Source: https://www.federalregister.gov/articles/2013/02/25/2013-04298/proposed-significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2016-05-31 21:54:08
Document Index: 706901389

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Federal Register | Proposed Significant New Use Rules on Certain Chemical Substances
Dates: Comments must be received on or before April 26, 2013.
Comments Close: 04/26/2013
-12701 (18 pages)
Shorter URL: https://federalregister.gov/a/2013-04298 Related Topics
Section 5(a)(2) of TSCA (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 bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) and 40 CFR part 721 require persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the chemical substance for that use. Persons who must report are described in § 721.5.
According to § 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). In particular, 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 may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
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.
This proposed rule includes 14 PMN substances whose reported chemical names include the term “carbon nanotube” or “carbon nanofibers.” Because of a lack of established nomenclature for carbon nanotubes, the TSCA Inventory names for carbon nanotubes are currently in generic form, e.g., carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT). EPA uses the specific structural characteristics provided by the PMN submitter to more specifically characterize the TSCA Inventory listing for an individual CNT. All submitters of new chemical notices for CNTs have claimed those specific structural characteristics as CBI. EPA is publishing the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Confidentiality claims preclude a more detailed description of the identity of these CNTs. If an intended manufacturer, importer, or processor of CNTs is unsure of whether its CNTs are subject to this proposed SNUR or any other SNUR, the company can either contact EPA or obtain a written determination from EPA pursuant to the bona fide procedures at § 721.11. EPA is using the specific structural characteristics for all CNTs submitted as new chemical substances under TSCA to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory. EPA has compiled a generic list of those structural characteristics entitled “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature.” A copy of this list is available in the docket for these proposed SNURs under docket ID number EPA-HQ-OPPT-2012-0727. If EPA develops a more specific generic chemical name for these materials, that name will be made publicly available.
This proposed rule includes 17 PMN substances for which EPA determined, pursuant to TSCA section 5(e), that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal may present an unreasonable risk of injury to human health or the environment. Accordingly, these substances are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I). Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “section 5(e) SNURs” on these PMN substances are proposed pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.
Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, 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) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will normally state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 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 section 5(e) consent order for the same chemical substance.
This proposed rule also includes SNURs on 20 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “non-section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-section 5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance. PMN Number P-00-835 Back to Top
Basis for action: The PMN states that the substance will be used as an intermediate in the manufacture of agricultural chemicals. Based on ecological structure activity relationship (EcoSAR) analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 90 parts per billion (ppb) of the PMN substance in surface waters. As described in the PMN, releases to surface water are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 90 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
PMN Number P-02-167 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an electrode material. Based on EcoSAR analysis of test data on analogous inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases to water are not expected to exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance presents an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
PMN Number P-02-668 Back to Top
Basis for action: The PMN substance will be used as a binder for silicone coatings. Based on structure activity relationship (SAR) analysis of test data on analogous epoxides and alkoxysilanes, EPA identified concerns for mutagenicity, oncogenicity, reproductive toxicity, developmental toxicity, lung toxicity, and sensitization from dermal and inhalation exposures to the PMN substance. For the use described in the PMN, significant occupational dermal and inhalation exposures are not expected due to the use of impervious gloves and a National Institute for Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 10, and consumer exposures are not expected as the substance is not used in consumer products. Therefore, EPA has not determined that manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without impervious gloves where there is a potential for dermal exposure; any use of the substance without a NIOSH-certified respirator with an APF of at least 10; or any use of the substance in consumer products may result in serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C) and (b)(3)(ii).
PMN Number P-03-135 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a compressor lubricant. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. There are two other chemical substances identified in the PMN that are already on the TSCA Inventory. The SNUR does not apply to those chemical substances. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
PMN Number P-03-255 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a diluent for coatings. Based on EcoSAR analysis of test data on analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, releases to water are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii). Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help to characterize the environmental effects of the PMN substance.
PMN Numbers P-03-762 and P-03-763 Back to Top
Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as hardeners. Based on SAR analysis of test data on analogous isocyanates, EPA has identified concerns for sensitization and irritation from dermal and inhalation exposure to the PMN substances. For the use described in the PMN, significant occupational inhalation and dermal exposures are not expected due to no domestic manufacture, use of impervious gloves, and no use of the substances involving an application method that generates a vapor, mist, or aerosol. Further, consumer exposures are not expected as the substance is not used in consumer products. Therefore, EPA has not determined that the proposed processing or use of the substances may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substances; any use of the substances without impervious gloves where there is a potential for dermal exposures; any use of the substance in consumer products; or any use of the substances involving an application method that generates a vapor, mist, or aerosol may result in serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).
PMN Number P-04-640 Back to Top
1. Use of personal protective equipment including impervious gloves (when there is potential dermal exposure) and either a NIOSH-certified respirator with an APF of at least 2,000, or compliance with a NCEL of 0.05 mg/m
PMN Number P-07-553 Back to Top
Basis for action: The PMN states that the substance will be used as a flame retardant. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity from inhalation exposures to the PMN substance. At an annual production volume of 100,000 kilograms (kgs), significant occupational inhalation exposures are not expected due to the use of a NIOSH-certified respirator with an APF of at least 10. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposure; or any increase of the annual 100,000 kg production volume may result in increased exposure to the PMN substance, which may cause serious human health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
PMN Number P-08-392 Back to Top
The SNUR would designate as a “significant new use” the absence of these protective measures. Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 413) in rats with a post exposure observation period of up to 3 months, including bronchoalveolar lavage fluid (BALF) analysis and certain material characterization data, would help characterize possible effects of the substance. In the consent order, the PMN submitter has agreed to perform these tests within 18 months of commencing non-exempt commercial manufacture.
PMN Number P-09-257 Back to Top
PMN Numbers P-10-115, P-10-116, P-10-117, P-10-118, P-10-119, P-10-120, P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, and P-10-126 Back to Top
Recommended testing: EPA has determined that the results of certain physical/chemical properties data, workplace exposure monitoring and characterization testing, and a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) in rats would help characterize the human health effects of the PMN substances. The PMN submitter agreed to provide the physical/chemical properties data for the PMN substances within one year after submitting the notice of commencement. The consent order contains two additional production volume limits. The PMN submitter agreed not to exceed the first production volume limit without submitting workplace exposure monitoring and characterization testing (including byproducts) as well as quantification and characterization of substances that may be released during exposures typical during the use phase, such as handling, tearing and cutting the PMN substances. The PMN submitter has also agreed not to exceed the second production volume limit without performing two 90-day inhalation toxicity tests, with a post-exposure observation period of up to 3 months, BALF analysis, aggregation/agglomeration state, shape, size/size particle distribution and surface properties of materials as administered, aggregation/agglomeration state, shape, size/size particle distribution and surface properties of materials of the delivered materials after administration, determination of cardiovascular toxicity, heart histopathology, and data on pulmonary deposition. One 90-day inhalation toxicity test will be conducted from a representative PMN substance in the group P-10-115, P-10-116, P-10-117, P-10-118, P-10-119, and the other 90-day inhalation toxicity test will be conducted from a representative PMN substance in the group P-10-120, P-10-121, P-10-122, P-10-123, P-10-124, P-10-125, and P-10-126.
PMN Numbers P-10-545 and P-10-546 Back to Top
PMN Number P-11-115 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for respiratory and dermal sensitization. For the use described in the PMN, significant occupational dermal and inhalation exposures are not expected due to the use of a NIOSH-certified respirator with an APF of at least 10, and consumer exposures are not expected as the substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures, or any use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
PMN Number P-11-155 Back to Top
Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as a colorant for cleaners and detergents may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
PMN Number P-11-290 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a sensor element in an electrochemical sensor. Based on SAR analysis of test data on respirable, poorly soluble particulates, EPA identified concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity if the substances were manufactured by a method other than described in the PMN. Further, available data suggests that pulmonary deposition of some carbon-based nanoparticles, may induce cardiovascular toxicity if inhaled. EPA identified concerns for lung toxicity to workers from inhalation exposures to the PMN substance. For the manufacture method described in the PMN, significant dermal and inhalation exposures are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that manufacture of the substance by a method other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
PMN Numbers P-11-309, P-11-311, P-11-312, P-11-313, and P-11-314 Back to Top
Basis for action: The PMNs state that the generic (non-confidential) use of the substances will be as industrial adhesives. Based on SAR analysis of test data on analogous isocyanates, EPA identified concerns for sensitization from dermal and inhalation exposure to the PMN substances. For the use described in the PMNs, significant occupational dermal and inhalation exposures are not expected due to the use of a NIOSH-certified respirator with an APF of at least 10, and consumer exposures are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures, or any use of the substances in consumer products may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).
PMN Number P-12-73 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance is as an industrial adhesive. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for sensitization. For the use described in the PMN, significant occupational dermal and inhalation exposures are not expected due to the use of a NIOSH-certified respirator with an APF of at least 10, and consumer exposures are not expected as the substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures, or any use of the substances in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
PMN Number P-12-133 Back to Top
Basis for action: The PMN states that the substance will be used as a coating for wind craft wings. Based on SAR analysis of test data on structurally similar chemicals submitted under TSCA section 8(e), EPA identified concerns for oncogenicity and mutagenicity. Additionally, based on the isocyanate moiety, the Agency identified concerns for sensitization. For the use described in the PMN, significant occupational inhalation exposures are not expected due to the use of a NIOSH-certified respirator with an APF of at least 10, and consumer exposures are not expected as the substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures, or any use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
PMN Number P-12-143 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a crosslinking resin. Based on SAR analysis of test data on analogous isocyanates, EPA identified concerns for sensitization from dermal and respiratory exposures to the PMN substance. For the use described in the PMN, significant occupational dermal and inhalation exposures are not expected due to the use of a NIOSH-certified respirator with an APF of at least 10, and consumer exposures are not expected as the substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures, or any use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
PMN Number P-12-274 Back to Top
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an adhesive. Based on SAR analysis of test data on analogous isocyanates, EPA identified concern for sensitization from dermal and inhalation exposure to the PMN substance. Additionally, liquid and vapor contact with the eye can cause moderate to severe irritation. For the use described in the PMN, significant occupational dermal and inhalation exposures are not expected due to the use of a NIOSH-certified respirator with an APF of at least 10, and consumer exposures are not expected as the substance is not used in consumer products. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance without a NIOSH-certified respirator with an APF of at least 10, where there is a potential for inhalation exposures; or any use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for 17 of the 37 chemical substances regulation was warranted under TSCA section 5(e) pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The proposed SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are being proposed pursuant to § 721.160.
VI. Notice and Comment Procedures Back to Top
EPA is issuing these SNURs by notice and comment procedure, as described in § 721.170(d)(4). In accordance with § 721.170(d)(4)(ii)(A), persons are being given the opportunity to submit comments on or before April 26, 2013 on whether EPA should establish notification requirements.
VII. Applicability of Proposed Rule to Uses Occurring Before Effective Date of the Final Rule Back to Top
EPA has promulgated provisions to allow persons to comply with these proposed SNURs before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. VIII. Test Data and Other Information Back to Top
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data 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. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or Source OECD at http://www.sourceoecd.org. To access the European Standard, EN 15051 method, issued by The European Committee for Standardization (CEN), please go to http://www.cen.eu/cen/products.
When physical/chemical properties of test material and/or material characterization tests are recommended for nanoscale substances that are the subject of this proposed rule, you should take into consideration the characterizations identified in the Guidance Manual for the Testing of Manufactured Nanomaterials: OECD's Sponsorship Programme, which is available at http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev&amp;doclanguage=en.
2.Add § 721.10637 to subpart E to read as follows: § 721.10637 Substituted picolinate (generic).
(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=90).
3.Add § 721.10638 to subpart E to read as follows: § 721.10638 Lithium metal phosphate (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as lithium metal phosphate (PMN P-02-167) 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) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=1).
4.Add § 721.10639 to subpart E to read as follows: § 721.10639 Siloxanes and Silicones, di-Me, polymers with Ph silsesquioxanes, hydrolyzed, reaction products with 2-[[3-(trimethoxysilyl)propoxy]methyl]oxirane.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (b) (concentration set at 0.1 percent), 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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
5.Add § 721.10640 to subpart E to read as follows: § 721.10640 11,2-Cyclohexanedicarboxylic acid, 1-(2-ethylhexyl) 2-(2-methylpropyl) ester.
6.Add § 721.10641 to subpart E to read as follows: § 721.10641 Phenol and vinyltoluene based hydrocarbon resin (generic).
7.Add § 721.10642 to subpart E to read as follows: § 721.10642 Modified polyisocyanates (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1 percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f), (o), and (y)(l).
8.Add § 721.10643 to subpart E to read as follows: § 721.10643 Diisocyanate terminated polycarbodiimide (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as diisocyanate terminated polycarbodiimide (PMN P-04-640) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance that have been completely reacted (cured).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(3), (a)(4), and (a)(6)(ii). 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. A National Institute for Occupational Safety and Health (NIOSH)-certified supplied-air respirator operated in pressure demand or other positive pressure mode and equipped with a tight-fitting full facepiece with an assigned protection factor (APF) of at least 2,000 meets the minimum requirements§ 721.63(a)(4). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 0.05 mg/m
. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory protection or maintain airborne concentrations at or below an 8-hour time-weighted average of 0.05 mg/m
), (g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a) through (i) are applicable to manufacturers, importers, and processors of this substance.
9.Add § 721.10644 to subpart E to read as follows: § 721.10644 Reaction product of aluminum hydroxide and modified alkoxysilane (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (b) (concentrations set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (100,000 kilograms).
10.Add § 721.10645 to subpart E to read as follows: § 721.10645 Multi-walled carbon nanotube (generic) (P-08-392).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (a)(6) (particulate, including solids or liquid droplets). 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. A National Institute for Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N100 filters with an assigned protection factor (APF) of at least 50 meet the minimum requirements of § 721.63(a)(4).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f), (k), and (q) (within 18 months of commencing non-exempt commercial manufacture).
11.Add § 721.10646 to subpart E to read as follows: § 721.10646 Multi-walled carbon nanotube (generic) (P-09-257).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (a)(6) (particulate, including solids or liquid droplets). 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. A National Institute for Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N100 filters with an assigned protection factor (APF) of at least 50 meets the minimum requirements of § 721.63(a)(4).
(iii) Release to water. Requirements as specified in § 721.90 (b)(1) and (c)(1).
12.Add § 721.10647 to subpart E to read as follows: § 721.10647 Multi-walled carbon nanofibers (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), and (a)(6)(i). 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. A National Institute for Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N100 filters with an assigned protection factor (APF) of at least 50 meets the minimum requirements of § 721.63(a)(4).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (k) (electrical and thermal conductivity additive in encapsulated thermoplastics, thermosets, elastomers, glass, metals, and ceramics; mechanical reinforcement additive in encapsulated thermoplastics, thermosets, elastomers, glass, metals, and ceramics; energy storage additive; or chemical intermediate), (l) and (q).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers, importers, and processors of these substances.
13.Add § 721.10648 to subpart E to read as follows: § 721.10648 Modified lithium iron phosphates (generic).
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (a), (b), (c), (k), and (q).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of these substances.
14.Add § 721.10649 to subpart E to read as follows: § 721.10649 MDI modified polyalkylene glycol adipate polyester (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for§ 721.63 (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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
15.Add § 721.10650 to subpart E to read as follows: § 721.10650 Polyether substituted anthraquinone derivative (generic).
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (colorant for cleaners and detergents).
16.Add § 721.10651 to subpart E to read as follows: § 721.10651 Carbide derived nanocarbon (generic).
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (manufacture of the substance by the method described in the premanufacture notice).
17.Add § 721.10652 to subpart E to read as follows: § 721.10652 Hexanedioic acid, polymer with polyether polyol, 1,1′-methylenebis[4-isocyanatobenzene] and dihydroxydialkyl ether (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for§ 721.63(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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
18.Add § 721.10653 to subpart E to read as follows: § 721.10653 Hexanedioic acid, polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1′-methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether and dialkanol ether (generic).
19.Add § 721.10654 to subpart E to read as follows: § 721.10654 Hexanedioic acid, polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-methylenebis[isocyanatobenzene], dihydroxydialkyl ether and dialkanol ether (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63 (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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
20.Add § 721.10655 to subpart E to read as follows: § 721.10655 Hexanedioic acid, polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether, reaction products with dialkylcarbinol (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
21.Add § 721.10656 to subpart E to read as follows: § 721.10656 Hexanedioic acid, polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)],1,1'-methylenebis[4-isocyanatobenzene], dihydroxydialkyl ether reaction products with dialkylcarbinol (generic).
22.Add § 721.10657 to subpart E to read as follows: § 721.10657 Castor oil, polymer with hydrogenated vegetable oil, 1,1'-methylenebis[isocyanatobenzene] and isocyanate (generic).
23.Add § 721.10658 to subpart E to read as follows: § 721.10658 2-Oxepanone, polymer with 1,6-diisocyanatohexane, 2,2-dimethyl-1,3-propanediol and 2,2'-oxybis[ethanol].
24.Add § 721.10659 to subpart E to read as follows: § 721.10659 Poly(oxy-1,4-butanediyl), -hydro—hydroxy-, polymer with alkyldiisocyanates (generic).
25.Add § 721.10660 to subpart E to read as follows: § 721.10660 Aliphatic diisocyanate adduct with substituted amino alkyl silane (generic).
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(6)(i), (a)(6)(ii), (a)(6)(v), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(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. The following National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):