['Toxic Substances Control Act - EPA']
['Toxic Subtances Control Act - EPA']
06/11/2024
...
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2022-0771; FRL-11912-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (22-4.5e)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to a TSCA Order. 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 conditions of use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.
DATES: Comments must be received on or before July 11, 2024.
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2022-0771, at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:For technical information contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: wysong.william@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. 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 factors in TSCA section 5(a)(2) (see also the discussion in Unit II.).
B. What action is the Agency taking?
EPA is proposing SNURs for the chemical substances discussed in Unit III. These SNURs, if finalized as proposed, would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
C. Does this action apply to me?
1. General Applicability
This action applies to you if you manufacture, process, or use the chemical substances identified in Unit III. This may include entities in North American Industrial Classification System (NAICS) codes 325 and 324110, e.g., chemical manufacturing and petroleum refineries.
2. Applicability to Importers and Exporters
This action may also apply to certain entities through pre-existing import certification and export notification requirements under TSCA ( https://www.epa.gov/tsca-import-export-requirements ).
Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28), and the EPA policy in support of import certification at 40 CFR part 707, subpart B. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV.
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 July 11, 2024 are subject to TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.
D. What are the incremental economic impacts of this action?
EPA has evaluated the potential costs of establishing SNUN reporting requirements for potential manufacturers (including importers) and processors of the chemical substances subject to these proposed SNURs. This analysis, which is available in the docket, is briefly summarized here.
1. Estimated Costs for SNUN Submissions
If a SNUN is submitted, costs are an estimated $45,000 per SNUN submission for large business submitters and $14,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission for SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in these SNURs. Additionally, these estimates reflect the costs and fees as they are known at the time of this rulemaking.
2. Estimated Costs for Export Notifications
EPA has also evaluated the potential costs associated with the export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by these SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $106.
E. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
This unit provides general information about SNURs. For additional information about EPA's new chemical program go to https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
A. Significant New Use Determination Factors
TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit and discussed in Unit III.
These proposed SNURs 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 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).
B. Rationale and Objectives of the SNURs
1. Rationale
Under TSCA, no person may manufacture a new chemical substance or manufacture or process a chemical substance for a significant new use until EPA makes a determination as described in TSCA section 5(a) and takes any required action. The issuance of a SNUR is not a risk determination itself, only a notification requirement for “significant new uses,” so that the Agency has the opportunity to review the SNUN for the significant new use and make a TSCA section 5(a)(3) risk determination.
During review of the PMNs submitted for these chemical substances, 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 these chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow 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.
2. Objectives
EPA is proposing these SNURs because the Agency wants:
• To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
• To have an opportunity to review and evaluate data submitted in a SNUN before the submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.
Issuance of a proposed 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 at https://www.epa.gov/tsca-inventory.
C. Significant New Uses Claimed as CBI
EPA is proposing to establish certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with the situation where a specific significant new use is CBI.
Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.11 into a single step.
If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.
D. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to SNURs, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule.
Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with the same requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. In addition, provisions relating to user fees appear at 40 CFR part 700.
Once EPA receives a SNUN, EPA must either determine that the significant new 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 under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence. If EPA determines that the conditions of use of the chemical substance is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to publish a statement of EPA's findings in the Federal Register .
As discussed in Unit I.C.2., persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b), and persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements. See also https://www.epa.gov/tsca-import-export-requirements.
E. Applicability of the Proposed SNURs to Uses Occurring Before the Effective Date of the Final Rule
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 and received determinations under TSCA section 5(a)(3)(C). TSCA Orders have been issued for these chemical substances and the PMN submitters are required by the TSCA Orders to submit a SNUN before undertaking activities that would be designated as significant new uses in these SNURs. Additionally, the identities of many of the chemical substances subject to this proposed rule have been claimed as confidential per 40 CFR 720.85, further reducing the likelihood that another party would manufacture or process the substances for an activity that would be designated as a significant new use. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses identified in Unit III. are ongoing.
When the chemical substances identified in Unit III. 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. Persons who begin manufacture or processing of the chemical substances for a significant new use identified on or after the designated cutoff date specified in Unit III.A. 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 EPA would have to take action under TSCA section 5 allowing manufacture or processing to proceed.
F. Important Information About SNUN Submissions
1. SNUN Submissions
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
2. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. To assist with EPA's analysis of the SNUN, submitters are encouraged, but not required, to provide the potentially useful information identified for the chemical substance in Unit III.C.
EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information described in Unit III.C. for these chemical substances may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any information may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests to provide useful information with their SNUN submission.
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.
III. Chemical Substances Subject to These Proposed SNURs
A. What is the designated cutoff date for ongoing uses?
EPA designates June 11, 2024, as the cutoff date for determining whether the new use is ongoing. This designation is explained in more detail in Unit II.E.
B. What information is provided for each chemical substance?
For each chemical substance identified in Unit III.C., EPA provides the following information:
• PMN number (the proposed CFR citation assigned in the regulatory text section of this document).
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service Registry Number (CASRN) (if assigned for non-confidential chemical identities).
• Basis for the action or, as applicable, the effective date of and basis for the TSCA Order.
• Potentially useful information.
The regulatory text section of the proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the proposed rules, may be claimed as CBI.
These 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). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs provisions in TSCA Orders include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions for SNURs currently exist in 40 CFR part 721, subpart B. 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 are approved by EPA, will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA Order.
C. Which chemical substances are subject to this proposed rule?
The substances subject to the proposed rules in this document are as follows:
PMN Number: P-18-398 (40 CFR 721.11860)
Chemical Name: 1,2-Ethanediamine, N-(1-methylethyl)-N-[2-[(1-methylethyl)amino]ethyl]-.
CASRN: 10507-06-9.
Effective Date of TSCA Order: April 13, 2022.
Basis for TSCA Order: The PMN states that the use will be as an intermediate. Based on comparison to analogous substances, EPA has identified concerns for acute toxicity, skin sensitization, eyes, skin, and respiratory tract corrosion, and systemic, reproductive, and developmental effects. Based on comparison to analogous aliphatic amines, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 210 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified full facepiece gas/vapor respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS; and
• No use of the PMN substance other than for the confidential use allowed in the 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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity and skin sensitization testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-19-49 (40 CFR 721.11861)
Chemical Name: Fatty acids, polymers with substituted carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and halo-substituted heteromonocycle, formates (salts) (generic).
CASRN: Not available.
Effective Date of Modified TSCA Order: May 19, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an isolated intermediate coating resin. Based on the amine content and the surfactant properties of the PMN substance, EPA has identified concerns for irritation to all tissues. Based on formic acid, EPA has also identified concerns for neurotoxicity, blood toxicity, and developmental toxicity. Based on test data on the PMN substance, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 114 ppb. EPA issued an Order 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. The Order, effective October 27, 2020, required the submitter of P-19-49 to submit to EPA the results of certain toxicity testing before any manufacturing (which includes import), processing, or use of the PMN substance. On September 17, 2021, the PMN submitter provided the results of three environmental toxicity studies in accordance with the requirements of the Order. EPA reviewed those studies and determined the studies to be valid. EPA subsequently modified the terms of the Order to mitigate any unreasonable risks to human health and the environment and issued a modified Order, effective May 19, 2022. To protect against these potential risks, the modified Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No manufacture or processing of the PMN substance in a manner that generates a vapor, mist, or aerosol;
• No use of the PMN substance in a manner that generates a vapor, mist, or aerosol that results in inhalation to industrial or commercial workers;
• No manufacture the PMN substance to contain the confidential residual identified in the Order at greater than 0.1%; and
• No release of the PMN substance resulting in surface water concentrations that exceed 114 ppb.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, eye irritation, developmental/reproductive toxicity, pulmonary effects, and neurotoxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-19-160 (40 CFR 721.11862)
Chemical Name: Alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-substituted]-, sodium salt (1:1), polymer with .alpha.-[2,2-bis(hydroxymethyl)butyl]-.omega.-methoxypoly(oxy-1,2-ethanediyl) and 1,1′-methylenebis[4-isocyanatocyclohexane], acrylic acid-dipenthaerythritol reaction products- and polypropylene glycol ether with pentaerythritol (4:1) triacrylate-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: July 27, 2022.
Basis for TSCA Order: The PMN states that the use will be as a component of a UV curable printing ink. Based on analogue data and information provided in the SDS, EPA has identified concerns for skin irritation and dermal and respiratory sensitization. Based on analogue data and data on a component of the PMN substance, EPA has identified concerns for eye irritation/corrosion and genotoxicity. Based on analogue data, EPA has also identified concerns for systemic toxicity, developmental toxicity, and neurotoxicity. Based on comparison to analogous polyanionic polymers, EPA predicts that the PMN substance has low environmental hazard. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure; and
• No release of the PMN substance resulting in surface water concentrations that exceed 302 ppb.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, reproductive toxicity (developmental effects), skin sensitization, skin irritation, eye damage, carcinogenicity, and genetic toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-20-101 (40 CFR 721.11863)
Chemical Name: Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), (haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy-carbomonocycle] alkenoate and isocyanate-alkyl-carbomonocycle, hydroxyalkyl acrylate-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: July 27, 2022.
Basis for TSCA Order: The PMN states that the use will be as a coating resin. Based on structural alerts and test data for an analogue and feedstock component, EPA has identified concerns for skin, eye, and respiratory tract irritation; skin and respiratory sensitization; acute neurotoxicity; and systemic and reproductive effects. Based on test data for a metabolite of the PMN substance, as well as analogues of the LMW fraction, EPA has identified concerns for eye and respiratory tract irritation; skin sensitization; portal-of-entry effects; and systemic, reproductive, and developmental effects. Based on hazard data for an analogous chemical and comparison to analogous polyanionic polymers (and monomers), EPA predicts that the substance has moderate environmental 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 Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified combination particulate and gas/vapor respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No manufacture or processing of the PMN substance with greater than 20% (by weight) oligomer content below 1,000 daltons ( i.e., low molecular weight species);
• No processing or use of the PMN substance for manual spray application;
• No processing of the PMN substance for use in a consumer product; and
• No use of the PMN substance in a consumer product.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require this test, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-20-182 (40 CFR 721.11864)
Chemical Name: 1,4-Benzenedicarboxylic acid, bis[2-(2-butoxyethoxy)ethyl] ester (9CI).
CASRN: 90430-63-0.
Effective Date of TSCA Order: April 21, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a plasticizer for PVC formulations. Based on the structural alert for ethylene glycol ethers, EPA has identified concerns for neurotoxicity, kidney effects, immunotoxicity, and blood effects. Based on test data on the PMN substance, EPA has identified concerns for skin sensitization and mutagenicity. Based on test data for an analogue, EPA has identified concerns for skin sensitization. Based on test data on potential metabolites, EPA has also identified concerns for acute toxicity (mortality), lung toxicity, systemic effects, and developmental effects. Based on test data on the PMN substance and comparison to analogous chemical substances, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate respirator with an APF of at least 1,000 where there is a potential for inhalation exposure, or compliance with an NCEL of 0.01 mg/m 3 as an 8-hour time-weighted average to prevent inhalation exposure;
• No release of the PMN substance resulting in surface water concentrations that exceed 4 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of metabolism or pharmacokinetics, skin sensitization, reproductive toxicity, developmental toxicity, immunotoxicity, neurotoxicity, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-56 (40 CFR 721.11865)
Chemical Name: Isocyanic acid, polyalkylenepolyarylene ester, polymer with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and alkoxylalkoxyalcohol-blocked (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 11, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a component of coatings. Based on data on an analogous chemical substance, EPA has identified concerns for acute neurotoxicity and skin sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate, gas/vapor, or combination particulate and gas/vapor (as appropriate to the conditions) respirator with an APF of at least 50, or 1,000 if spray applied, where there is a potential for inhalation exposure;
• No manufacture of the PMN substance beyond 24 months without submittal to EPA of the results of certain testing described in the Testing section of the Order;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS; and
• No use of the PMN substance in a consumer product.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of neurotoxicity and acute toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. In addition, the submitter has agreed not to exceed the time limit specified in the Order without performing the required testing outlined in the Testing section of the Order.
PMN Numbers: P-21-58 (40 CFR 721.11866), P-21-60 (40 CFR 721.11867), and P-21-61 (40 CFR 721.11868)
Chemical Names: Substituted alkanoic acid, compound with aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol (generic) (P-21-58); Bisphenol A epichlorohydrin polymer with alkylpolyalkene-polyarylene-hydroxypolyoxyalkyldiyl reaction products with alkylalkylidenealkylalkylidene- aminoalkyl-alkanepolyamine and alkylaminoalkanol (generic) (P-21-60); and Sulfur based acid, compds. with modified bisphenol A-epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-dialkylalkylidene-N- (dialkylalklyidene)aminoalkyl-alkanepolyamine-alkylaminoalkanol reaction products (generic) (P-21-61).
CASRNs: Not available.
Effective Date of TSCA Order: May 9, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-confidential) use will be as a component in coatings (P-21-58 and P-21-61) and as an isolated intermediate (P-21-60). Based on the surfactant-like properties of P-21-58, EPA has identified concerns for lung effects and irritation to the skin, eyes, and respiratory tract. Based on data for an analogue of the lower molecular weight fraction of P-21-58, EPA has also identified concerns for neurotoxicity, cardiovascular effects, and systemic effects. Based on a structural alert for aliphatic amines and data for the expected hydrolysis product, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract; neurotoxicity; mortality; systemic effects; developmental effects; and carcinogenicity for P-21-60 and P-21-61. Based on comparison to analogous polycationic polymers, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 50 ppb for P-21-58. Based on comparison to analogous aliphatic amines and polycationic polymers, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 11 ppb for P-21-60. Based on comparison to analogous aliphatic amines, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 11 ppb for P-21-61. 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 Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No manufacture, processing, or use the PMN substances in any manner that results in inhalation exposure;
• No use of the PMN substances in a consumer product;
• No release of P-21-58 resulting in surface water concentrations that exceed 50 ppb;
• No release of P-21-60, or any waste stream containing P-21-60, into water; and
• No release of P-21-61 resulting in surface water concentrations that exceed 11 ppb.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, neurotoxicity, skin irritation, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances. EPA has also determined that the results of eye irritation, pulmonary effects, developmental toxicity, and carcinogenicity testing may be potentially useful to characterize the health effects of P-21-60 and P-21-61. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-66 (40 CFR 721.11869)
Chemical Name: 1,2-Alkanediol, 3-aryloxy, mono phosphate ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 10, 2022.
Basis for TSCA Order: The PMN states that the use will be as a blended or standalone epoxy curative (hardener) and foaming agent when blended with certain ingredients. Based on information provided in the SDS and the low pH of the PMN substance when neat, EPA has identified concerns for skin, eye, and respiratory tract corrosion. Based on release of the free phosphate, EPA has also identified concerns for blood effects and irritation to the skin, eyes, and respiratory tract. Based on analogue data and the structural alert for phosphate esters, EPA has identified concerns for acute toxicity, acute neurotoxicity, corrosion to skin and eyes, and delayed neurotoxicity. Based on test data for an analogue of the hydrolysis product, EPA has also identified concerns for acute toxicity, eye irritation, systemic effects, and developmental effects. Based on comparison to an analogous chemical substance, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No use of the PMN substance in a consumer product;
• No use of the PMN substance other than as an epoxy curative;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure or that results in fugitive air emissions; and
• No release of the PMN substance, or any waste stream containing the PMN substance, into water.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, eye irritation/corrosion, skin corrosion, specific target organ toxicity, pulmonary effects, developmental toxicity, neurotoxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-68 (40 CFR 721.11870)
Chemical Name: Metalloxanes, alkyl, alkyl group-terminated, reaction products with dihalo-dialkylalkylaryl-alkyl-polycyclic-ylidene(dialkylsilylene)-dialkylalkylaryl-alkylalkyl-polycyclic- ylidene, metal oxide and nonmetallic oxide (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 27, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a polymerization catalyst. Based on the reactivity of the PMN substance and the release of hydrochloric acid, EPA has identified concerns for an acute handling hazard; irritation and corrosion to the skin, eyes, and respiratory tract; and lung overload (if respirable, poorly soluble particulates are inhaled). Based on analogue data, EPA has identified concerns for irritation to skin, eyes, and respiratory tract; lung effects; serious eye damage and ocular corrosion; portal-of-entry effects; mutagenicity; acute neurotoxicity; systemic effects; reproductive/developmental effects; and dermal and respiratory sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No manufacture, processing, or use of the PMN substance other than in an enclosed process;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation or dermal exposure to the PMN substance; and
• No release of the PMN substance resulting in surface water concentrations that exceed 50 ppb.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, skin sensitization, skin corrosion, specific target organ toxicity, pulmonary effects, reproductive toxicity, and mutagenicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-83 (40 CFR 721.11871)
Chemical Name: Alkenoic acid, reaction products with pentaerythritol, polymers with diisocyanatoalkane and heteromonocyle homopolymer esters with alkanoic acid-pentaerythritol reaction products (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 6, 2022.
Basis for TSCA Order: The PMN states that the use will be as a UV curable resin. Based on information provided in the SDS and a structural alert for acrylates, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract. Based on a structural alert for acrylates for the low molecular weight fraction, OECD QSAR Toolbox results for the feedstock present as a residual, and information provided in the SDS, EPA has also identified concerns for skin and respiratory sensitization. Based on multifunctional reactive groups, EPA has identified respiratory sensitization. Based on test data for the feedstock residual, EPA has identified concerns for skin irritation, clinical signs, systemic effects, and irritation in the GI tract. Based on comparison to analogous acrylates/methacrylates and esters, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified Combination Particulate and Gas/Vapor respirator with an APF of 1,000 where there is a potential for inhalation exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No use of the PMN substance in a consumer product; and
• No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, eye damage, specific target organ toxicity, and skin sensitization testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-84 (40 CFR 721.11872)
Chemical Name: Carbopolycycle octa-alkene, halo (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 27, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a chemical intermediate. Based on test data for an analogue, EPA has identified concerns for severe irritation/corrosion to the skin, eyes, and respiratory tract, acute toxicity, and mutagenicity. Based on OECD Toolbox results, EPA has also identified concerns for skin sensitization. Based on comparison to analogous benzyl halides, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified Gas/Vapor respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• No release of the PMN substance resulting in surface water concentrations that exceed 7 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, specific target organ toxicity, skin corrosion, eye damage, skin sensitization, genetic toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-92 (40 CFR 721.11873)
Chemical Name: 2-Propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-yl)alkyl ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: April 5, 2022.
Basis for TSCA Order: The PMN states that the uses of the PMN substance will be for thermoset composites, 3D printing, and industrial coatings. Based on test data for the PMN substance, EPA has identified concerns for skin irritation. Based on information provided in the SDS, EPA has also identified concerns for skin irritation and eye irritation. Based on test data for a hydrolysis product, EPA has identified concerns for developmental, body weight, and portal-of-entry (inhalation and oral) effects. Based on test data for an analogue, EPA has also identified concerns for clinical signs, skin irritation, eye irritation, and developmental, body weight, and lung effects. Based on test data for an analogue, EPA identified concerns for portal-of-entry (inhalation) and liver effects. Based on comparison to analogous acrylates/methacrylates and imides, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 13 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified combination particulate and gas/vapor respirator with an APF of at least 10 to prevent inhalation exposure where there is a potential for inhalation exposure;
• Disposal of the PMN substance only by incineration or by RCRA Subtitle C landfill;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No use of the PMN substance in a consumer product;
• No use of the PMN substance where the concentration of the PMN substance exceeds 40% in formulation when inhalation exposure is expected; and
• No release of the PMN substance, or any waste stream containing the PMN substance, into water.
The proposed SNUR designates as a “significant new use” the absence of these protective measures.
Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR. EPA has determined that the results of developmental toxicity, specific target organ toxicity, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the environmental and human health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-102 (40 CFR 721.11874)
Chemical Name: Heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).
CASRN: Not available.
Effective Date of TSCA Order: May 20, 2022.
Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a raw material for industrial additive manufacturing, UV-curable inks, coatings and adhesives. Based on TSCA New Chemical Category document for acrylates, EPA has identified concerns for skin sensitization and irritation to the skin, eyes, and respiratory tract. Based on test data for an analogue of the low molecular weight fraction, EPA has also identified concerns for systemic and developmental effects. Based on comparison to analogous acrylates/methacrylates and esters, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 337 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified Combination Particulate and Gas/Vapor respirator with an APF of at least 10 where there is a potential for inhalation exposure;
• No use of the PMN substance in a consumer product;
• No release of the PMN substance resulting in surface water concentrations that exceed 337 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, skin sensitization, eye damage, developmental toxicity, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Numbers: P-21-109 (40 CFR 721.11875), P-21-110 (40 CFR 721.11876), P-21-111 (40 CFR 721.11877), P-21-112 (40 CFR 721.11878), P-21-113 (40 CFR 721.11879), P-21-114 (40 CFR 721.11880), P-21-116 (40 CFR 721.11881), P-21-117 (40 CFR 721.11882), P-21-118 (40 CFR 721.11883), P-21-119 (40 CFR 721.11884), P-21-121 (40 CFR 721.11885), P-21-122 (40 CFR 721.11886), and P-21-123 (40 CFR 721.11887)
Chemical Names: Hydrocarbons linear and branched, light alkylate (generic) (P-21-109), Hydrocarbons linear and branched, light catalytic cracked (generic) (P-21-110), Hydrocarbons linear and branched, heavy catalytic cracked (generic) (P-21-111), Hydrocarbons linear and branched, light hydrocracked (generic) (P-21-112), Hydrocarbons linear and branched, isomerization (generic) (P-21-113), Hydrocarbons linear and branched, heavy catalytic reformed (generic) (P-21-114), Hydrocarbons linear and branched, hydrotreated light (generic) (P-21-116), Hydrocarbons linear and branched, hydrotreated light paraffinic (generic) (P-21-117), Hydrocarbons linear and branched, light catalytic cracked (generic) (P-21-118), Hydrocarbons linear and branched, heavy hydrocracked (generic) (P-21-119), Hydrocarbons linear and branched, heavy catalytic cracked (generic) (P-21-121), Hydrocarbons linear and branched, heavy hydrocracked (generic) (P-21-122), and Hydrocarbons linear and branched, light hydrocracked (generic) (P-21-123).
CASRNs: Not available.
Effective Date of TSCA Order: July 14, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-confidential) use will be as a component in fuels (P-21-109, P-21-110, P-21-111, P-21-112, P-21-113, P-21-114, P-21-116, P-21-117, P-21-121, and P-21-123) or as a chemical intermediate (P-21-118, P-21-119, and P-21-122). Based on available information on compositionally analogous mixtures and on constituents of the PMN substances, EPA has identified concerns for skin and eye irritation, acute toxicity, systemic toxicity (neurotoxicity, body weight effects, and liver, kidney, blood, spleen, and other organ effects), reproductive and developmental toxicity, oral and inhalation portal entry effects, genetic toxicity, and carcinogenicity. Based on the chemical composition (petroleum) of the PMN substances, EPA has also identified concerns for hydrocarbon pneumonia/aspiration hazard. EPA assumes that respiratory tract irritation is possible from exposure to the PMN substances. Based on comparison to analogous chemical substances and data on constituents of the PMN substances, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 0.3 ppb. 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 Order requires:
• No manufacture, processing, or use of the PMN substances other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, eye irritation, respiratory depression/irritation, hydrocarbon developmental toxicity, systemic toxicity, genetic toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances. Additionally, the results of consumer inhalation exposure testing/monitoring at gas stations may be potentially useful to characterize the degree of exposure to the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Number: P-21-197 (40 CFR 721.11888)
Chemical Name: Imidazole-carboxylic acid, substituted (generic).
CASRN: Not available.
Effective Date of TSCA Order: June 20, 2022.
Basis for TSCA Order: The PMN states that the use will be as an additive for use in battery electrolyte formulations. Based on analogue data, EPA has identified concerns for acute neurotoxicity and skin sensitization. Based on test data for potential metabolites, EPA has also identified concerns for acute toxicity, skin corrosion, eye irritation, and systemic, respiratory tract, reproductive, and developmental effects. Based on acute hazard data for an analogous chemical substance, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 380 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified Combination Particulate and Gas/Vapor respirator with an APF of 50 where there is a potential for inhalation exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No domestic manufacture of the PMN substance (i.e., import only);
• No processing or use of the PMN substance other than in an enclosed process, except that sampling and equipment cleaning operations need not occur in an enclosed process; and
• No disposal of the PMN substance or waste streams containing the PMN substance other than by incineration with 99.9% efficiency.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, acute toxicity, metabolism/pharmacokinetics, specific target organ toxicity, skin corrosion, eye damage, skin sensitization, pulmonary effects, reproductive toxicity, and developmental toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
PMN Numbers: P-21-216 (40 CFR 721.11889) and P-21-217 (40 CFR 721.11890)
Chemical Names: Multi-walled carbon nanotubes (generic) (P-21-216 and P-21-217).
CASRNs: Not available.
Effective Date of TSCA Order: May 31, 2022.
Basis for TSCA Order: The PMNs state that the generic (non-confidential) use will be as an additive in electrode materials and plastics (P-21-216) or as an additive in electrode materials and thermoplastics, and a component in electrodes (P-21-217). Based on comparison to analogous carbon-based nanomaterials, EPA has identified concerns for lung toxicity, lung fibrosis, lung cancer, pleural toxicity (inflammation), pleural fibrosis, and pleural cancer (mesothelioma). Based on hazard data for a residual and test data for multi-walled carbon nanotube analogues, EPA has also identified concerns acute neurotoxicity, skin and respiratory sensitization, reproductive and developmental toxicity, lung effects, systemic effects, immunotoxicity, eye and skin irritation, mutagenicity, genotoxicity, and carcinogenicity. EPA was unable to estimate the environmental hazard of the PMN substances. 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 Order requires:
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate respirator with an APF of at least 1,000 if the capture and reduction rate is at least 99.5% but not 99.975% or greater, or an APF of at least 50 if the capture and reduction rate is at least 99.975%, where there is a potential for inhalation exposure;
• No domestic manufacture of the PMN substances (i.e., import only);
• No manufacture of the PMN substances to contain the confidential impurity listed in the Order at greater than 1% (by weight);
• No use of the PMN substances other than for the confidential use allowed in the Order;
• No processing or use of the PMN substances other than in application methods that do not generate a vapor, mist, dust, or aerosol unless such application method occurs in an enclosed process;
• No disposal of the PMN substances or waste streams containing the PMN substances other than by landfill or incineration;
• No release of the PMN substances directly, either by point (stack) or non-point (fugitive) sources, to air;
• No release of the PMN substances, or any waste stream containing the PMN substances, into water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.
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 may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of carcinogenicity, eye irritation, skin irritation, genetic toxicity, developmental toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.
IV. 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 14094: Modernizing Regulatory Review
This action proposes to establish SNURs for 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 Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023).
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 requirements related to SNURs have already been approved by OMB pursuant to PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per submission. 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.
EPA always welcomes your feedback on the burden estimates. Send any comments about the accuracy of the burden estimate, and any suggested methods for improving the collection instruments or instruction or minimizing respondent burden, including through the use of automated collection techniques.
C. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ). The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities.
A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 16 in Federal Fiscal Year (FY) FY2018, five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in FY 2023, and only a fraction of these submissions were from small businesses.
In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $37,000 to $6,480. This lower fee reduces the total reporting and recordkeeping cost of submitting a SNUN to about $14,500 per SNUN submission for qualifying small firms. Therefore, the potential economic impacts of complying with these proposed SNURs 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 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)
This action does not contain an unfunded mandate of $100 million or more in any one year (in 1995 dollars) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by SNURs. In addition, the estimated costs of this action to the private sector do not exceed $183 million or more in any one year (the 1995 dollars are adjusted to 2023 dollars for inflation using the GDP implicit price deflator). The estimated costs for this action are discussed in Unit I.D.
E. Executive Order 13132: Federalism
This action will not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not expected to 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. Accordingly, the requirements of Executive Order 13132 do not apply to this action.
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action will not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 do not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern human health, EPA's 2021 Policy on Children's Health also does not apply. Although the establishment of these SNURs do not address an existing children's environmental health concern because the chemical uses involved are not ongoing uses, SNURs require that persons notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this rulemaking. This notification allows EPA to assess the conditions of use to identify potential risks and take appropriate actions before the activities commence.
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
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 and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All
This action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to the potential for disproportionate impacts on non-white and low-income populations in accordance with Executive Order 12898 (59 FR 7629, February 16, 1994) and Executive Order 14096 (88 FR 25251, April 26, 2023). Although this action does not concern human health or environmental conditions, the premanufacture notifications required by these SNURs allow EPA to assess the conditions of use to identify potential disproportionate risks and take appropriate actions before the activities commence.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Dated: June 6, 2024.
Mary Elissa Reaves,
Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to amend 40 CFR chapter 1 as follows:
PART 721—SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
1. The authority citation for part 721 continues to read as follows:
Authority:
15 U.S.C. 2604, 2607, and 2625(c)
2. Add §§721.11860 through 721.11890 to subpart E to read as follows:
Subpart E—Significant New Uses for Specific Chemical Substances
Sec.
* * * * *
721.11860 1,2-Ethanediamine, N-(1-methylethyl)-N-[2-[(1-methylethyl)amino]ethyl]-.
721.11861 Fatty acids, polymers with substituted carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and halo-substituted heteromonocycle, formates (salts) (generic).
721.11862 Alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-substituted]-, sodium salt (1:1), polymer with .alpha.-[2,2-bis(hydroxymethyl)butyl]-.omega.-methoxypoly(oxy-1,2-ethanediyl) and 1,1′-methylenebis[4-isocyanatocyclohexane], acrylic acid-dipenthaerythritol reaction products- and polypropylene glycol ether with pentaerythritol (4:1) triacrylate-blocked (generic).
721.11863 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), (haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy- carbomonocycle] alkenoate and isocyanate-alkyl-carbomonocycle, hydroxyalkyl acrylate-blocked (generic).
721.11864 1,4-Benzenedicarboxylic acid, bis[2-(2-butoxyethoxy)ethyl] ester (9CI).
721.11865 Isocyanic acid, polyalkylenepolyarylene ester, polymer with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and alkoxylalkoxyalcohol-blocked (generic).
721.11866 Substituted alkanoic acid, compound with aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol (generic).
721.11867 Bisphenol A epichlorohydrin polymer with alkylpolyalkene-polyarylene-hydroxypolyoxyalkyldiyl reaction products with alkylalkylidenealkylalkylidene-aminoalkyl-alkanepolyamine and alkylaminoalkanol (generic).
721.11868 Sulfur based acid, compds. with modified bisphenol A-epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-dialkylalkylidene-N- (dialkylalklyidene)aminoalkyl-alkanepolyamine-alkylaminoalkanol reaction products (generic).
721.118691 2-Alkanediol, 3-aryloxy, mono phosphate ester (generic).
721.11870 Metalloxanes, alkyl, alkyl group-terminated, reaction products with dihalo-dialkylalkylaryl-alkyl-polycyclic-ylidene(dialkylsilylene)-dialkylalkylaryl-alkylalkyl-polycyclic-ylidene, metal oxide and nonmetallic oxide (generic).
721.11871 Alkenoic acid, reaction products with pentaerythritol, polymers with diisocyanatoalkane and heteromonocyle homopolymer esters with alkanoic acid-pentaerythritol reaction products (generic).
721.11872 Carbopolycycle octa-alkene, halo (generic).
721.11873 2-Propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-yl)alkyl ester (generic).
721.11874 Heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).
721.11875 Hydrocarbons linear and branched, light alkylate (generic).
721.11876 Hydrocarbons linear and branched, light catalytic cracked (generic).
721.11877 Hydrocarbons linear and branched, heavy catalytic cracked (generic).
721.11878 Hydrocarbons linear and branched, light hydrocracked (generic).
721.11879 Hydrocarbons linear and branched, isomerization (generic).
721.11880 Hydrocarbons linear and branched, heavy catalytic reformed (generic).
721.11881 Hydrocarbons linear and branched, hydrotreated light (generic).
721.11882 Hydrocarbons linear and branched, hydrotreated light paraffinic (generic).
721.11883 Hydrocarbons linear and branched, light catalytic cracked (generic).
721.11884 Hydrocarbons linear and branched, heavy hydrocracked (generic).
721.11885 Hydrocarbons linear and branched, heavy catalytic cracked (generic).
721.11886 Hydrocarbons linear and branched, heavy hydrocracked (generic).
721.11887 Hydrocarbons linear and branched, light hydrocracked (generic).
721.11888 Imidazole-carboxylic acid, substituted (generic).
721.11889 Multi-walled carbon nanotubes (generic).
721.11890 Multi-walled carbon nanotubes (generic).
* * * * *
§721.11860 1,2-Ethanediamine, N-(1-methylethyl)-N-[2-[(1-methylethyl)amino]ethyl]-.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-ethanediamine, N-(1-methylethyl)-N-[2-[(1-methylethyl)amino]ethyl]- (PMN P-18-398; CASRN 10507-06-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; specific target organ toxicity; reproductive toxicity; skin corrosion; serious eye damage; skin sensitization. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(k).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11861 Fatty acids, polymers with substituted carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and halo-substituted heteromonocycle, formates (salts) (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, polymers with substituted carbomonocycles, dialkanolamine, alkyl substituted alkanediamine and halo-substituted heteromonocycle, formates (salts) (PMN P-19-49) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 1%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1), (3) and (5). For purposes of §721.72(e), the concentration is set at 1%. For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; reproductive toxicity; specific organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture or process the substance in any manner that generates a vapor, mist, or aerosol. It is a significant new use to use the substance in any manner that generates a vapor, mist, or aerosol that results in inhalation to industrial or commercial workers. It is a significant new use to manufacture the substance to contain the confidential residual identified in the TSCA Order for this substance at greater than 0.1%.
(iv) Release to Water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=114.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i) and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11862 Alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-substituted]-, sodium salt (1:1), polymer with .alpha.-[2,2-bis(hydroxymethyl)butyl]-.omega.-methoxypoly(oxy-1,2-ethanediyl) and 1,1′-methylenebis[4-isocyanatocyclohexane], acrylic acid-dipenthaerythritol reaction products- and polypropylene glycol ether with pentaerythritol (4:1) triacrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanesulfonic acid, 2-[(2-aminoethyl)heteroatom-substituted]-, sodium salt (1:1), polymer with .alpha.-[2,2-bis(hydroxymethyl)butyl]-.omega.-methoxypoly(oxy-1,2-ethanediyl) and 1,1′-methylenebis[4-isocyanatocyclohexane], acrylic acid-dipenthaerythritol reaction products- and polypropylene glycol ether with pentaerythritol (4:1) triacrylate-blocked (PMN P-19-160) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), 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), (f), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; serious eye damage; skin sensitization; respiratory sensitization; reproductive toxicity; specific organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure.
(iv) Release to Water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=302.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11863 Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), (haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy-carbomonocycle] alkenoate and isocyanate-alkyl-carbomonocycle, hydroxyalkyl acrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), (haloalkyl)oxiane polymer (alkylalkylidene)bis[hydroxy-carbomonocycle] alkenoate and isocyanate-alkyl-carbomonocycle, hydroxyalkyl acrylate-blocked (PMN P-20-101) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely cured.
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin irritation; eye irritation; respiratory sensitization; skin sensitization; reproductive toxicity; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture or process the substance with greater than 20% (by weight) oligomer content below 1,000 daltons ( i.e., low molecular weight species). It is a significant new use to use the substance in a manual spray application.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11864 1,4-Benzenedicarboxylic acid, bis[2-(2-butoxyethoxy)ethyl] ester (9CI).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,4-benzenedicarboxylic acid, bis[2-(2-butoxyethoxy)ethyl] ester (9CI) (PMN P-20-182; CASRN 90430-63-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 0.01 mg/m 3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to §721.63 respirator requirements may request to do so under §721.30. Persons whose §721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order.
(B) [Reserved]
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: skin sensitization; reproductive toxicity; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=4.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (h), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11865 Isocyanic acid, polyalkylenepolyarylene ester, polymer with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and alkoxylalkoxyalcohol-blocked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polyalkylenepolyarylene ester, polymer with alkyl-hydroxyalkyl-alkanediol, alkoxyalcohol and alkoxylalkoxyalcohol-blocked (PMN P-21-56) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50 or 1,000 if spray applied.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture the substance beyond 24 months.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11866 Substituted alkanoic acid, compound with aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted alkanoic acid, compound with aminoalkylalkyl-aminoalkylalkoxy-polyoxyalkylalkanediyl, polymer with haloalkyl-epoxide and alkylalkylidene-cycloarylalcohol (PMN P-21-58) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 1%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1), (3) and (5). For purposes of §721.72(e), the concentration is set at 1%. For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=50.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11867 Bisphenol A epichlorohydrin polymer with alkylpolyalkene-polyarylene-hydroxypolyoxyalkyldiyl reaction products with alkylalkylidenealkylalkylidene-aminoalkyl-alkanepolyamine and alkylaminoalkanol (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as bisphenol A epichlorohydrin polymer with alkylpolyalkene-polyarylene-hydroxypolyoxyalkyldiyl reaction products with alkylalkylidenealkylalkylidene-aminoalkyl-alkanepolyamine and alkylaminoalkanol (PMN P-21-60) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1), (3) and (5). For purposes of §721.72(e), the concentration is set at 0.1%. For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; carcinogenicity; reproductive toxicity; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11868 Sulfur based acid, compds. with modified bisphenol A-epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-dialkylalkylidene-N- (dialkylalklyidene)aminoalkyl-alkanepolyamine-alkylaminoalkanol reaction products (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfur based acid, compds. with modified bisphenol A-epichlorohydrin-polyalkylene polyol ether with bisphenol A polymer-N-dialkylalkylidene-N- (dialkylalklyidene)aminoalkyl-alkanepolyamine-alkylaminoalkanol reaction products (PMN P-21-61) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1), (3) and (5). For purposes of §721.72(e), the concentration is set at 0.1%. For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; carcinogenicity; reproductive toxicity; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure.
(iv) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=11.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11869 1,2-Alkanediol, 3-aryloxy, mono phosphate ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 1,2-alkanediol, 3-aryloxy, mono phosphate ester (PMN P-21-66) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely destroyed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 1.0%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1), (3) and (5). For the purposes of §721.72(e), the concentration is set at 1.0%. For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; skin irritation; serious eye damage; eye irritation; reproductive toxicity; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure or that results in fugitive air emissions. It is a significant new use to use the substance other than as an epoxy curative.
(iv) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11870 Metalloxanes, alkyl, alkyl group-terminated, reaction products with dihalo-dialkylalkylaryl-alkyl-polycyclic-ylidene(dialkylsilylene)-dialkylalkylaryl-alkylalkyl-polycyclic-ylidene, metal oxide and nonmetallic oxide (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as metalloxanes, alkyl, alkyl group-terminated, reaction products with dihalo-dialkylalkylaryl-alkyl-polycyclic-ylidene(dialkylsilylene)-dialkylalkylaryl-alkylalkyl-polycyclic-ylidene, metal oxide and nonmetallic oxide (PMN P-21-68) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), 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), (f), and (g)(1) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; skin irritation; serious eye damage; eye irritation; respiratory sensitization; skin sensitization; germ cell mutagenicity; reproductive toxicity; specific target organ toxicity. 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(a) through (c). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation or dermal exposure.
(iv) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=50.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11871 Alkenoic acid, reaction products with pentaerythritol, polymers with diisocyanatoalkane and heteromonocyle homopolymer esters with alkanoic acid-pentaerythritol reaction products (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, reaction products with pentaerythritol, polymers with diisocyanatoalkane and heteromonocyle homopolymer esters with alkanoic acid-pentaerythritol reaction products (PMN P-21-83) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; respiratory sensitization; skin sensitization; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o).
(iv) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=1.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11872 Carbopolycycle octa-alkene, halo (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbopolycycle octa-alkene, halo (PMN P-21-84) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; serious eye damage; skin sensitization; genetic toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=7.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (h), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11873 2-Propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-yl)alkyl ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, (polyhydro-1,3-dioxo-2H-isoindol-2-yl)alkyl ester (PMN P-21-92) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the PMN substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), (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(b), the concentration is set at 1.0%. 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.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (f), and (g)(1) and (3). For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; specific target organ toxicity; reproductive toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. For purposes of §721.72(e), the concentration is set at 1.0%. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o). It is a significant new use to use the substance at a concentration of greater than 40% in formulation when inhalation exposure is expected.
(iv) Disposal. It is a significant new use to dispose of the substance or waste streams containing the substance other than by incineration or RCRA subtitle C landfill.
(v) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11874 Heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteromonocycle, polymer, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester (PMN P-21-102) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: skin irritation; eye irritation; specific target organ toxicity; developmental toxicity; skin sensitization. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(o).
(iv) Release to water. Requirements as specified in §721.90(a)(4), (b)(4), and (c)(4), where N=337.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11875 Hydrocarbons linear and branched, light alkylate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, light alkylate (PMN P-21-109) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11876 Hydrocarbons linear and branched, light catalytic cracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, light catalytic cracked (PMN P-21-110) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11877 Hydrocarbons linear and branched, heavy catalytic cracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, heavy catalytic cracked (PMN P-21-111) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11878 Hydrocarbons linear and branched, light hydrocracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, light hydrocracked (PMN P-21-112) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through(i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11879 Hydrocarbons linear and branched, isomerization (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, isomerization (PMN P-21-113) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11880 Hydrocarbons linear and branched, heavy catalytic reformed (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, heavy catalytic reformed (PMN P-21-114) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11881 Hydrocarbons linear and branched, hydrotreated light (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, hydrotreated light (PMN P-21-116) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11882 Hydrocarbons linear and branched, hydrotreated light paraffinic (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, hydrotreated light paraffinic (PMN P-21-117) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11883 Hydrocarbons linear and branched, light catalytic cracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance generically identified as hydrocarbons linear and branched, light catalytic cracked (PMN P-21-118) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11884 Hydrocarbons linear and branched, heavy hydrocracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, heavy hydrocracked (PMN P-21-119) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11885 Hydrocarbons linear and branched, heavy catalytic cracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, heavy catalytic cracked (PMN P-21-121) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11886 Hydrocarbons linear and branched, heavy hydrocracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, heavy hydrocracked (PMN P-21-122) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11887 Hydrocarbons linear and branched, light hydrocracked (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hydrocarbons linear and branched, light hydrocracked (PMN P-21-123) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel, fuel additive, fuel blending stock, or used as a refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting).
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3), (b) and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(b), the concentration is set at 0.1%.
(ii) Hazard communication. Requirements as specified in §721.72(a).
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than for processing and use as a fuel, fuel additive, fuel blending stock, or refinery feedstock (including, but not limited to cracking, coking, hydroprocessing, distillation, or deasphalting) subject to 40 CFR parts 79 or 1090.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (i), are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11888 Imidazole-carboxylic acid, substituted (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as imidazole-carboxylic acid, substituted (P-21-197) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into an article.
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1) and (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; eye irritation; serious eye damage; skin sensitization; reproductive toxicity; specific target organ toxicity. For purposes of §721.72(g)(3) this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to process or use the substance other than in an enclosed process, except that sampling and equipment cleaning operations need not occur in an enclosed process.
(iv) Disposal. It is a significant new use to dispose of the substance or waste streams containing the substance other than by incineration with 99.9% efficiency.
(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 (j) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11889 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as multi-walled carbon nanotubes (PMN P-21-216) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured), entrained in a polymer, or incorporated into an article.
(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000 if the capture and reduction rate is at least 99.5% but not 99.975% or greater, or at least 50 if the capture and reduction rate is at least 99.975%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: eye irritation; skin irritation; respiratory sensitization; skin sensitization; genetic toxicity; reproductive toxicity; carcinogenicity; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to manufacture the substance to contain the confidential impurity listed in the Order at greater than 1% (by weight). It is a significant new use to process or use the substance other than for the confidential use allowed in the Order. It is a significant new use to process or use the substance other than in application methods that do not generate a vapor, mist, dust, or aerosol, unless such application method occurs in an enclosed process.
(iv) Disposal. Requirements as specified in §721.85 (a)(1) and (2), (b)(1) and (2), and (c)(1) and (2). It is a significant new use to release the substance directly, whether by point (stack) or non-point (fugitive) sources, to air.
(v) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
§721.11890 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as multi-walled carbon nanotubes (PMN P-21-217) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured), entrained in a polymer, or incorporated into an article.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in §721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for §721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000 if the capture and reduction rate is at least 99.5% but not 99.975% or greater or of at least 50 if the capture and reduction rate is at least 99.975%.
(ii) Hazard communication. Requirements as specified in §721.72(a) through (d), (f), and (g)(1), (3) and (5). For purposes of §721.72(g)(1), this substance may cause: eye irritation; skin irritation; respiratory sensitization; skin sensitization; genetic toxicity; reproductive toxicity; carcinogenicity; specific target organ toxicity. For purposes of §721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(f). It is a significant new use to manufacture the substance to contain the confidential impurity listed in the Order at greater than 1% (by weight). It is a significant new use to process or use the substance other than for the confidential use allowed in the Order. It is a significant new use to process or use the substance other than in application methods that do not generate a vapor, mist, dust, or aerosol, unless such application method occurs in an enclosed process.
(iv) Disposal. Requirements as specified in §721.85 (a)(1) and (2), (b)(1) and (2), and (c)(1) and (2). It is a significant new use to release the substance directly, either by point (stack) or non-point (fugitive) sources, to air.
(v) Release to water. Requirements as specified in §721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a) through (k) are applicable to manufacturers, importers, and processors of this substance.
(2) Limitation or revocation of certain notification requirements. The provisions of §721.185 apply to this section.
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[FR Doc. 2024-12764 Filed 6-10-24; 8:45 am]
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