Proposed Rule2022-26252
Significant New Use Rules on Certain Chemical Substances (22-1.5e)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 2, 2022
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to Orders issued by EPA pursuant to TSCA. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required in association with that determination.
Full Text
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<title>Federal Register, Volume 87 Issue 231 (Friday, December 2, 2022)</title>
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[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Proposed Rules]
[Pages 74072-74096]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26252]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2021-0847; FRL-9972-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (22-
1.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances that were
the subject of premanufacture notices (PMNs) and are also subject to
Orders issued by EPA pursuant to TSCA. The SNURs would require persons
who intend to manufacture (defined by statute to include import) or
process any of these chemical substances for an activity that is
proposed as a significant new use by this rule to notify EPA at least
90 days before commencing that activity. The required notification
initiates EPA's evaluation of the use,
[[Page 74073]]
under the conditions of use for that chemical substance, within the
applicable review period. Persons may not commence manufacture or
processing for the significant new use until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and has
taken such actions as are required in association with that
determination.
DATES: Comments must be received on or before January 3, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0847, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting and visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
William Wysong, New Chemicals Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-4163; email address: <a href="/cdn-cgi/l/email-protection#314648425e5f561f46585d5d58505c715441501f565e47"><span class="__cf_email__" data-cfemail="1e69676d7170793069777272777f735e7b6e7f30797168">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#5501061614781d3a21393c3b30153025347b323a23"><span class="__cf_email__" data-cfemail="c296918183ef8aadb6aeabaca782a7b2a3eca5adb4">[email protected]</span></a>.
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 any of the chemical substances contained in this
proposed rule. The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and Orders under
TSCA, which would include the SNUR requirements should these proposed
rules be finalized. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR
721.20, any persons who export or intend to export a chemical substance
that is the subject of this proposed rule on or after January 3, 2023
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) for certain chemical substances that were the subject of
PMNs. These proposed SNURs would require persons to notify EPA at least
90 days before commencing the manufacture or processing of any of these
chemical substances for an activity proposed as a significant new use.
Receipt of such notices would allow EPA to assess risks and, if
appropriate, to regulate the significant new use before it may occur.
The docket for these proposed SNURs, identified as docket ID number
EPA-HQ-OPPT-2021-0847, includes information considered by the Agency in
developing these proposed SNURs.
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. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same significant new use notice (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 and before the manufacture or processing
for the significant new use can commence, 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.
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.
For each proposed SNUR containing significant new uses not based on
the Order requirements as described in Unit III., EPA is proposing that
the general reporting exemption described in 40 CFR 721.45(i) not
apply. 40 CFR 721.45(i) provides that the notification requirements of
40 CFR 721.25 do not apply, unless otherwise specified in a specific
SNUR, if: ``The person is operating under the terms of a consent order
issued under section 5(e) of the Act applicable to that person. If a
provision of such section 5(e) order is inconsistent with a specific
significant new use identified in subpart E of this part, abiding by
the provision of the
[[Page 74074]]
section 5(e) order exempts the person from submitting a significant new
use notice for that specific significant new use.'' EPA is proposing to
make that exemption inapplicable to each SNUR in this proposed rule
with significant new uses not based on Order requirements to ensure
that persons subject to the Order would also be subject to the
significant new use notification requirements in this proposed rule
that are not based on Order requirements.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with possible uses of these chemical substances, in the
context of the four TSCA section 5(a)(2) factors listed in this unit.
The proposed rules include PMN substances that are subject to
Orders issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I),
and in some cases also under TSCA section 5(e)(1)(A)(ii)(II). The TSCA
Orders require protective measures to limit exposures or otherwise
mitigate the potential unreasonable risk. The proposed SNURs identify
significant new uses as any manufacturing, processing, use,
distribution in commerce, or disposal that does not conform to the
restrictions imposed by the underlying TSCA Orders, consistent with
TSCA section 5(f)(4). The proposed rules also include other significant
new uses EPA proposes to determine are not ongoing based on information
showing that the chemical is either not on the TSCA Inventory or had
limited Chemical Data Reporting (CDR) under TSCA section 8(a).
IV. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are the subject of these proposed 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 V. 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 the TSCA Orders with a SNUR that
identifies the absence of those protective measures as significant new
uses to ensure that all manufacturers and processors--not just the
original submitter--are held to the same standard.
EPA did not previously issue SNURs following these Orders. EPA is
now proposing these SNURs to require notice to EPA by any other person
who wishes to manufacture or process the chemical substance in a way
that does not conform to the protective measures contained in the
Order.
The proposed SNURs also include significant new uses EPA proposes
to determine are not ongoing based either on information showing that
the chemical is not on the TSCA Inventory or based on EPA's review of
CDR reporting submissions under TSCA section 8(a). EPA believes that
these uses could significantly increase the magnitude and duration of
exposure to humans and the environment to these chemical substances.
Accordingly, EPA wants the opportunity to evaluate and manage risks,
where appropriate, from activities associated with those uses, before
manufacturing or processing for those uses were to begin.
If a notice of commencement had not been received for the chemical
and it is not on the TSCA Inventory, the proposed SNUR includes a
significant new use for uses other than as described in the PMN, and
annual production volume greater than 2500 pounds. If the chemical is
on the TSCA Inventory, EPA conducted a search of CDR reporting for the
chemical in the 2020 reporting cycle. If there was no CDR reporting for
the chemical in the 2020 reporting cycle, the proposed SNUR includes
significant new uses for use other than as described in the PMN and
annual production volume greater than the threshold for CDR reporting
for chemicals subject to a TSCA section 5(e) order which is 2500
pounds. If there is CDR reporting for the chemical from the 2020
reporting cycle, the proposed SNUR includes significant new uses for
use other than reported in CDR.
This proposed rule advances one of the ``key actions'' in the PFAS
Strategic Roadmap where EPA stated it plans to revisit past PFAS
regulatory decisions and address those that are insufficiently
protective by imposing additional notification requirements. In this
way, the Agency can ensure it has the opportunity to review PFAS before
they are used in new ways that might present concerns. To view the PFAS
Strategic Roadmap and learn more about EPA actions to address PFAS,
please visit <a href="https://www.epa.gov/pfas/epa-actions-address-pfas">https://www.epa.gov/pfas/epa-actions-address-pfas</a> and
<a href="https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf">https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf</a>.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants:
<bullet> 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 TSCA Orders,
consistent with TSCA section 5(f)(4).
<bullet> To identify as significant new uses, other specific uses
and production volumes that are not ongoing uses and that could result
in changes to the type, form, magnitude, or duration of exposure of
human beings or the environment to these chemical substances.
<bullet> 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.
<bullet> 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.
V. Substances Subject to this Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for certain chemical substances in 40 CFR part 721, subpart E. In this
unit, EPA provides the following information for each chemical
substance that is
[[Page 74075]]
identified in this unit as subject to this proposed rule:
<bullet> PMN number (the proposed CFR citation assigned in the
regulatory text section of the proposed rule).
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities) or Accession number
(if assigned for confidential chemical identities).
<bullet> Effective date of and basis for the TSCA section 5(e)
Order.
<bullet> Potentially Useful Information.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-00-1085 (40 CFR 721.11716).
Chemical Name: Fluoroacrylate copolymer (generic).
CAS or Accession Number: Accession No. 249720.
Effective Date of TSCA Order: February 6, 2001.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a surfactant. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. Based on
comparison to analogous chemical substances, EPA predicted toxicity to
aquatic organisms may occur at acute concentrations that exceed 100
ppb. The Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA section 5(e)(1)(A)(ii)(II), based on a
finding that the substance is or will be produced in substantial
quantities and that the substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substance. To protect against these risks, the Order required:
<bullet> No manufacture of the PMN substance beyond 29 months
without submittal to EPA of the results of certain testing described in
the Testing section of the Order; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of the hazard communication requirements. Additionally, the
proposed SNUR would designate the following as significant new uses:
<bullet> Use other than as a surfactant in paint and coatings
manufacturing.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, acute and chronic human health toxicity, acute and
chronic ecotoxicity, and environmental fate testing may be potentially
useful to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
Manufacturers or processors considering submitting a SNUN and/or
developing this information should also know that the PMN submitter
agreed not to exceed the time limit specified in the Order without
performing the required testing outlined in the Testing section of the
Order.
PMN Number: P-01-584 (40 CFR 721.11717).
Chemical Name: Perfluoroalkylsulfonamidoalkyl acrylate, polymer
with acrylic acid derivatives (generic).
CAS or Accession Number: Accession No. 254456.
Effective Date of TSCA Order: October 3, 2001.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a surfactant. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. Based on
comparison to analogous chemical substances, EPA predicted toxicity to
aquatic organisms may occur at acute concentrations that exceed 100
ppb. The Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA section 5(e)(1)(A)(ii)(II), based on a
finding that the substance is or will be produced in substantial
quantities and that the substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substance. To protect against these risks, the Order required:
<bullet> No manufacture of the PMN substance beyond 29 months
without submittal to EPA of the results of certain testing described in
the Testing section of the Order; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of the hazard communication requirement. Additionally, the
proposed SNUR would designate the following as significant new uses:
<bullet> Use other than as a surfactant in adhesive and synthetic
rubber manufacturing.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, acute and chronic human health toxicity, acute and
chronic ecotoxicity, and environmental fate testing performed on a
confidential analog of the PMN substance may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
Manufacturers or processors considering submitting a SNUN and/or
developing this information should also know that the PMN submitter
agreed not to exceed the time limit specified in the Order without
performing the required testing outlined in the Testing section of the
Order.
PMN Number: P-02-16 (40 CFR 721.11718).
Chemical Name: Urethane polymer modified with
perfluoroalkylsulfonamide (generic).
CAS or Accession Number: Accession No. 252290.
Effective Date of TSCA Order: January 30, 2002.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a protective coating. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these
[[Page 74076]]
degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. The Order was also issued under TSCA section
5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be
produced in substantial quantities and that the substance either enters
or may reasonably be anticipated to enter the environment in
substantial quantities, or there is or may be significant (or
substantial) human exposure to the substance. To protect against these
risks, the Order required the establishment of certain hazard
communication requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as a finishing agent in textiles, apparel,
and leather manufacturing.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, acute and chronic human health toxicity, acute and
chronic ecotoxicity, and environmental fate testing performed on
confidential analog of the PMN substance may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-02-195 (40 CFR 721.11719).
Chemical Name: Urethane polymer modified with
perfluoroalkylsulfonamide and polyethoxylate (generic).
CAS or Accession Number: Accession No. 271739.
Effective Date of TSCA Order: May 2, 2002.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a protective treatment. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. The Order was
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based
on a finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. The Order was also issued
under TSCA section 5(e)(1)(A)(ii)(II), based on a finding that the
substance is or will be produced in substantial quantities and that the
substance either enters or may reasonably be anticipated to enter the
environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the Order required:
<bullet> Submit to EPA the results of certain testing described in
the Testing section of the Order at least 14 weeks before manufacturing
or importing the confidential volume listed in the Order; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of the hazard communication protective measure. Additionally,
the proposed SNUR would designate the following as significant new
uses:
<bullet> Use other than as a finishing agent in textiles, apparel,
and leather manufacturing.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, acute and chronic human health toxicity, acute and
chronic ecotoxicity, and environmental fate testing performed on the
confidential analog of the PMN substance may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
Manufacturers or processors considering submitting a SNUN and/or
developing this information should also know that the PMN submitter
agreed not to exceed the time limit specified in the Order without
performing the required testing outlined in the Testing section of the
Order.
PMN Number: P-02-609 (40 CFR 721.11720).
Chemical Name: Urethane polymer modified with
perfluoroalkylsulfonamide (generic).
CAS or Accession Number: Accession No. 279755.
Effective Date of TSCA Order: July 22, 2002.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a protective coating. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. The Order was
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based
on a finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. The Order was also issued
under TSCA section 5(e)(1)(A)(ii)(II), based on a finding that the
substance is or will be produced in substantial quantities and that the
substance either enters or may reasonably be anticipated to enter the
environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the Order required the establishment of
certain hazard communication requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as an anti-stain agent.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, acute and chronic human health toxicity, acute and
chronic ecotoxicity, and environmental fate testing performed on
confidential analog of the PMN substance may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the
[[Page 74077]]
Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-02-700 (40 CFR 721.11721).
Chemical Name: Copolymer of perfluoroalkylsulfonamidoalkyl acrylate
and alkyl acrylate modified fatty acid dimers (generic).
CAS or Accession Number: Accession No. 259360.
Effective Date of TSCA Order: August 28, 2002.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a protective coating. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. The Order was
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based
on a finding that in the absence of sufficient information to permit a
reasoned evaluation, the substance may present an unreasonable risk of
injury to human health or the environment. The Order was also issued
under TSCA section 5(e)(1)(A)(ii)(II), based on a finding that the
substance is or will be produced in substantial quantities and that the
substance either enters or may reasonably be anticipated to enter the
environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substance. To
protect against these risks, the Order required the establishment of
certain hazard communication requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as a finishing agent in textiles, apparel,
and leather manufacturing.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, acute and chronic human health toxicity, acute and
chronic ecotoxicity, and environmental fate testing performed on
confidential analog of the PMN substance may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-02-891 (40 CFR 721.11722).
Chemical Name: Phosphonium, triphenyl(phenylmethyl)-, salt with
1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1).
CAS or Accession Number: CAS No. 332350-93-3.
Effective Date of TSCA Order: July 15, 2003.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a cure catalyst. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. Based on 8(e)
test data on analogous chemical substances, EPA had identified concerns
for possible acute lethality. Based on comparison to analogous chemical
substances, EPA predicted toxicity to aquatic organisms may occur at
concentrations that exceed 2 ppb. The Order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order requires:
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 1 ppb;
<bullet> Use of the PMN substance only for the confidential use as
stated in the PMN; and
<bullet> Establishment of certain hazard communication
requirements.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
human health toxicity, chronic ecotoxicity, and environmental fate
testing performed on the confidential analog of the PMN substance may
be potentially useful to characterize the health and environmental
effects of the PMN substance. Although the Order does not require these
tests, the Order's restrictions remain in effect until the Order is
modified or revoked by EPA based on submission of this or other
relevant information.
PMN Number: P-02-920 (40 CFR 721.11223).
Chemical Name: Alkane carboxylic acids esters with long chain fatty
alcohol and fluorinated alkylsulfonamidoalkyl alcohol (generic).
CAS or Accession Number: Accession No. 257922.
Effective Date of TSCA Order: March 25, 2003.
Basis for TSCA Order: The PMN stated that the use will be as an
additive. Based on potential degradation products, byproducts,
unreacted material, and low molecular weight species, EPA had concerns
that these degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. The Order was also issued under TSCA section
5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be
produced in substantial quantities and that the substance either enters
or may reasonably be anticipated to enter the environment in
substantial quantities, or there is or may be significant (or
substantial) human exposure to the substance. To protect against these
risks, the Order required the establishment of certain hazard
communication requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as an additive; and
<bullet> Manufacture beyond an annual production volume of 2500
lbs.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, acute and chronic human health toxicity, acute and
chronic ecotoxicity, and environmental fate testing performed on
confidential analog of the PMN substance may be potentially useful to
characterize the health and environmental effects of the PMN substance.
Although the Order does not require these tests, the Order's
restrictions remain in effect until the
[[Page 74078]]
Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-03-32 (40 CFR 721.11724).
Chemical Name: Blocked fluorochemical urethane (generic).
CAS or Accession Number: Accession No. 234152.
Effective Date of TSCA Order: June 26, 2003.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a protective treatment. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. Based on test
data on structurally similar chemicals, EPA had identified concerns for
lung toxicity and irritation to the eyes and mucous membranes. The
Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA section and 5(e)(1)(A)(ii)(II), based
on a finding that the substance is or will be produced in substantial
quantities and that the substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substance. To protect against these risks, the Order required the
establishment of certain hazard communication requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as a protective treatment; and
<bullet> Manufacture beyond an annual production volume of 2500
lbs.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of human
health toxicity, ecotoxicity, and environmental fate testing performed
on confidential analog of the PMN substance may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Number: P-03-33 (40 CFR 721.11725).
Chemical Name: Polyperfluoro alkylene glycol, perfluoroalkoxy- and
hydroxy alkyl amido perfluoroalkyl terminated (generic).
CAS or Accession Number: Accession No. 242467.
Effective Date of TSCA Order: June 26, 2003.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a chemical intermediate. Based on
potential degradation products, byproducts, unreacted material, and low
molecular weight species, EPA had concerns that these degradation
products will persist in the environment, could bioaccumulate or
biomagnify, and could be toxic (PBT) to people, wild mammals, and
birds. Based on test data on structurally similar chemicals, EPA had
identified concerns for liver toxicity, acute toxicity, developmental
and reproductive toxicity, and cancer. Based on waterproofing of the
lungs if respirable aerosols are inhaled, EPA had also identified
concerns for chronic lung effects. The Order was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information to permit a reasoned
evaluation, the substance may present an unreasonable risk of injury to
human health or the environment. To protect against these risks, the
Order required:
<bullet> No manufacture of the PMN substance with an average
molecular weight (MW) less than 1000 daltons, more than 5 percent
oligomeric material less than 500 daltons or more than 10 percent
oligomeric material less than 1000 daltons;
<bullet> Analyzing the molecular weight of the PMN substance
produced at each facility; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as a chemical intermediate; and
<bullet> Manufacture beyond an annual production volume of 2500
lbs.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
human health toxicity testing may be potentially useful to characterize
the health effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-03-67 (40 CFR 721.11726).
Chemical Name: Fluoroalkene substituted alkene polymer (generic).
CAS or Accession Number: Not available.
Effective Date of TSCA Order: July 24, 2003.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a paint additive. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. Based on data
on analogous perfluorinated compounds and the high molecular weight of
the PMN substance, EPA had also identified concerns for lung effects
through lung overload. The Order was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. To protect against these risks, the Order required:
<bullet> Manufacture of the PMN substance as an alternating
copolymer made up of the confidential monomers specified in the Order
to prevent creation of long-chain perfluorinated acids including PFOA;
<bullet> Analysis of representative samples of the PMN substance or
measurement of initial concentrations of reactants as specified in the
Order to ensure compliance with the chemical composition requirements;
and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures. Additionally, the proposed SNUR
[[Page 74079]]
would designate the following as significant new uses:
<bullet> Use other than as a paint additive; and
<bullet> Manufacture beyond an annual production volume of 2500
lbs.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
physical/chemical, chronic human health toxicity, and environmental
fate testing may be potentially useful to characterize the health and
environmental effects of the PMN substance. Although the Order does not
require these tests, the Order's restrictions remain in effect until
the Order is modified or revoked by EPA based on submission of this or
other relevant information.
PMN Number: P-03-77 (40 CFR 721.11727).
Chemical Name: Phosphonium, tributyl (2-methoxypropyl)-, salt with
1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1).
CAS or Accession Number: CAS No. 332350-93-3.
Effective Date of TSCA Order: July 15, 2003.
Basis for TSCA Order: The PMN stated that use will be as a cure
catalyst. Based on potential degradation products, byproducts,
unreacted material, and low molecular weight species, EPA had concerns
that these degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. Based on comparison to analogous chemical
substances, EPA had identified concerns for liver toxicity,
developmental and reproductive effects, and irritation to mucous
membranes, lungs, and eye. Based on comparison to analogous cationic
surfactants, EPA predicted concern for toxicity to aquatic organisms.
The Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA section 5(e)(1)(A)(ii)(II), based on a
finding that the substance is or will be produced in substantial
quantities and that the substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substance. To protect against these risks, the Order required the
establishment of certain hazard communication requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as a cure catalyst or chemical
intermediate.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of human
health toxicity, ecotoxicity, and environmental fate testing performed
on confidential analog of the PMN substance may be potentially useful
to characterize the health and environmental effects of the PMN
substance. Although the Order does not require these tests, the Order's
restrictions remain in effect until the Order is modified or revoked by
EPA based on submission of this or other relevant information.
PMN Numbers: P-04-174 (40 CFR 721.11728) and P-04-176 (40 CFR
721.11729).
Chemical Names: Fluoroacrylate modified urethane (generic) (P-04-
174) and Fluorinated oligomer alcohol (generic) (P-04-176).
CAS or Accession Numbers: Accession Nos. 238427 (P-04-0174) and
236181 (P-04-0176).
Effective Date of TSCA Order: October 26, 2005.
Basis for TSCA Order: The PMNs stated that the generic (non-
confidential) use of P-04-174 will be as a protective coating and the
use of P-04-176 will be as a chemical intermediate. Based on potential
degradation products, byproducts, unreacted material, and low molecular
weight species, EPA had concerns that these degradation products will
persist in the environment, could bioaccumulate or biomagnify, and
could be toxic (PBT) to people, wild mammals, and birds. The Order was
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based
on a finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health or the environment. The Order was also issued
under TSCA section 5(e)(1)(A)(ii)(II), based on a finding that the
substances are or will be produced in substantial quantities and that
the substances either enter or may reasonably be anticipated to enter
the environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substances. To
protect against these risks, the Order required:
<bullet> Submit to EPA the results of certain testing on P-04-174
described in the Testing section of the Order at least 14 weeks before
manufacturing or importing the total confidential volume of both P-04-
174 and P-04-176 combined listed in the Order; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of the hazard communication protective measure. Additionally,
the proposed SNUR would designate the following as significant new
uses:
<bullet> Use other than as a protective coating (P-04-174) or a
chemical intermediate (P-04-176).
<bullet> Manufacture beyond an annual production volume of 2500 lbs
(P-04-174).
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
human health toxicity and chronic ecotoxicity testing performed on the
PMN substances may be potentially useful to characterize the health and
environmental effects of the PMN substances. Although the Order does
not require these tests, the Order's restrictions remain in effect
until the Order is modified or revoked by EPA based on submission of
this or other relevant information. Manufacturers or processors
considering submitting a SNUN and/or developing this information should
also know that the PMN submitter agreed not to exceed the time limit
specified in the Order without performing the required testing outlined
in the Testing section of the Order.
PMN Numbers: P-05-75 (40 CFR 721.11731), and P-05-107 (40 CFR
721.11732).
Chemical Names: Perfluoroalkylethyl methacrylate copolymer
(generic) (P-05-75) and Perfluoroalkylethyl methacrylate copolymer
organic acid salt (generic) (P-05-107).
CAS or Accession Numbers: Accession Nos. 257171 (P-05-107) and
245831 (P-05-75).
Effective Date of TSCA Order: January 5, 2006.
[[Page 74080]]
Basis for TSCA Order: The PMNs stated that the generic (non-
confidential) uses will be as a textile chemical (P-05-75) and paper/
textile chemical (P-05-107). Based on potential degradation products,
EPA had concerns that these degradation products will persist in the
environment, could bioaccumulate or biomagnify, and could be toxic
(PBT) to people, wild mammals, and birds. Based on comparison to
analogous perfluorinated chemicals, EPA had identified concerns for
lung effects under some conditions of use--particularly non-industrial,
commercial, or consumer use. Based on potential persistent degradation
products, EPA predicted high concern for possible environmental
effects. The Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substances may present
an unreasonable risk of injury to human health or the environment. The
Order was also issued under TSCA section 5(e)(1)(A)(ii)(II), based on a
finding that the substances are or will be produced in substantial
quantities and that the substances either enter or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substances. To protect against these risks, the Order required:
<bullet> Submit to EPA the results of certain testing described in
the Testing section of the Order at least 14 weeks before manufacturing
or importing the total confidential volume of P-04-213, P-05-75, and P-
05-107 combined listed in the Order; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of the hazard communication protective measure. Additionally,
the proposed SNUR would designate the following as significant new
uses:
<bullet> Use other than as finishing agents in textiles, apparel,
and leather manufacturing. Potentially Useful Information: EPA has
determined that certain information may be potentially useful in
support of a request by the PMN submitter to modify the Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that will be designated by this SNUR. EPA has
determined that the results of chronic human health toxicity and
chronic ecotoxicity testing performed on the PMN substances may be
potentially useful to characterize the health and environmental effects
of the PMN substances. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information. Manufacturers or processors considering submitting a SNUN
and/or developing this information should also know that the PMN
submitter agreed not to exceed the time limit specified in the Order
without performing the required testing outlined in the Testing section
of the Order.
PMN Number: P-04-289 (40 CFR 721.11733).
Chemical Name: Ethylene-tetrafluoroethylene-fluorinated alkene
copolymer (generic).
CAS or Accession Number: Accession No. 258981.
Effective Date of TSCA Order: November 5, 2005.
Basis for TSCA Order: The PMN stated that the use will be as a
copolymer for automotive and industrial parts. Based on potential
incineration, decomposition, and degradation products, byproducts,
unreacted material, and low molecular weight species, EPA had concerns
that these degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. The Order was also issued under TSCA section
5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be
produced in substantial quantities and that the substance either enters
or may reasonably be anticipated to enter the environment in
substantial quantities, or there is or may be significant (or
substantial) human exposure to the substance. To protect against these
risks, the Order required:
<bullet> Chemical synthesis of the substance and analysis of the
substance demonstrating compliance with the required synthesis
according to the confidential conditions in the Chemical Synthesis and
Composition section of the Order; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures. Additionally, the proposed SNUR
would designate the following as significant new uses:
<bullet> Use other than as a copolymer for automotive and
industrial parts; and
<bullet> Manufacture beyond an annual production volume of 2500
lbs.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
impurity data on the starting material and product and information
concerning the manufacture process or other verification that the
products do not contain long chain perfluorinated acids may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Although the Order does not require these tests,
the Order's restrictions remain in effect until the Order is modified
or revoked by EPA based on submission of this or other relevant
information.
PMN Number: P-04-537 (40 CFR 721.11334).
Chemical Name: Fluorochemical ester (generic).
CAS or Accession Number: Accession No. 264949.
Effective Date of TSCA Order: April 21, 2005.
Basis for TSCA Order: The PMN stated that the generic (non-
confidential) use will be as a polymer additive. Based on potential
incineration, decomposition, and degradation products, byproducts,
unreacted material, and low molecular weight species, EPA had concerns
that these degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that in the
absence of sufficient information to permit a reasoned evaluation, the
substance may present an unreasonable risk of injury to human health or
the environment. The Order was also issued under TSCA section
5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be
produced in substantial quantities and that the substance either enters
or may reasonably be anticipated to enter the environment in
substantial quantities, or there is or may be significant (or
substantial) human exposure to the substance. To protect against these
risks, the Order required:
<bullet> Submit to EPA the results of certain testing described in
the Testing section of the Order at least 14 weeks before manufacturing
or importing the
[[Page 74081]]
aggregate confidential volume listed in the Order; and
<bullet> Establishment of certain hazard communication
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of the hazard communication protective measures. Additionally,
the proposed SNUR would designate the following as significant new
uses:
<bullet> Use other than as a finishing agent in textiles, apparel,
and leather manufacturing or as a chemical intermediate.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
human health toxicity and chronic ecotoxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance. Manufacturers or processors considering
submitting a SNUN and/or developing this information should also know
that the PMN submitter agreed not to exceed the time limit specified in
the Order without performing the required testing outlined in the
Testing section of the Order.
PMN Numbers: P-05-491 (40 CFR 721.11735), P-05-492 (40 CFR
721.11736), P-05-503 (40 CFR 721.11737), P-05-504 (40 CFR 721.11738),
P-05-505 (40 CFR 721.11739), P-05-838 (40 CFR 721.11740), P-06-206 (40
CFR 721.11741), P-06-207 (40 CFR 721.11742), P-06-208 (40 CFR
721.11743), P-06-211 (40 CFR 721.11744), P-06-212 (40 CFR 721.11745),
P-06-213 (40 CFR 721.11746), P-06-214 (40 CFR 721.11747), P-06-215 (40
CFR 721.11748), P-06-216 (40 CFR 721.11749), P-06-217 (40 CFR
721.11750), and P-06-224 (40 CFR 721.11751).
Chemical Names: Fluoroalkylacrylate copolymer (generic) (P-05-491,
P-05-492, P-05-504, P-05-505, P-05-838, P-06-207, P-06-208, P-06-211,
P-06-212, P-06-213, P-06-214, P-06-215, P-06-216, P-06-217, and P-06-
224), Fluorochemical urethane; (generic) (P-05-503), and Fluoroalkyl
acrylate (generic) (P-06-206).
CAS or Accession Numbers: Not Available.
Effective Date of TSCA Orders: May 1, 2006.
Basis for TSCA Order: The PMNs stated that the generic (non-
confidential) uses will be as textile treatment additives (P-05-491, P-
05-492, P-05-505, P-05-838, P-06-207, P-06-208, P-06-211, P-06-215, P-
06-217, and P-06-224), carpet treatment additive (P-05-503, P-06-213,
and P-06-216), tile surface treatment (P-05-504), monomer for textile
treatment additive (P-06-206), nonwoven internal additive (P-06-212)
and paper treatment additive (P-06-214). Based on potential
incineration and degradation products, byproducts, unreacted material,
and low molecular weight species, EPA had concerns that these
degradation products will persist in the environment, could
bioaccumulate or biomagnify, and could be toxic (PBT) to people, wild
mammals, and birds. Based on comparison to analogous perfluorinated
chemicals, EPA had identified concerns for lung effects. Based on
submitted test data, EPA had also identified concerns for systemic
effects for P-06-206. Based on potential persistent perfluorinated
degradation products and submitted data for P-06-206, EPA predicted
concern for possible environmental effects. The Order was issued under
TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to human health or the environment. The Order was also issued under
TSCA section 5(e)(1)(A)(ii)(II), based on a finding that the substances
are or will be produced in substantial quantities and that the
substances either enter or may reasonably be anticipated to enter the
environment in substantial quantities, or there is or may be
significant (or substantial) human exposure to the substances. To
protect against these risks, the Order required:
<bullet> Submit to EPA the results of certain testing described in
the Testing section of the Order at least 14 weeks before manufacturing
or importing the total confidential volume of all PMNs combined,
excluding volumes of the monomer P-06-206, listed in the Order;
<bullet> Report annually the impurity content of all confidential
impurities and carbon chain length impurities listed in the Order by
analyzing representative samples; and
<bullet> Establishment of certain hazard communication program
requirements.
The proposed SNUR would designate as a ``significant new use'' the
absence of the second and third of these protective measures.
Additionally, the proposed SNUR would designate the following as
significant new uses:
<bullet> Use other than as textile treatment additives (P-05-491,
P-05-492, P-05-505, P-05-838, P-06-207, P-06-208, P-06-211, P-06-215,
P-06-217, and P-06-224), carpet treatment additives (P-05-503, P-06-
213, and P-06-216), a tile surface treatment (P-05-504), a monomer for
textile treatment additives (P-06-206), a nonwoven internal additive
(P-06-212), or a paper treatment additive (P-06-214); and
<bullet> Manufacture beyond an annual production volume of 2500
lbs.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of chronic
human health toxicity, physical/chemical properties, fate, transport,
and chronic ecotoxicity testing performed on the PMN substances may be
potentially useful to characterize the health and environmental effects
of the PMN substances. Manufacturers or processors considering
submitting a SNUN and/or developing this information should also know
that the PMN submitter agreed not to exceed the time limit specified in
the Order without performing the required testing outlined in the
Testing section of the Order.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the proposed significant new uses are not ongoing.
For chemical substances identified in this proposed rule that have
been added to the TSCA Inventory, EPA recognizes that, before the rule
is effective, other persons might engage in a use that has been
identified as a significant new use. However, TSCA Orders have been
issued for these chemical substances, and the PMN submitters are
prohibited by the TSCA Orders from undertaking activities which would
be designated as significant new uses. The identities of many of the
chemical substances subject to this proposed rule have been claimed as
confidential per 40 CFR 720.85. In addition, for other significant new
uses EPA has identified in this proposed rule that are not related to
Order
[[Page 74082]]
requirements, EPA reviewed CDR reporting for those chemicals as
described in Unit IV and determined that the uses were either not
ongoing or were unlikely to be ongoing. Based on this, the Agency
proposes to conclude that none of the significant new uses described in
the regulatory text of this proposed rule are ongoing. EPA solicits
comment on whether any of the uses that would be regulated as a
``significant new use'' if this proposed rule is finalized are ongoing.
EPA designates December 2, 2022 as the cutoff date for determining
whether the new use is ongoing. The objective of EPA's approach is to
ensure that a person cannot defeat a SNUR by initiating a significant
new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use after
the date this proposal publishes in the Federal Register, that person
would have to cease any such activity upon the effective date of the
final rule. To resume their activities, these persons would have to
first comply with all applicable SNUR notification requirements and
wait until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required with that determination.
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
<a href="https://www.epa.gov/tsca-inventory">https://www.epa.gov/tsca-inventory</a>.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A)
requires such information to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, 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 or reasonably ascertainable (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. Unit V. lists potentially
useful information for the SNURs listed in this document. Descriptions
of this information is provided for informational purposes. The
potentially useful information identified in Unit V. will be useful to
EPA's evaluation in the event that someone submits a SNUN for the
significant new use.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing in vertebrate animals, EPA
encourages dialog with the Agency on the use of alternative test
methods and strategies (also called New Approach Methodologies, or
NAMs), if available, to generate the recommended test data. EPA
encourages dialog with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
The potentially useful information listed in Unit V. 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 be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
<bullet> Human exposure and environmental releases that may result
from the significant new use of the chemical substances.
<bullet> Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, 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. E-PMN software is available electronically
at <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket for this rulemaking.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This action proposes to establish SNURs for several new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
The information collection activities associated with SNURs have
already been approved by OMB under the PRA and assigned OMB control
number 2070-0012 (EPA ICR No. 574). This proposed rule does not contain
any burden requiring additional OMB approval. If an entity were to
submit a SNUN to the Agency, the annual burden is estimated to average
between 30 and 170 hours per response. This burden estimate includes
the time needed to review instructions, search existing data sources,
gather and maintain the data needed, and complete, review, and submit
the required SNUN.
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The 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.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing
[[Page 74083]]
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 the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs would not have
a significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, 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 10 in Federal fiscal year (FY) FY2016, 14
in FY2017, 16 in FY2018, five in FY2019, seven in FY2020, and 13 in
FY2021, 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 $19,020 to $3,330.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,094 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the states, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action would not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it is
not expected to have substantial direct effects on Indian Tribes. This
action would not significantly nor uniquely affect the communities of
Indian Tribal governments, nor would it involve or impose any
requirements that affect Indian Tribes.
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 proposed rule is not expected to affect
energy supply, distribution, or use, and because this action is not
expected to affect energy supply, distribution, or use and because this
action has not otherwise been designated as a significant energy action
by the Administrator of OMB's Office of Information and Regulatory
Affairs.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Orders 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations and 14008:
Tackling the Climate Crisis at Home and Abroad
EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) and Executive Order 14008 (86 FR
7619, January 27, 2021) because it does not establish an environmental
health or safety standard.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: November 28, 2022.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, it is proposed
that 40 CFR chapter I be amended as follows:
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11716 through 721.11751 to subpart E to read as
follows:
Subpart E-Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11716 Fluoroacrylate copolymer (generic).
721.11717 Perfluoroalkylsulfonamidoalkyl acrylate, polymer with
acrylic acid derivatives (generic).
721.11718 Urethane polymer modified with perfluoroalkylsulfonamide
(generic).
721.11719 Urethane polymer modified with perfluoroalkylsulfonamide
and polyethoxylate (generic).
721.11720 Urethane polymer modified with perfluoroalkylsulfonamide
(generic).
721.11721 Copolymer of perfluoroalkylsulfonamidoalkyl acrylate and
alkyl acrylate modified fatty acid dimers (generic).
721.11722 Phosphonium, triphenyl(phenylmethyl)-, salt with
1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1).
721.11723 Alkane carboxylic acids esters with long chain fatty
alcohol and fluorinated alkylsulfonamidoalkyl alcohol (generic).
[[Page 74084]]
721.11724 Blocked fluorochemical urethane (generic).
721.11725 Polyperfluoro alkylene glycol, perfluoroalkoxy- and
hydroxy alkyl amido perfluoroalkyl terminated (generic).
721.11726 Fluoroalkene substituted alkene polymer (generic).
721.11727 Phosphonium, tributyl (2-methoxypropyl)-, salt with
1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1).
721.11728 Fluoroacrylate modified urethane (generic).
721.11729 Fluorinated oligomer alcohol (generic).
721.11731 Perfluoroalkylethyl methacrylate copolymer (generic).
721.11732 Perfluoroalkylethyl methacrylate copolymer organic acid
salt (generic).
721.11733 Ethylene-tetrafluoroethylene-fluorinated alkene copolymer
(generic).
721.11734 Fluorochemical ester (generic).
721.11735 Fluoroalkylacrylate copolymer (generic).
721.11736 Fluoroalkylacrylate copolymer (generic).
721.11737 Fluorochemical urethane (generic).
721.11738 Fluoroalkylacrylate copolymer (generic).
721.11739 Fluoroalkylacrylate copolymer (generic).
721.11740 Fluoroalkylacrylate copolymer (generic).
721.11741 Fluoroalkyl acrylate (generic).
721.11742 Fluoroalkylacrylate copolymer (generic).
721.11743 Fluoroalkylacrylate copolymer (generic).
721.11744 Fluoroalkylacrylate copolymer (generic).
721.11745 Fluoroalkylacrylate copolymer (generic).
721.11746 Fluoroalkylacrylate copolymer (generic).
721.11747 Fluoroalkylacrylate copolymer (generic).
721.11748 Fluoroalkylacrylate copolymer (generic).
721.11749 Fluoroalkylacrylate copolymer (generic).
721.11750 Fluoroalkylacrylate copolymer (generic).
721.11751 Fluoroalkylacrylate copolymer (generic).
Sec. 721.11716 Fluoroacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
fluoroacrylate copolymer (PMN P-00-1085; Accession No. 249720) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a surfactant in
paint and coatings manufacturing.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11717 Perfluoroalkyl sulfonamidoalkyl acrylate, polymer with
acrylic acid derivatives (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoroalkylsulfonamidoalkyl acrylate, polymer with acrylic acid
derivatives (PMN P-01-584; Accession No. 254456) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a surfactant in
adhesive and synthetic rubber manufacturing.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11718 Urethane polymer modified with
perfluoroalkylsulfonamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
urethane polymer modified with perfluoroalkylsulfonamide (PMN P-02-16;
Accession No. 252290) 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. A significant new use of the substance is
[[Page 74085]]
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a finishing
agent in textiles, apparel, and leather manufacturing.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11719 Urethane polymer modified with
perfluoroalkylsulfonamide and polyethoxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
urethane polymer modified with perfluoroalkylsulfonamide and
polyethoxylate (PMN P-02-195; Accession No. 271739) 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: A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a finishing
agent in textiles, apparel, and leather manufacturing.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11720 Urethane polymer modified with
perfluoroalkylsulfonamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
urethane polymer modified with perfluoroalkylsulfonamide (PMN P-02-609;
Accession No. 279755) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as an anti-stain
agent.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11721 Copolymer of perfluoroalkylsulfonamidoalkyl acrylate
and alkyl acrylate modified fatty acid dimers (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
copolymer of perfluoroalkylsulfonamidoalkyl acrylate and alkyl acrylate
modified fatty acid
[[Page 74086]]
dimers (PMN P-02-700; Accession No. 259360) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a finishing
agent in textiles, apparel, and leather manufacturing.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11722 Phosphonium, triphenyl(phenylmethyl)-, salt with
1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonium,
triphenyl(phenylmethyl)-, salt with 1,1,2,2,3,3,4,4,4-nonafluoro-N-
methyl-1-butanesulfonamide (1:1) (PMN P-02-891; CAS No. 332350-93-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N=1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11723 Alkane carboxylic acids esters with long chain fatty
alcohol and fluorinated alkylsulfonamidoalkyl alcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane
carboxylic acids esters with long chain fatty alcohol and fluorinated
alkylsulfonamidoalkyl alcohol (PMN P-02-920; Accession No. 257922) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as an additive. It
is a significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs.
(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), a (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 74087]]
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11724 Blocked fluorochemical urethane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as blocked
fluorochemical urethane (PMN P-03-32; Accession No. 242467) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a protective
treatment. It is a significant new use to manufacture the substance
beyond an annual production volume of 2500 lbs.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11725 Polyperfluoro alkylene glycol, perfluoroalkoxy- and
hydroxy alkyl amido perfluoroalkyl terminated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyperfluoro alkylene glycol, perfluoroalkoxy- and hydroxy alkyl amido
perfluoroalkyl terminated (PMN P-03-33; Accession No. 242467) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g). It is a significant new use to
manufacture the substance with an average molecular weight less than
1000 daltons, more than 5 percent oligomeric material less than 500
daltons, or more than 10 percent oligomeric material less than 1000
daltons. It is a significant new use to manufacture the substance
without analyzing the molecular weight of the substance produced at
each facility as described in the TSCA 5(e) order for the substance. It
is a significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11726 Fluoroalkene substituted alkene polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkene substituted alkene polymer (PMN P-03-67) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance
[[Page 74088]]
other than primarily as an alternating copolymer made up of the
confidential monomers specified in the Order to prevent creation of
long-chain perfluorinated acids including PFOA. It is a significant new
use to manufacture or import the substance without analyzing
representative samples of the substance or measuring initial
concentrations of reactants consistent with the procedure specified in
the TSCA Order. It is a significant new use to use the substance other
than as a paint additive. It is a significant new use to manufacture
the substance beyond an annual production volume of 2500 lbs.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11727 Phosphonium, tributyl (2-methoxypropyl)-, salt with
1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Phosphonium,
tributyl (2-methoxypropyl)-, salt with 1,1,2,2,3,3,4,4,4-nonafluoro-N-
methyl-1-butanesulfonamide (1:1) (PMN P-03-77; CAS No. 332350-93-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a cure catalyst
or a chemical intermediate.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11728 Fluoroacrylate modified urethane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroacrylate modified urethane (PMN P-04-174; Accession No. 238427)
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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a protective coating.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11729 Fluorinated oligomer alcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorinated oligomer alcohol (PMN P-04-176; Accession No. 236181) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used
[[Page 74089]]
in the employer's workplace, the employer must add the new information
to an SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11731 Perfluoroalkylethyl methacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoroalkylethyl methacrylate copolymer (PMN P-05-75; Accession No.
245831) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a finishing
agent in textiles, apparel, and leather manufacturing.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11732 Perfluoroalkylethyl methacrylate copolymer organic
acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoroalkylethyl methacrylate copolymer organic acid salt (PMN P-05-
107: Accession No. 257171) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a finishing
agent in textiles, apparel, and leather manufacturing.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11733 Ethylene-tetrafluoroethylene-fluorinated alkene
copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethylene-tetrafluoroethylene-fluorinated alkene copolymer (PMN P-04-
289; Accession No. 258981) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not
[[Page 74090]]
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to an SDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance other than according
to the confidential synthesis and composition requirements in the
Order. It is a significant new use to use the substance other than as a
copolymer for automotive and industrial parts. It is a significant new
use to manufacture the substance beyond an annual production volume of
2500 lbs.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11734 Fluorochemical ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorochemical ester (PMN P-04-537; Accession No. 264949) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance other than as a finishing
agent in textiles, apparel, and leather manufacturing or as a chemical
intermediate.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11735 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-491) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11736 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-492) 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: A significant new use of the substance is
any manner or method of manufacture,
[[Page 74091]]
import, or processing associated with any use of the substance without
the following hazard communication: (A) If the employer becomes aware
of any significant new information regarding hazards of the substance
or ways to protect against the hazards, the employer must incorporate
this new information and any information on methods for protecting
against such hazards, into an SDS as described in Sec. 721.72(c)
within 90 days from the time the employer becomes aware of the new
information. If the substance is not being manufactured, processed, or
used in the employer's workplace, the employer must add the new
information to an SDS before the substance is reintroduced into the
workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11737 Fluorochemical urethane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluorochemical urethane (PMN P-05-503) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a carpet treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11738 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-504) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a tile surface treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for the substance.
(b) Specific requirements. The provisions of subpart A of this part
[[Page 74092]]
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11739 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-505) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11740 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-05-838) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11741 Fluoroalkyl acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkyl acrylate (PMN P-06-206) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have
[[Page 74093]]
received the substance from the employer within 5 years from the date
the employer becomes aware of the new information described in
paragraph (a)(2)(i)(A) of this section, are provided an SDS containing
the information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a monomer for textile treatment additives. It
is a significant new use to manufacture the substance without the
analysis, reporting of the analysis to EPA, and minimizing of the
impurity content of all confidential impurities and carbon chain
lengths as described in the Chemical Synthesis and Composition section
of the TSCA section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11742 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-207) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11743 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-208) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11744 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-211) is subject to reporting
under this section for the
[[Page 74094]]
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11745 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-212) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a nonwoven internal additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11746 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-213) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a carpet treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis
[[Page 74095]]
and Composition section of the TSCA section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11747 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-214) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a paper treatment additive. It is a significant
new use to manufacture the substance without the analysis, reporting of
the analysis to EPA, and minimizing of the impurity content of all
confidential impurities and carbon chain lengths as described in the
Chemical Synthesis and Composition section of the TSCA section 5(e)
Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11748 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-215) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11749 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-216) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information
[[Page 74096]]
to an SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a carpet treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11750 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-217) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
Sec. 721.11751 Fluoroalkylacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkylacrylate copolymer (PMN P-06-224) 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. A significant new use of the substance is
any manner or method of manufacture, import, or processing associated
with any use of the substance without the following hazard
communication: (A) If the employer becomes aware of any significant new
information regarding hazards of the substance or ways to protect
against the hazards, the employer must incorporate this new information
and any information on methods for protecting against such hazards,
into an SDS as described in Sec. 721.72(c) within 90 days from the
time the employer becomes aware of the new information. If the
substance is not being manufactured, processed, or used in the
employer's workplace, the employer must add the new information to an
SDS before the substance is reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the
substance from the employer, or who have received the substance from
the employer within 5 years from the date the employer becomes aware of
the new information described in paragraph (a)(2)(i)(A) of this
section, are provided an SDS containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the substance beyond an annual
production volume of 2500 lbs. It is a significant new use to use the
substance other than as a textile treatment additive. It is a
significant new use to manufacture the substance without the analysis,
reporting of the analysis to EPA, and minimizing of the impurity
content of all confidential impurities and carbon chain lengths as
described in the Chemical Synthesis and Composition section of the TSCA
section 5(e) Order for 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 (c), (f), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Exemptions. The exemption of Sec. 721.45(i) does not apply to
this section.
[FR Doc. 2022-26252 Filed 12-1-22; 8:45 am]
BILLING CODE 6560-50-P
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</html>Indexed from Federal Register on December 2, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.