Source: https://www.federalregister.gov/documents/2010/02/01/2010-1936/significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2018-07-17 15:56:04
Document Index: 741814648

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

A Rule by the Environmental Protection Agency on 02/01/2010
The effective date of this rule is April 2, 2010 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before March 3, 2010. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on February 16, 2010.
75 FR 4983
4983-4996 (14 pages)
FRL-8438-4
2010-1936
https://www.federalregister.gov/d/2010-1936 https://www.federalregister.gov/d/2010-1936
EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 15 chemical substances which were the subject of premanufacture notices (PMNs). Three of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, Start Printed Page 4984import, or process any of these 15 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 March 3, 2010, 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 February 1, 2010. 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 March 3, 2010 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.
Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2008-0918. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2008-0918. 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 Start Printed Page 4985127.28 (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 March 3, 2010 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.
To determine what would constitute a significant new use for the 15 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.Start Printed Page 4986
This rule includes 3 PMN substances that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.
This rule also includes SNURs on 12 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-03-141
Chemical name: Cyclopentane, methoxy-.
CAS number: 5614-37-9.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an industrial solvent. Based on test data on the PMN substance, EPA has identified concerns for systemic toxicity and neurotoxicity. For the use 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 any use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of the following tests would help characterize the human health effects of the PMN substance: A 90-day oral toxicity test in rodents (OPPTS Harmonized Test Guideline 870.3100); a flammability test (OPPTS Harmonized Test Guideline 830.6315); a sediment and soil adsorption/desorption isotherm test (OPPTS Harmonized Test Guideline 835.1220); and a standard practice for determination of odor and taste threshold by a forced-choice ascending concentration series method of limits (American Society for Testing and Materials (ASTM) E679-04 test guideline).
CFR citation: 40 CFR 721.10169.
PMN Number P-03-197
Chemical name: Polyoxyethylene polyalkylarylphenylether sulfate ammonium salt (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a surface active agent for emulsion polymerization. Based on test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 parts per billion (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 waters concentrations that exceed 5 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 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 Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, 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. All aquatic toxicity testing should be performed using the flow-through method with measured concentrations. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10170.
PMN Number P-03-285
Chemical name: 1H-benz(e)indolium, 1,1,2,3-tetramethyl-, 4-methylbenzenesulfonic acid (1:1).
CAS number: 141914-99-0.
Basis for action: The PMN states that the substance will be used as a chemical intermediate for the manufacture of a dye in imaging media/products. Based on test data on the PMN substance, EPA identified concerns for acute lethality from inhalation of the PMN substance. As described in the PMN, worker inhalation exposure will be minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of a National Institute for Occupational Safety and Health (NIOSH)-approved respirator with an assigned protection factor (APF) of at least 10 where there is a potential for inhalation exposure, or exceedance of the 11,000 kilogram annual manufacture and import volume may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(i).Start Printed Page 4987
Recommended testing: EPA has determined that the results of a repeated dose 28-day oral toxicity in rodents (OPPTS Harmonized Test Guideline 870.3050 or Organisation for Economic Co-operation and Development (OECD) 407 test guideline) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10171.
PMN Number P-03-633
Chemical name: Alkylamide derivative (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a raw material for the manufacture of photosensitive materials. Based on test data on analogous substances, 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 Harmonized Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Harmonized Test Guideline 850.1300); 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 721.10172.
PMN Number P-03-793
Chemical name: Silanamine,1,1,1-triethoxy-N,N-diethyl-.
CAS number: 35077-00-0.
Basis for action: The PMN states that the substance will be used as an external donor for olefin polymerization. Based on submitted test data, EPA has identified health concerns for corrosion. Also, based on test data on analogous alkoxysilanes and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN substance in surface waters. As described in the PMN, significant worker exposure is unlikely and releases to surface waters are not expected. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the substance could result in exposures which 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)(ii).
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, 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 daphnid testing should be performed using the flow-through method with measured concentrations. Algal toxicity testing should be performed using the static method with measured concentrations. No human health testing is recommended at this time. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10173.
PMN Number P-04-139
Chemical name: 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-peanut-oil acyl derivs., inner salts.
CAS number: 691401-28-2.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an oil well additive. Based on test data on analogous substances, EPA identified concerns for irritation, possible corrosion, and developmental toxicity. For the use described in the PMN, worker inhalation exposure is not expected and worker dermal exposures will be minimal due to the use of adequate personal protective equipment. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of impervious gloves where there is a potential for dermal exposure, or use of the substance other than as described in the PMN may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a prenatal developmental toxicity test (OPPTS Harmonized Test Guideline 870.3700) would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10174.
PMN Number P-04-141
Chemical name: 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18 and C18-unsatd. acyl) derivs., inner salts.
CAS number: 691400-36-9.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be used as an additive for various cleaners. Based on test data on analogous amphoteric surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 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 6 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 6 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 porous pot test (OPPTS Harmonized Test Guideline 835.3220); an aquatic invertebrate acute toxicity test, 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. Daphnid 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 material.
CFR citation: 40 CFR 721.10175.
PMN Number P-04-144
Chemical name: Amides, peanut-oil, N-[3-(dimethylamino)propyl].
CAS number: 691400-76-7.
Basis for action: The PMN states that the generic (non-confidential) use of 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 Start Printed Page 49881 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 the following tests would help characterize the environmental effects of the PMN substance: A fish acute toxicity test, freshwater and marine (OPPTS Harmonized Test Guideline 850.1075); a fish acute toxicity test mitigated by humic acid (OPPTS Harmonized Test Guideline 850.1085) with the chloride salt adjusted to a pH of 7; an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400). All aquatic toxicity 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 721.10176.
PMN Number P-04-153
Chemical name: Phosphoric acid, yttrium(3+) salt (1:1).
CAS number: 13990-54-0.
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a phosphor. Based on test data on analogous inorganic phosphates and soluble yttrium compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 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 6 ppb. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or any use of the substance resulting in surface water concentrations exceeding 6 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 Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, 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. All aquatic toxicity testing should be performed using the static method with measured concentrations of yttrium. Further, a certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10177.
PMN Number P-04-319
Chemical name: Distillates (Fischer-Tropsch), hydroisomerized middle, C10-13-branched alkane fraction.
CAS number: 642928-30-1.
Basis for action: The PMN states that the substance will be used as industrial/commercial paint and ink formulations; indoor industrial heating oil; and solvent blend for industrial cleaning. Based on test data on structurally similar chemicals with a carbon chain range of C5 to C21, EPA has identified health concerns for liver toxicity, kidney toxicity, developmental toxicity, mutagenicity, cancer, neurotoxicity, skin sensitization, hydrocarbon pneumonia, and irritation to mucous membranes. Also, based on test data on analogous neutral organic compounds, 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, worker dermal and inhalation exposure will be minimal due to the use of adequate personal protective equipment, and releases to water are not expected. Therefore, EPA has not determined that the proposed import, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance without the use of impervious gloves where there is the potential for dermal exposure, use of the substance without the use of a NIOSH-approved respirator with an APF of at least 100 where there is potential for inhalation exposure, domestic manufacturing, or any use of the substance resulting in release to surface waters, may cause serious health effects and significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
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 prenatal developmental toxicity test (OPPTS Harmonized Test Guideline 870.3700), using one species via the oral route; a fish early-life stage toxicity test (OPPTS Harmonized Test Guideline 850.1400) with fathead minnows, a daphnid chronic toxicity test (OPPTS Harmonized Test Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400). Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Dilution water total organic carbon (TOC) concentration should be less than 2.0 mg TOC per liter. 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 721.10178.
PMN Numbers P-04-346 and P-04-347
Chemical name: Copolymers of phenol and aromatic hydocarbon (generic).
Effective date of TSCA section 5(e) consent order: November 15, 2004.
Basis for TSCA section 5(e) consent order: The consolidated PMN states that the generic (non-confidential) use of the substances will be as binder components. 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 these substances may present an unreasonable risk of injury to the environment. To protect against this risk, the consent order requires the company to not manufacture or import the PMN substances unless the average molecular weight is greater than 500 daltons. To ensure compliance, the consent order also requires that the substances be analyzed both at the time of initial commencement and annually thereafter. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: Based on test data on analogous phenols, EPA predicts toxicity to aquatic organisms varies with the average number molecular weight of the PMN substances. As the average number molecular weight decreases, the aquatic toxicity of the substances increases. When the average molecular weight is 366 daltons, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters. The PMN substances with a molecular weight greater than 500 daltons are of lower concern for toxicity because the expected water solubility is estimated to be less than 1 ppb.
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Harmonized Test Guideline 850.1400), a daphnid chronic toxicity test (OPPTS Harmonized Test Guideline 850.1300); Start Printed Page 4989and an algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 850.5400) would help characterize possible environmental effects of the PMN substances. Fish and daphnid testing should be performed using the flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA should be consulted to determine what form of the chemical substances should be tested. The order does not require submission of the 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 chemical substances 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 721.10179.
PMN Number P-04-692
Chemical name: Trifunctional acrylic ester (generic).
Effective date of TSCA section 5(e) consent order: December 6, 2004.
Basis for TSCA section 5(e) consent order: The PMN states that the substance will be used in lacquer/dry film manufacture. 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 the environment. To protect against this risk, the consent order requires the company to not manufacture or import the PMN substance unless the mean number of moles of the ethoxy group is greater than or equal to 8. To ensure compliance, the consent order also requires that the substance be analyzed both at the time of initial commencement and annually thereafter. The SNUR designates as a “significant new use” the absence of these protective measures.
Toxicity concern: Based on test data on analogous esters, EPA predicts toxicity to aquatic organisms varies with the average number of moles of the ethoxy group. As the number of moles of ethoxy group decreases, the aquatic toxicity of the substance increases. For the PMN substance with an average of 3 moles of ethoxy, EPA predicts toxicity to aquatic organisms at concentrations that exceed 40 ppb of the PMN substance in surface waters.
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, 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 daphnid testing should be performed using flow-through method with measured concentrations. Algal testing should be performed using the static method with measured concentrations. EPA should be consulted to determine what form of the chemical substance should be tested. The order does not require submission of the 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 chemical 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 721.10180.
PMN Number P-07-453
Chemical name: Halide salt of an alkylamine (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a solder adjuvant, an open, non-dispersive use. Based on test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 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 any use of the substance other than as described in the PMN could result in release to surface waters 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 fish acute toxicity test, freshwater and marine (OPPTS Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, 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. All 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 721.10181.
Basis for action: The PMN states that the substance will be used as a motor vehicle air conditioning (MVAC) refrigerant in new passenger cars and vehicles (i.e., as defined in 40 CFR 82.32 (c) and (d)). Initial charging of MVAC units with the PMN substance will be done by the motor vehicle original equipment manufacturer. All servicing, maintenance, and disposal involving the PMN substance will be done only by Clean Air Act (CAA) section 609 certified technicians using CAA section 609 certified refrigerant handling equipment. Based on test data on the PMN substance, EPA identified health concerns for developmental toxicity and lethality to workers and consumers if they were exposed to a significant amount of the PMN substance via inhalation. The PMN substance has an ozone depletion potential of zero, and based on test data, has a low global warming potential (GWP100 of about 4). For the use scenario described in the PMN, significant industrial or commercial worker exposure is unlikely due to the use of CAA section 609 certified refrigerant handling equipment and other protective measures. Potential consumer (vehicle passenger) exposure from refrigerant leaks into the passenger compartment of a vehicle is not expected to present significant risk of serious health effects. Flammability concerns with the PMN substance are being addressed through regulatory actions by EPA's Office of Air and Radiation (see the following paragraph). Further, “do-it-yourself” consumer exposures are not expected because the PMN substance only will be sold or distributed in 20-pound containers or larger. Therefore, EPA has not determined that the manufacturing, processing, or use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that (1) use of the substance other than as a MVAC refrigerant in new passenger cars and vehicles as defined in 40 CFR 82.32 (c) and (d), (2) initial charging of MVAC units with the PMN substance by any person other than CAA section 609 certified technicians without using CAA section 609 certified refrigerant handling equipment, (3) servicing, maintenance, and disposal involving the PMN substance by persons other than CAA section 609 certified technicians without using CAA section 609 certified refrigerant Start Printed Page 4990handling equipment, or (4) sale or distribution of the PMN substance in containers smaller than 20-pounds (net weight) may cause serious health effects in accordance with 40 CFR 721.170(b)(3)(i).
This SNUR is intended to complement recently proposed and forthcoming regulations on the PMN substance under the CAA in that this SNUR addresses health risk issues of the subject refrigerant. On October 19, 2009, EPA published a proposed rule on the PMN substance entitled “Protection of Stratospheric Ozone: New Substitute in the Motor Vehicle Air Conditioning Sector under the Significant New Alternatives Policy (SNAP) Program” (74 FR 53445) (FRL-8969-7). The SNAP Program, mandated under section 612 of the CAA, requires EPA to develop a program for evaluating alternatives to ozone-depleting substances and to create lists of substitutes for specific uses that do not present greater overall risk to human health and the environment than other alternatives that are available. In the October 19, 2009, action, EPA proposed to find HFO-1234yf acceptable, subject to certain use conditions, as a substitute for CFC-12 in new motor vehicle air conditioning systems (passenger cars and trucks). The proposed use conditions include incorporation of engineering strategies and/or devices to mitigate flammability risks for this substance (see Unit V. of the proposed rule). Use of most flammable refrigerants, including the PMN substance, in existing MVAC systems as a retrofit has previously been determined by EPA to be unacceptable. The proposed rule would require a petition and a new SNAP submission specifically for the use of the PMN substance in existing MVAC equipment as a retrofit before EPA would consider allowing such use (see Unit VI. of the proposed rule). EPA also intends to promulgate a follow-on rulemaking under section 609 of the CAA to address service equipment, technician certification, and end-of-life disposal specifications.
Recommended testing: EPA has determined that the results of an acute inhalation toxicity study (OPPTS Harmonized Test Guideline 870.1300 or OECD 403 test guideline) with rabbits would help characterize the human health effects of the PMN substance. Exposure concentrations of 10,000, 50,000, and 100,000 parts per million (ppm) should be used. Further, rabbits should be exposed for 1 hour, and pregnant rabbits should be exposed on Gravid Day 12.
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 3 of the 15 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160.
In the other 12 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.
EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is April 2, 2010 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before March 3, 2010.
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 3 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 6 of the 15 chemical substances contained in this rule have Start Printed Page 4991CBI 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. Please go to http://www.epa.gov/​oppts and select “Test Methods and Guidelines” on the left-side navigation menu. 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. The American Society for Testing and Materials (ASTM) test guidelines are available at http://www.astm.org/​standard/​index.shtml.
Under these procedures a manufacturer, importer, or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since many of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers, importers, and processors can combine the bona fide submission under the procedure in § 721.1725(b)(1) with that under § 721.11 into a single step.
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 4992EPA 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.
This rule establishes SNURs for several new chemical substances that were the subject of PMNs or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
This rule does not have Tribal implications because it is not expected Start Printed Page 4993to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this rule.
721.10169 2070-0012
721.10170 2070-0012
721.10171 2070-0012
721.10172 2070-0012
721.10173 2070-0012
721.10174 2070-0012
721.10175 2070-0012
721.10176 2070-0012
721.10177 2070-0012
721.10178 2070-0012
721.10179 2070-0012
721.10180 2070-0012
721.10181 2070-0012
4. Add § 721.10169 to subpart E to read as follows:
§ 721. 10169
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cyclopentane, methoxy- (PMN P-03-141; CAS No. 5614-37-9) 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(j).
5. Add § 721.10170 to subpart E to read as follows:
§ 721.10170
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyoxyethylene polyalkylarylphenylether sulfate ammonium salt (PMN P-03-197) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.Start Printed Page 4994
6. Add § 721.10171 to subpart E to read as follows:
§ 721.10171
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1H-benz(e)indolium, 1,1,2,3-tetramethyl-, 4-methylbenzenesulfonic acid (1:1) (PMN P-03-285; CAS No. 141914-99-0) 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)(4), (a)(5), (b) (concentration set at 1 percent), and (c). Respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. The following NIOSH-approved respirators with an APF of 10-25 meet the minimum requirements for § 721.63(a)(4): Air-purifying, tight-fitting respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters (either half- or full-face); powered air-purifying respirator equipped with a loose-fitting hood or helmet and High Efficiency Particulate Air (HEPA) filters; powered air-purifying respirator equipped with a tight-fitting facepiece (either half- or full-face) and HEPA filters; supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (either half- or full-face).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (11,000 kilograms).
7. Add § 721.10172 to subpart E to read as follows:
§ 721.10172
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylamide derivative (PMN P-03-633) 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 =1).
8. Add § 721.10173 to subpart E to read as follows:
§ 721.10173
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as silanamine,1,1,1-triethoxy-N,N-diethyl- (PMN P-03-793; CAS No. 35077-00-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
9. Add § 721.10174 to subpart E to read as follows:
§ 721.10174
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-peanut-oil acyl derivs., inner salts (PMN P-04-139; CAS No. 691401-28-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).
10. Add § 721.10175 to subpart E to read as follows:
§ 721.10175
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18 and C18-unsatd. acyl) derivs., inner salts (PMN P-04-141; CAS No. 691400-36-9) 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=6).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.Start Printed Page 4995
11. Add § 721.10176 to subpart E to read as follows:
§ 721.10176
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amides, peanut-oil, N-[3-(dimethylamino)propyl] (PMN P-04-144; CAS No. 691400-76-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
12. Add § 721.10177 to subpart E to read as follows:
§ 721.10177
Phosphoric acid, yttrium(3+) salt (1:1).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phosphoric acid, yttrium(3+) salt (1:1) (PMN P-04-153; CAS No. 13990-54-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(ii) Release to water. Requirements as specified in § 721.90 (b)(4) and (c)(4) (N=6).
13. Add § 721.10178 to subpart E to read as follows:
§ 721.10178
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as distillates (Fischer-Tropsch), hydroisomerized middle, C10-13-branched alkane fraction (PMN P-04-319; CAS No. 642928-30-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (b) (concentration set at 0.1 percent), and (c). Respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 100. The following NIOSH-approved respirator meets the minimum requirements for § 721.63(a)(4): Supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f).
14. Add § 721.10179 to subpart E to read as follows:
§ 721.10179
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as copolymers of phenol and aromatic hydocarbon (PMNs P-04-346 and P-04-347) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (no manufacture or import of the PMN substances unless the average molecular weight is greater than 500 daltons). Representative samples of the PMN substances must be analyzed and determined to comply with these requirements both at the time of initial commencement and annually thereafter.
15. Add § 721.10180 to subpart E to read as follows:
§ 721.10180
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as trifunctional acrylic ester (PMN P-04-692) 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. Requirement as specified in § 721.80(k) (no manufacture or import of the PMN substance unless the mean number of moles of the ethoxy group is greater than or equal to 8). Representative samples of the PMN substance must be analyzed and determined to comply with these requirements both at the time of initial commencement and annually thereafter.
16. Add § 721.10181 to subpart E to read as follows:
§ 721.10181
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as halide salt of an alkylamine (PMN P-07-453) is subject Start Printed Page 4996to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
17. Add § 721.10182 to subpart E to read as follows:
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j) (use as a motor vehicle air conditioning (MVAC) refrigerant in new passenger cars and vehicles as defined in 40 CFR 82.32 (c) and (d). The initial charging of MVAC units with the PMN substance will be done by the motor vehicle original equipment manufacturer. All servicing, maintenance, and disposal involving the PMN substance will be done only by Clean Air Act (CAA) section 609 certified technicians using CAA section 609 certified refrigerant handling equipment. The PMN substance only will be sold or distributed in 20-pound (net weight) containers or larger).
[FR Doc. 2010-1936 Filed 1-29-10; 8:45 am]