Significant New Use Rules on Certain Chemical Substances, 46133-46156 [2021-17392]
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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
dialkanolamine, acetates (salts) (PMN
P–19–27) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in any manner that
results in inhalation exposure to vapor,
particulate, mist, or aerosols. It is a
significant new use to manufacture the
PMN substance beyond an annual
production volume of 95,600 kg.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11329 Non-metal tetrakis
(hydroxyalkyl)-, halide, polymer with amide
oxidized (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as non-metal tetrakis
(hydroxyalkyl)-, halide, polymer with
amide oxidized (PMN P–19–45) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j). It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposure. It is a significant
new use to manufacture the substance to
contain greater than 0.1% residual
unbound formaldehyde by weight.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
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of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
[FR Doc. 2021–17388 Filed 8–17–21; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2018–0627, EPA–HQ–
OPPT–2018–0777, EPA–HQ–OPPT–2019–
0359, EPA–HQ–OPPT–2019–0228, EPA–HQ–
OPPT–2019–0494, and EPA–HQ–OPPT–
2019–0530; FRL–8000–02–OCSPP]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is issuing significant new
use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for
chemical substances that were the
subject of premanufacture notices
(PMNs). The SNURs require persons
who intend to manufacture (defined by
statute to include import) or process any
of these 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 use,
under the conditions of use for that
chemical substance, within the
applicable review period. Persons may
not commence manufacture or
processing for the significant new use
until EPA has conducted a review of the
notice, made an appropriate
determination on the notice, and has
taken such actions as are required by
that determination.
DATES: This rule is effective on October
18, 2021. For purposes of judicial
review, this rule shall be promulgated at
1 p.m. (e.s.t.) on September 1, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
William Wysong, New Chemicals
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–4163;
email address: wysong.william@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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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 provisions
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, which would include 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 are subject
to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b))
(see 40 CFR 721.20), and must comply
with the export notification
requirements in 40 CFR part 707,
subpart D.
B. How can I access the dockets?
The dockets include information
considered by the Agency in developing
the proposed and final rules. The
dockets for this action, identified by
docket identification (ID) numbers EPA–
HQ–OPPT–2018–0627, –2018–0777,
–2019–0359, –2019–0228, –2019–0494,
and –2019–0530, are available at https://
www.regulations.gov and at the Office of
Pollution Prevention and Toxics Docket
(OPPT Docket), Environmental
Protection Agency Docket Center (EPA/
DC), West William Jefferson Clinton
Bldg., Rm. 3334, 1301 Constitution Ave.
NW, Washington, DC. The Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280.
Due to the public health concerns
related to COVID–19, the EPA Docket
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Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA
section 5(a)(2) for certain chemical
substances which were the subject of
PMNs. EPA will address the other
proposed SNURs in future Federal
Register notices.
Previously, EPA proposed SNURs for
these chemical substances and
established the record for these SNURs
in the following Federal Registers and
docket ID numbers:
• October 3, 2018 (83 FR 49903)
(FRL–9983–81); Docket ID No. EPA–
HQ–OPPT–2018–0627;
• July 31, 2019 (84 FR 37199) (FRL–
9994–62); Docket ID No. EPA–HQ–
OPPT–2018–0777;
• August 6, 2019 (84 FR 38158) (FRL–
9996–62); Docket ID No. EPA–HQ–
OPPT–2019–0359;
• October 11, 2019 (84 FR 54816)
(FRL–9998–64); Docket ID No. EPA–
HQ–OPPT–2019–0228;
• November 4, 2019 (84 FR 59335)
(FRL–10000–54); Docket ID No. EPA–
HQ–OPPT–2019–0494; and
• December 6, 2019 (84 FR 66855)
(FRL–10001–48); Docket ID No. EPA–
HQ–OPPT–2019–0530.
The dockets include information
considered by the Agency in developing
the proposed and final rules, including
public comments and EPA’s responses
to the public comments received.
B. What is the Agency’s authority for
taking this action?
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four bulleted TSCA
section 5(a)(2) factors listed in Unit III.
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C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to
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these SNURs must comply with the
significant new use notice (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 sections 5(b) and 5(d)(1), the
exemptions authorized by TSCA
sections 5(h)(1), (h)(2), (h)(3), and (h)(5),
and the regulations at 40 CFR part 720.
Once EPA receives a SNUN and before
the manufacture or processing for the
significant new use can commence, 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. 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
A. Considerations for Significant New
Use Determinations
When the Agency issues an order
under TSCA section 5(e), section 5(f)(4)
requires that the Agency consider
whether to promulgate a SNUR for any
use not conforming to the restrictions of
the TSCA Order or publish a statement
describing the reasons for not initiating
the rulemaking. TSCA section 5(a)(2)
states that EPA’s determination that a
use of a chemical substance is a
significant new use must be made after
consideration of all relevant factors,
including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In determining what would constitute
a significant new use for the chemical
substances that are the subject of these
SNURs, EPA considered relevant
information about the toxicity of the
chemical substances, and potential
human exposures and environmental
releases that may be associated with
possible uses of these chemical
substances, in the context of the four
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bulleted TSCA section 5(a)(2) factors
listed in this unit.
B. Procedures for Significant New Uses
Claimed as CBI
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 40 CFR 721.1725(b)(1) and has
referenced it to apply to other SNURs.
Under these procedures a
manufacturer or processor may request
EPA to determine whether a specific 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 40 CFR
721.1725(b)(1) with that under 40 CFR
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.
IV. Public Comments on Proposed Rule
and EPA Responses
EPA received public comments from
nine identifying entities on the
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proposed rules. The Agency’s responses
are presented in the Response to Public
Comments document that is available in
each of the dockets for these rules. EPA
made changes to three of the proposed
rules as described in the response to
comments.
V. Substances Subject to This Rule
EPA is establishing significant new
use and recordkeeping requirements for
chemical substances in 40 CFR part 721,
subpart E. In Unit IV. of the proposed
SNURs, EPA provided the following
information for each chemical
substance:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as
confidential business information
(CBI)).
• Chemical Abstracts Service (CAS)
Registry number (if assigned for nonconfidential chemical identities).
• Effective date of and basis for the
TSCA Order.
• Potentially Useful Information. This
is information identified by EPA that
would help characterize the potential
health and/or environmental effects of
the chemical substances if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use designated by the
SNUR.
• CFR citation assigned in the
regulatory text section of these rules.
The regulatory text section of these
rules specifies the activities designated
as significant new uses. Certain new
uses, including production volume
limits and other uses designated in the
rules, may be claimed as CBI.
These final rules include PMN
substances that are subject to orders
issued under TSCA section 5(e)(1)(A), as
required by the determinations made
under TSCA section 5(a)(3)(B). Those
TSCA Orders require protective
measures to limit exposures or
otherwise mitigate the potential
unreasonable risk. The final 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 TSCA
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 Order usually requires 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
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Chemical Exposure Limit (NCEL). The
comprehensive NCELs provisions in
TSCA Orders include requirements
addressing performance criteria for
sampling and analytical methods,
periodic monitoring, respiratory
protection, and recordkeeping. No
comparable NCEL provisions currently
exist in 40 CFR part 721, subpart B, for
SNURs. Therefore, for these cases, the
individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject
to the SNUR who wish to pursue NCELs
as an alternative to the 40 CFR 721.63
respirator requirements may request to
do so under 40 CFR 721.30. EPA expects
that persons whose 40 CFR 721.30
requests to use the NCELs approach for
SNURs that are approved by EPA will
be required to comply with NCELs
provisions that are comparable to those
contained in the corresponding TSCA
Order.
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these SNURs and as further
discussed in Unit IV. of the proposed
rules, EPA concluded that 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. Based on such
findings, TSCA Orders requiring the use
of appropriate exposure controls were
negotiated with the PMN submitters. As
a general matter, EPA believes it is
necessary to follow TSCA Orders with
a SNUR that identifies the absence of
those protective measures as significant
new uses to ensure that all
manufacturers and processors—not just
the original submitter—are held to the
same standard.
B. Objectives
EPA is issuing these SNURs because
the Agency wants to
• 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.
• 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; and
• Be obligated to make a
determination under TSCA section
5(a)(3) regarding the use described in
the SNUN, under the conditions of use.
The Agency will either determine under
TSCA section 5(a)(3)(C) that significant
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new use is not likely to present an
unreasonable risk, including an
unreasonable risk to a potentially
exposed or susceptible subpopulation
identified as relevant by the
Administrator under the conditions of
use, or make a determination under
TSCA section 5(a)(3)(A) or (B) and take
the required regulatory action associated
with the determination, before
manufacture or processing for the
significant new use of the chemical
substance can occur.
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 https://www.epa.gov/tscainventory.
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 Orders have been issued for all
the chemical substances that are the
subject of this rule, and the PMN
submitters are prohibited by the TSCA
Orders from undertaking activities
which will be designated as significant
new uses. The identities of 50 of the 57
chemical substances subject to this rule
have been claimed as confidential (per
40 CFR 720.85). 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.
Furthermore, EPA designated the
publication dates of the proposed rules
(see Unit II.) as the cutoff dates for
determining whether the new uses are
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 final rule.
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In the unlikely event that a person
began commercial manufacture or
processing of the chemical substances
for a significant new use identified as of
the abovementioned dates, that person
will have to cease any such activity
upon the effective date of the final rule.
To resume their activities, that person
would have to first comply with all
applicable SNUR notification
requirements and wait until EPA has
conducted a review of the notice, made
an appropriate determination on the
notice, and has taken such actions as are
required with that determination.
VIII. Development and Submission of
Information
EPA recognizes that TSCA section 5
does not require development of any
particular new information (e.g.,
generating test data) before submission
of a SNUN. There is an exception:
If a person is required to submit
information for a chemical substance
pursuant to a rule, TSCA Order or
consent agreement under TSCA section
4, then TSCA section 5(b)(1)(A) requires
such information to be submitted to
EPA at the time of submission of the
SNUN.
In the absence of a rule, TSCA Order,
or consent agreement under TSCA
section 4 covering the chemical
substance, persons are required only to
submit information in their possession
or control and to describe any other
information known to them 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. of the proposed rule lists
potentially useful information for all
SNURs listed in this document.
Descriptions are provided for
informational purposes. The
information identified in Unit IV. of the
proposed rule will be potentially useful
to EPA’s evaluation in the event that
someone submits a SNUN for the
significant new use. Companies who are
considering submitting a SNUN are
encouraged, but not required, to develop
the information on the substance.
EPA strongly encourages persons,
before performing any testing, to consult
with the Agency. 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
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data needs and the objective of TSCA
section 4(h). For more information on
alternative test methods and strategies
to reduce vertebrate animal testing, visit
https://www.epa.gov/assessing-andmanaging-chemicals-under-tsca/
alternative-test-methods-and-strategiesreduce.
In some of the TSCA Orders for the
chemical substances identified in 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. The SNURs contain the
same production volume limits as the
TSCA 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
TSCA Orders was made based on EPA’s
consideration of available screeninglevel 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.
The potentially useful information
identified in Unit IV. of the proposed
rule may not be the only means of
addressing the potential risks of the
chemical substance associated with the
designated significant new uses.
However, submitting a SNUN without
any test data or other information may
increase the likelihood that EPA will
take action under TSCA sections 5(e) or
5(f). EPA recommends that potential
SNUN submitters contact EPA early
enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs that provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
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• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. SNUN Submissions
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notification requirements and
EPA regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in 40
CFR 720.50. SNUNs must be submitted
on EPA Form No. 7710–25, generated
using e-PMN software, and submitted to
the Agency in accordance with the
procedures set forth in 40 CFR 720.40
and 721.25. E–PMN software is
available electronically at https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca.
X. 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
analyses are available in each docket
listed in Unit II.
XI. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This action establishes SNURs for
several new chemical substances that
were the subject of PMNs. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Orders 12866
(58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011).
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
This action is not subject to Executive
Order 13771 (82 FR 9339, February 3,
2017), because this action is not a
significant regulatory action under
Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The information
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collection requirements associated with
SNURs have already been approved by
OMB pursuant to the PRA under OMB
control number 2070–0012 (EPA ICR
No. 574). This rule does not impose any
burden requiring additional OMB
approval.
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. The Information Collection
Request (ICR) covering the SNUR
activities 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.
If an entity were to submit a SNUN to
the Agency, the annual burden is
estimated to average between 30 and
170 hours per response. This burden
estimate includes the time needed to
review instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Regulatory
Support Division, Office of Mission
Support (2822T), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
Please remember to include the OMB
control number in any correspondence,
but do not submit any completed forms
to this address.
D. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of these
SNURs would not have a significant
adverse economic impact on a
substantial number of small entities.
The requirement to submit a SNUN
applies to any person (including small
or large entities) who intends to engage
in any activity described in the final
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rule as a ‘‘significant new use.’’ Because
these uses are ‘‘new,’’ based on all
information currently available to EPA,
EPA has concluded that no small or
large entities presently engage in such
activities. A SNUR requires that any
person who intends to engage in such
activity in the future must first notify
EPA by submitting a SNUN. Although
some small entities may decide to
pursue a significant new use in the
future, EPA cannot presently determine
how many, if any, there may be.
However, EPA’s experience to date is
that, in response to the promulgation of
SNURs covering over 1,000 chemicals,
the Agency receives only a small
number of notices per year. For
example, EPA received 7 SNUNs in
Federal fiscal year (FY) 2013, 13 in
FY2014, 6 in FY2015, 10 in FY2016, 14
in FY2017, and 11 in FY2018 and only
a fraction of these were from small
businesses. In addition, the Agency
currently offers relief to qualifying small
businesses by reducing the SNUN
submission fee from $16,000 to $2,800.
This lower fee reduces the total
reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for
qualifying small firms. Therefore, the
potential economic impacts of
complying with this SNUR are not
expected to be significant or adversely
impact a substantial number of small
entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR
29684) (FRL–5597–1), the Agency
presented its general determination that
final SNURs are not expected to have a
significant economic impact on a
substantial number of small entities,
which was provided to the Chief
Counsel for Advocacy of the Small
Business Administration.
E. 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.).
F. Executive Order 13132: Federalism
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
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responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
G. Executive Order 13175: Consultation
and Coordination With Indian Tribe
Governments
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
(65 FR 67249, November 9, 2000), do
not apply to this action.
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
EPA interprets Executive Order 13045
as applying only to those regulatory
actions that concern environmental
health or safety risks that EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
J. National Technology Transfer and
Advancement Act (NTTAA)
In addition, since this action does not
involve any technical standards subject
to NTTAA section 12(d) (15 U.S.C. 272
note).
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not entail special
considerations of environmental justice
related issues as delineated by
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Executive Order 12898 (59 FR 7629,
February 16, 1994).
OMB control
No.
40 CFR citation
OMB control
No.
40 CFR citation
XII. Congressional Review Act
This action is subject to the CRA (5
U.S.C. 801 et seq.), and EPA will submit
a rule report containing this rule and
other required information to each
House of the Congress and to the
Comptroller General of the United
States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
*
*
*
*
Significant New Uses of Chemical
Substances
*
721.11426
721.11427
721.11428
721.11429
721.11430
721.11431
721.11432
721.11433
721.11434
721.11435
721.11436
721.11437
721.11438
721.11439
721.11440
721.11441
721.11442
721.11443
*
*
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
721.11150 .............................
*
*
2070–0012
*
721.11267
721.11268
721.11269
721.11270
721.11271
721.11272
721.11273
721.11274
721.11275
721.11276
721.11277
*
*
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
721.11279 .............................
721.11280 .............................
721.11281 .............................
*
*
2070–0012
2070–0012
2070–0012
*
*
*
721.11284 .............................
*
*
2070–0012
*
*
*
721.11288 .............................
*
*
2070–0012
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT
*
*
*
721.11305 .............................
*
*
2070–0012
Subpart E—Significant New Uses for
Specific Chemical Substances
■
1. The authority citation for part 9
continues to read as follows:
*
*
*
721.11308 .............................
*
*
2070–0012
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; 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.
*
*
*
721.11315 .............................
721.11316 .............................
*
*
2070–0012
2070–0012
*
*
*
721.11319 .............................
721.11320 .............................
721.11321 .............................
*
*
2070–0012
2070–0012
2070–0012
*
721.11346
721.11347
721.11348
721.11349
721.11350
*
*
.............................
.............................
.............................
.............................
.............................
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
721.11360 .............................
721.11361 .............................
*
*
2070–0012
2070–0012
*
*
*
721.11372 .............................
*
*
2070–0012
*
*
*
721.11383 .............................
*
*
2070–0012
*
721.11390
721.11391
721.11392
721.11393
*
*
.............................
.............................
.............................
.............................
*
*
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
721.11422 .............................
*
*
2070–0012
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 9, 2021.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, for the reasons stated in the
preamble, 40 CFR chapter I is amended
as follows:
2. In § 9.1, amend the table by adding
entries for §§ 721.11150, 721.11267
through 721.11277, 721.11279 through
721.11281, 721.11284, 721.11288,
721.11305, 721.11308, 721.11315 and
721.11316, 721.11319 through
721.11321, 721.11346 through
721.11350, 721.11360 and 721.11361,
721.11372, 721.11383, 721.11390
through 721.11393, 721.11422, and
721.11426 through 721.11443 in
numerical order under the undesignated
center heading ‘‘Significant New Uses of
Chemical Substances’’ to read as
follows:
■
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*
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
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*
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*
*
*
*
*
*
*
*
*
*
PART 721—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
3. The authority citation for part 721
continues to read as follows:
■
■
4. Add § 721.11150 to read as follows:
§ 721.11150
2-Pyrrolidinone, 1-butyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-pyrrolidinone, 1-butyl- (PMN P–14–
627, CAS No. 3470–98–2) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iv), (a)(3),
(b), and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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. For
purposes of § 721.63(a)(2)(i), butyl or
Silver Shield gloves may be used. For
purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(i) and (ix), (g)(2)(i)
through (iii) and (v), and (g)(5).
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Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used. For purposes of § 721.72(e), the
concentration is set at 1.0%.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f). It is a significant
new use to import the substance in
containers of less than 55 gallons when
the concentration of the confidential
component identified in the TSCA
Order is greater than 5% by weight for
any product either intended for sale or
distribution for consumer use, including
for use in consumer products, or both
intended for commercial use and made
available to consumers for retail
purchase of any kind. It is a significant
new use to use or sell the PMN
substance in handheld spray
applications that generate a vapor, mist
or aerosol.
(iv) Significant new use to import. It
is a significant new use to import the
PMN substance other than to be
processed or sold for:
(A) Dispersions for industrial coatings
(e.g., polyurethane, acrylic, epoxy);
(B) Coating for consumer and
professional use;
(C) Adhesives and sealants;
(D) Solvent-borne industrial coatings;
(E) Silicon wafer cleaning in
microelectronics in clean rooms;
(F) Photoresist stripping in
microelectronics in clean rooms;
(G) Coatings for microelectronics (e.g.,
casting of polymer films) in clean
rooms;
(H) Reaction medium for
polymerization, polymer coatings for
industrial and professional applications
(e.g., wire enamel, non-stick and friction
reduction coating) membranes;
(I) Solvent for chemical synthesis
reactions (e.g., pharmaceuticals);
(J) Formulation of inks;
(K) Industrial cleaner (e.g., cleaner for
wind turbine, oil rigs, large engines);
(L) Solvent for cleaning industrial
reactors;
(M) Wax inhibitors (in hydrocarbon
lines);
(N) Petrochemical extraction
processes;
(O) Paint stripper;
(P) Solvents for production and
formulation of fertilizer;
(Q) Solvent for production and
formulation of active ingredients for
agriculture;
(R) Solvent for formulation of active
ingredients for agriculture-end use
pesticide product).
(v) Significant new use to use or sell.
It is a significant new use to use or sell
the PMN substance for:
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(A) Dispersions for industrial coatings
(e.g., polyurethane, acrylic, epoxy) in a
concentration greater than 18% in
formulated products;
(B) Adhesives and sealants in
concentrations greater than 18% in
formulated products;
(C) Solvent-borne industrial coatings
in concentrations greater than 30% in
formulated products;
(D) Coatings for microelectronics (e.g.,
casting of polymer films) in clean rooms
in concentrations greater than 20% in
formulated products;
(E) Reaction medium for
polymerization, polymer coatings for
industrial and professional applications
(e.g., wire enamel, non-stick and friction
reduction coating) membranes in
concentrations greater than 40% in
formulated products;
(F) Inks in concentrations greater than
15% in formulated products;
(G) Solvent for chemical synthesis
reactions (e.g., pharmaceuticals) in
concentrations greater than 40% in
formulated products;
(H) Industrial cleaner (e.g., cleaner for
wind turbine, oil rigs, large engines) in
concentrations greater than 20% in
formulated products;
(I) Wax inhibitors (in hydrocarbon
lines) in concentrations greater than
20% in formulated products;
(J) Petrochemical extraction processes
in concentrations greater than 60% in
formulated products;
(K) Paint stripper only for industrial
use in concentrations greater than 20%
in formulated products;
(L) Solvent for formulation of active
ingredients for agriculture-end use
pesticide product) in concentrations
greater than 70% in formulated
products;
(M) Paint removers in concentrations
greater than 5% in formulated products
intended for sale or distribution for
‘‘consumer’’ use, including ‘‘commercial
use’’ when the ‘‘saleable good or
service’’ could introduce PMN material
into a ‘‘consumer’’ setting;
(N) Coatings in concentrations greater
than 1% in formulated products
intended for sale or distribution for
‘‘consumer’’ use, including ‘‘commercial
use’’ when the ‘‘sealable good or
service’’ could introduce PMN material
into a ‘‘consumer’’ setting.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
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provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 5. Add §§ 721.11267 through
721.11277 to read as follows:
Sec.
*
*
*
*
*
721.11267 Silane amine carbonate (generic).
721.11268 Hydrochlorofluoroolefin
(generic).
721.11269 Fatty acid modified aromatic
polyester polyol (generic).
721.11270 Dodecanedioic acid and 1,6hexanediol polymer with 3-hydroxy-2,2dimethylpropyl-2,2dimethylhydracrylate, neopentylglycol,
1,2-ethanediol, adipic acid, isophthalic
acid, terephthalic acid, 2-Oxooxopane,
BayFlex 2002H and 1,1′methylenebis(isocyanatobenzene)
(generic).
721.11271 Ethanone, 1-[4-(4chlorophenoxy)-2(trifluoromethyl)phenyl]-.
721.11272 Vegetable oil, polymer with
alkanedioic acid, alkali lignin,
diethylene glycol- and polyol-depolymd.
poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid
anhydride (generic).
721.11273 Vegetable oil, polymer with
alkanedioic acid, alkali lignin,
diethylene glycol- and polyol-depolymd.
poly(ethylene terephthalate) waste
plastics (generic).
721.11274 Waste plastics, poly(ethylene
terephthalate), depolymd. with
diethylene glycol, polymers with
alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (generic).
721.11275 Waste plastics, poly(ethylene
terephthalate), depolymd. with
diethylene glycol and polyol, polymers
with alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (generic).
721.11276 Vegetable oil, polymer with
alkanedioic acid, alkali lignin,
diethylene glycol- and polyol-depolymd.
poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid
anhydride (generic).
721.11277 Vegetable oil, polymer with
alkanedioic acid, alkali lignin,
diethylene glycol-depolymd.
poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid
anhydride (generic).
*
*
§ 721.11267
(generic).
*
*
*
Silane amine carbonate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as silane amine carbonate
(PMN P–17–157) 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:
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(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through (5), (a)(6)(v)
and (vi), and (b). When determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
and (4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000. For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(i) and (ii), (g)(2)(i)
through (v), and (g)(5). Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(e), the
concentration is set at 1.0%.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (h), are applicable
to manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11268
(generic).
Hydrochlorofluoroolefin
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as hydrochlorofluoroolefin
(PMN P–17–295) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through (5), (a)(6)(v)
and (vi), and (b). When determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
and (4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
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must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 10. For purposes of
§ 721.63(b), the concentration is set at
1.0%.
(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 Order for this substance.
The NCEL is 23.6 mg/m3 (3.9 ppm) as
an 8-hour time weighted average.
Persons who wish to pursue NCELs as
an alternative to § 721.63 respirator
requirements may request to do so
under § 721.30. Persons whose § 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 Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1) and (2). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Internal organ
effects; reproductive effects; fatality. For
purposes of § 721.72(g)(2), when using
this substance: Avoid skin contact;
avoid breathing substance; avoid
ingestion; use respiratory protection or
maintain workplace airborne
concentrations at or below an 8-hour
time-weighted average of 23.6 mg/m3
(3.9 ppm); use skin protection.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (o). For
purposes of § 721.80(k), the use is as a
refrigerant used in closed systems for
chillers (commercial comfort air
conditioners) and industrial process
refrigeration.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11269 Fatty acid modified aromatic
polyester polyol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fatty acid modified
aromatic polyester polyol (PMN P–17–
306 and PMN P–17–307) are subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
(b), and (c). When determining which
persons are reasonably likely to be
exposed as required for § 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. For
purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) and (v), and
(g)(5). For purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Internal organ
effects; ocular effects. 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. It is a significant
new use to use an application method
that generates a vapor, mist, aerosol, or
dust containing the substance resulting
in inhalation exposures.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i), are applicable
to manufacturers and processors of
these substances.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11270 Dodecanedioic acid and 1,6hexanediol polymer with 3-hydroxy-2,2dimethylpropyl-2,2-dimethylhydracrylate,
neopentylglycol, 1,2-ethanediol, adipic acid,
isophthalic acid, terephthalic acid, 2Oxooxopane, BayFlex 2002H and 1,1′methylenebis(isocyanatobenzene)
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance identified
generically as dodecanedioic acid and
1,6-hexanediol polymer with 3-hydroxy2,2-dimethylpropyl-2,2dimethylhydracrylate, neopentylglycol,
1,2-ethanediol, adipic acid, isophthalic
acid, terephthalic acid, 2-Oxooxopane,
BayFlex 2002H and 1,1′methylenebis(isocyanatobenzene) (PMN
P–17–320) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through (5), (a)(6)(v)
and (vi), and (c). When determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
and (4), engineering control measures
(e.g., enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(6), the airborne form(s) of the
substance include particulate (including
solids or liquid droplets).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1), (g)(2)(i), (ii), (iv),
and (v), and (g)(5). For purposes of
§ 721.72(g)(1), this substance may cause:
Skin irritation; respiratory
complications; mutagenicity.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o), (y)(1), and
(y)(2). It is a significant new use to
manufacture the substance containing
more than 1% residual isocyanate by
weight.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11271 Ethanone, 1-[4-(4chlorophenoxy)-2-(trifluoromethyl)phenyl]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
ethanone, 1-[4-(4-chlorophenoxy)-2(trifluoromethyl)phenyl]- (PMN P–17–
329, CAS No. 1417782–28–5) 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
§ 721.63(a)(1), (a)(2)(i) through (iv),
(a)(3) through (5), (a)(6)(v) and (vi), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4)
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate
(including solids or liquid droplets).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1), (g)(2)(i), (ii), (iv),
and (v), (g)(3)(i) and (ii), and (g)(4) and
(5). For purposes of § 721.72(g)(1), this
substance may cause: Respiratory
complications, internal organ effects,
reproductive effects; sensitization. For
purposes of § 721.72(g)(4), notice to
users: Do not release to water at
concentrations that exceed 7 parts per
billion. 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 § 721.80(k).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=7.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11272 Vegetable oil, polymer with
alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and
arylcarboxylic acid anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as vegetable oil, polymer
with alkanedioic acid, alkali lignin,
diethylene glycol- and polyoldepolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid
anhydride (PMN P–17–367) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance with greater than the
confidential percentages of low
molecular weight components specified
in the Order or less than the
confidential average molecular weight
specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11273 Vegetable oil, polymer with
alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as vegetable oil, polymer
with alkanedioic acid, alkali lignin,
diethylene glycol- and polyoldepolymd. poly(ethylene terephthalate)
waste plastics (PMN P–17–368) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
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the substance with greater than the
confidential percentages of low
molecular weight components and less
than the confidential average molecular
weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
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§ 721.11274 Waste plastics, poly(ethylene
terephthalate), depolymd. with diethylene
glycol, polymers with alkanedioic acid,
alkali lignin and arylcarboxylic acid
anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as waste plastics,
poly(ethylene terephthalate), depolymd.
with diethylene glycol, polymers with
alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (PMN P–
17–369) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance with greater than the
confidential percentages of low
molecular weight components and less
than the confidential average molecular
weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
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§ 721.11275 Waste plastics, poly(ethylene
terephthalate), depolymd. with diethylene
glycol and polyol, polymers with
alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as waste plastics,
poly(ethylene terephthalate), depolymd.
with diethylene glycol and polyol,
polymers with alkanedioic acid, alkali
lignin and arylcarboxylic acid
anhydride (PMN P–17–370) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance with greater than the
confidential percentages of low
molecular weight components specified
in the Order or less than the
confidential average molecular weight
specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11276 Vegetable oil, polymer with
alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and
arylcarboxylic acid anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as vegetable oil, polymer
with alkanedioic acid, alkali lignin,
diethylene glycol- and polyoldepolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid
anhydride (PMN P–17–371) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance with greater than the
confidential percentages of low
molecular weight components and less
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than the confidential average molecular
weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11277 Vegetable oil, polymer with
alkanedioic acid, alkali lignin, diethylene
glycol-depolymd. poly(ethylene
terephthalate) waste plastics and
arylcarboxylic acid anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as vegetable oil, polymer
with alkanedioic acid, alkali lignin,
diethylene glycol-depolymd.
poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid
anhydride (PMN P–17–372) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance with greater than the
confidential percentages of low
molecular weight components specified
in the Order or less than the
confidential average molecular weight
specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 6. Add §§ 721.11279 through
721.11281 to read as follows:
*
*
*
*
*
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Sec.
721.11279 Substituted propanoic acid,
polymer with alkylisocyanatesubstituted carbomonocycle, dialkyl
carbonate, hydroxyl alkyl substituted
alkanediol, alkanediol, isocyanato
substituted carbomonocycle, alkanol
substituted amines-blocked, compds.
with (alkylamino)alkanol (generic).
721.11280 Propanediol phosphate (generic).
721.11281 Substituted cashew, nutshell
liquid, polymer with epichlorohydrin,
phosphate (generic).
*
*
*
*
*
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§ 721.11279 Substituted propanoic acid,
polymer with alkylisocyanate-substituted
carbomonocycle, dialkyl carbonate,
hydroxyl alkyl substituted alkanediol,
alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted
amines-blocked, compds. with
(alkylamino)alkanol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted propanoic
acid, polymer with alkylisocyanatesubstituted carbomonocycle, dialkyl
carbonate, hydroxyl alkyl substituted
alkanediol, alkanediol, isocyanato
substituted carbomonocycle, alkanol
substituted amines-blocked, compds.
with (alkylamino)alkanol (PMN P–17–
394) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f). It is a significant
new use to use the substance for any use
other than as a coating to improve
chemical resistance. It is a significant
new use to import the substance with
average molecular weight greater than
1,000 daltons, containing greater than
0.1% residual isocyanate by weight, or
with greater than 4% of the confidential
chemical component specified in the
Order.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
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§ 721.11280
(generic).
Propanediol phosphate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as propanediol phosphate
(PMN P–18–23) 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 fully
reacted (cured).
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1) and (2), (g)(3)(i)
and (ii), (g)(4)(iii), and (g)(5). For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; internal
organ effects; eye irritation. For
purposes of § 721.72(g)(2), when using
this substance: Avoid skin contact;
avoid breathing substance; use skin
protection; use eye protection; avoid eye
contact. Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the substance in any
manner that generates a vapor, spray,
mist, or aerosol.
(iii) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11281 Substituted cashew, nutshell
liquid, polymer with epichlorohydrin,
phosphate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted cashew,
nutshell liquid, polymer with
epichlorohydrin, phosphate (PMN P–
18–24) 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
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substance after they have been fully
reacted (cured).
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1) and (2), (g)(3)(i)
and (ii), (g)(4)(iii), and (g)(5). For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; eye irritation.
For purposes of § 721.72(g)(2), when
using this substance: Avoid skin
contact; avoid breathing substance; use
skin protection; use eye protection;
avoid eye contact. Alternative hazard
and warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(o). It is a
significant new use to manufacture,
process, or use the substance in any
manner that generates a vapor, spray,
mist, or aerosol.
(iii) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
■ 7. Add § 721.11284 to read as follows:
§ 721.11284 Di(substituted-1,3trialkylammonium) dialkylammonium salt
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as di(substituted-1,3trialkylammonium) dialkylammonium
salt (PMN P–18–88) 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 fully reacted (cured).
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(ii) through (iv),
(g)(2)(i) through (iii) and (v), and (g)(5).
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
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be used. For purposes of § 721.72(e), the
concentration is set at 1.0%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). It is a
significant new use to manufacture,
process, or use the substance in any
manner that generates a vapor, mist,
particulate, or aerosol.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=1000.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
■ 8. Add § 721.11288 to read as follows:
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§ 721.11288
methyl-.
Benzene, 1-(chloromethyl)-3-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzene, 1-(chloromethyl)-3-methyl(PMN P–18–134; CAS No. 620–19–9) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3)
through (5), (a)(6)(v) and (vi), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate and
combination gas/vapor and particulate.
For purposes of § 721.63(b), the
concentration is set at 0.1%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (v),
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(g)(3)(i) and (ii), (g)(4)(iii), and (g)(5). For
purposes of § 721.72(e), the
concentration is set at 0.1%. For
purposes of § 721.72(g)(1), this
substance may cause: Respiratory
irritation; severe skin burns and eye
damage; sensitization (respiratory and
dermal); serious eye irritation;
respiratory complications; central
nervous system effects; reproductive
effects; cancer; developmental effects.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(k). It is a
significant new use to vary the process
or use methods described in the PMN
such that occupational exposure is
increased.
(iv) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 9. Add § 721.11305 to read as follows:
§ 721.11305 Unsaturated polycyclic
hydrocarbon (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as unsaturated polycyclic
hydrocarbon (PMN P–17–419) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3) through
(5), (a)(6)(v) and (vi), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
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Fmt 4700
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prevent exposure, where feasible. For
purposes of 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
721.63(b), the concentration is set at
1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i), (ii), (iv) and
(v), (g)(3)(i) and (ii), (g)(4)(iii), and (g)(5).
For purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin sensitization;
specific target organ toxicity; skin
irritation; respiratory complications;
reproductive effects; developmental
effects. Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t). It is a
significant new use to manufacture the
substance for more than 9 months.
(iv) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 10. Add § 721.11308 to read as
follows:
§ 721.11308
Mixed metal oxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as mixed metal oxide (PMN
P–18–55) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
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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. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate. For
purposes of § 721.63(b), the
concentration is set at 0.1%.
(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 Order for this substance.
The NCEL is 0.04 mg/m3 as an 8-hour
time weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by the
EPA will be required to follow NCELs
provisions comparable to those
contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 0.1%. For
purposes of § 721.72(g)(1), this
substance may cause: Allergic skin
reaction; respiratory sensitization; germ
cell mutagenicity; respiratory
complications; cancer. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing substance; avoid ingestion;
use skin protection; use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.04
mg/m3. Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
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provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 11. Add § 721.11315 to read as
follows:
§ 721.11315
Lithium nickel hydride oxide.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
lithium nickel hydride oxide (PMN P–
18–123; CAS No. 2081933–92–6) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate.
(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 Order for this substance.
The NCEL is 0.05 mg/m3 as an 8-hour
time weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 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
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1)(ii) through (iv)
and (vii) through (ix), (g)(2), (g)(3)(ii),
(g)(4)(i), and (g)(5). For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing substance; avoid ingestion;
use skin protection; use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.05
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Fmt 4700
Sfmt 4700
46145
mg/m3. Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture the substance
for more than four years.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=32.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
■ 12. Add § 721,11316 to read as
follows:
§ 721.11316
oxide.
Lithium nickel potassium
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
lithium nickel potassium oxide (PMN
P–18–124, CAS No. 210352–95–7) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate.
(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 Order for this substance.
The NCEL is 0.05 mg/m3 as an 8-hour
time weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
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request to do so under § 721.30. Persons
whose § 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
Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1)(ii) through (iv)
and (vii) through (ix), (g)(2), (g)(3)(ii),
(g)(4)(i), and (g)(5). For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing substance; avoid ingestion;
use skin protection; use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.05
mg/m3. Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture the substance
for more than four years.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=32.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
■ 13. Add §§ 721.11319 through
721.11321 to read as follows:
Sec.
*
*
*
*
*
721.11319 Waste plastics, poly(ethylene
terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol,
triethylene glycol, trimethylolalkane and
polypropylene glycol (generic).
721.11320 Waste plastics, poly(ethylene
terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, phthalic
anhydride, triethylene glycol,
trimethylolalkane and polypropylene
glycol (generic).
721.11321 Naphtha oils (generic).
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*
*
*
*
*
§ 721.11319 Waste plastics, poly(ethylene
terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, triethylene
glycol, trimethylolalkane and polypropylene
glycol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance identified
generically as waste plastics,
poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol,
polyerythritol, triethylene glycol,
trimethylolalkane and polypropylene
glycol (PMN P–18–200) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate. For
purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and
(ii), and (g)(4) and (5). For purposes of
§ 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(2),
when using this substance: Avoid skin
contact; avoid eye contact; use skin
protection; use respiratory protection;
use eye protection. For purposes of
§ 721.72(g)(4), notice to users: Water
release restrictions apply. 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 § 721.80(o).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=280.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11320 Waste plastics, poly(ethylene
terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, phthalic
anhydride, triethylene glycol,
trimethylolalkane and polypropylene glycol
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as waste plastics,
poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol,
polyerythritol, phthalic anhydride,
triethylene glycol, trimethylolalkane
and polypropylene glycol (PMN P–18–
201) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), (b), and
(c). When determining which persons
are reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 10. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate. For
purposes of § 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and
(ii), and (g)(4) and (5). For purposes of
§ 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(2),
when using this substance: Avoid skin
contact; avoid eye contact; use skin
protection; use respiratory protection;
use eye protection. For purposes of
§ 721.72(g)(4), notice to users: Water
release restrictions apply. 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 § 721.80(o).
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=280.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11321
Naphtha oils (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as naphtha oils (PMN P–18–
235) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section. The requirements of this section
do not apply to quantities of the
substance incorporated into a gasoline
or transportation fuel formulation below
the maximum confidential
concentration specified in the Order for
the substance.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (k).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraphs
(a)(1) and (a)(2)(i) of this section.
■ 14. Add §§ 721.11346 through
721.11350 to read as follows:
*
*
*
*
*
Sec.
721.11346 Perfluoropolyether halide
(generic).
721.11347 Perfluoropolyether aryl (generic).
721.11348 Substituted aryl
perfluoropolyether (generic).
721.11349 Sulfonated perfluoropolyether
aromatic transition metal salt (generic).
721.11350 Sulfonated perfluoropolyether
aryl alkali metal salt (generic).
*
*
*
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§ 721.11346
(generic).
*
*
Perfluoropolyether halide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as perfluoropolyether halide
(PMN P–16–151) is subject to reporting
under this section for the significant
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new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(3)(i) and (ii), (g)(4)(i) and
(iii), and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(e), the
concentration is set at 1.0%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t). It is a
significant new use to manufacture the
substance for more than one year.
(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11347
(generic).
Perfluoropolyether aryl
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as perfluoropolyether aryl
(PMN P–16–152) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard Communication.
Requirements as specified in § 721.72(a)
through (f), (g)(3)(i) and (ii), (g)(4)(i) and
(iii), and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(e), the
concentration is set at 1.0%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
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(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11348 Substituted aryl
perfluoropolyether (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted aryl
perfluoropolyether (PMN P–16–153) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(3)(i) and (ii), (g)(4)(i) and
(iii), and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(e), the
concentration is set at 1.0%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(k) are applicable to manufacturers and
processors of this substance.
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(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11349 Sulfonated perfluoropolyether
aromatic transition metal salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonated
perfluoropolyether aromatic transition
metal salt (PMN P–16–154) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(3)(i) and (ii), (g)(4)(i) and
(iii), and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(e), the
concentration is set at 1.0%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
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§ 721.11350 Sulfonated perfluoropolyether
aryl alkali metal salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonated
perfluoropolyether aryl alkali metal salt
(PMN P–16–155) is subject to reporting
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under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(3)(i) and (ii), (g)(4)(i) and
(iii), and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
For purposes of § 721.72(e), the
concentration is set at 1.0%.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
(iii) Disposal. Requirements as
specified in § 721.85(a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
■ 15. Add § 721.11360 to read as
follows:
§ 721.11360 Benzenepropanal,
.alpha.,.alpha.,3-trimethyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenepropanal, .alpha.,.alpha.,3trimethyl- (PMN P–18–129; CAS No.
107737–97–3) 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 § 721.80(t).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
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applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 16. Add § 721.11361 to read as
follows:
§ 721.11361
(generic).
Multiwalled carbon nanotubes
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as multiwalled carbon
nanotubes (PMN P–18–182) 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 that
have been:
(i) Embedded or incorporated into a
polymer matrix that itself has been
reacted (cured);
(ii) Embedded in a permanent solid/
polymer form that is not intended to
undergo further processing, except
mechanical processing; or
(iii) Incorporated into an article as
defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3) through (6), and (c).
When determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 50. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate.
(ii) Industrial, commercial, and
consumer activities. It is a significant
new use to use an application method
that generates a dust, mist, or aerosol,
unless such application method occurs
in an enclosed process. It is a significant
new use to use the substance other than
for heat transfer, heat storage, thermal
emission, and general temperature
management in heat-generating systems
such as electronics, to improve
mechanical properties or electrical
conductivities of other materials or
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products, and for light absorption
properties.
(iii) Disposal. Requirements as
specified in § 721.85(a)(1) and (2), (b)(1)
and (2), and (c)(1) and (2).
(iv) Release to water. Requirements as
specified in § 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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (k) are applicable
to manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
■ 17. Add § 721.11372 to read as
follows:
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§ 721.11372 Phenol-formaldehyde epoxy,
polymer with an alkyl polyether polysulfide
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as phenol-formaldehyde
epoxy, polymer with an alkyl polyether
polysulfide (PMN P–19–5) 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
§ 721.63(a)(1) and (3).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), (g)(1), (g)(2)(i), (ii), and
(v), (g)(3)(i) and (ii), and (g)(4) and (5).
For purposes of § 721.72(g)(1), this
substance may cause: Internal organ
effects; reproductive effects; cancer; skin
and respiratory sensitization; germ cell
mutagenicity. For purposes of
§ 721.72(g)(4), notice to users: Water
release restrictions apply. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposure.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
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§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
■ 18. Add § 721.11383 to read as
follows:
§ 721.11383
(generic).
Triarylsulfonium salt
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as triarylsulfonium salt
(PMN P–16–548) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (t). It is
a significant new use to process or use
the substance in a manner that generates
a vapor, mist, or aerosol.
(ii) Release to water. Requirements as
specified in § 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
§ 721.125(a) through (c), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
■ 19. Add §§ 721.11390 through
721.11393 to read as follows:
*
*
*
*
*
Sec.
721.11390 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
721.11391 Alkane, alkene, styrenic
compounds derived from plastic
depolymerization (generic).
721.11392 Carbon compound derived from
plastic depolymerization (generic).
721.11393 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
*
*
*
*
*
§ 721.11390 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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46149
generically as branched cyclic and
linear hydrocarbons from plastic
depolymerization (PMN P–17–398) 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 that
have been refined or blended into other
chemical or fuel formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). For purposes of
§ 721.80(k), the use is as a refinery
feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11391 Alkane, alkene, styrenic
compounds derived from plastic
depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkane, alkene, styrenic
compounds derived from plastic
depolymerization (PMN P–17–399) 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 that
have been refined or blended into other
chemical or fuel formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). For purposes of
§ 721.80(k), the use is as a refinery
feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11392 Carbon compound derived
from plastic depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as carbon compound derived
from plastic depolymerization (PMN P–
18–1) 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. It is a significant
new use to manufacture the substance
containing more than 1% of the
particles less than 75 microns. It is a
significant new use to manufacture the
substance other than by the enclosed
process described in the premanufacture
notice.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
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§ 721.11393 Branched cyclic and linear
hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as branched cyclic and
linear hydrocarbons from plastic
depolymerization (PMN P–18–28) 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 that
have been refined or blended into other
chemical or fuel formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). For purposes of
§ 721.80(k), the use is as a refinery
feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
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§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
■ 20. Add § 721.11422 to read as
follows:
§ 721.11422 Alkanediamine, dialkyl-,
polymer with .alpha.-hydro-.omega.-[(1-oxo2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl)
ether with substituted alkyl-substituted
alkanediol, reaction products with alkylalkanamine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkanediamine, dialkyl-,
polymer with .alpha.-hydro-.omega.-[(1oxo-2-propen-1-yl)oxy]poly(oxy-1,2ethanediyl) ether with substituted alkylsubstituted alkanediol, reaction
products with alkyl-alkanamine (PMN
P–17–393) 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
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(4) through (6) and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(4), engineering
control measures (e.g., enclosure or
confinement of the operation, general,
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible. For purposes
of § 721.63(a)(5), respirators must
provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 1,000. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate.
(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 Order for this substance.
The NCEL is 0.039 mg/m3 as an 8-hour
time-weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 721.30 requests to use the
NCELs approach are approved by EPA
will be required to follow NCELs
provisions comparable to those
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contained in the corresponding TSCA
Order.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (f), and (g)(1) through (3)
and (5). For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications; eye
irritation; skin sensitization. For
purposes of § 721.72(g)(2), when using
this substance: Avoid skin contact;
avoid breathing substance; avoid
ingestion; use skin protection; use
respiratory protection or maintain
workplace airborne concentrations at or
below an 8-hour time-weighted average
of 0.039 mg/m3. For purposes of
§ 721.72(g)(3), this substance may be:
Toxic to aquatic organisms; hazardous
to the aquatic environment. Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). It is a
significant new use to manufacture the
substance with an average molecular
weight less than 1,000 daltons and with
more than 10% less than 500 daltons.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=1.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (d), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
■ 21. Add §§ 721.11426 through
721.11443 to read as follows:
*
*
*
*
*
Sec.
721.11426 Halogenated sodium benzene
alkylcarboxylate (generic) (P–19–86).
721.11427 Halogenated sodium benzene
alkylcarboxylate (generic) (P–19–87).
721.11428 Halogenated sodium benzene
alkylcarboxylate (generic) (P–19–89).
721.11429 Halogenated sodium benzoate
(generic) (P–19–90).
721.11430 Halogenated benzene
alkylcarboxylic acid (generic) (P–19–91).
721.11431 Halogenated benzene
alkylcarboxylic acid (generic) (P–19–92).
721.11432 Halogenated benzoic acid
(generic) (P–19–93).
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721.11433 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–97).
721.11434 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–100).
721.11435 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–101).
721.11436 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–102).
721.11437 Halogenated benzoic acid, ethyl
ester (generic) (P–19–103).
721.11438 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–104).
721.11439 Halogenated benzoic acid, ethyl
ester (generic) (P–19–105).
721.11440 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–106).
721.11441 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–107).
721.11442 Halogenated alkylbenzoic acid,
ethyl ester (generic) (P–19–108).
721.11443 Halogenated benzoic acid, ethyl
ester (generic) (P–19–110).
*
*
*
*
*
jbell on DSKJLSW7X2PROD with RULES
§ 721.11426 Halogenated sodium benzene
alkylcarboxylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
benzene alkylcarboxylate (PMN P–19–
86) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; central
nervous system effects; internal organ
effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture,
process, or use the substance other than
in a liquid formulation. It is a significant
new use to manufacture or process the
substance without including the
engineering controls/processes
described in the premanufacture notice.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
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(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11427 Halogenated sodium benzene
alkylcarboxylate (generic) (P–19–87).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
benzene alkylcarboxylate (PMN P–19–
87) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; central
nervous system effects; internal organ
effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture,
process, or use the substance other than
in a liquid formulation. It is a significant
new use to manufacture or process the
substance without including the
engineering controls/processes
described in the premanufacture notice.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11428 Halogenated sodium benzene
alkylcarboxylate (generic) (P–19–89).
(a) Chemical substance and
significant new uses subject to reporting.
PO 00000
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Sfmt 4700
46151
(1) The chemical substance identified
generically as halogenated sodium
benzene alkylcarboxylate (PMN P–19–
89) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; central
nervous system effects; internal organ
effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture,
process, or use the substance other than
in a liquid formulation. It is a significant
new use to manufacture or process the
substance without including the
engineering controls/processes
described in the premanufacture notice.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11429 Halogenated sodium benzoate
(generic) (P–19–90).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated sodium
benzoate (PMN P–19–90) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
and (g)(5). For purposes of § 721.72(e),
the concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
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substance may cause: Skin irritation;
respiratory complications; central
nervous system effects; internal organ
effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture,
process, or use the substance other than
in a liquid formulation. It is a significant
new use to manufacture or process the
substance without including the
engineering controls/processes
described in the premanufacture notice.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
jbell on DSKJLSW7X2PROD with RULES
§ 721.11430 Halogenated benzene
alkylcarboxylic acid (generic) (P–19–91).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzene
alkylcarboxylic acid (PMN P–19–91) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (iii), and (iv),
(a)(3) through (6), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) as described in the TSCA Order
for this substance. For purposes of
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Jkt 253001
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor, and combination gas/vapor and
particulate. For purposes of § 721.63(b),
the concentration is set at 1.0%.
(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 Order for this substance.
The NCEL is 0.0273 mg/m3 as an 8-hour
time weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 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
Order.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e) concentration
set at 1.0%. For purposes of
§ 721.72(g)(1), this substance may cause:
Skin irritation; respiratory
complications; central nervous system
effects; internal organ effects;
reproductive effects; developmental
effects; eye irritation. For purposes of
§ 721.72(g)(2), when using this
substance: Avoid skin contact; avoid
breathing substance; avoid ingestion;
use skin protection; use respiratory
protection or maintain workplace
airborne concentrations at or below an
8-hour time-weighted average of 0.0273
mg/m3. Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
PO 00000
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Fmt 4700
Sfmt 4700
§ 721.11431 Halogenated benzene
alkylcarboxylic acid (generic) (P–19–92).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzene
alkylcarboxylic acid (PMN P–19–92) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (iii), and (iv),
(a)(3) through (6), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) as described in the TSCA Order
for this substance. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor, and combination gas/vapor and
particulate. For purposes of § 721.63(b),
the concentration is set at 1.0%.
(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 Order for this substance.
The NCEL is 0.0273 mg/m3 as an 8-hour
time weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 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
Order.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; central
nervous system effects; internal organ
effects; reproductive effects;
developmental effects; eye irritation. For
purposes of § 721.72(g)(2), when using
this substance: Avoid skin contact;
avoid breathing substance; avoid
ingestion; use skin protection; use
respiratory protection or maintain
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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
workplace airborne concentrations at or
below an 8-hour time-weighted average
of 0.0273 mg/m3. Alternative hazard
and warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
jbell on DSKJLSW7X2PROD with RULES
§ 721.11432 Halogenated benzoic acid
(generic) (P–19–93).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzoic acid
(PMN P–19–93) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (iii), and (iv),
(a)(3) through (6), (b), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 721.63(a)(1) and (4),
engineering control measures (e.g.,
enclosure or confinement of the
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible. For
purposes of § 721.63(a)(5), respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) as described in the TSCA Order
for the substance. For purposes of
§ 721.63(a)(6), the airborne form(s) of
the substance include particulate, gas/
vapor, and combination gas/vapor and
particulate.
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
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16:01 Aug 17, 2021
Jkt 253001
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA Order for this substance.
The NCEL is 0.0273 mg/m3 as an 8-hour
time weighted average. Persons who
wish to pursue NCELs as an alternative
to § 721.63 respirator requirements may
request to do so under § 721.30. Persons
whose § 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
Order.
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (f) and (g)(1), (2), and (5). For
purposes of § 721.72(e), the
concentration is set at 1.0%. For
purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; central
nervous system effects; internal organ
effects; reproductive effects;
developmental effects; eye irritation. For
purposes of § 721.72(g)(2), when using
this substance: Avoid skin contact;
avoid breathing substance; avoid
ingestion; use skin protection; use
respiratory protection or maintain
workplace airborne concentrations at or
below an 8-hour time-weighted average
of 0.0273 mg/m3. Alternative hazard
and warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k), (q), and (t). It is
a significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
manufacturers and processors of this
substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11433 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–97).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
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Fmt 4700
Sfmt 4700
46153
acid, ethyl ester (PMN P–19–97) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11434 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–100).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid, ethyl ester (PMN P–19–100) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
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organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
jbell on DSKJLSW7X2PROD with RULES
§ 721.11435 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–101).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid, ethyl ester (PMN P–19–101) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
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16:01 Aug 17, 2021
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(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11436 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–102).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid, ethyl ester (PMN P–19–102) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
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Fmt 4700
Sfmt 4700
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11437 Halogenated benzoic acid,
ethyl ester (generic) (P–19–103).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzoic acid,
ethyl ester (PMN P–19–103) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e) concentration set at 1.0%.
For purposes of § 721.72(g)(1), this
substance may cause: Skin irritation;
respiratory complications; central
nervous system effects; internal organ
effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11438 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–104).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid, ethyl ester (PMN P–19–104) is
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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
jbell on DSKJLSW7X2PROD with RULES
§ 721.11439 Halogenated benzoic acid,
ethyl ester (generic) (P–19–105).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzoic acid,
ethyl ester (PMN P–19–105) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
VerDate Sep<11>2014
16:01 Aug 17, 2021
Jkt 253001
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11440 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–106).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid, ethyl ester (PMN P–19–106) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i), (ii), and (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
PO 00000
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Fmt 4700
Sfmt 4700
46155
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11441 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–107).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid, ethyl ester (PMN P–19–107) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
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18AUR1
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Federal Register / Vol. 86, No. 157 / Wednesday, August 18, 2021 / Rules and Regulations
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11442 Halogenated alkylbenzoic
acid, ethyl ester (generic) (P–19–108).
jbell on DSKJLSW7X2PROD with RULES
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated alkylbenzoic
acid, ethyl ester (PMN P–19–108) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11443 Halogenated benzoic acid,
ethyl ester (generic) (P–19–110).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as halogenated benzoic acid,
ethyl ester (PMN P–19–110) is subject to
VerDate Sep<11>2014
16:01 Aug 17, 2021
Jkt 253001
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (f), (g)(1), (g)(2)(i) through (iii),
(g)(3)(i) and (ii), and (g)(5). For purposes
of § 721.72(e), the concentration is set at
1.0%. For purposes of § 721.72(g)(1),
this substance may cause: Skin
irritation; respiratory complications;
central nervous system effects; internal
organ effects; reproductive effects;
developmental effects; eye irritation.
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture or
process the substance without including
the engineering controls/processes
described in the premanufacture notice.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N=14.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (f) through (i),
and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain
notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
[FR Doc. 2021–17392 Filed 8–17–21; 8:45 am]
BILLING CODE 6560–50–P
Federal Food, Drug, and Cosmetic Act
(FFDCA).
This regulation is effective
August 18, 2021. Objections and
requests for hearings must be received
on or before October 18, 2021, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0118, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
Due to the public health concerns
related to COVID–19, the EPA Docket
Center (EPA/DC) and Reading Room is
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, Registration
Division (7505P), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
telephone number: (703) 305–7090;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. General Information
A. Does this action apply to me?
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0118; FRL–8653–01–
OCSPP]
Fluensulfone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerance for residues of fluensulfone in
or on soybean, seed. Makhteshim Agan
of North America (d/b/a ADAMA)
requested these tolerances under the
SUMMARY:
PO 00000
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Fmt 4700
Sfmt 4700
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. 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:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
E:\FR\FM\18AUR1.SGM
18AUR1
Agencies
[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Rules and Regulations]
[Pages 46133-46156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17392]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2018-0627, EPA-HQ-OPPT-2018-0777, EPA-HQ-OPPT-2019-0359,
EPA-HQ-OPPT-2019-0228, EPA-HQ-OPPT-2019-0494, and EPA-HQ-OPPT-2019-
0530; FRL-8000-02-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is issuing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances that were
the subject of premanufacture notices (PMNs). The SNURs require persons
who intend to manufacture (defined by statute to include import) or
process any of these 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 use, under the conditions of use for
that chemical substance, within the applicable review period. Persons
may not commence manufacture or processing for the significant new use
until EPA has conducted a review of the notice, made an appropriate
determination on the notice, and has taken such actions as are required
by that determination.
DATES: This rule is effective on October 18, 2021. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
September 1, 2021.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, New Chemicals
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; 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
provisions 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, which would include 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 are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
40 CFR 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. How can I access the dockets?
The dockets include information considered by the Agency in
developing the proposed and final rules. The dockets for this action,
identified by docket identification (ID) numbers EPA-HQ-OPPT-2018-0627,
-2018-0777, -2019-0359, -2019-0228, -2019-0494, and -2019-0530, are
available at https://www.regulations.gov and at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280.
Due to the public health concerns related to COVID-19, the EPA
Docket
[[Page 46134]]
Center (EPA/DC) and Reading Room is closed to visitors with limited
exceptions. The staff continues to provide remote customer service via
email, phone, and webform. For the latest status information on EPA/DC
services and docket access, visit https://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs under TSCA section 5(a)(2) for certain
chemical substances which were the subject of PMNs. EPA will address
the other proposed SNURs in future Federal Register notices.
Previously, EPA proposed SNURs for these chemical substances and
established the record for these SNURs in the following Federal
Registers and docket ID numbers:
October 3, 2018 (83 FR 49903) (FRL-9983-81); Docket ID No.
EPA-HQ-OPPT-2018-0627;
July 31, 2019 (84 FR 37199) (FRL-9994-62); Docket ID No.
EPA-HQ-OPPT-2018-0777;
August 6, 2019 (84 FR 38158) (FRL-9996-62); Docket ID No.
EPA-HQ-OPPT-2019-0359;
October 11, 2019 (84 FR 54816) (FRL-9998-64); Docket ID
No. EPA-HQ-OPPT-2019-0228;
November 4, 2019 (84 FR 59335) (FRL-10000-54); Docket ID
No. EPA-HQ-OPPT-2019-0494; and
December 6, 2019 (84 FR 66855) (FRL-10001-48); Docket ID
No. EPA-HQ-OPPT-2019-0530.
The dockets include information considered by the Agency in
developing the proposed and final rules, including public comments and
EPA's responses to the public comments received.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four bulleted TSCA section 5(a)(2)
factors listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
significant new use notice (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 sections 5(b) and 5(d)(1), the exemptions
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and
the regulations at 40 CFR part 720. Once EPA receives a SNUN and before
the manufacture or processing for the significant new use can commence,
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. 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
A. Considerations for Significant New Use Determinations
When the Agency issues an order under TSCA section 5(e), section
5(f)(4) requires that the Agency consider whether to promulgate a SNUR
for any use not conforming to the restrictions of the TSCA Order or
publish a statement describing the reasons for not initiating the
rulemaking. TSCA section 5(a)(2) states that EPA's determination that a
use of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with possible uses of these chemical substances, in the
context of the four bulleted TSCA section 5(a)(2) factors listed in
this unit.
B. Procedures for Significant New Uses Claimed as CBI
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 40 CFR
721.1725(b)(1) and has referenced it to apply to other SNURs.
Under these procedures a manufacturer or processor may request EPA
to determine whether a specific 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 40 CFR
721.1725(b)(1) with that under 40 CFR 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.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments from nine identifying entities on the
[[Page 46135]]
proposed rules. The Agency's responses are presented in the Response to
Public Comments document that is available in each of the dockets for
these rules. EPA made changes to three of the proposed rules as
described in the response to comments.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for chemical substances in 40 CFR part 721, subpart E. In
Unit IV. of the proposed SNURs, EPA provided the following information
for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as confidential business information (CBI)).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Effective date of and basis for the TSCA Order.
Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substances if a
manufacturer or processor is considering submitting a SNUN for a
significant new use designated by the SNUR.
CFR citation assigned in the regulatory text section of
these rules.
The regulatory text section of these rules specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits and other uses designated in the rules, may be
claimed as CBI.
These final rules include PMN substances that are subject to orders
issued under TSCA section 5(e)(1)(A), as required by the determinations
made under TSCA section 5(a)(3)(B). Those TSCA Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The final 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 TSCA 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 Order usually requires 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). The comprehensive NCELs
provisions in TSCA Orders include requirements addressing performance
criteria for sampling and analytical methods, periodic monitoring,
respiratory protection, and recordkeeping. No comparable NCEL
provisions currently exist in 40 CFR part 721, subpart B, for SNURs.
Therefore, for these cases, the individual SNURs in 40 CFR part 721,
subpart E, will state that persons subject to the SNUR who wish to
pursue NCELs as an alternative to the 40 CFR 721.63 respirator
requirements may request to do so under 40 CFR 721.30. EPA expects that
persons whose 40 CFR 721.30 requests to use the NCELs approach for
SNURs that are approved by EPA will be required to comply with NCELs
provisions that are comparable to those contained in the corresponding
TSCA Order.
VI. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs and as further discussed in Unit IV. of
the proposed rules, EPA concluded that 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. Based on such findings, TSCA Orders requiring the
use of appropriate exposure controls were negotiated with the PMN
submitters. As a general matter, EPA believes it is necessary to follow
TSCA Orders with a SNUR that identifies the absence of those protective
measures as significant new uses to ensure that all manufacturers and
processors--not just the original submitter--are held to the same
standard.
B. Objectives
EPA is issuing these SNURs because the Agency wants to
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.
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; and
Be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that significant new use is not likely to present an unreasonable risk,
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant by the Administrator under the
conditions of use, or make a determination under TSCA section
5(a)(3)(A) or (B) and take the required regulatory action associated
with the determination, before manufacture or processing for the
significant new use of the chemical substance can occur.
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
https://www.epa.gov/tsca-inventory.
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 Orders have been issued for all the
chemical substances that are the subject of this rule, and the PMN
submitters are prohibited by the TSCA Orders from undertaking
activities which will be designated as significant new uses. The
identities of 50 of the 57 chemical substances subject to this rule
have been claimed as confidential (per 40 CFR 720.85). 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.
Furthermore, EPA designated the publication dates of the proposed
rules (see Unit II.) as the cutoff dates for determining whether the
new uses are 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 final rule.
[[Page 46136]]
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of the abovementioned dates, that person will have to
cease any such activity upon the effective date of the final rule. To
resume their activities, that person would have to first comply with
all applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.
VIII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception:
If a person is required to submit information for a chemical
substance pursuant to a rule, TSCA Order or consent agreement under
TSCA section 4, then TSCA section 5(b)(1)(A) requires such information
to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known to them 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. of the proposed rule lists potentially useful information for
all SNURs listed in this document. Descriptions are provided for
informational purposes. The information identified in Unit IV. of the
proposed rule will be potentially useful to EPA's evaluation in the
event that someone submits a SNUN for the significant new use.
Companies who are considering submitting a SNUN are encouraged, but not
required, to develop the information on the substance.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. 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). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
In some of the TSCA Orders for the chemical substances identified
in 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. The SNURs contain the same production volume
limits as the TSCA 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 TSCA 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.
The potentially useful information identified in Unit IV. of the
proposed rule may not be the only means of addressing the potential
risks of the chemical substance associated with the designated
significant new uses. However, submitting a SNUN without any test data
or other information may increase the likelihood that EPA will take
action under TSCA sections 5(e) or 5(f). EPA recommends that potential
SNUN submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that 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. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
X. 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 analyses are
available in each docket listed in Unit II.
XI. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action establishes SNURs for several new chemical substances
that were the subject of PMNs. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011).
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not subject to Executive Order 13771 (82 FR 9339,
February 3, 2017), because this action is not a significant regulatory
action under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The information
[[Page 46137]]
collection requirements associated with SNURs have already been
approved by OMB pursuant to the PRA under OMB control number 2070-0012
(EPA ICR No. 574). This rule does not impose any burden requiring
additional OMB approval.
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. The
Information Collection Request (ICR) covering the SNUR activities 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.
If an entity were to submit a SNUN to the Agency, the annual burden
is estimated to average between 30 and 170 hours per response. This
burden estimate includes the time needed to review instructions, search
existing data sources, gather and maintain the data needed, and
complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Regulatory Support Division, Office of Mission Support (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001. Please remember to include the OMB control number in any
correspondence, but do not submit any completed forms to this address.
D. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs would not have
a significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, EPA has concluded that no small or large entities
presently engage in such activities. A SNUR requires that any person
who intends to engage in such activity in the future must first notify
EPA by submitting a SNUN. Although some small entities may decide to
pursue a significant new use in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of SNURs covering over
1,000 chemicals, the Agency receives only a small number of notices per
year. For example, EPA received 7 SNUNs in Federal fiscal year (FY)
2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 in
FY2018 and only a fraction of these were from small businesses. In
addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this SNUR
are not expected to be significant or adversely impact a substantial
number of small entities. In a SNUR that published in the Federal
Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
E. 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.).
F. Executive Order 13132: Federalism
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 (64 FR 43255,
August 10, 1999).
G. Executive Order 13175: Consultation and Coordination With Indian
Tribe Governments
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 (65 FR 67249, November 9, 2000), do not apply
to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children. EPA interprets Executive Order
13045 as applying only to those regulatory actions that concern
environmental health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
J. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by
[[Page 46138]]
Executive Order 12898 (59 FR 7629, February 16, 1994).
XII. Congressional Review Act
This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report containing this rule and other required
information to each House of the Congress and to the Comptroller
General of the United States. 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 9, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, 40 CFR chapter I
is amended as follows:
PART 9--OMB APPROVALS UNDER THE PAPERWORK REDUCTION ACT
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; 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, amend the table by adding entries for Sec. Sec.
721.11150, 721.11267 through 721.11277, 721.11279 through 721.11281,
721.11284, 721.11288, 721.11305, 721.11308, 721.11315 and 721.11316,
721.11319 through 721.11321, 721.11346 through 721.11350, 721.11360 and
721.11361, 721.11372, 721.11383, 721.11390 through 721.11393,
721.11422, and 721.11426 through 721.11443 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 control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11150............................................... 2070-0012
* * * * *
721.11267............................................... 2070-0012
721.11268............................................... 2070-0012
721.11269............................................... 2070-0012
721.11270............................................... 2070-0012
721.11271............................................... 2070-0012
721.11272............................................... 2070-0012
721.11273............................................... 2070-0012
721.11274............................................... 2070-0012
721.11275............................................... 2070-0012
721.11276............................................... 2070-0012
721.11277............................................... 2070-0012
* * * * *
721.11279............................................... 2070-0012
721.11280............................................... 2070-0012
721.11281............................................... 2070-0012
* * * * *
721.11284............................................... 2070-0012
* * * * *
721.11288............................................... 2070-0012
* * * * *
721.11305............................................... 2070-0012
* * * * *
721.11308............................................... 2070-0012
* * * * *
721.11315............................................... 2070-0012
721.11316............................................... 2070-0012
* * * * *
721.11319............................................... 2070-0012
721.11320............................................... 2070-0012
721.11321............................................... 2070-0012
* * * * *
721.11346............................................... 2070-0012
721.11347............................................... 2070-0012
721.11348............................................... 2070-0012
721.11349............................................... 2070-0012
721.11350............................................... 2070-0012
* * * * *
721.11360............................................... 2070-0012
721.11361............................................... 2070-0012
* * * * *
721.11372............................................... 2070-0012
* * * * *
721.11383............................................... 2070-0012
* * * * *
721.11390............................................... 2070-0012
721.11391............................................... 2070-0012
721.11392............................................... 2070-0012
721.11393............................................... 2070-0012
* * * * *
721.11422............................................... 2070-0012
* * * * *
721.11426............................................... 2070-0012
721.11427............................................... 2070-0012
721.11428............................................... 2070-0012
721.11429............................................... 2070-0012
721.11430............................................... 2070-0012
721.11431............................................... 2070-0012
721.11432............................................... 2070-0012
721.11433............................................... 2070-0012
721.11434............................................... 2070-0012
721.11435............................................... 2070-0012
721.11436............................................... 2070-0012
721.11437............................................... 2070-0012
721.11438............................................... 2070-0012
721.11439............................................... 2070-0012
721.11440............................................... 2070-0012
721.11441............................................... 2070-0012
721.11442............................................... 2070-0012
721.11443............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
Subpart E--Significant New Uses for Specific Chemical Substances
0
4. Add Sec. 721.11150 to read as follows:
Sec. 721.11150 2-Pyrrolidinone, 1-butyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-pyrrolidinone, 1-
butyl- (PMN P-14-627, CAS No. 3470-98-2) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (b), and (c). 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. For purposes of Sec. 721.63(a)(2)(i), butyl
or Silver Shield gloves may be used. For purposes of Sec. 721.63(b),
the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(i) and (ix), (g)(2)(i) through (iii) and
(v), and (g)(5).
[[Page 46139]]
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used. For purposes of Sec. 721.72(e), the concentration is set at
1.0%.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to import
the substance in containers of less than 55 gallons when the
concentration of the confidential component identified in the TSCA
Order is greater than 5% by weight for any product either intended for
sale or distribution for consumer use, including for use in consumer
products, or both intended for commercial use and made available to
consumers for retail purchase of any kind. It is a significant new use
to use or sell the PMN substance in handheld spray applications that
generate a vapor, mist or aerosol.
(iv) Significant new use to import. It is a significant new use to
import the PMN substance other than to be processed or sold for:
(A) Dispersions for industrial coatings (e.g., polyurethane,
acrylic, epoxy);
(B) Coating for consumer and professional use;
(C) Adhesives and sealants;
(D) Solvent-borne industrial coatings;
(E) Silicon wafer cleaning in microelectronics in clean rooms;
(F) Photoresist stripping in microelectronics in clean rooms;
(G) Coatings for microelectronics (e.g., casting of polymer films)
in clean rooms;
(H) Reaction medium for polymerization, polymer coatings for
industrial and professional applications (e.g., wire enamel, non-stick
and friction reduction coating) membranes;
(I) Solvent for chemical synthesis reactions (e.g.,
pharmaceuticals);
(J) Formulation of inks;
(K) Industrial cleaner (e.g., cleaner for wind turbine, oil rigs,
large engines);
(L) Solvent for cleaning industrial reactors;
(M) Wax inhibitors (in hydrocarbon lines);
(N) Petrochemical extraction processes;
(O) Paint stripper;
(P) Solvents for production and formulation of fertilizer;
(Q) Solvent for production and formulation of active ingredients
for agriculture;
(R) Solvent for formulation of active ingredients for agriculture-
end use pesticide product).
(v) Significant new use to use or sell. It is a significant new use
to use or sell the PMN substance for:
(A) Dispersions for industrial coatings (e.g., polyurethane,
acrylic, epoxy) in a concentration greater than 18% in formulated
products;
(B) Adhesives and sealants in concentrations greater than 18% in
formulated products;
(C) Solvent-borne industrial coatings in concentrations greater
than 30% in formulated products;
(D) Coatings for microelectronics (e.g., casting of polymer films)
in clean rooms in concentrations greater than 20% in formulated
products;
(E) Reaction medium for polymerization, polymer coatings for
industrial and professional applications (e.g., wire enamel, non-stick
and friction reduction coating) membranes in concentrations greater
than 40% in formulated products;
(F) Inks in concentrations greater than 15% in formulated products;
(G) Solvent for chemical synthesis reactions (e.g.,
pharmaceuticals) in concentrations greater than 40% in formulated
products;
(H) Industrial cleaner (e.g., cleaner for wind turbine, oil rigs,
large engines) in concentrations greater than 20% in formulated
products;
(I) Wax inhibitors (in hydrocarbon lines) in concentrations greater
than 20% in formulated products;
(J) Petrochemical extraction processes in concentrations greater
than 60% in formulated products;
(K) Paint stripper only for industrial use in concentrations
greater than 20% in formulated products;
(L) Solvent for formulation of active ingredients for agriculture-
end use pesticide product) in concentrations greater than 70% in
formulated products;
(M) Paint removers in concentrations greater than 5% in formulated
products intended for sale or distribution for ``consumer'' use,
including ``commercial use'' when the ``saleable good or service''
could introduce PMN material into a ``consumer'' setting;
(N) Coatings in concentrations greater than 1% in formulated
products intended for sale or distribution for ``consumer'' use,
including ``commercial use'' when the ``sealable good or service''
could introduce PMN material into a ``consumer'' setting.
(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) Limitation 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
5. Add Sec. Sec. 721.11267 through 721.11277 to read as follows:
Sec.
* * * * *
721.11267 Silane amine carbonate (generic).
721.11268 Hydrochlorofluoroolefin (generic).
721.11269 Fatty acid modified aromatic polyester polyol (generic).
721.11270 Dodecanedioic acid and 1,6-hexanediol polymer with 3-
hydroxy-2,2-dimethylpropyl-2,2-dimethylhydracrylate,
neopentylglycol, 1,2-ethanediol, adipic acid, isophthalic acid,
terephthalic acid, 2-Oxooxopane, BayFlex 2002H and 1,1'-
methylenebis(isocyanatobenzene) (generic).
721.11271 Ethanone, 1-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-.
721.11272 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
721.11273 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic).
721.11274 Waste plastics, poly(ethylene terephthalate), depolymd.
with diethylene glycol, polymers with alkanedioic acid, alkali
lignin and arylcarboxylic acid anhydride (generic).
721.11275 Waste plastics, poly(ethylene terephthalate), depolymd.
with diethylene glycol and polyol, polymers with alkanedioic acid,
alkali lignin and arylcarboxylic acid anhydride (generic).
721.11276 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
721.11277 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol-depolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid anhydride (generic).
* * * * *
Sec. 721.11267 Silane amine carbonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as silane
amine carbonate (PMN P-17-157) 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 46140]]
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), and (b). 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. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
For purposes of Sec. 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(i) and (ii), (g)(2)(i) through (v), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(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 (h), are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11268 Hydrochlorofluoroolefin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hydrochlorofluoroolefin (PMN P-17-295) 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)(3) through (5), (a)(6)(v) and (vi), and (b). 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. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 10. For
purposes of Sec. 721.63(b), the concentration is set at 1.0%.
(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 Order for this substance. The NCEL is 23.6 mg/m\3\ (3.9 ppm) 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
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1) and (2). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Internal organ effects;
reproductive effects; fatality. For purposes of Sec. 721.72(g)(2),
when using this substance: Avoid skin contact; avoid breathing
substance; avoid ingestion; use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 23.6 mg/m\3\ (3.9 ppm); use skin protection. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (o). For purposes of Sec.
721.80(k), the use is as a refrigerant used in closed systems for
chillers (commercial comfort air conditioners) and industrial process
refrigeration.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11269 Fatty acid modified aromatic polyester polyol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid modified aromatic polyester polyol (PMN P-17-306 and PMN P-17-307)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (b), and (c). 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. For purposes of Sec. 721.63(b), the
concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) and (v), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Internal
organ effects; ocular effects. 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. It is a
significant new use to use an application method that generates a
vapor, mist, aerosol, or dust containing the substance resulting in
inhalation exposures.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), are applicable to manufacturers and processors
of these substances.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11270 Dodecanedioic acid and 1,6-hexanediol polymer with 3-
hydroxy-2,2-dimethylpropyl-2,2-dimethylhydracrylate, neopentylglycol,
1,2-ethanediol, adipic acid, isophthalic acid, terephthalic acid, 2-
Oxooxopane, BayFlex 2002H and 1,1'-methylenebis(isocyanatobenzene)
(generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 46141]]
(1) The chemical substance identified generically as dodecanedioic acid
and 1,6-hexanediol polymer with 3-hydroxy-2,2-dimethylpropyl-2,2-
dimethylhydracrylate, neopentylglycol, 1,2-ethanediol, adipic acid,
isophthalic acid, terephthalic acid, 2-Oxooxopane, BayFlex 2002H and
1,1'-methylenebis(isocyanatobenzene) (PMN P-17-320) 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)(3) through (5), (a)(6)(v) and (vi), and (c). 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. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 50. For
purposes of Sec. 721.63(6), the airborne form(s) of the substance
include particulate (including solids or liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i), (ii), (iv), and (v), and
(g)(5). For purposes of Sec. 721.72(g)(1), this substance may cause:
Skin irritation; respiratory complications; mutagenicity. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o), (y)(1), and (y)(2). It is a
significant new use to manufacture the substance containing more than
1% residual isocyanate by weight.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11271 Ethanone, 1-[4-(4-chlorophenoxy)-2-
(trifluoromethyl)phenyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanone, 1-[4-(4-
chlorophenoxy)-2-(trifluoromethyl)phenyl]- (PMN P-17-329, CAS No.
1417782-28-5) 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) through (iv), (a)(3) through (5), (a)(6)(v) and
(vi), and (c). 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. For purposes of Sec.
721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 50. For purposes of Sec. 721.63(a)(6), the airborne
form(s) of the substance include particulate (including solids or
liquid droplets).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i), (ii), (iv), and (v),
(g)(3)(i) and (ii), and (g)(4) and (5). For purposes of Sec.
721.72(g)(1), this substance may cause: Respiratory complications,
internal organ effects, reproductive effects; sensitization. For
purposes of Sec. 721.72(g)(4), notice to users: Do not release to
water at concentrations that exceed 7 parts per billion. 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(k).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=7.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11272 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (PMN P-17-367) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components specified in the Order or less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11273 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics (PMN P-17-368) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use
[[Page 46142]]
the substance with greater than the confidential percentages of low
molecular weight components and less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11274 Waste plastics, poly(ethylene terephthalate),
depolymd. with diethylene glycol, polymers with alkanedioic acid,
alkali lignin and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), depolymd. with diethylene
glycol, polymers with alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (PMN P-17-369) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11275 Waste plastics, poly(ethylene terephthalate),
depolymd. with diethylene glycol and polyol, polymers with alkanedioic
acid, alkali lignin and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), depolymd. with diethylene
glycol and polyol, polymers with alkanedioic acid, alkali lignin and
arylcarboxylic acid anhydride (PMN P-17-370) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components specified in the Order or less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11276 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol- and polyol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol- and polyol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (PMN P-17-371) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components and less than the confidential average molecular weight
specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11277 Vegetable oil, polymer with alkanedioic acid, alkali
lignin, diethylene glycol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymer with alkanedioic acid, alkali lignin, diethylene
glycol-depolymd. poly(ethylene terephthalate) waste plastics and
arylcarboxylic acid anhydride (PMN P-17-372) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance with
greater than the confidential percentages of low molecular weight
components specified in the Order or less than the confidential average
molecular weight specified in the Order.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation 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
6. Add Sec. Sec. 721.11279 through 721.11281 to read as follows:
* * * * *
[[Page 46143]]
Sec.
721.11279 Substituted propanoic acid, polymer with alkylisocyanate-
substituted carbomonocycle, dialkyl carbonate, hydroxyl alkyl
substituted alkanediol, alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted amines-blocked, compds. with
(alkylamino)alkanol (generic).
721.11280 Propanediol phosphate (generic).
721.11281 Substituted cashew, nutshell liquid, polymer with
epichlorohydrin, phosphate (generic).
* * * * *
Sec. 721.11279 Substituted propanoic acid, polymer with
alkylisocyanate-substituted carbomonocycle, dialkyl carbonate, hydroxyl
alkyl substituted alkanediol, alkanediol, isocyanato substituted
carbomonocycle, alkanol substituted amines-blocked, compds. with
(alkylamino)alkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted propanoic acid, polymer with alkylisocyanate-substituted
carbomonocycle, dialkyl carbonate, hydroxyl alkyl substituted
alkanediol, alkanediol, isocyanato substituted carbomonocycle, alkanol
substituted amines-blocked, compds. with (alkylamino)alkanol (PMN P-17-
394) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to use the
substance for any use other than as a coating to improve chemical
resistance. It is a significant new use to import the substance with
average molecular weight greater than 1,000 daltons, containing greater
than 0.1% residual isocyanate by weight, or with greater than 4% of the
confidential chemical component specified in the Order.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11280 Propanediol phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propanediol phosphate (PMN P-18-23) 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 fully reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (2), (g)(3)(i) and (ii),
(g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; respiratory complications;
internal organ effects; eye irritation. For purposes of Sec.
721.72(g)(2), when using this substance: Avoid skin contact; avoid
breathing substance; use skin protection; use eye protection; avoid eye
contact. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, spray, mist, or aerosol.
(iii) 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 (c), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11281 Substituted cashew, nutshell liquid, polymer with
epichlorohydrin, phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted cashew, nutshell liquid, polymer with epichlorohydrin,
phosphate (PMN P-18-24) 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 fully reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1) and (2), (g)(3)(i) and (ii),
(g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; respiratory complications; eye
irritation. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid breathing substance; use skin
protection; use eye protection; avoid eye contact. Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, spray, mist, or aerosol.
(iii) 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 (c), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.11284 to read as follows:
Sec. 721.11284 Di(substituted-1,3-trialkylammonium) dialkylammonium
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
di(substituted-1,3-trialkylammonium) dialkylammonium salt (PMN P-18-88)
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 fully reacted (cured).
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(ii) through (iv), (g)(2)(i) through (iii)
and (v), and (g)(5). Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may
[[Page 46144]]
be used. For purposes of Sec. 721.72(e), the concentration is set at
1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture, process, or use the substance in any manner that generates
a vapor, mist, particulate, or aerosol.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=1000.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
8. Add Sec. 721.11288 to read as follows:
Sec. 721.11288 Benzene, 1-(chloromethyl)-3-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, 1-
(chloromethyl)-3-methyl- (PMN P-18-134; CAS No. 620-19-9) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3) through (5), (a)(6)(v) and
(vi), (b), and (c). 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. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 1,000. For purposes of Sec. 721.63(a)(6), the airborne
form(s) of the substance include particulate and combination gas/vapor
and particulate. For purposes of Sec. 721.63(b), the concentration is
set at 0.1%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (v), (g)(3)(i) and
(ii), (g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 0.1%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Respiratory irritation; severe skin burns and eye
damage; sensitization (respiratory and dermal); serious eye irritation;
respiratory complications; central nervous system effects; reproductive
effects; cancer; developmental effects. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to vary
the process or use methods described in the PMN such that occupational
exposure is increased.
(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) Limitation 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
9. Add Sec. 721.11305 to read as follows:
Sec. 721.11305 Unsaturated polycyclic hydrocarbon (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
unsaturated polycyclic hydrocarbon (PMN P-17-419) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) through (5), (a)(6)(v) and (vi), (b),
and (c). 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. For purposes of 721.63(a)(5), respirators
must provide a National Institute for Occupational Safety and Health
(NIOSH) assigned protection factor (APF) of at least 50. For purposes
of 721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i), (ii), (iv) and (v), (g)(3)(i)
and (ii), (g)(4)(iii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin sensitization; specific target organ
toxicity; skin irritation; respiratory complications; reproductive
effects; developmental effects. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t). It is a significant new use to
manufacture the substance for more than 9 months.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
0
10. Add Sec. 721.11308 to read as follows:
Sec. 721.11308 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as mixed
metal oxide (PMN P-18-55) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), (b), and (c). 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.,
[[Page 46145]]
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. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
For purposes of Sec. 721.63(a)(6), the airborne form(s) of the
substance include particulate. For purposes of Sec. 721.63(b), the
concentration is set at 0.1%.
(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 Order for this substance. The NCEL is 0.04 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by the EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e), the concentration is set at 0.1%. For purposes of Sec.
721.72(g)(1), this substance may cause: Allergic skin reaction;
respiratory sensitization; germ cell mutagenicity; respiratory
complications; cancer. For purposes of Sec. 721.72(g)(2), when using
this substance: Avoid skin contact; avoid breathing substance; avoid
ingestion; use skin protection; use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.04 mg/m\3\. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitation 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
11. Add Sec. 721.11315 to read as follows:
Sec. 721.11315 Lithium nickel hydride oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium nickel
hydride oxide (PMN P-18-123; CAS No. 2081933-92-6) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). 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. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(ii) through (iv) and (vii) through
(ix), (g)(2), (g)(3)(ii), (g)(4)(i), and (g)(5). For purposes of Sec.
721.72(g)(2), when using this substance: Avoid skin contact; avoid
breathing substance; avoid ingestion; use skin protection; use
respiratory protection or maintain workplace airborne concentrations at
or below an 8-hour time-weighted average of 0.05 mg/m\3\. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance for more than four
years.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=32.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
12. Add Sec. 721,11316 to read as follows:
Sec. 721.11316 Lithium nickel potassium oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium nickel
potassium oxide (PMN P-18-124, CAS No. 210352-95-7) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). 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. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate.
(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 Order for this substance. The NCEL is 0.05 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may
[[Page 46146]]
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 Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1)(ii) through (iv) and (vii) through
(ix), (g)(2), (g)(3)(ii), (g)(4)(i), and (g)(5). For purposes of Sec.
721.72(g)(2), when using this substance: Avoid skin contact; avoid
breathing substance; avoid ingestion; use skin protection; use
respiratory protection or maintain workplace airborne concentrations at
or below an 8-hour time-weighted average of 0.05 mg/m\3\. Alternative
hazard and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance for more than four
years.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=32.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
13. Add Sec. Sec. 721.11319 through 721.11321 to read as follows:
Sec.
* * * * *
721.11319 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, triethylene
glycol, trimethylolalkane and polypropylene glycol (generic).
721.11320 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, phthalic
anhydride, triethylene glycol, trimethylolalkane and polypropylene
glycol (generic).
721.11321 Naphtha oils (generic).
* * * * *
Sec. 721.11319 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, triethylene glycol,
trimethylolalkane and polypropylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, triethylene glycol, trimethylolalkane
and polypropylene glycol (PMN P-18-200) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), (b), and (c). 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. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate. For purposes of Sec. 721.63(b), the concentration is set
at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and (ii), and
(g)(4) and (5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid eye contact; use skin protection;
use respiratory protection; use eye protection. For purposes of Sec.
721.72(g)(4), notice to users: Water release restrictions apply.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard
may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=280.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11320 Waste plastics, poly(ethylene terephthalate), polymers
with diethylene glycol, glycerol, polyerythritol, phthalic anhydride,
triethylene glycol, trimethylolalkane and polypropylene glycol
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as waste
plastics, poly(ethylene terephthalate), polymers with diethylene
glycol, glycerol, polyerythritol, phthalic anhydride, triethylene
glycol, trimethylolalkane and polypropylene glycol (PMN P-18-201) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), (b), and (c). 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. For purposes of Sec. 721.63(a)(5), respirators must
provide a National Institute for Occupational Safety and Health (NIOSH)
assigned protection factor (APF) of at least 10. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate. For purposes of Sec. 721.63(b), the concentration is set
at 1.0%.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1)(iv), (g)(2), (g)(3)(i) and (ii), and
(g)(4) and (5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid eye contact; use skin protection;
use respiratory protection; use eye protection. For purposes of Sec.
721.72(g)(4), notice to users: Water release restrictions apply.
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System (GHS) and OSHA Hazard Communication Standard
may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=280.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
[[Page 46147]]
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11321 Naphtha oils (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as naphtha
oils (PMN P-18-235) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance incorporated into a gasoline or transportation fuel
formulation below the maximum confidential concentration specified in
the Order for the substance.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k).
(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) Limitation 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)(1) and
(a)(2)(i) of this section.
0
14. Add Sec. Sec. 721.11346 through 721.11350 to read as follows:
* * * * *
Sec.
721.11346 Perfluoropolyether halide (generic).
721.11347 Perfluoropolyether aryl (generic).
721.11348 Substituted aryl perfluoropolyether (generic).
721.11349 Sulfonated perfluoropolyether aromatic transition metal
salt (generic).
721.11350 Sulfonated perfluoropolyether aryl alkali metal salt
(generic).
* * * * *
Sec. 721.11346 Perfluoropolyether halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoropolyether halide (PMN P-16-151) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t). It is a significant new use to
manufacture the substance for more than one year.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11347 Perfluoropolyether aryl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoropolyether aryl (PMN P-16-152) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard Communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11348 Substituted aryl perfluoropolyether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted aryl perfluoropolyether (PMN P-16-153) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
[[Page 46148]]
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11349 Sulfonated perfluoropolyether aromatic transition
metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated perfluoropolyether aromatic transition metal salt (PMN P-16-
154) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11350 Sulfonated perfluoropolyether aryl alkali metal salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated perfluoropolyether aryl alkali metal salt (PMN P-16-155) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(3)(i) and (ii), (g)(4)(i) and (iii), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used. For purposes of Sec. 721.72(e),
the concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
15. Add Sec. 721.11360 to read as follows:
Sec. 721.11360 Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenepropanal,
.alpha.,.alpha.,3-trimethyl- (PMN P-18-129; CAS No. 107737-97-3) 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(t).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation 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
16. Add Sec. 721.11361 to read as follows:
Sec. 721.11361 Multiwalled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
multiwalled carbon nanotubes (PMN P-18-182) 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 that have been:
(i) Embedded or incorporated into a polymer matrix that itself has
been reacted (cured);
(ii) Embedded in a permanent solid/polymer form that is not
intended to undergo further processing, except mechanical processing;
or
(iii) Incorporated into an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3) through (6), and (c). 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. For
purposes of Sec. 721.63(a)(5), respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 50. For purposes of Sec.
721.63(a)(6), the airborne form(s) of the substance include
particulate.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use an application method that generates a dust,
mist, or aerosol, unless such application method occurs in an enclosed
process. It is a significant new use to use the substance other than
for heat transfer, heat storage, thermal emission, and general
temperature management in heat-generating systems such as electronics,
to improve mechanical properties or electrical conductivities of other
materials or
[[Page 46149]]
products, and for light absorption properties.
(iii) Disposal. Requirements as specified in Sec. 721.85(a)(1) and
(2), (b)(1) and (2), and (c)(1) and (2).
(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.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers and processors
of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
17. Add Sec. 721.11372 to read as follows:
Sec. 721.11372 Phenol-formaldehyde epoxy, polymer with an alkyl
polyether polysulfide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol-
formaldehyde epoxy, polymer with an alkyl polyether polysulfide (PMN P-
19-5) 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) and (3).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), (g)(1), (g)(2)(i), (ii), and (v), (g)(3)(i)
and (ii), and (g)(4) and (5). For purposes of Sec. 721.72(g)(1), this
substance may cause: Internal organ effects; reproductive effects;
cancer; skin and respiratory sensitization; germ cell mutagenicity. For
purposes of Sec. 721.72(g)(4), notice to users: Water release
restrictions apply. Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
18. Add Sec. 721.11383 to read as follows:
Sec. 721.11383 Triarylsulfonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
triarylsulfonium salt (PMN P-16-548) 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), (k), and (t). It is a significant new
use to process or use the substance in a manner that generates a vapor,
mist, or aerosol.
(ii) 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 (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation 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
19. Add Sec. Sec. 721.11390 through 721.11393 to read as follows:
* * * * *
Sec.
721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
721.11391 Alkane, alkene, styrenic compounds derived from plastic
depolymerization (generic).
721.11392 Carbon compound derived from plastic depolymerization
(generic).
721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
* * * * *
Sec. 721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-17-398) 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 that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). For purposes of Sec. 721.80(k), the
use is as a refinery feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11391 Alkane, alkene, styrenic compounds derived from
plastic depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane,
alkene, styrenic compounds derived from plastic depolymerization (PMN
P-17-399) 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 that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). For purposes of Sec. 721.80(k), the
use is as a refinery feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 46150]]
Sec. 721.11392 Carbon compound derived from plastic depolymerization
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
compound derived from plastic depolymerization (PMN P-18-1) 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. It is a
significant new use to manufacture the substance containing more than
1% of the particles less than 75 microns. It is a significant new use
to manufacture the substance other than by the enclosed process
described in the premanufacture notice.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-18-28) 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 that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). For purposes of Sec. 721.80(k), the
use is as a refinery feedstock or a fuel blending additive.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
20. Add Sec. 721.11422 to read as follows:
Sec. 721.11422 Alkanediamine, dialkyl-, polymer with .alpha.-
hydro-.omega.-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether
with substituted alkyl-substituted alkanediol, reaction products with
alkyl-alkanamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanediamine, dialkyl-, polymer with .alpha.-hydro-.omega.-[(1-oxo-2-
propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) ether with substituted alkyl-
substituted alkanediol, reaction products with alkyl-alkanamine (PMN P-
17-393) 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 completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4) through (6) and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general, and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible. For purposes of
Sec. 721.63(a)(5), respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 1,000. For purposes of Sec. 721.63(a)(6), the airborne
form(s) of the substance include particulate.
(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 Order for this substance. The NCEL is 0.039 mg/m\3\ as an 8-hour
time-weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (f), and (g)(1) through (3) and (5). For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; eye irritation; skin
sensitization. For purposes of Sec. 721.72(g)(2), when using this
substance: Avoid skin contact; avoid breathing substance; avoid
ingestion; use skin protection; use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.039 mg/m\3\. For purposes of Sec. 721.72(g)(3), this
substance may be: Toxic to aquatic organisms; hazardous to the aquatic
environment. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the substance with an average molecular weight less than
1,000 daltons and with more than 10% less than 500 daltons.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation 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
21. Add Sec. Sec. 721.11426 through 721.11443 to read as follows:
* * * * *
Sec.
721.11426 Halogenated sodium benzene alkylcarboxylate (generic) (P-
19-86).
721.11427 Halogenated sodium benzene alkylcarboxylate (generic) (P-
19-87).
721.11428 Halogenated sodium benzene alkylcarboxylate (generic) (P-
19-89).
721.11429 Halogenated sodium benzoate (generic) (P-19-90).
721.11430 Halogenated benzene alkylcarboxylic acid (generic) (P-19-
91).
721.11431 Halogenated benzene alkylcarboxylic acid (generic) (P-19-
92).
721.11432 Halogenated benzoic acid (generic) (P-19-93).
[[Page 46151]]
721.11433 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-97).
721.11434 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-100).
721.11435 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-101).
721.11436 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-102).
721.11437 Halogenated benzoic acid, ethyl ester (generic) (P-19-
103).
721.11438 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-104).
721.11439 Halogenated benzoic acid, ethyl ester (generic) (P-19-
105).
721.11440 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-106).
721.11441 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-107).
721.11442 Halogenated alkylbenzoic acid, ethyl ester (generic) (P-
19-108).
721.11443 Halogenated benzoic acid, ethyl ester (generic) (P-19-
110).
* * * * *
Sec. 721.11426 Halogenated sodium benzene alkylcarboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzene alkylcarboxylate (PMN P-19-86) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; central nervous system effects;
internal organ effects; reproductive effects; developmental effects;
eye irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11427 Halogenated sodium benzene alkylcarboxylate (generic)
(P-19-87).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzene alkylcarboxylate (PMN P-19-87) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; central nervous system effects;
internal organ effects; reproductive effects; developmental effects;
eye irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11428 Halogenated sodium benzene alkylcarboxylate (generic)
(P-19-89).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzene alkylcarboxylate (PMN P-19-89) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this substance may cause: Skin
irritation; respiratory complications; central nervous system effects;
internal organ effects; reproductive effects; developmental effects;
eye irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11429 Halogenated sodium benzoate (generic) (P-19-90).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated sodium benzoate (PMN P-19-90) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), and (g)(5). For
purposes of Sec. 721.72(e), the concentration is set at 1.0%. For
purposes of Sec. 721.72(g)(1), this
[[Page 46152]]
substance may cause: Skin irritation; respiratory complications;
central nervous system effects; internal organ effects; reproductive
effects; developmental effects; eye irritation. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the substance other than in a liquid
formulation. It is a significant new use to manufacture or process the
substance without including the engineering controls/processes
described in the premanufacture notice.
(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 (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11430 Halogenated benzene alkylcarboxylic acid (generic) (P-
19-91).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzene alkylcarboxylic acid (PMN P-19-91) 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), (iii), and (iv), (a)(3) through (6), (b), and
(c). 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. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) as described in the
TSCA Order for this substance. For purposes of Sec. 721.63(a)(6), the
airborne form(s) of the substance include particulate, gas/vapor, and
combination gas/vapor and particulate. For purposes of Sec. 721.63(b),
the concentration is set at 1.0%.
(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 Order for this substance. The NCEL is 0.0273 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e) concentration set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; respiratory
complications; central nervous system effects; internal organ effects;
reproductive effects; developmental effects; eye irritation. For
purposes of Sec. 721.72(g)(2), when using this substance: Avoid skin
contact; avoid breathing substance; avoid ingestion; use skin
protection; use respiratory protection or maintain workplace airborne
concentrations at or below an 8-hour time-weighted average of 0.0273
mg/m\3\. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (q), and (t). It is a significant new
use to manufacture or process the substance without including the
engineering controls/processes described in the premanufacture notice.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11431 Halogenated benzene alkylcarboxylic acid (generic)
(P-19-92).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzene alkylcarboxylic acid (PMN P-19-92) 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), (iii), and (iv), (a)(3) through (6), (b), and
(c). 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. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) as described in the
TSCA Order for this substance. For purposes of Sec. 721.63(a)(6), the
airborne form(s) of the substance include particulate, gas/vapor, and
combination gas/vapor and particulate. For purposes of Sec. 721.63(b),
the concentration is set at 1.0%.
(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 Order for this substance. The NCEL is 0.0273 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; respiratory
complications; central nervous system effects; internal organ effects;
reproductive effects; developmental effects; eye irritation. For
purposes of Sec. 721.72(g)(2), when using this substance: Avoid skin
contact; avoid breathing substance; avoid ingestion; use skin
protection; use respiratory protection or maintain
[[Page 46153]]
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.0273 mg/m\3\. Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (q), and (t). It is a significant new
use to manufacture or process the substance without including the
engineering controls/processes described in the premanufacture notice.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11432 Halogenated benzoic acid (generic) (P-19-93).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid (PMN P-19-93) 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), (iii), and (iv), (a)(3) through (6), (b), and
(c). 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. For purposes of Sec. 721.63(a)(5),
respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (APF) as described in the
TSCA Order for the substance. For purposes of Sec. 721.63(a)(6), the
airborne form(s) of the substance include particulate, gas/vapor, and
combination gas/vapor and particulate.
(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 Order for this substance. The NCEL is 0.0273 mg/m\3\ as an 8-hour
time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
Order.
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f) and (g)(1), (2), and (5). For purposes of Sec.
721.72(e), the concentration is set at 1.0%. For purposes of Sec.
721.72(g)(1), this substance may cause: Skin irritation; respiratory
complications; central nervous system effects; internal organ effects;
reproductive effects; developmental effects; eye irritation. For
purposes of Sec. 721.72(g)(2), when using this substance: Avoid skin
contact; avoid breathing substance; avoid ingestion; use skin
protection; use respiratory protection or maintain workplace airborne
concentrations at or below an 8-hour time-weighted average of 0.0273
mg/m\3\. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k), (q), and (t). It is a significant new
use to manufacture or process the substance without including the
engineering controls/processes described in the premanufacture notice.
(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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11433 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-97).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-97) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11434 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-100).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-100) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal
[[Page 46154]]
organ effects; reproductive effects; developmental effects; eye
irritation. Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11435 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-101).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-101) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11436 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-102).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-102) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11437 Halogenated benzoic acid, ethyl ester (generic) (P-19-
103).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid, ethyl ester (PMN P-19-103) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e) concentration set at
1.0%. For purposes of Sec. 721.72(g)(1), this substance may cause:
Skin irritation; respiratory complications; central nervous system
effects; internal organ effects; reproductive effects; developmental
effects; eye irritation. Alternative hazard and warning statements that
meet the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11438 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-104).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-104) is
[[Page 46155]]
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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11439 Halogenated benzoic acid, ethyl ester (generic) (P-
19-105).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid, ethyl ester (PMN P-19-105) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11440 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-106).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-106) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i), (ii), and (iii), (g)(3)(i)
and (ii), and (g)(5). For purposes of Sec. 721.72(e), the
concentration is set at 1.0%. For purposes of Sec. 721.72(g)(1), this
substance may cause: Skin irritation; respiratory complications;
central nervous system effects; internal organ effects; reproductive
effects; developmental effects; eye irritation. Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11441 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-107).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-107) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The
[[Page 46156]]
provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11442 Halogenated alkylbenzoic acid, ethyl ester (generic)
(P-19-108).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkylbenzoic acid, ethyl ester (PMN P-19-108) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11443 Halogenated benzoic acid, ethyl ester (generic) (P-
19-110).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzoic acid, ethyl ester (PMN P-19-110) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (f), (g)(1), (g)(2)(i) through (iii), (g)(3)(i) and
(ii), and (g)(5). For purposes of Sec. 721.72(e), the concentration is
set at 1.0%. For purposes of Sec. 721.72(g)(1), this substance may
cause: Skin irritation; respiratory complications; central nervous
system effects; internal organ effects; reproductive effects;
developmental effects; eye irritation. Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture or process the substance without including the engineering
controls/processes described in the premanufacture notice.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=14.
(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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
[FR Doc. 2021-17392 Filed 8-17-21; 8:45 am]
BILLING CODE 6560-50-P