Source: https://www.federalregister.gov/documents/2009/06/24/E9-14780/significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2018-02-21 04:15:38
Document Index: 747044590

Matched Legal Cases: ['art 707', '§\u2009721', 'art 707', 'art 721', 'art 700', '§\u2009721', 'art 720', 'art 707', '§\u2009721', 'art 707', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009720', '§\u2009721', '§\u2009720', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', 'art\n22', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721']

The effective date of this rule is August 24, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 24, 2009. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on July 8, 2009.
29982-29998 (17 pages)
FRL-8417-6
https://www.federalregister.gov/d/E9-14780 https://www.federalregister.gov/d/E9-14780
Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2008-0252. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2008-0252. EPA's policy is that all comments received will be included in the public docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/​epahome/​dockets.htm.
Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Start Printed Page 29983Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
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 (the corresponding EPA policy appears 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. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after July 24, 2009 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, Start Printed Page 29984exemptions 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 § 721.1(c), persons subject to these SNURs must comply with the same notice 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.
Chemical importers are subject to the TSCA section 13 (15 U.S.C. 1612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28 (the corresponding EPA policy appears 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. Importers of chemical substances subject to a proposed or final SNUR must certify their compliance with the SNUR requirements. In addition, any 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) (15 U.S.C. 2612 (b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
To determine what would constitute a significant new use for the 23 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the above four factors listed in TSCA section 5(a)(2).
The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e. limits on manufacture and importation) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.
This rule includes 4 PMN substances that are subject to “risk-based” consent 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 consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.
This rule also includes SNURs on 19 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). EPA, however, 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-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-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 Start Printed Page 29985be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.
Basis for action: The PMN states that the substance will be used as a curing agent for epoxy coating systems. Based on test data on analogous phenols, aliphatic amines, and benzyl amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 parts per billion (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 release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Basis for action: The PMN states that the substance will be used as a flame retardant for polyamide thermoplastic epoxy resins. Based on test data on the PMN substance and analogous zinc salts, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 12 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 12 ppb. 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 12 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii).
Basis for action: The PMN states that the substance will be used as a base resin in UV/EB curable and peroxide curable formulations. Based on test data on analogous methacrylates and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 100 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 release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Basis for action: The PMN states that the substance will be used as a fungicide intermediate. EPA identified health and environmental concerns because the substance may be a persistent, bioaccumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on test data on analogous neutral organic substances, EPA predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and 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 predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Basis for action: The PMN states that the substance will be used as an herbicide safener in formulated pesticide products. Based on test data on the PMN substance submitted under TSCA section 8(e), the substance may cause liver, kidney, heart and spleen toxicity. Also, based on information submitted in the PMN Material Safety Data Sheet (MSDS), EPA has concerns for dermal sensitization. In addition, based on test data on the PMN substance and analogous aliphatic amines, 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, significant worker exposure is not expected. Further, general population exposure is not expected as the substance is not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in release to surface waters may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(4)(i), and (b)(4)(ii).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate. Based on test data on the PMN substance, EPA has concerns for acute toxicity, strong solvent (defatting) irritation, and dermal sensitization. Also, based on test data on analogous chloroalkanes, EPA has concerns for potential mutagenicity. In addition, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 500 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is unlikely due to the use of adequate personal protective equipment. Significant general population exposure is not expected to result from the identified environmental releases from the proposed manufacturing, processing, or use of the substance. Further, significant environmental exposure is unlikely as the substance is not released to surface waters resulting in stream concentrations that exceed 500 ppb. 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 use of the substance other than as an intermediate or any use of the substance resulting in surface water concentrations exceeding 500 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
Basis for action: The PMN states that the substance will be used as a pigment in plastic compounds for laser marking and laser welding. Based on test data on the PMN substance and on analogous respirable, poorly soluble particulates, EPA has identified concerns that the PMN substance may cause lung overload, immunotoxicity, and reproductive toxicity. Also, based on test data on the PMN substance and analogous inorganic phosphates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is unlikely due to the use of adequate personal protective equipment. Further, environmental exposure is unlikely, as the substance is not released to surface waters. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or any use of the substance resulting in release to surface waters may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
Basis for action: The PMN states that the substance will be used in fragrance compositions in cosmetic products, air fresheners, household cleaners, dishwashing detergents, and laundry detergents. Based on test data on analogous methyl eugenol, EPA identified concerns that the PMN substance may cause cancer. As described in the PMN, significant worker dermal exposure is unlikely due to the use of adequate dermal protection. Although there is potential for consumer exposure, significant dermal and inhalation exposures are not expected. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has Start Printed Page 29987determined, however, that domestic manufacture or use of the substance without the use of impervious gloves, where there is a potential for potential worker dermal exposure, may cause 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).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a monomer. Based on test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 7 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be 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 release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. EPA identified health and environmental concerns because the substance may be a PBT chemical, based on physical/chemical properties of the PMN substance, as described in the New Chemicals Program's PBT Category (64 FR 60194; November 4, 1999). EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms. As described in the PMN, significant worker exposure is unlikely and 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 predictable or purposeful release of the PMN substance into the waters of the United States may cause serious health effects and significant environmental effects, since the PMN substance has been characterized by EPA as a PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a mining chemical reagent. Based on test data on a structurally similar substance, EPA identified human health concerns for toxicity to liver, thymus, spleen, kidney, and red blood cells from exposure via drinking water and fish ingestion resulting from releases to surface and ground water. Further, based on test data on the PMN substance and analogous imides, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 70 ppb of the PMN substance in surface waters. As described in the PMN, the substance will not be released to surface and ground 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 release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a hydrophobic surface active agent for cellulosic substrates and similar materials. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment and human health, the substance may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance and its potential degradation products. To protect against this exposure and risk, the consent order requires that the PMN substance be tested, before a certain production volume is reached, in various fate and physical/chemical tests to determine its fate and composition in various media and conditions in the environment. In addition, for the fluorinated portion of the polymer, the submitter has agreed to Start Printed Page 29988analyze, report, and limit specific fluorinated impurities of the PMN substance where the carbon chain meets or exceeds a specified length, if these values exceed those reported in the PMN. The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing: EPA has determined that the results of certain fate and physical/chemical property tests would help characterize possible effects of the substance. The PMN submitter has agreed not to exceed the production volume limits without performing these tests. The consent order contains three production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing the following studies: A modified SCAS test for insoluble and volatile chemicals (OPPTS 835.5045 or OECD 302A test guidelines), with analysis for degradation products; a UV visible light Start Printed Page 29989absorption test (OPPTS 830.7050 or OECD 101 test guidelines); a direct photolysis rate in water by sunlight test (OPPTS 835.2210 test guideline), if wavelengths greater than 290 nm are absorbed in the previous test; an indirect photolysis screening test (OPPTS 835.5270 test guideline); a hydrolysis as a function of pH and temperature test (OPPTS 835.2130 test guideline); an aerobic and anaerobic transformation in soil test (OECD 307 test guideline); and an anaerobic biodegradability of organic compounds in digested sludge test (OECD 311 test guideline). The PMN submitter has also agreed not to exceed the second higher production volume limit without performing the following tests: A phototransformation of chemicals on soil surfaces test (Draft OECD guideline January 2002) using two soils; an aerobic sewage treatment simulation test (OECD 303A test guideline); and an aerobic and anaerobic transformation in aquatic sediment systems test (OECD 308 test guideline). Finally, the PMN submitter has also agreed not to exceed the highest production volume limit without performing an aerobic and anaerobic transformation in soil test (OECD 307 test guideline).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a film coating additive. Based on test data on analogous respirable, poorly soluble particulates, EPA has concerns for lung effects for the PMN substance. Based on physical properties, EPA has concerns for potential systemic effects from dermal exposure to the PMN substance. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 use of the substance without the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as colorant process intermediates. Based on test data on analogous respirable, poorly soluble particulates, EPA has concerns for lung effects for the PMN substances. Based on physical properties, EPA has concerns for potential systemic effects from dermal exposure to the PMN substances. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 use of the substances without the use of impervious gloves where there is a potential for dermal exposure; use of the substances other than as described in the PMN; or manufacture, processing, or use of the substances in a powder form, may cause serious health effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a cleaning and polishing chemical for semiconductor manufacturing. Based on test data on analogous respirable, poorly soluble particulates, EPA has concerns for lung effects for the PMN substance. Based on physical properties, EPA has concerns for potential systemic effects from dermal exposure to the PMN substance. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 use of the substance without the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, may cause serious health effects. Based on Start Printed Page 29990this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a protective coating. Based on test data on analogous respirable, poorly soluble particulates, EPA believes that the PMN substance may cause lung effects. Based on physical properties, EPA believes that the PMN substance may cause systemic effects via dermal exposure. As described in the PMN, significant worker exposure is unlikely due to use in an enclosed process with adequate personal protective equipment. 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 use of the substance without the use of impervious gloves where there is a potential for dermal exposure; use of the substance in non-enclosed processes during spray application; use other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a resin for coatings. Based on test data on analogous respirable, poorly soluble particulates, EPA believes that the PMN substance might cause lung effects. Based on physical properties, EPA believes that the PMN substance may cause systemic effects via dermal exposure. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 use of the substance without the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as raw material for the manufacture of release coatings. Based on test data on analogous respirable, poorly soluble particulates, EPA believes that the PMN substance may cause lung effects. Based on physical properties of the PMN substance, EPA believes that it may cause systemic effects via dermal exposure. As described in the PMN, worker inhalation exposure to particulates is not expected and dermal exposure is minimal due to the use of adequate dermal protection. 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 use of the substance without the use of impervious gloves where there is a potential for dermal exposure; use of the substance other than as described in the PMN; or manufacture, processing, or use of the substance in a powder form, may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance Start Printed Page 29991will be as a property modifier in electronic applications and as a property modifier in polymer composites. The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA. Based on test data on analogous respirable, poorly soluble particulates and on other carbon nanotubes (CNTs), EPA believes that the PMN substance might cause lung effects. To protect against this risk, the consent order requires use of a National Institute for Occupational Safety and Health (NIOSH)-approved full-face respirator with N-100 cartridges. Based on physical properties of the PMN substance, EPA believes it may cause health effects via dermal exposure. To protect against this risk, the consent order requires that workers wear gloves and protective clothing impervious to the chemical substance. The SNUR designates as a “significant new use” the absence of these protective measures.
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 4 of the 23 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 SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160.
In the other 19 cases, where the proposed uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.
EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), this rule is effective August 24, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 24, 2009.
This rule establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments, or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in the comment. EPA solicits comments on Start Printed Page 29992whether any of the uses described as significant new uses are ongoing.
To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 4 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 16 of the 23 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per § 720.25 and § 721.11), 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.
EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN, except where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)). 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 § 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. Many test guidelines are now available on the Internet at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm. The OECD test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org. The ASTM test guidelines are available at http://www.astm.org/​Standard/​index.shtml.
Under these procedures a manufacturer, importer, or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to Start Printed Page 29993manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, 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, importers, and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of these SNURs will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. 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 rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. 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 over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted from 2006-2008, only one appears to be from a small entity. In addition, the estimated reporting cost for submission of a SNUN (see Unit XI.) is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with these 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 proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this rule. As such, EPA has determined that this rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).Start Printed Page 29994
2. By adding new § 721.10134 to subpart E to read as follows:
§ 721.10134
3. By adding new § 721.10135 to subpart E to read as follows:
§ 721.10135
(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=12).
4. By adding new § 721.10136 to subpart E to read as follows:
§ 721.10136
(2) Limitations or revocation of certain notification requirements. The Start Printed Page 29995provisions of § 721.185 apply to this section.
5. By adding new § 721.10137 to subpart E to read as follows:
§ 721.10137
6. By adding new § 721.10138 to subpart E to read as follows:
§ 721.10138
7. By adding new § 721.10139 to subpart E to read as follows:
§ 721.10139
(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=500).
8. By adding new § 721.10140 to subpart E to read as follows:
§ 721.10140
Phosphoric acid, tin (2+) salt (2:3).
9. By adding new § 721.10141 to subpart E to read as follows:
§ 721.10141
10. By adding new § 721.10142 to subpart E to read as follows:
§ 721.10142
11. By adding new § 721.10143 to subpart E to read as follows:
§ 721.10143
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amines, bis (C11-14-branched and linear alkyl) (PMN P-06-733; CAS No. 900169-60-0) is subject to reporting Start Printed Page 29996under this section for the significant new uses described in paragraph (a)(2) of this section.
12. By adding new § 721.10144 to subpart E to read as follows:
§ 721.10144
13. By adding new § 721.10145 to subpart E to read as follows:
§ 721.10145
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities) and (q).
14. By adding new § 721.10146 to subpart E to read as follows:
§ 721.10146
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (analysis and reporting and limitations of maximum impurity levels of certain fluorinated impurities), (l) (maximum percentage of the PMN substance in a non-industrial product or distributed for use as a non-industrial product), (o) (use in a consumer product that could be spray applied), and (q).
15. By adding new § 721.10147 to subpart E to read as follows:
§ 721.10147
16. By adding new § 721.10148 to subpart E to read as follows:
§ 721.10148
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), and (i) are applicable to manufacturers, importers, and processors of this substance.Start Printed Page 29997
17. By adding new § 721.10149 to subpart E to read as follows:
§ 721.10149
18. By adding new § 721.10150 to subpart E to read as follows:
§ 721.10150
19. By adding new § 721.10151 to subpart E to read as follows:
§ 721.10151
20. By adding new § 721.10152 to subpart E to read as follows:
§ 721.10152
Oxirane, substituted silylmethyl-, hydrolysis products with alkanol zirconium(4+) salt and silica, acetates (generic).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (a), (j), (v)(1), (w)(1), and (x)(1).
21. By adding new § 721.10153 to subpart E to read as follows:
§ 721.10153
Start Printed Page 29998 Start Amendment Part
22. By adding new § 721.10154 to subpart E to read as follows:
§ 721.10154
23. By adding new § 721.10155 to subpart E to read as follows:
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (j) and (q).
24. By adding new § 721.10156 to subpart E to read as follows:
[FR Doc. E9-14780 Filed 6-23-09; 8:45 am]