[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Rules and Regulations]
[Pages 40986-41006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17348]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2017-0414; FRL-9971-37]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 27 chemical substances
which were the subject of premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA pursuant to section 5(e)
of TSCA. This action requires persons who intend to manufacture
(defined by statute to include import) or process any of these 27
chemical substances for an activity that is designated as a significant
new use by this rule to notify EPA at least 90 days before commencing
that activity. The required notification initiates EPA's evaluation of
the intended use within the applicable review period. Persons may not
commence manufacture or processing for the significant new use until
EPA has conducted a review of the notice, made an appropriate
determination on the notice, and has taken such actions as are required
with that determination.
DATES: This rule is effective on October 16, 2018. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
August 31, 2018.
Written adverse comments on one or more of these SNURs must be
received on or before September 17, 2018 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If EPA receives written adverse comments on
one or more of these SNURs before September 17, 2018, EPA will withdraw
the relevant sections of this direct final rule before its effective
date.
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: Submit your comments, identified by docket identification
(ID)
[[Page 40987]]
number EPA-HQ-OPPT-2017-0414, 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 rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after September 17,
2018 are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see Sec. 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark 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?
1. Direct Final Rule. EPA is promulgating these SNURs using direct
final procedures. These SNURs will require persons to notify EPA at
least 90 days before commencing the manufacture or processing of a
chemical substance for any activity designated by these SNURs as a
significant new use. Receipt of such notices obligates EPA to assess
risks that may be associated with the significant new uses under the
conditions of use and, if appropriate, to regulate the proposed uses
before they occur.
2. Proposed Rule. In addition to this Direct Final Rule, elsewhere
in this issue of the Federal Register, EPA is issuing a Notice of
Proposed Rulemaking for this rule. If EPA receives no adverse comment,
the Agency will not take further action on the proposed rule and the
direct final rule will become effective as provided in this action. If
EPA receives adverse comment on one or more of SNURs in this action by
September 17, 2018 (see Unit VI. of the SUPPLEMENTARY INFORMATION), the
Agency will publish in the Federal Register a timely withdrawal of the
specific SNURs that the adverse comments pertain to, informing the
public that the actions will not take effect. EPA would then address
all adverse public comments in a response to comments document in a
subsequent final rule, based on the proposed rule.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
requires persons to submit a significant new use notice (SNUN) to EPA
at least 90 days before they manufacture or process the chemical
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore
prohibits such manufacturing or processing from commencing until EPA
has conducted a review of the notice, made an appropriate determination
on the notice, and taken such actions as are required in association
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in
Unit V., the general SNUR provisions are found at 40 CFR part 721,
subpart A.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once
[[Page 40988]]
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
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for 27 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 VIII. for more information.
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of each rule specifies the activities
designated as significant new uses. Certain new uses, including
exceedance of production volume limits (i.e., limits on manufacture
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
These rules include 27 PMN substances that are subject to Orders
issued under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that
it has insufficient information to conduct a reasoned evaluation and
the activities associated with the PMN substances may present
unreasonable risk to human health or the environment. Those Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The SNURs identify as significant new
uses any manufacturing, processing, use, distribution in commerce, or
disposal that does not conform to the restrictions imposed by the
underlying Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) Order usually requires, among other
things, that potentially exposed employees wear specified respirators
unless actual measurements of the workplace air show that air-borne
concentrations of the PMN substance are below a New Chemical Exposure
Limit (NCEL) that is established by EPA to provide adequate protection
to human health. In addition to the actual NCEL concentration, the
comprehensive NCELs provisions in TSCA section 5(e) Orders, which are
modeled after Occupational Safety and Health Administration (OSHA)
Permissible Exposure Limits (PELs) provisions, include requirements
addressing performance criteria for sampling and analytical methods,
periodic monitoring, respiratory protection, and recordkeeping.
However, no comparable NCEL provisions currently exist in 40 CFR part
721, subpart B, for SNURs. Therefore, for these cases, the individual
SNURs in 40 CFR part 721, subpart E, will state that persons subject to
the SNUR who wish to pursue NCELs as an alternative to the 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-12-277, P-12-278, P-12-280, P-12-281, P-12-282, P-12-
283, and P-12-284
Chemical names: Alkanes, C20-28, chloro (P-12-277),
Slack waxes (petroleum), chloro (P-12-278), Hexacosane, chloro derivs.
and octacosane, chloro derivs. (P-12-280), Alkanes, C20-24,
chloro (P-12-281), Alkanes, C14-16, chloro (P-12-282),
Tetradecane, chloro derivs. (P-12-283), and Octadecane, chloro derivs.
(P-12-284).
CAS numbers: 2097144-43-7 (P-12-277), 2097144-44-8 (P-12-278),
2097144-46-0 and 2097144-47-1 (P-12-280), 2097144-45-9 (P-12-281),
1372804-76-6 (P-12-282), 198840-65-2 (P-12-283), 2097144-48-2 (P-12-
284).
Effective date of TSCA section 5(e) Order: June 5, 2017.
Basis for TSCA section 5(e) Order: The PMNs state that the PMN
substances will be used as flame retardants and plasticizers in
polyvinyl chloride (PVC), polymers, and rubber; flame retardants,
plasticizers, and
[[Page 40989]]
lubricants in adhesives, caulk, sealants, and coatings; additives in
lubricants including metalworking fluids; and flame retardants and
waterproofers in textiles. 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; FRL-6097-7) and test data on
structurally similar medium-chain chlorinated paraffins (MCCP), the PMN
substances are a potentially persistent, bioaccumulative, and toxic
(PBT) chemicals. EPA estimates that the PMN substances will persist in
the environment more than 2 months and estimates a bioaccumulation
factor of greater than or equal to 1,000. Based on data on MCCP, EPA
has identified concerns for systemic toxicity as well as aquatic and
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 the
substances may present an unreasonable risk of injury to health or the
environment. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing on the representative
congener groups prior to exceeding a certain time period specified in
the Order.
2. Use of the PMN substances only for the uses specified in the
Order: Flame retardants and plasticizers in PVC, polymers, and rubber;
flame retardants, plasticizers, and lubricants in adhesives, caulk,
sealants, and coatings; additives in lubricants including metalworking
fluids; and flame retardants and waterproofers in textiles.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the fate, and terrestrial and aquatic toxicity 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 will be designated by
this SNUR. The submitter has agreed not to exceed a certain time limit
without performing chronic aquatic and terrestrial toxicity and
biodegradation testing.
CFR citations: 40 CFR 721.11068 (P-12-277), 40 CFR 721.11069 (P-12-
278), 40 CFR 721.11070 (P-12-280), 40 CFR 721.11071 (P-12-281), 40 CFR
721.11072 (P-12-282 and P-14-684), 40 CFR 721.11073 (P-12-283 and P-14-
683), and 40 CFR 721.11074 (P-12-284).
PMN Numbers: P-12-433, P-12-453, and P-12-505
Chemical names: Alkanes, C18-20, chloro (P-12-433),
Alkanes, C14-17, chloro (P-12-453) and Alkanes,
C22-30, chloro (P-12-505).
CAS numbers: 106262-85-3 (P-12-433), 85535-85-9 (P-12-453) and
288260-42-4 (P-12-505).
Effective date of TSCA section 5(e) Order: June 5, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the PMN
substances will be used as flame retardants and plasticizers in PVC,
polymers, and rubber; flame retardants, plasticizers, and lubricants in
adhesives, caulk, sealants, and coatings; additives in lubricants
including metalworking fluids; and flame retardants and waterproofers
in textiles. 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; FRL-6097-7) and test data on
structurally similar medium-chain chlorinated paraffins (MCCP), the PMN
substances are potentially persistent, bioaccumulative, and toxic (PBT)
chemicals. EPA estimates that the PMN substances will persist in the
environment more than 2 months and estimates a bioaccumulation factor
of greater than or equal to 1,000. Based on test data on MCCP EPA has
identified concerns for systemic toxicity as well as aquatic and
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 the
substances may present an unreasonable risk of injury to health or the
environment. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing on the representative
congener groups prior to exceeding a certain time period specified in
the Order.
2. Use of the PMN substances only for the uses specified in the
Order: Flame retardants and plasticizers in PVC, polymers, and rubber;
flame retardants, plasticizers, and lubricants in adhesives, caulk,
sealants, and coatings; additives in lubricants including metalworking
fluids; and flame retardants and waterproofers in textiles.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the fate, and terrestrial and aquatic toxicity 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 will be designated by
this SNUR. The submitter has agreed not to exceed a certain time limit
without performing chronic aquatic and terrestrial toxicity and
biodegradation testing.
CFR citations: 40 CFR 721.11075 (P-12-433), 40 CFR 721.11076 (P-12-
453), 40 CFR 721.11077 (P-12-505).
PMN Numbers: P-14-683 and P-14-684
Chemical names: Tetradecane, chloro derivs. (P-14-683) and Alkanes,
C14-16, chloro (P-14-684).
CAS numbers: 198840-65-2 (P-14-683) and 1372804-76-6 (P-14-684).
Effective date of TSCA section 5(e) Order: May 17, 2017.
Basis for TSCA section 5(e) Order: The PMNs state that the
substances will be used as flame retardants and plasticizers in PVC,
polymers, and rubber; flame retardants, plasticizers, and lubricants in
adhesives, caulk, sealants, and coatings; additives in lubricants
including metalworking fluids; and flame retardants and waterproofers
in textiles. 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; FRL-6097-7) and test data on
structurally similar medium-chain chlorinated paraffins (MCCP), the PMN
substances are potentially persistent, bioaccumulative, and toxic (PBT)
chemicals. EPA estimates that the PMN substances will persist in the
environment more than 2 months and estimates a bioaccumulation factor
of greater than or equal to 1,000. Further, EPA has identified concerns
for systemic toxicity, as well as aquatic and 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 the substances may present
an unreasonable risk of injury to health or the environment. To protect
against these risks, the Order requires:
1. Submission of certain toxicity testing on the representative
congener groups prior to exceeding a certain time period specified in
the Order.
2. Use of the PMN substances only for the uses specified in the
Order: Flame retardants and plasticizers in PVC, polymers, and rubber;
flame retardants, plasticizers, and lubricants in adhesives, caulk,
sealants, and coatings; additives in lubricants including metalworking
fluids; and flame retardants and waterproofers in textiles.
[[Page 40990]]
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the fate, and terrestrial and aquatic toxicity 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 will be designated by
this SNUR. The submitter has agreed not to exceed a certain time limit
without performing chronic aquatic and terrestrial toxicity and
biodegradation testing.
CFR citations: 40 CFR 721.11072 (P-12-282 and P-14-684), 40 CFR
721.11073 (P-12-283 and P-14-683).
PMN Number: P-16-150
Chemical name: Chloroflurocarbon (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: May 31, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an intermediate.
Based on test data on the PMN substance, EPA identified concerns for
acute human toxicity. Based on analogue data EPA identified concerns
for toxicity to aquatic and terrestrial organisms. The Order was issued
under TSCA sections 5(a)(3)(B)(ii)(I), 5(a)(3)(B)(ii)(II) and
5(e)(1)(A)(ii)(I), based on a finding that the substance may present an
unreasonable risk of injury to health and the environment and that the
substance will be produced in substantial quantities and may be
reasonably anticipated to enter the environment in substantial
quantities. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing on the substance prior to
exceeding the production limits specified in the Order.
2. Use of personal protective equipment to prevent dermal exposure
(where there is a 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 a potential for inhalation exposure)
in conjunction with a minimum set of engineering controls described in
the PMN, or compliance with a new chemical exposure limit (NCEL) of 170
parts per billion (ppb) as an 8-hour time-weighted average to prevent
inhalation exposure.
4. Use of engineering controls to limit worker exposure and air
release of the PMN substance to the environment.
5. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the Safety Data Sheet (SDS).
6. Manufacture, processing, and use in an enclosed process.
7. Use only as a chemical intermediate.
8. No release of the substance resulting in surface water
concentrations that exceed 240 ppb.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity 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 will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing specific target organ toxicity testing,
reproductive and developmental toxicity testing, and acute and chronic
aquatic toxicity testing.
CFR citation: 40 CFR 721.11078.
PMN Number: P-16-379
Chemical name: Silane, 1,1'-(1,2-ethanediyl)bis[1,1-dichloro-1-
methyl]-, hydrolysis products with chloroethenyldimethylsilane.
CAS number: 1485477-78-8.
Effective date of TSCA section 5(e) Order: June 8, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance is as a chemical intermediate
for polymer synthesis. Based on SAR analysis of test data on analogous
substances, EPA has identified concerns for liver toxicity and
mutagenicity. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the
substances may present an unreasonable risk of injury to health and the
environment. To protect against these risks, the Order requires:
1. Submission of certain toxicity testing on the substance prior to
exceeding the confidential production volume limit specified in the
Order.
2. Use of personal protective equipment including impervious gloves
and clothing which covers any other exposed areas of the arms, legs and
torso (where there is a potential for dermal exposure).
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. No domestic manufacture of the substance.
5. Use of the substance only for the confidential uses specified in
the Order.
6. No use involving application methods that generate a dust, mist,
vapor, or aerosol.
7. Disposal of the substance only by water or landfill.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity 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 will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit without
performing specific target organ toxicity and mutagenicity testing. In
addition, EPA has determined that the results of other specific target
organ toxicity testing of the PMN substance may be potentially useful
in characterizing the health effects of the PMN substance. Although the
Order does not require this additional testing, the Order's
restrictions on manufacture, processing, distribution in commerce, use,
and disposal will remain in effect until the Order is modified or
revoked by EPA based on submission of this or other information that
EPA determines is relevant and needed to evaluate a modification
request.
CFR citation: 40 CFR 721.11079.
PMN Number: P-16-410
Chemical name: Silicophosphonate--sodium silicate (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: May 4, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an automotive engine
fluid additive. Based on test data on the PMN substance, EPA has
identified concerns for skin and eye irritation, corrosion, and
systemic 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 the
substance may present an unreasonable risk of injury to human health.
To protect against these risks, the Order requires:
[[Page 40991]]
1. No domestic manufacture of the substance.
2. Use of the substance in formulations containing no greater than
0.2% of the chemical substance and for the confidential uses specified
in the Order.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the effects of the 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 will be designated by this SNUR. EPA has
determined that the results of irritation testing may be potentially
useful in characterizing the 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 will remain in effect until the Order is modified or
revoked by EPA based on submission of this or other information that
EPA determines is relevant and needed to evaluate a modification
request.
CFR citation: 40 CFR 721.11080.
PMN Number: P-16-438
Chemical name: 3-Butenenitrile, 2-(acetyloxy)-.
CAS number: 15667-63-7.
Effective date of TSCA section 5(e) Order: June 23, 2017.
Basis for TSCA section 5(e) Order: The PMN states the substance
will be used as a chemical intermediate for a pesticide inert. Based on
test data on the PMN substance, EPA identified concerns for acute
toxicity, irritation to all tissues, developmental toxicity, and
neurotoxicity. EPA identified concerns for aquatic organism toxicity
based on submitted data. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that the
substance may present an unreasonable risk of injury to health and the
environment. Further, based on SAR analysis of test data on analogous
vinyl/allyl esters vinyl/allyl esters nitriles and test data on the PMN
substance, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 8 ppb in surface waters. To protect against
these risks, the Order requires:
1. Submission of monitoring data on the substance.
2. Use of personal protective equipment including impervious gloves
and protective clothing (where there is a potential for dermal
exposures) and a NIOSH-certified powered air purifying particulate
respirator with an Assigned Protection Factor (APF) of at least 1000
(where there is a potential for inhalation exposures).
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. Manufacture, process, and use of the substance in a closed
system as specified in the PMN.
5. Use of the substance only as a chemical intermediate.
6. No release of the substance into the surface waters of the
United States.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the aquatic toxicity 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 will be designated by this SNUR. EPA has
determined that the results of chronic aquatic toxicity testing of the
PMN substance may be potentially useful in characterizing the
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 will remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other information that EPA determines is relevant and needed to
evaluate a modification request.
CFR citation: 40 CFR 721.11081.
PMN Number: P-16-543
Chemical name: Halogenophosphoric acid metal salt (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: May 24, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use will be as a battery ingredient. Based on test
data on the PMN substance and an analogue, EPA has identified concerns
for irritation, corrosion, acute toxicity, immunotoxicity,
developmental toxicity, neurotoxicity, and cancer. Further, based on
test data on the PMN substance, EPA identified concerns for aquatic
organism toxicity at surface water concentrations that exceed 3 ppb.
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that the substance may present an
unreasonable risk of injury to health and the environment. To protect
against these risks, the Order requires:
1. Submission of monitoring data as specified in the Order.
2. Use of personal protective equipment as specified in the Order
(where there is a potential for dermal exposure).
3. Use of a NIOSH-certified respirator with an APF of at least 1000
(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. No domestic manufacture of the substance.
6. Use of the substance only in an enclosed process.
7. Use of the substance only for the confidential uses specified in
the Order.
8. Manufacture, process, or use of the substance without the
engineering controls required by the Order to control dermal and
inhalation exposure.
9. Disposal of the substance by hazardous waste incineration except
when in wastewater.
10. No release of the substance resulting in surface water
concentrations that exceed 3 ppb.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity, human exposure, aquatic
toxicity, and fate 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 will be designated by this SNUR. The submitter has agreed to
conduct an exposure monitoring program for employees who are reasonably
likely to be exposed to the PMN substance and a hydrolysis product of
the PMN substance. In addition, EPA has determined that the results of
specific target organ toxicity, acute aquatic toxicity, and
biodegradation testing of the PMN substance may be potentially useful
in characterizing the health and environmental effects of the PMN
substance. Although the Order does not require this additional testing,
the Order's restrictions on manufacture, processing, distribution in
commerce, use, and disposal will remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
information that EPA determines
[[Page 40992]]
is relevant and needed to evaluate a modification request.
CFR citation: 40 CFR 721.11082.
PMN Number: P-16-596
Chemical names: Alkenoic acid, reaction products with polyethylene
glycol ether with hydroxyalkyl substituted alkane (generic).
CAS numbers: Not available.
Effective date of TSCA section 5(e) Order: June 5, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a site-limited intermediate used for
production of ultraviolet (UV) curable coating resin. Based on SAR
analysis on structurally similar substances, EPA has identified
concerns for irritation, sensitization, developmental toxicity, liver
and kidney effects, and oncogenicity. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that the substances may present an unreasonable risk of injury to
health and the environment. EPA's estimates indicate that variations of
the parameters (including batch size, number of processing sites, days
per year of operation) of the uses identified below would not result in
inhalation exposure. To protect against these risks, the Order
requires:
1. Submission of test data on the substance prior to exceeding the
confidential production volume limit specified in the Order.
2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. No domestic manufacture of the substance.
5. Use of the substance only as a site-limited intermediate for the
production of UV curable coating resin.
6. No release of the substance to surface waters of the United
States.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance 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 will be designated by this SNUR. EPA has
determined that the results of a reproductive/developmental toxicity
testing may be potentially useful in characterizing the health effects
of the PMN substance. The submitter has agreed not to manufacture
beyond a certain production volume limit without performing
reproductive/developmental toxicity testing.
CFR citation: 40 CFR 721.11083.
PMN Number: P-17-10
Chemical name: Alkyl substituted alkenoic acid, alkyl ester,
polymer with alkyl substituted alkenoate and alkenoic acid, hydroxy
substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic
acid, dipentaerythritil and isocyanate substituted carbomonocycle,
compds. with alkylamine (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: June 31, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a UV curable coating resin. Based on test
data on structurally similar substances, EPA has identified concerns
for irritation, sensitization, developmental effects, internal organ
effects (liver and kidney), and cancer. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that the 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 including impervious gloves
to prevent dermal exposure (where there is a potential for dermal
exposure).
2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
3. No domestic manufacture of the substance.
4. No manufacture, process, or use of the substance that results in
generation of a vapor, mist, or aerosol.
5. No manufacture of the substance where there is more than 0.1%
residual isocyanate by weight.
6. Use of the substance only as a UV curable coating resin.
7. Only import the substance in totes.
8. Manufacture of the substance to have an average molecular weight
of greater than 2,000 daltons.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance 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 will be designated by this SNUR. EPA has
determined that the results of reproductive/developmental toxicity
testing may be potentially useful in characterizing the 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 will remain in effect until the Order is modified or
revoked by EPA based on submission of this or other information that
EPA determines is relevant and needed to evaluate a modification
request.
CFR citation: 40 CFR 721.11084.
PMN Number: P-17-15
Chemical name: Heteromonocycle ester with alkanediol (generic).
CAS numbers: Not available.
Effective date of TSCA section 5(e) Order: June 13, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance is a precursor for a
photochromatic substance. Based on SAR analysis of test data on
analogous esters, EPA has identified concerns for irritation to skin,
eye, and mucous membrane, and systemic toxicity. Further, based on SAR
analysis of test data on analogous nonionic esters, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 3
ppb of the PMN substance in surface waters. The Order was issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that the substances may present an unreasonable risk of injury
to health and the environment. EPA's estimates indicate that variations
of the parameters (including batch size, number of processing sites,
days per year of operation of the uses identified below) would not
result in inhalation exposure. To protect against these risks, the
Order requires:
1. Submission of certain toxicity testing on the substance prior to
exceeding the confidential production volume limit specified in the
Order.
2. Use of personal protective equipment including impervious gloves
to prevent dermal exposure (where there is a potential for dermal
exposure).
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. No domestic manufacture of the substance.
5. No use of the substance other than other than for the
confidential uses identified in the Order.
[[Page 40993]]
6. No release of the substance resulting in surface water
concentrations that exceed 3 ppb.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity 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 will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing reproductive/developmental toxicity and acute
aquatic toxicity testing.
CFR citation: 40 CFR 721.11085.
PMN Number: P-17-29
Chemical name: Substituted carbomonocycle, polymer with
(aminoalkyl)-alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine
and alkyl-alkanamine, reaction products with dialkanolamine and
[[(alkyl)oxy]alkyl]oxirane (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: May 10, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance is an intermediate prepolymer.
Based on the physical/chemical properties of the substance and SAR
analysis of test data on analogous aliphatic amines, EPA has identified
concerns for irritation, lung effects, and aquatic 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 the substance may present an unreasonable risk
of injury to health and the environment. To protect against these
risks, the Order requires:
1. Submission of certain toxicity testing on the substance prior to
exceeding the confidential production volume limit specified in the
Order.
2. Use of personal protective equipment including impervious gloves
to prevent dermal exposure (where there is a potential for dermal
exposure).
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. No use other than for the confidential uses identified in the
Order.
5. No use involving an application method that generates a vapor,
mist, or aerosol.
6. No domestic manufacture of the substance.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health and aquatic toxicity 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 will be designated by this SNUR.
The submitter has agreed not to exceed the confidential production
limit without performing irritation and acute aquatic toxicity testing.
In addition, EPA has determined that the results of a pulmonary effects
testing of the PMN substance may be potentially useful in
characterizing the health effects of the PMN substance. Although the
Order does not require this additional testing, the Order's
restrictions on manufacture, processing, distribution in commerce, use,
and disposal will remain in effect until the Order is modified or
revoked by EPA based on submission of this or other information that
EPA determines is relevant and needed to evaluate a modification
request.
CFR citation: 40 CFR 721.11086.
PMN Numbers: P-17-154, P-17-155, and P-17-156
Chemical names: Carboxylic acid amine (1:1) (generic) (P-17-154),
Mix fatty acids compd. with amine (1:1) (generic) (P-17-155), and Mix
fatty acids compd. with amine (1:1) (generic) (P-17-156).
CAS number: Not available.
Effective date of TSCA section 5(e) Order: June 15, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substances is as a coating. Based on
physical/chemical properties of the substances and SAR analysis of test
data on amines, EPA identified concerns for irritation, corrosion,
developmental toxicity, reproductive toxicity, neurotoxicity, and
thyroid toxicity. Further, based on test data on analogous anionic
surfactants and aliphatic amines, EPA identified concern for toxicity
to aquatic organisms at surface water concentrations that exceed 240
ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that the substances may present
an unreasonable risk of injury to health and the environment. EPA's
estimates indicate that variations of the parameters (including batch
size, number of processing sites, days per year of operation) of the
uses for the chemical substance would not result in increased
inhalation exposure. To protect against these risks, the Order
requires:
1. Submission of certain toxicity testing on the substances prior
to exceeding the confidential production volume limit specified in the
Order.
2. Use of personal protective equipment to prevent dermal exposure
(where there is a potential for dermal exposure).
3. Establishment and use of a hazard communication program,
including human health and environmental precautionary statements on
each label and in the SDS.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity 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 will be designated by this SNUR. The submitter
has agreed to not exceed a confidential production volume without
performing reproductive/developmental toxicity testing.
CFR citation: 40 CFR 721.11087 (P-17-154), 40 CFR 721.11088 (P-17-
155), 40 CFR 721.11089 (P-17-156).
PMN Number: P-17-218
Chemical name: Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-
dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).
CAS number: 67019-84-5.
Effective date of TSCA section 5(e) Order: May 19, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance is a processing aid for
membrane production. Based on SAR analysis of test data on structurally
similar respirable particles, EPA identified concerns for corrosivity,
irritation, sensitization, developmental toxicity, specific target
organ toxicity, and neurotoxicity. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that the substance may present an unreasonable risk of injury to health
and the environment. To protect against these risks, the Order
requires:
1. Submission of certain toxicity testing on the substance prior to
[[Page 40994]]
exceeding the confidential production volume limit specified in the
Order.
2. Use of personal protective equipment including impervious gloves
to prevent dermal exposure (where there is a potential for dermal
exposure).
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. No manufacture, processing, or use involving an application
method that generates a vapor, mist, aerosol, or dust.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity 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 will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit without
performing a skin sensitization study. In addition, EPA has determined
that the results of reproductive/developmental toxicity testing of the
PMN substance may be potentially useful in characterizing the health
effects of the PMN substance. Although the Order does not require this
additional testing, the Order's restrictions on manufacture,
processing, distribution in commerce, and use will remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other information that EPA determines is relevant and needed to
evaluate a modification request.
CFR citation: 40 CFR 721.11090.
PMN Number: P-17-226
Chemical name: Manganese(2+), bisoctahydro-1,4,7-trimethyl-1H-
1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7)tri-.mu.-oxidi-,
hexafluorophosphate(1-) (1:2).
CAS number: 116633-52-4.
Effective date of TSCA section 5(e) Order: June 15, 2017.
Basis for TSCA section 5(e) Order: The PMN states the generic (non-
confidential) use of the substance will be as a detergent additive.
Based on test data on the substance and analogue test data, EPA has
identified concerns for eye irritation, thyroid, blood, and liver
toxicity, male reproductive toxicity, neurotoxicity, immunosuppression,
respiratory sensitization, and mutagenicity. Based on test data on the
substance and test data on analogous neutral organics, EPA identified
concern for toxicity to aquatic organisms at surface water
concentrations that exceed 240 ppb. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that the 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. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
3. No use other than the confidential use allowed in the Order.
4. No domestic manufacture of the substance.
5. No processing without appropriate engineering controls to
prevent inhalation exposure, including dust removal with 99.9%
efficiency when loading or unloading the substance in powder form.
6. No release of the substance resulting in surface water
concentrations that exceed 240 ppb.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity 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 will be designated by this SNUR. EPA has
determined that the results of specific target organ toxicity testing
of the PMN substance may be potentially useful in characterizing the
health effects of the PMN substance. Although the Order does not
require this additional testing, the Order's restrictions on
manufacture, processing, distribution in commerce, and use will remain
in effect until the Order is modified or revoked by EPA based on
submission of this or other information that EPA determines is relevant
and needed to evaluate a modification request.
CFR citation: 40 CFR 721.11091.
PMN Numbers: P-17-228 and P-17-229
Chemical names: 2'-Fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl
(generic) (P-17-228) and 4-ethyl-2'-fluoro-4''-alkyl-1,1':4'1''-
terphenyl (generic) (P-17-229).
CAS numbers: Not available.
Effective date of TSCA section 5(e) Order: May 18, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substances is a coating for displays.
Based on the physical/chemical properties of the substances (as
described in the New Chemical Program's PBT category at 64 FR 60194;
November 4, 1999; FRL-6097-7) and test data on structurally similar
substances, the substances are potentially persistent, bioaccumulative,
and toxic (PBT) chemicals. EPA estimates that the substances will
persist in the environment more than 2 months and estimates a
bioaccumulation factor of greater than or equal to 1,000. Further,
based on test data on structurally similar chemicals, EPA has
identified concerns for reproductive effects, adrenal and liver
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 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 including impervious gloves
to prevent dermal exposure (where there is a potential for dermal
exposure).
2. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
3. No manufacture beyond the confidential annual production volume
limit specified in the Order.
4. No processing or use of the substances in an application method
that generates a dust, mist, or aerosol.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the fate and human health toxicity 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 will be designated by this SNUR.
EPA has determined that the results of biodegradation and reproductive/
developmental toxicity testing of the PMN substances may be potentially
useful in characterizing the health effects of the PMN substances.
Although the Order does not require this additional testing, the
Order's restrictions on manufacture, processing, distribution in
commerce, use, and disposal will remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
[[Page 40995]]
information that EPA determines is relevant and needed to evaluate a
modification request.
CFR citations: 40 CFR 721.11092 (P-17-228) and 40 CFR 721.11093 (P-
17-229).
PMN Number: P-17-261
Chemical name: Poly(oxy-1,2-ethanediyl),-.alpha.-(2-
benzoylbenzoyl)-.omega.-[(2-benzoylbenzoyl)oxy]-.
CAS number: Not available.
Effective date of TSCA section 5(e) Order: June 19, 2017.
Basis for TSCA section 5(e) Order: The PMN states that the
substance will be used as a difunctional type II photoinitiator for use
in inks and coatings. Based on physical/chemical properties, SAR
analysis and test data on analogous esters with branched polyols, EPA
has identified concerns for corrosion of the skin, eyes, and mucous
membranes, developmental toxicity, systemic toxicity, and blood
effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that the substance may present an
unreasonable risk of injury to health and the environment. EPA's
estimates indicate that variations of the parameters (including batch
size, number of processing sites, days per year of operation) of the
uses identified for the chemical substance would not result in
increased inhalation exposure. To protect against these risks, the
Order requires:
1. Submission of certain toxicity testing on the substance prior to
exceeding the confidential production volume limit specified in the
Order.
2. Use of personal protective equipment including impervious gloves
(where there is a potential for dermal exposure).
3. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
4. No domestic manufacture of the substance.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health toxicity 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 will be designated by this SNUR. The submitter
has agreed not to exceed the confidential production limit in the Order
without performing irritation testing.
CFR citation: 40 CFR 721.11094.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for all 27 chemical
substances regulation was warranted under TSCA section 5(e), pending
the development of information sufficient to make reasoned evaluations
of the health or environmental effects of the chemical substances. The
basis for such findings is outlined in Unit IV. Based on these
findings, TSCA section 5(e) Orders requiring the use of appropriate
exposure controls were negotiated with the PMN submitters.
The SNURs identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying Orders,
consistent with TSCA section 5(f)(4).
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA will be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
EPA will identify as significant new uses any
manufacturing, processing, use, distribution in commerce, 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. Direct Final Procedures
EPA is issuing these SNURs as direct final rules. The effective
date of these rules is September 17, 2018 without further notice,
unless EPA receives written adverse comments before September 17, 2018.
If EPA receives written adverse comments on one or more of these
SNURs before September 17, 2018, EPA will withdraw the relevant
sections of this direct final rule before its effective date.
This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse comments must identify the chemical
substance and the new use to which it applies. EPA will not withdraw a
SNUR for a chemical substance not identified in the comment.
VII. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. In cases where EPA has not received 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 rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) Orders have been issued
for all of the chemical substances, and the PMN submitters are
prohibited by the TSCA section 5(e) Orders from undertaking activities
which will be designated as significant new uses. The identities of 13
of the 27 chemical substances subject to this rule have been claimed as
confidential and EPA has received no post-PMN bona fide submissions
(per Sec. Sec. 720.25 and 721.11) for a chemical substance covered by
this action. Based on this, the Agency believes that it is highly
unlikely that any of the significant new uses described in the
regulatory text of this rule are ongoing.
[[Page 40996]]
Therefore, EPA designates August 17, 2018 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach has been to ensure that a person could not defeat a SNUR by
initiating a significant new use before the effective date of the
direct final rule.
Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified as of that
date will have to cease any such activity upon the effective date of
the final rule. To resume their activities, these persons will have to
first comply with all applicable SNUR notification requirements and
wait until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required with that determination.
VIII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: Development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (see 40 CFR 720.50). However, upon
review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. Unit IV. lists potentially useful information for
all of the listed SNURs. Descriptions of this information are provided
for informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
protocol selection. Furthermore, pursuant to TSCA section 4(h), which
pertains to reduction of testing in vertebrate animals, EPA encourages
consultation with the Agency on the use of alternative test methods and
strategies (also called New Approach Methodologies, or NAMs), if
available, to generate the recommended test data. EPA encourages dialog
with Agency representatives to help determine how best the submitter
can meet both the data needs and the objective of TSCA section 4(h). 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 (OECD) 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 regulated under this rule, EPA has established production
volume 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. Under recent TSCA
section 5(e) Orders, each PMN submitter is required to submit each
study at least 14 weeks (earlier TSCA section 5(e) Orders required
submissions at least 12 weeks) before reaching the specified production
limit. The SNURs contain the same production volume limits as the TSCA
section 5(e) Orders. Exceeding these production limits is defined as a
significant new use. Persons who intend to exceed the production limit
must notify the Agency by submitting a SNUN at least 90 days in advance
of commencement of non-exempt commercial manufacture or processing.
Any request by EPA for the triggered and pended testing described
in the Orders was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substances. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
Potentially useful information identified in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. However, submitting a SNUN without any test data or other
information may increase the likelihood that EPA will take action under
TSCA section 5(e), particularly if satisfactory test results have not
been obtained from a prior PMN or SNUN submitter. EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to generate useful information.
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.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at Sec.
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
721.1725(b)(1) with that under Sec. 721.11 into a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
[[Page 40997]]
X. SNUN Submissions
According to Sec. 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2017-0414.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This action establishes SNURs for several new chemical substances
that were the subject of PMNs 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. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
action.
This action is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a
significant economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not
apply to this action.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this
[[Page 40998]]
action is not a significant regulatory action under Executive Order
12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: August 3, 2018.
Mark A. Hartman,
Acting Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326,
1330, 1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f,
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q,
7542, 9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB
40 CFR citation control
No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11068................................................... 2070-0012
721.11069................................................... 2070-0012
721.11070................................................... 2070-0012
721.11071................................................... 2070-0012
721.11072................................................... 2070-0012
721.11073................................................... 2070-0012
721.11074................................................... 2070-0012
721.11075................................................... 2070-0012
721.11076................................................... 2070-0012
721.11077................................................... 2070-0012
721.11078................................................... 2070-0012
721.11079................................................... 2070-0012
721.11080................................................... 2070-0012
721.11081................................................... 2070-0012
721.11082................................................... 2070-0012
721.11083................................................... 2070-0012
721.11084................................................... 2070-0012
721.11085................................................... 2070-0012
721.11086................................................... 2070-0012
721.11087................................................... 2070-0012
721.11088................................................... 2070-0012
721.11089................................................... 2070-0012
721.11090................................................... 2070-0012
721.11091................................................... 2070-0012
721.11092................................................... 2070-0012
721.11093................................................... 2070-0012
721.11094................................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.11068 to subpart E to read as follows:
Sec. 721.11068 Alkanes, C20-28, chloro.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes,
C20-28, chloro (PMN P-12-277, CAS No. 2097144-43-7) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
5. Add Sec. 721.11069 to subpart E to read as follows:
Sec. 721.11069 Slack waxes (petroleum), chloro.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as slack waxes
(petroleum), chloro (PMN P-12-278, CAS No. 2097144-44-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Add Sec. 721.11070 to subpart E to read as follows:
[[Page 40999]]
Sec. 721.11070 Hexacosane, chloro derivs. and octacosane, chloro
derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as hexacosane, chloro
derivs. and octacosane, chloro derivs. (PMN P-12-280, CAS Nos. 2097144-
46-0 and 2097144-47-1) 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) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.11071 to subpart E to read as follows:
Sec. 721.11071 Alkanes, C20-24, chloro.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes,
C20-24, chloro (PMN P-12-281, CAS No. 2097144-45-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
8. Add Sec. 721.11072 to subpart E to read as follows:
Sec. 721.11072 Alkanes, C14-16, chloro.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes,
C14-16, chloro (PMNs P-12-282 and P-14-684, CAS No. 1372804-
76-6) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
9. Add Sec. 721.11073 to subpart E to read as follows:
Sec. 721.11073 Tetradecane, chloro derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as tetradecane, chloro
derivs. (PMNs P-12-283 and P-14-683, CAS No. 198840-65-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
10. Add Sec. 721.11074 to subpart E to read as follows:
Sec. 721.11074 Octadecane, chloro derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as octadecane, chloro
derivs. (PMN P-12-284, CAS No. 2097144-48-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
11. Add Sec. 721.11075 to subpart E to read as follows:
Sec. 721.11075 Alkanes, C18-20, chloro.
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 41000]]
(1) The chemical substance identified as alkanes, C18-20,
chloro (PMN P-12-433, CAS No. 106262-85-3) 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) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
12. Add Sec. 721.11076 to subpart E to read as follows:
Sec. 721.11076 Alkanes, C14-17, chloro.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes,
C14-17, chloro (PMN P-12-453, CAS No. 85535-85-9) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
13. Add Sec. 721.11077 to subpart E to read as follows:
Sec. 721.11077 Alkanes, C22-30, chloro.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes,
C22-30, chloro (PMN P-12-505, CAS No. 288260-42-4) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (flame retardants and plasticizers in
polyvinyl chloride, polymers, and rubber; flame retardant, plasticizer,
and lubricant in adhesives, caulk, sealants, and coatings; additive in
lubricants including metalworking fluids; and flame retardant and
waterproofer in textiles). It is a significant new use to manufacture
the chemical substance more than 5 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 (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
14. Add Sec. 721.11078 to subpart E to read as follows:
Sec. 721.11078 Chloroflurocarbon (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
chloroflurocarbon (PMN P-16-150) 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), and (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 (NIOSH) assigned protection factor (APF) of at least 1,000),
(a)(6) (liquid), 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 170 ppb 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 (d), (f), (g)(1) (fatal if inhaled), (g)(2)(ii),
(iv), (use respiratory protection or maintain workplace airborne
concentrations at or below an 8-hour time-weighted average of 170 ppb),
(g)(2)(v), (g)(3)(i), (ii), (g)(4) (release to water restrictions
apply), and (g)(5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System (GHS) and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a) through (c), (g), and (q). It is a
significant new use to manufacture, process, or use the PMN substance
without the engineering controls described in the corresponding TSCA
section 5(e) Order to prevent worker and environmental exposures. It is
a significant new use to manufacture the chemical substance more than
one year.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 240.
(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.
[[Page 41001]]
(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
15. Add Sec. 721.11079 to subpart E to read as follows:
Sec. 721.11079 Silane, 1,1'-(1,2-ethanediyl)bis[1,1-dichloro-1-
methyl]-, hydrolysis products with chloroethenyldimethylsilane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Silane, 1,1'-(1,2-
ethanediyl)bis[1,1-dichloro-1-methyl]-, hydrolysis products with
chloroethenyldimethylsilane (PMN P-16-379, CAS No. 1485477-78-8) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iv), (a)(3), when determining which persons
are reasonably likely to be exposed as required for Sec. 721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible,
(a)(6)(particulate), (a)(6)(v), (vi), (b) (concentration set at 1.0%),
and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1) (liver
toxicity), (mutagenicity), (g)(2)(i), (ii), (iii), (v), (g)(4)(i), (do
not incinerate), and (g)(5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System (GHS) and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), (q), (y)(1) and (2).
(iv) Disposal. Requirements as specified in Sec. 721.85(a)
(water), (a)(2), (b) (water), (b)(2), (c) (water), and (c)(2).
(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 (j) 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
16. Add Sec. 721.11080 to subpart E to read as follows:
Sec. 721.11080 Silicophosphonate--sodium silicate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
silicophosphonate--sodium silicate (PMN P-16-410) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). A significant new use is any
use in formulations containing greater than 0.2% of the chemical
substance.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
17. Add Sec. 721.11081 to subpart E to read as follows:
Sec. 721.11081 3-Butenenitrile, 2-(acetyloxy).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3-butenenitrile, 2-
(acetyloxy) (PMN P-16-438, CAS No. 15667-63-7) 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), (a)(2)(i), (ii), (iii), (a)(3), (a)(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 (NIOSH) assigned protection factor
(APF) of at least 1000), (a)(6)(particulate), (a)(6)(v), (vi),
(b)(concentration set at 1.0%), and (c). It is a significant new use to
manufacture, process or use the substance without following the
monitoring procedure as specified in the worker protection section of
the corresponding TSCA section 5(e) Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1) (fatal if
swallowed), (fatal if in contact with skin), (toxic if inhaled),
(g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), (g)(4)(i), (ii),
(iii), and (g)(5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System (GHS) and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g). It is a significant new use to
manufacture or use the substance other than in an enclosed system as
described in the PMN.
(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
18. Add Sec. 721.11082 to subpart E to read as follows:
Sec. 721.11082 Halogenophosphoric acid metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenophosphoric acid metal salt (PMN P-16-543) 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:
[[Page 41002]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(the confidential dermal protection described in
the corresponding TSCA section 5(e) Order ``the Order''), (a)(2)(ii),
(iii), (iv), (a)(3), (a)(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 (NIOSH) assigned protection factor of at least 1,000),
(a)(6) (particulate), (a)(6)(v), (vi), (b)(concentration set at 0.1%),
and (c). It is a significant new use to manufacture, process or use the
substance without following the monitoring procedure as specified in
the worker protection section of the Order.
(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), (vii), (viii), (ix), (g)(2)(i), (ii), (iii),
(use protective engineering controls or equipment for dermal and
inhalation protection, (g)(3)(i), (ii), (g)(4)(i), (ii), (water release
restrictions apply), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(c), (f), and (k). It is a significant new
use to vary or alter, the manufacturing, processing, and use,
distribution/transportation, treatment and disposal processes, process
equipment, engineering controls, and handling practices (including
worker activities and cleaning procedures) described in the PMN in such
a way as to increase the magnitude of inhalation exposure.
(iv) Disposal. Requirements as specified in Sec. 721.85. It is a
significant new use to dispose of the substance other than by hazardous
waste incineration according to 40 CFR parts 260 through 299 unless the
substance is in waste water. When the substance is in wastewater it may
be disposed of as required in paragraph (a)(2)(v) of this section.
(v) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=3.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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)(i)
and (iii) of this section.
0
19. Add Sec. 721.11083 to subpart E to read as follows:
Sec. 721.11083 Alkenoic acid, reaction products with polyethylene
glycol ether with hydroxyalkyl substituted alkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, reaction products with polyethylene glycol ether with
hydroxyalkyl substituted alkane (PMN P-16-596) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (b) (concentration
set at 0.1%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72 (a) through (e)(concentration set at 0.1%), (f), (g)(1)(i),
(dermal sensitization), (g)(1)(iv), (cancer, if inhaled), (g)(1)(ix),
(g)(2)(i), (ii), (iii), (v), (g)(4)(iii), and (g)(5). Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System (GHS) and OSHA Hazard Communication Standard may be
used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (q).
(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
20. Add Sec. 721.11084 to subpart E to read as follows:
Sec. 721.11084 Alkyl substituted alkenoic acid, alkyl ester, polymer
with alkyl substituted alkenoate and alkenoic acid, hydroxy
substituted[(oxoalkyl)oxy]alkyl ester, reaction products with alkanoic
acid, dipentaerythritil and isocyanate substituted carbomonocycle,
compds. with alkylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
substituted alkenoic acid, alkyl ester, polymer with alkyl substituted
alkenoate and alkenoic acid, hydroxy substituted[(oxoalkyl)oxy]alkyl
ester, reaction products with alkanoic acid, dipentaerythritil and
isocyanate substituted carbomonocycle, compds. with alkylamine (PMN P-
17-10) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible,
(a)(6)(particulate), (a)(6)(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),
(sensitization), (g)(1)(vii), (systemic effects), (g)(1)(ix),
(g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
[[Page 41003]]
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k) (ultraviolet curable coating
resin), and (y)(1). It is a significant new use to manufacture the
chemical substance with an average molecular weight below 2,000 daltons
or containing greater than 0.1% residual isocyanate. It is a
significant new use to import the substance other than in totes.
(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. 721.11085 to subpart E to read as follows:
Sec. 721.11085 Heteromonocycle ester with alkanediol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocycle ester with alkanediol (PMN P-17-15) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (b) (concentration set at 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),
(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4) (release to water
restrictions apply), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (q).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=3.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (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
22. Add Sec. 721.11086 to subpart E to read as follows:
Sec. 721.11086 Substituted carbomonocycle, polymer with
(aminoalkyl)-alkanediamine, (haloalkyl)oxirane, dialkyl-alkanediamine
and alkyl-alkanamine, reaction products with dialkanolamine and
[[(alkyl)oxy]alkyl]oxirane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carbomonocycle, polymer with (aminoalkyl)-alkanediamine,
(haloalkyl)oxirane, dialkyl-alkanediamine and alkyl-alkanamine,
reaction products with dialkanolamine and [[(alkyl)oxy]alkyl]oxirane
(PMN P-17-29) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), 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), (eye
irritation), (g)(1)(ii), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii),
(g)(4)(iii), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System (GHS) and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), (q), and (y)(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) 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
23. Add Sec. 721.11087 to subpart E to read as follows:
Sec. 721.11087 Carboxylic acid amine (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carboxylic acid amine (1:1) (PMN P-17-154) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iv), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (a)(6) (particulate), (a)(6)(v), (vi), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii),
(iii), (v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
[[Page 41004]]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
24. Add Sec. 721.11088 to subpart E to read as follows:
Sec. 721.11088 Mix fatty acids compd with amine (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mix
fatty acids compd with amine (1:1) (PMN P-17-155) 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 PMN substance after they have been
reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iv), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (a)(6) (particulate), (a)(6)(v), (vi), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii),
(iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii),
(v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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) 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
25. Add Sec. 721.11089 to subpart E to read as follows:
Sec. 721.11089 Mix fatty acids compd with amine (1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mix
fatty acids compd with amine (1:1) (PMN P-17-156) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible, (a)(6) (particulate), (a)(6)(v), (vi), (b)
(concentration set a 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),
(iii), (thyroid effects), (g)(1)(vi), (ix), (g)(2)(i), (ii), (iii),
(v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System
(GHS) and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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) 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
26. Add Sec. 721.11090 to subpart E to read as follows:
Sec. 721.11090 Bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-
dimethyl-2-oxo-, compd. with N,N-diethylethanamine (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
bicyclo[2.2.1]heptane-1-methanesulfonic acid, 7,7-dimethyl-2-oxo-,
compd. with N,N-diethylethanamine (1:1) (PMN P-17-218. CAS No. 67019-
84-5) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (a)(6)
(particulate), (a)(6)(v), (vi), (b) (concentration set 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),
(corrosivity), (sensitization), (g)(1)(iii), (iv), (ix), (g)(2)(i),
(ii), (iii), (v), and (g)(5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System (GHS) and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q), (y)(1) and (2).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions
[[Page 41005]]
of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.
0
27. Add Sec. 721.11091 to subpart E to read as follows:
Sec. 721.11091 Manganese (2+), bisoctahydro-1,4,7-trimethyl-1H-
1,4,7-triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-,
hexafluorophosphate(1-) (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as manganese (2+),
bisoctahydro-1,4,7-trimethyl-1H-1,4,7-
triazonine-.kappa.N1,.kappa.N4,.kappa.N7) tri-.mu.-oxidi-,
hexafluorophosphate(1-) (1:2) (1:1) (PMN P-17-226, CAS No. 116633-52-4)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (ii), (iii), (a)(3), when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1) engineering control measures (e.g., enclosure or
confinement of 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) (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) (eye
irritation), (respiratory sensitization), (g)(1)(iii), (iv), (vi),
(vii), (viii), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4)
(release to water provisions apply), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System (GHS) and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
process or use the substance without engineering controls to prevent
exposure, including dust removal with 99.9% efficiency when loading or
unloading the substance in powder form.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=240.
(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
28. Add Sec. 721.11092 subpart E to read as follows:
Sec. 721.11092 2'-Fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2'-
fluoro-4''-alkyl-4-propyl-1,1':4'1''-terphenyl (PMN P-17-228) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (b) (concentration
set at 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),
(adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System (GHS) and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(t) and (y)(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) 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
29. Add Sec. 721.11093 to subpart E to read as follows:
Sec. 721.11093 4-ethyl-2'-fluoro-4''-alkyl-1,1':4',1''-terphenyl
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 4-
ethyl-2'-fluoro-4''-alkyl-1,1':4',1''-terphenyl (PMN P-17-229) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (b) (concentration
set 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set 1.0%), (f), (g)(1)(vi),
(adrenal effects), (liver effects), (g)(2)(i), (ii), (iii), (v), and
(g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(t) and (y)(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) 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
30. Add Sec. 721.11094 to subpart E to read as follows:
Sec. 721.11094 Poly(oxy-1,2-ethanediyl),alpha-(2-benzoyl)-omega-[(2-
benzoylbenzoyl)oxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl),alpha-(2-benzoyl)-omega-[(2-benzoylbenzoyl)oxy]- (PMN P-17-
261) 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
[[Page 41006]]
apply to quantities of the substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1)
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (b) (concentration
set at 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)
(irritation), (photosensitization), (g)(2)(i), (ii), (iii), (v), and
(g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) 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) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[FR Doc. 2018-17348 Filed 8-16-18; 8:45 am]
BILLING CODE 6560-50-P