Significant New Use Rules on Certain Chemical Substances (17-5), 55058-55071 [2019-22205]
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Federal Register / Vol. 84, No. 199 / Tuesday, October 15, 2019 / Rules and Regulations
The safety zone will extend to all
navigable waters of the Sacramento
River, from surface to bottom, within a
circle formed by connecting all points
100 feet out from the fireworks barge
during the loading, transit, and arrival
of the fireworks barge from the loading
location to the display location and
until the start of the fireworks display.
From noon through 4 p.m. October 12,
2019, the fireworks barge will be
loading pyrotechnics from the Dutra
Group, 160 River Road, Rio Vista, CA.
The fireworks barge will remain at the
loading location until its transit to the
display location. From 7 p.m. to 8 p.m.
on October 12, 2019 the loaded
fireworks barge will transit from the
Dutra Group to the launch site off of Rio
Vista, CA in approximate position
38°09′15.53″ N, 121°41′17.01″ W (NAD
83), where it will remain until the
conclusion of the fireworks display.
During the15-minute fireworks display,
scheduled to begin at approximately
8:45 p.m. on October 12, 2019, and 30
minutes after the conclusion of the
fireworks display, the safety zone will
increase in size and encompass all
navigable waters of the Sacramento
River, from surface to bottom, within a
circle formed by connecting all points
1000 feet out from the fireworks barge
near Rio Vista, CA in approximate
position 38°09′15.53″ N, 121°41′17.01″
W (NAD 83). This safety zone will be
enforced from noon until 9:30 p.m. on
October 12, 2019, or as announced via
Broadcast Notice to Mariners.
In addition to this notification in the
Federal Register, the Coast Guard plans
to provide notification of the safety zone
and its enforcement period via the Local
Notice to Mariners.
Under the provisions of 33 CFR
165.1191, unauthorized persons or
vessels are prohibited from entering
into, transiting through, or anchoring in
the safety zone during all applicable
effective dates and times, unless
authorized to do so by the PATCOM or
other Official Patrol defined as a
Federal, state, or local law enforcement
agency on scene to assist the Coast
Guard in enforcing the regulated area.
Additionally, each person who receives
notice of a lawful order or direction
issued by the PATCOM or Official
Patrol shall obey the order or direction.
The PATCOM or Official Patrol may,
upon request, allow the transit of
commercial vessels through regulated
areas when it is safe to do so.
If the Captain of the Port determines
that the regulated area need not be
enforced for the full duration stated in
this notice of enforcement, a Broadcast
Notice to Mariners may be used to grant
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general permission to enter the
regulated area.
Dated: October 7, 2019.
Marie B. Byrd,
Captain, U.S. Coast Guard, Captain of the
Port, San Francisco.
[FR Doc. 2019–22300 Filed 10–11–19; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2018–0567; FRL–10000–
42]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (17–5)
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is issuing significant new
use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for 29
chemical substances which are the
subject of 28 premanufacture notices
(PMNs). The chemical substances are
subject to Orders issued by EPA
pursuant to section 5(e) of TSCA. This
action requires persons who intend to
manufacture (defined by statute to
include import) or process any of these
29 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. 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
December 16, 2019. For purposes of
judicial review, this rule shall be
promulgated at 1 p.m. (e.s.t.) on October
29, 2019.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution
Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
telephone number: (202) 564–9232;
email address: moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, process,
or use the chemical substances
contained in this rule. The following list
of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and Orders under TSCA. Importers
of chemicals subject to these SNURs
must certify compliance with the SNUR
requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
that is the subject of this rule on or after
November 14, 2019 are subject to the
export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)) (see 40
CFR 721.20), and must comply with the
export notification requirements in 40
CFR part 707, subpart D.
B. How can I access the docket?
The docket includes information
considered by the Agency in developing
the proposed and final rules. The docket
for this action, identified by docket
identification (ID) number EPA–HQ–
OPPT–2018–0567, is available at https://
www.regulations.gov or 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. Please review the visitor
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instructions and additional information
about the docket available at https://
www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing these SNURs under
TSCA section 5(a)(2) for 29 chemical
substances which were the subject of 28
PMNs. These SNURs require persons
who intend to manufacture or process
any of these chemical substances for an
activity that is designated as a
significant new use to notify EPA at
least 90 days before commencing that
activity.
In the Federal Register of September
17, 2018 (83 FR 47026) (FRL–9983–59),
EPA proposed a SNUR for these
chemical substances in 40 CFR part 721
subpart E. This comment period closed
on October 17, 2018. More information
on the specific chemical substances
subject to this final rule can be found in
the Federal Register documents for the
direct final SNUR of September 17, 2018
(83 FR 47004) (FRL–9983–14), which is
referenced in the proposed SNUR. The
direct final rule was withdrawn in the
Federal Register of November 16, 2018
(83 FR 57689) (FRL–9986–15).
B. What is the Agency’s authority for
taking this action?
TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four TSCA section 5(a)(2)
factors listed in Unit III.
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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. According to
40 CFR 721.1(c), persons subject to
these SNURs must comply with the
same SNUN requirements and EPA
regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A).
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, EPA must
either determine that the use is not
likely to present an unreasonable risk of
injury under the conditions of use for
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the chemical substance or take such
regulatory action as is associated with
an alternative determination before the
manufacture or processing for the
significant new use can commence. In
the case of a determination other than
not likely to present unreasonable risk,
the applicable review period must also
expire before manufacturing or
processing for the new use may
commence. If EPA determines that the
use is not likely to present an
unreasonable risk, EPA is required
under TSCA section 5(g) to make public,
and submit for publication in the
Federal Register, a statement of EPA’s
findings.
III. Significant New Use Determination
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 section 5(e) 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, likely human
exposures and environmental releases
associated with possible uses, and the
four TSCA section 5(a)(2) factors listed
in this unit.
IV. Public Comments on Proposed Rule
and EPA Responses
EPA received public comments on the
proposed rule from eight identifying
entities. The Agency’s responses are in
the Response to Public Comments
document in the public docket for this
rule, EPA–HQ–OPPT–2018–0567.
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V. Substances Subject to This Rule
EPA is establishing significant new
use and recordkeeping requirements for
29 chemical substances in 40 CFR part
721, subpart E. In Unit IV. of the
original direct final rule (83 FR 47004,
September 17, 2018) (FRL–9983–14),
EPA provides the following information
for each chemical substance:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS)
Registry number (if assigned for nonconfidential chemical identities).
• Basis for the TSCA section 5(e)
Order.
• Potentially Useful Information. This
is information identified by EPA that
would help characterize the potential
health and/or environmental effects of
the chemical substance in support of a
request by the PMN submitter to modify
the TSCA section 5(e) Order, or 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 this rule.
The regulatory text section of each
rule specifies the activities designated
as significant new uses. Certain new
uses, including exceedance of
production volume limits (i.e., limits on
manufacture volume) and other uses
designated in this rule, may be claimed
as CBI. Unit IX. discusses a procedure
companies may use to ascertain whether
a proposed use constitutes a significant
new use.
These final rules include 29 chemical
substances that are subject to Orders
under TSCA section 5(e)(1)(A)(ii)(I)
where EPA determined that activities
associated with the PMN substances
may present unreasonable risk to human
health or the environment. Those
Orders require protective measures to
limit exposures or otherwise mitigate
the potential unreasonable risk. The
SNURs identify as significant new uses
any manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to the restrictions
imposed by the underlying Orders,
consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN
substance may present an unreasonable
risk of injury to human health via
inhalation exposure, the underlying
TSCA section 5(e) Order usually
requires 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 the New Chemical Exposure
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Limit (NCEL). The comprehensive
NCELs provisions in TSCA section 5(e)
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
section 5(e) 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, 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. The basis for such findings
is outlined in Unit IV. Based on these
findings, TSCA section 5(e) Orders
requiring the use of appropriate
exposure controls were negotiated with
the PMN submitters. As a general
matter, EPA believes it is necessary to
follow TSCA section 5(e) 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.
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B. Objectives
EPA is issuing these SNURs because
the Agency wants:
• To identify as significant new uses
any manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to the restrictions
imposed by the underlying Orders,
consistent with TSCA section 5(f)(4).
• 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.
• To have an opportunity to review
and evaluate data submitted in a SNUN
before the notice submitter begins
manufacturing or processing a listed
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chemical substance for the described
significant new use.
• To be able to either determine that
the prospective manufacture or
processing is not likely to present an
unreasonable risk, or to take necessary
regulatory action associated with any
other determination, before the
described significant new use of the
chemical substance occurs.
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/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
VII. Applicability of the Significant
New Use Designation
To establish a significant new use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this rule have undergone
premanufacture review. In cases where
EPA has not received a notice of
commencement (NOC) and the chemical
substance has not been added to the
TSCA Inventory, no person may
commence such activities without first
submitting a PMN. Therefore, for
chemical substances for which an NOC
has not been submitted, EPA concludes
that the designated significant new uses
are not ongoing.
When chemical substances identified
in this rule are added to the TSCA
Inventory, EPA recognizes that, before
the rule is effective, other persons might
engage in a use that has been identified
as a significant new use. However,
TSCA section 5(e) Orders have been
issued for all the chemical substances,
and the PMN submitters are prohibited
by the TSCA section 5(e) Orders from
undertaking activities which will be
designated as significant new uses. The
identities of the 29 chemical substances
subject to this rule have been claimed as
confidential. 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
September 17, 2018 (the date of public
release of the original direct final and
proposed rules) as the cutoff date for
determining whether the new use is
ongoing. The objective of EPA’s
approach has been to ensure that a
person could not defeat a SNUR by
initiating a significant new use before
the effective date of the final rule.
In the unlikely event that a person
began commercial manufacture or
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processing of the chemical substances
for a significant new use identified as of
September 17, 2018, that person will
have to cease any such activity upon the
effective date of the final rule. To
resume their activities, these persons
will have to first comply with all
applicable SNUR notification
requirements and wait until EPA has
conducted a review of the notice, made
an appropriate determination on the
notice, and has taken such actions as are
required with that determination.
VIII. Development and Submission of
Information
EPA recognizes that TSCA section 5
does not require developing any
particular new information (e.g.,
generating test data) before submission
of a SNUN. There is an exception: If a
person is required to submit information
for a chemical substance pursuant to a
rule, Order or consent agreement under
TSCA section 4 (15 U.S.C. 2603), then
TSCA section 5(b)(1)(A) (15 U.S.C.
2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, Order, or
consent agreement under TSCA section
4 covering the chemical substance,
persons are required only to submit
information in their possession or
control and to describe any other
information known to or reasonably
ascertainable (see 40 CFR 720.50).
However, upon review of PMNs and
SNUNs, the Agency has the authority to
require appropriate testing under 40
CFR part 721, subpart E. In Unit IV. of
the original direct final rule (83 FR
47004, September 17, 2018) (FRL–9983–
14), the EPA lists potentially useful
information that will be useful to EPA’s
evaluation. 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 on 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).
In some of the TSCA section 5(e)
Orders for the chemical substances
regulated under this rule, EPA has
established production volume limits.
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These limits cannot be exceeded unless
the PMN submitter submits the results
of specified tests. The SNURs contain
the same production volume limits as
the TSCA section 5(e) Orders. Exceeding
these production limits is defined as a
significant new use. Persons who intend
to exceed the production limit must
notify the Agency by submitting a
SNUN at least 90 days in advance of
commencement of non-exempt
commercial manufacture or processing.
Any request by EPA for the triggered
and pended testing described in the
Orders was made based on EPA’s
consideration of available 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 original
direct final rule may not be the only
means of addressing the potential risks
of the chemical substance. However,
submitting a SNUN without any test
data or other information may increase
the likelihood that EPA will take action
under TSCA section 5(e) 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 provide
detailed information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing
certain significant new uses which have
been claimed as CBI subject to Agency
confidentiality regulations at 40 CFR
part 2 and 40 CFR part 720, subpart E.
Absent a final determination or other
disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is
required to keep this information
confidential. EPA promulgated a
procedure to deal with the situation
where a specific significant new use is
CBI, at 40 CFR 721.1725(b)(1).
Under these procedures a
manufacturer or processor may request
EPA to determine whether a proposed
use would be a significant new use
under the rule. The manufacturer or
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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.
X. 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/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this rule. EPA’s complete economic
analysis is available in the docket under
docket ID number EPA–HQ–OPPT–
2018–0567.
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XII. 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 and TSCA
section 5(e) Orders. 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. 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 the
PRA, unless it has been approved by
OMB and displays a currently valid
OMB control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable. EPA is amending the table in
40 CFR part 9 to list the OMB approval
number for the information collection
requirements contained in this action.
This listing of the OMB control numbers
and their subsequent codification in the
CFR satisfies the display requirements
of PRA and OMB’s implementing
regulations at 5 CFR part 1320. This
Information Collection Request (ICR)
was previously subject to public notice
and comment prior to OMB approval,
and given the technical nature of the
table, EPA finds that further notice and
comment to amend it is unnecessary. As
a result, EPA finds that there is ‘‘good
cause’’ under section 553(b)(3)(B) of the
Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table
without further notice and comment.
The information collection activities
in this action have already been
approved by OMB pursuant to the PRA
under OMB control number 2070–0012
(EPA ICR No. 574). This action does not
impose any burden requiring additional
OMB approval. If an entity were to
submit a SNUN to the Agency, the
annual burden is estimated to average
between 30 and 170 hours per response.
This burden estimate includes the time
needed to review instructions, search
existing data sources, gather and
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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 using
automated collection techniques, to the
Director, Regulatory Support Division,
Office of Mission Support (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b) (5
U.S.C. 601 et seq.), the Agency hereby
certifies that promulgation of this SNUR
will not have a significant adverse
economic impact on a substantial
number of small entities. The
requirement to submit a SNUN applies
to any person (including small or large
entities) who intends to engage in any
activity described in the final rule as a
‘‘significant new use.’’ Because these
uses are ‘‘new,’’ based on all
information currently available to EPA,
it appears that no small or large entities
presently engage in such activities. A
SNUR requires that any person who
intends to engage in such activity in the
future must first notify EPA by
submitting a SNUN. EPA’s experience to
date is that, in response to the
promulgation of SNURs covering over
1,000 chemicals, the Agency receives
only a small number of notices per year.
For example, the number of SNUNs
received was seven in Federal fiscal
year (FY) 2013, 13 in FY2014, six in
FY2015, 10 in FY2016, 14 in FY2017,
and 18 in FY2018 and only a fraction of
these were from small businesses. In
addition, the Agency currently offers
relief to qualifying small businesses by
reducing the SNUN submission fee from
$16,000 to $2,800. This lower fee
reduces the total reporting and
recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying
small firms. Therefore, the potential
economic impacts of complying with
this 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.
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D. Unfunded Mandates Reform Act
(UMRA)
I. National Technology Transfer and
Advancement Act (NTTAA)
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.).
In addition, since this action does not
involve any technical standards,
NTTAA section 12(d) (15 U.S.C. 272
note) does not apply to this action.
E. Executive Order 13132: Federalism
XIII. Congressional Review Act (CRA)
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).
Pursuant to the CRA (5 U.S.C. 801 et
seq.), EPA will submit a report
containing this rule and other required
information to the U.S. Senate, the U.S.
House of Representatives, and the
Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
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.
G. 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.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
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J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: October 4, 2019.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are
amended as follows:
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
■
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
2. In § 9.1, add entries for
§§ 721.11124 through 721.11148 in
numerical order under the undesignated
center heading ‘‘Significant New Uses of
Chemical Substances’’ to read as
follows:
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Significant New Uses of Chemical
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721.11124
721.11125
721.11126
721.11127
721.11128
721.11129
721.11130
721.11131
721.11132
721.11133
721.11134
721.11135
721.11136
721.11137
721.11138
721.11139
721.11140
721.11141
721.11142
721.11143
721.11144
721.11145
721.11146
721.11147
721.11148
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2070–0012
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2070–0012
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PART 721—[AMENDED]
3. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
4. Add §§ 721.11124 through
721.11148 to subpart E to read as
follows:
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Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
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721.11124 2-Propenenitrile, polymer with
methanamine, hydrogenated, 3aminopropylterminated, ethoxylated
propoxylated.
721.11125 Dicarboxylic acids, polymers
with alkyl prop-2-enoate, alkyl 2ethylprop-2-enoate,
alkyl[(alkenyl)alkyl]alkanediol,
alkanediol, alkanedioic acid, alkyl 2methylprop-2-enoate, alkyl prop-2-enoic
acid, alkylene
[isocyanatocarbomonocycle] and
alkanediol, alkanolamine-blocked,
compds. with 2-(alkylamino)alkanol
(generic).
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721.11126 Mixed metal oxide (generic).
721.11127 Modified alkyl polyamine
(generic).
721.11128 Alkyl polyamine (generic).
721.11129 Silica gel, reaction products with
chromium oxide (CrO3) and
ethoxydiethyl aluminum.
721.11130 Carboxylic acids, C6-18 and C515-di-, polymers with diethylene glycol,
glycerol, sorbitol and terephthalic acid.
721.11131 1-Tetradecene, homopolymer,
hydrogenated.
721.11132 Fluorocyanophenyl
alkylbenzoate (generic).
721.11133 Fluorinated acrylic copolymer
(generic).
721.11134 Oxyalkylene urethane polyolefin
(generic).
721.11135 Imino alkane amine phosphate
(generic).
721.11136 Fatty acids, tall-oil, reaction
products with 2-[(2aminoalkyl)amino]alkanol, compds. with
alkylene oxide-glycidyl o-tolyl ether
polymer dihydrogen phosphate alkyl
ether (generic).
721.11137 Oxirane, 2-alkyl-, polymer with
oxirane, mono[N-[3-(carboxyamino)-4(or
6)-alkylphenyl]carbamate], alkyl ether,
ester with 2,2′,2″-nitrilotris-[alkanol]
(generic).
721.11138 Formaldehyde, polymer with
(chloromethyl)oxirane and substituted
aromatic compounds (generic).
721.11139 Acid, reaction products with
cadmium selenide (CdSe),
trioctylphosphine and trioctylphosphine
oxide (generic).
721.11140 Acid, reaction products with
cadmium selenide sulfide, acid,
trioctylphosphine and trioctylphosphine
oxide (generic).
721.11141 Acid, reaction products with
cadmium zinc selenide sulfide,
trioctylphosphine and trioctylphosphine
oxide (generic).
721.11142 Metal oxide reaction products
with cadmium metal selenide sulfide,
and amine (generic).
721.11143 Alkanoic acid, alkyl-, substituted
alkyl ester, polymer with alkyl alkenoate,
substituted carbomonocycle, substituted
alkyl alkenoate and alkyl substituted
alkenoate, substituted alkanenitrileinitiated, polymers with substituted
alkanenitrile-initiated, alkanoic acidalkane substituted acrylates-substituted
carbomonocycle polymer, compds. with
alkylamino alkanol (generic).
721.11144 Manganese bipyridine
carboxylate complex (generic).
721.11145 Sulfuric acid mixed salt
(generic).
721.11146 2-Propenoic acid, alkyl-2(alkylalkyl)alkyl ester (generic).
721.11147 Allyloxymethylacrylate
(generic).
721.11148 Polyurethane, methacrylate
blocked (generic).
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55063
§ 721.11124 2-Propenenitrile, polymer with
methanamine, hydrogenated, 3aminopropylterminated, ethoxylated
propoxylated.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenenitrile, polymer with
methanamine, hydrogenated, 3aminopropylterminated, ethoxylated
propoxylated (PMN P–14–758; CAS No.
2055838–16–7) 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
chemical 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)(1), (a)(2)(i), (a)(3) through
(5)(respirators must provide a National
Institute for Occupational Safety and
Health assigned protection factor of at
least 50), (a)(6)(v) (particulate (including
solids or liquid droplets)), (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 operation,
general and local ventilation) or
administrative control measures (e.g.
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e) (concentration set at
1.0%), (f), (g)(1)(ii), (g)(2)(ii), (g)(4)(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.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (k). A
significant new use is any spray
application method that results in
greater worker inhalation exposures to
vapor, mist, or aerosol than the roller
coating application.
(iv) Release to water. Requirements as
specified in § 721.90(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) Limitations 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.
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§ 721.11125 Dicarboxylic acids, polymers
with alkyl prop-2-enoate, alkyl 2-ethylprop2-enoate, alkyl[(alkenyl)alkyl]alkanediol,
alkanediol, alkanedioic acid, alkyl 2methylprop-2-enoate, alkyl prop-2-enoic
acid, alkylene [isocyanatocarbomonocycle]
and alkanediol, alkanolamine-blocked,
compds. with 2-(alkylamino)alkanol
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as dicarboxylic acids,
polymers with alkyl prop-2-enoate,
alkyl 2-ethylprop-2-enoate,
alkyl[(alkenyl)alkyl]alkanediol,
alkanediol, alkanedioic acid, alkyl 2methylprop-2-enoate, alkyl prop-2-enoic
acid, alkylene
[isocyanatocarbomonocycle] and
alkanediol, alkanolamine-blocked,
compds. with 2-(alkylamino)alkanol
(PMN P–16–493) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
section do not apply to quantities of the
substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f). It is a significant
new use to import the chemical
substance to contain more than 0.1%
residual isocyanate by weight. It is a
significant new use to import the
chemical substance to contain more
than 1% of a confidential component 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) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11126
Mixed metal oxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
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generically as a mixed metal oxide
(PMN P–16–514) 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)(respirators must provide a National
Institute for Occupational Safety and
Health assigned protection factor of at
least 1,000), (a)(6)(particulate (including
solids or liquid droplets)), (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 operation,
general and local ventilation) or
administrative control measures (e.g.
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(A) As an alternative to the respirator
requirements in paragraph (a)(2)(i) of
this section, a manufacturer or processor
may choose to follow the new chemical
exposure limit (NCEL) provision listed
in the TSCA section 5(e) Order for this
substance. The NCEL is 0.04 mg/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 section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e)(concentration set at 1.0%),
(f), (g)(1)(iv), (lung toxicity if inhaled),
(eye irritation), (allergic skin reaction),
(g)(2)(i) through (iii) and (v)(use
respiratory protection or maintain
workplace airborne concentrations at or
below an 8-hour time-weighted average
of 0.04 mg/m3), (g)(4)(i), and (g)(5).
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(e), (f), (k), and (q).
(iv) Disposal. It is a significant new
use to dispose of the chemical substance
other than by recycling as described in
the Order.
(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 (j) are applicable to
manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) and (iv) of this section.
§ 721.11127
(generic).
Modified alkyl polyamine
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as modified alkyl polyamine
(PMN P–16–576) 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),
(a)(6)(particulate (including solids or
liquid droplets)), (vapor), (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), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (ii), (vi), and (viii), (g)(2)(i)
through (iii) and (v), (g)(3)(i) and (ii),
and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). It is a
significant new use to manufacture the
chemical substance more than 9
months.
(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) Limitations 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.
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§ 721.11128
Alkyl polyamine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyl polyamine (PMN P–
16–577) 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), (a)(3),
(a)(6)(v) (particulate (including solids or
liquid droplets)), (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), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (ii), (vi), and (viii), (g)(2)(i)
through (iii) and (v), (g)(3)(i) and (ii),
and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). It is a
significant new use to manufacture the
chemical substance more than nine
months.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 2.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 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.
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§ 721.11129 Silica gel, reaction products
with chromium oxide (CrO3) and
ethoxydiethyl aluminum.
§ 721.11130 Carboxylic acids, C6-18 and
C5-15-di-, polymers with diethylene glycol,
glycerol, sorbitol and terephthalic acid.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
silica gel, reaction products with
chromium oxide (CrO3) and
ethoxydiethyl aluminum is (PMN P–16–
590, CAS No. 932384–12–8) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1) and (a)(3) through
(5)(respirators must provide a National
Institute for Occupational Safety and
Health assigned protection factor of 10
to 1,000 depending on the results of the
exposure monitoring as described in the
Order for P16–590 and required by this
section (a)(2)(i), (a)(6)(particulate
(including solids or liquid droplets)),
(a)(6)(vapor), (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
operation, general and local ventilation)
or administrative control measures (e.g.
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), (b)
(concentration set at 0.1%), and (c). It is
a significant new use to not conduct the
exposure monitoring required in the
Order for P–16–590 when workers are
reasonably likely to be exposed by
inhalation.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. It is a significant
new use to manufacture, process, or use
the chemical substance other than in a
system where the chemical substance is
handled in an inert atmosphere and is
not designed to be exposed to air.
(iii) Disposal. It is a significant new
use to dispose of all waste streams
containing the PMN substance and the
constituent breakdown products of the
PMN substance other than in a Resource
Conservation and Recovery Act (RCRA)
hazardous waste landfill.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (j) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
carboxylic acids, C6-18 and C5-15-di-,
polymers with diethylene glycol,
glycerol, sorbitol and terephthalic acid
(PMN P–16–593, CAS No. 1967778–37–
5) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section. The requirements of this section
do not apply to quantities of the
substance after they have been reacted
(cured).
(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)
(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 operation, general and
local ventilation) or administrative
control measures (e.g. workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(ii), (irritation), (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 be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (aromatic
polyester polyol for rigid foam). It is a
significant new use to manufacture,
process, or use the chemical substance
to result in inhalation exposure to a
vapor, mist or aerosol.
(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 this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11131 1-Tetradecene, homopolymer,
hydrogenated.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1-tetradecene, homopolymer,
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hydrogenated (PMN P–17–5, CAS No.
1857296–89–9) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(ii), (g)(2)(ii), 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.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (base fluid/
carrier fluid for additives in motor oil,
automatic transmission fluid, and
industrial lubricants). It is a significant
new use to manufacture the chemical
substance more than 9 months. It is a
significant new use to manufacture,
process, or use the chemical substance
to results in inhalation exposure to a
vapor, mist or aerosol.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (f) through
(i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11132 Fluorocyanophenyl
alkylbenzoate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fluorocyanophenyl
alkylbenzoate (PMNs P–17–149, P–17–
150, P–17–151, and P–17–165) 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), (iii) and (iv),
(a)(3), (a)(6)(v), (particulate (including
solids or liquid droplets)), (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 operation, general and
local ventilation) or administrative
control measures (e.g. workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
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(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (ii), (iii), (iv), (vi) and (ix),
(g)(2)(i), (ii), (iii) and (v), (g)(3)(i) and
(ii), and (g)(5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture,
process, or use the chemical substance
to result in inhalation exposures to
vapor, dust, mist, or aerosols to the
substance.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), (c)(4)
where N = 2 for P–17–165 and N = 4 for
P–17–149, P–17–150, and P–17–151.
(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 these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11133
(generic).
Fluorinated acrylic copolymer
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fluorinated acrylic
copolymer (PMN P–17–175) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (t) (60
kilograms). It is a significant new use to
use the substance other than as a
leveling agent for coatings applied to
aluminum printing plates.
(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
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applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
significant new use rule.
§ 721.11134 Oxyalkylene urethane
polyolefin (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as oxyalkylene urethane
polyolefin (PMN P–17–199) 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 chemical
substance with an average molecular
weight greater than specified in the
Order or with more than 1.0% of the
molecular weight content below 1,000
Daltons.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11135
(generic).
Imino alkane amine phosphate
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as imino alkane amine
phosphate (PMN P–17–206, chemical A
and P–17–206, chemical B) are subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substances
after they have been reacted (cured).
(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),
(a)(6)(v) (particulate (including solids or
liquid droplets)), (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
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of operation, general and local
ventilation) or administrative control
measures (e.g. workplace policies and
procedures) shall be considered and
implemented to prevent exposure,
where feasible), (b) (concentration set at
1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (g)(2)(i) and (v), (g)(3)(i) and
(ii), (g)(4)(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.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f) and (k). It is a
significant new use to modify
processing or use if it results in
inhalation exposure to vapor, dust, mist,
or aerosols to the substances.
(iv) Disposal. Requirements as
specified in § 721.85(a)(1), (b)(1), and
(c)(1).
(v) 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 (k) are applicable
to manufacturers and processors of
these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
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§ 721.11136 Fatty acids, tall-oil, reaction
products with 2-[(2aminoalkyl)amino]alkanol, compds. with
alkylene oxide-glycidyl o-tolyl ether
polymer dihydrogen phosphate alkyl ether
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acids, tall-oil,
reaction products with 2-[(2aminoalkyl)amino]alkanol, compds.
with alkylene oxide-glycidyl o-tolyl
ether polymer dihydrogen phosphate
alkyl ether (PMN P–17–223) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been reacted (cured).
(2) The significant new uses are:
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(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v),
(particulate (including solids or liquid
droplets)), (when determining which
persons are reasonably likely to be
exposed as required for § 721.63(a)(1)
and, engineering control measures (e.g.
enclosure or confinement of operation,
general and local ventilation) or
administrative control measures (e.g.
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i) and (ii), (g)(2)(i), (ii) and (v),
(g)(3)(i) and (ii), and (g)(5), Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (q). It is
a significant new use to modify any
processing if such modification would
result in inhalation exposures to the
chemical substance by vapor, dust, mist,
or aerosol, at a concentration of greater
than 1.0% by weight or volume. It is a
significant new use to use the chemical
substance in the confidential
formulation identified in the Order at
concentration greater than 1.0% by
weight or volume. It is a significant new
use to manufacture, process, or use the
substance for consumer use or for
commercial uses that could introduce
the substance into a consumer setting.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), (c)(4)
where N = 15.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 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.
§ 721.11137 Oxirane, 2-alkyl-, polymer with
oxirane, mono[N-[3-(carboxyamino)-4(or 6)alkylphenyl]carbamate], alkyl ether, ester
with 2,2′,2″-nitrilotris-[alkanol] (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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55067
(1) The chemical substance identified
generically as oxirane, 2-alkyl-, polymer
with oxirane, mono[N-[3(carboxyamino)-4(or 6)alkylphenyl]carbamate], alkyl ether,
ester with 2,2′,2″-nitrilotris-[alkanol]
(PMN P–17–230) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
section do not apply to quantities of the
substance after they have been reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
(a)(6)(v) (particulate (including solids or
liquid droplets)), (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 operation, general and local
ventilation) or administrative control
measures (e.g. workplace policies and
procedures) shall be considered and
implemented to prevent exposure,
where feasible), (b) (concentration set at
1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (ii), (eye irritation), (g)(2)(i),
(ii), and (v), (g)(3)(i) and (ii), and (g)(5).
Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (q). It is
a significant new use to modify
processing methods if such modification
would result in inhalation exposures to
the chemical substance by vapor, dust,
mist, or aerosol, at a concentration of
greater than 1.0% by weight or volume.
It is a significant new use to use the
chemical substance in the confidential
formulation at a concentration greater
than 1.0% by weight or volume. It is a
significant new use to manufacture,
process, or use the substance for
consumer use or for commercial uses
that could introduce the substance into
a consumer setting.
(iv) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 65.
(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
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applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
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§ 721.11138 Formaldehyde, polymer with
(chloromethyl)oxirane and substituted
aromatic compounds (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as formaldehyde, polymer
with (chloromethyl)oxirane and
substituted aromatic compounds (PMN
P–17–236) 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 the chemical substance
after it has been incorporated into the
confidential forms identified in the
Order.
(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), (a)(6) (particulate (including
solids or liquid droplets)), (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 operation, general and
local ventilation) or administrative
control measures (e.g. workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(ii), (vi), (vii), and (ix), (skin
sensitization), (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 be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (q). It is
a significant new use to modify
manufacture, processing, or use if it
results in inhalation exposure to vapor,
dust, mist, or aerosols to the substance.
(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
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manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraphs
(a)(1) and (a)(2)(iii) of this section.
§ 721.11139 Acid, reaction products with
cadmium selenide (CdSe),
trioctylphosphine and trioctylphosphine
oxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acid, reaction products
with cadmium selenide (CdSe),
trioctylphosphine and
trioctylphosphine oxide (PMN P–17–
241) 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 (a)(3),
(a)(6)(particulate (including solids or
liquid droplets)), (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), and (c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g) and (y)(1). It is
a significant new use to manufacture,
process, or use the substance other than
in a liquid formulation.
(iii) Disposal. It is a significant new
use to dispose of the substance and any
waste stream containing the substance
other than in a permitted hazardous
waste incinerator.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (j) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11140 Acid, reaction products with
cadmium selenide sulfide, acid,
trioctylphosphine and trioctylphosphine
oxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acid, reaction products
with cadmium selenide sulfide, acid,
trioctylphosphine and
trioctylphosphine oxide (PMN P–17–
242) 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),
(a)(6)(particulate (including solids or
liquid droplets)), (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), and (c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g) and (y)(1). It is
a significant new use to manufacture,
process, or use the substance other than
in a liquid formulation.
(iii) Disposal. It is a significant new
use to dispose of the substance and any
waste stream containing the substance
other than in a permitted hazardous
waste incinerator.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (j) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11141 Acid, reaction products with
cadmium zinc selenide sulfide,
trioctylphosphine and trioctylphosphine
oxide (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as acid, reaction products
with cadmium zinc selenide sulfide,
trioctylphosphine and
trioctylphosphine oxide (PMN P–17–
243) is subject to reporting under this
section for the significant new uses
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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),
(a)(6)(particulate (including solids or
liquid droplets)), (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), and (c).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(g) and (y)(1). It is
a significant new use to manufacture,
process, or use the substance other than
in a liquid formulation.
(iii) Disposal. It is a significant new
use to dispose of the substance and any
waste stream containing the substance
other than in a permitted hazardous
waste incinerator.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (j) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11142 Metal oxide reaction products
with cadmium metal selenide sulfide, and
amine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as metal oxide reaction
products with cadmium metal selenide
sulfide, and amine (PMN P–17–244) 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)(respirators must provide a National
Institute for Occupational Safety and
Health assigned protection factor (APF)
of at least 50), (a)(6) (particulate
(including solids or liquid droplets)),
(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
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operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), and
(c). It is a significant new use to handle
the solid form of the substance without
use of a fume hood or glove box.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (down
converting phosphor particle for use in
conjunction with optoelectronic
components), (q), and (y)(1) and (2).
(iii) Disposal. It is a significant new
use to dispose of the substance and any
waste stream containing the substance
other than in a permitted hazardous
waste incinerator.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (e), (i), and (j) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
us subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(ii) of this section.
§ 721.11143 Alkanoic acid, alkyl-,
substituted alkyl ester, polymer with alkyl
alkenoate, substituted carbomonocycle,
substituted alkyl alkenoate and alkyl
substituted alkenoate, substituted
alkanenitrile-initiated, polymers with
substituted alkanenitrile-initiated, alkanoic
acid-alkane substituted acrylatessubstituted carbomonocycle polymer,
compds. with alkylamino alkanol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkanoic acid, alkyl-,
substituted alkyl ester, polymer with
alkyl alkenoate, substituted
carbomonocycle, substituted alkyl
alkenoate and alkyl substituted
alkenoate, substituted alkanenitrileinitiated, polymers with substituted
alkanenitrile-initiated, alkanoic acidalkane substituted acrylates-substituted
carbomonocycle polymer, compds. with
alkylamino alkanol (PMN P–17–265) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted
(cured).
(2) The significant new uses are:
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55069
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture the chemical
substance with an acid concentration
greater than 20%. It is a significant new
use to manufacture the chemical
substance with an amine concentration
greater than 5%.
(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), (b), (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11144 Manganese bipyridine
carboxylate complex (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as manganese bipyridine
carboxylate complex (PMN P–17–301) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this Order do not apply
to quantities of the chemical substance
after they have been entrained in cured
coating or ink.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(3) through
(5)(respirators must provide a National
Institute for Occupational Safety and
Health (NIOSH) assigned protection
factor (APF) of at least 10),
(a)(6)(particulate (including solids or
liquid droplets)), (when determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
and (a)(4), engineering control measures
(e.g., enclosure or confinement of
operation, general and local ventilation)
or administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (ii), (iii), and (ix) (eye
irritation), (g)(2)(ii), (iii), and (iv), (avoid
skin and eye contact), (use skin and eye
protection), and (g)(5). Alternative
hazard and warning statements that
meet the criteria of the Globally
Harmonized System and OSHA Hazard
Communication Standard may be used.
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(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (surface drier in
clear and pigmented coatings systems)
and (p) (430,000 kilograms).
(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) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
khammond on DSKJM1Z7X2PROD with RULES
§ 721.11145
(generic).
Sulfuric acid mixed salt
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfuric acid mixed salt
(PMN P–17–318) 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), (a)(6)(v),
(particulate (including solids or liquid
droplets)), (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 operation,
general and local ventilation) or
administrative control measures (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (irritation to eye,
respiratory, and GI tract), (corrosion),
(acute toxicity), (g)(2)(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.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (q). It is a
significant new use to manufacture of
the chemical substance with more than
1.0% free ammonia content.
(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
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manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
§ 721.11146 2-Propenoic acid, alkyl-2(alkylalkyl)alkyl ester (generic).
§ 721.11147
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as 2-propenoic acid, alkyl-2(alkylalkyl)alkyl ester (PMN P–17–323)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (iii) and (iv),
(a)(3), (a)(6)(v), (particulate (including
solids or liquid droplets)), (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 operation, general and
local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(iv), (ix), (skin and eye
irritation), (oncogenicity),
(sensitization), (g)(2)(i), (iii) and (v), (use
eye protection), (g)(4)(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.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k)(reactive
monomer for use in producing
polymers), and (q).
(iv) Release to water. 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
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as allyloxymethylacrylate
(PMN P–17–326) is subject to reporting
under this section for the significant
new uses as described in paragraph
(a)(2) of this section. The requirements
of this section do not apply to quantities
of the substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (iii), and (iv),
(a)(3) through (5)(respirators must
provide a National Institute for
Occupational Safety and Health
assigned protection factor of at least 10),
(a)(6)(v), (particulate (including solids
or liquid droplets)), (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 measure (e.g.,
workplace policies and procedures)
shall be considered and implemented to
prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(i), (iv), (vi), and (ix),
(sensitization), (g)(2)(i) through (v),
(g)(3)(i) and (ii), (g)(4)(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.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(f), (k), and (q).
(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. Requirements as
specified in § 721.125(a) through (i) and
(k) are applicable to manufacturers and
processors of this substance.
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Allyloxymethylacrylate
15OCR1
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(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
khammond on DSKJM1Z7X2PROD with RULES
§ 721.11148 Polyurethane, methacrylate
blocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyurethane,
methacrylate blocked (PMN P–17–345)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance after
they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i) and (iii), (a)(3),
(a)(6)(v), (particulate (including solids
or liquid droplets)), (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 measure (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication.
Requirements as specified in § 721.72(a)
through (e) (concentration set at 1.0%),
(f), (g)(1)(irritation to skin, eyes, lungs,
and mucous membranes), (g)(2)(i), (ii),
(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 be used.
(iii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k). It is a
significant new use to manufacture the
chemical substance more than 6
months. It is a significant new use to
modify manufacture, processing, or use
if it results in inhalation exposure to
vapor, dust, mist, or aerosols to the
substance.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except ss modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (i) are applicable to
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manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(iii) of this section.
[FR Doc. 2019–22205 Filed 10–11–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 180831813–9170–02]
RIN 0648–XY047
Fisheries of the Exclusive Economic
Zone Off Alaska; Pacific Cod in the
Central Regulatory Area of the Gulf of
Alaska
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS is prohibiting retention
of Pacific cod by vessels using trawl
gear and not participating in the
cooperative fishery of the Rockfish
Program in the Central Regulatory Area
of the Gulf of Alaska (GOA). This action
is necessary because the 2019 total
allowable catch of Pacific cod allocated
to vessels using trawl gear and not
participating in the cooperative fishery
of the Rockfish Program in the Central
Regulatory Area of the GOA has been
reached.
SUMMARY:
Effective 1200 hours, Alaska
local time (A.l.t.), October 9, 2019,
through 2400 hours, A.l.t., December 31,
2019.
FOR FURTHER INFORMATION CONTACT: Josh
Keaton, 907–586–7228.
SUPPLEMENTARY INFORMATION: NMFS
manages the groundfish fishery in the
GOA exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Gulf of
Alaska (FMP) prepared by the North
Pacific Fishery Management Council
under authority of the MagnusonStevens Fishery Conservation and
Management Act. Regulations governing
fishing by U.S. vessels in accordance
with the FMP appear at subpart H of 50
CFR part 600 and 50 CFR part 679.
DATES:
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55071
The 2019 total allowable catch (TAC)
of Pacific cod allocated to vessels using
trawl gear and not participating in the
cooperative fishery of the Rockfish
Program in the Central Regulatory Area
of the GOA is 2,148 metric tons (mt) as
established by the final 2019 and 2020
harvest specifications for groundfish of
the GOA (84 FR 9416, March 14, 2019).
In accordance with § 679.20(d)(2), the
Administrator, Alaska Region, NMFS
(Regional Administrator), has
determined that the 2019 TAC of Pacific
cod allocated to vessels using trawl gear
and not participating in the cooperative
fishery of the Rockfish Program in the
Central Regulatory Area of the GOA will
be reached. Therefore, NMFS is
requiring that Pacific cod caught by
vessels using trawl gear and not
participating in the cooperative fishery
of the Rockfish Program in the Central
Regulatory Area of the GOA be treated
as prohibited species in accordance
with § 679.21(b). This closure does not
apply to fishing by vessels participating
in the cooperative fishery of the
Rockfish Program for the Central
Regulatory Area of the GOA.
Classification
This action responds to the best
available information recently obtained
from the fishery. The Assistant
Administrator for Fisheries, NOAA
(AA), finds good cause to waive the
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such requirement is
impracticable and contrary to the public
interest. This requirement is
impracticable and contrary to the public
interest as it would prevent NMFS from
responding to the most recent fisheries
data in a timely fashion and would
delay prohibiting the retention of Pacific
cod by vessels using trawl gear and not
participating in the cooperative fishery
of the Rockfish Program in the Central
Regulatory Area of the GOA. NMFS was
unable to publish a notice providing
time for public comment because the
most recent, relevant data only became
available as of October 7, 2019.
The AA also finds good cause to
waive the 30-day delay in the effective
date of this action under 5 U.S.C.
553(d)(3). This finding is based upon
the reasons provided above for waiver of
prior notice and opportunity for public
comment.
This action is required by § 679.20
and § 679.21 and is exempt from review
under Executive Order 12866.
Authority: 16 U.S.C. 1801 et seq.
E:\FR\FM\15OCR1.SGM
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Agencies
[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Rules and Regulations]
[Pages 55058-55071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22205]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2018-0567; FRL-10000-42]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (17-5)
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 29 chemical substances which
are the subject of 28 premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA pursuant to section 5(e)
of TSCA. This action requires persons who intend to manufacture
(defined by statute to include import) or process any of these 29
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. 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 December 16, 2019. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
October 29, 2019.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: Kenneth Moss, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-9232; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and Orders
under TSCA. Importers of chemicals subject to these SNURs must certify
compliance with the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this rule on or after November 14,
2019 are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. How can I access the docket?
The docket includes information considered by the Agency in
developing the proposed and final rules. The docket for this action,
identified by docket identification (ID) number EPA-HQ-OPPT-2018-0567,
is available at https://www.regulations.gov or 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. Please review the visitor
[[Page 55059]]
instructions and additional information about the docket available at
https://www.epa.gov/dockets.
II. Background
A. What action is the Agency taking?
EPA is finalizing these SNURs under TSCA section 5(a)(2) for 29
chemical substances which were the subject of 28 PMNs. These SNURs
require persons who intend to manufacture or process any of these
chemical substances for an activity that is designated as a significant
new use to notify EPA at least 90 days before commencing that activity.
In the Federal Register of September 17, 2018 (83 FR 47026) (FRL-
9983-59), EPA proposed a SNUR for these chemical substances in 40 CFR
part 721 subpart E. This comment period closed on October 17, 2018.
More information on the specific chemical substances subject to this
final rule can be found in the Federal Register documents for the
direct final SNUR of September 17, 2018 (83 FR 47004) (FRL-9983-14),
which is referenced in the proposed SNUR. The direct final rule was
withdrawn in the Federal Register of November 16, 2018 (83 FR 57689)
(FRL-9986-15).
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to 40 CFR 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). 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, EPA must either determine that the use is not likely to present
an unreasonable risk of injury under the conditions of use for the
chemical substance or take such regulatory action as is associated with
an alternative determination before the manufacture or processing for
the significant new use can commence. In the case of a determination
other than not likely to present unreasonable risk, the applicable
review period must also expire before manufacturing or processing for
the new use may commence. If EPA determines that the use is not likely
to present an unreasonable risk, EPA is required under TSCA section
5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
III. Significant New Use Determination
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 section 5(e)
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,
likely human exposures and environmental releases associated with
possible uses, and the four TSCA section 5(a)(2) factors listed in this
unit.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received public comments on the proposed rule from eight
identifying entities. The Agency's responses are in the Response to
Public Comments document in the public docket for this rule, EPA-HQ-
OPPT-2018-0567.
V. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for 29 chemical substances in 40 CFR part 721, subpart E.
In Unit IV. of the original direct final rule (83 FR 47004, September
17, 2018) (FRL-9983-14), EPA provides the following information for
each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the TSCA section 5(e) Order.
Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substance in support of a
request by the PMN submitter to modify the TSCA section 5(e) Order, or
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
this rule.
The regulatory text section of each rule specifies the activities
designated as significant new uses. Certain new uses, including
exceedance of production volume limits (i.e., limits on manufacture
volume) and other uses designated in this rule, may be claimed as CBI.
Unit IX. discusses a procedure companies may use to ascertain whether a
proposed use constitutes a significant new use.
These final rules include 29 chemical substances that are subject
to Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined
that activities associated with the PMN substances may present
unreasonable risk to human health or the environment. Those Orders
require protective measures to limit exposures or otherwise mitigate
the potential unreasonable risk. The SNURs identify as significant new
uses any manufacturing, processing, use, distribution in commerce, or
disposal that does not conform to the restrictions imposed by the
underlying Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via inhalation exposure,
the underlying TSCA section 5(e) Order usually requires 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 the New Chemical Exposure
[[Page 55060]]
Limit (NCEL). The comprehensive NCELs provisions in TSCA section 5(e)
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 section 5(e) 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, 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. The basis for such
findings is outlined in Unit IV. Based on these findings, TSCA section
5(e) Orders requiring the use of appropriate exposure controls were
negotiated with the PMN submitters. As a general matter, EPA believes
it is necessary to follow TSCA section 5(e) 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 identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the restrictions imposed by the underlying Orders,
consistent with TSCA section 5(f)(4).
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.
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
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/opptintr/existingchemicals/pubs/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 section 5(e) Orders have been issued
for all the chemical substances, and the PMN submitters are prohibited
by the TSCA section 5(e) Orders from undertaking activities which will
be designated as significant new uses. The identities of the 29
chemical substances subject to this rule have been claimed as
confidential. 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 September 17, 2018 (the date of public
release of the original direct final and proposed rules) as the cutoff
date for determining whether the new use is ongoing. The objective of
EPA's approach has been to ensure that a person could not defeat a SNUR
by initiating a significant new use before the effective date of the
final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of September 17, 2018, that person will have to cease any
such activity upon the effective date of the final rule. To resume
their activities, these persons will have to first comply with all
applicable SNUR notification requirements and wait until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required with that
determination.
VIII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, Order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, Order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known to or reasonably ascertainable (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing under 40 CFR part 721, subpart
E. In Unit IV. of the original direct final rule (83 FR 47004,
September 17, 2018) (FRL-9983-14), the EPA lists potentially useful
information that will be useful to EPA's evaluation. 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 on 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).
In some of the TSCA section 5(e) Orders for the chemical substances
regulated under this rule, EPA has established production volume
limits.
[[Page 55061]]
These limits cannot be exceeded unless the PMN submitter submits the
results of specified tests. The SNURs contain the same production
volume limits as the TSCA section 5(e) Orders. Exceeding these
production limits is defined as a significant new use. Persons who
intend to exceed the production limit must notify the Agency by
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture or processing.
Any request by EPA for the triggered and pended testing described
in the Orders was made based on EPA's consideration of available
screening-level data, if any, as well as other available information on
appropriate testing for the PMN substances. Further, any such testing
request on the part of EPA that includes testing on vertebrates was
made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.
The potentially useful information identified in Unit IV. of the
original direct final rule may not be the only means of addressing the
potential risks of the chemical substance. However, submitting a SNUN
without any test data or other information may increase the likelihood
that EPA will take action under TSCA section 5(e) 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 provide detailed information on the
following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in 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.
X. 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/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2018-0567.
XII. 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 and TSCA section 5(e) Orders. 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. 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 the PRA,
unless it has been approved by OMB and displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR part 9, and included on the related collection instrument or
form, if applicable. EPA is amending the table in 40 CFR part 9 to list
the OMB approval number for the information collection requirements
contained in this action. This listing of the OMB control numbers and
their subsequent codification in the CFR satisfies the display
requirements of PRA and OMB's implementing regulations at 5 CFR part
1320. This Information Collection Request (ICR) was previously subject
to public notice and comment prior to OMB approval, and given the
technical nature of the table, EPA finds that further notice and
comment to amend it is unnecessary. As a result, EPA finds that there
is ``good cause'' under section 553(b)(3)(B) of the Administrative
Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without
further notice and comment.
The information collection activities in this action have already
been approved by OMB pursuant to the PRA under OMB control number 2070-
0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
[[Page 55062]]
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 using
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (2822T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that promulgation of this SNUR will not have a
significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018
and only a fraction of these were from small businesses. In addition,
the Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this SNUR are not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published in the Federal Register of June 2,
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general
determination that final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: 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).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal 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.
G. 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.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not apply to
this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
XIII. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 4, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add entries for Sec. Sec. 721.11124 through 721.11148
in numerical order under the undesignated center heading ``Significant
New Uses of Chemical Substances'' to read as follows:
[[Page 55063]]
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.11124............................................... 2070-0012
721.11125............................................... 2070-0012
721.11126............................................... 2070-0012
721.11127............................................... 2070-0012
721.11128............................................... 2070-0012
721.11129............................................... 2070-0012
721.11130............................................... 2070-0012
721.11131............................................... 2070-0012
721.11132............................................... 2070-0012
721.11133............................................... 2070-0012
721.11134............................................... 2070-0012
721.11135............................................... 2070-0012
721.11136............................................... 2070-0012
721.11137............................................... 2070-0012
721.11138............................................... 2070-0012
721.11139............................................... 2070-0012
721.11140............................................... 2070-0012
721.11141............................................... 2070-0012
721.11142............................................... 2070-0012
721.11143............................................... 2070-0012
721.11144............................................... 2070-0012
721.11145............................................... 2070-0012
721.11146............................................... 2070-0012
721.11147............................................... 2070-0012
721.11148............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. Sec. 721.11124 through 721.11148 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11124 2-Propenenitrile, polymer with methanamine, hydrogenated,
3-aminopropylterminated, ethoxylated propoxylated.
721.11125 Dicarboxylic acids, polymers with alkyl prop-2-enoate,
alkyl 2-ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol,
alkanediol, alkanedioic acid, alkyl 2-methylprop-2-enoate, alkyl
prop-2-enoic acid, alkylene [isocyanatocarbomonocycle] and
alkanediol, alkanolamine-blocked, compds. with 2-(alkylamino)alkanol
(generic).
721.11126 Mixed metal oxide (generic).
721.11127 Modified alkyl polyamine (generic).
721.11128 Alkyl polyamine (generic).
721.11129 Silica gel, reaction products with chromium oxide (CrO3)
and ethoxydiethyl aluminum.
721.11130 Carboxylic acids, C6-18 and C5-15-di-, polymers with
diethylene glycol, glycerol, sorbitol and terephthalic acid.
721.11131 1-Tetradecene, homopolymer, hydrogenated.
721.11132 Fluorocyanophenyl alkylbenzoate (generic).
721.11133 Fluorinated acrylic copolymer (generic).
721.11134 Oxyalkylene urethane polyolefin (generic).
721.11135 Imino alkane amine phosphate (generic).
721.11136 Fatty acids, tall-oil, reaction products with 2-[(2-
aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-
tolyl ether polymer dihydrogen phosphate alkyl ether (generic).
721.11137 Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-
(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester
with 2,2',2''-nitrilotris-[alkanol] (generic).
721.11138 Formaldehyde, polymer with (chloromethyl)oxirane and
substituted aromatic compounds (generic).
721.11139 Acid, reaction products with cadmium selenide (CdSe),
trioctylphosphine and trioctylphosphine oxide (generic).
721.11140 Acid, reaction products with cadmium selenide sulfide,
acid, trioctylphosphine and trioctylphosphine oxide (generic).
721.11141 Acid, reaction products with cadmium zinc selenide
sulfide, trioctylphosphine and trioctylphosphine oxide (generic).
721.11142 Metal oxide reaction products with cadmium metal selenide
sulfide, and amine (generic).
721.11143 Alkanoic acid, alkyl-, substituted alkyl ester, polymer
with alkyl alkenoate, substituted carbomonocycle, substituted alkyl
alkenoate and alkyl substituted alkenoate, substituted
alkanenitrile-initiated, polymers with substituted alkanenitrile-
initiated, alkanoic acid-alkane substituted acrylates-substituted
carbomonocycle polymer, compds. with alkylamino alkanol (generic).
721.11144 Manganese bipyridine carboxylate complex (generic).
721.11145 Sulfuric acid mixed salt (generic).
721.11146 2-Propenoic acid, alkyl-2-(alkylalkyl)alkyl ester
(generic).
721.11147 Allyloxymethylacrylate (generic).
721.11148 Polyurethane, methacrylate blocked (generic).
* * * * *
Sec. 721.11124 2-Propenenitrile, polymer with methanamine,
hydrogenated, 3-aminopropylterminated, ethoxylated propoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenenitrile,
polymer with methanamine, hydrogenated, 3-aminopropylterminated,
ethoxylated propoxylated (PMN P-14-758; CAS No. 2055838-16-7) 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 chemical substance after they
have been completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3) through (5)(respirators must provide a
National Institute for Occupational Safety and Health assigned
protection factor of at least 50), (a)(6)(v) (particulate (including
solids or liquid droplets)), (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
operation, general and local ventilation) or administrative control
measures (e.g. workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f),
(g)(1)(ii), (g)(2)(ii), (g)(4)(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.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). A significant new use is any
spray application method that results in greater worker inhalation
exposures to vapor, mist, or aerosol than the roller coating
application.
(iv) Release to water. Requirements as specified in Sec.
721.90(b)(1) and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 55064]]
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. 721.11125 Dicarboxylic acids, polymers with alkyl prop-2-enoate,
alkyl 2-ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol,
alkanediol, alkanedioic acid, alkyl 2-methylprop-2-enoate, alkyl prop-
2-enoic acid, alkylene [isocyanatocarbomonocycle] and alkanediol,
alkanolamine-blocked, compds. with 2-(alkylamino)alkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dicarboxylic acids, polymers with alkyl prop-2-enoate, alkyl 2-
ethylprop-2-enoate, alkyl[(alkenyl)alkyl]alkanediol, alkanediol,
alkanedioic acid, alkyl 2-methylprop-2-enoate, alkyl prop-2-enoic acid,
alkylene [isocyanatocarbomonocycle] and alkanediol, alkanolamine-
blocked, compds. with 2-(alkylamino)alkanol (PMN P-16-493) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section. The requirements of this section
do not apply to quantities of the substance after they have been
reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f). It is a significant new use to import
the chemical substance to contain more than 0.1% residual isocyanate by
weight. It is a significant new use to import the chemical substance to
contain more than 1% of a confidential component 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 Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11126 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a mixed
metal oxide (PMN P-16-514) 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)(respirators must provide a National
Institute for Occupational Safety and Health assigned protection factor
of at least 1,000), (a)(6)(particulate (including solids or liquid
droplets)), (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 operation, general and local
ventilation) or administrative control measures (e.g. workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible), (b) (concentration set at 1.0%), and (c).
(A) As an alternative to the respirator requirements in paragraph
(a)(2)(i) of this section, a manufacturer or processor may choose to
follow the new chemical exposure limit (NCEL) provision listed in the
TSCA section 5(e) Order for this substance. The NCEL is 0.04 mg/m\3\ as
an 8-hour time weighted average. Persons who wish to pursue NCELs as an
alternative to Sec. 721.63 respirator requirements may request to do
so under Sec. 721.30. Persons whose Sec. 721.30 requests to use the
NCELs approach are approved by EPA will be required to follow NCELs
provisions comparable to those contained in the corresponding TSCA
section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(iv),
(lung toxicity if inhaled), (eye irritation), (allergic skin reaction),
(g)(2)(i) through (iii) and (v)(use respiratory protection or maintain
workplace airborne concentrations at or below an 8-hour time-weighted
average of 0.04 mg/m\3\), (g)(4)(i), and (g)(5). Alternative hazard and
warning statements that meet the criteria of the Globally Harmonized
System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(e), (f), (k), and (q).
(iv) Disposal. It is a significant new use to dispose of the
chemical substance other than by recycling as described in the Order.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (j) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
and (iv) of this section.
Sec. 721.11127 Modified alkyl polyamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified alkyl polyamine (PMN P-16-576) 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), (a)(6)(particulate
(including solids or liquid droplets)), (vapor), (when determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (vi), and (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and
(ii), and (g)(5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the chemical substance more than 9 months.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i), are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 55065]]
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. 721.11128 Alkyl polyamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
polyamine (PMN P-16-577) 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), (a)(3), (a)(6)(v) (particulate (including
solids or liquid droplets)), (when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (vi), and (viii), (g)(2)(i) through (iii) and (v), (g)(3)(i) and
(ii), and (g)(5). Alternative hazard and warning statements that meet
the criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k). It is a significant new use to
manufacture the chemical substance more than nine months.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11129 Silica gel, reaction products with chromium oxide
(CrO3) and ethoxydiethyl aluminum.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silica gel,
reaction products with chromium oxide (CrO3) and ethoxydiethyl aluminum
is (PMN P-16-590, CAS No. 932384-12-8) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (a)(3) through (5)(respirators must provide a National
Institute for Occupational Safety and Health assigned protection factor
of 10 to 1,000 depending on the results of the exposure monitoring as
described in the Order for P16-590 and required by this section
(a)(2)(i), (a)(6)(particulate (including solids or liquid droplets)),
(a)(6)(vapor), (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 operation, general
and local ventilation) or administrative control measures (e.g.
workplace policies and procedures) shall be considered and implemented
to prevent exposure, where feasible), (b) (concentration set at 0.1%),
and (c). It is a significant new use to not conduct the exposure
monitoring required in the Order for P-16-590 when workers are
reasonably likely to be exposed by inhalation.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. It is a significant new use to
manufacture, process, or use the chemical substance other than in a
system where the chemical substance is handled in an inert atmosphere
and is not designed to be exposed to air.
(iii) Disposal. It is a significant new use to dispose of all waste
streams containing the PMN substance and the constituent breakdown
products of the PMN substance other than in a Resource Conservation and
Recovery Act (RCRA) hazardous waste landfill.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (j) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11130 Carboxylic acids, C6-18 and C5-15-di-, polymers with
diethylene glycol, glycerol, sorbitol and terephthalic acid.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carboxylic acids,
C6-18 and C5-15-di-, polymers with diethylene glycol, glycerol,
sorbitol and terephthalic acid (PMN P-16-593, CAS No. 1967778-37-5) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3) (when determining which
persons are reasonably likely to be exposed as required for Sec.
721.63(a)(1), engineering control measures (e.g. enclosure or
confinement of operation, general and local ventilation) or
administrative control measures (e.g. workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii),
(irritation), (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 be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (aromatic polyester polyol for rigid
foam). It is a significant new use to manufacture, process, or use the
chemical substance to result in inhalation exposure to a vapor, mist or
aerosol.
(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 this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11131 1-Tetradecene, homopolymer, hydrogenated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-tetradecene,
homopolymer,
[[Page 55066]]
hydrogenated (PMN P-17-5, CAS No. 1857296-89-9) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii),
(g)(2)(ii), 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.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (base fluid/carrier fluid for additives
in motor oil, automatic transmission fluid, and industrial lubricants).
It is a significant new use to manufacture the chemical substance more
than 9 months. It is a significant new use to manufacture, process, or
use the chemical substance to results in inhalation exposure to a
vapor, mist or aerosol.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (f) through (i) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11132 Fluorocyanophenyl alkylbenzoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
fluorocyanophenyl alkylbenzoate (PMNs P-17-149, P-17-150, P-17-151, and
P-17-165) 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), (iii) and (iv), (a)(3), (a)(6)(v),
(particulate (including solids or liquid droplets)), (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 operation, general and local ventilation) or
administrative control measures (e.g. workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (iii), (iv), (vi) and (ix), (g)(2)(i), (ii), (iii) and (v),
(g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning
statements that meet the criteria of the Globally Harmonized System and
OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture, process, or use the chemical substance to result in
inhalation exposures to vapor, dust, mist, or aerosols to the
substance.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), (c)(4) where N = 2 for P-17-165 and N = 4 for P-
17-149, P-17-150, and P-17-151.
(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 these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11133 Fluorinated acrylic copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorinated acrylic copolymer (PMN P-17-175) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (t) (60 kilograms). It is a
significant new use to use the substance other than as a leveling agent
for coatings applied to aluminum printing plates.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
Sec. 721.11134 Oxyalkylene urethane polyolefin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxyalkylene urethane polyolefin (PMN P-17-199) 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 chemical substance with an
average molecular weight greater than specified in the Order or with
more than 1.0% of the molecular weight content below 1,000 Daltons.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11135 Imino alkane amine phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as imino
alkane amine phosphate (PMN P-17-206, chemical A and P-17-206, chemical
B) are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the substances after they
have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (a)(6)(v) (particulate
(including solids or liquid droplets)), (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
[[Page 55067]]
of operation, general and local ventilation) or administrative control
measures (e.g. workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(g)(2)(i) and (v), (g)(3)(i) and (ii), (g)(4)(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.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (k). It is a significant new use to
modify processing or use if it results in inhalation exposure to vapor,
dust, mist, or aerosols to the substances.
(iv) Disposal. Requirements as specified in Sec. 721.85(a)(1),
(b)(1), and (c)(1).
(v) 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 (k) are applicable to manufacturers and processors
of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11136 Fatty acids, tall-oil, reaction products with 2-[(2-
aminoalkyl)amino]alkanol, compds. with alkylene oxide-glycidyl o-tolyl
ether polymer dihydrogen phosphate alkyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, tall-oil, reaction products with 2-[(2-aminoalkyl)amino]alkanol,
compds. with alkylene oxide-glycidyl o-tolyl ether polymer dihydrogen
phosphate alkyl ether (PMN P-17-223) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(6)(v), (particulate (including
solids or liquid droplets)), (when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and,
engineering control measures (e.g. enclosure or confinement of
operation, general and local ventilation) or administrative control
measures (e.g. workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and
(ii), (g)(2)(i), (ii) and (v), (g)(3)(i) and (ii), and (g)(5),
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (q). It is a significant new
use to modify any processing if such modification would result in
inhalation exposures to the chemical substance by vapor, dust, mist, or
aerosol, at a concentration of greater than 1.0% by weight or volume.
It is a significant new use to use the chemical substance in the
confidential formulation identified in the Order at concentration
greater than 1.0% by weight or volume. It is a significant new use to
manufacture, process, or use the substance for consumer use or for
commercial uses that could introduce the substance into a consumer
setting.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), (c)(4) where N = 15.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11137 Oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-
(carboxyamino)-4(or 6)-alkylphenyl]carbamate], alkyl ether, ester with
2,2',2''-nitrilotris-[alkanol] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxirane, 2-alkyl-, polymer with oxirane, mono[N-[3-(carboxyamino)-4(or
6)-alkylphenyl]carbamate], alkyl ether, ester with 2,2',2''-
nitrilotris-[alkanol] (PMN P-17-230) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (a)(6)(v) (particulate
(including solids or liquid droplets)), (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
operation, general and local ventilation) or administrative control
measures (e.g. workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (eye irritation), (g)(2)(i), (ii), and (v), (g)(3)(i) and (ii),
and (g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (q). It is a significant new
use to modify processing methods if such modification would result in
inhalation exposures to the chemical substance by vapor, dust, mist, or
aerosol, at a concentration of greater than 1.0% by weight or volume.
It is a significant new use to use the chemical substance in the
confidential formulation at a concentration greater than 1.0% by weight
or volume. It is a significant new use to manufacture, process, or use
the substance for consumer use or for commercial uses that could
introduce the substance into a consumer setting.
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 65.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are
[[Page 55068]]
applicable to manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11138 Formaldehyde, polymer with (chloromethyl)oxirane and
substituted aromatic compounds (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with (chloromethyl)oxirane and substituted
aromatic compounds (PMN P-17-236) 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 the
chemical substance after it has been incorporated into the confidential
forms identified in the Order.
(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), (a)(6) (particulate
(including solids or liquid droplets)), (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
operation, general and local ventilation) or administrative control
measures (e.g. workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii),
(vi), (vii), and (ix), (skin sensitization), (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 be used.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (q). It is a significant new
use to modify manufacture, processing, or use if it results in
inhalation exposure to vapor, dust, mist, or aerosols to the substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraphs (a)(1) and
(a)(2)(iii) of this section.
Sec. 721.11139 Acid, reaction products with cadmium selenide (CdSe),
trioctylphosphine and trioctylphosphine oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acid,
reaction products with cadmium selenide (CdSe), trioctylphosphine and
trioctylphosphine oxide (PMN P-17-241) 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 (a)(3), (a)(6)(particulate (including
solids or liquid droplets)), (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), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (y)(1). It is a significant new use
to manufacture, process, or use the substance other than in a liquid
formulation.
(iii) Disposal. It is a significant new use to dispose of the
substance and any waste stream containing the substance other than in a
permitted hazardous waste incinerator.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (j) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11140 Acid, reaction products with cadmium selenide sulfide,
acid, trioctylphosphine and trioctylphosphine oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acid,
reaction products with cadmium selenide sulfide, acid,
trioctylphosphine and trioctylphosphine oxide (PMN P-17-242) 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), (a)(6)(particulate (including solids
or liquid droplets)), (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), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (y)(1). It is a significant new use
to manufacture, process, or use the substance other than in a liquid
formulation.
(iii) Disposal. It is a significant new use to dispose of the
substance and any waste stream containing the substance other than in a
permitted hazardous waste incinerator.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (j) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11141 Acid, reaction products with cadmium zinc selenide
sulfide, trioctylphosphine and trioctylphosphine oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acid,
reaction products with cadmium zinc selenide sulfide, trioctylphosphine
and trioctylphosphine oxide (PMN P-17-243) is subject to reporting
under this section for the significant new uses
[[Page 55069]]
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), (a)(6)(particulate (including solids
or liquid droplets)), (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), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g) and (y)(1). It is a significant new use
to manufacture, process, or use the substance other than in a liquid
formulation.
(iii) Disposal. It is a significant new use to dispose of the
substance and any waste stream containing the substance other than in a
permitted hazardous waste incinerator.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (j) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11142 Metal oxide reaction products with cadmium metal
selenide sulfide, and amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal
oxide reaction products with cadmium metal selenide sulfide, and amine
(PMN P-17-244) 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)(respirators must provide a
National Institute for Occupational Safety and Health assigned
protection factor (APF) of at least 50), (a)(6) (particulate (including
solids or liquid droplets)), (when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), and (c). It is a
significant new use to handle the solid form of the substance without
use of a fume hood or glove box.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (down converting phosphor particle for
use in conjunction with optoelectronic components), (q), and (y)(1) and
(2).
(iii) Disposal. It is a significant new use to dispose of the
substance and any waste stream containing the substance other than in a
permitted hazardous waste incinerator.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (e), (i), and (j) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use us subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11143 Alkanoic acid, alkyl-, substituted alkyl ester,
polymer with alkyl alkenoate, substituted carbomonocycle, substituted
alkyl alkenoate and alkyl substituted alkenoate, substituted
alkanenitrile-initiated, polymers with substituted alkanenitrile-
initiated, alkanoic acid-alkane substituted acrylates-substituted
carbomonocycle polymer, compds. with alkylamino alkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanoic acid, alkyl-, substituted alkyl ester, polymer with alkyl
alkenoate, substituted carbomonocycle, substituted alkyl alkenoate and
alkyl substituted alkenoate, substituted alkanenitrile-initiated,
polymers with substituted alkanenitrile-initiated, alkanoic acid-alkane
substituted acrylates-substituted carbomonocycle polymer, compds. with
alkylamino alkanol (PMN P-17-265) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to
quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the chemical substance with an acid
concentration greater than 20%. It is a significant new use to
manufacture the chemical substance with an amine concentration greater
than 5%.
(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), (b), (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11144 Manganese bipyridine carboxylate complex (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
manganese bipyridine carboxylate complex (PMN P-17-301) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this Order do not
apply to quantities of the chemical substance after they have been
entrained in cured coating or ink.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3) through (5)(respirators must provide a National
Institute for Occupational Safety and Health (NIOSH) assigned
protection factor (APF) of at least 10), (a)(6)(particulate (including
solids or liquid droplets)), (when determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(a)(4), engineering control measures (e.g., enclosure or confinement of
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(ii), (iii), and (ix) (eye irritation), (g)(2)(ii), (iii), and (iv),
(avoid skin and eye contact), (use skin and eye protection), and
(g)(5). Alternative hazard and warning statements that meet the
criteria of the Globally Harmonized System and OSHA Hazard
Communication Standard may be used.
[[Page 55070]]
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (surface drier in clear and pigmented
coatings systems) and (p) (430,000 kilograms).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11145 Sulfuric acid mixed salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfuric acid mixed salt (PMN P-17-318) 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), (a)(6)(v), (particulate (including
solids or liquid droplets)), (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
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(irritation to eye, respiratory, and GI tract), (corrosion), (acute
toxicity), (g)(2)(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.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (q). It is a significant new use to
manufacture of the chemical substance with more than 1.0% free ammonia
content.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11146 2-Propenoic acid, alkyl-2-(alkylalkyl)alkyl ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, alkyl-2-(alkylalkyl)alkyl ester (PMN P-17-323) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply to quantities of the substance after they have
been reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii) and (iv), (a)(3), (a)(6)(v),
(particulate (including solids or liquid droplets)), (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 operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv),
(ix), (skin and eye irritation), (oncogenicity), (sensitization),
(g)(2)(i), (iii) and (v), (use eye protection), (g)(4)(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.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k)(reactive monomer for use in
producing polymers), and (q).
(iv) Release to water. Release to water requirements as specified
in Sec. 721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11147 Allyloxymethylacrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
allyloxymethylacrylate (PMN P-17-326) is subject to reporting under
this section for the significant new uses as described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance after they have been completely reacted
(cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3) through
(5)(respirators must provide a National Institute for Occupational
Safety and Health assigned protection factor of at least 10),
(a)(6)(v), (particulate (including solids or liquid droplets)), (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 measure (e.g., workplace
policies and procedures) shall be considered and implemented to prevent
exposure, where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i),
(iv), (vi), and (ix), (sensitization), (g)(2)(i) through (v), (g)(3)(i)
and (ii), (g)(4)(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.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (k), and (q).
(iv) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Requirements as specified in Sec. 721.125(a)
through (i) and (k) are applicable to manufacturers and processors of
this substance.
[[Page 55071]]
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
Sec. 721.11148 Polyurethane, methacrylate blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyurethane, methacrylate blocked (PMN P-17-345) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply to quantities of the substance after they have been
completely reacted (cured).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (a)(6)(v), (particulate
(including solids or liquid droplets)), (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
measure (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible), (b)
(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in Sec.
721.72(a) through (e) (concentration set at 1.0%), (f),
(g)(1)(irritation to skin, eyes, lungs, and mucous membranes),
(g)(2)(i), (ii), (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 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 chemical substance more than 6 months. It is a
significant new use to modify manufacture, processing, or use if it
results in inhalation exposure to vapor, dust, mist, or aerosols to the
substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except ss modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(iii)
of this section.
[FR Doc. 2019-22205 Filed 10-11-19; 8:45 am]
BILLING CODE 6560-50-P