Source: https://www.federalregister.gov/documents/2014/07/08/2014-15874/significant-new-use-rules-on-certain-chemical-substances
Timestamp: 2019-08-20 03:25:46
Document Index: 186482194

Matched Legal Cases: ['ART 721', '§\u200914', 'art 721', 'art 700', '§\u2009721', 'art 720', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009720', '§\u2009721', 'art 9', 'art 9', 'art 1320', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721', '§\u2009721']

A Rule by the Environmental Protection Agency on 07/08/2014
This rule is effective on September 8, 2014. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on July 22, 2014.
79 FR 38464
38464-38475 (12 pages)
EPA-HQ-OPPT-2014-0277
FRL-9911-05
2014-15874
Consent Order for P12-0125
Economic Analysis of Expedited New Use Rule for Thirteen...
SAT Report for P12-0100
Exposure Report for P12-0100
Engineering Report for P12-0100
SAT Report for P14-0143
SAT Report for P14-0060
SAT Report for P14-0016
SAT Report for P14-0015
SAT Report for P14-0013
PMN Numbers P-12-100 and P-12-150
PMN Number P-12-125
PMN Number P-13-369
PMN Number P-13-854
PMN Numbers P-14-12, P-14-13, P-14-15, and P-14-16
PMN Number P-14-60
PMN Number P-14-143
PART 721—AMENDED
https://www.federalregister.gov/d/2014-15874 https://www.federalregister.gov/d/2014-15874
EPA is promulgating significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances which were the subject of premanufacture notices (PMNs). Three of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture or process any of these 13 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Start Printed Page 38465
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 August 7, 2014 (see Unit VI. of the SUPPLEMENTARY INFORMATION). 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 August 7, 2014, EPA will withdraw the relevant sections of this direct final rule before its effective date.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2014-0277, by one of the following methods:
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. Start Printed Page 38466Once 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 § 14;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 SNUN 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 sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 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 sections 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 13 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.
Basis for the TSCA section 5(e) consent order or, the basis for non-TSCA section 5(e) SNURs, (i.e., SNURs without TSCA section 5(e) consent orders).
This rule includes two PMN substances, P-10-5 and P-11-339, whose reported chemical names include the term “carbon nanotube” or “CNT”. Because of a lack of established nomenclature for carbon nanotubes, the TSCA Inventory names for carbon nanotubes are currently in generic form, e.g., carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube (SWCNT). EPA uses the specific structural characteristics provided by the PMN submitter to more specifically characterize the Inventory listing for an individual CNT. All submitters of new chemical notices for CNTs in this SNUR have claimed those specific structural characteristics as CBI. EPA is publishing the generic chemical name along with the PMN number to identify that a distinct chemical substance was the subject of the PMN without revealing the confidential chemical identity of the PMN substance. Confidentiality claims preclude a more detailed description of the identity of these CNTs. If an intended manufacturer or processor of CNTs is unsure of whether its CNTs are subject to this SNUR or any other SNUR, the company can either contact EPA or obtain a written determination from EPA pursuant to the bona fide procedures at § 721.11. EPA is using the specific structural characteristics, for all CNTs submitted as new chemical substances under TSCA, to help develop standard nomenclature for placing these chemical substances on the TSCA Inventory. EPA has compiled a generic list of those structural characteristics entitled “Material Characterization of Carbon Nanotubes for Molecular Identity (MI) Determination & Nomenclature.” A copy of this list is available in the docket for these SNURs under docket ID number EPA-HQ-OPPT-2014-0277. If EPA develops a more specific generic chemical name for these materials, that name will be made publicly available.
The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.
This rule includes 3 PMN substances (P-10-5, P-11-339 and P-12-125) that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “TSCA section 5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The TSCA section 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.
This rule also includes SNURs on 10 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in changes in exposures, thereby constituting a “significant new use.” These so-called “non-TSCA section 5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-TSCA section 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, Start Printed Page 38467deletions, 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.
Effective date of TSCA section 5(e) consent order: November 30, 2010.
Basis for TSCA section 5(e) consent order: The PMN states that the uses of the substance will be as a component for a conductive coating using the PMN substance in a dispersion or ink, and as an additive in resins/thermoplastics/elastomers for mechanical reinforcement. Based on structure-activity relationship (SAR) analysis of test data on analogous respirable, poorly soluble particulates and other carbon nanotubes (CNTs), EPA identified concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity. Further, available data suggests that pulmonary deposition of some nanoparticles, including CNT may induce cardiovascular toxicity if inhaled. Based on the uncertainty of the characterization and exposure of nanoscale materials in general, there may be additional potential for translocation across the dermis and effects on target organs via the oral route of exposure. Finally, EPA expects that some fraction of the CNTs, if released into the environment, will eventually be suspended in water. Based on findings of sublethal effects observed for CNTs in rainbow trout at levels as low as 100 parts per billion (ppb) and that toxicity of CNTs may be further altered by the presence of natural organic matter that may be associated with nanomaterials when released into the natural environment, EPA identified concerns for toxicity to aquatic organisms. The Order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the Order requires:
1. Use of personal protective equipment including gloves and protective clothing impervious to the substance when there is potential dermal exposure and use of a National Institute of Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N-100 cartridges when there is potential inhalation exposure.
2. Use of the substance only as a component for a conductive coating using the PMN substance in a dispersion or ink or as an additive in resins/thermoplastics/elastomers for mechanical reinforcement.
3. Manufacture of the substance at a volume not to exceed a confidential volume specified in the consent order unless the company has submitted the results of certain health studies and physical/chemical properties data.
4. No surface water releases of the PMN substance, except for limited water releases resulting in no more than 1 ppb waste water effluent concentration determined by monitoring. The Company shall analyze the concentration of the PMN substance in waste water discharged to the city sewer from the facility every year and adhere to the monitoring procedure referenced in the consent order.
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study in rats (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-operation and Development (OECD) Test Guideline 413) with a post-exposure observation period of up to 3 months, including bronchoalveolar lavage fluid (BALF) analysis, a determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart; and certain physical/chemical properties, would help characterize possible effects of the substance. The PMN submitter has agreed not to exceed the confidential production volume stated in the consent order without performing the inhalation toxicity study. In addition, in the consent order, the PMN submitter agreed to provide physical/chemical properties data within a specified time limit.
CFR citation: 40 CFR 721.10755.
Effective date of TSCA section 5(e) consent order: August 25, 2011.
Basis for TSCA section 5(e) consent order: The PMN states that the use of the substance will be as an additive in resins, thermoplastics, and elastomers for mechanical reinforcement and enhanced electrical performance, as a coating on metallic foils for battery applications, or in the manufacture of fabric composites. Based on SAR analysis of test data on analogous respirable, poorly soluble particulates and other CNTs, EPA identified concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity. Further, available data suggests that pulmonary deposition of some nanoparticles, including CNT may induce cardiovascular toxicity if inhaled. Finally, EPA expects that some fraction of the CNTs, if released into the environment, will eventually be suspended in water. Based on findings of sublethal effects observed for CNTs in rainbow trout at levels as low as 100 ppb and that toxicity of CNTs may be further altered by the presence of natural organic matter that may be associated with nanomaterials when released into the natural environment, EPA identified concerns for toxicity to aquatic organisms. The Order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the Order requires:
1. Use of personal protective equipment including gloves and protective clothing impervious to the substance when there is potential dermal exposure and a NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-100, R-100, or P-100 cartridges when there is potential for inhalation exposure.
2. Use of the substance only as an additive in resins, thermoplastics, and elastomers for mechanical reinforcement and enhanced electrical performance, as a coating on metallic foils for battery applications, or in the manufacture of fabric composites.
Recommended testing: EPA has determined that the results of a 90-day inhalation toxicity study in rats (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) with a post exposure observation period of up to 3 months, including BALF analysis, a Start Printed Page 38468determination of cardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart; and certain physical/chemical properties, would help characterize possible effects of the substance. The PMN submitter has agreed not to exceed the confidential production volume stated in the consent order without performing the inhalation toxicity study. In the consent order, the PMN submitter agreed to provide physical/chemical properties data within a specified time limit.
CFR citation: 40 CFR 721.10756.
Chemical names: Fatty acids, diesters with dihydroxy bicyclic diether (generic).
Basis for action: The PMNs state that the uses of the substances will be as a polymer modifier and a seal swell additive for industrial applications. Based on test data on the PMN substances, as well as SAR analysis of test data on analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substances in surface waters for greater than 20 days per year. This 20-day criterion is derived from partial life cycle tests (daphnid chronic and fish early life stage tests) that typically range from 21 to 28 days in duration. EPA predicts toxicity to aquatic organisms may occur if releases of the substances to surface water, from uses other than as described in the PMNs, exceed releases from the uses described in the PMNs. For the uses described in the PMNs, environmental releases did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances other than as polymer modifiers and seal swell additives for industrial applications may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would help characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10757.
Chemical name: Thermolized wasted plastic (generic).
Effective date of TSCA section 5(e) consent order: October 2, 2013.
Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a petroleum feedstock. Based on SAR analysis of test data on analogous styrenes and benzenes, EPA identified concerns for solvent irritation and solvent neurotoxicity; hydrocarbon pneumonia; liver, kidney, blood, developmental and reproductive toxicities; immunotoxicity, mutagenicity, and oncogenicity. Further, polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) impurities in the PMN substance are known to be highly persistent, bioaccumulative, and toxic (PBT) chemicals that cause developmental toxicity, inhalation effects, carcinogenicity and are highly toxic to aquatic life. The Order was issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that the substance may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the consent order requires:
2. Manufacture of the PMN substance: (a) According to the chemical composition section of the consent order, including analyzing and reporting PCDD and PCDF levels in the PMN substance to EPA; (b) without exceeding the maximum established limit of 110 picogram/gram (pg/g) of PCDD/PCDF toxic equivalents (using the World Health Organization 2005 Toxic Equivalency Factors as detailed in the consent order); and (c) while monitoring the pH of the aqueous effluent stream from the manufacturing process as outlined in the consent order.
Recommended testing: EPA has determined, at this time, that there is no testing that would help further characterize the environmental/human health effects of the PMN substance. In the consent order, the PMN submitter agreed to analyze for PCDD and PCDF impurities every quarter during manufacture of the PMN substance, using EPA Test Method 8290A.
CFR citation: 40 CFR 721.10758.
Chemical name: Polyphosphoric acids, esters with substituted amines, compounds with alkyl pyridines (generic).
Basis for action: The PMN states that the use of the substance is as a solids conglomeration additive for down-hole treatment of oil and gas wells to prevent the undesirable production of solids. Based on test data on the PMN substance, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 8 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 8 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 8 ppb or use other than as described in the PMN, or if disposed of during manufacturing by means other than incineration may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of a mysid chronic toxicity test (OCSPP Test Guideline 850.1350); an algal toxicity test (OCSPP Test Guideline 850.4500); and a modified algal toxicity test (OCSPP Test Guideline 850.4500) where the PMN substance is substituted for the phosphate nutrient in the algal growth medium would help characterize the environmental effects of the PMN substance:
CFR citation: 40 CFR 721.10759.
Chemical name: Zinc carboxylate salt (generic).
Basis for action: The PMN states that the use of the substance is as a petroleum production chemical. Based on SAR analysis of test data on analogous organozinc compounds, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb of the PMN substance in surface waters. As described in the PMN, releases of the substance are not expected to result in surface water concentrations that exceed 3 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has Start Printed Page 38469determined, however, that any use of the substance resulting in surface water concentrations exceeding 3 ppb may result in significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
CFR citation: 40 CFR 721.10760.
Chemical names: Fatty acid amide (generic).
Basis for action: The PMNs state that the substances will be used as emulsifiers for use in asphalt applications. Based on SAR analysis of test data on analogous aliphatic amines, EPA predicts chronic toxicity to aquatic organisms may occur at concentrations that exceed the following values of the PMN substances in surface waters.
PMN No.
P-14-12 110 ppb.
P-14-13 240 ppb.
P-14-15 53 ppb.
P-14-16 110 ppb.
For the use described in the PMNs, releases of the substances are not expected to result in surface water concentrations exceeding these values. 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 substances other than as emulsifiers for use in asphalt applications may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance. The Agency recommends that testing be conducted on P-14-15 as EPA predicts this substance to be the most acutely toxic to aquatic organisms of these four PMN substances.
CFR citation: 40 CFR 721.10761.
Chemical name: 1,1'-methylenebis[isocyanatobenzene], polymer with polycarboxylic acids in alkane polyols (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a coating component. Based on SAR analysis of test data on analogous diisocyanates, EPA identified concerns for dermal and respiratory sensitization to persons exposed to the PMN substance. As described in the PMN, worker exposure will be minimal due to the use of adequate personal protective equipment, and EPA does not expect significant consumer exposure as the substance is not used in a consumer product. 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 a NIOSH-certified respirator with an assigned protection factor (APF) of at least 10, where there is potential inhalation exposure; or any use of the substance in consumer products may cause serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(3)(ii).
CFR citation: 40 CFR 721.10762.
Chemical name: Alkanaminium, [substituted carbomonocycle [(alkylamino)carbomonocycle]alkylene]-substituted carbomonocycle, carboxylate salt (generic).
Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as an ingredient used in pigment synthesis. Based on SAR analysis of test data on analogous delocalized cationic dyes, 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, environmental releases are not expected to result in surface water concentrations that exceed 1 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations exceeding 1 ppb may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity mitigated by humic acid test (OPPTS Test Guideline 850.1085); an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10763.
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 3 of the 13 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit VI.).
In the other 10 cases, where the uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.
EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:Start Printed Page 38470
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 September 8, 2014 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before August 7, 2014.
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 August 7, 2014, 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.
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 person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted, EPA concludes that the designated significant new uses are not ongoing.
When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) consent orders have been issued for 3 of the 13 chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which would be designated as significant new uses. The identities of all 13 of the chemical substances subject to this rule have been claimed as confidential and EPA has received no post-PMN bona fide submissions (per §§ 720.25 and 721.11). Based on this, 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.
Therefore, EPA designates July 8, 2014 as the cutoff date for determining whether the new use is ongoing. Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until the notice review period, including any extensions, expires. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the Federal Register document of April 24, 1990 for a more detailed discussion of the cutoff date for ongoing uses.
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 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-TSCA section 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.” 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.
In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Under recent TSCA section 5(e) consent orders, each PMN submitter is required to submit each study before reaching the specified production limit. Listings of the tests specified in the TSCA section 5(e) consent orders are included in Unit IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.Start Printed Page 38471
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers 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-2014-0277.
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 SNUR submitted by any small entity would not cost significantly more than $8,300.Start Printed Page 38472
721.10755 2070-0012
721.10756 2070-0012
721.10757 2070-0012
721.10758 2070-0012
721.10759 2070-0012
721.10760 2070-0012
721.10761 2070-0012
721.10762 2070-0012
721.10763 2070-0012
4. Add § 721.10755 to subpart E to read as follows:
§ 721.10755
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as single-walled carbon nanotubes (PMN P-10-5) 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 PMN substance after it has been completely reacted (cured); embedded or incorporated into a Start Printed Page 38473polymer matrix that has been reacted (cured); or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(ii) (clothing that covers other exposed areas of the arms, legs, and torso), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N100 cartridges), (a)(6)(i), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (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.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as a component for a conductive coating using the PMN substance in a dispersion or ink, and additive in resins/thermoplastics/elastomers for mechanical reinforcement.) and (q).
(iii) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1), except for water releases determined by monitoring the concentration of the PMN substance in waste water effluent according to a monitoring procedure approved for such purpose by EPA and when the concentration of the PMN substance does not exceed 1 part per billion (ppb). EPA will review and act on written requests to approve monitoring procedures within 90 days after such requests are received. EPA will inform submitters of the disposition of such requests in writing, and will explain the reasons therefore when they are denied.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to manufacturers and processors of this substance.
(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to paragraphs (a)(2)(ii) and (a)(2)(iii) of this section.
5. Add § 721.10756 to subpart E to read as follows:
§ 721.10756
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as multi-walled carbon nanotubes (PMN P-11-339) 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 PMN substance after it has been completely reacted (cured); embedded or incorporated into a polymer matrix that has been reacted (cured); or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i), (a)(2)(ii) (clothing that covers other exposed areas of the arms, legs, and torso), (a)(3), (a)(4) (National Institute for Occupational Safety and Health (NIOSH)-certified air-purifying, tight-fitting full-face respirator equipped with N100, P100, or R100 cartridges), (a)(6)(i), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (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.
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as an additive in resins, thermoplastics, and elastomers for mechanical reinforcement and enhanced electrical performance, as a coating on metallic foils for battery applications, or in the manufacture of fabric composites.) and (q).
6. Add § 721.10757 to subpart E to read as follows:
§ 721.10757
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acids, diesters with dihydroxy bicyclic diether (PMNs P-12-100 and P-12-150) 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. A significant new use is any use other than as a polymer modifier or a seal swell additive for industrial applications.
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers and processors of these substances.
7. Add § 721.10758 to subpart E to read as follows:
§ 721.10758
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as thermolized wasted plastic (PMN P-12-125) 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 PMN substance after Start Printed Page 38474it has been completely fractionated, distilled, or chemically reacted resulting in the manufacture of one or more new chemical substances subject to PMN review or other chemical substances listed on the TSCA Inventory.
(i) Hazard communication program. Requirements as specified in § 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), (f), (g)(1)(i) to (g)(1)(ix), (g)(2)(i) to (g)(2)(v), (g)(3)(i), (g)(3)(ii), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k) (a significant new use is any use other than as allowed by the TSCA section 5(e) consent order which includes analysis and reporting and limitations of maximum levels of polychlorinated dibenzo-p-dioxin and polychlorinated dibenzofuran impurities and monitoring the pH of the aqueous effluent stream from the manufacturing process as outlined in the Consent Order.)
8. Add § 721.10759 to subpart E to read as follows:
§ 721.10759
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyphosphoric acids, esters with substituted amines, compounds with alkyl pyridines (PMN P-13-369) 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 PMN substance other than as a solids conglomeration additive for down-hole treatment of oil and gas wells to prevent the undesirable production of solids.
(ii) Disposal. Requirements as specified in § 721.85(a)(1).
(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4) (N=8) (for marine discharges, a dilution factor of 65 should be applied).
(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), (i), (j), and (k) are applicable to manufacturers and processors of this substance.
9. Add § 721.10760 to subpart E to read as follows:
§ 721.10760
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as zinc carboxylate salt (PMN P-13-854) 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=3).
10. Add § 721.10761 to subpart E to read as follows:
§ 721.10761
(a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as fatty acid amide (PMNs P-14-12, P-14-13, P-14-15, P-14-16) 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. A significant new use is any use of the PMN substance other than as an emulsifier for use in asphalt applications.
11. Add § 721.10762 to subpart E to read as follows:
§ 721.10762
1,1′-methylenebis[isocyanatobenzene], polymer with polycarboxylic acids in alkane polyols (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 1,1′-methylenebis[isocyanatobenzene], polymer with polycarboxylic acids in alkane polyols (PMN P-14-60) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(i) Protection in the workplace. Requirements as specified in § 721.63(a)(4), (a)(6)(i) through (a)(6)(iv), 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 National Institute for Occupational Safety and Health (NIOSH)-certified respirators with an assigned protection factor (APF) of at least 10 meet the requirements of § 721.63(a)(4):
(B) NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet; and
(b) Specific requirements. The provisions of subpart A of this part Start Printed Page 38475apply to this section except as modified by this paragraph.
12. Add § 721.10763 to subpart E to read as follows:
§ 721.10763
Alkanaminium, [substituted carbomonocycle [(alkylamino)carbomonocycle]alkylene]-substituted carbomonocycle, carboxylate salt (generic).
(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanaminium, [substituted carbomonocycle [(alkylamino)carbomonocycle]alkylene]-substituted carbomonocycle, carboxylate salt (PMN P-14-143) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
[FR Doc. 2014-15874 Filed 7-7-14; 8:45 am]