Source: https://www.federalregister.gov/documents/2009/09/18/E9-22533/significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2017-08-23 13:56:22
Document Index: 722813460

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A Rule by the Environmental Protection Agency on 09/18/2009
The effective date of this rule is November 17, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before October 19, 2009. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on October 2, 2009.
47877-47888 (12 pages)
EPA-HQ-OPPT-2009-0729
FRL-8430-3
https://www.federalregister.gov/d/E9-22533 https://www.federalregister.gov/d/E9-22533
EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 12 chemical substances which were the subject of premanufacture notices (PMNs). Two of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 12 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. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before October 19, 2009, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.
Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule September 18, 2009. See the discussion in Unit VII. for more specific details.
Any persons intending to import or export a chemical substance that is the subject of this rule on or after October 19, 2009 are subject to the TSCA section 13 import certification requirements and the export notification provisions of TSCA section 12(b). See the discussion in Unit I.A. and Unit II.C. for more specific details.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2009-0729, by one of the following methods:
Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Start Printed Page 47878Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2009-0729. 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-2009-0729. EPA's policy is that all comments received will be included in the 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 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.
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 October 19, 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.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.Start Printed Page 47879
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 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 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 12 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 four factors listed in TSCA section 5(a)(2) and this unit.
EPA is establishing significant new use and recordkeeping requirements for 12 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
This rule includes 2 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 Start Printed Page 47880measures required in the corresponding consent orders.
This rule also includes SNURs on 10 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 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-05-775
Chemical name: Benzeneethanol,halo-,halocycloalkyl-,hydrazinealkyl- (generic).
Effective date of TSCA section 5(e) consent order: May 8, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate used in a closed process. The order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the consent order requires dermal protection, hazard communication, and water release restrictions. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: Based on test data on the PMN substance, analogous hydrazines and other (confidential) moieties of the PMN substance, EPA identified concerns for mutagenicity, skin sensitization, liver toxicity, kidney toxicity, neurotoxicity, and eye irritation from dermal exposure. Further, based on test data for analogous hydrazines, EPA predicts aquatic toxicity at concentrations that exceed 0.1 parts per billion (ppb) from releases of the PMN substance to the environment.
Recommended testing: EPA has determined that the results of the following tests would help characterize the human health and environmental effects of the PMN substance: A fish early-life stage toxicity test (OPPTS Harmonized Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Harmonized Test Guideline 850.1300); an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400); a repeated dose oral toxicity in rodents with reproductive, developmental and neurotoxicity screening (Organisation for Economic Co-operation and Development (OECD) 422 test guideline) for a duration of 90-days; a bacterial reverse mutation test (OPPTS Harmonized Test Guideline 870.5100); and a mammalian erythrocyte micronucleus test (OPPTS Harmonized Test Guideline 870.5395) via the intraperitoneal route. Depending upon the results of mutagenicity testing, a two year carcinogenicity study (OPPTS Harmonized Test Guideline 870.4200) may be warranted. Further, a certificate of analysis should be provided for the test substance. The order does not require the submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10157.
PMN Number P-06-16
Chemical name: 2-Pentanone, 3,5-dichloro-.
CAS number: 58371-98-5.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an intermediate used in a closed process. The order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the consent order requires dermal and respiratory protection, hazard communication, and water release restrictions. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: Based on test data on the PMN substance and analogous haloketones, EPA identified concerns for acute inhalation toxicity, mutagenicity, developmental toxicity, skin sensitization, systemic toxicity, and neurotoxicity from inhalation or dermal exposure. Further, based on test data on analogous neutral organic chemicals and haloketones, and potential excess toxicity due to reactivity (hydrolysis), EPA predicts aquatic toxicity at concentrations that exceed 0.1 ppb resulting from releases of the PMN substance to the environment.
Recommended testing: EPA has determined that the results of the following tests would help characterize possible human health and environmental effects of the PMN substance: A fish early-life stage toxicity test (OPPTS Harmonized Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Harmonized Test Guideline 850.1300); an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400); a repeated dose oral toxicity in rodents with reproductive, developmental and neurotoxicity screening (OECD 422 test guideline) for a duration of 90-days; a Start Printed Page 47881bacterial reverse mutation test (OPPTS Harmonized Test Guideline 870.5100); and a mammalian erythrocyte micronucleus test (OPPTS Harmonized Test Guideline 870.5395) via the intraperitoneal route. Depending upon the results of mutagenicity testing, a 2-year carcinogenicity study (OPPTS Harmonized Test Guideline 870.4200) may be warranted. Further, a certificate of analysis should be provided for the test substance. The order does not require the submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10158.
PMN Number P-07-587
Chemical name: 1-Docosanamine, N,N-dimethyl-.
CAS number: 21542-96-1.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. 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, 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)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish acute toxicity test mitigated by humic acid (OPPTS Harmonized Test Guideline 850.1085) would help characterize the environmental effects of the PMN substance. The test substance should be the chloride salt of the PMN substance at pH 7. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10159.
PMN Number P-07-629
Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-[(13Z)-1-oxo-13-docosen-1-yl]-.omega.-[[(13Z)-1-oxo-13-docosen-1-yl]oxy]-.
CAS number: 56565-72-1.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a polymer additive. Based on test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the PMN substance in surface waters. For the use described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 20 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 described in the PMN could result in exposures which 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 ready biodegradability test (OPPTS Harmonized Test Guideline 835.3110); a fish acute toxicity test (OPPTS Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test with freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Aquatic toxicity testing should be performed using the static method with nominal concentrations. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10160.
PMN Number P-08-3
Chemical name: Substituted silyl methacrylate (generic).
Basis for action: The PMN states that the substance will be used as an intermediate for a paint binder. Based on test data on analogous acrylates and neutral organic chemicals, 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 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).
Recommended testing: EPA has determined that the results of a hydrolysis as a function of pH test (OPPTS Harmonized Test Guideline 835.2120) and a ready biodegradability test (OPPTS Harmonized Test Guideline 835.3110) would help characterize the possible fate attributes of the PMN substance. If the results of the ready biodegradation test demonstrate that the hydrolysis product remains intact, then a shake-flask die-away test (OPPTS Harmonized Test Guideline 835.3170) and a fish bioconcentration test (OPPTS Harmonized Test Guideline 850.1730) may be warranted. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10161.
PMN Number P-08-24
Chemical name: 1,3 Dioxolane-4-butanol, 2-ethenyl-.
CAS number: 2421-08-1.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a crosslinking agent to be ultimately used in the manufacture of automotive and aircraft coating materials. Based on test data on an expected hydrolysis product for an analogous chemical, EPA has concerns for mutagenicity, oncogenicity, developmental toxicity, liver toxicity, kidney toxicity, and skin sensitization and irritation for the PMN substance. As described in the PMN, significant worker exposure is 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 use of the substance other than as described in the PMN could result in exposures which may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a repeated dose 28-day oral toxicity study (OPPTS Harmonized Test Guideline 870.3050) in rodents would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10162.
PMN Number P-08-33
Chemical name: Chloro fluoro alkane (generic).
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 persistent, bioaccumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PMN substance, as Start Printed Page 47882described 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 for more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also, based on test data on analogous haloalkanes, 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 processing or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture, exceedance of the annual import volume limit of 50,000 kilograms, or any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant adverse 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).
Recommended testing: EPA has determined that the results of the tiered testing as described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. The fish bioconcentration factor (BCF) test should be conducted using the flow through method with measured concentrations and include a certificate of analysis for the test substance showing percentage and level of impurities; measured BCF should be based on 100% active ingredient and measured concentrations.
CFR citation: 40 CFR 721.10163.
PMN Number P-08-36
Chemical name: Benzenecarboximidamide, N-hydroxy-4-nitro-.
CAS number: 1613-86-1.
Basis for action: The PMN states that the substance will be used as a chemical intermediate. Based on test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 400 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not expected to 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).
Recommended testing: EPA has determined that the results of a fish acute toxicity test (OPPTS Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test with freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnia testing should be performed using the flow through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10164.
PMN Number P-08-138
Chemical name: Carbonotrithioic acid, bis(phenylmethyl) ester.
CAS number: 26504-29-0.
Basis for action: The PMN states that the substance will be used as a chain transfer agent. EPA identified health and envronmental 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 for more than two months and estimates a bioaccumulation factor of greater than or equal to 5,000. Also, based on test data for analogous esters, 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 processing or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or any predictable or purposeful release containing the PMN substance into the waters of the United States may cause serious health effects and significant adverse 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).
Recommended testing: EPA has determined that the results of the tiered testing described in the New Chemicals Program's PBT Category would help characterize the PBT attributes of the PMN substance. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10165.
PMN Number P-08-180
Chemical name: 1,3-Cyclohexanedione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-, ion(1-), potassium salt (1:1).
CAS number: 1121649-70-4.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a precursor to another chemical substance. Based on test data on the PMN substance, EPA has concerns for developmental and systemic toxicity in humans. EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.1 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is not expected for the use described and the substance will not be released to surface waters in amounts resulting in surface water concentrations that exceed 0.1 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 waters concentrations that exceed 0.1 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) and (b)(4)(i).
Recommended testing: EPA has determined that the results of the following tests would help characterize the human health and environmental effects of the PMN substance: A porous pot test (OPPTS Harmonized Test Guideline 835.3220); and either (1) a sediment/water microcosm biodegradation test (OPPTS Harmonized Test Guideline 835.3180), (2) a site-specific aquatic microcosm test, laboratory (OPPTS Harmonized Test Guideline 850.1925), or (3) a field testing for aquatic organisms (OPPTS Harmonized Test Guideline 850.1950).
CFR citation: 40 CFR 721.10166.
PMN Number P-08-212
Chemical name: Tetrafluoro nitrotoluene (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 200 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not expected to be released to surface Start Printed Page 47883waters. 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).
Recommended testing: EPA has determined that the results of a fish acute toxicity test (OPPTS Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test with freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance. Fish and daphnia testing should be performed using the flow-through method with measured concentrations. Algal testing should be preformed using the static method with measured concentrations. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10167.
PMN Number P-08-275
Chemical name: Cesium tungsten oxide.
CAS number: 52350-17-1.
Basis for action: The PMN states that the substance will be used as a component of infrared absorption material. Based on test data on analogous crystalline respirable, poorly soluble particulates, EPA has concerns for lung overload and lung cancer for the PMN substance. As described in the PMN, significant worker exposure is unlikely as dermal absorption is not expected and inhalation exposures are expected to be negligible because the PMN substance is used in aqueous form. 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 manufacturing, processing, or use of the substance as a solid 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).
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study (OPPTS Harmonized Test Guideline 870.3465) with a 60-day holding period in rats and with special attention to the histopathology of the lungs would help characterize the human health effects of the PMN substance. Depending on the results of this testing, a 2-year inhalation carcinogenicity study (OPPTS Harmonized Test Guideline 870.4200) may be warranted.
CFR citation: 40 CFR 721.10168.
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 2 of the 12 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.
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), the effective date of this rule is November 17, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before October 19, 2009.
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 2 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, Start Printed Page 47884other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 4 of the 12 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 OPPTS Harmonized Test Guidelines are now available on the Internet at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm. The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, Start Printed Page 47885EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.
As stated in Unit II.C., according to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be mailed to the Environmental Protection Agency, OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Information must be submitted in the form and manner set forth in EPA Form No. 7710-25. This form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 (see § 721.25 and § 720.40). Forms and information are also available electronically at http://www.epa.gov/​opptintr/​newchems/​pubs/​pmnforms.htm.
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.
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 discussed in this unit. 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 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.
This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).Start Printed Page 47886
721.10157 2070-0012
721.10158 2070-0012
721.10159 2070-0012
721.10160 2070-0012
721.10161 2070-0012
721.10162 2070-0012
721.10163 2070-0012
721.10164 2070-0012
721.10165 2070-0012
721.10166 2070-0012
721.10167 2070-0012
721.10168 2070-0012
4. By adding new § 721.10157 to subpart E to read as follows:
§ 721.10157
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzeneethanol,halo-,halocycloalkyl-,hydrazinealkyl (PMN P-05-775) 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)(2)(ii), (a)(3), (b) (concentration set at 1.0%), and (c).
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0%), (f), (g)(1)(i) (eye irritation), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii) (sensitization), (g)(1)(ix), (g)(2)(i), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4) (resulting in receiving stream levels exceeding 0.1 parts per billion (ppb)), and (g)(5).
(iii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=0.1).
5. By adding new § 721.10158 to subpart E to read as follows:
§ 721.10158
(a) Chemical substance and significant new uses subject to reporting. Start Printed Page 47887(1) The chemical substance identified as 2-pentanone, 3,5-dichloro- (PMN P-06-16; CAS No. 58371-98-5) 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), (a)(2)(ii), (a)(3), (a)(4), (a)(5), (a)(6), (b) (concentration set at 1.0%), and (c). Respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. The following NIOSH-approved respirator with an APF of 50 meets the minimum requirements for § 721.63(a)(4): NIOSH-approved air-purifying, tight-fitting full facepiece respirator equipped with combination organic gas/vapor P100 cartridges (organic vapor, acid gas, or substance-specific).
(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0%), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4) (resulting in receiving stream levels exceeding 0.1 parts per billion (ppb)), and (g)(5).
6. By adding new § 721.10159 to subpart E to read as follows:
§ 721.10159
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-docosanamine, N,N-dimethyl- (PMN P-07-587; CAS No. 21542-96-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
7. By adding new § 721.10160 to subpart E to read as follows:
§ 721.10160
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly(oxy-1,2-ethanediyl), .alpha.-[(13Z)-1-oxo-13-docosen-1-yl]-.omega.-[[(13Z)-1-oxo-13-docosen-1-yl]oxy]- (PMN P-07-629; CAS No. 56565-72-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
8. By adding new § 721.10161 to subpart E to read as follows:
§ 721.10161
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted silyl methacrylate (PMN P-08-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
9. By adding new § 721.10162 to subpart E to read as follows:
§ 721.10162
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3 dioxolane-4-butanol, 2-ethenyl- (PMN P-08-24; CAS No. 2421-08-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
10. By adding new § 721.10163 to subpart E to read as follows:
§ 721.10163
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as chloro fluoro alkane (PMN P-08-33) 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) and (s) (50,000 kilograms).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 Start Printed Page 47888(a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.
11. By adding new § 721.10164 to subpart E to read as follows:
§ 721.10164
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzenecarboximidamide, N-hydroxy-4-nitro- (PMN P-08-36; CAS No. 1613-86-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
12. By adding new § 721.10165 to subpart E to read as follows:
§ 721.10165
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as carbonotrithioic acid, bis(phenylmethyl) ester (PMN P-08-138; CAS No.26504-29-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
13. By adding new § 721.10166 to subpart E to read as follows:
§ 721.10166
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-cyclohexanedione, 2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl]-, ion(1-), potassium salt (1:1) (PMN P-08-180; CAS No. 1121649-70-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N= 0.1).
14. By adding new § 721.10167 to subpart E to read as follows:
§ 721.10167
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as tetrafluoro nitrotoluene (PMN P-08-212) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
15. By adding new § 721.10168 to subpart E to read as follows:
§ 721.10168
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cesium tungsten oxide (PMN P-08-275; CAS No. 52350-17-1) 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 (v)(2), (w)(2), and (x)(2).
[FR Doc. E9-22533 Filed 9-17-09; 8:45 am]