing would help characterize the potential health effects of
the PMN substance.
CFR Citation: 40 CFR 721.11301.
PMN Number: P-17-191
Chemical Name: Alkyldiamine, aminoalkyl dimethylaminoalkyl
dimethyl-, reaction products with propylene oxide (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a polyurethane catalyst. Based on the estimated physical
chemical properties of the PMN substance and data on analogous
compounds, EPA has identified concerns for skin, eye, and lung
corrosion, neurotoxicity, and systemic effects if the chemical
substance 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:
No manufacture, processing, or use of the PMN substance
that would generate a spray, mist, or aerosol.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
[[Page 38161]]
Potentially useful information: EPA has determined that certain
information about the human health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of skin
irritation/corrosion and neurotoxicity testing would help characterize
the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11302.
PMN Number: P-17-220
Chemical Name: 2-Oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-
2H-pyran-2-one (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an additive, open,
non-dispersive use. Based on the estimated physical chemical properties
of the PMN substance, comparison with structurally analogous chemical
substances, and Structure Analysis Relationships (SAR) analysis of test
data on polycationic polymers, EPA has identified hazards for
irritation to the eye, lung, and mucous membranes, lung effects, and
aquatic toxicity if the chemical substance 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:
1. No domestic manufacture of the PMN substance;
2. No manufacture or import of the PMN substance other than in
liquid form; and
3. No manufacture, processing, or use of the PMN substance other
than for the confidential use stated in the PMN.
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 human health and environmental effects of the PMN
substance may be potentially useful 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 and pulmonary effects testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11303.
PMN Numbers: P-17-387 and P-17-388
Chemical Name: Dicarboxylic acids, polymers with alkanoic acid,
alkanediol, substituted-alkylalkanoic acid, substituted alkyl
carbomonocycle, alkanedioic acid, alkanolamine blocked compds with
alkanolamine (P-17-387 and P-17-388) (generic).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as paint. Based on the
estimated physical/chemical properties of the PMN substances and
available PMN data, EPA has identified developmental and reproductive
effects, lung toxicity, and nasal and ocular irritation if the chemical
substances are not used following the limitations noted. The conditions
of use of the PMN substances as described in the PMNs include the
following protective measures:
1. No manufacture (including import) of the PMN substances that
results in amine counter ions greater than 4% by weight;
2. No manufacture (including import) of the PMN substances that
results in isocyanate residuals greater than 0.1% by weight;
3. No manufacture (including import) of the PMN substances that
results in a proportion of the acid group greater than 20% by weight;
and
4. No manufacture (including import) of the PMN substances that
results in the average molecular weight smaller than the confidential
molecular weight specified in the PMNs or proportion of the low
molecular weight species greater than the confidential values specified
in the PMNs for the 500 and 1000 dalton species.
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 human health effects of the PMN substances may be
potentially useful 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/reproductive and pulmonary effects testing would help
characterize the potential health effects of the PMN substances.
CFR Citation: 40 CFR 721.11304.
PMN Number: P-17-419
Chemical name: Unsaturated polycyclic hydrocarbon (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: February 6, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a cyclic hydrocarbon
building block. Based on physical/chemical properties of the PMN
substance (as described in the New Chemical Program's PBT category at
64 FR 60194; November 4, 1999) and test data on structurally similar
substances, the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN
substance will persist in the environment more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
EPA has also identified concern for skin irritation, reproductive and
developmental toxicity based on analog data and concern for
sensitization based on Safety Data Sheet (SDS) information. Based on
SAR analysis of test data on analogous neutral organics, EPA has
identified concern for aquatic toxicity. The Order was issued under
5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available
information is insufficient to permit a reasoned evaluation of the
human health and environmental effects of the PMN substance. The Order
was also issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that the substance may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
1. Submit to EPA certain toxicity testing within 9 months from the
effective date of the Order.
2. Submit to EPA certain toxicity testing for within 12 months from
EPA's direction to proceed with that testing.
3. Refrain from manufacturing (including import) more than the
confidential annual production volume limit specified in the Order.
4. Use of the PMN substance only for the confidential use allowed
by the Order.
5. No release of the PMN substance to surface waters.
6. Use of personal protective equipment to its workers to prevent
dermal exposure where there is potential for dermal exposure.
7. Use of a National Institute for Occupational Safety and Health
(NIOSH) certified respirator with an Assigned Protection Factor (APF)
of at least 50 where there is a potential for inhalation exposure.
8. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
[[Page 38162]]
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this SNUR. The submitter has agreed to perform certain
acute aquatic toxicity testing within 9 months of the effect of the
Order, and certain chronic aquatic toxicity testing within 12 months of
EPA's direction to proceed. The Agency has determined that specific
target organ toxicity, reproductive and developmental toxicity,
sensitization, and fate information would help EPA determine the
potential health effects of the PMN substance. Although the Order does
not require this information, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
CFR citation: 40 CFR 721.11305.
PMN Numbers: P-18-7 and P-18-8
Chemical Names: Glycerides, soya mono- and di-, epoxidized,
acetates (P-18-7) and Glycerides, C16-18 and C18-unsatd. mono- and di-,
epoxidized, acetates (P-18-8).
CAS Numbers: 2097734-14-8 (P-18-7) and 2097734-15-9 (P-18-8).
Basis for action: The PMNs state that the use of the substances
will be as plasticizers/stabilizers for flexible polyvinyl chloride.
Based the estimated physical/chemical properties of the PMN substances
and comparison with structurally analogous chemical substances, EPA has
identified skin irritation and kidney and liver hazards if the chemical
substances are not used following the limitations noted. The conditions
of use of the PMN substances as described in the PMNs include the
following protective measures:
1. No manufacture, processing, or use that results in inhalation
exposures; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substances into the waters of the
United States exceeding a surface water concentration of 9,000 parts
per billion (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 human effects of the PMN substances may be
potentially useful 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 specific
target organ toxicity and skin irritation testing would help
characterize the potential health effects of the PMN substances.
CFR Citations: 40 CFR 721.11306 (P-18-7) and 40 CFR 721.11307 (P-
18-8).
PMN Number: P-18-55
Chemical Name: Mixed metal oxide (generic).
CAS Number: Not Available.
Effective date of TSCA section 5(e) Order: April 2, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
use of the PMN substance will be as a catalyst. EPA identified concerns
for lung effects including cancer, and respiratory and dermal
sensitization based on the estimated physical/chemical properties,
available PMN data, and by comparison to structurally analogous
chemical substances. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
1. Use of personal protective equipment where there is a potential
for dermal exposure;
2. Use of a NIOSH-certified respirator with an APF of at least
1,000 where there is a potential for inhalation exposure or compliance
with a NCEL of 0.04 mg/m\3\ as an 8-hour time-weighted average to
prevent inhalation exposure;
3. Use of the PMN substance only for the confidential use allowed
by the Order; and
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
The SNUR designate as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information about the health effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the Order, or if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this SNUR. EPA has also determined that specific pulmonary toxicity and
sensitization effects testing of the PMN substance would be useful in
determining the health effects of the PMN substance. Although the Order
does not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
CFR citation: 40 CFR 721.11308.
PMN Number: P-18-77
Chemical Name: Urea, reaction products with N-butylphosphorothioic
triamide and formaldehyde.
CAS Number: 2093385-47-6.
Basis for action: The PMN states that the use of the PMN substance
will be as an additive for urea-containing fertilizer. Based on
physical-chemical properties, available test data, and test data on
analogous chemical substances for the PMN substance, EPA has identified
concerns for neurotoxicity, reproductive toxicity, kidney toxicity,
irritation and sensitization if the chemical substance 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:
1. No manufacture, processing, or use of the substance that results
in inhalation exposure; and
2. No use of the substance in a consumer product.
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 health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of
neurotoxicity, specific target organ toxicity, irritation,
sensitization, and reproductive/developmental toxicity testing would
help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11309.
PMN Number: P-18-85
Chemical Name: Fatty acid reaction products with ethyleneamines and
dialkyl ester (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for industrial use in
oilfields. Based on the estimated physical chemical properties of the
PMN substance and comparison with structurally analogous chemical
substances, EPA has identified irritation to the eyes, lungs, and skin,
and lung effects if the chemical substance is not used following the
limitation noted. The
[[Page 38163]]
condition of use of the PMN substance as described in the PMN includes
the following protective measure:
No manufacture, processing, or use that results in
inhalation exposures.
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 health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of pulmonary
effects testing would help characterize the potential health effects of
the PMN substance.
CFR Citation: 40 CFR 721.11310.
PMN Number: P-18-101
Chemical Name: Pentaerythritol, mixed esters with linear and
branched fatty acids (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for industrial use.
Based on the estimated physical chemical properties of the PMN
substance and comparison with structurally analogous chemical
substances, EPA has identified concerns for developmental effects,
blood and thyroid effects, and skin and eye irritation if the chemical
substance 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:
No manufacturing, processing, or use involving an
application method that generates a vapor, mist, or aerosol.
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 health effects of the PMN substance may be
potentially useful 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 specific
organ toxicity and reproductive/developmental testing would help
characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11311.
PMN Number: P-18-107
Chemical Name: Alcohol capped polycarbodiimide from
diethyldiisocyanatobenzene (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a hydrolysis stabilizer. Based on the physical chemical
properties of the PMN substance and comparison with structurally
analogous chemical substances, EPA has identified concerns for systemic
toxicity and developmental toxicity if the chemical substance is not
used following the limitation noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
No manufacture (including import) of the PMN substances
that results in isocyanate residuals greater than 0.1% by weight.
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 human health toxicity of the PMN substance may be
potentially useful 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
reproductive/development toxicity testing would help characterize the
potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11312.
PMN Numbers: P-18-118 and P-18-119
Chemical Names: Oxirane, 2-methyl-, polymer with methoxirane
homopolymer, 1,1'-methylenebis[4-isocyanatobenzene], and glycerol-
propylene oxide polymer (generic) (P-18-118) and Oxirane, 2-methyl-,
polymer with methoxirane homopolymer, 1,1'-
methylenebis[isocyanatobenzene], and glycerol-propylene oxide polymer
(generic) (P-18-119).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as industrial adhesives.
Based on the estimated physical chemical properties of the PMN
substances and comparison with structurally analogous chemical
substances. EPA has identified concerns for lung effects, irritation,
and sensitization if the chemical substances are not used following the
limitations noted. The conditions of use of the PMN substances as
described in the PMNs include the following protective measures:
1. No manufacturing, processing, or use that results in inhalation
exposures;
2. No manufacturing, processing, or use of the PMN substances with
isocyanate residuals greater than 0.1%; and
3. Refrain from using the PMN substance for consumer use.
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 health effects of the PMN substances may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of skin
sensitization testing would help characterize the potential health
effects of the PMN substances.
CFR Citations: 40 CFR 721.11313 (P-18-118) and 40 CFR 721.11314 (P-
18-119).
PMN Numbers: P-18-123 and P-18-124
Chemical Name: Lithium nickel hydride oxide (P-18-123) and Lithium
nickel potassium oxide (P-18-124).
CAS Numbers: 2081933-92-6 (P-18-123) and 210352-95-7 (P-18-124).
Effective date of TSCA section 5(e) Order: December 7, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substances will be as a chemical intermediate used in the
production of battery electrodes (P-18-123) and a cathode material for
standard and premium (P-18-124). Based on physical/chemical properties
and on test data submitted with the PMN, EPA identified concerns for
pulmonary effects, neurotoxicity, developmental toxicity, kidney
toxicity, carcinogenicity, skin and respiratory sensitization, and
irritation to the eye, skin, and respiratory tract. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation the substances may present an unreasonable
risk of injury to human health and the environment. The Order was also
issued under TSCA section 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II),
based on a finding that the substances are or will be produced in
substantial quantities and that the substances either enter or may
reasonably be anticipated to enter the environment in substantial
quantities, or there is or may be significant (or substantial) human
exposure to the substances. To protect against these risks, the Order
requires:
1. Use of personal protective equipment where there is a potential
for dermal exposure.
2. Use a NIOSH-certified respirator with an APF of at least 50
where there is potential for inhalation exposure or
[[Page 38164]]
compliance with a NCEL of 0.05 mg/m\3\ as an 8-hour time-weighted
average to prevent inhalation exposure.
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. Submit to EPA certain environmental and health hazard testing
within six months and four years of the first manufacture (including
import), respectively on P-18-124.
5. No release of the PMN substances resulting in surface water
concentrations that exceed 32 ppb.
The SNUR designate as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substances may be potentially useful in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this SNUR. The submitter has agreed to submit an algal
toxicity test 6 months after the date of first manufacture and a
specific organ toxicity test 4 years after the date of first
manufacture on PMN substance P-18-124. EPA has also determined that
information on specific target organ toxicity and reproductive/
developmental toxicity would help characterize the potential health
effects of the PMN substances. Although the Order does not require
these tests, the Order's restrictions remain in effect until the Order
is modified or revoked by EPA based on submission of this or other
relevant information.
CFR Citations: 40 CFR 721.11315 (P-18-123) and 40 CFR 721.11316 (P-
18-124).
PMN Number: P-18-152
Chemical Name: Hydrolyzed functionalized di-amino silanol polymer
(generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an intermediate.
Based on the estimated physical chemical properties of the PMN
substance, data on the PMN substance, comparison with structurally
analogous chemical substances, and Structure Analysis Relationships
(SAR) analysis of test data on analogous aliphatic amines, EPA has
identified irritation and corrosion to all tissues, sensitization, lung
toxicity, and aquatic toxicity at surface water concentrations
exceeding 3 parts per billion (ppb) if the chemical substance 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:
1. No manufacturing, processing, or use of the PMN substance in any
manner that results in inhalation exposure; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 3 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 health and environmental effects of the PMN
substance may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of skin toxicity, sensitization, and aquatic toxicity testing of would
help characterize the potential health and environmental effects of the
PMN substance.
CFR Citation: 40 CFR 721.11317.
PMN Number: P-18-169
Chemical Name: Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-
methyl-, polymer with dimethyl carbonate, 1,6-hexanediol, diamine and
1,1'-methylenebis[4-isocyanatocyclohexane], pentaerythritol,
triacrylate-blocked, compds. with triethylamine (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a protective coating.
Based on estimated physical chemical properties of the PMN substance
and comparison with structurally analogous acrylates/methacrylates, EPA
has identified dermal and respiratory irritation and sensitization,
developmental toxicity, and neurotoxicity if the chemical substance 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:
1. Use of personal protective equipment including impervious gloves
where there is a potential for dermal exposure;
2. Use of a NIOSH certified respirator with an APF of at least
1,000 for spray applications and 50 for non-spray applications; and
3. No manufacture (including import) of the PMN substance with
triethylamine concentrations greater than the confidential
concentration described in the PMN.
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 health effects of the PMN substance may be
potentially useful 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 composition
of Low Molecular Weight (LMW) species and specific organ toxicity
testing for the LMW species would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11318.
PMN Numbers: P-18-200 and P-18-201
Chemical names: Waste plastics, poly(ethylene terephthalate),
polymers with diethylene glycol, glycerol, polyerythritol, triethylene
glycol, trimethylolalkane and polypropylene glycol (P-18-200) (generic)
and Waste plastics, poly(ethylene terephthalate), polymers with
diethylene glycol, glycerol, polyerythritol glycol, trimethylolalkane
and polypropylene glycol (P-18-201) (generic).
CAS numbers: Not available.
Effective date of TSCA section 5(e) Order: January 20, 2019.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as insulation
components. Based on analogue data for low molecular weight components
and metabolites of high molecular weight components, EPA identified
concerns for bladder and kidney effects. . Based on SAR predictions for
nonionic polymers EPA also identified concerns for aquatic toxicity at
concentrations that exceed 280 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that the substances may present an unreasonable risk of injury to human
health and the environment. The Order was also issued under TSCA
sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding
that the substances are or will be produced in substantial quantities
and that the substances either enter or may reasonably be anticipated
to enter the environment in substantial quantities, or there is or may
be significant (or substantial) human exposure to the substances. To
protect against these risks, the Order requires:
1. Use of personal protective equipment involving impervious gloves
where there is a potential for dermal exposure;
[[Page 38165]]
2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
3. Use of a NIOSH-certified respirator with an APF of at least 10
where there is a potential for inhalation exposure;
4. Refrain from using the PMN substances for consumer use; and
5. No release of the PMN substances resulting in surface water
concentrations that exceed 280 ppb.
The 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 human and environmental health effects of the PMN
substances may be potentially useful in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this SNUR. A toxicokinetics test, a specific target organ
toxicity test, and a chronic aquatic organism toxicity test would help
EPA determine the potential health and environmental effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions remain in effect until the Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR citations: 40 CFR 721.11319 (P-18-200) and 40 CFR 721.11320 (P-
18-201).
PMN Number: P-18-235
Chemical Name: Naphtha oils (generic).
CAS Number: Not Available.
Effective date of TSCA section 5(e) Order: April 10, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
use of the PMN substance will be as a component in automotive gasoline
and transportation fuel for consumer use. EPA identified concerns for
neurological, liver, kidney, developmental, immunological,
carcinogenic, mutagenic and irritation effects based on estimated
physical/chemical properties and analysis of test data on structurally
analogous chemical substances. In addition, based on SAR analysis of
test data on analogous neutral organics, EPA predicts acute and chronic
toxicity to aquatic organisms may occur at concentrations greater than
88 ppb and 3 ppb respectively. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation the
substance may present an unreasonable risk of injury to human health
and the environment. The Order was also issued under TSCA sections
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the
substance is or will be produced in substantial quantities and that the
substance either enters or may reasonably be anticipated to enter the
environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the Order requires:
1. No domestic manufacture of the PMN substance (import only).
2. Processing and use of the PMN substance only for the
confidential use specified in the PMN.
The SNUR designate as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this SNUR. EPA has also determined that specific product
composition testing of the PMN substance would be useful in determining
the health and environmental effects of the PMN substance. Although the
Order does not require this test, the Order's restrictions remain in
effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citation: 40 CFR 721.11321.
PMN Number: P-18-238
Chemical Name: Saccharide reaction products with acid anhydride,
etherified (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a binder for wood panels. Based on the estimated physical
chemical properties of the PMN substance, structural alerts, data on an
analogue of a potential metabolites, and test data on analogous esters,
EPA has identified skin and respiratory sensitization, germ cell
mutagenicity, carcinogenicity, reproductive/developmental, liver, and
kidney toxicity if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include this protective measure:
No manufacturing, processing, or use that results 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 health effects of the PMN substance may be
potentially useful 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 absorption,
specific target organ toxicity, sensitization, genetic toxicology, and
reproductive/developmental toxicity testing would help characterize the
potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11322.
PMN Number: P-18-307
Chemical Name: Alkyl alkenoic acid, alkyl ester, telomer with alkyl
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol, substituted
carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate
(generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a binder resin in
coatings. Based on the estimated and measured physical chemical
properties of the PMN substance, data submitted on the new chemical
substance, and comparison with structurally analogous chemical
substances, EPA has identified concerns for systemic effects if the
chemical substance 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:
No manufacture (including import) of the PMN substance
with more than 5% of the molecular weight content less than 1,000
Daltons.
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 health effects of the PMN substance may be
potentially useful to 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
toxicokinetic and specific target organ toxicity testing would help
characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11323.
PMN Number: P-18-312
Chemical Name: Formaldehyde, polymer with 2-phenoxyalkanol and
.alpha.-phenyl-.omega.
[[Page 38166]]
hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen phosphate 2-phenoxyalkyl
hydrogen phosphate, alkaline salt (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a dispersing agent.
Based on the estimated physical chemical properties of the PMN
substance and hazard data on chemically analogous substances, EPA has
identified concerns for lung effects, eye irritation, and systemic
(blood/kidney) effects, if the chemical substance 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:
1. No manufacturing, processing, or use that results in inhalation
exposures; and
2. No manufacture of the PMN substance with greater than 20%
(weight percent) components with molecular weight below 500 Daltons.
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 health effects of the PMN substance may be
potentially useful 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 composition
of low molecular weight (LMW) species and specific organ toxicity
testing for the LMW species would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11324.
PMN Number: P-19-8
Chemical Name: Substituted polyalkylenepolycarbomonocycle ester,
polymer with dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs.,
(alkoxyalkoxy) alkanol-blocked (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a component in coating resin products that are applied by
cathodic electrodeposition and used as additives for corrosion
protection. Based on the estimated physical chemical properties of the
PMN substance and comparison with structurally analogous chemical
substances, EPA has identified concerns for irritation, lung effects,
immunotoxicity, and blood effects if the chemical substance 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:
1. No manufacture (including import) or processing the PMN
substance in the forms of a powder or solid; and
2. No use of the PMN substance involving application methods that
generate 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 health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of pulmonary
effects and specific target organ toxicity testing would help
characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11325.
PMN Number: P-19-9
Chemical Name: Carbonmonocycles, polymer with haloalkyl substituted
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamineterminated, hydroxyalkylated, acetates (salts) (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a corrosion protection additive in resin for cathodic
electrodeposition dip coating for metal substrates. Based on the
estimated physical chemical properties of the PMN substance and
comparison with structurally analogous chemical substances, EPA has
identified concerns for lung effects and irritation if the chemical
substance 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:
1. No manufacturing (including import), processing, or use that
results in inhalation exposures; and
2. No manufacture beyond an annual production volume of 85,000 kg.
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 health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of pulmonary
effects and skin irritation testing would help characterize the
potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11326.
PMN Number: P-19-26
Chemical Name: Alkanoic acid, compds. with substituted
carbomonocycle-dialkyl-alkanediamine-halosubstituted heteromonocycle-
polyalkylene glycol polymerdialkanolamine reaction products (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a component in coating resin products that are applied by
cathodic electrodeposition and as an additive for corrosion protection.
Based on the estimated physical chemical properties of the PMN
substance, comparison with structurally analogous chemical substances,
and Structure Analysis Relationships (SAR) analysis of test data on
cationic polymers, EPA has identified concerns for irritation, lung
effects, and aquatic toxicity at concentrations greater than 15 ppb if
the chemical substance is not used following the limitation noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
1. No manufacturing (including import), processing, or use that
results in inhalation exposures to vapor, particulate, mist or
aerosols; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance exceeding a surface water
concentration of 15 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 human health and environmental effects of the PMN
substance may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of pulmonary effects, skin irritation, and aquatic toxicity testing
would help characterize the potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11327.
PMN Number: P-19-27
Chemical Name: Substituted carbomoncycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide
and dialkanolamine, acetates (salt) (generic).
[[Page 38167]]
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an isolated intermediate incorporated as a component in
coating resin products that are applied by cathodic electrodeposition
and used as additives for corrosion protection. Based on the estimated
physical chemical properties of the PMN substance, comparison with
structurally analogous chemical substances, and Structure Analysis
Relationships (SAR) analysis of test data on analogous cationic
polymers, EPA has identified lung effects and aquatic toxicity if the
chemical substance 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:
1. No manufacturing, processing, or use that results in inhalation
exposures to vapor, particulate, mist or aerosols; and
2. No manufacture (including import) of an annual production volume
of the PMN substance greater than 95,600 kg.
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 human health and environmental effects of the PMN
substance may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of pulmonary effects and aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11328.
PMN Number: P-19-45
Chemical Name: Non-metal tetrakis (hydroxyalkyl)-, halide, polymer
with amide oxidized (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of a
textile coating. Based on the estimated physical chemical properties of
the PMN substance and comparison with structurally analogous chemical
substances, EPA has identified effects concerns for irritation to the
skin and eyes, skin sensitization, and reproductive and developmental
toxicity if the chemical substance 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:
1. No manufacturing, processing, or use that results in inhalation
exposures;
2. No manufacturing that results in unbound formaldehyde residuals
greater than 0.1%; and
3. No manufacturing, processing, or use other than the confidential
use described in the PMN.
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 human health toxicity of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of skin and eye
irritation, skin sensitization, and developmental toxicity testing
would help characterize the potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11329.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these proposed SNURs, EPA concluded that for 7
chemical substances regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) Orders requiring the use of
appropriate exposure controls were negotiated with the PMN/MCAN
submitters. The SNURs would identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to the restrictions imposed by the underlying
Orders, consistent with TSCA section 5(f)(4).
During review of the other 24 chemical substances that are the
subject of these SNURs and as further discussed in Unit IV, EPA
identified circumstances different from the intended conditions of use
identified in the PMNs that raised potential risk concerns. EPA
determined that deviations from the protective measures identified in
the submissions could result in changes in the type or form of exposure
to the chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances, and therefore warranted SNURs. The
SNURs would identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the protection measures in the submission.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with respect to the significant new
uses that would be designated in this proposed rule:
EPA would receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
EPA would be required to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA would be required to either determine that the
prospective manufacture or processing is not likely to present an
unreasonable risk, or to take necessary regulatory action associated
with any other determination, before the described significant new use
of the chemical substance occurs.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. 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 chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use.
[[Page 38168]]
However, TSCA section 5(e) Orders have been issued for 7 of the 31
chemical substances, and the PMN submitters are prohibited by the TSCA
section 5(e) Orders from undertaking activities which would be
designated as significant new uses. The identities of 25 of the 31
chemical substances subject to this proposed rule have been claimed as
confidential (per Sec. Sec. 720.85 and 725.85) for a chemical
substance covered by this action. Based on this, the Agency believes
that it is highly unlikely that any of the significant new uses
described in the regulatory text of this proposed rule are ongoing.
Therefore, EPA designates August 6, 2019 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 as of 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
wait until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required with that determination.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: Development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (see 40 CFR 720.50 and 725.155).
However, upon review of PMNs and SNUNs, the Agency has the authority to
require appropriate testing. Unit IV. lists potentially useful
information identified by EPA that would help characterize the
potential health and/or environmental effects of the PMN/SNUN substance
for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg
Amendments have led to modifications in our approach to testing
requirements, including an increased consideration of alternatives to
vertebrate testing. Descriptions of tests/information needs are
provided for informational purposes only and EPA strongly encourages
persons, before performing any testing, to consult with the Agency
pertaining to protocol selection. 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 potentially useful information. EPA
encourages dialogue with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development test guidelines are available from the
OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN or MCAN, including submission of test data
on health and environmental effects as described in 40 CFR 720.50 or
725.160. 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 (or 40 CFR 725.25
and Sec. 725.27). E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0359.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNURs for several new chemical
substances that were the subject of PMNs and TSCA section 5(e) Orders.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to this proposed
rule 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,
[[Page 38169]]
but do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the Regulatory Flexibility Act (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, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a
fraction of these were from small businesses. In addition, the Agency
currently offers relief to qualifying small businesses by reducing the
SNUN submission fee from $16,000 to $2,800. This lower fee reduces the
total reporting and recordkeeping of cost of submitting a SNUN to about
$10,116 for qualifying small firms. Therefore, the potential economic
impacts of complying with this proposed SNUR are not expected to be
significant or adversely impact a substantial number of small entities.
In a SNUR that published in the Federal Register of June 2, 1997 (62 FR
29684) (FRL-5597-1), the Agency presented its general determination
that final SNURs are not expected to have a significant economic impact
on a substantial number of small entities, which was provided to the
Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 11632
This proposed rule would not have a substantial direct effect on
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled ``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action.
G. Executive Order 13045
This proposed rule is not subject to Executive Order 13045,
entitled ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001),
because this proposed rule is not expected to affect energy supply,
distribution, or use and because this proposed rule is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this proposed rule would not involve any
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not
apply to this action.
J. Executive Order 12898
This proposed rule does not entail special considerations of
environmental justice related issues as delineated by Executive Order
12898, entitled ``Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations'' (59 FR 7629, February
16, 1994).
List of Subjects in 40 CFR Parts 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 26, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PARTS 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625(c).
0
2. Add Sec. Sec. 721.11300 through 721.11329 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11300 Alkanes, C11-16-branched and linear.
721.11301 Alkyl alkenoic acid, alkoxyalkyl ester, polymer with alkyl
alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl
alkenaote (generic).
721.11302 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-,
reaction products with propylene oxide (generic).
721.11303 2-Oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and
tetrahydro-2H-pyran-2-one (generic).
721.11304 Dicarboxylic acids, polymers with alkanoic acid,
alkanediol, substituted-alkylalkanoic acid, substituted alkyl
carbomonocycle, alkanedioic acid, alkanolamine blocked compds with
alkanolamine (generic).
721.11305 Unsaturated polycyclic hydrocarbon (generic).
721.11306 Glycerides, soya mono- and di-, epoxidized, acetates.
721.11307 Glycerides, C16-18 and C18-unsatd. mono- and di-,
epoxidized, acetates.
721.11308 Mixed metal oxide (generic).
721.11309 Urea, reaction products with N-butylphosphorothioic
triamide and formaldehyde.
721.11310 Fatty acid reaction products with ethyleneamines and
dialkyl ester (generic).
[[Page 38170]]
721.11311 Pentaerythritol, mixed esters with linear and branched
fatty acids (generic).
721.11312 Alcohol capped polycarbodiimide from
diethyldiisocyanatobenzene (generic).
721.11313 Oxirane, 2-methyl-, polymer with methoxirane homopolymer,
1,1'-methylenebis[4-isocyanatobenzene], and glycerol-propylene oxide
polymer (generic).
721.11314 Oxirane, 2-methyl-, polymer with methoxirane homopolymer,
1,1'-methylenebis[isocyanatobenzene], and glycerol-propylene oxide
polymer (generic).
721.11315 Lithium nickel hydride oxide.
721.11316 Lithium nickel potassium oxide.
721.11317 Hydrolyzed functionalized di-amino silanol polymer
(generic).
721.11318 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-
methylenebis[4-isocyanatocyclohexane], pentaerythritol, triacrylate-
blocked, compds. with triethylamine (generic).
721.11319 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, triethylene
glycol, trimethylolalkane and polypropylene glycol (generic).
721.11320 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol glycol,
trimethylolalkane and polypropylene glycol (generic).
721.11321 Naphtha oils (generic).
721.11322 Saccharide reaction products with acid anhydride,
etherified (generic).
721.11323 Alkyl alkenoic acid, alkyl ester, telomere with alkyl
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol,
substituted carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl
alkyl alkenoate (generic).
721.11324 Formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-
phenyl-.omega.hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen
phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt
(generic).
721.11325 Substituted polyalkylenepolycarbomonocycle ester, polymer
with dialkanolamine, (hydroxyalkoxy)carbonyl] derivs.,
(alkoxyalkoxy) alkanol blocked (generic).
721.11326 Carbonmonocycles, polymer with haloalkyl substituted
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)],
dialkyl-alkanediamineterminated, hydroxyalkylated, acetates (salts)
(generic).
721.11327 Alkanoic acid, compds. with substituted carbomonocycle-
dialkyl-alkanediamine-halosubstituted heteromonocycle-polyalkylene
glycol polymerdialkanolamine reaction products (generic).
721.11328 Substituted carbomoncycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal
oxide and dialkanolamine, acetates (salt) (generic).
721.11329 Non-metal tetrakis (hydroxyalkyl)-, halide, polymer with
amide oxidized (generic).
* * * * *
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec. 721.11300 Alkanes, C11-16-branched and linear.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes, C11-16-
branched and linear (PMN P-16-400, CAS No. 1809170-78-2) 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 use the
substance other than as a chemical intermediate, in cured coatings,
cleaning fluids, metalworking fluids/rolling oils, and in
agrochemicals.
(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. 721.11301 Alkyl alkenoic acid, alkoxyalkyl ester, polymer with
alkyl alkenoate, alkyl alkyl alkenoate and tris alkyl silyl alkyl
alkenaote (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alkyl
alkenoic acid, alkoxyalkyl ester, polymer with alkyl alkenoate, alkyl
alkyl alkenoate and tris alkyl silyl alkyl alkenoate (PMN P-17-119) 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(f). It is a significant new use to
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposures.
(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. 721.11302 Alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-
, reaction products with propylene oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified
alkyldiamine, aminoalkyl dimethylaminoalkyl dimethyl-, reaction
products with propylene oxide (PMN P-17-191) 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 any manner that generates a spray, mist, or aerosol.
(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. 721.11303 2-Oxepanone, reaction products with alkylenediamine-
alkyleneimine polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-
2H-pyran-2-one (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2-
oxepanone, reaction products with alkylenediamine-alkyleneimine
polymer, 2-[[(2-alkyl)oxy]alkyl]oxirane and tetrahydro-2H-pyran-2-one
(PMN P-17-220) 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(f) and (j). It is a significant new use to
manufacture or import the PMN substance other than in liquid form.
(ii) [Reserved]
[[Page 38171]]
(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. 721.11304 Dicarboxylic acids, polymers with alkanoic acid,
alkanediol, substituted-alkylalkanoic acid, substituted alkyl
carbomonocycle, alkanedioic acid, alkanolamine blocked compds with
alkanolamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as
dicarboxylic acids, polymers with alkanoic acid, alkanediol,
substituted-alkylalkanoic acid, substituted alkyl carbomonocycle,
alkanedioic acid, alkanolamine blocked compds with alkanolamine (P-17-
387 and P-17-388) are 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 substances
resulting in amine counter ions greater than 4% by weight, isocyanate
residuals greater than 0.1% by weight, or a proportion of the acid
group greater than 20% by weight. It is a significant new use to
manufacture, process, or use the PMN substances that results in the
average molecular weight smaller than the molecular weight specified in
the PMNs or proportion of the low molecular weight species greater than
the values specified in the PMNs for the 500 and 1000 dalton species.
(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 these substances.
(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. 721.11305 Unsaturated polycyclic hydrocarbon (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
unsaturated polycyclic hydrocarbon (PMN P-17-419) 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), (4), when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (5)(respirators
must provide a National Institute for Occupational Safety and Health
(NIOSH) assigned protection factor (APF) of at least 50), (6)(v), (vi),
(b)(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (vi), (ix), (skin sensitization), (specific target organ
toxicity), (2)(i), (ii), (iv), (v), (3)(i), (ii), (4)(iii), and (5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (t). It is a significant new use to
manufacture the substance for more than 9 months.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11306 Glycerides, soya mono- and di-, epoxidized, acetates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycerides, soya
mono- and di-, epoxidized, acetates (P-18-7, CAS No. 2097734-14-8) 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 substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=9,000.
(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. 721.11307 Glycerides, C16-18 and C18-unsatd. mono- and di-,
epoxidized, acetates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycerides, C16-18
and C18-unsatd. mono- and di-, epoxidized, acetates (P-18-8, CAS No.
2097734-15-9) 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 substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=9,000.
(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.
[[Page 38172]]
Sec. 721.11308 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as mixed
metal oxide (PMN P-18-55) 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), (3), (4) when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (5)(respirators
must provide a National Institute for Occupational Safety and Health
(NIOSH) assigned protection factor (APF) of at least 1,000),
(6)(particulate), (b)(concentration set at 0.1%), and (c).
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 0.04 mg/m\3\ as
an 8-hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by the EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
(B) [Reserved]
(ii) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d) (e)(concentration set at 0.1%), (f), (g)(1)(ii),
(vii), (allergic skin reaction), (respiratory sensitization), (germ
cell mutagenicity), (2)(i), (ii), (iii), (iv) (use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.04 mg/m\3\), (v), and (5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11309 Urea, reaction products with N-butylphosphorothioic
triamide and formaldehyde.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as urea, reaction
products with N-butylphosphorothioic triamide and formaldehyde (P-18-
77, CAS No. 2093385-47-6) 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 any manner that results
in inhalation exposures.
(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 (f) 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. 721.11310 Fatty acid reaction products with ethyleneamines and
dialkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as fatty
acid reaction products with ethyleneamines and dialkyl ester (P-18-85)
is subject to reporting under this section for the significant new use
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 substance in
any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11311 Pentaerythritol, mixed esters with linear and branched
fatty acids (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
pentaerythritol, mixed esters with linear and branched fatty acids (PMN
P-18-101) 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 (y)(1).
(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. 721.11312 Alcohol capped polycarbodiimide from
diethyldiisocyanatobenzene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alcohol
capped polycarbodiimide from diethyldiisocyanatobenzene (PMN P-18-107)
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 the substance with a residual
isocyanate level greater than 0.1%.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 38173]]
(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. 721.11313 Oxirane, 2-methyl-, polymer with methoxirane
homopolymer, 1,1'-methylenebis[4-isocyanatobenzene], and glycerol-
propylene oxide polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1'-
methylenebis[4-isocyanatobenzene], and glycerol-propylene oxide polymer
(P-18-118) 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 any manner that results
in inhalation exposures. It is a significant new use to manufacture,
process, or use the substance with isocyanate residuals greater than
0.1%.
(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. 721.11314 Oxirane, 2-methyl-, polymer with methoxirane
homopolymer, 1,1'-methylenebis[isocyanatobenzene], and glycerol-
propylene oxide polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
oxirane, 2-methyl-, polymer with methoxirane homopolymer, 1,1'-
methylenebis[isocyanatobenzene], and glycerol-propylene oxide polymer
(P-18-119) 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 any manner that results
in inhalation exposures. It is a significant new use to manufacture,
process, or use the substance with isocyanate residuals greater than
0.1%.
(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. 721.11315 Lithium nickel hydride oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium nickel
hydride oxide (P-18-123, CAS No. 2081933-92-6) 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), (3), (4), (5)(respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50), When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (6)(particulate), and (c).
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order for this substance. The NCEL is 0.05
mg/m\3\ as an 8-hour time weighted average. Persons who wish to pursue
NCELs as an alternative to Sec. 721.63 respirator requirements may
request to do so under Sec. 721.30. Persons whose Sec. 721.30
requests to use the NCELs approach are approved by EPA will be required
to follow NCELs provisions comparable to those contained in the
corresponding TSCA section 5(e) consent order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (ii), (iii), (iv), (vii),
(viii), (ix), (eye irritation), (2)(i), (ii), (iii), (iv)(use
respiratory protection or maintain workplace airborne concentrations at
or below an 8-hour time-weighted average of 0.05 mg/m\3\), (v), (skin
irritation), (3)(ii), (4)(i), (5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance for more than six
months.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=32.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k), are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11316 Lithium nickel potassium oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium nickel
potassium oxide (P-18-124, CAS No. 210352-95-7) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2), (3), (4), (5)(respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50), When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
and (a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (6)(particulate), and (c).
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) consent order
[[Page 38174]]
for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour time weighted
average. Persons who wish to pursue NCELs as an alternative to Sec.
721.63 respirator requirements may request to do so under Sec. 721.30.
Persons whose Sec. 721.30 requests to use the NCELs approach are
approved by EPA will be required to follow NCELs provisions comparable
to those contained in the corresponding TSCA section 5(e) consent
order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (ii), (iii), (iv), (vii),
(viii), (ix), (eye irritation), (2)(i), (ii), (iii), (iv)(use
respiratory protection or maintain workplace airborne concentrations at
or below an 8-hour time-weighted average of 0.05 mg/m\3\), (v), (skin
irritation), (3)(ii), (4)(i), (5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance for more than six
months.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=32.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k), are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11317 Hydrolyzed functionalized di-amino silanol polymer
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
hydrolyzed functionalized di-amino silanol polymer (PMN P-18-152) 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 any manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N=3.
(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. 721.11318 Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-,
polymer with dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-
methylenebis[4-isocyanatocyclohexane], pentaerythritol, triacrylate-
blocked, compds. with triethylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with
dimethyl carbonate, 1,6-hexanediol, diamine and 1,1'-methylenebis[4-
isocyanatocyclohexane], pentaerythritol, triacrylate-blocked, compds.
with triethylamine (PMN P-18-169) 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)(2)(i), (3), (4) and (5) (respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 1,000 for spray applications and of
at least 50 for non-spray applications). When determining which persons
are reasonably likely to be exposed as required for in Sec.
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure
or confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture (including import) the PMN substance
with triethylamine concentration no greater than the confidential
concentration described in the PMN.
(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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11319 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, triethylene glycol,
trimethylolalkane and polypropylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as waste
plastics, poly(ethylene terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, triethylene glycol, trimethylolalkane
and polypropylene glycol. (PMN P-18-200) 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), (3), (4), (5)(respirators must provide a National
Institute for Occupational Safety and Health assigned protection factor
of at least 10), when determining which persons are reasonably likely
to be exposed as required for Sec. 721.63(a)(1), (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, (6)(particulate),
(b)(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv),
(2)(i), (iv), (v), (avoid eye contact), (use eye protection), (3)(i),
(ii), (4)(water releases restrictions apply), and (5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System (GHS) and OSHA Hazard Communication Standard may be
used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=280.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are
[[Page 38175]]
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. 721.11320 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol glycol,
trimethylolalkane and polypropylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as waste
plastics, poly(ethylene terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol glycol, trimethylolalkane and
polypropylene glycol (P-18-201) 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), (3), (4), (5)(respirators must provide a National
Institute for Occupational Safety and Health assigned protection factor
of at least 10), when determining which persons are reasonably likely
to be exposed as required for Sec. 721.63(a)(1), (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, (6)(particulate),
(b)(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv),
(2)(i), (iv), (v), (avoid eye contact), (use eye protection), (3)(i),
(ii), (4)(water releases restrictions apply), and (5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System (GHS) and OSHA Hazard Communication Standard may be
used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N=280.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11321 Naphtha oils (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as naphtha
oils (PMN P-18-235) 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 (f) and (j).
(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. 721.11322 Saccharide reaction products with acid anhydride,
etherified (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
saccharide reaction products with acid anhydride, etherified (PMN P-18-
238) 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 substance in
any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11323 Alkyl alkenoic acid, alkyl ester, telomere with alkyl
alkenoate, substituted alkyl alkyl alkenoate, alkylthiol, substituted
carbomonocycle, hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alkyl
alkenoic acid, alkyl ester, telomer with alkyl alkenoate, substituted
alkyl alkyl alkenoate, alkylthiol, substituted carbomonocycle,
hydroxyalkyl alkyl alkenoate and alkyl alkyl alkenoate (PMN P-18-307)
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 (including import) the PMN substance
with more than 5% of the molecular weight content less than 1,000
Daltons.
(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. 721.11324 Formaldehyde, polymer with 2-phenoxyalkanol and
.alpha.-phenyl-.omega. hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen
phosphate 2-phenoxyalkyl hydrogen phosphate, alkaline salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
formaldehyde, polymer with 2-phenoxyalkanol and .alpha.-phenyl-.omega.
hydroxypoly(oxy-1,2-alkylenediyl), dihydrogen phosphate 2-phenoxyalkyl
hydrogen phosphate, alkaline salt (PMN P-18-312) 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 substance in
any manner that results in inhalation exposure. It is a significant new
use to manufacture the PMN substance with greater than 20% (weight
percent) components with molecular weight below 500 Daltons.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 38176]]
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. 721.11325 Substituted polyalkylenepolycarbomonocycle ester,
polymer with dialkanolamine, (hydroxyalkoxy)carbonyl] derivs.,
(alkoxyalkoxy) alkanol blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted polyalkylenepolycarbomonocycle ester, polymer with
dialkanolamine, [(hydroxyalkoxy)carbonyl] derivs., (alkoxyalkoxy)
alkanol-blocked (PMN P-19-8) 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(w)(1)(2), (x)(1)(2), and (y)(1)(2).
(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. 721.11326 Carbonmonocycles, polymer with haloalkyl substituted
heteromonocycle and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamineterminated, hydroxyalkylated, acetates (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
carbonmonocycles, polymer with haloalkyl substituted heteromonocycle
and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], dialkyl-
alkanediamineterminated, hydroxyalkylated, acetates (salts) (PMN P-19-
9) 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 substance in
any manner that results in inhalation exposure to vapor, particulate,
mist or aerosols. It is a significant new use to manufacture the PMN
substance beyond an annual production volume of 85,000 kg.
(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. 721.11327 Alkanoic acid, compds. with substituted
carbomonocycle-dialkyl-alkanediamine-halosubstituted heteromonocycle-
polyalkylene glycol polymerdialkanolamine reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkanoic acid, compds. with substituted carbomonocycle-dialkyl-
alkanediamine-halosubstituted heteromonocycle-polyalkylene glycol
polymerdialkanolamine reaction products (PMN P-19-26) 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 substance in
any manner that results in inhalation exposure to vapor, particulate,
mist or aerosols.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=15.
(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 (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. 721.11328 Substituted carbomoncycle, polymer with haloalkyl
substituted heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide
and dialkanolamine, acetates (salt) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted carbomoncycle, polymer with haloalkyl substituted
heteromonocycle, dialkyl-alkanediamine and hydro-
hydroxypoly[oxy(alkylalkanediyl)], reaction products with metal oxide
and dialkanolamine, acetates (salt) (PMN P-19-27) 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 any manner that results in inhalation exposure to vapor,
particulate, mist or aerosols. It is a significant new use to
manufacture the PMN substance beyond an annual production volume of
95,600 kg.
(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. 721.11329 Non-metal tetrakis (hydroxyalkyl)-, halide, polymer
with amide oxidized (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as non-
metal tetrakis (hydroxyalkyl)-, halide, polymer with amide oxidized
(PMN P-19-45) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure. It is a significant new use to manufacture the
substance that results in unbound formaldehyde residuals greater than
0.1%.
(ii) [Reserved]
[[Page 38177]]
(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.
[FR Doc. 2019-16539 Filed 8-5-19; 8:45 am]
BILLING CODE 6560-50-P