Source: http://thefederalregister.com/2012/09/21/2012-23235.html
Timestamp: 2018-03-24 08:06:56
Document Index: 131961649

Matched Legal Cases: ['art 707', '§ 721', 'art 707', 'art 721', 'art 700', '§ 721', 'art 720', 'art 721', '§ 721', 'art 721', 'art 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721', '§ 721']

[EPA-HQ-OPPT-2011-0941; FRL-9357-2]
SUMMARY: EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 107 chemical substances which were the subject of premanufacture notices (PMNs). Eight of these chemical substances are subject to TSCA consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 107 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.
DATES: Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before October 22, 2012 (see Unit VI. of theSUPPLEMENTARY INFORMATION).
*Hand Delivery:OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2011-0941. 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-2011-0941. EPA's policy is that all comments received will be included in the docket without change and may be made available online athttp://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 email. The regulations.gov Web site 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 email comment directly to EPA without going through regulations.gov, your email 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.
For general information contact:The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave. Rochester, NY 14620; telephone number: (202) 554-1404; email address:TSCA-Hotline@epa.gov.
• Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110),e.g.,chemical manufacturing and petroleum refineries.
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; see also 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicablerules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule 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, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 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 sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(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 theFederal Registerits reasons for not taking action.
To determine what would constitute a significant new use for the 107 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, taking into consideration the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is establishing significant new use and recordkeeping requirements for 107 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
• Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).
• Basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (i.e.,SNURs without TSCA section 5(e) consent orders).
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 volume) 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 8 PMN substances (P-00-346, P-01-470, P-02-120, P-02-285, P-04-834, P-10-58, P-10-59, and P-10-60) 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 and 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 “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 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 SNUR 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, 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 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.
This rule also includes SNURs on 99 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-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-96-308
Chemical name:Aminoalkanol (generic).
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a chemical intermediate. Based on structure-activity relationship (SAR) analysis of the potential reaction of the PMN substance with nitrosating agents, and by analogy to monoethanolamine, diethanolamine and dimethylisopropylamine, EPA identified concerns for skin, eye, liver, kidney, lung, bone marrow, brain, testes, heart, and blood toxicity from exposure to the PMN substance via inhalation and dermal exposures, and the gastrointestinal (GI) tract. In addition, based on ecological structure-activity relationship (EcoSAR) analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 600 ppb of the PMN substance in surface waters. For the use described in the PMN, EPA does not expect dermal or inhalation exposures to manufacturing or processing workers or other targeted populations, nor does it expect releases 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 other than as described in the PMN, or any use of the substance resulting in surface water concentrations exceeding 600 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)(ii).
Recommended testing:EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a functional observational battery and histopathology; a prenatal developmental toxicity test (OPPTS Test Guideline 870.3700); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help to characterize the human health and environmental effect of the PMN substance.
CFR citation:40 CFR 721.10427.
PMN Numbers P-96-1021 and P-96-1022
Chemical names:(P-96-1021) Fatty acids, C18-unsatd., dimers, reaction products with 1-piperazineethanamine and (P-96-1022) Fatty acids, C18-unsatd., dimers, reaction products with 1-piperazineethanamine and tall-oil fatty acids.
CAS numbers:(P-96-1021) 206565-90-4 and (P-96-1022) 206565-89-1.
Basis for action:The consolidated PMN states that the substances will be used as water based epoxy curing agents. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. As described in the PMN, the substances are not released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substances may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing:EPA has determined that the results of a modified semi-continuous activatedsludge (SCAS) test (OPPTS Test Guideline 835.3210); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) on PMN P-96-1022 would help characterize the environmental effects of the PMN substances.
CFR citations:40 CFR 721.10428 (P-96-1021) and 40 CFR 721.10429 (P-96-1022).
PMN Number P-97-823
Chemical name:Tetra alkyl ammonium salt (generic).
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a curing agent for coatings. Based on test data submitted on the PMN substance at varying concentrations, EPA identified concerns for ocular lethality for occupational exposures to the PMN substance at concentrations greater than 25 percent. For the use described in the PMN, significant worker exposures are not expected as the PMN substance is used at concentrations no greater than 25 percent, and the material safety data sheet (MSDS) provides the ocular lethality results from the submitted eye irritation studies. 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 including the hazard communication warnings concerning the eye irritation test results in the MSDS, or any use of the substance in concentrations greater than 25 percent may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).
Recommended testing:EPA has determined that the results of an acute eye irritation test (OPPTS Test Guideline 870.2400) on the PMN substance at concentrations greater than 25 percent would help characterize human health effects of the PMN substance.
CFR citation:40 CFR 721.10430.
PMN Numbers P-98-141 and P-98-142
Chemical name:Phosphoric acid esters (generic).
Basis for action:The consolidated PMN states that the generic (non-confidential) use of the substances will be as metal extractants. Based on EcoSAR analysis of test data on analogous anionic surfactants, 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 PMN substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 100 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 acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) on the PMN substances would help characterize the environmental effects of the PMN substances.
CFR citation:40 CFR 721.10431.
PMN Number P-98-1028
Chemical name:1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl-.
CAS number:24748-23-0.
Basis for action:The PMN states that the substance will be used as a viscosity modifier in the manufacture of polypropylene, manufactured and supplied as a solution in at least 40 percent mineral spirits. Based on EcoSAR analysis of test data on analogous peroxides, EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, where the PMN substance is supplied as a solution of at least 40 percent mineral spirits, significant environmental releases are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any use of the substance other than as a viscosity modifier, manufactured and supplied as a solution in at least 40 percent mineral spirits, in the manufacture of polypropylene may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing:EPA has determined that the results of a porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.
CFR citation:40 CFR 721.10432.
PMN Number P-99-184
Chemical name:Cyclopentene, 1,2,3,3,4,4,5,5-octafluoro-.
CAS number:559-40-0.
Basis for action:The PMN states that the substance will be used as a dry etching agent and a chemical vapor deposition (CVD) agent for the production of semiconductors. Based on test data on the PMN substance, EPA identified concerns for acute toxicity, systemic toxicity, developmental toxicity, cardiac sensitization, and mutagenicity from inhalation exposures. As described in the PMN, the substance will be imported and not manufactured in the United States. As described in the PMN, EPA does not expect significant worker exposures during processing and use activities for the uses described in the PMN nor does it expect general population exposures for the uses described in the PMN. Therefore, EPA has not determined that the proposed processing or use may present an unreasonable risk. EPA has determined, however, that domestic manufacture, or any use of the substance other than as a dry etching agent and a CVD agent for the production of semiconductors may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).
Recommended testing:EPA has determined that inhalation monitoring data, collected according to the EPA draft Inhalation Monitoring Data Collection Guidelines (located in the docket under docket ID number EPA-HQ-OPPT-2011-0941), would help characterize the human health effects of the PMN substance.
CFR citations:40 CFR 721.10433.
PMN Number P-99-214
Chemical name:Cyclopentane, 1,1,2,2,3,3,4-heptafluoro-.
CAS number:15290-77-4.
Basis for action:The PMN states that the substance will be used as a solvent and a cleaning and drying agent. Based on test data on the PMN substance, EPA identified concerns for acute, systemic,and developmental toxicity, cardiac sensitization, and mutagenicity from inhalation exposures. As described in the PMN, the substance will be imported and not manufactured in the United States. As described in the PMN, EPA does not expect significant worker exposures during processing and use activities for the uses described in the PMN nor does it expect general population or consumer exposures for the uses described in the PMN. Therefore, EPA has not determined that the proposed processing or use may present an unreasonable risk. EPA has determined, however, that any domestic manufacture of the substance, use of the substance other than as a solvent or a cleaning and drying agent, or use in a consumer product may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).
CFR citation:40 CFR 721.10434.
PMN Number P-99-1179
Chemical name:Phenol, 2-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)-.
CAS number:73936-80-8.
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as an ultraviolet (UV) stabilizer for automotive coatings. Based on EcoSAR analysis of test data on analogous phenols, 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 of the substance are not expected to result in surface water concentrations that exceed 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 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 characterize the environmental effects of the PMN substance.
CFR citation:40 CFR 721.10435.
PMN Numbers P-99-1217 and P-99-1218
Chemical name:Amine neutralized phosphated polyesters (generic).
Basis for action:The consolidated PMN states that the generic (non-confidential) use of the substances will be as pigment dispersants. Based on EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur as a result of releases of the PMN substances in quantities greater than the combined 50,000 kilograms (kgs) per year production volume stated in the PMN. At the annual production volume of 50,000 kgs stated in the consolidated PMN, there were no significant environmental releases. 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 exceeding an annual aggregate manufacturing and importation volume of 50,000 kgs may cause significant adverse environmental effects. Based on this information, the PMN substances meet 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) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substances.
CFR citation:40 CFR 721.10436.
PMN Numbers P-99-1280, P-99-1281, and P-99-1282
Chemical name:Sulfonic acid, linear xylene alkylate, mono, sodium salts (generic).
Basis for action:The consolidated PMN states that the substances will be used as enhanced oil recovery surfactants. Based on EcoSAR analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substances to surface water, from uses other than as described in the PMNs, exceed releases from the use described in the PMNs. For the use described in the PMNs, environmental releases did not exceed 2 ppb more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the PMN substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as enhanced oil recovery surfactants may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing:EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances.
CFR citation:40 CFR 721.10437.
PMN Number P-00-346
Chemical name:Dialkyl hydroxybenzenealkanoic acid ester (generic).
Effective date of TSCA section 5(e) consent order:August 16, 2001.
Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the substance will be as a petroleum additive. Based on test data on the PMN substance and SAR analysis of structurally similar substances, EPA identified concerns for liver and thyroid toxicity from dermal exposures. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that this substance may present an unreasonable risk of injury to human health, the substance may be produced in substantial quantities, and there may be significant (or substantial) human exposure to the substance. To protect against these risks, the consent order requires:
1. Use of personal protective equipment including impervious gloves (when there is potential dermal exposure).
Recommended testing:EPA has determined that the results of a 28-day dermal toxicity test (The Organisation for Economic Co-operation and Development (OECD) Test Guideline 410) with emphasis on the thyroid (per OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. The PMN submitter has agreed not to exceed the confidential production volume limit specified in the consent order without performing this test.
CFR citation:40 CFR 721.10438.
PMN Number P-00-635
Chemical name:1,3-Dioxolan-2-one, 4-ethenyl.
CAS number:4427-96-7.
Basis for action:The PMN states that the generic (non-confidential) uses of the substance will be as a chemical intermediate and an industrial chemical additive. Based on test data on the PMN substance and SAR analysis of test data on analogous vinylene carbonate, EPA predicts acute toxicity, liver toxicity, kidney toxicity, developmental toxicity, immunotoxicity, and oncogenicity. For the uses described in the PMN, significant dermal exposures are not expected due to the use of impervious gloves. 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 the use of impervious gloves where there is a potential for dermal exposures, or any use other than as described in the PMN may cause serious human health effects. Based on this information the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing:EPA has determined that no additional testing is recommended at this time as the health effects have been adequately characterized by the testing submitted on the PMN substance.
CFR citation:40 CFR 721.10439.
PMN Number P-00-1165
Chemical name:Diphosphoric acid, polymers with ethoxylated reduced Me esters of reduced polymd, oxidized tetrafluoroethylene.
CAS number:200013-65-6.
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a surface active agent. Based on analogous high molecular weight polymers, EPA identified concerns from inhalation exposures. For the industrial uses described in the PMN, worker inhalation exposures are not expected as the substance is not applied by a method that generates a vapor, mist, or spray. Therefore, EPA has not determined that the proposed manufacturing, processing, or use may present an unreasonable risk. EPA has determined, however, that any use of the substance in consumer products, or any use involving an application method that generates a vapor, mist, or spray may cause serious health effects. Based on the information, the PMN substance meets the criteria at 721.170(b)(3)(ii).
Recommended testing:EPA has determined that the results of an acute inhalation toxicity test (OPPTS Test Guideline 870.1300) would help characterize the human health effects of the PMN substance.
CFR citation:40 CFR 721.10440.
PMN Numbers P-01-382 and P-01-383
Chemical names:(P-01-382) 1, 2-Benzenedicarboxylic acid, di-C7-14-branched and linear alkyl esters and (P-01-383) 1,2-Benzenedicarboxylic acid, di-C6-14-branched and linear alkyl esters.
CAS numbers:(P-01-382) 309934-68-7 and (P-01-383) 309934-69-8.
Basis for action:The consolidated PMN states that the substances will be used as plasticizers for flexible poly-vinyl chloride. Based on SAR analysis of the expected ester hydrolysis product of the PMNs, EPA identified concerns for liver, developmental, and reproductive toxicity; and oncogenicity. For the use described in the PMNs, neither significant worker exposures nor general population exposures are 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 in children's toys (e.g.,pacifiers, rattles, and teethers) may cause serious health effects. Based on this information, the PMN substances meet the criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing:EPA has determined that the results of an acute oral toxicity test (OECD Test Guideline 401 or 420); an acute dermal toxicity test (OECD Test Guideline 402); an acute inhalation toxicity test (OECD Test Guideline 403); a repeated dose 28-day oral toxicity test in rodents (OECD Test Guideline 407); a 28-day dermal toxicity test (OECD Test Guideline 410); a 28-day subacute inhalation toxicity test (OECD Test Guideline 412); a prenatal developmental toxicity test (OECD Test Guideline 414); a 1-generation reproduction test (OECD Test Guideline 415); a reproduction and fertility effects test (OECD Test Guideline 416); a reproduction/development toxicity screening test (OECD Test Guideline 421); a combined repeated dose toxicity test with the reproduction/development toxicity screening test (OECD Test Guideline 422); a bacterial reverse mutation test (OECD Test Guideline 471); anin vitromammalian chromosome aberration test (OECD Test Guideline 473); a mammalian erythrocyte micronucleus test (OECD Test Guideline 474); and a mammalian bone marrow chromosomal aberration test (OECD Test Guideline 475) would help characterize the human health effects of the PMN substances.
CFR citations:40 CFR 721.10441 (P-01-382) and 40 CFR 721.10442 (P-01-383).
PMN Number P-01-470
Chemical name:Ethoxylated alkylphenol sulfate, ammonium salt (generic).
Effective date of TSCA section 5(e) consent order:August 26, 2002.
Basis for TSCA section 5(e) consent order:The PMN states that the substance will be used as a dispersant for carbon black and organic pigments. Based on test data on the PMN substance, and EcoSAR analysis of test data on analogous ethoxylated anionic surfactants, EPA predicts environmental toxicity that varies depending on the average number of moles of ethoxylate. As the number of ethoxylate decreases, the aquatic toxicity of the substance increases. For this PMN substance, the average number of moles may vary. Based on submitted test data on the PMN—with an average number of 16.4 moles of ethoxylate—EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 200 ppb of the PMN substance in surface waters. When the average number of moles of ethoxylate is less than or equal to 10, EPA expects toxicity to aquatic organisms may occur at concentrations that exceed 60 ppb of the substance in surface waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a finding that the substance may present an unreasonable risk of injury to the environment, may be produced in substantial quantities, and may be reasonably anticipated to enter the environment in substantial quantities. To protect against these risks, the consent order prohibits the company from manufacturing or importing the PMN substance unless either: The mean number of moles of the ethoxy group is greater than or equal to 10, or theaverage number molecular weight is greater than 950 daltons. The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing:EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize environmental effects of the PMN substance. Testing should be conducted on the PMN substance with less than 10 moles of ethoxylate, or an average number molecular weight of less than 950 daltons. The consent order does not require the submission of the aforementioned testing 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 will remain in effect until the consent order is modified or revoked by EPA based on submission of that or other relevant information.
CFR citation:40 CFR 721.10443.
PMN Number P-01-499 and P-01-500
Chemical name:(P-01-499) Propanol, mercapto- and (P-01-500) 2-Propen-1-ol, reaction products with hydrogen sulfide, distn. residues.
CAS number:(P-01-499) 63947-56-8 and (P-01-500) 374078-75-8.
Basis for action:The PMNs state that the substances will be used as chemical intermediates. Based on SAR analysis of test data on structurally similar 3- mercaptopropanol, EPA identified concerns for developmental and maternal effects from dermal exposures to the PMN substances. In addition, based on test data on P-01-499 and EcoSAR analysis of analogous thiols, EPA predicts toxicity to aquatic organisms may occur at surface water concentrations that exceed 11 ppb for P-01-499 and 1 ppb for P-01-500. For the chemical intermediate use described in the PMNs, significant worker exposures are not expected due to the use of impervious dermal protection, and the substances are not released to surface water. 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 impervious dermal protection where there is a potential for dermal exposures, or any use of the substances resulting in surface water concentrations exceeding 11 ppb (P-01-499) or 1 ppb (P-01-500) may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
Recommended testing:EPA has determined that the results of an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010) on P-01-500 would help to characterize the environmental effects of the PMN substances.
CFR citation:40 CFR 721.10444 (P-01-499) and 40 CFR 721.10445 (P-01-500).
PMN Number P-01-762
Chemical name:1,9-Cyclohexadecadiene.
CAS number:4277-06-9.
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as open, non-dispersive use with limited employee exposure. Based on test data on the PMN substance, EPA identified concerns for dermal sensitization and irritation. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the PMN substance in surface waters. As described in the PMN, significant dermal exposures are not expected due to the use of impervious gloves, and releases of the substance to surface waters are not expected in concentrations that exceed 1 ppb. 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 protective equipment where there is a potential for dermal exposures, or any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria in § 721.170(b)(3)(i), (b)(4)(i), and (b)(4)(ii).
CFR citation:40 CFR 721.10446.
PMN Number P-01-829
Chemical name:17-Oxabicyclo[14.1.0]heptadec-8-ene.
CAS number:34748-97-5.
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as open, non-dispersive with limited employee exposure. Based on test data on the PMN substance, EPA identified concerns for dermal sensitization, respiratory sensitization, mutagenicity, developmental toxicity, male reproductive toxicity, liver toxicity, and kidney toxicity. In addition, based on test data on the PMN substance and EcoSAR analysis of test data on analogous epoxides, EPA predicts toxicity to aquatic organisms at concentrations that exceed 1 ppb of the substance in surface waters. As described in the PMN, significant exposures are not expected due to the use of protective dermal and respiratory equipment, and the substance is not released to surface waters in concentrations that exceed 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 without impervious dermal and adequate respiratory protection where there is a potential for exposures, or any use of the substance resulting in surface water concentrations exceeding 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), (b)(4)(i), and (b)(4)(ii).
CFR citation:40 CFR 721.10447.
PMN Number P-02-120
Chemical name:Acetic acid, hydroxymethoxy-, methyl ester, reaction products with substituted alkylamine (generic).
Effective date of TSCA section 5(e) consent order:September 12, 2003.
Basis for TSCA section 5(e) consent order:The PMN states that the generic (non-confidential) use of the substance will be as an emulsifier. Based on EcoSAR analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur when the average number molecular weight is below 850 daltons. The order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I) and 5(e)(1)(A)(ii)(II), based on a finding that this substance may reasonably be anticipated to enter the environment in substantial quantities and may present an unreasonable risk of injury to the environment. The consent order for this substance prohibits manufacturing or importing of the PMN substance unless the average number molecular weight is greater than or equal to 850 daltons. The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing:EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500), on the PMN substance where the average number molecular weight is less than 850 daltons would help characterize possible environmental effects of the substance. The order does not require 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 721.10448.
PMN Number P-02-172
Chemical name:Aromatic polyester polyol (generic).
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as an adhesive component. Based on EcoSAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 40 ppb of the PMN substance in surface waters. As described in the PMN, EPA does not expect releases to surface waters to exceed 40 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has, however, determined that any use of the substance resulting in surface water concentrations exceeding 40 ppb may cause significant adverse environmental effects. Based on this information, the substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation:40 CFR 721.10449.
PMN Number P-02-285
Chemical name:Oxirane, 2-[[3-(trimethoxysilyl)propoxy]methyl]-, reaction products with wollastonite (Ca(SiO3)).
CAS number:100402-91-3.
Effective date of TSCA section 5(e) consent order:October 14, 2002.
Basis for TSCA section 5(e) consent order:The PMN states that the substance will be used as functional filler for polymer systems. Based on SAR analysis of analogous respirable, poorly soluble particulates, EPA identified concerns for lung toxicity based on lung overload, and concern for carcinogenicity based on test data on the starting raw material—wollastonite. The consent order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this substance may present an unreasonable risk of injury to human health. To protect against this exposure and risk, the consent order requires the company to manufacture and process the PMN substance with an average aspect ratio of no greater than 5, and no more than 15 percent of the PMN substance shall have an aspect ratio greater than 10. The SNUR designates as a “significant new use” the absence of these protective measures.
Recommended testing:EPA had determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day holding period and a carcinogenicity test (OPPTS Test Guideline 870.4200) would help characterize the human health effects of the PMN substance. These tests should be conducted on the PMN substance with an average aspect ratio of greater than 5, and more than 15 percent of the PMN substance with an aspect ratio of greater than 10. The order does not require 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 721.10450.
PMN Number P-02-436
Chemical name:Alkyd amide polyol (generic).
Basis for action:The PMN states that the substance will be used as an intermediate for polyurethane polymers. Based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 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 3 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation:40 CFR 721.10451.
PMN Number P-02-659
Chemical name:9-Octadecenoic acid (9Z)-, 1,1′-(dimethylstannylene) ester.
CAS number:3865-34-7.
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a catalyst. Based on EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the 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 exceeding10 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation:40 CFR 721.10452.
PMN Number P-02-796
Chemical name:Polyglycerin alkyl ether (generic).
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a lubricant additive. Based on test data on the PMN substance and EcoSAR analysis of test data on analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 3 ppb more than 20 days per year. 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 described in the PMN 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 ready biodegradability test (OPPTS Test Guideline 835.3110) would help characterize the environmental effects of the PMN substance.
CFR citation:40 CFR 721.10453.
PMN Number P-02-828
Chemical name:Propoxylated ethoxylated alkylamine (generic).
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as a concrete admixture. Based on EcoSAR analysis of analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 80 ppb of the PMN substance in surface waters. As described in the PMN, the substance is not released to surface waters in concentrations that exceed 80 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 80 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 ready biodegradability test (OPPTS Test Guideline 835.3110); fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.
CFR citation:40 CFR 721.10454.
PMN Number P-03-61
Chemical name:Oxirane, 2,2′,2″-[ethylidynetris(4,1-phenyleneoxymethylene)]tris-.
CAS number:87093-13-8.
Basis for action:The PMN states that the substance will be used as a high-density cross-linked polymer in resins, composites, and adhesives. Based on test data on the PMN substance and SAR analysis of test data on analogous epoxides, EPA identified concerns for cancer, reproductive toxicity in males, developmental toxicity, and sensitization to lungs from worker and consumer inhalation exposures. As described in the PMN, significant occupational and consumer inhalation exposures are not expected, as the substance is not spray applied. 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 involving an application method that generates a mist, vapor, or aerosol may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing:EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats would help characterize the human health effects of the PMN substance.
CFRcitation: 40 CFR 721.10455.
PMN Number P-03-104
Chemical name:Tristyryl phenol alkoxylate salt (generic).
Basis for action:The PMN states that the generic (non-confidential) use of the substance will be as an agricultural inert. Based on EcoSAR analysis of test data on analogous cationic and anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the substance in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the PMN substance to surface water, from uses other than as described in the PMN, exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 2 ppb more than 20 days per year. 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 described in the PMN 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, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN subst