['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA']
07/19/2024
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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.
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, 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 17, 2023.
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0847, through the Federal eRulemaking Portal at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:For technical information contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: wysong.william@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.
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:
• 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 https://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
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 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:
- The projected volume of manufacturing and processing of a chemical substance.
- The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
- The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
- The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four 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 https://www.epa.gov/pfas/epa-actions-address-pfas and https://www.epa.gov/system/files/documents/2021-10/pfas-roadmap_final-508.pdf.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants:
- To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
- 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.
- To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
- To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination before the described significant new use of the chemical substance occurs.
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 identified in this unit as subject to this proposed rule:
- PMN number (the proposed CFR citation assigned in the regulatory text section of the proposed rule).
- Chemical name (generic name, if the specific name is claimed as CBI).
- Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities) or Accession number (if assigned for confidential chemical identities).
- Effective date of and basis for the TSCA section 5(e) Order.
- 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:
- 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
- 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:
- 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:
- 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
- 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:
- 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 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:
- 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:
- 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
- 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:
- 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:
- 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 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:
- 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:
- No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb;
- Use of the PMN substance only for the confidential use as stated in the PMN; and
- 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:
- Use other than as an additive; and
- 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 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:
- Use other than as a protective treatment; and
- 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:
- 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;
- Analyzing the molecular weight of the PMN substance produced at each facility; and
- 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:
- Use other than as a chemical intermediate; and
- 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:
- 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;
- 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
- 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:
- Use other than as a paint additive; and
- 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. 332350-90-0.
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:
- 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:
- 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
- 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:
- Use other than as a protective coating (P-04-174) or a chemical intermediate (P-04-176).
- 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.
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:
- 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
- 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:
- 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:
- 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
- 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:
- Use other than as a copolymer for automotive and industrial parts; and
- 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:
- 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 aggregate confidential volume listed in the Order; and
- 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:
- 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:
- 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;
- Report annually the impurity content of all confidential impurities and carbon chain length impurities listed in the Order by analyzing representative samples; and
- 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:
- 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
- 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 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 https://www.epa.gov/tsca-inventory.
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 https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
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:
- Human exposure and environmental releases that may result from the significant new use of the chemical substances.
- Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to 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 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
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 https://www.epa.gov/laws-regulations/laws-and-executive-orders.
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 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
1. The authority citation for part 721 continues to read as follows:
Authority:
15 U.S.C. 2604, 2607, and 2625(c).
2. Add §§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).
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).
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §721.80(j).
(iii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4) where N=1.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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. 332350-90-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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, 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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
§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 §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 §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 §721.185 apply to this section.
(3) Exemptions. The exemption of §721.45(i) does not apply to this section.
[FR Doc. 2022-26252 Filed 12-1-22; 8:45 am]
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