Source: https://www.federalregister.gov/documents/2019/11/25/2019-24946/significant-new-use-rules-on-certain-chemical-substances-18-1
Timestamp: 2019-12-09 16:13:21
Document Index: 197409001

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Federal Register :: Significant New Use Rules on Certain Chemical Substances (18-1)
This rule is effective on January 24, 2020. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on December 9, 2019.
64754-64765 (12 pages)
FRL-10001-30
D. Applicability of General Provisions
II. Significant New Use Determination
III. Public Comments on Proposed Rule and EPA Responses
VIII. Procedural Determinations
https://www.federalregister.gov/d/2019-24946 https://www.federalregister.gov/d/2019-24946
EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 22 chemical substances which are the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA under TSCA. This action requires persons who intend to manufacture (defined by Start Printed Page 64755statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA. Importers of chemicals subject to these SNURs must certify compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after December 26, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
EPA is finalizing these SNURs under TSCA section 5(a)(2) for 22 substances which were the subject of PMNs. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA is not finalizing four proposed SNURs at 40 CFR 721.11150, 721.11163, 721.11164, and 721.11165 for the chemical substances P-14-627, P-17-200, P-17-204, and P-17-205, respectively, because the Agency is currently reviewing data submitted in support of a request to modify the underlying TSCA 5(e) Orders that forms the basis for the proposed SNURs.
In the Federal Register of October 3, 2018 (83 FR 49903) (FRL-9983-81), EPA proposed a SNUR for 26 chemical substances in 40 CFR part 721, subpart E. This comment period closed on November 2, 2018. More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents for the direct final SNUR of October 3, 2018 (83 FR 49806) (FRL-9983-82). This direct final SNUR was withdrawn on December 4, 2018 (83 FR 62463) (FRL-9986-74) due to adverse public comments related to SNURs identified in the document.
The record for the batch SNUR was established in the docket under docket ID number EPA-HQ-OPPT-2018-0627. That docket includes information considered by the Agency in developing the proposed and final rules, public comments submitted for the rule, and EPA's responses to public comments received on the proposed rule.
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit II.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.
The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.Start Printed Page 64756
EPA received public comments from three identifying entities on the proposed rule. The Agency's responses are described in a separate Response to Public Comments document contained in the public docket for this rule, EPA-HQ-OPPT-2018-0627. In addition, EPA is not finalizing the proposed SNURs for the substances described in P-14-627, P-17-200, P-17-204, and P-17-205 (40 CFR 721.11150, 721.11163, 721.11164, and 721.11165, respectively) because the Agency is currently reviewing data submitted in support of a request to modify the underlying TSCA 5(e) Orders that form the basis for the proposed SNURs. EPA will finalize those proposed SNURs after the data has been reviewed and any changes to the Orders and/or SNUR have been considered and identified.
Furthermore, the Response to Comments describes comments and responses that resulted in changes to the SNURs for P-17-24 and P-17-25. The regulatory text of the SNURs at 40 CFR 721.11159 and 40 CFR 721.11160 have been revised to include that dust inhalation exposure is a significant new use and to specify a significant new use as commercial use when saleable goods or service could introduce the PMN substances into a consumer setting.
EPA is establishing significant new use and recordkeeping requirements for 22 chemical substances in 40 CFR part 721, subpart E. In Unit IV. of the original direct final rule (83 FR 49806, October 3, 2018), EPA provides the following information for each chemical substance:
Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
The regulatory text section of each rule specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit VII. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.
These final rules include 22 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV of the October 3, 2018 direct final rule. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.
When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The Start Printed Page 64757identities of 14 of the 22 chemical substances subject to this rule have been claimed as confidential. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.
Furthermore, EPA designated October 3, 2018 (the date of public release of the original direct final and proposed rules) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of October 3, 2018, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.
In the absence of a rule, Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing under 40 CFR part 721, subpart E. In Unit IV. of the original direct final rule (October 3, 2018; 83 FR 49806), the EPA lists potentially useful information that will be useful to EPA's evaluation. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance. EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing on vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).
The potentially useful information identified in Unit IV. of the original direct final rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 Start Printed Page 64758CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/​opptintr/​newchems.
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2018-0627.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this is not an Start Printed Page 64759economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
2. In § 9.1, add §§ 721.11149, 721.11151 through 721.11162, and 721.11166 through 721.11172 in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:
4. Add §§ 721.11149 through 721.11172 to subpart E to read as follows:
721.11149
721.11150
721.11151
721.11152
721.11153
721.11154
721.11155
721.11156
721.11157
721.11158
721.11159
721.11160
721.11161
721.11162
721.11163-721.11165
721.11166
721.11167
721.11168
721.11169
2-Pentanone, 2,2′,2″- [O,O′,Oz″-(methylsilylidyne)trioxime].
721.11170
721.11171
721.11172
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbon nanomaterial (PMN P-10-366) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured), incorporated or embedded into a polymer matrix that itself has been completely reacted (cured), embedded in a permanent solid polymer, metal, glass, or ceramic form, or completely embedded in an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:Start Printed Page 64760
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (ii), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health certified air purifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 filter with an Assigned Protection Factor of at least 50), (a)(6) (particulate (including solids or liquid droplets)), (when determining which persons are reasonable 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 exposures, where feasible), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (l), (q), and (y)(1) (when the substance is in liquid resin form). It is a significant new use to process or use the powder form of the substance outside of the site of manufacture or processing.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-butanone 1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)- (PMN P-15-114, CAS No. 756-12-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) through (3) (when determining which persons are reasonable 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 exposures, where feasible), (b)(concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1)(i), (g)(2)(i)(v), (g)(3)(ii) (harmful to fish), (g)(4)(iii), and (g)(5). It is a significant new use unless containers of the PMN substance are labeled with the statement: “contains a dielectric fluid which should not be mixed or used in conjunction with sulfur hexafluoride (SF6)”. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as propanenitrile, 2,3,3,3 tetrafluoro-2-(trifluoromethyl)- (PMN P-15-320, CAS No. 42532-60-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), and (g)(5). It is a significant new use unless containers of the PMN substance are labeled with the statement: “contains a dielectric fluid which should not be mixed or used in conjunction with sulfur hexafluoride (SF6)”. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. It is a significant new use to use the substance other than as a dielectric medium for medium and high voltage power generation and distribution equipment.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymeric sulfide (PMN P-15-734) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are reasonable 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 exposures, where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (vi), and (ix) (neurotoxicity), (g)(2)(i), (iii), and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (wastewater heavy metal removal) and (q). It is a Start Printed Page 64761significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to workers.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as quaternary ammonium salts (PMNs P-16-356 and P-16-357) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substances after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified § 721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and (ii) (neurotoxicity), (g)(2)(i), (iii), and (v), (g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl methacrylates, polymer with olefins (PMN P-16-375) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f). It is a significant new use to import the substance other than according to the confidential molecular weight parameters specified in the TSCA Order for the substance.
(a) Chemical substance and significant new uses subject to reporting. (1) the chemical substance identified as hexanedioic acid, 1,6-bis(3,5,5-trimethylhexyl) ester (PMN P-16-386, CAS No. 20270-50-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation shall be considered and implemented to prevent exposure, where feasible), (a)(6)(v) and (vi) (particulate (including solids or liquid droplets)), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iii), (iv), and (ix), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (motor oil formulations and gear oil lubricants) and (p) (1,545,000 kilograms).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylaminium hydroxide (PMN P-16-396) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (ii), (iii), and (iv), (a)(3) (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposures, where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.71(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iii), (vi), and (ix), (eye damage), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative hazard and warning Start Printed Page 64762statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (q), (v)(1) and (2), (w)(1) and (2), (x)(1) and (2), and (y)(1) and (2).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as polyamine polyacid adducts (PMNs P-16-572 and P-16-573) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. It is a significant new to use to manufacture the substances in any manner other than they are not amine terminated in order to maintain water solubility levels below 1 part per billion.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic isocyanate, polymer with alkyloxirane polymer with oxirane ether with alkyldiol (2:l) and alkyloxirane polymer with oxirane ether with alkyltriol (3:l) (PMN P-17-24) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (a)(6)(v) and (vi) (particulate (including solids or liquid droplets)), (when determining which persons are reasonable 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 exposures, where feasible), (b) (concentration set at 0.1%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i) and (ii) (asthma), (g)(2)(i), (ii), (iii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in generation of a vapor, dust, mist or aerosol. It is a significant new use is manufacture, processing, or use of the PMN substance for commercial purposes when the sealable goods or service could introduce the chemical substance into consumer settings.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic isocyanate polymer with alkyloxirane, alkyloxirane polymer with oxirane ether with alkanetriol and oxirane (PMN P-17-25) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (a)(6)(v) and (vi), (particulate (including solids or liquid droplets)), (when determining which persons are reasonable 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 exposures, where feasible), (b) (concentration set at 0.1%), and (c).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oils, hedychium flavescens, (PMN P-17-148, CAS No. 1902936-65-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), (a)(4) (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), (a)(5) (respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor of at least 50), (a)(6)(v) and (vi), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1)(iv), (vi), (vii), and (ix) (respiratory sensitization), (g)(2)(i), (ii), (iii), (iv), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k) (odoriferous component of fragrance compounds) and (s) (70 kilograms). It is a significant new use to manufacture, process, or use the substance in any manner that generates a mist or aerosol.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as siloxanes and silicones, cetyl Me, di-Me, Me 2-(triethoxysilyl)ethyl (PMN P-17-174, CAS No. 1887149-13-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3) (when determining which persons are reasonable 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 exposures, where feasible), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and (ix) (neurotoxicity), (g)(2)(i) and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
§§ 721.11163-721.11165
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 1H-benz[de] isoquinoline-1,3(2H)-dione-2-(alkyl)-(alkylamino) (PMN P-17-251) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), (when determining which persons are reasonably likely to be exposed as required as § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation shall be considered and implemented to prevent exposure, where feasible), (a)(6)(v) and (vi) (particulate (including solids or liquid droplets)), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1) (acute toxicity, mutagenicity, eye irritation), (g)(2)(i), (ii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as siloxanes and silicones, di-Me, hydrogen-terminated, reaction products with acrylic acid and 2-ethyl-2-[(2-propen-1-yloxyl)methyl]-1,3-propanediol, polymers with chlorotrimethylsilane-iso-Pr alc.-sodium silicate reaction products (PMN P-17-296, CAS No. 2014386-23-1) 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).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) through (iii), (a)(3) through (5) (respirators must Start Printed Page 64764provide a National Institute for Occupational Safety and Health assigned protection factor of at least 1,000 and are required for any process generating a spray, mist, or aerosol), (when determining which persons are reasonable 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 exposures, where feasible), (a)(6)(v) and (vi) (particulate (including solids or liquid droplets)), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (sensitization) (iv), (vii), and (ix), (g)(2)(i), (ii), (iii), (iv), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-pentanone, 2,2′,2″-[O,O′,O″-(ethenylsilylidyne)trioxime] (PMN P-17-308, CAS No. 58190-62-8) 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).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(3) (when determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (iii), (iv), (vi), (vii), (viii), and (ix), (g)(2)(i), (iii), and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System, and OSHA Hazard Communication Standard may be used.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-pentanone, 2,2′,2″- [O,O′,O″-(methylsilylidyne)trioxime] (PMN P-17-309, CAS No. 37859-55-5) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as naphthalene trisulfonic acid sodium salt (PMN P-17-321) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iv), (a)(3) through (5) (respirators must provide a National Institute for Occupational Safety and Health assigned protection factor of at least 50), (when determining which persons are reasonable 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 exposures, where feasible), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii), (iv), and (ix), (g)(2)(i) through (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Start Printed Page 64765Harmonized System and OSHA Hazard Communication Standard may be used.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polymer of aliphatic dicarboxylic acid and dicycloalkaneamine (PMN P-17-327) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture (includes import) the substance to have an average molecular weight of greater than 10,000 Daltons.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as hexanedioic acid, polymer with trifunctional polyol, 1,1′-methylenebis [isocyanatobenzene], and 2,2′-oxybis[ethanol] (PMN P-17-330) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) through (iv), (a)(3) (when determining which persons are reasonable 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 exposures, where feasible), and (c).
(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1)(i) (eye and respiratory irritation), (g)(2)(i) through (iii) and (v), and (g)(5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.
(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance for consumer use or for commercial uses that could introduce the substance into a consumer setting. It is a significant new use to manufacture, process, or use the substance in any manner that generates a dust, mist, or aerosol.
[FR Doc. 2019-24946 Filed 11-22-19; 8:45 am]