Source: https://www.federalregister.gov/documents/2015/04/09/2015-08090/modification-of-significant-new-uses-of-certain-chemical-substances
Timestamp: 2017-11-24 09:52:45
Document Index: 352506600

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Federal Register :: Modification of Significant New Uses of Certain Chemical Substances
Modification of Significant New Uses of Certain Chemical Substances
A Proposed Rule by the Environmental Protection Agency on 04/09/2015
Comments must be received on or before May 11, 2015.
80 FR 19037
19037-19050 (14 pages)
EPA-HQ-OPPT-2014-0649
FRL-9924-10
2015-08090
IV. Substances Subject to a Proposed Significant New Use Rule Amendment
PMN Number P-99-669, SNUN Number S-09-1, and SNUN Number S-13-29
PMN Number P-00-618 and SNUN Numbers S-05-03 and S-11-4
PMN Number P-98-1275 and SNUN Number S-11-10
PMN Number P-00-7 and SNUN Numbers S-05-1, S-06-4, S-07-3, and S-07-5
PMN Number P-95-169 and SNUN Numbers S-08-7 and S-14-1
PMN Numbers P-88-2179 and P-89-0539 and SNUN Number S-08-3
PMN Number P-95-638 and SNUN Numbers P-97-79 and S-06-8
PMN Number P-00-1220 and SNUN Number S-07-2
PMN Number P-01-320 and SNUN Numbers S-04-2 and S-11-1
PMN Number P-01-781
PMN Number P-00-1132 and SNUN Number S-11-5
PMN Numbers P-97-296, P-97-297, P-97-298, and P-97-299 and SNUN Numbers S-03-10, S-03-11, S-03-12, and S-03-13
PMN Number P-90-226 and SNUN Numbers P-96-1408, S-08-6, S-09-4, and S-13-49
PMN Number P-93-1649 and SNUN Numbers S-04-3 and S-11-3
PMN Number P-00-1121
PMN Number P-07-601 and SNUN Number S-14-11
PMN Numbers P-10-486 and P-10-487
PMN Numbers P-10-58, P-10-59, P-10-60, and P-10-184
V. Rationale for the Proposed Rule
VI. Applicability of the Proposed Rule to Uses Occurring Before Effective Date of the Final Rule
https://www.federalregister.gov/d/2015-08090 https://www.federalregister.gov/d/2015-08090
This PDF is the current document as it appeared on Public Inspection on 04/08/2015 at 08:45 am.
Start Preamble Start Printed Page 19037
EPA is proposing to amend the significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 24 chemical substances which were the subject of premanufacture notices (PMNs). This action would amend the SNURs to allow certain uses without requiring a significant new use notice (SNUN), and would extend SNUN requirements to certain additional uses. EPA is proposing these amendments based on review of new data as described for each chemical substance. This action would requires persons who intend to manufacture (including import) or process any of these 24 chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0649, by one of the following methods:
For technical information contact: Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-8974; email address: alwood.jim@epa.gov.
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 a modified SNUR 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 the chemical substance that is the subject of a final 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.
EPA is proposing amendments to the SNURs for 24 chemical substances in 40 CFR part 721 subpart E. This proposed action would require persons who intend to manufacture or process these chemical substances for an activity that is designated as a significant new use by these amended rules to notify EPA at least 90 days before commencing that activity. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs.Start Printed Page 19038
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors, listed in Unit III. of this document. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use. Persons who must report are described in § 721.5.
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 section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
To determine what would constitute a significant new use for the 24 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substance, 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 proposing to amend the significant new use and recordkeeping requirements for 24 chemical substances in 40 CFR part 721 Subpart E. In this unit, EPA provides the following information for each chemical substance:
PMN number and SNUN number.
Chemical Abstracts Service (CAS) number (if assigned for non-confidential chemical identities).
Federal Register publication date and reference for the final SNUR previously issued.
Basis for the Proposed Amendment.
Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VII. for more information).
Chemical name: Oxirane, methyl-, polymer with oxirane, mono (3,5,5,-trimethylhexyl) ether.
CAS number: 204336-40-3.
Federal Register publication date and reference: March 28, 2003 (68 FR 15061) (FRL-6758-7).
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substance for the PMN and the SNUN is as a wetting agent. The original SNUR was issued based on meeting the concern criteria at § 721.170 (b)(4)(ii). The original SNUR required notification if the chemical substance was used for uses other than as described in the PMN. On November 12, 2008 EPA received a SNUN, S-09-1, and on June 4, 2013 EPA received a SNUN, S-13-29 for the chemical substance describing uses different than those in the PMN. The 90-day review period for the SNUNs expired with EPA not taking action on the significant new uses described in the SNUNs. Based on structural analogy to nonionic surfactants, EPA is still concerned that toxicity to aquatic organisms may occur at a concentration of 600 parts per billion (ppb) in surface waters. Because EPA finds that the substance is not released to surface waters in significant quantities as described in either the PMN or the SNUNs, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance may cause significant adverse environmental effects. Based on this the substance meets the concern criteria at § 721.170 (b)(4)(ii). Based on these findings, EPA is proposing to modify the SNUR to allow the uses described in S-09-01 and S-13-29.
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 text, 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 chemical substance.
CFR citation: 40 CFR 721.522.
Chemical name: 1-Butanol, 3-methoxy-3-methyl-, acetate.
CAS number: 103429-90-9.
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substance for the PMN is as a processing aid. The uses of the chemical substance for the SNUNs are as an organic solvent of polyurethane plastic coating, an ingredient in various kinds of paint thinner, an organic solvent of polyurethane resin, an ingredient of cleaning agents, an organic solvent for screen ink, an ingredient in airplane paint, and a solvent for inkjet printer ink. EPA identified concerns for liver toxicity, kidney toxicity, developmental neurotoxicity and carcinogenicity based on analog data. The original SNUR was issued based on meeting the concern criteria at § 721.170 (b)(3)(i), (b)(3)(ii), and (b)(1)(i)(C). The original SNUR required notification if the chemical substance was used for use other than as described in the PMN. On March 23, 2005, EPA received a SNUN, S-05-3, for the chemical substance describing Start Printed Page 19039uses different than those in the PMN. Based on the activities described in this SNUN, a TSCA section 5(e) consent order was issued for the SNUN submitter under sections 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) based on a finding that the substance may present an unreasonable risk of injury to human health. On October 26, 2010, EPA received a SNUN, S-11-4, for a new use, which was as a solvent for inkjet printer ink. The SNUN submitter also submitted a chromosome aberration study, a mouse lymphoma assay and a combined repeated dose study with reproductive and developmental toxicity. Based on the test data for the chemical substance which was submitted with S-11-4, EPA continues to have concerns for liver toxicity and kidney toxicity for exposed workers and consumers. In response to S-11-4, EPA allowed the new use and modified the consent order accordingly, while continuing to protect against any unreasonable risks of injury to human health. The modified consent order requires:
1. Workers to use personal protective equipment to prevent dermal exposure.
2. Establishment and use of a hazard communication program, including human health, environmental hazard precautionary statements on each label and the Material Safety Data Sheet (MSDS).
3. Not manufacture the substance in the United States.
4. Not use the substance in consumer products.
5. Limit the percent concentration of the substance to 10% or less in final products whose use involves an application method that generates a vapor, mist, or aerosol, except for commercial/professional inkjet printing in a commercial (excluding retail) print shop.
The proposed SNUR designates as a significant new use the absence of these protective measures when using the substance for any use other than as described in the PMN.
Recommended testing: EPA has determined that the results of a two-year chronic toxicity study (OPPTS Test Guideline 870.4100) via the dermal and inhalation routes would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.532.
Chemical name: Aluminosilicates, phospho-.
CAS number: 201167-69-3.
Federal Register publication date and reference: December 26, 2000 (65 FR 81386) (FRL-6592-8).
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substance for the PMN and the SNUN is as a catalyst. A consent order was issued for the PMN under section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a finding that the substance may present an unreasonable risk of injury to human health. The original SNUR, based on the requirements in the TSCA section 5(e) consent order, required notification if the PMN substance was used without the respiratory protection described in the SNUR (i.e., a National Institute of Occupational Safety and Health (NIOSH) respirator with an Assigned Protection Factor (APF) of 2000), the hazard communication program described in the SNUR was not used, or the aggregate production volume in the consent order was exceeded. Upon receipt and evaluation of the 90-day inhalation study required in the consent order, EPA continues to find that the substance may present an unreasonable risk of lung effects and cancer, although at a higher dose/effect level. Based on this finding, EPA modified the consent order to remove the production volume limit and reduce the required protection level for the respirator to an APF of 50. On June 14, 2011, EPA received a SNUN, S-11-10, for the chemical substance to use a respirator with an APF of 50 and to exceed the production volume limit. EPA permitted the new uses for the same reasons it modified the consent order. The proposed SNUR designates as a “significant new use” the absence of the respiratory protection and hazard communication measures in the modified consent order.
Recommended testing: EPA has determined that the results of a two-year two-species oral carcinogenicity study (OPPTS Test Guideline 870.4200) would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.633.
Chemical name: D-Glucuronic acid, polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt.
CAS number: 125005-87-0.
Federal Register publication date and reference: December 17, 2003 (68 FR 70155) (FRL-7307-3).
Basis for the modified significant new use rule: The uses of the chemical substance as described in the PMN are as an oilfield drilling fluid, an oilfield spacer fluid, in oilfield cementing, in cementitious packaged products, in concrete applications, and in foam applications. Based on structural analogues and submitted test data, EPA identified concerns for lung effects from inhalation exposure to the chemical substance. The original SNUR was issued based on meeting the concern criteria at § 721.170(b)(3)(i) and (b)(3)(ii). The original SNUR required notification if the chemical substance was used for any use other than those described in PMN. EPA received SNUN S-05-1 on December 1, 2004, S-06-4 on February 28, 2006, S-07-3 on June 5, 2007, and S-07-5 on July 17, 2007. Each SNUN described different uses for the chemical substance than those described in the PMN: S-05-1 described use as a sealant, S-06-4 described a generic use in pipeline transmission systems, S-07-3 described any uses other than those already allowed in the SNUR where less than 5 percent of the chemical substance consists of particles below 10 microns, and S-07-05 described a generic use in a commercial dry wash additive. As with the PMN, the Agency in its review of the SNUNs found that significant inhalation exposure remains unlikely when used as described in the SNUNs, and accordingly, EPA has not determined that the proposed manufacturing, processing, and use of the chemical substance may present an unreasonable risk. EPA has determined, however, that use of the chemical substance where more than 5 percent of the chemical substance contains particles below 10 microns may cause significant health effects. Based on this information, the chemical substance meets the concern criteria at § 721.170(b)(3)(i) and (b)(3)(ii). Based on these findings EPA is proposing to modify the SNUR to remove the notification requirement for specific end uses and instead require notification where more than 5 percent of the chemical substance consists of particles below 10 microns.
Recommended testing: EPA has determined that the 90-day inhalation toxicity study with a 60-day holding period (OPPTS Test Guideline 870.3465) would help to characterize the human health effects of the PMN substance. Attention should be given to the lungs, including histopathology of the lungs (inflammation, epithelial hyperplasia, and fibrosis), (HAL) analysis for markers of lung injury, and lung burden analysis for clearance of the test material (EPA-748-R-96-001). The neurotoxicity components and examination of organs other than the Start Printed Page 19040lungs are not required in the 90-day study.
CFR citation: 40 CFR 721.2076.
Chemical name: 2-Propen-1-one, 1-(4-morpholinyl)-.
CAS number: 5117-12-4.
Federal Register publication date and reference: Jan. 5, 2000 (65 FR 354) (FRL-6055-2), amended May 13, 2011 (76 FR 27910) (FRL-8871-5).
Basis for the modified significant new use rule: The use for P-95-169 is as a diluent for ultraviolet and electron beam curable resins for coatings, inks, and curable adhesives, and the use for S-14-1 is as a monomer for use in ultraviolet ink jet applications. The generic (non-confidential) use for S-08-7 is a contained use in energy production. A consent order for the PMN was issued under sections 5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based on a finding that the chemical substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Agency issued a TSCA section 5(e) consent order which became effective on November 27, 1998. The order required the use of dermal personal protective equipment (including gloves demonstrated to be impervious) and respiratory personal protective equipment (including a NIOSH-approved respirator); required establishment of a hazard communication program; prohibited domestic manufacturing; prohibited processing and use activities in non-enclosed processes; established maximum production volume limits for submission of required testing; established waste disposal practices (including restrictions for no release to surface waters and requirement of disposal only in a Resource Conservation Recovery Act ((RCRA) hazardous waste landfill); and prohibited use of the chemical substance involving an application method that generates a vapor, mist, or aerosol.
A SNUR was issued for this chemical substance on January 5, 2000. The SNUR designated as a “significant new use” the absence of the protective measures required in the consent order.
Subsequent to issuance of the SNUR, the PMN submitter completed the following studies under the terms of the TSCA section 5(e) consent order: An in vivo mouse micronucleus test, a 90-day oral toxicity study in rats, and a reproductive toxicity screening study in rats. The results of the micronucleus test were negative. Based on the results of the 90-day study, the Agency established a no observed adverse effect level (NOAEL) of 20 milligram/kilogram/day (mg/kg/day) for neurotoxicity. Further, based on the results of the reproductive toxicity screening study, a NOAEL of 75 mg/kg/day (highest dose tested) was established for reproductive effects. From these data, the Agency calculated Margins of Exposure (MOEs) for predicted workplace exposures.
Based on these new data, concerns remained for possible effects to the liver, testes, kidney, and blood from dermal exposure. However, EPA no longer had substantial human health concerns for mutagenicity and neurotoxicity. In addition, Agency concerns for carcinogenicity by inhalation were reduced, but were further mitigated by retaining the original consent order prohibition of industrial processing and use in a non-enclosed process and any use application methods that generate a vapor, mist, or aerosol form of the PMN substance.
In addition, to account for data received on analogous substances since the initial PMN was submitted and to address Agency environmental concerns, a re-review of the environmental toxicity profile for the chemical substance was conducted. The results of this evaluation indicated a low concern for chronic aquatic toxicity. Therefore, EPA could no longer make a “may present unreasonable risk” finding for releases of the PMN substance to surface waters. As a result of this review, EPA issued a modified TSCA section 5(e) consent order which became effective on May 9, 2006. The modified order removed requirements for respiratory protection, waived further required trigger testing, removed the restriction on domestic manufacture, and removed waste disposal restrictions. Pursuant to § 721.185(a)(5), the Agency examined new information and reexamined the test data and other information supporting its finding under section 5(e)(1)(A)(ii)(I) of TSCA, and concluded that a rational basis no longer existed to support findings that certain activities involving the substance may present an unreasonable risk of injury to human health and the environment required under section 5(e)(1)(A) of TSCA.
To protect against the remaining potential risks, the modified consent order:
Requires the use of dermal personal protective equipment (including gloves demonstrated to be impervious).
Requires establishment of a hazard communication program.
Prohibits processing and use activities in non-enclosed processes.
Prohibits the use of the chemical substance involving an application method that generates a vapor, mist, or aerosol.
On June 27, 2008, the Agency received a SNUN, S-08-7, for the subject chemical substance. The significant new use identified in the notice was release to water for the generic (non-confidential) use of “contained use in energy production”. The 90-day review period for the SNUN expired on October 2, 2008 with EPA not taking action on the “significant new use” of release of the substance to water.
On May 13, 2011, EPA issued a modified SNUR based on and consistent with the provisions in the underlying modified consent order which no longer included release to water as a significant new use. In addition, EPA included, in the regulatory text, clarifying language for those forms of the PMN substance which are exempt from the provisions of the proposed SNUR. The SNUR does not apply to quantities of the PMN substance after it has been completely reacted (cured) because the PMN substance will no longer exist.
On October 21, 2013, EPA received a second SNUN, S-14-1, for the subject chemical substance. The significant new use identified in the notice was processing and use in a non-enclosed process as a monomer for use in ultraviolet ink jet applications. The 90-day review period for the SNUN expired on March 13, 2014, with EPA not taking action on the significant new use of processing and use in a non-enclosed process as a monomer for use in ultraviolet ink jet applications. When evaluating this new use, EPA also evaluated potential environmental releases. Based on a new review of test data on the chemical substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 100 ppb of the chemical substance in surface waters. As described in the PMN and SNUNs, releases of the substance are not expected to result in surface water concentrations that exceed 100 ppb. EPA has determined, however, that any use of the substance resulting in surface waters concentrations exceeding 100 ppb may result in significant adverse environmental effects. Based on this information, the chemical substance meets the concern criteria at § 721.170 (b)(4)(i). The proposed SNUR designates as a “significant new use” the absence of the protective measures required in the modified consent order, any water releases during manufacturing, processing, and use that exceed 100 Start Printed Page 19041ppb, or use other than as a monomer for use in ultraviolet ink jet applications unless the chemical substance is processed and used in an enclosed process.
Recommended testing: EPA has determined that the results of the combined repeated dose toxicity with the reproductive/developmental toxicity screening test (OPPTS Test Guideline 870.3650) would help further characterize the human health effects of the PMN substance. The modified TSCA section 5(e) consent order does not require submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacturing, 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 721.5185.
Chemical name: Oxirane, 2,2′-(1,6-hexanediylbis(oxymethylene))bis-.
CAS number: 16096-31-4.
Federal Register publication date and reference: April 25, 1991 (56 FR 19228).
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substance in the PMNs and the SNUN is in coatings and as a diluent. A consent order was issued under sections 5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based on a finding that the chemical substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Agency issued a TSCA section 5(e) consent order which became effective on October 12, 1990. The order required the use of dermal personal protective equipment including impervious gloves and respiratory personal protective equipment including a NIOSH-approved respirator; required establishment of a hazard communication program; prohibited non-industrial use; established maximum production volume limits for submission of required testing; established requirements for release to surface waters during manufacturing and allowed no release to surface waters during processing and use. On February 4, 2008, EPA received a SNUN, S-08-3, for the chemical substance. The significant new use identified in the notice was a non-industrial use. The 90-day review period for the SNUN expired on October 2, 2008, with EPA not taking action on the “significant new use” of the industrial use described in the SNUN. The proposed SNUR designates as a “significant new use” any non-industrial use other than as described in the SNUN and retains the other significant new uses which are the absence of the other protective measures required in the consent order.
Recommended testing: EPA has determined that the results of a 90-day oral subchronic study with special attention given to the pathology of the reproductive organs (OPPTS Test Guideline 870.3100), a two-year two-species oral carcinogenicity study (OPPTS Test Guideline 870.4200), a fish acute toxicity test (OPPTS Test Guideline 850.1075), an aquatic invertebrate acute toxicity text (OPPTS Test Guideline 850.1010) and an algal toxicity test (OCSPP Test Guideline 850.4500) would help further characterize the human health and environmental effects of the PMN substance. The consent order requires the PMN submitter to conduct the 90-day oral toxicity test (OPPTS Test Guideline 870.3100) before exceeding the confidential production limit in the consent order.
CFR citation: 40 CFR 721.5575.
Chemical name: Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.
CAS number: 138495-42-8.
Federal Register publication date and reference: January 22, 1998 (63 FR 3394) (FRL-5720-3).
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substance for the PMN is as a carrier fluid and for the two SNUNs the generic (non-confidential) use is as test media. The original SNUR was issued based on meeting the concern criteria at § 721.170 (b)(4)(i). The original SNUR required notification if the chemical substance was used for uses other than described in the PMN or the first SNUN P-97-79 (at that time SNUNs were designated with a “P” number; later submissions received an “S” designation). On February 4, 2008, EPA received a second SNUN, S-06-8, for the subject chemical substance. The significant new use identified in S-06-8 was the specific confidential use described in the notice. The 90-day review period for the SNUN expired on July 17, 2006, with EPA not taking action on the significant new use described in the SNUN. The proposed SNUR designates as a significant new use, any use other than the uses described in the PMN and the SNUNs.
Recommended testing: None.
CFR citation: 40 CFR 721.5645.
Chemical name: Phenol-biphenyl polymer condensate (generic).
Federal Register publication date and reference: August 20, 1998 (63 FR 44562) (FRL-5788-7).
Basis for the modified significant new use rule: The use of the chemical substance for the PMN is in electric molding and for the SNUN is as a component in photoresist manufacture. The original SNUR was issued based on meeting the concern criteria at § 721.170(b)(4)(ii). The original SNUR required notification if the PMN substance was released to water. On January 8, 2007, EPA received SNUN, S-07-2, for the chemical substance describing releases to water. The 90-day review period for the SNUN expired with the Agency not taking action on the significant new uses described in the SNUN because the water releases did not exceed 1 ppb, the Agency's surface water concentration of concern for adverse effects of the substance to aquatic organisms. The PMN submitter subsequently submitted a fish early-life stage ecotoxicity study for the chemical substance. Based on this submitted study and structural analogy to phenols, EPA is still concerned that toxicity to aquatic organisms may occur at a concentration of 5 ppb in surface waters. Because EPA finds that the chemical substance is not released to surface waters above 5 ppb as described in the PMN and SNUN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance may cause significant adverse environmental effects. Based on this the substance meets the concern criteria at § 721(b)(4)(i) and (b)(4)(ii). Based on these findings, EPA is proposing to modify the SNUR to require notification if water releases exceed 5 ppb in surface waters.
Recommended testing: EPA has determined that an aquatic invertebrate acute toxicity text (OPPTS Test Guideline 850.1010) and an algal toxicity test (OCSPP Test Guideline 850.4500) would help further characterize the environmental effects of the chemical substance.
CFR citation: 40 CFR 721.5713.
Chemical name: Propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy-.Start Printed Page 19042
CAS number: 375-03-1.
Basis for the modified significant new use rule: The use of the chemical substance for the PMN is as a heat transfer fluid and a refrigerant. The use for S-04-2 is for aerosol spray cleaning. The use for S-11-1 is for flush cleaning, foam blowing, deposition coatings, histology baths, and vapor degreasing. The original SNUR was issued based on meeting the concern criteria at § 721.170 (b)(3)(i) and (b)(3)(ii). The original SNUR required notification if the chemical substance was used other than as a heat transfer fluid or refrigerant, or if the annual production volume exceeded 100,000 kilograms. On March 29, 2004, EPA received SNUN, S-04-2, for the chemical substance describing a new use of aerosol spray cleaning for industrial and commercial use. The 90-day review period for the SNUN expired on June 26, 2004 with EPA not taking action on the significant new use of aerosol spray cleaning for industrial and commercial use. On January 4, 2011, EPA received a SNUN, S-11-1, for the chemical substance describing new uses of flush cleaning, foam blowing, deposition coatings, histology baths, and vapor degreasing and exceeding an annual production volume of 100,000 kilograms. The 90-day review period for S-11-1 expired on September 23, 2011 with EPA not taking action on the significant new uses described in the SNUN. EPA continues to identify health concerns for liver and kidney toxicity based on submitted test data on the chemical substance and cardiac sensitization and developmental toxicity based on analog data. For the uses described in the PMN and SNUNs, significant occupational exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use will present an unreasonable risk. EPA has determined, however, that any uses of the substance other than those described in the PMN and SNUNs may result in serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i) and (b)(3)(ii). The proposed SNUR modification designates as a “significant new use” any use other than the uses described in the PMN and SNUNs. The proposed SNUR modification no longer designates the significant new use of exceeding an annual production volume of 100,000 kilograms.
Recommended testing: EPA has determined that the results of a 90-day oral subchronic study (OPPTS Test Guideline 870.3100) would help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.8145.
Chemical name: Silane, triethoxy[3-oxiranylmethoxy)propyl]-.
CAS number: 2602-34-8.
Federal Register publication date and reference: Dec. 17, 2003 (68 FR 70155) (FRL-7307-3).
Basis for the modified significant new use rule: The original SNUR was issued resulting in listing the incorrect CAS number as 2602-34-2 for the chemical substance in the Code of Federal Regulations. The proposed SNUR modification is designating the correct CAS number of 2602-34-8. The original findings and requirements of the SNUR are the same.
CFR citation: 40 CFR 721.9501.
Chemical name: Siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated salt (generic).
Basis for the modified significant new use rule: The use of the chemical substance for the PMN is in anti-graffiti systems and for the SNUN is as a surface treatment and additive for coatings, adhesives, sealants, paste, insulation and textiles for porous, non-porous, ceramic, metal, glass, plastic, wood and leather surfaces; and a surface treatment agent for inorganic filler particles. The original SNUR was issued based on meeting the concern criteria at § 721.170 (b)(3)(ii). The original SNUR required notification if the chemical substance was used for use other than described in PMN or for an application that generates a vapor, mist, or aerosol. On January 5, 2011, EPA received a SNUN, S-11-5, for the chemical substance describing uses different than those in the PMN. EPA also reviewed a 90-day inhalation study that was submitted for the substance in the SNUN. The results of the study demonstrated a Lowest Observed Adverse Effect Level (LOAEL) of 30 milligram/cubic meter (mg/m3) for lung effects. The 90-day review period for the SNUN expired with the Agency not taking action on the significant new uses described in the SNUN. Since EPA continues to find that significant worker exposure is unlikely when used as described in the PMN and SNUN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance or applications that generate a vapor, mist, or aerosol could result in exposures which may cause serious health effects. Based on this information the substance meets the concern criteria at § 721(b)(3)(ii). Based on these findings, EPA is proposing to modify the SNUR to require notification for any uses other than described in the PMN and the SNUN.
Recommended Testing: EPA has determined that the results of a decomposition kinetics by thermo gravimeter (ASTM Test Guideline E1641), a compositional analysis by thermo gravimeter (ASTM Test Guideline E1131), and a laboratory burn test by a protocol to be agreed upon by EPA and the company conducting the study, would help to further characterize the environmental fate of the PMN substance.
CFR citation: 40 CFR 721.9502.
Chemical name: Benzenesulfonic acid, mono C-10-16 -alkyl derivs., compds. with 2-propen-1-amine (PMN P-97-296 and SNUN S-03-10) and Alkyl benzene sulfonic acids and alkyl sulfates, amine salts (PMN P-97-297/298/299 and SNUN S-03-11/12/13).
CAS number: 195008-77-6 (PMN P-97-296 and SNUN S-03-10) and
Claimed confidential (PMN P-97-297/298/299 and SNUN S-03-11/12/13).
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substances for the PMNs and the SNUNs is as a processing aid. The original SNUR was issued based on meeting the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii). The original SNUR required notification if the PMN substances were released to water. On March 4, 2003, EPA received SNUNs S-03-10, S-03-11, S-03-12, and S-03-13 for the chemical substances describing releases to water. The 90-day review period for the SNUNs expired with EPA not taking action on the significant new uses described in the SNUNs because the water releases did not exceed 30 ppb. Based on submitted data and structural analogy to anionic surfactants, EPA is still concerned that toxicity to aquatic organisms may occur at a concentration of 30 ppb in surface waters. Because EPA finds that the substances are not Start Printed Page 19043released to surface waters above 30 ppb as described in the PMN and SNUN, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances may cause significant adverse environmental effects. Based on this the substances meet the concern criteria at § 721.170 (b)(4)(i) and (b)(4)(ii). Based on these findings EPA is proposing to modify the SNUR to require notification if water releases exceed 30 ppb in surface waters.
Recommended testing: EPA has determined that a fish acute toxicity test (OPPTS Test Guideline 850.1075), an aquatic invertebrate acute toxicity text (OPPTS Test Guideline 850.1010) and an algal toxicity test (OCSPP Test Guideline 850.4500) would help further characterize the human health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9595.
Chemical name: Titanate [Ti6 O13 (2-)], dipotassium.
CAS number: 12056-51-8.
Federal Register publication date and reference: August 13, 1991 (56 FR 40204).
Basis for the modified significant new use rule: The generic use of the chemical substance is as a friction material. A consent order was issued under sections 5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based on a finding that the chemical substance may present an unreasonable risk of injury to human health. To protect against these risks, EPA issued a TSCA section 5(e) consent order which became effective on February 21, 1991. The order required the establishment of a hazard communication program; prohibited domestic manufacturing; prohibited non-industrial use; established maximum production volume limits for submission of required testing; prohibited manufacture other than by the manufacturing method in P-90-226; and required the bulk density measurements of the PMN substance in the pure form to be less than 0.4 gram/cubic centimeter (g/cm3). A SNUR was issued for this chemical substance on August 13, 1991. The SNUR designated as a “significant new use” the absence of the protective measures required in the consent order. On July 15, 1996, EPA received a SNUN, P-96-1408 (at that time SNUNs were designated with a “P” number; later submissions received an “S” designation); on June 23, 2008, EPA received S-08-6; on March 30, 2009, EPA received S-09-4; and on July 17, 2013, EPA received S-13-49 for the chemical substance. The significant new use for each SNUN was a manufacturing method other than described in P-90-226. EPA took no action during the 90-day review periods for the SNUNs and allowed the significant new uses because EPA determined that none of the manufacturing processes produced respirable acicular fibers with an average aspect ratio of less than 5, and as a result were not considered by EPA to pose an unreasonable risk of lung toxicity to workers. In addition, a 90-day inhalation study was submitted by the PMN submitter under the terms of the TSCA section 5(e) consent order and an intratracheal instillation study submitted by the submitter of S-09-4 demonstrated no evidence of fibrosis in test animals. The proposed SNUR modification designates as a significant new use any domestic manufacture, non-industrial use, any manufacturing process other than described in the PMN and the SNUNs, and any manufacture that produces respirable, acicular fibers with an average aspect ratio greater than 5. The proposed SNUR modification no longer designates establishment of a hazard communication program or exceeding an aggregate production volume limit as a significant new use.
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) and a carcinogenicity test (OPPTS Test Guideline 870.4200) via the inhalation route would help characterize the potential human health effects of the chemical substance from alternate methods of manufacture.
CFR citation: 40 CFR 721.9675.
Chemical name: 1,3-Dimethyl-2-imidazolidinone.
CAS number: 80-73-9.
Federal Register publication date and reference: August 30, 1995 (60 FR 45072) (FRL-4926-2).
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substance for the PMN is as a process raw material and for the SNUNs is as a printing ink ingredient. The consent order was issued under sections 5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based on a finding that the chemical substance may present an unreasonable risk of injury to human health. To protect against these risks, EPA issued a TSCA section 5(e) consent order which became effective on August 25, 1994. The order required the use of dermal personal protective equipment (including gloves demonstrated to be impervious) and required establishment of a hazard communication program; prohibited domestic manufacture; prohibited non-industrial uses; and established maximum production volume limits for submission of required testing. The SNUR issued for this chemical substance on August 30, 1995, designated as a significant new use the absence of the protective measures required in the consent order. On August 16, 2004, EPA received S-04-3 and on October 21, 2010, EPA received S-11-3 for the chemical substance. The significant new use for both SNUNs was a non-industrial use. The 90-day review period for both SNUNs expired with the Agency not taking action on the significant new uses described in the SNUNs. The PMN submitter conducted a dermal developmental toxicity study and a 90-day dermal subchronic study on the PMN substance. The results of the developmental study was a maternal chronic toxicity NOAEL of 10 mg/kg/day and a development toxicity NOAEL of 100 mg/kg/day. The results of the 90-day dermal study was a NOAEL of 500 mg/kg/day. Because EPA continues to find that dermal exposures may cause an unreasonable risk of human health effects, EPA is proposing to modify the SNUR to allow the commercial use (specific use claimed confidential) as described in the SNUNs but is retaining all other significant new uses and requirements in the SNUR.
CFR citation: 40 CFR 721.9892.
Chemical name: Manganese strontium oxide (MnSrO3).
CAS number: 12163-45-0.
Federal Register publication date and reference: March 29, 2007 (72 FR 14681) (FRL-7699-5).
Basis for the modified significant new use rule: The generic (non-confidential) use of the chemical substance is as a pigment. A consent order was issued under sections 5(e)(1)(A)(i) and 5(e)(l)(A)(ii)(I) of TSCA based on a finding that the chemical substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the order required establishment of a hazard communication program; established maximum aggregate volume limits for submission of required testing; limited release to surface waters; and prohibited manufacture, process, or use of the PMN substance if the particle size is less than Start Printed Page 1904410 microns. EPA received a 96-hour toxicity test with rainbow trout for the chemical substance. No mortality was observed at concentrations up to the highest concentration tested of 16,000 milligram/Liter (mg/L). Based on these test results, EPA modified the consent order to remove the aggregate volume limit and the surface water release limits. The modified consent order retains the hazard communication requirements and the particle size limitations to continue to prevent any unreasonable risk of injury to human health. The proposed SNUR modification designates as a significant new use the absence of the protective measures in the modified consent order.
Recommended testing: EPA has determined that a 90-day inhalation toxicity study with a 60-day holding period (OPPTS Test Guideline 870.3465) and a two-year inhalation carcinogenicity study (OPPTS Test Guideline 870.4200) would help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10008.
Chemical name: 1-Propene, 2,3,3,3-tetrafluoro-.
CAS number: 754-12-1.
Federal Register publication date and reference: October 27, 2010 (75 FR 65987) (FRL-8846-8) and November 1, 2013 (78 FR 65570) (FRL-9901-97).
Basis for modification of the SNUR: The use of the chemical substance for the PMN was as a refrigerant in motor vehicle air conditioning systems in new passenger cars and vehicles and the use for the SNUN was as a refrigerant for stationary refrigeration and stationary air conditioning. The original SNUR was issued based on meeting the concern criteria at § 721.170. The original SNUR required notification if the chemical substance was used for uses other than as described in the PMN. On May 12, 2014 EPA received a SNUN, S-14-11, for the chemical substance describing uses different than those in the PMN. The 90-day review period for the SNUN expired with EPA not taking action on the significant new uses described in the SNUN. Based on toxicity test data conducted on the PMN substance, EPA is still concerned that toxicity to humans may occur at inhalation exposures of 1,900 ppm. Because EPA finds that exposures from uses described in either the PMN or the SNUN do not result in human exposures that cause an unreasonable risk to human health, EPA has not determined that the proposed manufacturing, processing, and use of the substance, including certain commercial, and consumer uses of the substance, may cause significant adverse health effects. Based on this the substance meets the concern criteria at § 721.170. Based on these findings, EPA is proposing to modify the SNUR to allow the uses described in S-14-11.
CFR citation: 40 CFR 721.10182.
Chemical name: Poly[oxy(methyl-1,2- ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium salts (P-10-486) and Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium salts (P-10-487).
CAS number: 958238-81-8 (P-10-486) and 958238-82-9 (P-10-487).
Federal Register publication date and reference: April 4, 2012 (77 FR 20296) (FRL-9333-3).
Basis for the modified significant new use rule: The PMNs state that the use of these substances will be for downhole injection for enhanced oil recovery. Based on structure activity relationship analysis of test data on analogous anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 28 ppb for P10-486 and 4 ppb for P10-487 in surface waters. The order was issued under TSCA sections 5(e)(1)(A)(i), (e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II) based on a finding that these substances may present an unreasonable risk of injury to the environment and will be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities. To protect against these risks, the Agency issued a TSCA section 5(e) consent order which became effective on July 22, 2011. To protect against the risk, the order requires certain hazard communication requirements, specific disposal requirements for processing and use, and prohibits releases from manufacture of the PMN substances resulting in surface water concentrations exceeding 28 ppb for P-10-486 and 4 ppb for P-10-487. A SNUR was issued for this chemical substance on April 4, 2012. The SNUR designated as a “significant new use” the absence of any of these measures required in the consent order.
EPA had evaluated the results of a combined biodegradation and aquatic toxicity test for P-10-486 during PMN review. The test was submitted as part of the PMN submissions. During the review, EPA accepted the data as valid for purposes of ascertaining the environmental fate of the PMN substances (the overall rate of ready biodegradation), but not for purposes of determining potential environmental toxicity of the transformation products to aquatic organisms. Subsequent to issuance of the SNUR, and based on discussions with the Company and other PMN submitters, EPA re-evaluated the data and determined that the data could be used to evaluate the aquatic toxicity of the PMN transformation products. The combined biodegradation/ecological toxicity testing demonstrated that, subsequent to the biodegradation portion of the combined study, no further ecologically toxic substances remained from the P-10-486 parent substance. EPA also believes the results of the test data for P-10-486 apply to the structurally analogous P-10-487 substance. Based on this evaluation EPA did not find that the PMN substances present an unreasonable risk to the environment or human health or will be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities based on activities described in the PMN. As a result EPA revoked the consent order. EPA has determined, however, that other uses of the substances may cause significant adverse environmental effects. Based on this information, the chemical substances meets the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii). Based on these findings EPA is proposing to modify the SNUR to require notification of any use of the substances without disposal by incineration or injection into a Class I or II waste disposal well; release to water without prior biological treatment (activated sludge or equivalent) plus clarification; or non-industrial use.
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10283 and 721.10284.
Chemical names: Partially fluorinated alcohol substituted glycols (generic).
CAS numbers: Not available.
Federal Register publication date and reference: September 11, 2013 (78 FR 55632) (FRL-9398-7).
Basis for the modified significant new use rule: The PMNs state that the Start Printed Page 19045generic (non-confidential) uses of P-10-58 and P-10-59 will be as intermediates in the manufacture of P-10-60, and the generic use of P-10-60 and P-10-184 will be as a surface active agent or surfactant. EPA has concerns for potential incineration or other decomposition products of the PMN substances. These perfluorinated decomposition products may be released to the environment from incomplete incineration of the PMN substances at low temperatures. EPA has preliminary evidence, including data on some fluorinated polymers, which suggests that, under some conditions, the PMN substances could degrade in the environment. EPA has concerns that these degradation products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to people, mammals, and birds. These concerns are based on data on analogous chemical substances, including perfluorooctanoic acid (PFOA) and other perfluorinated alkyls, including the presumed environmental degradant. The orders were 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 these substances may present an unreasonable risk of injury to the environment and human health, the substances may be produced in substantial quantities and may reasonably be anticipated to enter the environment in substantial quantities, and there may be significant (or substantial) human exposure to the substances and their potential degradation products. To protect against these risks, the consent order for P-10-58/59/60 requires manufacture (which includes import) of the PMN substances according to the chemical synthesis and composition section of the TSCA section 5(e) consent order, including analysis, reporting, and limitations of maximum impurity levels of certain fluorinated impurities, restricts the use of P-10-58 and P-10-59 as intermediates to make P-10-60, and submission of testing on the PMN substance P-10-60 at five identified aggregate manufacture volumes. A SNUR was issued for these chemical substances on September 11, 2013 designating as significant new uses the absence of these measures. To protect against potential risks, the consent order for P-10-184 requires manufacture of the PMN substance according to the chemical synthesis and composition section of the TSCA section 5(e) consent order, including analysis, reporting, and limitations of maximum impurity levels of certain fluorinated impurities and manufacture of P-10-184 only when the mean number of moles of the ethoxy group is between 3 and 11 or the average number molecular weight is between 496 and 848 daltons based on the amounts of raw materials charged to the reactor. EPA is modifying the SNUR to add P-10-184 because it is the same chemical substance as P-10-60 and to make the SNUR requirements consistent with both consent orders by proposing to add a significant new use that requires reporting if P-10-60/P-10-184 are manufactured other than when the mean number of moles of the ethoxy group is between 3 and 11 or the average number molecular weight is between 496 and 848 daltons.
Recommended testing: EPA has determined that the results of certain fate and physical/chemical property testing identified in the TSCA section 5(e) consent orders would help characterize possible effects of the PMN substances and their degradation products. The TSCA section 5(e) consent order for P-10-58/59/60 contains five production volume limits. The PMN submitter has agreed not to exceed the confidential production volume limits without performing the specified testing on PMN substance P-10-60. Additional testing is included in the preambles to the TSCA section 5(e) consent orders but this testing is not required at any specified time or production volume. However, the TSCA section 5(e) consent order restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the TSCA section 5(e) consent orders are modified or revoked by EPA based on submission of that or other relevant information.
CFR citation: 40 CFR 721.10515.
Pursuant to § 721.185 and as described in Unit IV, this proposed rule includes 23 chemical substances where EPA determined, based on new information, there is no need to require additional notice from persons who propose to engage in identical or similar activities, or a rational basis no longer exists for the findings that activities involving the substance may present an unreasonable risk of injury to human health or the environment required under section 5(e)(1)(A) of the Act.
This proposed rule also includes a chemical substance, P-01-781, where EPA is modifying the chemical identity information.
To establish a significant “new” use, EPA must determine that the use is not ongoing. EPA solicits comments on whether any of the uses proposed as significant new uses are ongoing. As discussed in the Federal Register issue of April 24, 1990 (55 FR 17376), 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 the proposed SNUR rather than as of the effective date of the final rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became effective, and then argue that the use was ongoing as of the effective date of the final rule.
Thus, any persons who begin commercial manufacture or processing activities with the chemical substances that are not currently a significant new use under the current rule but which would be regulated as a “significant new use” if this proposed rule is finalized, must cease any such activity as of the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under § 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities.
EPA recognizes that TSCA section 5 does not require the development of any particular test data before submission of a SNUN. The two exceptions are:
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 Start Printed Page 19046to 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 this case, EPA recommends 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.” 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. ASTM International standards are available at http://www.astm.org/​Standard/​index.shtml.
The recommended testing specified in Unit IV. of the proposed rule may not be the only means of addressing the potential risks of the chemical substance. However, SNUNs submitted without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
According to 40 CFR 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 on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available electronically at http://www.epa.gov/​opptintr/​newchems.
EPA evaluated the potential costs of SNUN requirements for potential manufacturers and processors of the chemical substances in the proposed rule. The Agency's complete Economic Analysis is available in the docket under docket ID number EPA-HQ-OPPT-2014-0649.
This proposed action would modify SNURs for 24 chemical substances that were the subject of PMNs. 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).
According to PRA, 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.
2. The SNUN submitted by any small entity would not cost significantly more than $8,300.
This proposed rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this final rule. As such, EPA has determined that this rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, Start Printed Page 19047or 205 of the UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
This action would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor 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 proposed rule.
Dated: April 1, 2015.
2. Amend § 721.522 as follows:
a. Revise paragraph (a)(1).
b. Revise paragraph (a)(2)(i).
§ 721.522
Oxirane, methyl-, polymer with oxirane, mono (3,5,5,-trimethylhexyl) ether.
(a) * * * (1) The chemical substance identified as oxirane, methyl-, polymer with oxirane, mono (3,5,5,-trimethylhexyl) ether (PMN P-99-669, SNUN S-09-1, and SNUN S-13-29; CAS No. 204336-40-3) 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. A significant new use is use other than as a wetting agent, dispersing agent and defoaming/deaerating agent in waterborne coatings, inks, and paints, water based adhesives, and ultraviolet curable coatings; wetting agent in water miscible metalworking fluids, powdered construction additives for use in cementitious mortars, grouts and tile adhesives, and in liquid admixtures for concrete; and a substrate wetting and anticratering additive for ultraviolet curable inkjet ink.
3. Amend § 721.532 as follows:
b. Revise paragraph (a)(1).
c. Revise paragraph (a)(2)(i).
d. Add paragraph (a)(3).
e. Revise paragraph (b)(1).
§ 721.532
1-Butanol, 3-methoxy-3-methyl-, acetate.
(a) * * * (1) The chemical substance identified as 1-butanol, 3-methoxy-3-methyl-, acetate (PMN P-00-618; SNUN S-05-03; and SNUN S-11-4; CAS No. 103429-90-9) is subject to reporting under this section for the significant new uses described in paragraphs (a)(2) and (a)(3) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. The significant new use is any use other than the use described in P-00-618.
(3) The significant new uses for any use other than the use described in P-00-618:
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3)(i), (b) (concentration set at 0.1 percent), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. Butyl rubber gloves with a minimum thickness of 16.6 mils or Silver shield gloves with a minimum thickness of 2.7 mils have been tested in accordance with the American Society for Testing Materials (ASTM) F739 method and found by EPA to satisfy the consent orders and § 721.63(a)(2)(i) requirements for dermal protection to 100 percent chemical substance. Silver Shield gloves with a minimum thickness of 2.7 mils have been tested in accordance with the American Society for Testing Materials (ASTM) F739 method and found by EPA to satisfy the consent orders and § 721.63(a)(2)(i) requirements for dermal protection for paint formulations where concentrations of the chemical substance is 10% or less. Gloves and other dermal protection may not be used for a time period longer than they are actually tested and must be replaced at the end of each work shift.
(ii) Hazard communication program. Requirements as specified in § 721.72(a), (b) (concentration set at 0.1 percent), (c), (d), (f), (g)(1)(iv), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v), (g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (o), and any application method that generates a vapor, mist, or aerosol when the percent concentration of the SNUN substance in the final product exceeds 10%.
(1) Recordkeeping. Recordkeeping requirements as specified in Start Printed Page 19048§ 721.125(a) through (i) are applicable to manufacturers and processors of this substance.
4. Amend § 721.633 as follows:
c. Remove paragraph (a)(2)(iii).
d. Revise paragraph (b)(1).
§ 721.633
Aluminosilicates, phospho-.
(a) * * *. (1) The chemical substance identified as aluminosilicates, phospho- (PMN P-98-1275 and SNUN S-11-10; CAS No. 201167-69-3) 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), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(4) engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. The following NIOSH-certified respirators with an APF of at least 50 meet the requirements of § 721.63(a)(4): NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N100 (if oil aerosols absent), R100, or P100 filters; NIOSH-certified powered air-purifying respirator equipped with a tight-fitting full facepiece and high efficiency particulate air (HEPA) filters; NIOSH-certified supplied-air respirator operated in positive pressure demand or continuous flow mode and equipped with a hood, or helmet or tight-fitting facepiece. As an alternative to the respiratory requirements listed here, a manufacturer or processor may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) consent order for these substances. The NCEL is 0.1 mg/m3 as an 8-hour time weighted average verified by actual monitoring data.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), (f), (g), and (h) are applicable to manufacturers and processors of this substance.
5. Amend § 721.2076 as follows:
§ 721.2076
D-Glucuronic acid, polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt.
(a) * * *. (1) The chemical substance identified as D-Glucuronic acid, polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt (PMN P-00-7; SNUN S-05-1; SNUN S-06-4; SNUN S-07-03; and SNUN S-07-5; CAS No. 125005-87-0) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 The significant new use is any use other than manufacture of the substance where greater than 5 percent of the chemical substance consists of particle sizes below 10 microns.
6. Amend § 721.5185 as follows:
b. Revise paragraph (a)(2)(iii).
c. Add paragraph (a)(2)(iv).
§ 721.5185
2-Propen-1-one, 1-(4-morpholinyl)-.
(a) * * * (1) The chemical substance identified as 2-Propen-1-one, 1-(4-morpholinyl)- (PMN P-95-169; SNUN S-08-7; and SNUN S-14-1; CAS No. 5117-12-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the chemical substance after it has been completely reacted (cured) because 2-Propen-1-one, 1-(4-morpholinyl)- will no longer exist.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(1). It is a significant new use to use the chemical substance for any use other than as a monomer for use in ultraviolet ink jet applications unless the chemical substance is processed and used in an enclosed process.
(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N = 100).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) and (k) are applicable to manufacturers and processors of this chemical substance.
7. Amend § 721.5575 as follows:
§ 721.5575
Oxirane, 2,2′-(1,6-hexanediylbis (oxymethylene)) bis-.
(a) * * * (1) The chemical substance identified as oxirane, 2,2′-(1,6-hexanediylbis(oxymethylene))bis- (PMN P-88-2179; PMN P-89-539; and SNUN S-08-3; CAS No. 16096-31-4) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q). A significant new use of the chemical substance is any non-industrial use other than the commercial use described in S-08-3.
8. Amend § 721.5645 as follows:
§ 721.5645
Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.
(a) * * * (1) The chemical substance identified as pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro (PMN P-95-638, SNUN P-97-79, and SNUN S-06-8; CAS No. 138495-42-8) 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. A significant new use is any use of the substance other than the uses as described in P-95-638, P-97-79, or S-06-8.
9. Amend § 721.5713 as follows:
§ 721.5713
Phenol—biphenyl polymer condensate (generic).
(a) * * * (1) The chemical substance identified generically as a phenol—biphenyl polymer condensate (PMN P-00-1220 and S-07-2) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Release to water. Requirements as specified § 721.90(a)(4), (b)(4), and (c)(4) (N = 5).
10. Amend § 721.8145 as follows:
Start Printed Page 19049
§ 721.8145
Propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy-.
(a) * * * (1) The chemical substance identified as propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy- (PMN P-01-320; SNUN S-04-2; and SNUN 11-1; CAS No. 375-03-1) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80. A significant new use is any use of the chemical substance other than as a heating transfer fluid, refrigerant, flush cleaning, foam blowing, deposition coatings, histology baths, vapor degreasing, and industrial and commercial aerosol spray cleaning.
11. Amend § 721.9501 by revising paragraph (a)(1) to read as follows:
§ 721.9501
Silane, triethoxy[3-oxiranylmethoxy)propyl]-.
(a) * * * (1) The chemical substance identified as silane, triethoxy[3-oxiranylmethoxy)propyl]- (PMN P-01-781; CAS No. 2602-34-8) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
12. Amend § 721.9502 as follows:
§ 721.9502
Siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated salt (generic).
(a) * * * (1) The chemical substance identified generically as siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated salt (PMN P-00-1132 and SNUN S-11-5) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(1). A significant new use is any use of the chemical substance other than in graffiti systems, as surface treatment and additive for coatings, adhesives, sealants, paste, insulation and textiles for porous, non-porous, ceramic, metal, glass, plastic, wood and leather surfaces or a surface treatment agent for inorganic filler particles.
13. Amend § 721.9595 as follows:
§ 721.9595
Benzenesulfonic acid, monoC-10-16 -alkyl derivs., compounds with 2-propen-1-amine and Alkyl benzene sulfonic acids and alkyl sulfates, amine salts.
(a) * * * (1) The chemical substances identified as benzenesulfonic acid, mono C-10-16 -alkyl derivs., compds. with 2-propen-1-amine (PMN P-97-296 and SNUN S-03-10; CAS No. 195008-77-6) and the chemical substances identified generically as alkyl benzene sulfonic acids and alkyl sulfates, amine salts (PMNs P-97-297/298/299 and SNUNs S-03-11/12/13) 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) N = 30.
14. Amend § 721.9675 as follows:
b. Revise paragraphs (a)(2)(i) and (a)(2)(ii).
c. Revise paragraph (b)(1).
§ 721.9675
Titanate [Ti6 O13 (2-)], dipotassium.
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as titanate [Ti6 O13 (2-)], dipotassium (PMN P-90-0226; SNUNs P-96-1408, S-08-6, S-09-4, and S-13-49; CAS No. 12056-51-8)) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (f) and (l). In addition, a significant new use of the substance is importation of the chemical substance if:
(A) Manufactured by other than the method described in premanufacture notice P-90-226 and significant new use notices P-96-1408, S-08-6, S-09-4, and S-13-49.
(B) Manufactured producing respirable, acicular fibers with an average aspect ratio of greater than 5. The average aspect ratio is defined as the ratio of average length to average diameter.
(1) Recordkeeping. The following recordkeeping requirements are applicable to manufacturers and processors of this substance as specified in § 721.125(a), (b), (c) and (i).
15. Amend § 721.9892 as follows:
c. Revise paragraph (a)(2)(iii).
§ 721.9892
1,3-Dimethyl-2-imidazolidinone.
(a) * * * (1) The chemical substance identified as 1,3-Dimethyl-2-imidazolidinone (PMN P-93-1649, SNUN S-04-3 and S-11-3; CAS No. 80-73-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(q). A significant new use is non-industrial use other than the commercial uses described in the S-04-3 and S-11-3.
16. Amend § 721.10008 as follows:
a. Revise paragraph (a)(2)(ii).
b. Remove paragraph (a)(2)(iii).
b. Remove paragraph (b)(3).
§ 721.10008
Manganese strontium oxide (MnSrO3).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (manufacture, processing, or use of the PMN substance if the particle size is less than 10 microns).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (f), (g), (h), and (i) are applicable to manufacturers and processors of this substance.
17. Amend § 721.10182 as follows:
§ 721.10182
1-Propene, 2,3,3,3-tetrafluoro-.
(1) The chemical substance identified as 1-propene, 2,3,3,3-tetrafluoro- (PMN P-07-601 and SNUN S-14-11; CAS No. 754-12-1) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Industrial, commercial, and consumer activities. A significant new use is:
(A) Use other than as a refrigerant: In motor vehicle air conditioning systems in new passenger cars and vehicles (i.e., as defined in 40 CFR 82.32(c) and (d)), in stationary refrigeration, or in stationary air conditioning.Start Printed Page 19050
(B) Section 721.80(m) (commercial use other than: In passenger cars and vehicles in which the original charging of motor vehicle air conditioning systems with the PMN substance was done by the motor vehicle original equipment manufacturer (OEM), in stationary refrigeration, or in stationary air conditioning).
(C) Section 721.80(o) (use in consumer products other than products used to recharge the motor vehicle air conditioning systems in passenger cars and vehicles in which the original charging of motor vehicle air conditioning systems with the PMN substance was done by the motor vehicle OEM).
18. Amend § 721.10283 as follows:
a. Revise paragraph (a)(2)(i).
b. Revise paragraph (a)(2)(ii).
d. Remove paragraph (a)(2)(iv).
§ 721.10283
Poly[oxy(methyl-1,2- ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C12-13-branched and linear alkyl ethers, sodium salts.
(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(l).
(ii) Disposal. Requirements as specified in § 721.85. A significant new of the substances is any method of disposal of a waste stream containing the PMN substances other than by incineration or by injection into a Class I or II waste disposal well.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (i), and (j) are applicable to manufacturers, importers, and processors of this substance.
19. Amend § 721.10284 as follows:
§ 721.10284
Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-sulfo-.omega.-hydroxy-, C14-15-branched and linear alkyl ethers, sodium salts.
20. Amend § 721.10515 as follows:
§ 721.10515
Partially fluorinated alcohol substituted glycols (generic).
(1) The chemical substances identified generically as partially fluorinated alcohol substituted glycols (PMNs P-10-58, P-10-59, P-10-60, and P-10-184) 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) (manufacture of the PMN substances according to the chemical synthesis and composition sections of the TSCA section 5(e) consent order, including analysis, reporting, and limitations of maximum impurity levels of certain fluorinated impurities; manufacture and import of P-10-60/P-10-184 other than when the mean number of moles of the ethoxy group is between 3 and 11 or the average number molecular weight is between 496 and 848 daltons based on the amounts of raw materials charged to the reactor; manufacture and import of P-10-58 and P-10-59 only as intermediates for the manufacture of P-10-60), and (q).
[FR Doc. 2015-08090 Filed 4-8-15; 8:45 am]