Source: https://www.federalregister.gov/documents/2012/12/20/2012-30695/significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2017-09-26 01:24:29
Document Index: 391248957

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This rule is effective on February 19, 2013. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on January 3, 2013.
77 FR 75390
75390-75399 (10 pages)
FRL-9372-8
2012-30695
PMN Number P-09-107
PMN Numbers P-11-619 and P-11-620
PMN Number P-12-64
PMN Number P-12-181
PMN Number P-12-276
PMN Number P-12-464
PMN Number P-12-480
PMN Number P-12-501
https://www.federalregister.gov/d/2012-30695 https://www.federalregister.gov/d/2012-30695
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 January 22, 2013 (see Unit VI. of the SUPPLEMENTARY INFORMATION). If adverse comment is received, EPA will publish a timely withdrawal of the rule in the Federal Register.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2012-0842, by one of the following methods:
Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC, ATTN: Docket ID Number EPA-HQ-OPPT-2012-0842. 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-2012-0842. EPA's policy is that all comments received will be included in the docket without change and may be made available online 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 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.
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. 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. 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 on or after January 22, 2013 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 9 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 bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is establishing significant new use and recordkeeping requirements for 9 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
This rule includes SNURs on 9 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.
Chemical name: Fatty acids, tall-oil, reaction products with modified fatty acids and polyalkanolamines (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance is as an asphalt emulsifier. Based on test data on the PMN substance, and ecological structural activity relationships (EcoSAR) analysis of test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 110 parts per billion (ppb) of the PMN substance in surface waters. As described in the PMN, releases of the PMN substance are not expected to result in surface water concentrations that exceed 110 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 110 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).
CFR citation: 40 CFR 721.10629.
Chemical name: Amino acid, carboxyalkyl, alkylsulfonate, alkali salts (generic).
Basis for action: The consolidated PMN states that the generic (non-confidential) use of the substances will be as an industrial cleaning solution component. Based on test data on the PMN substances and EcoSAR analysis of test data on analogous polyanionic monomers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 770 ppb for the aggregate of the PMN substances in surface waters. As described in the PMN, releases to surface waters are not expected to exceed 770 ppb for the aggregate of the PMN substances. Therefore, EPA has not determined that the proposed manufacturing or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in surface water concentrations exceeding 770 ppb for the aggregate of the PMN substances 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 an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10630.
Chemical name: Mixed metal borate (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an illuminating phosphor. Based on test data on analogous respirable, poorly soluble particulates, EPA identified concerns for lung overload and oncogenicity to workers exposed to the PMN substance. At the production volume described in the PMN, and because the uses described in the PMN do not use an application method that generates a vapor, mist, aerosol, or dust significant worker exposure is minimal. 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 exceeding the confidential annual manufacture and import volume stated in the PMN or any use of the substance using an application method that generates a vapor, mist, aerosol, or dust may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Guidelines 870.3465) with a 60-day holding period; dry particle size distribution/counting by transmission electron microscope (TEM) or scanning electron microscopy (SEM) methods; and images of the powder for morphology would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10631.
Chemical name: Benzamide, N-[(cyclohexylamino)thioxomethyl]-.
CAS number: 4921-92-0.
Basis for action: The PMN states that the use of the substance is as a cure initiator in adhesive formulations. Based on analysis of test data on analogous thioureas, EPA identified concerns for thyroid toxicity, developmental toxicity, and developmental neurotoxicity to the general population exposed to the PMN substance. Based on EcoSAR analysis of test data on analogous imides and thioureas, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb of the PMN substance in surface waters. For the uses described in the PMN, significant general population exposure is unlikely, as use in consumer product is not expected and releases of the PMN substance are not expected to result in surface water concentrations that exceed 2 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 in consumer products or use of the substance resulting in surface water concentrations exceeding 2 ppb may cause serious health effects or 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 an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); algal toxicity test (OCSPP Test Guideline 850.4500); and a combined repeated dose toxicity with the reproduction/developmental toxicity screening test (OPPTS Test Guideline 870.3650) would help characterize the environmental and health effects of the PMN substance.
CFR citation: 40 CFR 721.10632.
Chemical name: Aromatic sulfonic acid amino azo dye salts (generic).
Basis for action: The PMN states that the generic use of the PMN substance will be in exhaust dyeing of cellulosic fabrics. Based on the alkylation potential of the PMN substance, there are concerns for skin and lung sensitization; mutagenicity; oncogenicity; and developmental, liver, and kidney toxicities. In addition, there are concerns for mutagenicity and oncogenicity, based on the beta-aromatic azo reduction product, as this PMN substance is expected to undergo azo reduction in the GI tract with good absorption potential of the reduction products. As described in the PMN, EPA does not expect significant exposure to workers. 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 a NIOSH-certified M100 respirator with an APF of 10 or any increase in the annual manufacture and import volume of 10,000 kilograms (kgs) of the substance, could change the potential for exposure correspondingly, and may result in serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(c) and (b)(3)(ii).
Recommended testing: EPA has determined that results of an Ames test with the Prival modification (OPPTS Test Guideline 870.5100), and an unscheduled DNA synthesis test in mammalian cells in culture (OPPTS Test Guideline 870.5550) would help characterize the health effects of the PMN substance. The test material for the unscheduled DNA synthesis test must be the specific sulfonated beta-aromatic amine that would result from the azo reduction of the PMN substance, rather than the intact PMN compound. It is necessary that the specific sulfonated-aromatic amine in question be isolated prior to testing. For both tests, the beta-aromatic amine is to serve as an additional positive control.
CFR citation: 40 CFR 721.10633.
Chemical name: Iodonium, diphenyl-, 4,4′-di-C10-13-alkyl derivs., (OC-6-11)-hexafluoroantimonates(1-).
CAS number: 1370442-66-2.
Basis for action: The PMN states that the substance will be used as a photoinitiator used for ultraviolet release coatings. Based on the EcoSAR analysis of test data on analogous cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN 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 exceed releases from the use described in the PMN. For the use described in the PMN, environmental releases did not exceed 8 ppb for 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 use of the substance other than as described in the PMN could result in exposures which may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that 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. When testing the PMN substance, if difficulty is encountered in dissolving the chemical in the test media, the submitter may wish to consult the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000).
CFR citation: 40 CFR 721.10634.
Chemical name: Alkyl maleimide substituted bicyclic olefin (generic).
Basis for action: The PMN states that substance will be used as a monomer in the manufacture of a specialty polymer. Based on EcoSAR analysis of test data on analogous imides, 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 PMN 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 an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. When testing the PMN substance, if difficulty is encountered in dissolving the chemical in the test media, the submitter may wish to consult the special considerations for conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000).
CFR citation: 40 CFR 721.10635.
Chemical name: Slimes and sludges, automotive coating, wastewater treatment, solid waste.
CAS number: 1392095-50-9.
Chemical substance definition: The waste solids produced from the treatment of wastewaters from automotive pretreatment processes, electro-deposition coating processes, surface coating processes and topcoat coating processes. It may contain oxides of iron, calcium, aluminum, zinc, nickel, and magnesium.
Basis for action: The PMN substance will be used as a feedstock replacement in cement kiln production. Based on analogous crystalline chemical substances, EPA identified concerns for potential oncogenicity. These concerns are for effects to workers from inhalation exposure to the PMN substance in powder form. For the uses described in the PMN, significant worker exposure is unlikely, as inhalation 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 the manufacture, processing, or use of the substance in powder form may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(1)(i)(C).
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) would help characterize the human health effects of the PMN substance. Test should be conducted with special attention to histopathology (inflammation and cell proliferation) of the lung tissues and to various parameters of the bronchoalveolar lavage fluid (BALF), e.g., marker enzyme activities, total protein content, total cell count, cell differential, and cell viability. It is not necessary to look at internal organs. A recovery period of 60 days should be included to assess the progression or regression of any lesions. If the results of the 90-day inhalation toxicity test indicate that the PMN particles have carcinogenic potential, a 2-year inhalation bioassay in rats may be warranted.
CFR citation: 40 CFR 721.10636.
In these 9 cases, 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 February 19, 2013 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before January 22, 2013.
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 January 22, 2013, 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, December 20, 2012.
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. 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 9 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per §§ 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.
As discussed in the April 24, 1990 SNUR, EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notification requirements because a person could defeat the SNUR by initiating the significant new use before the rule became effective, and then argue that the use was ongoing before the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions expires.
In the absence of a TSCA section 4 test rule or a TSCA section 5(b)(4) listing covering the chemical substance, persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”
According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2012-0842.
721.10629 2070-0012
721.10630 2070-0012
721.10631 2070-0012
721.10632 2070-0012
721.10633 2070-0012
721.10634 2070-0012
721.10635 2070-0012
721.10636 2070-0012
4. Add § 721.10629 to subpart E to read as follows:
§ 721.10629
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, tall-oil, reaction products with modified fatty acids and polyalkanolamines (PMN P-09-107) 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=110).
5. Add § 721.10630 to subpart E to read as follows:
§ 721.10630
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as amino acid, carboxyalkyl, alkylsulfonate, alkali salts (PMNs P-11-619 and P-11-620) are 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) (where N = 770 parts per billion (ppb) for the aggregate of the PMN substances, P-11-619 and P-11-620). When calculating the surface water concentrations according to the instructions in § 721.90(a)(4), (b)(4), and (c)(4), the statement that the amount of the substances that will be released will be calculated before the substances enter control technology does not apply. Instead, if the waste stream containing the substances will be treated before release, then the amount of the substances reasonably likely to be removed from the waste stream by such treatment may be subtracted in calculating the number of kilograms released. No more than 90 percent removal efficiency may be attributed to such treatment.
6. Add § 721.10631 to subpart E to read as follows:
§ 721.10631
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as mixed metal borate (PMN P-12-64) 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(s), (y)(1), and (y)(2).
7. Add § 721.10632 to subpart E to read as follows:
§ 721.10632
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzamide, N-[(cyclohexylamino)thioxomethyl]- (PMN P-12-181; CAS No. 4921-92-0) 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(a)(4), (b)(4), and (c)(4) (N= 2).
8. Add § 721.10633 to subpart E to read as follows:
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic sulfonic acid amino azo dye salts (PMN P-12-276) 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) (National Institute for Occupational Safety and Health (NIOSH)-certified M100 respirator with an assigned protection factor of at least 10), (a)(6), (b) (concentration set at 0.1 percent), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (10,000 kilograms).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), and (i) are applicable to manufacturers, importers, and processors of this substance.
9. Add § 721.10634 to subpart E to read as follows:
§ 721.10634
Iodonium, diphenyl-, 4,4′-di-C10-13-alkyl derivs., (OC-6-11)-hexafluoroantimonates(1-).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as iodonium, diphenyl-, 4,4′-di-C10-13-alkyl derivs., (OC-6-11)-hexafluoroantimonates(1-) (PMN P-12-464; CAS No. 1370442-66-2) 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) (photoinitiator used for ultraviolet release coatings).
10. Add § 721.10635 to subpart E to read as follows:
§ 721.10635
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl maleimide substituted bicyclic olefin (PMN P-12-480) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
11. Add § 721.10636 to subpart E to read as follows:
§ 721.10636
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as slimes and sludges, automotive coating, wastewater treatment, solid waste (PMN P-12-501; CAS No. 1392095-50-9) 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(v)(1), (w)(1), and (x)(1).
[FR Doc. 2012-30695 Filed 12-19-12; 8:45 am]