2020-21471. Significant New Use Rules on Certain Chemical Substances (20-2.5e)

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). The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is 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 by that determination.

DATES:

Comments must be received on or before November 9, 2020.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0131, through the Federal eRulemaking Portal at http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: William Wysong, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this 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 November 9, 2020 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 this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/​dockets/​comments.html.

II. Background

A. What action is the Agency taking?

EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) for 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-2020-0131, 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.

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, 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 section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). 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).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL), and includes requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA Order for the same chemical substance.

These proposed rules include PMN substances that received “not likely to present an unreasonable risk” determination in TSCA section 5(a)(3)(c). However, during the course of these reviews, EPA identified concerns for certain health and/or environmental risks if the chemicals were not used following the limitations identified by the submitters in the notices. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the protection measures.

IV. 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.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
• Basis for the SNUR or TSCA Order.
• Effective date of the TSCA Order (if applicable).
• Potentially Useful Information.
• CFR citation assigned in the regulatory text section of the proposed rule.

The chemicals subject to these proposed SNURs are as follows:

PMN Numbers: P-18-241, P-18-244, and P-18-245.

Chemical Names: 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl acrylate, formats (salts) (P-18-241) (generic); 2-Propenoic acid, 2-methyl, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl methacrylate, formats (salts) (P-18-244) (generic); 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with alkylene glycol monoacrylate, formats (salts) (P-18-245) (generic).

CAS Numbers: Not available.

Basis for the action: The PMNs state that the generic (non-confidential) use of the substances will be as additives for automotive coatings. EPA estimated the human health hazard of the chemical substances based on their measured and estimated physical/chemical properties and by comparison with structurally analogous chemical substances. EPA determined environmental hazard for the new chemical substances based on Structural Activity Relationships (SAR) analysis for polycationic polymers. EPA has identified concerns for potential neurotoxicity, blood toxicity, reproductive and developmental toxicity, and moderate environmental hazard if the chemical substances are not manufactured and not used following the limitations identified by the submitters in the notices. This proposed SNUR designates the following circumstances of use as “significant new uses” requiring further review by EPA:

• Use of the PMN substances other than as described in the PMNs.

Potentially useful information: EPA has determined that information about the human health and environmental effects of the PMN substances may be potentially useful if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. EPA has determined that the results of neurotoxicity, reproductive/developmental toxicity, and aquatic toxicity testing would help characterize the potential health and environmental effects of the PMN substances.

CFR Citations: 40 CFR 721.11401 (P-18-241), 40 CFR 721.11402 (P-18-244), and 40 CFR 721.11403 (P-18-245).

PMN Numbers: P-16-539, P-18-157, P-18-158, P-18-159, and P-19-33.

Chemical Names: Organic sulfonate compound (generic) (P-16-539), thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic) (P-18-157), sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (generic) (P-18-158), thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (P-18-159), and sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative (generic) (P-19-33).

CAS Numbers: Not available.

Effective Date of TSCA Order: January 31, 2020.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the substances will be for photolithography (P-16-539, P-18-158, and P-19-33) and as a photosensitizer for photoresist (P-18-158 and P-18-159). Based on the physical/chemical properties of the PMN substances and test data on structurally similar substances, the PMN substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals (as described in the New Chemical Program's PBT category policy statement (64 FR 60194, November 4, 1999; FRL-6097-7)). EPA estimates that the PMN substances will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on physical/chemical properties and comparison with analogous chemical substances, EPA has also identified concerns for photosensitization, eye corrosion, irritation, acute toxicity, neurotoxicity, lung overload, aquatic toxicity, and reproductive/developmental toxicity. The TSCA 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 substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

1. No manufacture of any of the PMN substances beyond the time limits specified in the TSCA Order without submittal to EPA of the results of certain testing described in the Testing section of the TSCA Order;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. Establishment of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS);

4. No modification of the processing of the PMN substances in any way that generates a dust, mist, or aerosol in a non-enclosed process;

5. Use of the PMN substances only as described in the TSCA Order;

6. No domestic manufacture of the PMN substances (i.e., import only);

7. Import of the PMN substances only in solution, or in any form in sealed containers weighing 5 kilograms or less; and

8. No exceedance of the confidential annual production volumes listed in the TSCA Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the TSCA Order without performing the required Tier I and Tier II testing outlined in the Testing section of the TSCA Order.

CFR Citations: 40 CFR 721.11514 (P-16-539), 40 CFR 721.11515 (P-18-157), 40 CFR 721.11516 (P-18-158), 40 CFR 721.11517 (P-18-159), and 40 CFR 721.11518 (P-19-33).

PMN Numbers: P-17-178, P-18-13, P-18-14, P-18-37, P-19-78, P-19-79, P-19-111, P-19-112, P-19-114 and P-19-133.

Chemical Names: Sulfonium, triphenyl-, salt with substituted-alkyl 4-substituted-benzoate (generic) (P-17-178), substituted-triphenylsulfonium, inner salt (generic) (P-18-13), sulfonium, triphenyl-, salt with disubstituted-heterocyclic compound (1:1) (generic) (P-18-14), sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-benzenesulfonate (1:1) (generic) (P-18-37), substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene, 1-ethenyl-4-[(1-ethylcyclopentyl)oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic) (P-19-78), substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene 1-ethenyl-4-[[1-(1-methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic) (P-19-79), dibenzothiophenium, aryl substituted trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (generic) (P-19-111), substituted heterocyclic onium compound, salt with 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with 3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-2-propenoate and 1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-methyl-2-propenoate, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropenoate]-initiated (generic) (P-19-112), sulfonium, triphenyl-, trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (generic) (P-19-114), and heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1) (generic) (P-19-133).

CAS Numbers: Not available.

Effective Date of TSCA Order: January 31, 2020.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses of the substances will be for microlithography for electronic device manufacturing (P-17-178, P-18-13, P-18-14, and P-18-37), polymers for photo resist (P-19-78 and P-17-79), and microlithography for electronic device manufacturing (P-19-78, P-19-79, P-19-111, P-19-112, P-19-114, and P-19-133). Based on the physical/chemical properties of the PMN substances and test data on structurally similar substances, the PMN substances are potentially PBT chemicals (as described in the New Chemical Program's PBT category policy statement (64 FR 60194, November 4, 1999; FRL-6097-7)). EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on physical/chemical properties and comparison with analogous chemical substances, EPA has also identified concerns for photosensitization, eye corrosion, irritation, acute toxicity, neurotoxicity, lung overload, aquatic toxicity, and reproductive/developmental toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that 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. To protect against these risks, the TSCA Order requires:

1. No manufacture of any of the PMN substances beyond the time limits specified in the TSCA Order without submittal to EPA of the results of certain testing described in the Testing section of the TSCA Order;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;

4. No modification of the processing of the PMN substances in any way that generates a dust, mist, or aerosol in a non-enclosed process;

5. Use of the PMN substances only as described in the TSCA Order;

6. No domestic manufacture of the PMN substances (i.e., import only);

7. Import of the PMN substances only in solution, or in any form in sealed containers weighing 5 kilograms or less; and

8. No exceedance of the confidential annual importation volumes listed in the TSCA Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the TSCA Order without performing the required Tier I and Tier II testing outlined in the Testing section of the TSCA Order.

CFR Citations: 40 CFR 721.11519 (P-17-178), 40 CFR 721.11520 (P-18-13), 40 CFR 721.11521 (P-18-14), 40 CFR 721.11522 (P-18-37), 40 CFR 721.11523 (P-19-78), 40 CFR 721.11524 (P-19-79), 40 CFR 721.11525 (P-19-111), 40 CFR 721.11526 (P-19-112), 40 CFR 721.11527 (P-19-114), and 40 CFR 721.11528 (P-19-133).

PMN Number: P-18-16.

Chemical Name: Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).

CAS Number: None available.

Effective Date of TSCA Order: February 11, 2020.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a photoacid generator (PAG). Based on the physical/chemical properties of the PMN substance, the PMN substance is a potentially PBT chemical (as described in the New Chemical Program's PBT category policy statement (64 FR 60194, November 4, 1999; FRL-6097-7)). EPA estimates that the PMN substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on physical/chemical properties and comparison with analogous chemical substances, EPA has also identified concerns for photosensitization, eye corrosion, irritation, acute toxicity, liver toxicity, neurotoxicity, reproductive/developmental toxicity, and aquatic toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that 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 TSCA Order requires:

1. No manufacture of the PMN substance beyond the time limits specified in the TSCA Order without submittal to EPA of the results of certain testing described in the Testing section of the TSCA Order;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;

4. No modification of the processing of the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process;

5. Use of the PMN substance only as described in the TSCA Order;

6. No domestic manufacture of the PMN substance (i.e., import only);

7. Import of the PMN substance only in solution, or in any form in sealed containers weighing 5 kilograms or less; and

8. No exceedance of the confidential annual importation volume listed in the TSCA Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the TSCA Order without performing the required Tier I and Tier II testing outlined in the Testing section of the TSCA Order.

CFR Citation: 40 CFR 721.11529.

PMN Numbers: P-18-297, P-18-311, P-18-314, and P-18-315.

Chemical Names: Substituted, (alkylaromatic)diaromatic salt with trihalo-[(trihaloalkyl)substituted]substituted alkaneamide (generic) (P-18-297), triarylsulfonium substituted oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (generic) (P-18-311), substituted triarylsulfonium carbopolycyclic heteromonocyclic dihalo sulfoacetate (generic) (P-18-314), and substituted triarylsulfonium substituted carbopolycyclic carboxylate (generic) (P-18-315).

CAS Numbers: Not available.

Effective Date of TSCA Order: February 4, 2020.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the substances will be as components of material for fabrication. Based on the physical/chemical properties of the PMN substances and test data on structurally similar substances, the PMN substances are potentially PBT chemicals (as described in the New Chemical Program's PBT category policy statement (64 FR 60194, November 4, 1999; FRL-6097-7)). EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on physical/chemical properties and comparison with analogous chemical substances, EPA has also identified concerns for photosensitization, eye corrosion, irritation, acute toxicity, neurotoxicity, lung overload, aquatic toxicity, and reproductive/developmental toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that 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. To protect against these risks, the TSCA Order requires:

1. No manufacture of any of the PMN substances beyond the time limits specified in the TSCA Order without submittal to EPA of the results of certain testing described in the Testing section of the TSCA Order;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;

4. No modification of the processing of the PMN substances in any way that generates a dust, mist, or aerosol in a non-enclosed process;

5. Use of the PMN substances only as described in the TSCA Order;

6. No domestic manufacture of the PMN substances (i.e., import only);

7. Import of the PMN substances only in solution, or in any form in sealed containers weighing 5 kilograms or less; and

8. No exceedance of the confidential annual importation volumes listed in the TSCA Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the TSCA Order without performing the required Tier I and Tier II testing outlined in the Testing section of the TSCA Order.

CFR Citations: 40 CFR 721.11530 (P-18-297), 40 CFR 721.11531 (P-18-311), 40 CFR 721.11532 (P-18-314), and 40 CFR 721.11533 (P-18-315).

PMN Numbers: P-18-304, P-18-316, P-18-338, P-19-76, P-19-115, and P-19-142.

Chemical Names: Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with substituted heteropolycycle dihalo sulfoalkanoate (1:1) (generic) (P-18-304), heteropolycycle, alkylaromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (generic) (P-18-316), sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl polycarbocyclic alkane-1-carboxylate (1:1) (P-18-338), sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1) (generic) (P-19-76), sulfonium, bis(dihalocarbomonocycle) carbomonocycle, substituted carbomonocyclic ester (generic) (P-19-115), and heteropolycycle, aromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (1:1) (generic) (P-19-142).

CAS Numbers: Not available.

Effective Date of TSCA Order: January 30, 2020.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the substances will be as ingredients used in the manufacture of photoresist. Based on the physical/chemical properties of the PMN substances and test data on structurally similar substances, the PMN substances are potentially PBT chemicals (as described in the New Chemical Program's PBT category policy statement (64 FR 60194, November 4, 1999; FRL-6097-7)). EPA estimates that the PMN substances will persist in the environment more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on physical/chemical properties and comparison with analogous chemical substances, EPA has also identified concerns for photosensitization, eye corrosion, irritation, acute toxicity, neurotoxicity, lung overload, aquatic toxicity, and reproductive/developmental toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that 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. To protect against these risks, the TSCA Order requires:

1. No manufacture of any of the PMN substances beyond the time limits specified in the TSCA Order without submittal to EPA of the results of certain testing described in the Testing section of the TSCA Order;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;

4. No modification of the processing of the PMN substances in any way that generates a dust, mist, or aerosol in a non-enclosed process;

5. Use of the PMN substances only as described in the PMNs;

6. No domestic manufacture of the PMN substances (i.e., import only);

7. Import of the PMN substances only in solution, or in any form in sealed containers weighing 5 kilograms or less; and

8. No exceedance of the confidential annual importation volumes listed in the TSCA Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the TSCA Order without performing the required Tier I and Tier II testing outlined in the Testing section of the TSCA Order.

CFR Citations: 40 CFR 721.11534 (P-18-304), 40 CFR 721.11535 (P-18-316), 40 CFR 721.11536 (P-18-338), 40 CFR 721.11537 (P-19-76), 40 CFR 721.11538 (P-19-115), and 40 CFR 721.11539 (P-19-142).

PMN Number: P-19-166.

Chemical Name: Triarylsulfonium alkylestersulfonate (generic).

CAS Number: None available.

Effective Date of TSCA Order: February 12, 2020.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a photoacid generator (PAG). Based on the physical/chemical properties of the PMN substance, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999). EPA estimates that the PMN substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on physical/chemical properties and comparison with analogous chemical substances, EPA has also identified concerns for photosensitization, eye corrosion, irritation, acute toxicity, liver toxicity, neurotoxicity, reproductive/developmental toxicity, and aquatic toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that 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 TSCA Order requires:

1. No manufacture of the PMN substance beyond the time limits specified in the TSCA Order without submittal to EPA of the results of certain testing described in the Testing section of the TSCA Order;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;

4. No modification of the processing of the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process;

5. Use of the PMN substance only as described in the TSCA Order;

6. No domestic manufacture of the PMN substance (import only);

7. Import of the PMN substance only in solution, or in any form in sealed containers weighing 5 kilograms or less; and

8. No exceedance of the confidential annual importation volume listed in the TSCA Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the TSCA Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the TSCA Order without performing the required Tier I and Tier II testing outlined in the Testing section of the TSCA Order.

CFR Citation: 40 CFR 721.11540.

PMN Numbers: P-19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, P-19-179, P-19-180, P-19-181, P-19-182, P-19-184, and P-19-187.

Chemical Names: Halogenated alkylbenzoic acid (generic) (P-19-168, P-19-169, P-19-175, P-19-176, P-19-177, P-19-178, and P-19-179), halogenated benzoic acid (P-19-171, P-19-172, and P-19-173), halogenated sodium benzoate (P-19-180, P-19-181, and P-19-182), and halogenated sodium alkylbenzoate (P-19-184 and P-19-187).

CAS Numbers: Not available.

Effective Date of TSCA Order: January 31, 2020.

Basis for TSCA Order: The PMNs states that the generic (non-confidential) use will be to monitor oil and gas well performance (P-19-180, P-19-181, P-19-182, P-19-184, and P-19-187) and as well performance tracers (P-19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, and P-19-179). Based on the estimated physical/chemical properties of the PMN substances and comparison with analogous chemical substances, EPA has identified concerns for developmental toxicity and neurotoxicity for all of the PMN substances and additionally irritation to skin, eyes, and respiratory tract for P-19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, and P-19-179. 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 substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the TSCA Order requires:

1. No manufacture (including import), processing, or use of any of the PMN substances other than for the confidential use described in each PMN;

2. Submission to EPA of certain toxicity testing before manufacturing (including import) beyond the confidential cumulative production volumes listed in the Testing Section of the TSCA Order;

3. Use of personal protective equipment where there is a potential for dermal exposure to PMN substances P-19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, or P-19-179;

4. Use of engineering controls/processes as specified in the TSCA Order;

5. Use of a NIOSH-certified respirator with an APF of at least 10 where there is a potential for inhalation exposure to PMN substances P-19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, or P-19-179 or compliance with a NCEL of 0.0195 mg/m³ as an 8-hour time-weighted average to prevent inhalation exposure;

6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

7. No manufacture or use of PMN substances P-19-180, P-19-181, P-19-182, P-19-184, or P-19-187 other than in liquid formulations; and

8. No manufacture of the PMN substances P-19-168, P-19-169, P-19-171, P-19-172, P-19-173, P-19-175, P-19-176, P-19-177, P-19-178, or P-19-179 beyond the confidential annual production volume limit specified in the TSCA Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially Useful Information: EPA has determined that certain information about the human health effects of the PMN substances may be potentially useful in support of a request by the PMN submitter to modify the TSCA 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 skin irritation, eye damage, neurotoxicity, reproductive/developmental toxicity, pulmonary effects, and specific target organ toxicity testing may be potentially useful to characterize the human health effects of the PMN substances. Although the TSCA Order does not require these tests, the TSCA Order's restrictions remain in effect until the TSCA Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR Citations: 40 CFR 721.11541 (P-19-168), 40 CFR 721.11542 (P-19-169), 40 CFR 721.11543 (P-19-171), 40 CFR 721.11544 (P-19-172), 40 CFR 721.11545 (P-19-173), 40 CFR 721.11546 (P-19-175), 40 CFR 721.11547 (P-19-176), 40 CFR 721.11548 (P-19-177), 40 CFR 721.11549 (P-19-178), 40 CFR 721.11550 (P-19-179), 40 CFR 721.11551 (P-19-180), 40 CFR 721.11552 (P-19-181), 40 CFR 721.11553 (P-19-182), 40 CFR 721.11554 (P-19-184), and 40 CFR 721.11555 (P-19-187).

V. Rationale and Objectives of the Proposed Rule

A. Rationale

During review of the PMNs submitted for some of the chemical substances that are the subject to 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 IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow 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.

During review of the other chemical substances that are the subject of these proposed SNURs and as further discussed in Unit IV., EPA identified certain other circumstances of use different from the intended conditions of use identified in the PMNs and determined that those changes could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances.

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 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.

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 designated significant new uses are not ongoing.

When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA Orders have been issued for 42 of the 45 chemical substances that are the subject of this proposed SNUR, and the PMN submitters are prohibited by the TSCA Orders from undertaking activities which would be designated as significant new uses. The identities of all of the chemical substances subject to this proposed rule have been claimed as confidential per 40 CFR 720.85. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

Therefore, EPA designates October 9, 2020 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 identified as of that date 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, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known or reasonably ascertainable (40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for all SNURs listed here. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN. EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing on vertebrate animals, EPA encourages 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 potentially useful information. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/​ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

The potentially useful information listed in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) 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 release that may result from the significant new use of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

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 under docket ID number EPA-HQ-OPPT-2020-0131.

X. Statutory and Executive Order Reviews

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/​laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulations and Regulatory Review

This proposed rule would 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)

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.

The information collection activities related to this action have already been approved by OMB under the PRA under 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.

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 seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this 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 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. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This proposed rule 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 proposed rule 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.

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 Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

Dated: September 14, 2020.

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:

PARTS 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, 2613, and 2625(c).

2. Add §§ 721.11401 through 721.11403 and §§ 721.11514 through 721.11555 to subpart E to read as follows:

Subpart E—Significant New Uses for Specific Chemical Substances

* * * * *

* * * * *

721.11401

2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl acrylate, formats (salts) (generic).

721.11402

2-Propenoic acid, 2-methyl, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl methacrylate, formats (salts) (generic).

721.11403

2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with alkylene glycol monoacrylate, formats (salts) (generic).

*  *  *  *  *

721.11514

Organic sulfonate compound (generic).

721.11515

Thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).

721.11516

Sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (generic).

721.11517

Thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).

721.11518

Sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative (generic).

721.11519

Sulfonium, triphenyl-, salt with substituted-alkyl 4-substituted-benzoate (generic).

721.11520

Substituted-triphenylsulfonium, inner salt (generic).

721.11521

Sulfonium, triphenyl-, salt with disubstituted-heterocyclic compound (1:1) (generic).

721.11522

Sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-benzenesulfonate (1:1) (generic).

721.11523

Substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene, 1-ethenyl-4-[(1-ethylcyclopentyl)oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic).

721.11524

Substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene 1-ethenyl-4-[[1-(1-methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic).

721.11525

Dibenzothiophenium, aryl substituted trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (generic).

721.11526

Substituted heterocyclic onium compound, salt with 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with 3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-2-propenoate and 1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-methyl-2-propenoate, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropenoate]-initiated (generic).

721.11527

Sulfonium, triphenyl-, trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (generic).

721.11528

Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1) (generic).

721.11529

Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic)

721.11530

Substituted, (alkylaromatic)diaromatic salt with trihalo-[(trihaloalkyl)substituted]substituted alkaneamide (generic).

721.11531

Triarylsulfonium substituted oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (generic).

721.11532

Substituted triarylsulfonium carbopolycyclic heteromonocyclic dihalo sulfoacetate (generic).

721.11533

Substituted triarylsulfonium substituted carbopolycyclic carboxylate (generic).

721.11534

Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with substituted heteropolycycle dihalo sulfoalkanoate (1:1) (generic).

721.11535

Heteropolycycle, alkylaromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (generic).

721.11536

Sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl polycarbocyclic alkane-1-carboxylate (1:1) (generic).

721.11537

Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1) (generic).

721.11538

Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, substituted carbomonocyclic ester (generic).

721.11539

Heteropolycycle, aromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (1:1) (generic).

721.11540

Triarylsulfonium alkylestersulfonate (generic).

721.11541

Halogenated alkylbenzoic acid (generic).

721.11542

Halogenated alkylbenzoic acid (generic).

721.11543

Halogenated benzoic acid (generic).

721.11544

Halogenated benzoic acid (generic).

721.11545

Halogenated benzoic acid (generic).

721.11546

Halogenated alkylbenzoic acid (generic).

721.11547

Halogenated alkylbenzoic acid (generic).

721.11548

Halogenated alkylbenzoic acid (generic).

721.11549

Halogenated alkylbenzoic acid (generic).

721.11550

Halogenated alkylbenzoic acid (generic).

721.11551

Halogenated sodium benzoate (generic).

721.11552

Halogenated sodium benzoate (generic).

721.11553

Halogenated sodium benzoate (generic).

721.11554

Halogenated sodium alkylbenzoate (generic).

721.11555

Halogenated sodium alkylbenzoate (generic).

* * * * *

§ 721.11401

2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl acrylate, formats (salts) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl acrylate, formats (salts) (PMN P-18-241) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of these substances.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

§ 721.11402

2-Propenoic acid, 2-methyl, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl methacrylate, formats (salts) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as 2-propenoic acid, 2-methyl, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with substituted-alkyl methacrylate, formats (salts) (PMN P-18-244) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of these substances.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

§ 721.11403

2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with alkylene glycol monoacrylate, formats (salts) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as 2-propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, ethyl 2-propenoate, 2-oxrianylmethyl 2-methyl-2-propenoate, and 1,2-propaneidol mono(2-methyl-2-propenoate), reaction products with diethanolamine, polymers with alkylene glycol monoacrylate, formats (salts) (PMN P-18-245) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c), and (i) are applicable to manufacturers and processors of these substances.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.

* * * * *

§ 721.11514

Organic sulfonate compound (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as organic sulfonate compound (PMN P-16-539) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11515

Thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (PMN P-18-157) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11516

Sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, triphenyl-, salt with 2,3-bis(substituted) 5-sulfocarbopolycyclic-2,3-carboxylate derivative (1:1) (PMN P-18-158), is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11517

Thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as thiophenium, 1-(2,7-disubstituted-1-naphthalenyl)tetrahydro-, salt with polyfluoro-N-polyfluoroalkylsulfonyl-1-alkanesulfonamide (1:1) (PMN P-18-159) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11518

Sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, triphenyl-, 5-(alkyl) fluoropentane derivative (PMN P-19-33) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11519

Sulfonium, triphenyl-, salt with substituted-alkyl 4-substituted-benzoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, triphenyl-, salt with substituted-alkyl 4-substituted-benzoate (PMN P-17-178) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), and (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11520

Substituted-triphenylsulfonium, inner salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted-triphenylsulfonium, inner salt (PMN P-18-13) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11521

Sulfonium, triphenyl-, salt with disubstituted-heterocyclic compound (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, triphenyl-, salt with disubstituted-heterocyclic compound (1:1) (PMN P-18-14) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11522

Sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-benzenesulfonate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, triphenyl-, salt with 2,4,5-trisubstituted-benzenesulfonate (1:1) (PMN P-18-37) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11523

Substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene, 1-ethenyl-4-[(1-ethylcyclopentyl)oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene, 1-ethenyl-4-[(1-ethylcyclopentyl)oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-19-78) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11524

Substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene 1-ethenyl-4-[[1-(1-methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted heterocyclic onium compound, salt with 2,2,2-trifluoro-1-(sulfomethyl)-1-(trifluoromethyl)ethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with acenaphthylene 1-ethenyl-4-[[1-(1-methylethyl)cyclopentyl]oxy]benzene and 4-ethenylphenol, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-19-79) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11525

Dibenzothiophenium, aryl substituted trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as dibenzothiophenium, aryl substituted trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (PMN P-19-111) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11526

Substituted heterocyclic onium compound, salt with 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with 3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-2-propenoate and 1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-methyl-2-propenoate, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropenoate]-initiated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted heterocyclic onium compound, salt with 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl 3-[(2-methyl-1-oxo-2-propen-1-yl)oxy]tricyclo[3.3.1.13,7]decane-1-carboxylate (1:1), polymer with 3-ethenylphenol, 1-(1-methylethyl)cyclopentyl 2-methyl-2-propenoate and 1-(7-oxabicyclo[2.2.1]hept-2-yl)cyclopentyl 2-methyl-2-propenoate, di-Me 2,2′-(1,2-diazenediyl)bis[2-methylpropenoate]-initiated (PMN P-19-112) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11527

Sulfonium, triphenyl-, trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, triphenyl-, trifluoro-hydroxy-(triheterosubstitutedalkyl)alkanoate (1:1) (PMN P-19-114) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11528

Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, triphenylsulfonium (1:1) (PMN P-19-133) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11529

Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (PMN P-18-16) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to use or process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11530

Substituted, (alkylaromatic)diaromatic salt with trihalo-[(trihaloalkyl)substituted]substituted alkaneamide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted, (alkylaromatic)diaromatic salt with trihalo-[(trihaloalkyl)substituted]substituted alkaneamide (PMN P-18-297) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11531

Triarylsulfonium substituted oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as triarylsulfonium substituted oxatricycloalkyloxycarbonyl dihalo alkane sulfonate (PMN P-18-311) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11532

Substituted triarylsulfonium carbopolycyclic heteromonocyclic dihalo sulfoacetate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted triarylsulfonium carbopolycyclic heteromonocyclic dihalo sulfoacetate (PMN P-18-314) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11533

Substituted triarylsulfonium substituted carbopolycyclic carboxylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as substituted triarylsulfonium substituted carbopolycyclic carboxylate (PMN P-18-315) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11534

Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with substituted heteropolycycle dihalo sulfoalkanoate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with substituted heteropolycycle dihalo sulfoalkanoate (1:1) (PMN P-18-304) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11535

Heteropolycycle, alkylaromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified heteropolycycle, alkylaromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (PMN P-18-316) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11536

Sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl polycarbocyclic alkane-1-carboxylate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, triaryl-, salt with polyhalo-4-sulfoalkyl polycarbocyclic alkane-1-carboxylate (1:1) (PMN P-18-338) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11537

Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, bis(dihalocarbomonocycle) carbomonocycle, salt with dihalo substituted alkyl carbopolycyclic carboxylate (1:1) (PMN P-19-76) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11538

Sulfonium, bis(dihalocarbomonocycle) carbomonocycle, substituted carbomonocyclic ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as sulfonium, bis(dihalocarbomonocycle) carbomonocycle, substituted carbomonocyclic ester (PMN P-19-115) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11539

Heteropolycycle, aromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as heteropolycycle, aromatic-, salt with dihalo-substituted alkyl carbopolycycle carboxylate (1:1) (PMN P-19-142) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new use is:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11540

Triarylsulfonium alkylestersulfonate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as triarylsulfonium alkylestersulfonate (PMN P-19-166) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted or adhered (during the photolithographic process) onto a semiconductor water surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (e), (g)(1)(i), (2)(i) through (iii), and (v), (3)(i) and (ii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity.

(iii) Industrial, commercial, and consumer use. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the PMN substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to use or process the PMN substance in any way that generates a dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the PMN substance longer than 18 months.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11541

Halogenated alkylbenzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated alkylbenzoic acid (PMN P-19-168) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (iv), and (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11542

Halogenated alkylbenzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated alkylbenzoic acid (PMN P-19-169) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), (3) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11543

Halogenated benzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated benzoic acid (PMN P-19-171) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), (3) through (6), and (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11544

Halogenated benzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated benzoic acid (PMN P-19-172) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), and (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), (ix)(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11545

Halogenated benzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated benzoic acid (PMN P-19-173) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), and (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix)(eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11546

Halogenated alkylbenzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated alkylbenzoic acid (PMN P-19-175) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), and (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11547

Halogenated alkylbenzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated alkylbenzoic acid (PMN P-19-176) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), and (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11548

Halogenated alkylbenzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated alkylbenzoic acid (PMN P-19-177) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), and (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11549

Halogenated alkylbenzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated alkylbenzoic acid (PMN P-19-178) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11550

Halogenated alkylbenzoic acid (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated alkylbenzoic acid (PMN P-19-179) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (2)(i) and (iii), and (iv), and (3) through (6), and (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(a)(6), the airborne form(s) of the substance include particulate, gas/vapor (all substances in the gas form), combination gas/vapor and particulate (gas and liquid/solid physical states are present; a good example is paint spray mist, which contains both liquid droplets and vapor). For purposes of § 721.63(b), the concentration is set at 1.0%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.0195 mg/m³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons who § 721.30 requests to use the NCELs approach that are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) consent order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (v), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. For purposes of § 721.72(g)(2)(iv), use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.0195 mg/m³. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), and (t). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§ 721.11551

Halogenated sodium benzoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated sodium benzoate (PMN P-19-180) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (iii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance. It is a significant new use to manufacture or use the PMN substance other than in liquid formulations.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (f) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

§ 721.11552

Halogenated sodium benzoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated sodium benzoate (PMN P-19-181) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (iii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance. It is a significant new use to manufacture or use the PMN substance other than in liquid formulations.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (f) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

§ 721.11553

Halogenated sodium benzoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated sodium benzoate (PMN P-19-182) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (iii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance. It is a significant new use to manufacture or use the PMN substance other than in liquid formulations.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (f) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

§ 721.11554

Halogenated sodium alkylbenzoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated sodium alkylbenzoate (PMN P-19-184) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (iii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance. It is a significant new use to manufacture or use the PMN substance other than in liquid formulations.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (f) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

§ 721.11555

Halogenated sodium alkylbenzoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as halogenated sodium alkylbenzoate (PMN P-19-187) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (e), (f), (g)(1)(ii) through (iv), (vi), and (ix) (eye and skin irritation), (g)(2)(i) through (iii), and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1)(i), required human health hazard statements include acute toxicity, skin sensitization, serious eye damage, specific target organ toxicity, neurotoxicity, genetic toxicity, and reproductive toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) and (q). It is a significant new use to manufacture or process the PMN substance without including the engineering controls/processes described in the TSCA section 5(e) consent order for the substance. It is a significant new use to manufacture or use the PMN substance other than in liquid formulations.

(b) Specific requirements. The provision of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (c) and (f) through (i) are applicable to manufacturers and processors of this substance.

(2) Limitations or revocation of certain modification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.