[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Proposed Rules]
[Pages 9999-10019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04457]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2018-0697; FRL-9986-83]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 28 chemical substances which
were the subject of premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA pursuant to section 5(e)
of TSCA. This action would require persons who intend to manufacture
(defined by statute to include import) or process any of these 28
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 intended
use within the applicable review period. Persons may not commence
manufacture or processing for the significant new use until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.
DATES: Comments must be received on or before May 3, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0697, 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 April
18, 2019 are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
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 are subject to
Orders issued by EPA pursuant to section 5(e) of TSCA. 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 that may be presented by the intended
uses and, if appropriate, to regulate the proposed use before it
occurs. Additional rationale and background to these proposed rules are
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
[[Page 10000]]
further 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 rule, recordkeeping
requirements, and exemptions to reporting requirements. Provisions
relating to user fees appear at 40 CFR part 700. According 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). In particular, these requirements include the
information submission requirements of TSCA section 5(b) and 5(d)(1),
the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA must either determine that the significant new use is not
likely to present an unreasonable risk of injury or take such
regulatory action as is associated with an alternative determination
before the manufacture or processing for the significant new use can
commence. If EPA determines that the significant new use is not likely
to present an unreasonable risk, EPA is required under TSCA section
5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 28
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances and
potential human exposures and environmental releases that may be
associated with the conditions of use of the substances, in the context
of the four bulleted TSCA section 5(a)(2) factors listed in this unit.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 28 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the TSCA section 5(e) Order.
Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substance in support of a request by the PMN submitter to modify the
Order, or if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR. This information
may include testing required in a TSCA section 5(e) Order to be
conducted by the PMN submitter, as well as testing not required to be
conducted but which would also help characterize the potential health
and/or environmental effects of the PMN substance. Any recommendation
for information identified by EPA was made based on EPA's consideration
of available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models. EPA also recognizes that
whether testing/further information is needed will depend on the
specific exposure and use scenario in the SNUN. EPA encourages all SNUN
submitters to contact EPA to discuss any potential future testing. See
Unit 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 28 PMN substances that are subject to Orders issued under TSCA
section 5(e)(1)(A). Each Order is based on one or more of the findings
in TSCA section 5(a)(3)(B): There is insufficient information to permit
a reasoned evaluation; in the absence of sufficient information to
permit a reasoned evaluation, the activities associated with the PMN
substances may present unreasonable risk to health or the environment;
the substance is or will be produced in substantial quantities, and
enters or may reasonably be anticipated to enter the environment in
substantial quantities or there is or may be significant (substantial)
human exposure to the substance. Those Orders require protective
measures to limit exposures or otherwise mitigate the potential
unreasonable risk. The 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
[[Page 10001]]
show that air-borne concentrations of the PMN substance are below a New
Chemical Exposure Limit (NCEL) that is established by EPA to provide
adequate protection to human health. In addition to the actual NCEL
concentration, the comprehensive NCELs provisions in TSCA section 5(e)
Orders, which are modeled after Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) provisions,
include requirements addressing performance criteria for sampling and
analytical methods, periodic monitoring, respiratory protection, and
recordkeeping. However, no comparable NCEL provisions currently exist
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases,
the individual SNURs in 40 CFR part 721, subpart E, will state that
persons subject to the SNUR who wish to pursue NCELs as an alternative
to the Sec. 721.63 respirator requirements may request to do so under
Sec. 721.30. EPA expects that persons whose Sec. 721.30 requests to
use the NCELs approach for SNURs that are approved by EPA will be
required to comply with NCELs provisions that are comparable to those
contained in the corresponding TSCA section 5(e) Order for the same
chemical substance.
PMN Numbers: P-15-353 and P-15-433
Chemical Names: Fatty acids, C16 and C18-unsaturated, methyl
esters, chlorinated (P-15-353) and chlorinated complex esters (generic)
(P-15-433).
CAS Numbers: 1642303-17-0 (P-15-353) and not available (P-15-433).
Effective date of TSCA section 5(e) Order: July 25, 2018.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the PMN substances will be as lubricant
additives. Based on submitted analogue data, EPA has identified concern
for irritation. Based on the physical/chemical properties of the PMN
substances (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 substances are potentially persistent,
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN
substances will persist in the environment for more than two months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
The Order was issued under TSCA section 5(a)(3)(B)(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 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. Submission to EPA of certain testing before exceeding the three-
year time limit specified in the Order; and
2. Use of the PMN substances only for the confidential uses
specified in the Order.
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 fate and environmental effects of the PMN
substances may be potentially useful to characterize the effects of the
PMN substances in support of a request by the PMN submitter to modify
the Order, or if a manufacturer or processor is considering submitting
a SNUN for a significant new use that would be designated by this
proposed SNUR. The submitter has agreed not to manufacture the PMN
substances beyond three years without performing a specific
biodegradation study and an ecotoxicity testing scheme for P-15-353 to
determine the rate of loss of the parent PMN substances and formation
and identification of degradation products, and to assess their
toxicity.
CFR citation: 40 CFR 721.11221 (P-15-353) and 40 CFR 721.11222 (P-
15-433).
PMN Number: P-16-186
Chemical Name: Sodium branched chain alkyl hydroxyl and branched
chain alkenyl sulfonates (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: June 26, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a surfactant. EPA
identified concern for lung effects based on surfactant activity if
respirable particles are inhaled and concern for irritation based on
potential surfactant activity to all exposed tissues. EPA also
identified concern for developmental toxicity based on data provided
for an analogue. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health and the environment. To protect against these risks, the
Order requires:
1. Use of personal protective equipment to prevent dermal exposure
where there is a potential for dermal exposure;
2. Refraining from modifying the manufacture, processing or use of
the PMN substance in a manner that results in inhalation exposure to
vapor, dust, spray, mist or aerosol;
3. Use of the PMN substance only for the confidential use specified
in the Order; and
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and
Safety Data Sheet (SDS).
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 to characterize the effects of the PMN substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this proposed SNUR. EPA
has also determined that the results of specific pulmonary toxicity
testing would help characterize the potential health effects of the PMN
substance. Although the Order does not require this test, the Order's
restrictions on manufacture, processing, distribution in commerce, and
use of the PMN substance will 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 721.11223.
PMN Number: P-16-207
Chemical Name: Spiro tetrafluoroborate (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: August 6, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as an additive for an electrolyte solution. Based
on physical/chemical properties and analysis of test data on the PMN
substance, EPA has identified concern for developmental neurotoxicity,
effects to the bladder, liver, kidney, thymus, stomach, thyroid, and
blood. 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
[[Page 10002]]
risk of injury to human health or the environment. To protect against
these risks, the Order requires:
1. Submission to EPA of certain toxicity testing before exceeding
the aggregate volumes specified in the Order;
2. Use of personal protective equipment where there is potential
for dermal exposure;
3. Use of a National Institute of Occupational Safety and Health
(NIOSH)-certified respirator with an assigned protection factor (APF)
of at least 1000 (where there is potential for inhalation exposure) or
compliance with a NCEL of 0.2 mg/m\3\ as an 8-hour time-weighted
average;
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
5. Refraining from domestic manufacture in the United States (i.e.,
import only); and
6. Use of the PMN substance only for the confidential use specified
in the Order.
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 environmental and 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. The submitter has agreed not to exceed a certain production
volume limit without performing specific reproductive toxicity testing
and acute aquatic toxicity testing.
CFR citation: 40 CFR 721.11224.
PMN Numbers: P-16-246 and P-16-516
Chemical Names: 2-pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester (P-16-246) and 2-
pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-methoxyphenyl)-
5-fluoro-, phenylmethyl ester, hydrochloride (1:1) (P-16-516).
CAS Numbers: 1391033-38-7 (P-16-246) and not available (P-16-516).
Effective date of TSCA section 5(e) Order: May 21, 2017.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as chemical
intermediates. Based on analysis of test data on analogous esters, EPA
has identified concerns for carcinogenicity, developmental/reproductive
effects, systemic toxicity, sensitization, and aquatic/terrestrial
toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I)
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of
sufficient information to permit a reasoned evaluation, the substances
may present an unreasonable risk of injury human health and the
environment. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing on the PMN substances
prior to exceeding the time limits specified in the Order;
2. Use of personal protective equipment where there is a potential
for dermal exposure;
3. Use of a NIOSH-certified respirator with an APF of at least 50
where there is a potential for inhalation exposure;
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
5. Use of the PMN substances only for the confidential uses
specified in the Order; and
6. No release of the PMN substances to surface waters.
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 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 proposed SNUR. The submitter has agreed not to exceed certain time
limits without performing sensitization, mutagenicity, reproductive/
developmental, and carcinogenicity effects testing. EPA has also
determined that the results of acute aquatic toxicity testing would
help characterize the potential environmental effects of the PMN
substances. Although the Order does not require these tests, the
Order's restrictions on manufacture, processing, distribution in
commerce, and disposal will remain in effect until the Order is
modified or revoked by EPA based on submission of this or relevant
information.
CFR citations: 40 CFR 721.11225 (P-16-246) and 40 CFR 721.11226 (P-
16-516).
PMN Numbers: P-16-271 and P-16-450
Chemical Name: 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl
ester.
CAS Number: 1817723-10-6.
Effective date of TSCA section 5(e) Orders: June 22, 2018.
Basis for TSCA section 5(e) Orders: The PMNs state that the use of
the substance will be used as a plasticizer for wire and cable
insulation. EPA identified concerns for the PMN substance as a mild
skin irritant as well as for blood, developmental, systemic, maternal,
and male reproductive toxicity based on analysis of test data on
analogous trimellitate esters. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health 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 Orders require:
1. Submit to EPA certain toxicity testing before manufacturing
(including import) a total of 1,750,000 kilograms (in each Order) of
the PMN substance;
2. Submit to EPA additional toxicity testing which will be
determined upon EPA review of the initial toxicity testing results;
3. Use of personal protective equipment to prevent dermal exposure
where there is a potential for dermal exposure;
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS and worker training in accordance with the Hazard Communication
section of the Orders;
5. Refraining from domestic manufacture in the United States (i.e.,
import only); and
6. Use of the PMN substance only as plasticizer for wire and cable
insulation.
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 in support of a request by the PMN
submitters 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 proposed SNUR. The submitters have agreed not to
exceed certain production volume limits without performing
reproductive/
[[Page 10003]]
developmental toxicity tests and aquatic sediment toxicity tests.
CFR citation: 40 CFR 721.11227.
PMN Number: P-16-388
Chemical Name: Aliphatic polyamines, polymers with bisphenol A and
epichlorohydrin (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 23, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a hardener for epoxy
coating. Based on the high percentage of amines and a high pH when in
liquid formulation, EPA has identified concern for irritation to the
eyes, skin, mucous membranes, and lungs. The Order was issued under
TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that
the available information is insufficient to permit a reasoned
evaluation of the human health effects of the PMN substances. To
protect against these risks, the Order requires:
1. Use of the PMN substance only for the confidential use specified
in the Order;
2. Use of personal protective equipment to prevent dermal exposure
where there is potential for dermal exposure;
3. No use of the PMN substance in a consumer product; and
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 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 proposed SNUR. EPA has also determined that the results of skin
irritation and skin sensitization toxicity testing would help
characterize the potential health effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions on manufacture, distribution in commerce, and use of the
PMN substance will remain in effect until the Order is modified or
revoked by EPA based on submission of this or relevant information.
CFR citation: 40 CFR 721.11228.
PMN Numbers: P-16-489, P-16-490, and P-16-491
Chemical Name: Epoxy-amine adduct, methanesulfonates (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: June 11, 2018.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be open, non-dispersive.
Based on physical/chemical properties of the PMN substances, EPA has
identified concern for lung toxicity. Ecotoxicity hazards were
identified based on structural analysis relationship (``SAR'')
predictions for polycationic polymers. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to human health and the environment. To protect against these risks,
the Order requires:
1. Refrain from manufacture, processing, or use of the PMN
substances that result in inhalation exposure to vapor, mist, or
aerosols;
2. Refrain from manufacture, processing, or use of the PMN
substances for consumer use;
3. No release of the PMN substances from manufacturing, processing,
or use resulting in surface water concentrations that exceed 208 parts
per billion (ppb); and
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 physical/chemical properties, environmental and
health effects of the PMN substances may be potentially useful to
characterize the effects of the PMN substances in support of a request
by the PMN submitter to modify the Order, or if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has also determined
that the results of certain physical/chemical properties, acute aquatic
toxicity testing, and pulmonary effects testing would help characterize
the potential health effects of the PMN substances. Although the Order
does not require these tests, the Order's restrictions on manufacture,
distribution in commerce, and use of these PMN substances will remain
in effect until the Order is modified or revoked by EPA based on
submission of this or relevant information.
CFR citation: 40 CFR 721.11229.
PMN Number: P-16-509
Chemical Name: Modified ethylene-vinyl alcohol copolymer (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 23, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be for packaging
applications. EPA identified concerns for lung effects if respirable
particles are inhaled based on physical/chemical properties. 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. To protect against
these risks, the Order requires refraining from manufacturing (which
includes import), processing or using the PMN substance with particle
size less than 50 microns.
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 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 proposed SNUR. EPA has also determined that the results of
specific pulmonary toxicity testing would help characterize the
potential health effects of the PMN substance. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information.
CFR citation: 40 CFR 721.11230.
PMN Number: P-16-546
Chemical Name: Cashew, nutshell liq., polymer with acid and
halohydrin (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 20, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as an adhesion application. Based on the presence
of cashew, nutshell liquid in the PMN substance, EPA has identified
concerns for sensitization from dermal exposure. The Order was issued
under TSCA
[[Page 10004]]
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to human health and the environment. To protect against these risks,
the Order requires:
1. Use of personal protective equipment including chemically
impervious gloves and eye goggles where there is a potential for dermal
exposure;
2. Use of a NIOSH-certified respirator with an APF of at least 50
to mitigate inhalation exposure and 1000 where the PMN substance has a
use involving an application that generates vapor, mist, dust or
aerosol;
3. No use of the PMN substance use in a consumer product; and
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 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 proposed SNUR. EPA has also determined that the results of
sensitization testing would help characterize the potential health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions on manufacture, distribution in
commerce, and use of the PMN substance will remain in effect until the
Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citation: 40 CFR 721.11231.
PMN Number: P-16-589
Chemical Name: Pentaerythritol ester of mixed linear and branched
carboxylic acids (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: October 4, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as a synthetic aircraft
engine lubricant for contained use industrial lubricant. EPA identified
concern for developmental, kidney, liver, and specific organ effects
based on test data on the potential branch acid moiety hydrolysis
product of the PMN substance. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
health and the environment. To protect against these risks, the Order
requires:
1. Use of personal protective equipment to prevent dermal exposure
where there is a potential for dermal exposure;
2. Refraining from modifying the manufacture or processing of the
PMN substance in a manner that results in inhalation exposure to the
substance;
3. Use of the PMN substance only for the confidential use specified
in the Order;
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS; and
5. No release of the PMN substance resulting in exceedance of a
surface water concentration of 330 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 environmental fate and health effects of the PMN
substance would 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 the results of
hydrolysis testing and reproductive/developmental toxicity testing
would help characterize the potential health effects of the PMN
substance. Although the Order does not require this test, the Order's
restrictions on manufacture, processing, distribution in commerce, and
use of the PMN substance will remain in effect until the Order is
modified or revoked by EPA based on submission of this or relevant
information.
CFR citation: 40 CFR 721.11232.
PMN number: P-17-116
Chemical Name: Cashew nut shell liquid, branched polyester-
polyether polyol (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: September 6, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substance will be as a polyurethane foam to raise concrete
slabs. Based on the presence of cashew nut shell liquid, there is
concern for sensitization. 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 this risk, the Order requires:
1. Submit to EPA certain toxicity testing before manufacturing
(including import) a total of 65,000 kilograms of the PMN substance;
2. Provide personal protective equipment to its workers to prevent
dermal exposure, including impervious gloves where there is potential
for dermal exposure;
3. Refraining from domestic manufacture in the United States (i.e.,
import only);
4. Manufacture (including import) the PMN substance with no greater
than 0.1% weight cashew nut oil;
5. Not use the PMN substance involving an application method that
results in the generation of vapor, mist, or aerosol; and
6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 in support of a request by the PMN submitters 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 proposed SNUR. The submitter has agreed not to exceed certain
production volume limit without performing sensitization testing.
CFR citation: 40 CFR 721.11233.
PMN Number: P-17-121
Chemical Name: Methylene diphenyl diisocyanate terminated
polyurethane resin (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 17, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a polyurethane used in an adhesive. Based on
the isocyanate moiety, EPA has identified concerns for respiratory and
dermal sensitization and lung and mucous membrane irritation. The Order
was issued under TSCA section 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I)
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to
[[Page 10005]]
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 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. Submitting to EPA the results of annual medical surveillance
monitoring;
2. Use of personal protective equipment to prevent dermal exposure
where there is potential for dermal exposure;
3. Use of NIOSH-certified respirators with an APF of at least 50
where there is potential for inhalation exposure;
4. No application methods of the PMN substance that generate a
vapor, mist, aerosol, spray, or dust;
5. Refrain from manufacturing, processing, or using the PMN
substance for consumer use or for commercial uses that could introduce
the substance into a consumer setting; and
6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 in support of a request by the PMN submitters 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 proposed SNUR. The submitter has agreed to perform annual medical
surveillance monitoring as specified in the Order.
CFR citation: 40 CFR 721.11234.
PMN Number: P-17-328
Chemical Name: 2-Furancarboxylic acid, tetrahydro-.
CAS Number: 16874-33-2.
Effective date of TSCA section 5(e) Order: July 26, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a selective polishing agent for chemical
mechanical planarization slurry for semiconductor wafer processing.
Based on analysis of test data on an analogous chemical, EPA has
identified concern for severe eye irritation, blood effects,
reproductive effects, and immunotoxicity. Based on physical/chemical
properties the substance is also expected to be corrosive, cause skin
and eye burns, systemic effects, respiratory and digestive tract
irritation with possible burns, pulmonary edema, solvent neurotoxicity,
and solvent irritation. 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 or
the environment. To protect against these risks, the Order requires:
1. Use of personal protective equipment involving impervious gloves
and chemical safety goggles where there is potential for dermal
exposure;
2. Use of a NIOSH-certified respirator with an APF of at least 50
where there is a potential for inhalation exposure;
3. Refraining from domestic manufacture in the United States (i.e.,
import only); and
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 to characterize the effects of the PMN substance in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this proposed SNUR. EPA
has also determined that the results of reproductive/developmental
toxicity testing would help characterize the potential health effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions on manufacture, processing, distribution in
commerce, and use of the PMN substance will remain in effect until the
Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citation: 40 CFR 721.11235.
PMN Numbers: P-17-373 and P-17-374
Chemical Names: Substituted heteromonocycle, homopolymer, alkyl
substituted carbamate, substituted alkyl ester, substituted
heteromonocycle, homopolymer, alkyl substituted carbamate, substituted
alkyl ester (generic) (P-17-373) and polysiloxanes, di alkyl,
substituted alkyl group terminated, alkoxylated, reaction products with
alkanoic acid, isocyanate substituted-alkyl carbomonocycle and polyol
(generic) (P-17-374).
CAS Numbers: Not available.
Effective date of TSCA section 5(e) Order: June 7, 2018.
Basis for TSCA section 5(e) Order: The PMNs state that the use of
P-17-373 will be as an ultraviolet curable resin-overprint varnish and
P-17-374 will be as an ultraviolet curable resin. Based on test data
for structurally similar acrylates, EPA has identified concerns for eye
and skin irritation, sensitization, mutagenicity, oncogenicity, liver
and kidney toxicities. EPA also identified concern for developmental
toxicity based on analogy to triethanolamines. Based on analogy to
acrylates and carbamate esters, P-17-374 could cause environmental
effects at concentrations of 110 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 in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to health and the environment. To protect against these risks, the
Order requires:
1. Use of personal protective equipment to prevent dermal exposure
where there is potential for dermal exposure;
2. Use of NIOSH-certified respirators with an APF of at least 50
where there is potential for inhalation exposure;
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
4. Refraining from domestic manufacture in the United States (i.e.,
import only);
5. Import of P-17-374 with no more than 0.1% residual isocyanate;
6. Import of the PMN substances to have a number average molecular
weight of greater than or equal to 1000 daltons;
7. Refraining from using the PMN substances other than as an
ultraviolet curable resin for coatings; and
8. No release of P-17-374 resulting in surface water concentrations
that exceed 110 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 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 proposed SNUR. EPA
[[Page 10006]]
has also determined that the results of sensitization testing would
help characterize the potential health effects of the PMN substances.
Although the Order does not require this test, the Order's restrictions
on manufacture, processing, distribution in commerce, and use of the
PMN substances will remain in effect until the Order is modified or
revoked by EPA based on submission of this or relevant information.
CFR citation: 40 CFR 721.11236 (P-17-373) and 40 CFR 721.11239 (P-
17-374).
PMN Number: P-18-17
Chemical Name: Substituted carbomonocycle, polymer with substituted
heteromonocycle and substituted polyalkylene glycol (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: June 21, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be for corrosion protection. Based on the physical/
chemical properties of the PMN substance, analysis of test data, and
structurally analogous epoxides, EPA identified concerns for
mutagenicity, oncogenicity, developmental toxicity, male reproductive
effects, liver and kidney toxicity, and dermal and respiratory
sensitization. The Order was issued under TSCA section
5(a)(3)(B)(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 health and the environment. To
protect against these risks, the Order requires:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. Refrain from using the PMN substance other than for primer
coating for corrosion protection;
3. Import the PMN substance with an average molecular weight
greater than 1000 daltons with no more than 10% less than 500 daltons
and no more than 25% less than 1000 daltons;
4. Use of personal protective equipment to prevent dermal exposure
where there is potential for dermal exposure;
5. Use of NIOSH-certified respirators with an APF of at least 1000
where there is potential for inhalation exposure; and
6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 environmental and 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 proposed SNUR. EPA has also determined that the
results of water solubility, acute and chronic aquatic toxicity,
systemic toxicity, sensitization, and carcinogenicity testing would
help characterize the potential health and environmental effects of the
PMN substance. Although the Order does not require this information,
the Order's restrictions on manufacture, processing, distribution in
commerce, and use of the PMN substance will remain in effect until the
Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citation: 40 CFR 721.11240.
PMN Number: P-18-40
Chemical Name: Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid,
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl
substituted carbomonocycle and alkyl substituted alkanediol (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 26, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a binder for ultraviolet curable coating
resin. Based on physical/chemical properties, data on the PMN
substance, and analysis of test data on an analogous chemical, EPA has
identified concerns for developmental toxicity, oncogenicity, liver and
kidney toxicity, ocular irritation, sensitization, irritation/
corrosion, and eye damage. The Order was issued under TSCA section
5(a)(3)(B)(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 health or the environment. To protect
against these risks, the Order requires:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. Only use the PMN substance as a binder for ultraviolet curable
coating resins;
3. Import the PMN substance with a number average molecular weight
of greater than 1000 daltons;
4. Import the PMN substance with no greater than 20% of the acid
moiety;
5. Use of personal protective equipment where there is potential
for dermal exposure;
6. Use of a NIOSH-certified respirator with an APF of at least 1000
where there is a potential for inhalation exposure; and
7. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 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 proposed SNUR. EPA has also determined that the
results of water solubility, acute and chronic aquatic toxicity,
systemic toxicity, sensitization, and carcinogenicity testing would
help characterize the potential health and environmental effects of the
PMN substance. Although the Order does not require these tests, the
Order's restrictions on manufacture, processing, distribution in
commerce, and use of the PMN substance will remain in effect until the
Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citation: 40 CFR 721.11241.
PMN Number: P-18-46
Chemical Name: Substituted carbomonocycle, polymer with
diisocyanatoalkane, substituted alkylacrylate blocked (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: June 21, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as an ultraviolet curable resin. Based on
physical/chemical properties, analysis of test data on the PMN
substance, and structurally analogous acrylates, EPA has identified
concerns for mutagenicity, oncogenicity, developmental toxicity, liver
and kidney toxicity, dermal and respiratory sensitization. The Order
was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that
in the absence of sufficient information to permit a reasoned
evaluation, the substance may
[[Page 10007]]
present an unreasonable risk of injury to health and the environment.
To protect against these risks, the Order requires:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. Refrain from using the PMN substance other than as an
ultraviolet curable resin;
3. Import the PMN substance with an average molecular weight
greater than 1390 daltons with no more than 11% less than 500 daltons
and no more than 30% less than 1000 daltons;
4. Use of personal protective equipment to prevent dermal exposure
where there is potential for dermal exposure;
5. Use of NIOSH-certified respirators with an APF of at least 1000
where there is potential for inhalation exposure; and
6. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 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 proposed SNUR. EPA has also determined that the
results of water solubility, acute and chronic aquatic toxicity,
pulmonary toxicity, and sensitization, testing would help characterize
the potential health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions on manufacture, processing, distribution in commerce, and
use of the PMN substance will remain in effect until the Order is
modified or revoked by EPA based on submission of this or relevant
information.
CFR citation: 40 CFR 721.11242.
PMN Number: P-18-47
Chemical Name: 1,2-Ethanediol, 1,2-dibenzoate.
CAS Number: 94-49-5.
Effective date of TSCA section 5(e) Order: July 31, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a phlegmatizer (stabilizer for compounds
susceptible to detonation) for peroxides for use with polyester and
vinyl ester resins as well as with curable unsaturated polyester and
methacrylic resins. Based on test data on the PMN substance, and
analysis of test data on analogous chemicals, EPA has identified
concerns for blood, liver, and kidney toxicity, neurotoxicity,
immunotoxicity, and reproductive and developmental toxicity, and
ecotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(i) and
5(e)(1)(A)(i), based on a finding that the available information is
insufficient to permit a reasoned evaluation of the health 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 in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to health and the
environment. Additionally, the Order was issued under
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 reasonable 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. Use of personal protective equipment where there is potential
for dermal exposure;
2. Use of a NIOSH-certified respirator with an APF of at least 25
where there is a potential for inhalation exposure;
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS;
4. Refraining from domestic manufacture in the United States (i.e.,
import only);
5. Only use the PMN substance as a phlegmatizer (stabilizer for
compounds susceptible to detonation) for peroxides for use with
polyester and vinyl ester resins as well as with curable unsaturated
polyester and methacrylic resins; and
6. No release of the PMN substance resulting in surface water
concentrations that exceed 10 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 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 proposed SNUR. EPA has also determined that the
results of acute aquatic toxicity and neurotoxicity/developmental
neurotoxicity/prenatal development testing would help characterize the
potential health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions on manufacture, processing, distribution in commerce, and
use of the PMN substance will remain in effect until the Order is
modified or revoked by EPA based on submission of this or relevant
information.
CFR citation: 40 CFR 721.11243.
PMN Number: P-18-51
Chemical Name: Alkenoic acid, reaction products with polymers with
isocyanatoalkane and substituted alkanoic acid, substituted
monoacrylate alkanoate-blocked (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 30, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as a waterborne ultraviolet curable coating resin
binder for inkjet, ink, or overprint varnish. Based on physical/
chemical properties, available data on the PMN substance and comparison
to structurally analogous acrylates, EPA has identified concern for
developmental toxicity, sensitization, irritation, corrosion, and eye
damage. The Order was issued under TSCA section 5(a)(3)(B)(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 or the environment. To protect against these
risks, the Order requires:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. Only use the PMN substance as a waterborne ultraviolet curable
coating resin binder for inkjet, ink, or overprint varnish;
3. Import the PMN substance with no greater than 24% branched alkyl
acid moiety content;
4. Import the PMN substance with no greater than 0.1% isocyanate
content;
5. Use of personal protective equipment where there is potential
for dermal exposure;
6. Use of a NIOSH-certified respirator with an APF of at least 1000
where there is a potential for inhalation exposure;
7. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS; and
8. No release of the PMN substance resulting in surface water
concentrations that exceed 660 ppb.
[[Page 10008]]
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 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 proposed SNUR. EPA has also determined that the
results of water solubility, acute and chronic aquatic toxicity,
developmental toxicity, and sensitization testing would help
characterize the potential health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions on manufacture, processing, distribution in commerce, and
use of the PMN substance will remain in effect until the Order is
modified or revoked by EPA based on submission of this or relevant
information.
CFR citation: 40 CFR 721.11244.
PMN Numbers: P-18-71 and P-18-79
Chemical Names: Aromatic dicarboxylic acid, compd. with alkane
diamines, polymer with alkane diamine and alkane dicarboxylic acid
(generic) (P-18-71) and Aromatic dicarboxylic acid, compd. with alkyl
diamines, homopolymer (generic) (P-18-79).
CAS Numbers: Not available.
Effective date of TSCA section 5(e) Order: July 6, 2018.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances will be as engineering
thermoplastic. EPA identified concern for lung effects if the PMN
substances are made with a particle size less than 10 microns based on
analogy to similar poorly soluble particles. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on
a finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health and the environment. To protect against this
risk, the Order requires manufacture of the PMN substances with a
particle size greater than 10 microns. 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 substances would 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 proposed SNUR. EPA has also determined that the results of
pulmonary effects testing would help characterize the potential health
effects of the PMN substance. Although the Order does not require this
test, the Order's restrictions on manufacture, processing, distribution
in commerce, and use of the PMN substances will remain in effect until
the Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citations: 40 CFR 721.11245 (P-18-71) and 40 CFR 721.11246 (P-
18-79).
PMN Number: P-18-82
Chemical Name: Aspartic acid, tallow modified diester (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 3, 2018.
Basis for TSCA section 5(e) order: The PMN states that the use of
the substance will be as an intermediate used in the manufacture of a
surface-active agent. Based on test data available for an analogue, EPA
has identified concerns for irritation, blood effects, neurotoxicity
and surfactant effects in the lungs based on analogue data. Based on
SAR analysis of anionic surfactants, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 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 in the absence of sufficient information to
permit a reasoned evaluation, the substances may present an
unreasonable risk of injury to human health and the environment. To
protect against these risks, the Order requires:
1. Manufacture, process and use of the PMN substance only as stated
in the PMN submission;
2. Use only as an intermediate;
3. Refraining from modifying the manufacture, processing or use in
a manner resulting in inhalation exposure;
4. Use of personal protective equipment to prevent dermal exposure
(where there is potential for dermal exposure);
5. Establishment and use of a hazard communication program,
including human health precautionary statement on each label and in the
SDS;
6. That PMN residuals will be recycled back into the process as
stated in the PMN; and
7. No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the environmental and 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 proposed SNUR. EPA has also determined that the
results of acute aquatic toxicity, pulmonary effects, and specific
target organ toxicity testing would help characterize the potential
environmental and health effects of the PMN substance. Although the
Order does not require these tests, the Order's restrictions on
manufacture, processing, distribution in commerce, use, and disposal of
the PMN substance will remain in effect until the Order is modified or
revoked by EPA based on submission of this or relevant information.
CFR citation: 40 CFR 721.11247.
PMN Number: P-18-130
Chemical Name: Substituted alkanediol, polymer with
heteromonocycles, alkenoate, metal complexes (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 26, 2018.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the substance will be as an adhesion promoter for industrial
application. Based on analysis of analogous acrylates, and physical/
chemical properties, EPA has identified concerns for mutagenicity,
oncogenicity, developmental toxicity, sensitization, irritation, and
liver and kidney toxicity. 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 health and the
environment. 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 50
to mitigate inhalation and 1000 where the PMN substance has a use
involving spray application;
3. Refraining from domestic manufacture in the United States (i.e.,
import only);
[[Page 10009]]
4. Use of the PMN substance only as an adhesion promoter for
industrial applications; and
5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
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 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 proposed SNUR. EPA has also determined that the results of
absorption, distribution, metabolism, elimination, genotoxicity, and
sensitization testing would help characterize the potential health
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions on manufacture, distribution in
commerce, and use of the PMN substance will remain in effect until the
Order is modified or revoked by EPA based on submission of this or
relevant information.
CFR citation: 40 CFR 721.11248.
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 all 28
chemical substances regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) Orders requiring the use of
appropriate exposure controls were negotiated with the PMN submitters.
The SNURs 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).
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 about the significant new uses
designated in this 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 have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA would be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
EPA 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).
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. However, TSCA section 5(e) Orders have been
issued for all of the chemical substances, and the PMN submitters are
prohibited by the TSCA section 5(e) Orders from undertaking activities
which would be designated as significant new uses. The identities of 23
of the 28 chemical substances subject to this proposed rule have been
claimed as confidential (per Sec. Sec. 720.25) 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 March 19, 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. In
developing this proposed rule, EPA has recognized that, given EPA's
general practice of posting proposed rules on its website a week or
more in advance of Federal Register publication, this objective could
be thwarted even before Federal Register publication of the proposed
rule.
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). 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
[[Page 10010]]
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.
In certain of the TSCA section 5(e) Orders for the chemical
substances that would be regulated under this proposed rule, EPA has
established production limits in view of the lack of data on the
potential health and environmental risks that may be posed by the
significant new uses or increased exposure to the chemical substances.
These limits cannot be exceeded unless the PMN submitter first submits
the results of specified tests that would permit a reasoned evaluation
of the potential risks posed by these chemical substances. Listings of
the tests specified in the TSCA section 5(e) Orders are included in
Unit IV. The proposed SNURs contain the same production limits as the
TSCA section 5(e) Orders. Exceeding these production limits is defined
as a significant new use. Persons who intend to exceed the production
limit must notify the Agency by submitting a SNUN at least 90 days in
advance of commencement of non-exempt commercial manufacture or
processing 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.
Any request by EPA for the testing described in the Orders was made
based on EPA's consideration of available screening-level data, if any,
as well as other available information on appropriate testing for the
PMN substances. Further, any such testing/information request on the
part of EPA that includes testing on vertebrates was made after
consideration of available toxicity information, computational
toxicology and bioinformatics, and high-throughput screening methods
and their prediction models.
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.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and Sec. 721.25. 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-
2018-0650.
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,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RFA)
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
[[Page 10011]]
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, and 14 in FY2017,
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 13132
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 Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: February 27, 2019.
Jeffery Morris,
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. 721.11221 to subpart E to read as follows:
Sec. 721.11221 Fatty acids, C16 and C18-unsaturated, methyl esters,
chlorinated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as fatty acids, C16
and C18-unsaturated, methyl esters, chlorinated (PMN P-15-353, CAS No.
1642303-17-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substance beyond three years.
(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 (i) are applicable to manufacturers and processors
of the substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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.
0
3. Add Sec. 721.11222 to subpart E to read as follows:
Sec. 721.11222 Chlorinated complex esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
chlorinated complex esters (PMN P-15-433) 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(k). It is a significant new use to
manufacture the substance beyond three years.
(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
[[Page 10012]]
Sec. 721.125(a) through (i) are applicable to manufacturers and
processors of the substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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.
0
4. Add Sec. 721.11223 to subpart E to read as follows:
Sec. 721.11223 Sodium branched chain alkyl hydroxyl and branched
chain alkenyl sulfonates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as sodium
branched chain alkyl hydroxyl and branched chain alkenyl sulfonates (P-
16-186) 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), (iv), (3), (When determining which persons are
reasonable likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposures, where feasible), (6)(v), (vi),
(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)(i),
(ii), (ix), (eye irritation), (2)(i), (v), (eye protection), (4)(i),
(ii), (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(k). It is a significant new use to
manufacture, process or use of the substance in a manner that results
in inhalation exposure to vapor, dust, spray, mist, or aerosol.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
5. Add Sec. 721.11224 to subpart E to read as follows:
Sec. 721.11224 Spiro tetrafluoroborate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as spiro
tetrafluoroborate (PMN P-16-207) 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),
(a)(5)(respirators must provide a NIOSH assigned protection factor of
at least 1000), (a)(6)(particulate), (b)(concentration set at 1.0%),
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 0.2 mg/m\3\ as
an 8-hour time-weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(iv),
(ix), (2)(i), (ii), (iii), (iv)(use respiratory protection, or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.2 mg/m\3\, (v), (g)(5), alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (q).
(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.
0
6. Add Sec. 721.11225 to subpart E to read as follows:
Sec. 721.11225 2-Pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-methoxyphenyl)-4,5-
difluoro-, phenylmethyl ester (PMN P-16-246, CAS No. 1391033-38-7) 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)(i), (iv), (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),
(a)(5)(respirators must provide a National Institute for Occupational
Safety and Health assigned protection factor of at least 50),
(a)(6)(i), (ii), (v), (vi), (b)(concentration set at 0.1%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i),
(ii), (iv), (vi), (vii), (ix), (2)(i), (ii), (iii), (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(k). It is a
[[Page 10013]]
significant new use to manufacture the substance beyond nine 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.
0
7. Add Sec. 721.11226 to subpart E to read as follows:
Sec. 721.11226 2-Pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-
fluoro-3-methoxyphenyl)-5-fluoro-, phenylmethyl ester, hydrochloride
(1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-methoxyphenyl)-
5-fluoro-, phenylmethyl ester, hydrochloride (1:1) (PMN P-16-516) 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), (iv), (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),
(a)(5)(respirators must provide a National Institute for Occupational
Safety and Health assigned protection factor of at least 50), (6)(i),
(ii), (v), (vi), (b)(concentration set at 0.1%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set 0.1%), (f), (g)(1)(i), (ii),
(iv), (vi), (vii), (ix), (2)(i), (ii), (iii), (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(k). It is a significant new use to
manufacture the substance beyond nine 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.
0
8. Add Sec. 721.11227 to subpart E to read as follows:
Sec. 721.11227 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2,4-
benzenetricarboxylic acid, 1,2,4-trinonyl ester (P-16-271 and P-16-450,
CAS No. 1817723-10-6) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been incorporated into a polymer matrix.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2), (3), (When determining which persons are reasonable
likely to be exposed as required for Sec. 721.63(a)(1), engineering
control measures (e.g. enclosure or confinement of the operation,
general and local ventilation) or administrative control measures (e.g.
workplace policies and procedures) shall be considered and implemented
to prevent exposures, where feasible), (a)(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)(i), (iv),
(vi), (ix), (2)(i), (v), (4)(i), (ii), (iii), and (v). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (p)(1,750,000 kilograms). It is a
significant new use to use the substance other than as a plasticizer in
wire and cable insulation.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
9. Add Sec. 721.11228 to subpart E to read as follows:
Sec. 721.11228 Aliphatic polyamines, polymers with bisphenol A and
epichlorohydrin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aliphatic polyamines, polymers with bisphenol A and epichlorohydrin
(PMN P-16-388) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii), (3), (When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi),
(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)(i),
(mucous membrane irritation), (lung irritation), (eye irritation),
(g)(2)(i), (use gloves and eye protection), and (g)(5), alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (o).
(b) Specific requirements. The provisions of subpart A of this part
[[Page 10014]]
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.
0
10. Add Sec. 721.11229 to subpart E to read as follows:
Sec. 721.11229 Epoxy-amine adduct, methanesulfonates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as epoxy-
amine adduct, methanesulfonates (PMN P-16-489, PMN P-16-490, PMN P-16-
491), are subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been completely reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii),
(2)(ii), (3)(i), (ii), (5), alternative hazard and warning statement
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substances resulting in inhalation
exposure to vapor, mist, or aerosols.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 208 ppb.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (f), (i), and (k).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
11. Add Sec. 721.11230 to subpart E to read as follows:
Sec. 721.11230 Modified ethylene-vinyl alcohol copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (2) The chemical substance generically identified as
modified ethylene-vinyl alcohol copolymer (P-16-509) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
particle size less than 50 microns.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
12. Add Sec. 721.11231 to subpart E to read as follows:
Sec. 721.11231 Cashew, nutshell liq., polymer with acid and
halohydrin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as cashew,
nutshell liq., polymer with acid and halohydrin (PMN P-16-546) 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), (iv), (3), (4), (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), (a)(5)(respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor (APF) of
at least 50, or an APF of 1000 where the PMN substance has a use
involving an application method that generates vapor, mist or aerosol),
(6)(v), (vi), (particulate), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(skin sensitization),(respiratory
sensitization), (g)(2)(i), (ii), (iii), (iv), (v), (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(o).
(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.
0
13. Add Sec. 721.11232 to subpart E to read as follows:
Sec. 721.11232 Pentaerythritol ester of mixed linear and branched
carboxylic acids (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
pentaerythritol ester of mixed linear and branched carboxylic acids (P-
16-589) 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), (3), (When determining which persons are reasonable
likely to be exposed as required for Sec. 721.63(a)(1), engineering
control measures (e.g., enclosure or confinement of the operation,
general and local ventilation) or administrative control measures
(e.g., workplace policies and procedures) shall be considered and
implemented to prevent exposures, where feasible), (a)(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), (v),
(vi), (ix), (2)(i), (ii), (iii), (v), (4)(minimize release to water),
and (g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a
[[Page 10015]]
significant new use to manufacture or process this substance in any
manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4) and (b)(4), where N = 330 ppb.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers, importers, and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
14. Add Sec. 721.11233 to subpart E to read as follows:
Sec. 721.11233 Cashew nut shell liquid, branched polyester-polyether
polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as cashew
nut shell liquid, branched polyester-polyether polyol (PMN P-17-116) 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), (When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (6)(particulate),
(b)(concentration set at 0.1%) and (c).
(ii) Hazard communication: Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 0.1%), (f),
(g)(1)(sensitization), (g)(2)(i), (v), and (g)(5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (p)(65,000 kg), and (y)(1). It is a
significant new use to manufacture the PMN substance with greater than
0.1% weight residual cashew nut oil.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
15. Add Sec. 721.11234 to subpart E to read as follows:
Sec. 721.11234 Methylene diphenyl diisocyanate terminated
polyurethane resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
methylene diphenyl diisocyanate terminated polyurethane resin (PMN P-
17-121) 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), (iii), (iv), (3), (4), (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), (a)(5)(respirators must provide NIOSH assigned
protection factor of at least 50), (a)(6)(v), (vi), (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)(i), (ii),
(asthma), (g)(2)(i), (ii), (iii), (iv), (v), and (g)(5), alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance for
consumer use or for commercial uses that could introduce the substance
into a consumer setting. It is a significant new use to manufacture the
substance without conducting medical surveillance as specified in the
Order. It is a significant new use to use the substance in a spray
application that results in inhalation exposure to a vapor, dust, mist,
spray, or aerosol.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
16. Add Sec. 721.11235 to subpart E to read as follows:
Sec. 721.11235 2-Furancarboxylic acid, tetrahydro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-furancarboxylic
acid, tetrahydro- (PMN P-17-328, CAS No. 16874-33-2) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii), (iv), (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), (a)(5)(respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 50), (a)(6)(v), (vi), (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)(vi),
(severe eye irritation), (blood effects), (immunotoxicity), (g)(2)(i),
(ii), (iii), (v), (eye protection), (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(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
[[Page 10016]]
provisions of Sec. 721.185 apply to this section.
0
17. Add Sec. 721.11236 to subpart E to read as follows:
Sec. 721.11236 Substituted heteromonocycle, homopolymer, alkyl
substituted carbamate, substituted alkyl ester, substituted
heteromonocycle, homopolymer, alkyl substituted carbamate, substituted
alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted heteromonocycle, homopolymer, alkyl substituted carbamate,
substituted alkyl ester, substituted heteromonocycle, homopolymer,
alkyl substituted carbamate, substituted alkyl ester (PMN P-17-373) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of the
Order do not apply to quantities of the substance after they have been
completely reacted (cured).
(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
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible),
(a)(5)(respirators must provide a National Institute for Occupational
Safety and Health assigned protection factor of at least 50),
(a)(6)(v), (vi), (particulate), (b)(concentration set at 0.1%) and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i),
(vii), (ix), (sensitization), (systemic effects), (a)(2)(i), (ii),
(iii), (v), (a)(5), alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to
manufacture the substance unless the number average molecular weight is
greater than or equal to 1000 daltons. It is a significant new use to
use the substance other than as an ultraviolet curable coating resin.
(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.
0
18. Add Sec. 721.11237 to subpart E to read as follows:
Sec. 721.11237 Polysiloxanes, di alkyl, substituted alkyl group
terminated, alkoxylated, reaction products with alkanoic acid,
isocyanate substituted-alkyl carbomonocycle and polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
polysiloxanes, di alkyl, substituted alkyl group terminated,
alkoxylated, reaction products with alkanoic acid, isocyanate
substituted-alkyl carbomonocycle and polyol (PMN P-17-374) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of the Order do
not apply to quantities of the PMN substance after they have been
completely reacted (cured).
(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
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures.) shall be considered
and implemented to prevent exposure, where feasible),
(a)(5)(respirators must provide a NIOSH assigned protection factor of
at least 50), (a)(6)(v), (vi), (particulate), (b)(concentration set at
0.1%) and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i),
(vii), (ix), (sensitization), (systemic effects), (g)(2)(i), (ii),
(iii), (v), (g)(5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to import
the substance with more than 0.1% residual isocyanate. It is a
significant new use to import the substance at a number average
molecular weight less than 1000 daltons. It is a significant new use to
use the substance other than as an ultraviolet curable coating resin.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 110.
(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 (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.
0
19. Add Sec. 721.11238 to subpart E to read as follows:
Sec. 721.11238 Substituted carbomonocycle, polymer with substituted
heteromonocycle and substituted polyalkylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted carbomonocycle, polymer with substituted heteromonocycle
and substituted polyalkylene glycol (PMN P-18-17) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii), (iv), (3), (4), (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), (a)(5)(respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 1000), (a)(6)(particulate), (b)(concentration set at 0.1%) and
(c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (ii),
(iii), (iv), (v), (vi), (vii), (ix), (irritation to eyes, lungs, and
mucus membranes), (g)(2)(i), (ii), (iii), (iv), (v), (avoid eye
contact), (g)(5), alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
[[Page 10017]]
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), It is a significant new use to import
the substance if the average molecular weight is less than or equal to
1000 daltons, more than 10% is less than 500 daltons, or more than 25%
is less than 1000 daltons. It is a significant new use to use the
substance other than for primer coating for corrosion protection.
(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.
0
20. Add Sec. 721.11239 to subpart E to read as follows:
Sec. 721.11239 Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid,
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl
substituted carbomonocycle and alkyl substituted alkanediol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkanedioic acid, polymers with alkanoic acid-dipentaerythritol
reaction products, substituted alkanedioc acid, substituted alkanoic
acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle and
alkyl substituted alkanediol (PMN P-18-40) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii), (iv), (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), (a)(5)(respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 1000), (a)(6)(particulate), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (vii), (ix), (irritation to
eyes, lungs, and mucous membranes), (dermal sensitization),
(respiratory sensitization), (g)(2)(i), (ii), (iii), (iv), (v), (g)(5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to import
the substance if the number average molecular weight is less than or
equal to 1000 daltons or greater than 20% of the acid moiety. It is a
significant new use to use the substance other than as a binder for
ultraviolet curable coating resins.
(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.
0
21. Add Sec. 721.11240 to subpart E to read as follows:
Sec. 721.11240 Substituted carbomonocycle, polymer with
diisocyanatoalkane, substituted alkylacrylate blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted carbomonocycle, polymer with diisocyanatoalkane,
substituted alkylacrylate blocked (PMN P-18-46) 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), (iii), (iv), (3), (4), (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), (a)(5)(respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 1000), (a)(6)(particulate), (b)(concentration set at 0.1%) and
(c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (iv),
(v), (vii), (ix), (irritation to eyes, lungs, and mucus membranes),
(dermal and respiratory sensitization), (g)(2)(i), (ii), (iii), (iv),
(v), (avoid eye contact), (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to import
the substance if the average molecular weight is less than or equal to
1390 daltons, more than 11% is less than 500 daltons, or more than 30%
is less than 1000 daltons. It is a significant new use to use the
substance other than as an ultraviolet curable resin.
(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.
0
22. Add Sec. 721.11241 to subpart E to read as follows:
Sec. 721.11241 1,2-Ethanediol, 1,2-dibenzoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2-ethanediol,
1,2-dibenzoate (PMN P-18-47, CAS No. 94-49-5) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely
entrained in cured resin.
(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),
[[Page 10018]]
(a)(5)(respirators must provide a National Institute for Occupational
Safety and Health assigned protection factor of at least 25), (a)(6),
(v), (vi), (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)(iii),
(iv), (vi), (viii), (ix), (blood effects), (g)(2)(i), (ii), (iv), (v),
(3)(i), (ii), (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as a phlegmatizer (stabilizer for compounds
susceptible to detonation) for peroxides for use with polyester and
vinyl ester resins as well as with curable unsaturated polyester and
methacrylic resins.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 10.
(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.
0
23. Add Sec. 721.11242 to subpart E to read as follows:
Sec. 721.11242 Alkenoic acid, reaction products with polymers with
isocyanatoalkane and substituted alkanoic acid, substituted
monoacrylate alkanoate-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkenoic acid, reaction products with polymers with isocyanatoalkane
and substituted alkanoic acid, substituted monoacrylate alkanoate-
blocked (PMN P-18-51) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii), (iv), (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), (a)(5)(respirators must provide a National Institute
for Occupational Safety and Health assigned protection factor of at
least 1000), (a)(6)(particulate), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (ix), (irritation to eyes,
lungs, and mucous membranes), (dermal sensitization), (respiratory
sensitization), (g)(2)(i), (ii), (iii), (iv), (v), (avoid eye contact),
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as a waterborne ultraviolet curable coating resin
binder for inkjet, ink, or overprint varnish. It is a significant new
use to import the substance with greater than 24% of the branched alkyl
acid moiety content. It is a significant new use to import the
substance with greater than 0.1% isocyanate content.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 660.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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.
0
24. Add Sec. 721.11243 to subpart E to read as follows:
Sec. 721.11243 Aromatic dicarboxylic acid, compd. with alkane
diamines, polymer with alkane diamine and alkane dicarboxylic acid
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aromatic dicarboxylic acid, compd. with alkane diamines, polymer with
alkane diamine and alkane dicarboxylic acid (P-18-71) 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 particle size
less than 10 microns.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
0
25. Add Sec. 721.11244 to subpart E to read as follows:
Sec. 721.11244 Aromatic dicarboxylic acid, compd. with alkyl
diamines, homopolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aromatic dicarboxylic acid, compd. with alkyl diamines, homopolymer (P-
18-79) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new use is:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance with particle size
less than 10 microns.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
0
26. Add Sec. 721.11245 to subpart E to read as follows:
Sec. 721.11245 Aspartic acid, tallow modified diester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
aspartic acid, tallow modified diester (PMN P-18-82) 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
[[Page 10019]]
Sec. 721.63(a)(1), (2)(i), (iii), (3), (When determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)(concentration
set at 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),
(iv), (2)(i), (ii), (v), (3)(i), (ii), (4)(iii)(above concentration of
1 part per billion (ppb), (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g). It is a significant new use to
manufacture, process, or use the substance that results in inhalation
exposure. It is a significant new use to manufacture, process and use
the substance other than as stated in the PMN.
(iv) Disposal. Residuals must be recycled back into the process as
stated in the PMN.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), (c)(4) where N = 1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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 paragraphs (a)(2)(iii)
and (iv) of this section.
0
27. Add Sec. 721.11246 to subpart E to read as follows:
Sec. 721.11246 Substituted alkanediol, polymer with heteromonocycles,
alkenoate, metal complexes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
substituted alkanediol, polymer with heteromonocycles, alkenoate, metal
complexes (PMN P-18-130) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (2)(i), (iii), (3), (4), (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),
(a)(5)(respirators must provide a National Institute for Occupational
Safety and Health assigned protection factor (APF) of at least 50, or
if spray applied an APF of 1000), (a)(6)(v), (vi), (particulate), and
(c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(i), (sensitization), (mutagenicity),
(g)(2)(i), (ii), (iii), (iv), (v), (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance other than as an adhesion promoter for industrial
applications.
(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.
[FR Doc. 2019-04457 Filed 3-18-19; 8:45 am]
BILLING CODE 6560-50-P